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HQ 951871


August 18, 1992

CLA-2 CO:R:C:M 951871 KCC

CATEGORY: CLASSIFICATION

TARIFF NO.: 9018.90.60

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

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