CLA-2-90:OT:RR:NC:N3:135
Ms. Jonni P. Amidon
Seko Logistics
1100 Arlington Heights Road, Suite 600
Itasca, IL 60143
RE: The tariff classification of two parts of medical equipment from China
Dear Ms. Amidon:
In your letter dated February 10, 2020, you requested a tariff classification ruling on behalf of GCM Medical OEM, Inc. Additional information was provided via various email messages. A sample of one part received from the previous correspondence will be returned.
The products at issue are two machined aluminum custom parts of medical equipment. The first part (Item# 321731-02 – “Cap, Cable Termination, Plunger Monitor and IF1000”) is a small, flat rectangular-shaped plate with two holes and chamfered edges. The back of the plate also contains two recessed areas. This item is made from an aluminum plate undergoing saw cutting, CNC (computer numerical control) machining, deburring, process inspection, plating, final inspection, and packaging. It is a part of a System Cart, one of the components of an Ion Endoluminal System (Model IF 1000), and used to secure an electrical lead to a monitor in the System Cart. The Ion Endoluminal System is a robotic-assisted endoluminal platform (software-controlled, electro-mechanical system) designed to assist qualified physicians to navigate “a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures.” It consists of a Planning Laptop with PlanPoint™ Software, a System Cart with System Software, a Controller, instruments (e.g. Articulating Catheter and Biopsy Needles), and accessories. The System Cart contains an instrument arm (electronics for the slave portion of the servomechanism), two monitors, a monitor arm, and other components and allows the user to navigate the Catheter instrument with the Controller through the airway.
The second part (Item #317491-04, now 317491-05-MI_B – “Shell, Handlebar Upper, PSC, ISF4000”) is a handlebar shell (also called handlebar) resembling a hanger without the hook on top, described to be a 4-axis precision machined clamshell housing for internal sensors. It measures approximately 20 5/8 inches in length and 6 3/16 inches at its widest points and has the "da Vinci® Xi™ Surgical System" brand name on the center portion of the face panel and multiple holes in the back panel. This item is made from an aluminum plate undergoing CNC machining, deburring, process inspection, plating, hardware installing, final inspection, and packaging. This handlebar shell will be used to enclose sensors and electronics to form part of a Patient Cart Helm, one component of a Patient Cart. The Patient Cart (also called Patient Side Cart), a Surgeon Console, and a Vision Cart constitute the da Vinci Xi™ Surgical System (da Vinci Xi System), also known as an Endoscopic Instrument Control System Model IS4000. The da Vinci Xi System is a robotic technology (software-controlled, electromechanical system) that allows surgeons to perform minimally invasive procedures. It is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments (e.g. rigid endoscopes, scissors, scalpels, and electrocautery) and accessories during surgical procedures, such as urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, etc. The Patient Cart consists of a boom, a column, a helm, four arms, and a base. It is the operative component of the surgical system and its primary function is to support the Intuitive Surgical Endoscopic Instruments during surgical procedures. The handlebar and “cart drive enable switches” in the Patient Cart Helm are used to maneuver the Patient Cart around the operation room.
In your letter you believe that both items are classified in subheading 9018.90.6000, Harmonized Tariff Schedule of the United States (HTSUS), the provision for "[e]lectro-surgical instruments and appliances, other than extracorporeal shock wave lithotripters; all the foregoing and parts and accessories thereof.” While we concur with the classification of the second item, we disagree with the classification of the first item. According to FDA 510 (K) Premarket Notification Number K173760, the Ion Endoluminal System and the predicate Schoelly Video Bronchoscope “are similar in terms of technological characteristics and have fundamentally the same indications for use.” In Headquarters Ruling 953652 (April 13, 1994), Customs and Border Protection ruled that the video endoscope systems (such as bronchoscopes) with the exception of the laparoscope were classified under subheading 9018.19.40, HTSUS, as electro-diagnostic apparatus used for functional exploratory examination. Accordingly, the Ion Endoluminal System and the System Cart are classified under subheading 9018.19.40, HTSUS. The first item is a custom part of the System Cart and will be classified as such based on Note 2(b) to Chapter 90 since it is not excluded by Note 2(a) or (c) to Chapter 90 or by HTSUS Additional U.S. Rule of Interpretation 1 (c).
The applicable subheading for the first part (Item# 321731-02), will be 9018.19.4000, HTSUS, which provides for “[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences …; parts and accessories thereof: [e]lectro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters); parts and accessories thereof: [o]ther: [a]pparatus for functional exploratory examination, and parts and accessories thereof.” The general rate of duty will be free.
The applicable subheading for the second part (Item #317491-04, now 317491-05-MI_B) will be 9018.90.6000, HTSUS, which provides for “[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences …; parts and accessories thereof: … [e]lectro-medical instruments and appliances and parts and accessories thereof: [e]lectro-surgical instruments and appliances, other than extracorporeal shock wave lithotripters; all the foregoing and parts and accessories thereof.” The general rate of duty will be free.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 9018.19.4000 and 9018.90.6000, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.01, in addition to subheadings 9018.19.4000 and 9018.90.6000, HTSUS, listed above. In this case, the second part (Item #317491-04, now 317491-05-MI_B) will be eligible for an exclusion from the Section 301 tariffs granted by the U.S. Trade Representative and provided for in subheading 9903.88.11 and U.S. note 20(n) to subchapter III of chapter 99.
The HTSUS is subject to periodic amendment so you should exercise reasonable care in monitoring the status of goods covered by the Note cited above and the applicable Chapter 99 subheading. For background information regarding the trade remedy initiated pursuant to Section 301 of the Trade Act of 1974, you may refer to the relevant parts of the USTR and CBP websites, which are available at https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and https://www.cbp.gov/trade/remedies/301-certain-products-china, respectively.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at https://hts.usitc.gov/current.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Fei Chen at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division