N335974

N335974 November 8, 2023 OT:RR:NC:N3:135 CATEGORY: Origin Ryan Supek Measurement Specialties Inc. 1000 Lucas Way Hampton, VA 23666 RE: The country of origin of ForeSight tissue oximetry sensors Dear Mr. Supek: In your letter dated October 18, 2023, you requested a country of origin ruling on two ForeSight tissue oximetry sensors for the purpose of the Section 301 trade remedy duties. Additional information was provided by email dated October 20 and October 27, 2023. The products identified in your letters are ForeSight Large Sensor (PN 20020033-00) and ForeSight Medium Sensor (PN 20020032-00). Both sensors, as imported, consist of a flexible printed circuit board, two photodiodes, an LED emitter, a 1024 bit 1-wire EEPROM chip, a molded plastic top guide and bottom guide, a foam top cover, a bottom foam laminate, a foam gasket, adhesives, a release liner, various tapes, and labels. The Large Sensor also contains a plastic stiffener. Both are developed specifically to use with the Hemosphere medical monitoring platform, which delivers advanced pressure, flow, and tissue oximetry insights from a single, comprehensive monitor. The sensor and the Hemosphere monitor are collectively known as the ForeSight Tissue Oximetry system. The sensor will be applied directly to the patient’s skin. It will generate light and convert the reflected light signal into a current signal, then transfer the current signal through the circuit in the flexible printed circuit board assembly of the sensor to the monitoring system via a separate cable (not part of this ruling request). The system will process the current signal and calculate the StO2 percentage value in human patients. The emitter consists of 5 LED chips with different wavelengths. It will emit lights alternatively to the human tissue. The first photodiode, a deep detector, will receive the reflected lights with deeper penetration and transfer the light received to an electrical signal. The second photodiode, a shallow detector, is smaller and functions similarly, receiving reflected lights with shallow penetration and transferring them to an electrical signal. The electrical signal is transmitted as a current by the sensor into the monitoring system through the circuit in the printed circuit board assembly. The monitor provides proactive and continuous hemodynamic monitoring of critically ill and surgical patients. You propose two scenarios of the manufacturing process for each sensor. Scenario 1 – Large Sensor – the PCBA will be completed in Mexico The emitter, two photodiodes, and the flexible printed circuit board are made in China. The EEPROM chip is made in Thailand or the Philippines. These components will be sent to Mexico where they will be assembled to create a printed circuit board assembly (PCBA) using a surface mount technology (SMT) manufacturing process. A Chinese plastic stiffener will be added to the PCBA in Mexico. The PCBA will be sent back to China for final assembly and testing. In China, the foam top cover, bottom foam laminate, and additional components will be manually assembled onto the PCBA. Then, the plastic connector guides will be ultrasonically welded onto the assembly to make a sensor. The sensor will undergo the programming and testing phase prior to packaging. The goal of this phase will be to evaluate, calibrate, and program the ForeSight sensor after it is fully built to be suitable for clinical use. The sensor will be run through a test station that was originally developed and programmed in the US. The test station will perform three functions: Component verification: corroborate that all the components in the sensor are functional and behave within a specified range. Component calibration: quantify variations from nominal values for those parameters that are critical to the system. Sensor Programming: proper identification of each sensor will be programmed on their EEPROM component as well as the calibration values and an overall test status. The programming of the EEPROM will also be used for authentication purposes when used in the end system. After that, the sensor will be packaged for shipping. Scenario 2 – Large Sensor – the PCBA will be completed in Malaysia All the steps in this scenario will be the same as Scenario 1, except that the PCBA is made in Malaysia using the SMT manufacturing process. Scenario 3 – Medium Sensor – the PCBA will be assembled in Mexico In this scenario, the flexible printed circuit board will be sourced from China. The emitter will be sourced from Japan and the EEPROM Chip will be made in Thailand or the Philippines (depends on the batch). These components will be assembled in Mexico using the SMT manufacturing process to create an incomplete PCBA. The PCBA will be sent to China where two China-origin photodiodes will be attached to the unfinished PCBA from Mexico with conductive epoxy. They will undergo a wire bonding and potting/curing process. After that, the PCBA is completely assembled and fully-functional. Then, the foam top cover, bottom foam laminate, and additional components will be manually assembled onto the PCBA assembly. The plastic connector guides will be ultrasonically welded onto the assembly to make a sensor. The sensor will undergo the same programming and testing phase as described in Scenario 1 prior to packaging. After that, the sensor will be packaged for shipping. Scenario 4 – Medium Sensor – the PCBA will be assembled in Malaysia All the steps in this scenario will be the same as Scenario 3, except that the incomplete PCBA is made in Malaysia using the SMT manufacturing process. The "country of origin" is defined in 19 CFR 134.1(b) as "the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the 'country of origin' within the meaning of this part." When determining the country of origin for purposes of applying Section 301 measures, the substantial transformation analysis applies. See, e.g., Headquarters Ruling (“HQ”) H301619, dated November 6, 2018. A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. United States v. Gibson-Thomsen Co., Inc., 27 CCPA 267, C.A.D. 98 (1940); National Hand Tool Corp. v. United States, 16 CIT 308 (1992), aff’d, 989 F. 2d 1201 (Fed. Cir. 1993). However, if the manufacturing or combining process is merely a minor one that leaves the identity of the article intact, a substantial transformation has not occurred. Uniroyal, Inc. v. United States, 3 CIT 220, 542 F. Supp. 1026, 1029 (1982), aff’d, 702 F.2d 1022 (Fed. Cir. 1983). Substantial transformation determinations are based on the totality of the evidence. See Headquarters Ruling (HQ) W968434, date January 17, 2007, citing Ferrostaal Metals Corp. v. United States, 11 CIT 470, 478, 664 F. Supp. 535, 541 (1987). The issue of whether a substantial transformation occurs is determined on a case-by-case basis. See HQ 561353, dated September 19, 2002. The U.S. Court of International Trade has indicated that “[f]or courts to find a change in character, there often needs to be a substantial alteration in the characteristics of the article or components.” See Energizer Battery, Inc. v. United States, 190 F. Supp. 3d 1308, 1318 (2016) (citing Ran-Paige Co., Inc. v. United States, 35 Fed. Cl. 117, 121 (1996) and Nat’l Hand Tool Corp. v. United States, 16 Ct. Int’l Trade 308, 311 (1992)). Courts have also considered “the ‘essence’ of a completed article to determine whether an imported article has undergone a change in character as a result of post importation processing.” Id. (citing Uniden America Corp. v. United States, 120 F. Supp. 2d 1091, 1095-1098 (Ct. Int’l Trade 2000) and Uniroyal, Inc., 542 F. Supp. 1030). In Uniroyal, Inc., 542

applies. See, e.g., Headquarters Ruling (“HQ”) H301619, dated November 6, 2018.A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing.  United States v. Gibson-Thomsen Co., Inc., 27 CCPA 267, C.A.D. 98 (1940); National Hand Tool Corp. v. United States, 16 CIT 308 (1992), aff’d, 989 F. 2d 1201 (Fed. Cir. 1993). However, if the manufacturing or combining process is merely a minor one that leaves the identity of the article intact, a substantial transformation has not occurred. Uniroyal, Inc. v. United States, 3 CIT 220, 542 F. Supp. 1026, 1029 (1982), aff’d, 702 F.2d 1022 (Fed. Cir. 1983). Substantial transformation determinations are based on the totality of the evidence. See Headquarters Ruling (HQ) W968434, date January 17, 2007, citing Ferrostaal Metals Corp. v. United States, 11 CIT 470, 478, 664 F. Supp. 535, 541 (1987). The issue of whether a substantial transformation occurs is determined on a case-by-case basis. See HQ 561353, dated September 19, 2002.The U.S. Court of International Trade has indicated that “[f]or courts to find a change in character, there often needs to be a substantial alteration in the characteristics of the article or components.”  See Energizer Battery, Inc. v. United States, 190 F. Supp. 3d 1308, 1318 (2016) (citing Ran-Paige Co., Inc. v. United States, 35 Fed. Cl. 117, 121 (1996) and Nat’l Hand Tool Corp. v. United States, 16 Ct. Int’l Trade 308, 311 (1992)).  Courts have also considered “the ‘essence’ of a completed article to determine whether an imported article has undergone a change in character as a result of post importation processing.”  Id. (citing Uniden America Corp. v. United States, 120 F. Supp. 2d 1091, 1095-1098 (Ct. Int’l Trade 2000) and Uniroyal, Inc., 542 F. Supp. 1030).  In Uniroyal, Inc., 542 F. Supp. at 1029-1030, the court determined that the shoe upper was “the very essence of the completed shoe