APRO 45 Catheter

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION May 1, 2025 Alembic, LLC Stina Almaleh Regulatory and Quality Engineer 627 National Avenue Mountain View, California 94043 Re: K251014 Trade/Device Name: APRO 45 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: April 1, 2025 Received: April 2, 2025 Dear Stina Almaleh: 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. U.S. Food &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251014 - Stina Almaleh Page 2 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K251014 - Stina Almaleh Page 3 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} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K251014 | | | Device Name APRO 45 Catheter | | | Indications for Use (Describe) The APRO 45 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 45 Catheter is also indicated for use as a conduit for retrieval devices. | | | Type of Use (Select one or both, as applicable) ☑ 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} APRO 45 Catheter 510(k) Number: K251014 # 510(k) Summary This 510(k) Summary is provided in accordance with the requirements of 21 CFR §807.92. ## 1) Submitter information Submitter: Alembic, LLC 627 National Ave. Mountain View, CA 94043 Contact: Stina Almaleh Regulatory and Quality Engineer Email: salmaleh@alembicllc.com Telephone Number: (650) 388-5080 Date Prepared: April 29, 2025 ## 2) Device Name and Classification Trade/Proprietary Name: APRO® 45 Catheter Common Name: Percutaneous Catheter Classification Name: Percutaneous Catheter, 21 CFR 870.1250 Catheter, Percutaneous, Neurovasculature, 21 CFR 870.1250 Regulatory Class: Class II Product Codes: DQY, QJP Review Panel: Cardiovascular, Neurology ## 3) Legally Marketed Predicate Device Predicate Device: K234115 APRO 55 Catheter ## 4) Device Description The APRO 45 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 45 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 45 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 45 Catheter is provided with an Introducer Sheath. The APRO 45 Catheter contains animal derived materials made from tallow derivatives. ## 5) Indications for Use The APRO 45 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 45 Catheter is also indicated for use as a conduit for retrieval devices. Page 1 of 5 {5} APRO 45 Catheter 510(k) Number: K251014 # 6) Technological Characteristics Comparison Alembic has demonstrated that the APRO 45 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 45 Catheter with the predicate is summarized in Table 1 below. | Table 1. APRO 45 Catheter Comparison with the Predicate Device | | | | --- | --- | --- | | Category | Subject Device APRO 45 Catheter | Predicate Device APRO 55 Catheter | | 510(k) Number | K251014 | K234115 | | Regulatory Class | Same as predicate. | Class II, 21 CFR 870.1250, DQY, QJP | | Indications for Use | The APRO 45 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 45 Catheter is also indicated for use as a conduit for retrieval devices. | The APRO 55 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 55 Catheter is also indicated for use as a conduit for retrieval devices. | | Materials | | | | Hub | Same as predicate. | Nylon | | Adhesive | Same as predicate. | Cyanoacrylate | | Strain Relief | Same as predicate. | Thermoplastic elastomer | | Liner | Polytetrafluoroethylene (PTFE)/Pebax composite | PTFE/Tecoflex composite | | Shaft Coil or Braid | Same as predicate. | 304V stainless steel braid 304V stainless steel coil | | Extrusions | Polyether block amide | Thermoplastic polyurethanes, thermoplastic elastomer | | Marker Band | Same as predicate. | Platinum/ iridium | | Coating | Same as predicate. | Hydrophilic coating | | Dimensions | | | | Proximal Outer Diameter | 0.060 inch | 0.066 inch | | Distal Outer Diameter | 0.058 inch | 0.066 inch | | Inner Diameter | 0.045 inch | 0.055 inch | | Effective Lengths | 115, 125, 146, 160 cm | 125, 137 cm | | Coated Length | 60 cm | 90, 102 cm | | Tip Shape | Same as predicate. | Straight | | Accessories | | | | Introducer Sheath | Same as predicate. | Yes | | Packaging Materials | | | | Pouch | Same as predicate. | Nylon/polyethylene/ Tyvek | | Packaging Tube | N/A | Polyethylene | | Packaging Hoop Coil | Polyethylene | N/A | | Packaging Card | Same as predicate. | Polyethylene | | Shelf Carton | Same as predicate. | Solid bleached sulfate paperboard | | Other | | | | Sterilization | Same as predicate. | Ethylene oxide | | Shelf Life | 1 year | 6 months | | Use Conditions | Same as predicate. | Sterile, single use, disposable | {6} APRO 45 Catheter 510(k) Number: K251014 # 7) Performance Data Alembic performed non-clinical bench, sterility, shelf-life, and biocompatibility testing. The results demonstrate substantial equivalence of the APRO 45 Catheter to the legally marketed predicate device. # A. Design Verification Testing - Non-Clinical Bench Bench performance testing was conducted to support the APRO 45 Catheter submission. The results of the design verification and validation testing confirm that the APRO 45 Catheter conforms to the predefined specifications and meets the test acceptance criteria. A summary of the testing is shown in Table 2. | Table 2. Summary of Non-Clinical Bench Test Results | | | | --- | --- | --- | | Test | Acceptance Criteria | Conclusion | | Visual and Dimensional Characteristics | Catheter meets the visual and dimensional specifications. | The APRO 45 Catheter met the acceptance criteria. | | Particulate | Catheter meets the acceptance criteria. Subject device was evaluated with a predicate device under the same test conditions. | The APRO 45 Catheter met the acceptance criteria. | | Kink Resistance | Catheter shaft shall not kink at clinically relevant radii. | The APRO 45 Catheter met the acceptance criteria. | | Hub Air Leakage | Catheter does not leak air into hub assembly with methods specified in ISO 10555-1, Annex D. | The APRO 45 Catheter met the acceptance criteria. | | Hub Compatibility | Catheter meets the requirements specified in ISO 80369-7. | The APRO 45 Catheter met the acceptance criteria. | | Torque Strength | Catheter must withstand the minimum required number of rotations without breakage and without kinking compared to legally marketed devices. | The APRO 45 Catheter met the acceptance criteria. | | Dynamic Burst Pressure | No damage to catheter with dynamic pressure. | The APRO 45 Catheter met the acceptance criteria. | | Liquid Leakage | Catheter must withstand pressure with methods specified in ISO 10555-1, Annex C. | The APRO 45 Catheter met the acceptance criteria. | | Static Burst | Catheter must withstand pressures anticipated for clinical use. | The APRO 45 Catheter met the acceptance criteria. | | Hub and Shaft Tensile Strength | Catheter hub and shaft must meet tensile strength specification. | The APRO 45 Catheter met the acceptance criteria. | | Tip Tensile Strength | Catheter tip must meet tip tensile strength specification. | The APRO 45 Catheter met the acceptance criteria. | | 3-Point Bend | Catheter 3-Point Bend force must be acceptable. Forces were compared to the predicate. | The APRO 45 Catheter met the acceptance criteria. | | Delivery and Retrieval Force | Catheter delivery and retrieval force must be acceptable. Forces were compared to the predicate. | The APRO 45 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 45 Catheter met the acceptance criteria. | | Corrosion Resistance | Catheter shall show no signs of corrosion when tested in accordance with ISO 10555-1, Annex A. | The APRO 45 Catheter met the acceptance criteria. | {7} APRO 45 Catheter 510(k) Number: K251014 ## 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 45 Catheter is sterilized using an ethylene oxide sterilization cycle that was verified to a sterility assurance level of $1 \times 10^{-6}$ in accordance with ISO 11135. Aging studies for the APRO 45 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 45 Catheter as an externally communicating device with circulating blood contact for a limited ($\leq 24$ 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”.” | Table 3. Summary of Biocompatibility Test Results | | | | --- | --- | --- | | Test | Results | Conclusions | | Sensitization (Guinea Pig Maximization) | The APRO 45 Catheter did not elicit a sensitization response. | Non-sensitizing | | Irritation/Intracutaneous Reactivity | The APRO 45 Catheter demonstrated no evidence of irritation. | Non-irritant | | Cytotoxicity (MEM Elution, L929 cells) | The APRO 45 Catheter did not elicit a cytotoxic response at 24 hours and 48 hours. | Non-cytotoxic | | Hemolysis - Indirect | There were no significant differences between the test article extract and negative control article results. | Non-hemolytic | | Hemolysis - Direct | There were no differences between the hemolytic index of the test article and the negative control. | Non-hemolytic | | Thrombogenicity – Partial Thromboplastin Time (PTT) | The average clotting time of the test article was not significantly different from the vehicle and negative control. | Non-thrombogenic | | Thrombogenicity – Platelet Leukocyte Count | The test article performed similar to comparator and negative controls. | | | Thrombogenicity – Comparative Surface and Geometry Assessment | Comparative surface assessment using 40x optical microscopy at representative locations of the subject device and the predicate device did not find any differences in the roughness or presence of any defects. The subject device has similar surface morphology as the predicate device APRO 55 Catheter. | | | SC5b9 Complement Activation | The Sc5b9 concentration of the test article was statistically less than the positive control and was not statistically higher than the negative control. | Acceptable | | Acute Systemic Toxicity | No weight loss, mortality, or evidence of systemic toxicity from the extract exposure to the mice. | Non-toxic | {8} APRO 45 Catheter 510(k) Number: K251014 | Table 3. Summary of Biocompatibility Test Results | | | | --- | --- | --- | | Test | Results | Conclusions | | Material-Mediated Pyrogenicity | All individual rabbits for both the test article and negative control showed a total rise in temperature of < 0.5°C and were determined to 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. Page 5 of 5