ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. September 2, 2022 Silk Road Medical, Inc. Denise Aycox Senior Regulatory Affairs Specialist 1213 Innsbruck Drive Sunnyvale, California 94089 Re: K221414 Trade/Device Name: ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: May 12, 2022 Received: May 16, 2022 Dear Denise Aycox: 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. 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You must comply with all the Act's {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 (Sections 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 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, Gregory O'Connell 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 Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221414 Device Name ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter Indications for Use (Describe) The ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty and post-dilatation of self-expanding stents in the carotid arteries. | Type of Use (Select one or both, as applicable) | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------------------------------------| | <table style="border:none;"><tr><td style="border:none;">[X] Prescription Use (Part 21 CFR 801 Subpart D)</td><td style="border:none;">[ ] Over-The-Counter Use (21 CFR 807 Subpart C)</td></tr></table> | [X] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 807 Subpart C) | | [X] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 807 Subpart C) | | > Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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There is a greater than symbol at the end of the word "ROAD". ## 1. 510(k) Summary [as required by 21 CFR 807.92.(c)] Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Silk Road Medical is providing the summary of Substantial Equivalence for the ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter. ### 1.1. Sponsor/Applicant Silk Road Medical 1213 Innsbruck Drive Sunnyvale, CA 94089 #### 1.2. Sponsor Contact | Primary Contact | Alternate Contact | |------------------------------------|------------------------------| | Denise Aycox | Kym Rupp | | Sr. Regulatory Affairs Specialist. | Manager, Regulatory Affairs | | Ph: 408-585-2156 | (407) 756-0035 | | Email: daycox@silkroadmed.com | Email: krupp@silkroadmed.com | #### 1.3. Date of Preparation of 510(k)Summary May 12, 2022 #### 1.4. Device Trade or Proprietary Name Trade Name ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter #### 1.5. Device Classification | Regulatory Class | II | |------------------------------|---------------------------------| | Classification Panel | Cardiovascular | | Classification Name | Percutaneous Catheter | | Common Name | PTA balloon dilatation catheter | | Classification<br>Regulation | 870.1250 | | Product Code | LIT | #### 1.6. Predicate Device | Predicate Device | | | |---------------------------------|-------------------------------------------------|-----------------------------------------------------------| | 510(k) Number / Clearance Date | Name of Device | Name of Manufacturer | | K071189 Cleared on May 16, 2007 | AVIATOR PLUS PTA Balloon<br>Dilatation Catheter | Cordis Europa, N.V<br>Oosteinde 8<br>Roden, NL NI-9301 Lj | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a logo for Silk Road Medical. The words "SILK ROAD" are in orange, with the word "MEDICAL" in gray below. There is an orange arrow pointing to the right at the end of the word "ROAD". The logo is simple and modern. ## 1.7. Predicate Comparison | Predicate Comparison | | | | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Predicate Device | Subject Device | For any differences, justification of substantial equivalence | | 510(k) No. | K071189 | TBD | N/A | | Classification | Class II | | SAME | | Classification<br>Regulation | 870.1250 | | SAME | | Product Code | LIT | | SAME | | Indication for Use | The Cordis AVIATOR<br>PLUS PTA Balloon<br>Dilatation Catheter<br>is indicated for<br>Percutaneous<br>Transluminal<br>Angioplasty in the<br>peripheral<br>vasculature,<br>including iliac,<br>femoral, ilia-<br>femoral, popliteal,<br>infra popliteal,<br>renal, and carotid<br>arteries, and for the<br>treatment of<br>obstructive lesions<br>of native or<br>synthetic<br>arteriovenous<br>dialysis fistulae. This<br>device · 1s also<br>indicated for post-<br>dilatation of<br>balloon-expandable<br>and self-expanding<br>stents in the<br>peripheral<br>vasculature. | The ENROUTE<br>EnflateTM Transcarotid<br>RX Balloon Dilatation<br>Catheter is intended<br>for percutaneous<br>transluminal<br>angioplasty and post-<br>dilatation of self-<br>expanding stents in the<br>carotid arteries. | Both products are intended for<br>transluminal angioplasty and<br>post-dilatation of self-<br>expanding stents in the carotid<br>arteries. The predicate,<br>AVIATOR PLUS, has an<br>expanded indication while the<br>ENROUTE Enflate has a more<br>limited indication particularly<br>for use in the carotid arteries. | | Balloon Characteristics | | | | | Catheter Type | Rapid Exchange (RX) | | SAME | | Shaft | RX Coaxial | SAME | | | Construction | | | | | Guidewire<br>Compatibility | .014" | SAME | | | Sheath<br>Compatibility | 4 or 5F<br>(4F (up to 6mm), 5F for<br>7mm) | SAME<br>(4F for 4-5.5 mm<br>diameters, 5F for 6 mm<br>diameter) | Both the subject and predicate<br>are compatible with 4F or 5F<br>sheaths depending on the<br>balloon diameter. | | Nominal Pressure | 10 atm | 8 atm | The Nominal pressure is similar<br>to the predicate and is<br>consistent with other PTA<br>balloons. | | Rated Burst<br>Pressure | 14 atm (for diameters<br>up to 6mm), 12 atm for<br>7mm | 14 atm | The RBP for both the subject<br>and predicate are 14 atm for<br>balloon diameters up to 6mm.<br>The 12atm RBP is for a 7mm<br>diameter which is not an<br>offered diameter size for the<br>subject | | Contrast Infusion | No | | SAME | | Coating | None | | SAME | | Marker band # | 2 | | SAME | | Balloon Material | Duralyn | Nylon | The ENROUTE Enflate Catheter<br>is constructed of materials<br>commonly used for semi-<br>compliant PTA balloons. | | Dimensions | | | | | Catheter Working<br>Length | 142cm | 75cm | The shorter working length<br>was selected to accommodate<br>the TCAR procedure. The<br>product is designed to have<br>direct access to the carotid<br>artery rather than femoral<br>artery access. | | Catheter Shaft<br>Outer Diameter | 1.10mm | 1.14mm | The OD of the catheter shaft is<br>similar to the predicate and<br>falls in-line with other cleared<br>PTA catheters. | | Balloon Length | 15mm, 20mm, 30mm<br>or 40mm | 25mm or 35mm | These lengths are similar to<br>other cleared PTA balloon<br>catheters for use in the carotid<br>arteries. | | Balloon Diameter | 4.0, 4.5, 5.0, 5.5, 6.0 or<br>7.0 mm at nominal<br>pressure | 4.0, 4.5, 5.0, 5.5, or 6.0<br>mm at nominal<br>pressure | The diameter sizes are<br>identical to the predicate with<br>the exception of the 7.0mm<br>size. These diameters are | | | | | consistent with other cleared<br>PTA balloon catheters for use<br>in the carotid arteries. | | Packaging and Sterilization | | | | | Packaging<br>Configuration | Balloon and flushing<br>needle provided in<br>Tyvek pouch. The<br>balloon is packaged in a<br>protective hoop. | Balloon packaged in a<br>protective hoop in a<br>Tyvek pouch | The Packaging configuration is<br>identical to the predicate<br>except a flushing needle is not<br>included. | | Sterilization<br>Method | EO | SAME | | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Silk Road Medical. The words "SILK ROAD" are written in a sans-serif font, with "SILK" in orange and "ROAD" in gray. To the right of "ROAD" is an orange arrow pointing to the right. Below "ROAD" is the word "MEDICAL" in gray. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Silk Road Medical. The words "SILK ROAD" are in orange, with the "ROAD" portion in gray. Below that, the word "MEDICAL" is in gray, with a registered trademark symbol to the right of it. ## 1.8. Device Description: The Silk Road Medical ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is a standard rapid exchange (RX) 0.014" Percutaneous Transluminal Angioplasty (PTA) catheter with a proximal single lumen and distal coaxial lumen tubing with a dilatation balloon, and an atraumatic, tapered tip. The proximal luer lock hub allows for connection with a balloon inflation device for inflation with diluted contrast medium. The second lumen in the distal shaft permits the use of an 0.014" guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon has two radiopaque marker bands to aid in positioning the balloon in the stenosis, located either 25 or 35 mm apart as indicated on the package label. An external position marker is located 32.5 cm from the distal tip to indicate the relative position of the catheter tip to the guiding catheter/introducer sheath. The total working length of the catheter is 75 cm. The Silk Road Medical ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter will complement the TCAR procedure. #### 1.9. Indications for Use: The ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty and post-dilatation of self-expanding stents in the carotid arteries. #### 1.10. Summary of Performance Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding substantial equivalence of the device follows. Included in this section are descriptions of the testing performed on the subject ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter to support substantial equivalence to the predicate device: - Biocompatibility - Design Verification (Bench-Top Testing) . - Sterilization, Packaging Validation, and Shelf Life ● {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Silk Road Medical. The words "SILK ROAD" are in orange, with "MEDICAL" in gray below. The "A" in "ROAD" is shaped like an upward-pointing triangle, and there is an orange arrow pointing to the right after the word "ROAD". The subject, ENROUTE ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter met all established requirements. #### 1.10.1. Biocompatibility Testing The subject ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter uses equivalent materials, processing, and identical sterilization methods as those in the predicate device, AVIATOR PLUS PTA Balloon Dilatation Catheter [K071189]. Biocompatibility testing was successfully conducted per BS EN ISO 10993-1. The studies were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (< 24 hours), external communicating device with circulating blood contact. Studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP) and included: - Cytotoxicity - Intracutaneous reactivity (Irritation) - . Sensitization - Acute systemic toxicity - Hemocompatibility - o Direct and Indirect Contact - O Complement activation - In vivo thromboresistance O - Pyrogenicity #### 1.10.2. Design Verification - Bench-top Testing The physical and mechanical properties of the ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter were assessed in accordance with FDA draft guidance "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions" and the guidance "Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters- Class II Special Controls Guidance for Industry and FDA. Standard test methods and pre-determined acceptance criteria were used. The following tests were performed and all tests passed successfully: - . Visual and Dimensional Inspection - . Balloon Fatigue - Balloon Fatigue (Without Stent) - Balloon Rated Burst Pressure Simulated Use - Balloon Rated Burst Pressure (Without Stent) - - . Balloon Fatigue (In Stent) - Balloon Compliance - I Catheter Bond Strength - l Tip Pull Test - Flexibility and Kink Test - l Torque Strength ■ {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Silk Road Medical. The words "SILK ROAD" are in orange, with "SILK" on the left and "ROAD" on the right. The word "MEDICAL" is in gray below "ROAD". There is a right-pointing arrow after the word "ROAD". Radiopaci - l Balloon Rated Burst Pressure (In Stent) - . Balloon Inflation and Deflation Time # 1.10.3. Sterilization, Packaging Validation, and Shelf Life Sterility testing demonstrated that the device is compliant with ISO 11135:2014 "Sterilization of health care products – Ethylene oxide - Requirements for development, validation, and routine control of a sterilization process for medical devices". Packaging validation conducted in accordance with ISO 11607-1 & ISO 11607-2, and design verification testing performed on accelerated aged devices were used to establish shelf life. #### 1.11. Summary of Substantial Equivalence The subject, ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes. Substantial equivalence was demonstrated with non-clinical performance tests, which complied with the requirements specified in the international and FDA-recognized consensus standards. The results of these tests demonstrate that ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter met the acceptance criteria, is adequate for the intended use, and is substantially equivalent to the predicate.