INFINITI™ Ambi Angiographic Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line. November 21, 2023 Cordis US Corp. Zheng Wang Principal Specialist, Regulatory Affairs 14201 North West 60th Avenue Miami Lakes, Florida 33014 Re: K232573 Trade/Device Name: INFINITI™ Ambi Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: August 24, 2023 Received: August 25, 2023 Dear Zheng Wang: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Lydia S. Glaw -S Digitally signed by Lydia S. Glaw -S Date: 2023.11.21 13:17:34 -05'00' Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232573 Device Name INFINITI™ Ambi Angiographic Catheter Indications for Use (Describe) Cordis catheters are indicated for enabling diagnosis of various pathologies by facilitating of diagnostic devices within the coronary and peripheral vasculature. Type of Use (Select one or both, as applicable) | <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-----------------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | 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 word "Cordis" in a stylized, blue font. The font appears to be a serif font, with a slight curve to the letters. The word is the logo for Cordis, a medical device company. K232573 INFINITI™ Ambi Angiographic Catheter # 510(k) Summary # I. SUBMITTER INFORMATION (807.92(a)(1)) | Manufacturer (Applicant): | Cordis US Corp.<br>14201 North West 60th Avenue<br>Miami Lakes, Florida, 33014 USA<br>Establishment Registration: 1016427 | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person(s) | Zheng Wang (Jessie)<br>Principal Regulatory Affairs Specialist<br>Cordis US Corp.<br>5452 Betsy Ross Drive<br>Santa Clara, CA 95054, USA.<br>E-mail: zheng.wang04@cordis.com<br>Ana Lopez<br>Sr. Manager, Regulatory Affairs<br>Cordis US Corp.<br>5452 Betsy Ross Drive<br>Santa Clara, CA 95054, USA.<br>E-mail: ana.lopez02@cordis.com | Date Prepared: October 24, 2023 ## II. DEVICE NAME (807.92(a)(2)) | Proprietary Name: | INFINITIT™ Ambi Angiographic Catheter<br>(hereafter referred as INFINITI Ambi Catheter) | |----------------------|-----------------------------------------------------------------------------------------| | Common Name: | Diagnostic Intravascular Catheter | | Classification: | Class II CFR Part 780.1200 | | Classification Panel | Cardiovascular | | Product Code: | DQO | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "Cordis" in a stylized, blue font. The word is written in cursive, with the "C" being the largest letter and the other letters gradually decreasing in size. There is a registered trademark symbol to the right of the "s". #### III. PREDICATE DEVICE INFINITI™ Angiographic Catheter cleared on 9/30/1997 under K970854. #### IV. DEVICE DESCRIPTION The INFINITI Ambi Catheter is a 0.038" guidewire compatible catheter with a 3-staged braided nylon construction. The body is a braided nylon intended for torque responsiveness and stability. The proximal segment is a non-braided nylon for flexibility and shape retention. The Distal Tip is a soft, radiopaque nylon for minimal vessel cannulation. The INFINITI Ambi product line comes in 5F and 6F size and various curve style configurations. The device is a disposable intended for single use only. It is individually packaged and sterilized by ethylene oxide gas. #### V. INTENDED/INDICATIONS FOR USE Cordis catheters are indicated for enabling diagnosis of various pathologies by facilitating the positioning of diagnostic devices within the coronary and peripheral vasculature. ### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE A comparison of the intended use/indications for use and technological characteristics are summarized in the table below. The minor design changes do not negatively impact the safety and effectiveness of the device. | Element | Proposed Device<br>(INFINITI Ambi Catheter) | Predicate Device (K970854)<br>(INFINITI Catheter) | Note | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | FDA Product Code | DQO | DQO | Same | | Indications for Use | Cordis catheters are indicated for<br>enabling diagnosis of various pathologies<br>by facilitating the positioning of<br>diagnostic devices within the coronary<br>and peripheral vasculature. | Cordis catheters are designed to deliver<br>radiopaque contrast medium to selected<br>sites in the vascular system. | Different | | Intended Purpose | Cordis catheters are intended to delivery<br>radiopaque contrast medium to selected<br>sites in the vascular system. | Not included | Added | | Contra-indications | None known | None known | Same | | Manufacturer | Cordis US Corp. | Cordis Corporation | Different | | Manufacturing Site | Cardinal Health México<br>244 S de RL de CV<br>Santiago Troncoso #808<br>Parque Industrial Salvarcar<br>Ciudad Juarez, Chihuahua | Cordis Corporation<br>14201 North West 60th Avenue Miami<br>Lakes, Florida 33014<br>USA | Different | | Element | Proposed Device<br>(INFINITI Ambi Catheter) | Predicate Device (K970854)<br>(INFINITI Catheter) | Note | | Sterilization Site | C.P. 32574<br>México<br>STERIS-E2<br>Isomedix Operations, Inc<br>1441 Don Haskins Drive<br>El Paso, TX 79936<br>USA<br>STERIS-E1<br>Isomedix Operations, Inc<br>1435 Isomedix Place<br>El Paso, TX 79936<br>USA<br>Sterigenics US, LLC<br>2400 Airport Road<br>Santa Teresa, NM 88008<br>USA | Cordis Europa N.V.<br>Postbus 38<br>Oosteinde 8<br>9300 AA Roden<br>The Netherlands<br>These two sites are no longer used for<br>the manufacturing of the Cordis<br>products.<br>For product manufactured in Miami:<br>Isomedix, Inc.<br>2072 Southport Road<br>Spartanburg, S.C. 29301-9539<br>Isomedix. Inc.<br>435 Whitney Street<br>Northborough, MA 01532<br>For product manufactured in Roden:<br>Griffith Micro Science<br>Storkstraat 8-10<br>2722 NN Zoetermeer<br>The Netherlands<br>These three sites are no longer used for<br>the sterilization of the Cordis products. | Different | | Shelf Life | 3 years | 3 years | Same | | Sterilization<br>Method | 100% Ethylene Oxide (EO) | 100% Ethylene Oxide (EO) | Same | | Sterility Assurance<br>level (SAL) | $10^{-6}$ | $10^{-6}$ | Same | | Use | Single Use | Single Use | Same | | | Principle of Operation | | | | Mechanism of<br>Action | Facilitates the delivery of radiopaque<br>contrast medium to selected sites in the<br>vascular system. | Facilitates the delivery of radiopaque<br>contrast medium to selected sites in the<br>vascular system. | Same | | Overall length | 100cm, 125 cm | 100cm, 125 cm | Same | | Element | Proposed Device<br>(INFINITI Ambi Catheter) | Predicate Device (K970854)<br>(INFINITI Catheter) | Note | | Proximal OD | 5F – 0.066”<br>6F – 0.078” | 5F – 0.066”<br>6F – 0.078” | Same | | Distal Tip OD | 5F – 0.066”<br>6F – 0.078” | 5F – 0.066”<br>6F – 0.078” | Same | | Proximal ID | 5F – 0.047”<br>6F – 0.057” | 5F – 0.047”<br>6F – 0.057” | Same | | Distal ID | 5F – 0.047”, Flush: 0.042”<br>6F – 0.057”, Flush: 0.042” | 5F – 0.047”, Flush: 0.042”<br>6F – 0.057”, Flush: 0.042” | Same | | Guidewire<br>acceptance | 0.038” max | 0.038” max | Same | | Maximum pressure | 1200 psi | 1200 psi | Same | | Flow rate | 5F<br>21.3<br><br>6F<br>35 | 5F<br>21.3<br><br>6F<br>35 | Same | | Catheter Component Materials | | | | | Materials | Nylon and stainless-steel | Nylon and stainless-steel | Same | | Product Design Characteristics | | | | | Tip Length | 1.25 inches | 1.25 inches | Same | | Shapes | JK 4.0, TG 4.5, JK 3.5, TG 4.0 | JR/JL | New | | Packaging Configuration | | | | | Sterile Packaging | Individual package, pouch, and carton | Individual package, pouch, and carton | Same | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "Cordis" in a stylized, blue font. The font is a flowing script, with the letters connected to each other. The word is slightly slanted to the right, giving it a sense of movement. There is a trademark symbol to the right of the word. K232573 INFINITI™ Ambi Angiographic Catheter {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "Cordis" in a stylized, blue font. The word is written in cursive, with the letters connected to each other. There is a registered trademark symbol to the right of the word. The font is bold and the color is a vibrant blue. ### VII. PERFORMANCE DATA Performance testing was conducted to ensure the safety and effectiveness of the device with the minor design changes demonstrate substantial equivalence to the predicate device. No new issues of safety and effectiveness were raised with the testing performed. ### Biocompatibility Testing The INFINITI Ambi Catheter is an externally communicating device with limited contact duration (≤ 24 hours) in contact with circulating blood. Biocompatibility testing, Chemical Characterization, and Toxicological Risk Assessment on the patient contacting portions of predicate device INFINITI 5F were performed Testing was performed to meet the endpoints for evaluation from ISO 10993-1:2018 and FDA guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on September 4, 2020. Endpoints evaluated are as follows: {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "Cordis" in a stylized, blue font. The font appears to be italicized and has a slight curve to it. A registered trademark symbol is located to the bottom right of the word. - Physical and/or Chemical Information . - . Cytotoxicity - MEM Elution - Sensitization – Guinea Pig Maximization - Intracutaneous Irritation Reactivity - . Acute Systemic Toxicity - Material Mediated Pyrogenicity ● - Hemocompatibility ● #### Sterilization The sterilization conditions have been validated according to ISO 11135:2014 Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation, and routine control of a sterilization process for medical devices to provide a sterility assurance level (SAL) of 10°. Ethylene oxide and ethylene chlorohydrin residuals meet requirements for limited exposure devices (contact < 24 hours) in accordance with ISO 10993-7:2018, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals. #### Packaging There is no change to the packaging materials and configuration, therefore, no new packaging verification testing was required to be conducted on the subject INFINITI Ambi Catheter. #### Bench Testing The following testing was successfully completed for the INFINITI Ambi Catheter per applicable sections of the indicated standards and/or validated internal test methods: Catheter – Guidance for Industry and FDA Staff - Coronary and Peripheral Arterial Diagnostic Catheters (July 15, 2003) - . Dimensions - Outer Diameter performed for subject device, other dimensions leveraged from predicate. - . Shape Master - Performed for subject device. - Pull Test - Performed for subject device. - . Dynamic Pressure - Leveraged from predicate. - . Hydrostatic pressure - Leveraged from predicate. - Torque Test - Performed for subject device. - . Particulates - Performed for subject device. - Kink Radius Performed for subject device. . #### Risk Analysis A risk analysis was conducted in accordance with 14971, taking into account the modifications to the predicate device, and it was determined that no new risks were identified. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "Cordis" in a stylized, blue font. The word is written in cursive, with the letters connected to each other. The font is bold and has a slight shadow effect, which gives the word a three-dimensional appearance. There is a registered trademark symbol to the right of the word. ### VII. CLINICAL PERFORMANCE No clinical data was required in support of the proposed change to the predicate device cleared under K970854. #### VIII. CONCLUSIONS The INFINITI™ Ambi Angiographic Catheter was found to be substantially equivalent in its design, intended use, technology, principal of operation, and performance to the predicate device. There are no significant differences between the INFINITI™ Ambi Angiographic Catheter and the predicate device that raise new issues of safety and effectiveness.