(84 days)
The APRO 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Alembic Aspiration Tubing is intended to connect the APRO 70 Catheter to the aspiration pump.
The APRO 70 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 70 Catheter targets aspiration from the suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 70 Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 70 Catheter is available in lengths of 125 cm, and 135 cm and is provided with an introducer sheath.
The Alembic Aspiration Tubing connects the APRO 70 Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.
The provided text describes the acceptance criteria and performance data for the APRO 70 Catheter and Alembic Aspiration Tubing. However, it does not contain information about a study proving device performance in the context of AI/ML or human reader performance. The device described is a medical catheter and aspiration tubing, not an AI/ML diagnostic or assistive device. Therefore, questions related to AI/ML specific acceptance criteria, test set characteristics (ground truth, expert adjudication, sample size for test/training sets with medical images), and MRMC studies are not applicable this document.
Here's the relevant information based on the provided text, focusing on the mechanical and biological aspects of the device, and addressing the applicable parts of your request.
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| Visual and Dimensional Characteristics | Catheter meets the visual and dimensional specifications.Introducer Sheath meets the visual and dimensional specifications.Aspiration Tubing meets the visual and dimensional specifications. | The APRO 70 Catheter met the acceptance criteria.The Introducer Sheath met the acceptance criteria.The Alembic Aspiration Tubing 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 70 Catheter met the acceptance criteria. |
| Vacuum Integrity | Catheter with Aspiration Tubing is free from collapse and loss of vacuum between aspiration source and catheter tip. | The APRO 70 Catheter and Alembic Aspiration Tubing met the acceptance criteria. |
| Kink Resistance | Catheter distal shaft shall not kink. | The APRO 70 Catheter met the acceptance criteria. |
| Catheter Hub Leakage | Catheter does not leak into hub assembly during aspiration, with methods specified in ISO 10555-1, Annex D. | The APRO 70 Catheter met the acceptance criteria. |
| Catheter Torque Strength | Catheter must withstand the minimum required number of rotations without breakage. | The APRO 70 Catheter met the acceptance criteria. |
| Dynamic Burst Pressure | No damage to catheter with dynamic pressure. | The APRO 70 Catheter met the acceptance criteria. |
| Fluid Leakage | Catheter must withstand pressure with methods specified in ISO 10555-1, Annex C. | The APRO 70 Catheter met the acceptance criteria. |
| Static Burst (Rupture) | Catheter must withstand pressures anticipated for clinical use. | The APRO 70 Catheter met the acceptance criteria. |
| Tensile Strength of Catheter Hub and Shaft | Catheter hub and shaft must meet tensile strength specification. | The APRO 70 Catheter met the acceptance criteria. |
| Tensile Strength of Catheter Tip | Catheter tip must meet tip tensile strength specification. | The APRO 70 Catheter met the acceptance criteria. |
| Tensile Strength of Aspiration Tubing | Aspiration Tubing junction must meet tensile strength specification. | The Alembic Aspiration Tubing met the acceptance criteria. |
| Simulated Use | When used per the Instructions for Use with accessory devices in an anatomical neurovascular model, the Catheter and Aspiration Tubing must meet functionality specifications. | The APRO 70 Catheter and Alembic Aspiration Tubing met the acceptance criteria. |
| Usability | The Catheter and Aspiration Tubing were used per the Instructions for Use with accessory devices in an anatomical neurovascular model and compared to a predicate. | The APRO 70 Catheter and Alembic Aspiration Tubing met the acceptance criteria. |
| Corrosion Resistance | Catheter must be corrosion resistant per ISO 10555-1, Annex A. | The APRO 70 Catheter met the acceptance criteria. |
| Delivery and Retrieval Force | Catheter delivery and retrieval force must be acceptable. Forces were compared to a predicate. | The APRO 70 Catheter met the acceptance criteria. |
| Tip Buckling Force | Catheter tip buckling force must be acceptable. Forces were compared to a predicate. | The APRO 70 Catheter met the acceptance criteria. |
| Sensitization (Guinea Pig) | Did not elicit a sensitization response. | Non-sensitizing |
| Irritation/Intracutaneous Reactivity | Demonstrated no evidence of irritation. | Non-Irritant |
| Cytotoxicity (MEM Elution, L929 cells) | Did not elicit a cytotoxic response at 24 hours and 48 hours. | Non-cytotoxic |
| Hemolysis - Indirect | No significant differences between the test article and the negative control. | Non-Hemolytic |
| Hemolysis - Direct | No differences between the hemolytic index of the test article and the negative control. | Non-Hemolytic |
| Partial Thromboplastin Time (PTT) | The average clotting time of the test article was greater than vehicle control and negative control. | Acceptable clotting times |
| SC5b9 Complement Activation | Acceptable - during use, the circulating blood dilutes by over 800X the exposure during the test, providing assurance that the use of the APRO 70 Catheter will not constitute a complement activation safety concern. | Acceptable |
| Thrombogenicity | No significant thrombus was observed on any of the subject catheters, and the device was determined to not show thrombogenic potential. | Non-thrombogenic |
| Acute Systemic Toxicity | No weight loss, mortality, or evidence of systemic toxicity from the extract exposure to the mice. | Non-toxic |
| 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 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing: The text does not specify sample sizes (number of units tested) for each individual bench test. The source of this data is internal testing by Alembic, LLC.
- Animal Testing: Conducted on a "porcine model under Good Laboratory Practices (GLP)." The specific number of animals is not provided. This is prospective animal data.
- Biocompatibility Testing: The text does not specify sample sizes (e.g., number of guinea pigs for sensitization, number of rabbits for pyrogenicity). The provenance of this data is internal testing by Alembic, LLC.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The studies described are non-clinical (bench and animal) and do not involve human expert interpretation of medical images or data from a test set to establish ground truth in the context of an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there is no mention of human expert adjudication for a test set in the context of an AI/ML device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. No MRMC study was conducted, as this device is a physical medical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is established by direct measurement against predefined specifications, observation of physical properties, and biological responses in animal and in-vitro models according to established laboratory protocols and standards (e.g., ISO, GLP). Examples include:
- Bench Testing: Direct measurements (dimensions, forces, leak rates), visual inspection for defects, functional assessment in simulated models.
- Animal Testing: Direct observation (fluoroscopy, compatibility), pathological assessment (histology), and functional evaluation (clot aspiration effectiveness) in a live biological system.
- Biocompatibility: Standardized biological tests assessing specific endpoints like sensitization, irritation, cytotoxicity, hemolysis, and systemic toxicity.
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device, so there is no training set for an algorithm.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set for an algorithm.
{0}------------------------------------------------
February 17, 2023
Image /page/0/Picture/1 description: The image shows 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, with the letters "FDA" in a blue square. To the right of that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Alembic, LLC Lisa Yen Director of Regulatory and Quality 627 National Avenue Mountain View, California 94043
Re: K223545
Trade/Device Name: APRO 70 Catheter and Alembic Aspiration Tubing Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: November 23, 2022 Received: November 25, 2022
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 (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. 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.
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
{1}------------------------------------------------
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 (QS) 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,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K223545
Device Name
APRO 70 Catheter and Alembic Aspiration Tubing
Indications for Use (Describe)
The APRO 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Alembic Aspiration Tubing is intended to connect the APRO 70 Catheter to the aspiration pump.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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."
{3}------------------------------------------------
510(k) Summary
510(k) Number:
This 510(k) Summary is provided in accordance with the requirements of 21 CFR §807.92.
1) Submitter information
| 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 |
Date Prepared: February 16, 2023
2) Device Name and Classification
| Trade/Proprietary Name: | APRO TM 70 Catheter and Alembic Aspiration Tubing |
|---|---|
| Common Name: | Catheter, Thrombus Retriever |
| Classification Name: | Percutaneous Catheter, 21 CFR 870.1250 |
| Regulatory Class: | Class II |
| Product Code: | NRY |
| Review Panel: | Neurology |
3) Legally Marketed Predicate and Reference Devices
| Primary Predicate Device: | K142458 Penumbra System ACE 68 Reperfusion Catheter |
|---|---|
| Reference Device: | K173200 SOFIA Plus Aspiration Catheter |
4) Device Description
The APRO 70 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO
{4}------------------------------------------------
70 Catheter targets aspiration from the suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire under fluoroscopic visualization to the site of the primary occlusion. The distal shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. For the aspiration source, the APRO 70 Catheter is used in conjunction with an aspiration pump with pre-specified performance parameters that is connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 70 Catheter is available in lengths of 125 cm, and 135 cm and is provided with an introducer sheath.
The Alembic Aspiration Tubing connects the APRO 70 Catheter to the aspiration pump. The flow control valve allows control of the aspiration flow using an ON/OFF switch. It is available in one size.
5) Indications for Use
The APRO 70 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Alembic Aspiration Tubing is intended to connect the APRO 70 Catheter to the aspiration pump.
6) Technological Characteristics Comparison
Alembic has demonstrated the APRO 70 Catheter and Alembic Aspiration Tubing are 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 Catheter and Alembic Aspiration Tubing with the predicate device is summarized in Table 1 below.
| Device Characteristic | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| APRO 70 Catheter andAlembic Aspiration Tubing | Penumbra System ACE68 Reperfusion Catheter(K142458) | SOFIA Plus AspirationCatheter (K173200) | |
| Regulatory Class | II, 21 CFR 870.1250 | Same as subject device | Same as subject device |
| Product Code | NRY | Same as subject device | Same as subject device |
| DeviceCharacteristic | Subject DeviceAPRO 70 Catheter andAlembic Aspiration Tubing | Predicate DevicePenumbra System ACE68 Reperfusion Catheter(K142458) | Reference DeviceSOFIA Plus AspirationCatheter (K173200) |
| Indication for Use | The APRO 70 Catheter withan aspiration pump and theAlembic Aspiration Tubing isintended for use in therevascularization of patientswith acute ischemic strokesecondary to intracranial largevessel occlusive disease(within the internal carotid,middle cerebral - M1 and M2segments, basilar, andvertebral arteries) within 8hours of symptom onset.Patients who are ineligible forintravenous tissueplasminogen activator (IV t-PA) or who fail IV t-PAtherapy are candidates fortreatment.The Alembic AspirationTubing is intended to connectthe APRO 70 Catheter to theaspiration pump. | The Penumbra System isintended for use in therevascularization ofpatients with acuteischemic stroke secondaryto intracranial large vesselocclusive disease (withinthe internal carotid, middlecerebral - M1 and M2segments, basilar, andvertebral arteries) within 8hours of symptom onset.The Reperfusion CathetersACE 64 and ACE 68 areintended for use inrevascularization withinthe Internal Carotid Artery(ICA) within 8 hours ofsymptom onset. | The SOFIA Plus AspirationCatheter with the Gomco 405Aspiration Pump andMicroVention Tubing Kit isintended for use in therevascularization of patientswith acute ischemic strokesecondary to intracraniallarge vessel occlusive disease(within the internal carotid,middle cerebral - M1 and M2segments, basilar, andvertebral arteries) within 8hours of symptom onset.Patients who are ineligiblefor intravenous tissueplasminogen activator (IV t-PA) or who fail IV t-PAtherapy are candidates fortreatment. |
| Principles ofOperation | Using conventionalcatheterization techniquesunder fluoroscopic guidance,advance the catheter into thetarget vessel over anappropriate neurovascularguidewire. Position thecatheter proximal to thethrombus to aspirate. | Same as subject device | Same as subject device |
| Accessory DevicesProvided | Introducer sheath | Peelable sheath, rotatinghemostasis valve, shapingmandrel | Introducer sheath,shaping mandrel |
| Materials | |||
| Hub | Polycarbonate | Nylon (Grilamid) | Nylon (Grilamid) |
| Strain Relief | Santoprene (thermoplasticelastomer) | Nylon (Grilamid) / 304stainless steel | Polyurethane |
| Liner | Polytetrafluoroethylene(PTFE)/Tecoflex composite | Not described | Polytetrafluoroethylene/polyolefin elastomer |
| Shaft Coil andBraid | 304V stainless steel braid304V stainless steel coil | 304V stainless steel braidnitinol coil | Stainless steel braidStainless steel coil |
| Device | Subject Device | Predicate Device | Reference Device |
| Characteristic | APRO 70 Catheter and | Penumbra System ACE | SOFIA Plus Aspiration |
| Alembic Aspiration Tubing | 68 Reperfusion Catheter(K142458) | Catheter (K173200) | |
| Extrusions | Thermoplastic polyurethanes,thermoplastic elastomer | Thermoplasticpolyurethane (Pellethaneand Tecoflex), polyetherblock amide (Pebax),polyamide (Vestamid) | Polyurethane elastomer(polyblend and Pellethane),polyether block amide(Pebax), polyamide(Grilamid) |
| Marker band | Platinum/ iridium | Same as subject device | Same as subject device |
| Coating | Hydrophilic coating | Same as subject device | Same as subject device |
| Dimensions | |||
| Proximal OuterDiameter (OD) | 0.083 inch | 0.084 inch max | Same as subject device |
| Proximal InnerDiameter (ID) | 0.070 inch | 0.068 inch min | Same as subject device |
| Distal OD | 0.083 inch | 0.084 inch max | 0.082 inch |
| Distal ID | 0.070 inch | 0.068 inch min | Same as subject device |
| Effective Lengths | 125, 132, 135 cm | 115, 120, 125, 127, 132cm | 125 - 131 cm |
| Coated Length | 90, 97, 100 cm | 30 cm | Unknown |
| Tip Shape | Straight | Same as subject device | Same as subject device |
| Accessories | |||
| Peelable Sheath | Pebax | PTFE | Same as subject device |
| Packaging Materials | |||
| Pouch | Nylon/polyethylene/Tyvek | Polyester/polyethylene/Tyvek | Polyester/polyethylene/Tyvek |
| Packaging Tube | High density polyethylene | Polyethylene | Polyethylene |
| Packaging Card | High density polyethylene | Polyethylene | Polyethylene |
| Display Carton | Solid bleached sulfatepaperboard | Same as subject device | Same as subject device |
| Other | |||
| Sterilization | Ethylene oxide | Same as subject device | Same as subject device |
| Shelf-Life | 6 months | 36 months | 36 months |
| Use | Single use, disposable | Same as subject device | Same as subject device |
| Alembic Aspiration Tubing | |||
| Aspiration Tubing | 110 inch lengthTubing ID = 0.110 inch | 112 inch lengthTubing ID=0.110 inch | 112 inch lengthTubing ID = 0.110 inch |
Table 1 - APRO 70 Catheter and Alembic Aspiration Tubing Comparison with the Predicate and Reference Devices
{5}------------------------------------------------
{6}------------------------------------------------
7) Performance Data
A. Testing Summary
Alembic performed non-clinical bench, animal, sterility, shelf-life, and biocompatibility testing. The results demonstrate substantial equivalence of the APRO 70 Catheter and Alembic Aspiration Tubing to the legally marketed predicate device.
B. Design Verification Testing – Non-Clinical Bench
Performance testing was conducted to support the APRO 70 Catheter and Alembic Aspiration
{7}------------------------------------------------
Tubing submission. The results of the design verification and validation testing performed confirm that the APRO 70 Catheter and Alembic Aspiration Tubing conform to the predefined specifications and meet test acceptance criteria. Testing is shown in Table 2.
| Test | Acceptance Criteria | Conclusion | |
|---|---|---|---|
| Visual and Dimensional Characteristics | Catheter meets the visual and dimensional specifications.Introducer Sheath meets the visual and dimensional specifications.Aspiration Tubing meets the visual and dimensional specifications. | The APRO 70 Catheter met the acceptance criteria.The Introducer Sheath met the acceptance criteria.The Alembic Aspiration Tubing 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 70 Catheter met the acceptance criteria. | |
| Vacuum Integrity | Catheter with Aspiration Tubing is free from collapse and loss of vacuum between aspiration source and catheter tip. | The APRO 70 Catheter and Alembic Aspiration Tubing met the acceptance criteria. | |
| Kink Resistance | Catheter distal shaft shall not kink. | The APRO 70 Catheter met the acceptance criteria. | |
| Catheter Hub Leakage | Catheter does not leak into hub assembly during aspiration, with methods specified in ISO 10555-1, Annex D. | The APRO 70 Catheter met the acceptance criteria. | |
| Catheter Torque Strength | Catheter must withstand the minimum required number of rotations without breakage. | The APRO 70 Catheter met the acceptance criteria. | |
| Dynamic Burst Pressure | No damage to catheter with dynamic pressure. | The APRO 70 Catheter met the acceptance criteria. | |
| Fluid Leakage | Catheter must withstand pressure with methods specified in ISO 10555-1, Annex C. | The APRO 70 Catheter met the acceptance criteria. | |
| Static Burst (Rupture) | Catheter must withstand pressures anticipated for clinical use. | The APRO 70 Catheter met the acceptance criteria. | |
| Tensile Strength of Catheter Hub and Shaft | Catheter hub and shaft must meet tensile strength specification. | The APRO 70 Catheter met the acceptance criteria. | |
| Tensile Strength of Catheter Tip | Catheter tip must meet tip tensile strength specification. | The APRO 70 Catheter met the acceptance criteria. | |
| Tensile Strength of Aspiration Tubing | Aspiration Tubing junction must meet tensile strength specification. | The Alembic Aspiration Tubing met the acceptance criteria. | |
| Simulated Use | When used per the Instructions for Use with accessory devices in an anatomical neurovascular model, the Catheter and Aspiration Tubing must meet functionality specifications. | The APRO 70 Catheter and Alembic Aspiration Tubing met the acceptance criteria. | |
| Usability | The Catheter and Aspiration | The APRO 70 Catheter and | |
| Test | Acceptance Criteria | Conclusion | |
| Tubing were used per theInstructions for Use withaccessory devices in ananatomical neurovascular modeland compared to a predicate. | Alembic Aspiration Tubing met theacceptance criteria. | ||
| Corrosion Resistance | Catheter must be corrosionresistant per ISO 10555-1, AnnexA. | The APRO 70 Catheter met theacceptance criteria. | |
| Delivery and Retrieval Force | Catheter delivery and retrievalforce must be acceptable. Forceswere compared to a predicate. | The APRO 70 Catheter met theacceptance criteria. | |
| Tip Buckling Force | Catheter tip buckling force mustbe acceptable. Forces werecompared to a predicate. | The APRO 70 Catheter met theacceptance criteria. |
Table 2 – Summary of Non-Clinical Bench Test Results
{8}------------------------------------------------
C. Design Verification Testing - Animal
Non-clinical animal testing comparing the safety, usability, and performance of the APRO 70 Catheter and Alembic Aspiration Tubing to the Penumbra System ACE 68 Reperfusion Catheter was conducted on a porcine model under Good Laboratory Practices (GLP). Subchronic (3-day) and chronic (30-day) time points were assessed. Device visibility under fluoroscopy and compatibility with ancillary devices were comparable between test and control devices and acceptable. No thrombus was noted on any of the APRO 70 Catheters or on the predicate Penumbra System ACE 68 Reperfusion Catheters during thrombogenicity assessment. Experimental clot aspiration was comparable and effective with both the APRO 70 Catheter and the predicate Penumbra System ACE 68 Reperfusion Catheter. Both catheters were shown to be safe to use in porcine vessels via angiography and vessel histology.
D. Sterilization and Shelf-Life
The APRO 70 Catheter and the Alembic Aspiration Tubing are sterilized using an ethylene oxide sterilization cycle that was verified to a sterility assurance level of 1 x 106 in accordance with ISO 11135. Aging studies for the APRO 70 Catheter and Alembic Aspiration Tubing have established that the subject device and packaging remain functional for the labeled expiration date. Aging studies for packaging integrity, seal strength, and device functionality were performed and met the acceptance criteria.
E. Biocompatibility
Biocompatibility testing has been completed for the APRO 70 Catheter and Alembic Aspiration Tubing 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 use as shown in Table 3.
| Test | Results | Conclusions |
|---|---|---|
| Sensitization(Guinea Pig) | The APRO Catheter did not elicit a sensitizationResponse. | Non-sensitizing |
Table 3 - Biocompatibility Test Results
{9}------------------------------------------------
| Test | Results | Conclusions |
|---|---|---|
| Maximization) | The Alembic Aspiration Tubing did not elicit a sensitization response. | Non-sensitizing |
| Irritation/IntracutaneousReactivity | The APRO Catheter demonstrated no evidence of irritation. | Non-Irritant |
| The Alembic Aspiration Tubing demonstrated no evidence of irritation. | Non-Irritant | |
| Cytotoxicity(MEM Elution, L929cells) | The APRO 70 Catheter did not elicit a cytotoxic response at 24 hours and 48 hours. | Non-cytotoxic |
| The Alembic Aspiration Tubing did not elicit a cytotoxic response. | Non-cytotoxic | |
| Hemolysis - Indirect | There were no significant differences between the test article and the negative control. | Non-Hemolytic |
| Hemolysis - Direct | There were no differences between the hemolytic index of the test article and the negative control. | Non-Hemolytic |
| Partial ThromboplastinTime (PTT) | The average clotting time of the test article was greater than vehicle control and negative control. | Acceptable clottingtimes |
| SC5b9 ComplementActivation | Acceptable - during use, the circulating blood dilutes by over 800X the exposure during the test, providing assurance that the use of the APRO 70 Catheter will not constitute a complement activation safety concern. | Acceptable |
| Thrombogenicity | No significant thrombus was observed on any of the subject catheters, and the device was determined to not show thrombogenic potential. | Non-thrombogenic |
| Acute SystemicToxicity | No weight loss, mortality, or evidence of systemic toxicity from the extract exposure to the mice. | Non-toxic |
| Material-MediatedPyrogenicity | 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 |
F. 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).