(a) Identification. An endoscopic transhepatic venous access needle is inserted through the liver into the patient's portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient-contacting components of the device must be demonstrated to be biocompatible.

(2) Performance data must demonstrate the sterility of the patient-contacting components of the device.

(3) The patient-contacting components of the device must be demonstrated to be non-pyrogenic.

(4) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.

(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be tested:

(i) Needle crumple testing;

(ii) Tensile testing;

(iii) Dimensional verification for all components; and

(iv) Simulated use testing.

(6) Labeling must include the following:

(i) Instructions for use, including specific instructions regarding device preparation;

(ii) The recommended training for safe use of the device; and

(iii) A shelf life for any sterile components.

(a) Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

(b) Classification. (1) Class II (performance standards).

(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

(a) Identification. A gastroenterology-urology accessory to a biopsy instrument is an accessory used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

(a) Identification. An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.

(b) Classification. Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”

(a) Identification. A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing with the device under anticipated conditions of use must evaluate visualization of the intended region and document the adverse event profile.

(2) Non-clinical testing data must demonstrate the optical, mechanical, and functional integrity of the device under physically stressed conditions. The following performance characteristics must be tested, and detailed protocols must be provided for each test:

(i) A bite test must be performed to ensure that the capsule can withstand extreme cases of biting;

(ii) A pH resistance test must be performed to evaluate integrity of the capsule when exposed to a physiological relevant range of pH values;

(iii) A battery life test must be performed to demonstrate that the capsule's operating time is not constrained by the battery capacity;

(iv) A shelf life test must be performed to demonstrate that the device performs as intended at the proposed shelf life date;

(v) Optical testing must be performed to evaluate fundamental image quality characteristics such as resolution, field of view, depth of field, geometric distortion, signal to noise ratio, dynamic range, and image intensity uniformity;

(vi) A color performance test must be performed to compare the color differences between the input scene and output image;

(vii) A photobiological safety analysis must be performed based on maximum (worst-case) light exposure to internal gastrointestinal mucosa, and covering ultraviolet, visible, and near-infrared ranges, as appropriate. A mitigation analysis must be provided;

(viii) Performance testing must demonstrate that the viewing software clearly presents the current frame rate, which is either adjustable manually by the user or automatically by the device. Testing must demonstrate that the viewing software alerts the user when the video quality is reduced from nominal due to imaging data communication or computation problems;

(ix) A data transmission test must be performed to verify the robustness of the data transmission between the capsule and the receiver. This test must include controlled signal attenuation for simulating a non-ideal environment; and

(x) Magnetic field strength testing characterization must be performed to identify the distances from the magnet that are safe for patients and users with ferromagnetic implants, devices, or objects.

(3) Software validation, verification, and hazard analysis must be provided.

(4) Electrical safety, thermal safety, mechanical safety, and electromagnetic compatibility testing must be performed.

(5) The patient-contacting components of the device must be demonstrated to be biocompatible.

(6) Performance data must validate the reprocessing instructions for the reusable components of the device.

(7) Performance data must demonstrate the sterility of any device components labeled sterile.

(8) Human factors testing must demonstrate that the intended users can safely and correctly use the device, based solely on reading the instructions for use.

(9) Clinician labeling must include:

(i) Specific instructions and the clinical and technical expertise needed for the safe use of the device;

(ii) A detailed summary of the clinical testing pertinent to use of the device, including information on effectiveness and device- and procedure-related complications;

(iii) The patient preparation procedure;

(iv) A detailed summary of the device technical parameters;

(v) Magnetic field safe zones;

(vi) A screening checklist to ensure that all patients and operating staff are screened from bringing ferromagnetic implants, devices, or objects near the external magnet;

(vii) Reprocessing instructions for reusable components;

(viii) Shelf life for single use components; and

(ix) Use life for reusable components.

(10) Patient labeling must include:

(i) An explanation of the device and the mechanism of operation;

(ii) The patient preparation procedure;

(iii) A brief summary of the clinical study; and

(iv) A summary of the device- and procedure-related complications pertinent to use of the device.

(a) Identification. A prescription, single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the colon for the detection of polyps. It is intended for use only in patients who had an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The capsule must be demonstrated to be biocompatible.

(2) Non-clinical testing data must demonstrate the mechanical and functional integrity of the device under physically stressed conditions. The following performance characteristics must be tested and detailed protocols must be provided for each test:

(i) Bite test to ensure that the capsule can withstand extreme cases of biting.

(ii) pH resistance test to evaluate integrity of the capsule when exposed to a range of pH values.

(iii) Battery life test to demonstrate that the capsule's operating time is not constrained by the battery capacity.

(iv) Shelf-life testing to demonstrate that the device performs as intended at the proposed shelf-life date.

(v) Optical testing to evaluate fundamental image quality characteristics such as resolution, field of view, depth of field, distortion, signal-to-noise ratio, uniformity, and image artifacts. A test must be performed to evaluate the potential of scratches, caused by travelling through the gastrointestinal tract, on the transparent window of the capsule and their impact on the optical and color performance.

(vi) An optical safety analysis must be performed based on maximum (worst-case) light exposure to internal gastrointestinal mucosa, and covering ultraviolet, visible, and near-infrared ranges, as appropriate. A mitigation analysis must be provided.

(vii) A color performance test must be provided to compare the color differences between the input scene and output image.

(viii) The video viewer must clearly present the temporal or spatial relationship between any two frames as a real-time lapse or a travel distance. The video viewer must alert the user when the specific video interval is captured at a frame rate lower than the nominal one due to communication errors.

(ix) A performance test evaluating the latency caused by any adaptive algorithm such as adjustable frame rate must be provided.

(x) If the capsule includes a localization module, a localization performance test must be performed to verify the accuracy and precision of locating the capsule position within the colon.

(xi) A data transmission test must be performed to verify the robustness of the data transmission between the capsule and the recorder. Controlled signal attenuation should be included for simulating a non-ideal environment.

(xii) Software validation, verification, and hazards analysis must be provided.

(xiii) Electrical equipment safety, including thermal and mechanical safety and electromagnetic compatibility (EMC) testing must be performed. If the environments of intended use include locations outside of hospitals and clinics, appropriate higher immunity test levels must be used. Labeling must include appropriate EMC information.

(xiv) Information demonstrating immunity from wireless hazards.

(3) The clinical performance characteristics of the device for the detection of colon polyps must be established. Demonstration of the performance characteristics must include assessment of positive percent agreement and negative percent agreement compared to a clinically acceptable alternative structural imaging method.

(4) Clinician labeling must include:

(i) Specific instructions and the clinical and technical expertise needed for the safe use of the device.

(ii) A detailed summary of the clinical testing pertinent to use of the device, including the percentage of patients in which a polyp was correctly identified by capsule endoscopy, but also the percent of patients in which the capsule either missed or falsely identified a polyp with respect to the clinically acceptable alternative structural imaging method.

(iii) The colon cleansing procedure.

(iv) A detailed summary of the device technical parameters.

(v) A detailed summary of the device- and procedure-related complications pertinent to use of the device.

(vi) An expiration date/shelf life.

(5) Patient labeling must include:

(i) An explanation of the device and the mechanism of operation.

(ii) Patient preparation procedure.

(iii) A brief summary of the clinical study. The summary should not only include the percentage of patients in which a polyp was correctly identified by capsule endoscopy, but also the percent of patients in which the capsule either missed or falsely identified a polyp with respect to the clinically acceptable alternative structural imaging method.

(iv) A summary of the device- and procedure-related complications pertinent to use of the device.

(a) Identification. A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

(a) Identification. An esophageal tissue characterization system is a device intended for obtaining measurements of electrical properties within esophageal tissue.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) All patient contacting components of the device must be demonstrated to be biocompatible.

(2) Performance testing must demonstrate the device can accurately measure the designated electrical characteristics.

(3) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.

(4) Software verification, validation, and hazard analysis must be performed.

(5) Electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety of the device must be performed.

(6) Performance data must validate the reprocessing instructions for any reusable components of the device.

(7) Labeling must include:

(i) Specific instructions regarding the proper placement and use of the device;

(ii) Instructions for reprocessing of any reusable components; and

(iii) An expiration date for single use components.

(a) Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

(b) Classification—(1) Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

(a) Identification. A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including detection of gastrointestinal lesions and evaluation of all adverse events.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include:

(i) Standalone algorithm performance testing;

(ii) Pixel-level comparison of degradation of image quality due to the device;

(iii) Assessment of video delay due to marker annotation; and

(iv) Assessment of real-time endoscopic video delay due to the device.

(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.

(4) Performance data must demonstrate electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety testing for any hardware components of the device.

(5) Software verification, validation, and hazard analysis must be provided. Software description must include a detailed, technical description including the impact of any software and hardware on the device's functions, the associated capabilities and limitations of each part, the associated inputs and outputs, mapping of the software architecture, and a description of the video signal pipeline.

(6) Labeling must include:

(i) Instructions for use, including a detailed description of the device and compatibility information;

(ii) Warnings to avoid overreliance on the device, that the device is not intended to be used for diagnosis or characterization of lesions, and that the device does not replace clinical decision making;

(iii) A summary of the clinical performance testing conducted with the device, including detailed definitions of the study endpoints and statistical confidence intervals; and

(iv) A summary of the standalone performance testing and associated statistical analysis.

(a) Identification. A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

(a) Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.

(b) Classification. Class II (performance standards).

(a) Identification. An electrogastrography system (EGG) is a device used to measure gastric myoelectrical activity as an aid in the diagnosis of gastric motility disorders. The device system includes the external recorder, amplifier, skin electrodes, strip chart, cables, analytical software, and other accessories.

(b) Classification. Class II (Special Controls). The special controls are as follows:

(1) The sale, distribution and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.

(2) The labeling must include specific instructions:

(i) To describe proper patient set-up prior to the start of the test, including the proper placement of electrodes;

(ii) To describe how background data should be gathered and used to eliminate artifact in the data signal;

(iii) To describe the test protocol (including the measurement of baseline data) that may be followed to obtain the EGG signal; and

(iv) To explain how data results may be interpreted.

(3) The device design should ensure that the EGG signal is distinguishable from background noise that may interfere with the true gastric myoelectric signal.

(4) Data should be collected to demonstrate that the device has adequate precision and the EGG signal is reproducible and is interpretable.

(a) Identification. A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter.

(b) Classification. (1) Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.