CLA-2 CO:R:C:M 951871 KCC
District Director
U.S. Customs Service
Thomas P. O'Neill, Jr. Federal Building
10 Causeway Street
Room 603
Boston, Massachusetts
RE: Protest No. 0401-91-100779; "Pulsolith" Laser Lithotripter;
GRI 1; EN 90.18(IV)(6); 085366; Dorland's Illustrated
Medical Dictionary; surgical; surgery; endoscope; 554799
Dear Sir:
This is in response to the Application for Further Review of
Protest No. 0401-91-100779, dated November 27, 1991, which
pertains to the tariff classification of "Pulsolith" Laser
Lithotripter under the Harmonized Tariff Schedule of the United
States. A treatment video tape which describes how the product
is used and two clinical case studies were submitted for
examination.
FACTS:
The article under consideration is the "Pulsolith" Laser
Lithotripter ("laser"). Upon importation, the entries of the
laser were liquidated under subheading 9018.90.60, HTSUS, which
provides for "Instruments and appliances used in medical,
surgical, dental or veterinary sciences, including scintigraphic
apparatus, other electro-medical apparatus and sight-testing
instruments; parts and accessories thereof...Other instruments
and appliances and parts and accessories thereof...Other...
Electro-medical instruments and appliances and parts and
accessories thereof...Electro-surgical instruments and
appliances, other than extracorporeal shock wave lithotripters;
all the foregoing and parts and accessories thereof."
The protestant, Technomed International, contends that the
laser is properly classified under subheading 9018.90.70, HTSUS,
which provides for "...Electro-medical instruments and appliances
and parts and accessories thereof...Other." The protestant
contends that the laser was designed and is used as an
alternative to surgery. The laser is a pulsed dye laser used to
fragment ureteral, gallstone and common bile duct stones using a
photo acoustic effect. The laser beam is transmitted to the
stone through a flexible glass fiber with the use of a rigid or
flexible endoscope.
ISSUE:
Is the laser lithotripter classified under subheading
9018.90.60, HTSUS, as electro-surgical instruments and
appliances, or under subheading 9018.90.70, HTSUS, as other
electro-medical instruments and appliances?
LAW AND ANALYSIS:
The classification of merchandise under the HTSUS is
governed by the General Rules of Interpretation (GRI's). GRI 1,
HTSUS, states in part that "for legal purposes, classification
shall be determined according to the terms of the headings and
any relative section or chapter notes...." The laser is properly
classified under subheading 9018.90, HTSUS, which provides for
"Instruments and appliances used in medical, surgical, dental or
veterinary sciences, including scintigraphic apparatus, other
electro-medical apparatus and sight-testing instruments; parts
and accessories thereof...Other instruments and appliances and
parts and accessories thereof...Other...Electro-medical
instruments and appliances and parts and accessories thereof...."
This issue is whether or not the laser is considered an
electro-surgical instrument or appliance. Explanatory Note (EN)
90.18(IV)(6) of the Harmonized Commodity Description and Coding
System (HCDCS) lists electro-surgical apparatus as a type of
electro-medical apparatus. Electro-surgical apparatus "utilize
high-frequency electric currents, the needle, probe, etc.,
forming one of the electrodes. They can be employed to cut
tissue (electrocutting) with a lancet (electric lancet), or to
coagulate the blood (electrocoagulation). Certain combined
instruments may, by the use of the control pedals, be made to act
interchangeably as electrocutters or electrocoagulators." HCDCS,
Vol. 4, p. 1492. The Explanatory Notes, although not
dispositive, are to be looked to for the proper interpretation of
the HTSUS. 54 Fed. Reg. 35127, 35128 (Aug. 23, 1989). EN 90.18
(IV)(6) identifies only two types of electro-surgical apparatus
and should not be considered exclusive.
Customs has previously ruled that the provision for
electrocutting and electrocoagulation is not dispositive of
Congressional intent regarding the scope of electro-surgical
apparatus. Headquarters Ruling Letter (HRL) 085366 dated
December 4, 1989, classified a tube string subassembly of an
irrigation, suction, and illumination system of a disposable
surgical instrument under subheading 9018.90.60, HTSUS, as parts
and accessories of electro-surgical apparatus. Clearly, the
irrigation, suction and illumination system did not involve
electrocutting or electrocoagulation but was used while
performing a surgical procedure.
If an instrument is electrical and it is used principally in
a surgical procedure, it is classifiable as an electro-surgical
instrument unless it is more specifically provided for elsewhere
in the tariff. The term "surgical" is not defined in the HTSUS
or the Explanatory Notes. Tariff terms are construed in
accordance with their common and commercial meaning. Nippon
Kogasku (USA), Inc. v. United States, 69 CCPA 89, 673 F.2d 380
(1982). Common and commercial meaning may be determined by
consulting dictionaries, lexicons, scientific authorities and
other reliable sources. C.J. Tower & Sons v. United States, 69
CCPA 128, 673 F.2d 1268 (1982). Dorland's Illustrated Medical
Dictionary, p. 1501, defines "surgical" as:
of, pertaining to, or correctable by surgery.
"Surgery" is defined as:
1) that branch of medicine which treats diseases,
injuries, and deformities by manual or operative
methods.
2) the place in a hospital or doctor's or dentist office
where surgery is performed.
Id., p. 1504. There is nothing in the above definitions to
suggest that a procedure cannot be considered surgical if access
to a body cavity is gained through a body opening, such as the
mouth, penis, vagina, or rectum, nor is there any indication that
surgery entails the cutting of tissue. Endoscopic procedures,
such as the laser at issue, are recognized surgical procedures
which do not involve the cutting of tissue. See, the New York
State Nurses Association Benefits Fund "Summary Plan Description"
containing information on health insurance benefits provided to
members through Empire Blue Cross Blue Shield, New York. The
surgical nature of the fragmentation of the stones with the laser
is apparent. As ascertained from the submitted video tape the
procedure is performed in an operating room by a surgeon on a
patient who is under some form of anesthesia. The procedure
involves the use of energy to bring about physical changes within
the abdominal cavity of the patient. Moreover, it is noted that
the laser is also used in biliary procedures in which the
endoscope must be inserted percutaneously.
The protestant contends classification under subheading
9018.90.60, HTSUS, is inconsistent with HRL 554799 dated January
21, 1988 (C.S.D. 88-5), which held that the Dornier lithotripter
was classified in item 709.17, Tariff Schedules of the United
States (TSUS) (the precursor provision to subheading 9018.90.70,
HTSUS). The lithotripter in HRL 554799 was an electrical medical
apparatus designed to disintegrate kidney stones without surgical
intervention. It utilized shock waves transmitted through a
patient's tissues to the kidney stone, which disintegrates the
kidney stone. HRL 554799 noted that a urologist need not be
present to operate the lithotripter and that the lithotripter
procedure did not involve any intrusive operation, such as
cutting of tissue, which is often associated with a surgical
procedure. We note that under subheading 9018.90.60, HTSUS,
extracorporeal shock wave lithotripters, like the lithotripter in
HRL 554799, are excluded from classification under that tariff
provision. Therefore, an analysis of whether the lithotripter in
HRL 554799 is surgical or not would not be necessary under the
HTSUS.
The protestant states that the laser at issue is a second
generation device developed from the lithotripter in HRL 554799.
The protestant contends that both the lithotripter's and laser's
feature of operating without the cutting of tissue are similar,
whereas the only difference is that the lithotripter operates
outside of the body, while the laser operates from within the
body using a natural body opening as an entrance. This
distinction is where the difference in classification lies. The
actual entry of the body whether via a natural opening or a man-
made incision involves an invasive procedure which is normally
performed by a surgeon. Based on this difference and the above
discussion, we find that the HRL 554799 is not persuasive.
Therefore, as the laser is found to be a surgical instrument and
it is not an extracorporeal shock wave lithotripter, it is
properly classified under subheading 9018.90.60, HTSUS.
HOLDING:
The "Pulsolith" Laser Lithotripter is properly classified
under subheading 9018.90.60, HTSUS, which provides for
"Instruments and appliances used in medical, surgical, dental or
veterinary sciences, including scintigraphic apparatus, other
electro-medical apparatus and sight-testing instruments; parts
and accessories thereof...Other instruments and appliances and
parts and accessories thereof...Other...Electro-medical
instruments and appliances and parts and accessories thereof...
Electro-surgical instruments and appliances, other than
extracorporeal shock wave lithotripters; all the foregoing and
parts and accessories thereof."
This protest should be denied in full. A copy of this
decision should be attached to the Customs Form 19 and provided
to the protestant as part of the notice of action on the protest.
Sincerely,
John Durant, Director