APRO 70 Swift 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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION". January 14, 2025 Alembic, LLC Lisa Yen Vice President of Regulatory and Quality 627 National Avenue Mountain View. California 94043 Re: K243297 Trade/Device Name: APRO 70 Swift Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: December 17, 2024 Received: December 18, 2024 Dear Lisa Yen: 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. {1}------------------------------------------------ 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). Your device is also subject to, among other requirements, the Quality System (QS) 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-regulatory {2}------------------------------------------------ assistance/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, # Naira Muradyan -S Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K243297 Device Name APRO 70 Swift Catheter ### Indications for Use (Describe) The APRO 70 Swift Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 70 Swift Catheter is also indicated for use as a conduit for retrieval devices. | Type of Use (Select one or both, as applicable) | |----------------------------------------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | <input type="checkbox"/> 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}------------------------------------------------ # 510(k) Summary #### K243297 510(k) Number: This 510(k) Summary is provided in accordance with the requirements of 21 CFR §807.92. #### Submitter information 1) | Submitter: | Alembic, LLC<br>627 National Ave.<br>Mountain View, CA 94043 | |----------------|------------------------------------------------------------------------------------------------------------| | Contact: | Lisa Yen<br>VP of Regulatory and Quality<br>Telephone Number: (650) 388-5087<br>Email: lyen@alembicllc.com | | Date Prepared: | January 14, 2025 | #### 2) Device Name and Classification | Trade/Proprietary Name: | APRO® 70 Swift Catheter | |--------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Common Name: | Percutaneous Catheter | | Classification Name: | Percutaneous Catheter, 21 CFR 870.1250<br>Catheter, Percutaneous, Neurovasculature, 21 CFR 870.1250 | | Regulatory Class: | Class II | | Product Codes: | DQY, QJP | | Review Panel: | Cardiovascular, Neurology | | Legally Marketed Predicate Device and Reference Device | | | Predicate Device: | K234115 APRO 55 Catheter | | Reference Device: | K223545 APRO 70 Catheter and Alembic Aspiration Tubing | #### 4) Device Description 3) The APRO 70 Swift Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Swift Catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 70 Swift Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The APRO 70 Swift Catheter is provided with an Introducer Sheath. {5}------------------------------------------------ #### 5) Indications for Use The APRO 70 Swift Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 70 Swift Catheter is also indicated for use as a conduit for retrieval devices. #### Technological Characteristics Comparison 6) Alembic has demonstrated that the APRO 70 Swift Catheter is substantially equivalent to the predicate device based on the similarity in materials, similarity in design concept, and the same fundamental operating principles. A comparison of the APRO 70 Swift Catheter with the predicate device is summarized in Table 1 below. | Category | Subject Device<br>APRO 70 Swift Catheter | Predicate Device<br>APRO 55 Catheter | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K243297 | K234115 | | Regulatory Class | Class II, 21 CFR 870.1250, DQY,<br>QJP | Class II, 21 CFR 870.1250, DQY,<br>QJP | | Indications for Use | The APRO 70 Swift Catheter is<br>indicated for use in facilitating the<br>insertion and guidance of<br>appropriately sized interventional<br>devices into a selected blood vessel in<br>the peripheral and neurovascular<br>systems. The APRO 70 Swift<br>Catheter is also indicated for use<br>as a conduit for retrieval devices. | The APRO 55 Catheter is indicated<br>for use in facilitating the insertion<br>and guidance of appropriately sized<br>interventional devices into a selected<br>blood vessel in the peripheral and<br>neurovascular systems. The APRO<br>55 Catheter is also indicated for use<br>as a conduit for retrieval devices. | | Materials | | | | Hub | Nylon | Nylon | | Adhesive | Cyanoacrylate | Cyanoacrylate | | Strain Relief | Thermoplastic elastomer | Thermoplastic elastomer | | Liner | Polytetrafluoroethylene<br>(PTFE)/Tecoflex composite | PTFE/Tecoflex composite | | Shaft Coil and Braid | 304V stainless steel braid<br>304V stainless steel coil | 304V stainless steel braid<br>304V stainless steel coil | | Extrusions | Thermoplastic polyurethanes,<br>thermoplastic elastomer | Thermoplastic polyurethanes,<br>thermoplastic elastomer | | Marker Band | Platinum/ iridium | Platinum/ iridium | | Adhesive | None | None | | Coating | Hydrophilic coating | Hydrophilic coating | | Dimensions | | | | Proximal Outer<br>Diameter | 0.083 inch | 0.066 inch | | Distal Outer Diameter | 0.083 inch | 0.066 inch | | Inner Diameter | 0.070 inch | 0.055 inch | | Effective Lengths | 125, 132, 135 cm | 125, 137 cm | | Coated Length | 90, 97, 100 cm | 90, 102 cm | | Tip Shape | Straight | Straight | | Accessories | | | | Category | Subject Device<br>APRO 70 Swift Catheter | Predicate Device<br>APRO 55 Catheter | | Introducer Sheath | Yes | Yes | | Packaging Materials | | | | Pouch | Nylon/polyethylene/ Tyvek | Nylon/polyethylene/ Tyvek | | Packaging Tube | N/A | Polyethylene | | Packaging Hoop Coil | Polyethylene | N/A | | Packaging Card | Yes | Yes | | Shelf Carton | Solid bleached sulfate paperboard | Solid bleached sulfate paperboard | | Other | | | | Sterilization | Ethylene oxide | Ethylene oxide | | Shelf Life | 1 year | 6 months | | Use Conditions | Sterile, single use, disposable | Sterile, single use, disposable | ### Table 1 - APRO 70 Swift Catheter Comparison with the Predicate Device {6}------------------------------------------------ #### 7) Performance Data Alembic performed non-clinical bench, sterility, shelf-life, and biocompatibility testing. The results demonstrate substantial equivalence of the APRO 70 Swift Catheter to the legally marketed predicate device. ## A. Design Verification Testing – Non-Clinical Bench Performance testing was conducted to support the APRO 70 Swift Catheter submission. The results of the design verification and validation testing confirm that the APRO 70 Swift Catheter conforms to the predefined specifications and meets test acceptance criteria. A summary of the testing is shown in Table 2. | Test | Acceptance Criteria | Conclusion | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Visual and Dimensional<br>Characteristics | Catheter meets the visual and dimensional<br>specifications. | The APRO 70 Swift Catheter<br>met the acceptance criteria. | | Particulate | Catheter meets the acceptance criteria.<br>Subject device was evaluated with a<br>predicate device under the same test<br>conditions. | The APRO 70 Swift Catheter<br>particulates were comparable to<br>the predicate device. | | Kink Resistance | Catheter shaft shall not kink at clinically<br>relevant radii. | The APRO 70 Swift Catheter met<br>the acceptance criteria. | | Hub Air Leakage | Catheter does not leak air into hub<br>assembly with methods specified in ISO<br>10555-1, Annex D. | The APRO 70 Swift Catheter met<br>the acceptance criteria. | | Hub Compatibility | Catheter meets the requirements specified<br>in ISO 80369-7. | The APRO 70 Swift Catheter met<br>the acceptance criteria. | | Torque Strength | Catheter must withstand the minimum<br>required number of rotations without<br>breakage and without kinking compared to<br>legally marketed devices. | The APRO 70 Swift Catheter met<br>the acceptance criteria. | | Dynamic Burst Pressure | No damage to catheter with dynamic<br>pressure. | The APRO 70 Swift Catheter met<br>the acceptance criteria. | | Liquid Leakage | Catheter must withstand pressure<br>with methods specified in ISO 10555-<br>1, Annex C. | The APRO70 Swift Catheter met<br>the acceptance criteria. | | Static Burst | Catheter must withstand pressures<br>anticipated for clinical use. | The APRO 70 Swift Catheter met<br>the acceptance criteria | ### Table 2 - Summary of Non-Clinical Bench Test Results {7}------------------------------------------------ | Test | Acceptance Criteria | Conclusion | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | Hub and Shaft Tensile Strength | Catheter hub and shaft must meet tensile strength specification. | The APRO 70 Swift Catheter met the acceptance criteria. | | Tip Tensile Strength | Catheter tip must meet tip tensile strength specification. | The APRO 70 Swift Catheter met the acceptance criteria. | | Tip Buckling Force | Catheter tip buckling force must be acceptable. Forces were compared to a predicate. | The APRO 70 Swift Catheter was comparable to the predicate device. | | Delivery and Retrieval Force | Catheter delivery and retrieval force must be acceptable. Forces were compared to a predicate. | The APRO 70 Swift Catheter met the acceptance criteria. | | Simulated Use | When used per the Instructions for Use with accessory devices in an anatomical neurovascular model and during simulated clot retrieval, the Catheter must meet functionality specifications including compatibility with a stent retriever. | The APRO 70 Swift Catheter met the acceptance criteria. | ## B. Design Verification Testing - Animal Substantial equivalence was established based on non-clinical bench performance data. Animal testing data were not deemed necessary. ### C. Sterilization and Shelf-Life The APRO 70 Swift Catheter is sterilized using an ethylene oxide sterilization cycle that was verified to a sterility assurance level of 1 x 10 6 in accordance with ISO 11135. Aging studies for the APRO 70 Swift Catheter have established that the subject device and packaging remain functional for the labeled expiration date. Aging studies for packaging integrity, seal strength, and the device functionality were performed and met the acceptance criteria. ### D. Biocompatibility Biocompatibility testing has been completed for the APRO 70 Swift Catheter as an externally communicating device with circulating blood contact for a limited (≤24 hours) duration in accordance with ISO 10993-1 and the FDA guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process ". " | Test | Results | Conclusions | |--------------------------------------------|------------------------------------------------------------------------------------------|-----------------| | Sensitization<br>(Guinea Pig Maximization) | The APRO 70 Swift Catheter did not elicit a sensitization response. | Non-sensitizing | | Irritation/Intracutaneous<br>Reactivity | The APRO 70 Swift Catheter demonstrated no evidence of irritation. | Non-irritant | | Cytotoxicity<br>(MEM Elution, L929 cells) | The APRO 70 Swift Catheter did not elicit a cytotoxic response at 24 hours and 48 hours. | Non-cytotoxic | | Table 3 - Biocompatibility Test Results | | | |-----------------------------------------|--|--| | | | | {8}------------------------------------------------ | Test | Results | Conclusions | |---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Hemolysis - Indirect | There were no significant differences between<br>the test article extract and negative control<br>article results. | Non-hemolytic | | Hemolysis - Direct | There were no differences between the<br>hemolytic index of the test article and the<br>negative control. | Non-hemolytic | | Thrombogenicity -<br>Partial Thromboplastin<br>Time (PTT) | The average clotting time of the test article was<br>greater than vehicle control and negative<br>control. | Acceptable clotting<br>times | | Thrombogenicity - Platelet<br>Leukocyte Count | Performed similar to comparator and negative<br>controls. | Non-thrombogenic | | Thrombogenicity -<br>Comparative Surface and<br>Geometry Assessment | Comparative surface assessment using 40X<br>optical microscopy at representative locations<br>of the subject and the reference device APRO<br>70 Catheter did not find any differences in<br>roughness or presence of any defects. The<br>subject device has the same geometry as the<br>reference device APRO 70 Catheter. | Acceptable results | | SC5b9 Complement<br>Activation | The Sc5b9 concentration of the test article was<br>statistically less than the positive control and<br>was not statistically higher than the negative<br>control. | Acceptable | | Acute Systemic Toxicity | No weight loss, mortality, or evidence of<br>systemic toxicity from the extract exposure to<br>the mice. | Non-toxic | | Material-Mediated<br>Pyrogenicity | All individual rabbits for both the test article<br>and negative control showed a total rise in<br>temperature of < 0.5 °C and were determined to<br>be nonpyrogenic. | Non-pyrogenic | ### E. Clinical Testing Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary. #### 8) Conclusion Based on the comparison of the technological characteristics and the non-clinical testing, the subject device is found to be substantially equivalent to the predicate device. The differences in technological characteristics do not raise new questions of safety and effectiveness. Testing was conducted to demonstrate that the subject device meets the specifications and performs as intended.