(79 days)
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.
The APRO 55 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 55 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 55 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 55 Catheter is provided with an Introducer Sheath.
The provided document is a 510(k) summary for a medical device (APRO 55 Catheter) seeking FDA clearance, not a study report detailing acceptance criteria for an AI/ML device. Therefore, it does not contain information typically found in such a study, such as acceptance criteria for machine learning performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test sets in an AI context, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
The document describes non-clinical bench testing for a physical medical catheter, including mechanical, material, and biocompatibility tests. The "acceptance criteria" mentioned are for these engineering and biological tests, not for an AI/ML diagnostic or predictive model.
Therefore, I cannot fulfill your request for information related to AI/ML acceptance criteria and study details based on the provided text.
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March 15, 2024
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Alembic, LLC % Prithul Bom Most Responsible Person Regulatory Technology Services 1000 Westgate Drive, Suite #510k Saint Paul. Minnesota 55114
Re: K234115
Trade/Device Name: APRO 55 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: March 6, 2024 Received: March 6, 2024
Dear Prithul Bom:
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).
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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.
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,
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
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Indications for Use
510(k) Number (if known) K234115
Device Name APRO 55 Catheter
Indications for Use (Describe)
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.
| 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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary
510(k) Number: K234115
This 510(k) Summary is provided in accordance with the requirements of 21 CFR §807.92.
Submitter information 1)
Date Prepared:
| Submitter: | Alembic, LLC627 National Ave.Mountain View, CA 94043 |
|---|---|
| Contact: | Lisa YenDirector of Regulatory and QualityTelephone Number: (650) 388-5087Fax: (650) 390-0107Email: lyen@alembicllc.com |
March 13, 2024
2) Device Name and Classification
| Trade/Proprietary Name: | APRO® 55 Catheter |
|---|---|
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 21 CFR 870.1250Catheter, Percutaneous, Neurovasculature, 21 CFR 870.1250 |
| Regulatory Class: | Class II |
| Product Codes: | DQY, QJP |
| Review Panel: | Cardiovascular, Neurology |
3) Legally Marketed Predicate Device and Reference Device
| Predicate Device: | K151667 AXS Catalyst Distal Access Catheter |
|---|---|
| Reference Device: | K223545 APRO 70 Catheter and Alembic Aspiration Tubing |
4) Device Description
The APRO 55 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 55 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 55 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 55 Catheter is provided with an Introducer Sheath.
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5) Indications for Use
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.
6) Technological Characteristics Comparison
Alembic has demonstrated that the APRO 55 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 55 Catheter with the predicate device and reference device is summarized in Table 1 below.
| Category | Subject DeviceAPRO 55 Catheter | Predicate DeviceAXS Catalyst Distal AccessCatheter | Reference DeviceAPRO 70 Catheter andAlembic Aspiration Tubing |
|---|---|---|---|
| 510(k) Number | K234115 | K151667 | K223545 |
| Regulatory Class | Class II, 21 CFR 870.1250,DQY, QJP | Class II, 21 CFR 870.1250,DQY | Class II, 21 CFR 870.1250,NRY |
| Indications forUse | The APRO 55 Catheter isindicated for use infacilitating the insertion andguidance of appropriatelysized interventional devicesinto a selected blood vessel inthe peripheral andneurovascular systems. TheAPRO 55 Catheter is alsoindicated for use as a conduitfor retrieval devices. | The AXS Catalyst DistalAccess Catheter is indicated foruse in facilitating the insertionand guidance of appropriatelysized interventional devices intoa selected blood vessel in theperipheral and neurovascularsystems. The AXS CatalystDistal Access Catheter is alsoindicated for use as a conduitfor retrieval devices. | The APRO 70 Catheter with anaspiration pump and the AlembicAspiration Tubing is intended foruse in the revascularization ofpatients with acute ischemic strokesecondary to intracranial largevessel occlusive disease (within theinternal carotid, middle cerebral -M1 and M2 segments, basilar, andvertebral arteries) within 8 hours ofsymptom onset. Patients who areineligible for intravenous tissueplasminogen activator (IV t-PA) orwho fail IV t-PA therapy arecandidates for treatment.The Alembic Aspiration Tubing isintended to connect the APRO 70Catheter to the aspiration pump. |
| Materials | |||
| Hub | Nylon | Nylon | Polycarbonate |
| Adhesive | Cyanoacrylate | None | Cyanoacrylate |
| Strain Relief | Thermoplastic elastomer | Thermoplastic rubber | Thermoplastic elastomer |
| Liner | Polytetrafluoroethylene(PTFE)/Tecoflex composite | PTFE | PTFE/Tecoflex composite |
| Shaft Coil orBraid | 304V stainless steel braid304V stainless steel coil | Stainless steel with nitinol wireand polymer fiber | 304V stainless steel braid304V stainless steel coil |
| Extrusions | Thermoplastic polyurethanes,thermoplastic elastomer | Pebax, Nylon | Thermoplastic polyurethanes,thermoplastic elastomer |
| Marker Band | Platinum/ iridium | Platinum/ iridium | Platinum/ iridium |
| Adhesive | None | Cyanoacrylate | None |
| Coating | Hydrophilic coating, identical | Hydrophilic coating | Hydrophilic coating |
Table 1 - APRO 55 Catheter Comparison with the Predicate Device and Reference Device
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| Category | Subject DeviceAPRO 55 Catheter | Predicate DeviceAXS Catalyst Distal AccessCatheter | Reference DeviceAPRO 70 Catheter andAlembic Aspiration Tubing |
|---|---|---|---|
| to reference device | |||
| Dimensions | |||
| Proximal OuterDiameter | 0.066 inch | 5.6 F (0.073 inch)6.0 F (0.078 inch) | 0.083 inch |
| Distal OuterDiameter | 0.066 inch | 5.3 F (0.069 inch)5.4 F (0.070 inch) | 0.083 inch |
| Inner Diameter | 0.055 inch | 0.058 inch, 0.060 inch | 0.070 inch |
| Effective Lengths | 125, 137 cm | 115, 132 cm | 125, 132, 135 cm |
| Coated Length | 90, 102 cm | 65, 82 cm | 90, 97, 100 cm |
| Tip Shape | Straight | Straight | Straight |
| Accessories | |||
| Introducer Sheath | Yes | Yes | Yes |
| RotatingHemostasis Valve | None | Yes | None |
| Packaging Materials | |||
| Pouch | Nylon/polyethylene/ Tyvek | Nylon/polyethylene/ Tyvek | Nylon/polyethylene/ Tyvek |
| Packaging Tube | Polyethylene | Polyethylene | Polyethylene |
| Packaging Card | Yes | Yes | Yes |
| Shelf Carton | Solid bleached sulfatepaperboard | Solid bleached sulfatepaperboard | Solid bleached sulfatepaperboard |
| Other | |||
| Sterilization | Ethylene oxide | Ethylene oxide | Ethylene oxide |
| Shelf Life | 6 months | 2 years | 6 months |
| Use Conditions | Sterile, single use, disposable | Sterile, single use, disposable | Sterile, single use, disposable |
Performance Data 7)
Alembic performed non-clinical bench, sterility, shelf-life, and biocompatibility testing. The results demonstrate substantial equivalence of the APRO 55 Catheter to the legally marketed predicate device.
A. Design Verification Testing - Non-Clinical Bench
Performance testing was conducted to support the APRO 55 Catheter submission. The results of the design verification and validation testing performed confirm that the APRO 55 Catheter conforms to the predefined specifications and met test acceptance criteria. A summary of the testing is shown in Table 2.
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Visual and DimensionalCharacteristics | Catheter meets the visual and dimensionalspecifications. | The APRO 55 Catheter met theacceptance criteria. |
| Particulate | Catheter meets the acceptance criteria.Subject device was evaluated with apredicate device under the same testconditions. | The APRO 55 Catheter met theacceptance criteria. |
| Kink Resistance | Catheter shaft shall not kink at clinicallyrelevant radii. | The APRO 55 Catheter met theacceptance criteria. |
| Hub Air Leakage | Catheter does not leak air into hub | The APRO 55 Catheter met the |
Table 2 – Summary of Non-Clinical Bench Test Results
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| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Hub Compatibility | assembly with methods specified in ISO10555-1, Annex D. | acceptance criteria. |
| Torque Strength | Catheter meets the requirements specifiedin ISO 80369-7. | The APRO 55 Catheter met theacceptance criteria. |
| Dynamic Burst Pressure | Catheter must withstand the minimumrequired number of rotations withoutbreakage and without kinking compared tolegally marketed devices. | The APRO 55 Catheter met theacceptance criteria. |
| Liquid Leakage | No damage to catheter with dynamicpressure. | The APRO 55 Catheter met theacceptance criteria. |
| Static Burst | Catheter must withstand pressurewith methods specified in ISO 10555-1, Annex C. | The APRO 55 Catheter met theacceptance criteria. |
| Hub and Shaft TensileStrength | Catheter must withstand pressuresanticipated for clinical use. | The APRO 55 Catheter met theacceptance criteria. |
| Tip Tensile Strength | Catheter hub and shaft must meet tensilestrength specification. | The APRO 55 Catheter met theacceptance criteria. |
| Tip Buckling Force | Catheter tip must meet tip tensile strengthspecification. | The APRO 55 Catheter met theacceptance criteria. |
| Delivery and RetrievalForce | Catheter tip buckling force must beacceptable. Forces were compared to apredicate. | The APRO 55 Catheter met theacceptance criteria. |
| Simulated Use | Catheter delivery and retrieval force mustbe acceptable. Forces were compared to apredicate. | The APRO 55 Catheter met theacceptance criteria. |
| When used per the Instructions for Usewith accessory devices in an anatomicalneurovascular model, the Catheter mustmeet functionality specifications. | The APRO 55 Catheter met theacceptance 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 55 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 55 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 55 Catheter in accordance with ISO 10993-1 and the device is deemed non-toxic (local or systemic), non-sensitizing, not locally irritating or otherwise harmful. Test results obtained were acceptable for the intended
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use as shown in Table 3. The thrombogenicity evaluation of the APRO 55 Catheter was supplemented by the prior in vivo thrombogenicity evaluation of the reference device, APRO 70 Catheter, in a good laboratory practice animal study.
| Test | Results | Conclusions |
|---|---|---|
| Sensitization(Guinea Pig Maximization) | The APRO 55 Catheter did not elicit asensitization response. | Non-sensitizing |
| Irritation/IntracutaneousReactivity | The APRO 55 Catheter demonstrated noevidence of irritation. | Non-irritant |
| Cytotoxicity(MEM Elution, L929 cells) | The APRO 55 Catheter did not elicit acytotoxic response at 24 hours and 48 hours. | Non-cytotoxic |
| Hemolysis - Indirect | There were no significant differences betweenthe test article extract and negative controlarticle results. | Non-hemolytic |
| Hemolysis - Direct | There were no differences between thehemolytic index of the test article and thenegative control. | Non-hemolytic |
| Partial ThromboplastinTime (PTT) | The average clotting time of the test article wasgreater than vehicle control and negativecontrol. | Acceptable clottingtimes |
| SC5b9 ComplementActivation | The Sc5b9 concentration of the test article wasstatistically less than the positive control and wasnot statistically higher than the negative control. | Acceptable |
| Acute Systemic Toxicity | No weight loss, mortality, or evidence ofsystemic toxicity from the extract exposure tothe mice. | Non-toxic |
| Material-MediatedPyrogenicity | All individual rabbits for both the test articleand negative control showed a total rise intemperature of < 0.5 °C and were determined tobe nonpyrogenic. | Non-pyrogenic |
Table 3 - Biocompatibility Test Results
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.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).