NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 24, 2018 Abbott Vascular Emily Zhao Principal Regulatory Project Manager 3200 Lakeside Drive Santa Clara, California 95054 ## Re: K180040 Trade/Device Name: NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREKTM OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREKTM II OTW Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: August 5. 2018 Received: August 7, 2018 Dear Ms. Emily Zhao: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Gregory O'Connell 2018.08.24 11:56:50 -04'00' For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K180040 Device Name NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW and MNI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; and MINI TREK™ II OTW Coronary Dilatation Catheter ### Indications for Use (Describe) The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction; c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only). The NC TREK OTW Coronary Dilatation Catheter is indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only) The TREK RX Coronary Dilatation Catheters are indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation. The TREK OTW and MINI TREK OTW Coronary Dilatation Catheter is indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion: b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm -5.00 mm only). The MINI TREK RX Coronary Dilatation Catheters are indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm only); d) Balloon dilatation of de novo chronic total coronary occlusions (CTO). {3}------------------------------------------------ ## The MINI TREK II OTW Coronary Dilatation Catheter is indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction (MI); c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm only); - d) Balloon dilatation of de novo chronic total coronary occlusions (CTO). Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the words "ABBOTT VASCULAR" in a sans-serif font. The words are in all caps and are a light blue color. The words are arranged on one line and are centered in the image. Image /page/4/Picture/1 description: The image contains the logo for Abbott Laboratories. The logo features a stylized, sans-serif letter "a" in blue. Below the symbol is the word "Abbott" in a bold, serif typeface. 3200 Lakeside Drive Santa Clara, CA 95054 T: 408 845 3000 F: 408 845 3743 # K180040 – 510(k) SUMMARY The 510(k) Summary is submitted in accordance with 21 CFR 807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990. | 1. SUBMITTER'S NAME | Abbott Vascular | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. SUBMITTER'S ADDRESS | 3200 Lakeside Drive, Santa Clara, CA 95054 | | 3. TELEPHONE | (408) 845-3000 | | 4. FAX | (408) 845-3743 | | 5. CONTACT PERSON | Emily Zhao | | 6. DATE PREPARED | August 7, 2018 | | 7. DEVICE TRADE NAME | NC TREK™ RX Coronary Dilatation Catheter<br>NC TREK™ OTW Coronary Dilatation Catheter<br>TREK™ RX Coronary Dilatation Catheter<br>TREK™ OTW Coronary Dilatation Catheter<br>MINI TREK™ RX Coronary Dilatation Catheter<br>MINI TREK™ OTW Coronary Dilatation<br>Catheter<br>MINI TREK™ II OTW Coronary Dilatation<br>Catheter | | 8. DEVICE COMMON NAME | • Coronary Dilatation Catheter | - Percutaneous Transluminal Coronary . Angioplasty (PTCA) Catheter - 9. DEVICE CLASSIFICATION NAME PTCA Catheter, LOX, Class II # 10. PREDICATE DEVICE NAME | NC TREK™ RX Coronary Dilatation Catheter | K103153, K110134 | |--------------------------------------------|----------------------------| | NC TREK™ OTW Coronary Dilatation Catheter | K113464 | | TREK™ RX Coronary Dilatation Catheter | K103110, K110671, K123279 | | TREK™ OTW Coronary Dilatation Catheter | K103110, K110671, K121222, | | TREK™ OTW Coronary Dilatation Catheter | K123279 | | MINI TREK™ RX Coronary Dilatation Catheter | K103110, K110671, K123279 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Abbott Laboratories. The logo consists of a stylized, rounded letter "a" in blue, positioned above the company name "Abbott" in black, bold font. The logo is simple and modern, reflecting the company's focus on health and innovation. ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 T: 408 845 3000 F: 408 845 3743 | MINI TREK ^TM OTW Coronary Dilatation Catheter | K103110, K110671, K121222,<br>K123279 | |-------------------------------------------------------------|---------------------------------------| | MINI TREK ^TM II OTW Coronary Dilatation Catheter | K121222 | ### 11. DEVICE DESCRIPTION There are no design, materials, including colorants, manufacturing processes, or indications changes to the TREK family (TREK RX, MINI TREK RX, TREK OTW, MINI TREK OTW, MINI TREK II OTW, NC TREK RX, and NC TREK OTW) Coronary Dilatation Catheters. The intended use of the devices remains the same, as the changes are only to labeling and IFUs. #### NC TREK RX Device Description 11.1 The NC TREK RX Coronary Dilatation Catheter (CDC) is a medical device that is intended for use in percutaneous transluminal coronary angioplasty (PTCA) to treat patients with coronary artery disease as specified in the indications section of the instructions for use. The catheter is a rapid exchange co-axial design with a balloon at the distal tip. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at specified pressures. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is provided on the proximal end of the catheter to provide access to the inflation lumen. It is designed with a Luer - lock fitting for connection with an inflation device. #### NC TREK OTW Device Description 11.2 The NC TREK OTW Coronary Dilatation Catheter (CDC) is a medical device that is intended for use in percutaneous transluminal coronary angioplasty (PTCA) to treat patients with coronary artery disease as specified in the indications section of the instructions for use. NC TREK OTW {6}------------------------------------------------ 3200 Lakeside Drive Santa Clara, CA 95054 T: 408 845 3000 F: 408 845 3743 Image /page/6/Picture/2 description: The image shows the logo for Abbott. The logo consists of a stylized letter 'a' in blue, positioned above the company name 'Abbott' in black, bold font. The 'a' is designed with rounded edges and an open top, giving it a modern and recognizable appearance. is an over-the-wire co-axial design with a balloon at the distal tip. The outer lumen provides for inflation of the balloon with contrast medium. The inner lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The device has dual radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at specified pressures. The annular space between the outer member and the inner lumen provides a fluid path from the side arm adaptor to the balloon. The distal portion of the catheter is coated with a hydrophilic coating. The inner lumen of the inner member is coated with Microglide. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. A side arm adaptor is provided on the proximal end of the catheter to provide access to the inflation lumen and the guide wire lumen. It is designed with a luer - lock fitting for connection with an inflation device. ### TREK RX and MINI TREK RX Device Description 11.3 The TREK and MINI TREK RX (CDC) are medical devices intended for use in percutaneous transluminal coronary angioplasty (PTCA) to treat patients with coronary artery disease as specified in the indications section of the instructions for use. They are both rapid exchange coaxial designs with a balloon at the distal tip. The MINI TREK sizes range from 1.20x6mm through 2.00x30mm. The TREK sizes range from 2.25x6mm through 5.00x15mm. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Balloon markers aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at specified pressures. The following table describes the number of radiopaque markers by balloon diameter and length. | Balloon size | Balloon lengths | Number of markers | |----------------|-----------------|-------------------------| | 1.20 - 1.5mm | 6mm to 20mm | One (center of balloon) | | 2.0mm to 4.0mm | 6mm | One (center of balloon) | | 2.0mm to 5.0mm | 8mm to 30mm | Two markers | {7}------------------------------------------------ 3200 Lakeside Drive Santa Clara, CA 95054 T: 408 845 3000 F: 408 845 3743 Image /page/7/Picture/2 description: The image shows the logo for Abbott, a healthcare company. The logo features a stylized letter "A" in blue, positioned above the company name "Abbott" in bold, black font. The "A" symbol is a rounded, geometric shape, and the overall design is clean and modern. The logo is simple, yet recognizable. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter's position relative to the guiding catheter tip when introducing the dilatation catheter through the guiding catheter. An adaption arm is provided on the proximal end of the dilatation catheter to provide access to the inflation lumen. It is designed with a luer-lock fitting for connection with an inflation device. The annular space between the distal outer member and the central distal lumen provides a fluid path from the proximal lumen to the balloon. The shaft of the catheter, the tip, and tapers of the balloon are coated with a hydrophilic coating. The inner lumen of the inner member is coated with Microglide. ### 11.4 TREK OTW, MINI TREK OTW Device Description The TREK OTW, MINI TREK OTW, and MINI TREK II OTW Coronary Dilatation Catheters (CDC) are medical devices intended for use in percutaneous transluminal coronary angioplasty (PTCA) to treat patients with coronary artery disease as specified in the indications section of the instructions for use. The TREK OTW family are over-the wire co-axial design catheters with a balloon at the distal tip. The MINI TREK OTW sizes range from 1.20x6mm through 2.00x30mm. The MINI TREK II OTW sizes range from 1.20x6mm through 2.00x20mm. The TREK™ OTW sizes range from 2.25x6mm through 5.00x15mm. The outer lumen provides for inflation of the balloon with diluted contrast medium. The inner lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Balloon markers aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at specified pressures. The following table describes the number of radiopaque markers by balloon diameter and length. | Balloon size | Balloon lengths | Number of markers | |----------------|-----------------|--------------------------------------------------------| | 1.20 - 1.5mm | 6mm to 20mm | One (center of balloon) | | 2.0mm to 4.0mm | 6mm | One (center of balloon) | | 2.0mm to 5.0mm | 8mm to 30mm | Two markers (distal and<br>proximal balloon shoulders) | Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter's position relative to the guiding catheter tip when introducing the dilatation catheter through the guiding catheter. An adaption arm is provided on the proximal end of the dilatation catheter to provide access to the inflation lumen and the guide wire lumen. It is designed with a luer-lock fitting for connection with an inflation device. {8}------------------------------------------------ 3200 Lakeside Drive Santa Clara, CA 95054 T: 408 845 3000 F: 408 845 3743 Image /page/8/Picture/2 description: The image contains the logo for Abbott, a healthcare company. The logo features a stylized letter 'a' in blue, positioned above the company name 'Abbott' in black, bold font. The 'a' symbol is a rounded, geometric shape, and the company name is in a serif typeface. The annular space between the outer member and the inner lumen provides a fluid path from the side arm adaptor to the balloon. The outer shaft of the catheter, the tip, and tapers of the balloon are coated with a hydrophilic coating. The inner of the inner member is coated with Microglide. ### INDICATIONS FOR USE 12. The MINI TREK II OTW Coronary Dilatation Catheter is indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction (MI); c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm only); d) Balloon dilatation of de novo chronic total coronary occlusions (CTO). The MINI TREK RX Coronary Dilatation Catheters are indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm only); d) Balloon dilatation of de novo chronic total coronary occlusions (CTO). The NC TREK OTW Coronary Dilatation Catheter is indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion: b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only) The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion: b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only). The TREK OTW and MINI TREK OTW Coronary Dilatation Catheter is indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm -5.00 mm only). {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for Abbott Laboratories. The logo consists of a stylized, sans-serif letter 'a' in a light blue color. Below the symbol, the word "Abbott" is written in a bold, serif font. 3200 Lakeside Drive Santa Clara, CA 95054 T: 408 845 3000 F: 408 845 3743 The TREK RX Coronary Dilatation Catheters are indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation. #### 13. SUBSTANTIAL EQUIVALENCE The changes proposed in this special 510(k) submission only affect the IFU and the labels. The TREK family devices (TREK RX, MINI TREK RX, TREK OTW, MINI TREK OTW, MINI TREK II OTW, NC TREK RX, and NC TREK OTW) have not been changed. The devices are identical to their relevant predicate devices, with the exception of the updates to the labels and IFUs. The changes to the IFU and labels are being made for consistency across the various balloons and to align with bare metal stent (BMS) and drug eluting stent (DES) instructions for use, as appropriate. There is substantial equivalence to the predicate devices. #### 14. TECHNOLOGICAL CHARACTERISTICS The technological characteristics of the device are not affected by the proposed changes. Therefore, technological characteristics remain the same. The predicate device has identical indications, design, materials and manufacturing processes as the devices affected by the IFU changes. The current versions of these products are the predicate devices. Changes are being made to align IFUs and labels for consistency across all the CDCs and to align, as appropriate, with Abbott Vascular bare metal stent (BMS) and drug eluting stent (DES) system IFUs. Changes will include alignment of clinician instructions, warnings, precautions, contraindications and adverse events sections of the IFUs across all the CDCs and, as appropriate, to align with AV bare metal stent (BMS) and drug eluting stent (DES) system IFUs. Updates are also being made to align with the latest review of the Risk Master List (RML) for CDC products. A review of literature supports that the unprotected left main coronary artery is no longer a contraindication. However, considering the limitation of the available data and the risk associated with the device use in an unprotected left main coronary artery, the following statement has been added in the Warnings section: The safety and effectiveness of the device has not been established in patients with lesions located in an unprotected left main coronary artery. In addition, information required to meet certain EU MDR requirements are also included in the updated IFU and label. There are no manufacturing, materials, or design changes associated with the updates to the IFU and labels for the TREK family of coronary dilatation catheters. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image contains the logo for Abbott. The logo consists of a stylized letter 'A' in blue, positioned above the word "Abbott" in black, bold font. The 'A' is a rounded, geometric shape, and the word "Abbott" is in a simple, sans-serif typeface. 3200 Lakeside Drive Santa Clara, CA 95054 T: 408 845 3000 F: 408 845 3743 Because the changes proposed in this Special 510(k) submission do not present any device changes, the predicate device has identical indications, design, materials and manufacturing processes as the devices affected by the IFU changes. The current versions of these products are the predicate devices. ### PERFORMANCE DATA 14. No safety or effectiveness issues were raised by this change, as the change modifies and adds content to the IFU. The performance data that supports the predicate devices remains the same.