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