HQ 959752 - PRD 0401-96-100324; FemoStop, Femoral Compression System; Hemostasis, Apparatus for Stopping Flow or Circulation of Blood in the Femoral Artery; Medical Apparatus Used t o Control Bleeding After Surgery; Hemostatic Kit, Pump, Compression Arch, Mesh Fabric Belt, Plastic Connective Tubing; Sphygmomanometer, Medical Apparatus for Measuring Blood Pressure, Principal Use, Class or Kind, Additional U.S. Rule of Interpretation 1(a); Hartz Mountain Corp. v. United States; Chapter 90, Note 2 - United States International Trade Commision Rulings

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HQ 959752

MAY 23, 1997

CLA-2 RR:TC:MM 959752 JAS

CATEGORY: CLASSIFICATION

TARIFF NO.: 9018.90.50

Port Director of Customs
10 Causeway Street
Boston, MA 02222-1059

RE: PRD 0401-96-100324; FemoStop, Femoral Compression System; Hemostasis, Apparatus for Stopping Flow or Circulation of Blood in the Femoral Artery; Medical Apparatus Used t o Control Bleeding After Surgery; Hemostatic Kit, Pump, Compression Arch, Mesh Fabric Belt, Plastic Connective Tubing; Sphygmomanometer, Medical Apparatus for Measuring Blood Pressure, Principal Use, Class or Kind, Additional U.S. Rule of Interpretation 1(a); Hartz Mountain Corp. v. United States; Chapter 90, Note 2

Dear Port Director:

This is our decision on Protest 0401-96-100324, filed against your classification under the Harmonized Tariff Schedule of the United States (HTSUS), of a femoral compression system or FemoStop. The entries under protest were liquidated on May 3 and 10 and on June 21, 1996, and this protest timely filed on July 2, 1996. Counsel for the protestant made an additional submission on May 13, 1997, the contents of which were presented orally at a meeting in our office on May 15, 1997.

FACTS:

The FemoStop consists of four (4) components designed to achieve the controlled stoppage, under pressure, of blood flow at a surgical incision: a pump, consisting of a single hand-held manometer and rubber inflatable bulb, compression arch, a metal and plastic device incorporating an inflatable disc or dome, plastic tubing with a special ferrule at one end and a cut-off valve at the other end, and mesh fabric belt cut to the same width as the ends of the arch. In operation, the dome of the compression arch is placed over the puncture site and secured by the belt. The plastic tubing connects the pump to the arch and the pump is used to inflate the dome from 20-30 mmHg (millimeters - 2 -
of mercury) gradually to 60-80 mmHg until the bleeding subsides. After holding compression for routine duration, pressure is reduced gradually in increments of 10-20 mmHg every 2-3 minutes until the bleeding stops. The compression arch, plastic tubing and fabric belt are packaged together and are disposable after one use, while the pump is separately packaged and is used repeatedly. Shipments of the FemoStop pump will always include the disposable components. However, because more of the disposable components are required, some shipments will include only these components.

The merchandise was entered under a provision in heading 9018 for syringes, needles, catheters, cannulae and the like, and parts and accessories thereof. Your office determined that the articles comprising the FemoStop are marketed and used to stem the flow of blood from the femoral artery, a process called hemostasis. You liquidated the entries under a provision of heading 9018 as other medical and surgical instruments and appliances and parts and accessories thereof. Counsel for the protestant now maintains that notwithstanding its use in a femoral compression system, the pump component of the FemoStop belongs to the class or kind of instruments and appliances principally used in the United States to measure blood pressure. As such, it is classifiable as a sphygmomanometer, in subheading 9018.90.50, HTSUS, and the other three components are similarly classified as parts and accessories thereof.

The provisions under consideration are as follows:

9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus...; parts and accessories thereof:

9018.90 Other instruments and appliances and parts and accessories thereof:

9018.90.50 Sphygmomanometers, tensimeters and oscillometers; all the foregoing and parts and accessories thereof

9018.90.80 Other

ISSUE:

Whether the pump component of the FemoStop is of that class or kind of medical instruments or appliances principally used to measure blood pressure.

LAW AND ANALYSIS:

Merchandise is classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) in accordance with the General Rules of Interpretation (GRIs). GRI 1 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, and provided the headings or notes do not require otherwise, according to GRIs 2 through 6. Chapter 90, Note 2(b), HTSUS, states in part that parts and accessories are to be classified with the machines, instruments or apparatus with which they are solely or principally used.

Protestant maintains that the FemoStop pump is in fact a sphygmomanometer, an instrument for measuring blood pressure, and that the plastic tubing, mesh elastic belt and compression arch are parts and accessories thereof. The claim is that notwithstanding that the pump is used in the United States as a component of the FemoStop system, it is of the same quality and physical construction, and functions with the same certified precision as a hand aneroid sphyygmomanometer. Protestant concludes that the FemoStop pump is within the class or kind of instruments or apparatus principally used to measure blood pressure and, therefore, is classifiable in subheading 9018.90.50, HTSUS.

At the international level, the provisions of heading 9018 are governed by use. Moreover, we agree that in accordance with Additional U.S. Rule 1(a), HTSUS, applied at the subheading 9018.90.50 level, it is the principal use of the class or kind of merchandise to which the FemoStop pump belongs that controls. Though that subheading designates three particular medical appliances eo nomine, by name, the criteria of use must be applied to determined whether the FemoStop pump is encompassed by any of the named appliances. In order to determine whether an article falls within a particular class or kind, the Court of International Trade has sanctioned use of factors such as: (1) the use, if any, in the same manner as merchandise which defines the class; (2) the expectations of the purchasers of the merchandise; (3) the channels of trade in which the merchandise moves; (4) the environment of the sale of the merchandise, i.e., - 4 -
the accompanying accessories and the manner in which the merchandise is advertised and displayed; and (5) the physical appearance of the merchandise, when pertinent. Hartz Mountain Corp. v. United States, Slip Op. 95-154 (Ct. Int'l Trade, decided September 1, 1995). The FemoStop pump in issue here is the Speidel & Keller (S&K) Primus 50. In this case, while a purchaser of the FemoStop System would expect to use its components, to include the pump, to effect hemostasis, the Primus 50 is depicted in different parts of the same S&K catalog among recognized medical instruments designated as sphygmomanometers. More significantly, the manometer portion of both products consists of a metal-encased mechanism with dial running 0-300 mmHg, marked in identical 2mm increments, and labeled at 20 mm intervals. Both products are certified as to calibration ñ 3 mm accuracy over the full range, and both products have metal stems for connection to plastic or rubber tubing, a screw-type air release valve, metal spoon, and a black rubber bulb. In summary, though the Primus 50 is used in the FemoStop System as a pump to inflate and hold pressure in the compression arch, its physical characteristics make it virtually indistinguishable from medical appliances known as sphygmomanometers. Therefore, the available evidence warrants the conclusion that the FemoStop pump and sphygmomanometers belong to the same class or kind of medical instruments and appliances, the principal use of which is to measure blood pressure.

HOLDING:

Under the authority of GRI 1, the pump component of the FemoStop System, designated the Primus 50, is provided for in heading 9018. It is classifiable in subheading 9018.90.50, HTSUS. From their design and use, the compression arch, plastic tubing and mesh fabric belt qualify as parts and accessories principally used with the pump. Noting Chapter 90, Note 2(b), these articles are similarly classifiable.

The protest should be ALLOWED. In accordance with Section 3A(11)(b) of Customs Directive 099 3550-065, dated August 4, 1993, Subject: Revised Protest Directive, you should mail this decision, together with the Customs Form 19, to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to mailing the decision. Sixty days from the date of the decision the Office of Regulations and Rulings will take steps to make the decision - 5 -
available to Customs personnel via the Customs Rulings Module in ACS and to the public via the Diskette Subscription Service, the Freedom of Information Act and other public access channels.

Sincerely,

John Durant, Director
Tariff Classification
Appeals Division

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