(84 days)
No
The description focuses on the mechanical aspects of the catheter and aspiration system, with no mention of AI or ML for image analysis, decision support, or any other function.
Yes
The device is intended for revascularization and thrombus removal in patients with acute intracranial large vessel occlusive disease, which is a direct treatment for a medical condition.
No
The device is intended for the revascularization of patients with acute intracranial large vessel occlusive disease by removing thrombus, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components like a catheter, tubing, and mentions use with an aspiration pump, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to physically remove thrombus from blood vessels in patients with acute stroke. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a catheter designed for aspiration within the vasculature. It is a medical device used for treatment, not for analyzing samples taken from the body.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples (blood, tissue, etc.) to diagnose a condition or provide information about a patient's health status. Its function is purely mechanical removal of a blockage.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (inside the body) for therapeutic purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NRY
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic visualization
Anatomical Site
intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary.
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.
Design Verification Testing – Non-Clinical Bench: The APRO 70 Catheter and Alembic Aspiration Tubing conform to the predefined specifications and meet test acceptance criteria in various tests including Visual and Dimensional Characteristics, Particulate, Vacuum Integrity, Kink Resistance, Catheter Hub Leakage, Catheter Torque Strength, Dynamic Burst Pressure, Fluid Leakage, Static Burst (Rupture), Tensile Strength of Catheter Hub and Shaft, Tensile Strength of Catheter Tip, Tensile Strength of Aspiration Tubing, Simulated Use, Usability, Corrosion Resistance, Delivery and Retrieval Force, and Tip Buckling Force.
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.
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 10^6 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.
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. Specific tests include: Sensitization (Guinea Pig and Maximization), Irritation/Intracutaneous Reactivity, Cytotoxicity (MEM Elution, L929 cells), Hemolysis (Indirect and Direct), Partial Thromboplastin Time (PTT), SC5b9 Complement Activation, Thrombogenicity, Acute Systemic Toxicity, and Material-Mediated Pyrogenicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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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, LLC
627 National Ave.
Mountain View, CA 94043 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lisa Yen
Director of Regulatory and Quality
Telephone Number: (650) 388-5087
Fax: (650) 390-0107
Email: 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 and | |||
| Alembic Aspiration Tubing | Penumbra System ACE | ||
| 68 Reperfusion Catheter | |||
| (K142458) | SOFIA Plus Aspiration | ||
| Catheter (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 |
| Device | |||
| Characteristic | Subject Device | ||
| APRO 70 Catheter and | |||
| Alembic Aspiration Tubing | Predicate Device | ||
| Penumbra System ACE | |||
| 68 Reperfusion Catheter | |||
| (K142458) | Reference Device | ||
| SOFIA Plus Aspiration | |||
| Catheter (K173200) | |||
| Indication 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. | The Penumbra System 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. | |||
| The Reperfusion Catheters | |||
| ACE 64 and ACE 68 are | |||
| intended for use in | |||
| revascularization within | |||
| the Internal Carotid Artery | |||
| (ICA) within 8 hours of | |||
| symptom onset. | The SOFIA Plus Aspiration | ||
| Catheter with the Gomco 405 | |||
| Aspiration Pump and | |||
| MicroVention Tubing Kit 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. | |||
| Principles of | |||
| Operation | Using conventional | ||
| catheterization techniques | |||
| under fluoroscopic guidance, | |||
| advance the catheter into the | |||
| target vessel over an | |||
| appropriate neurovascular | |||
| guidewire. Position the | |||
| catheter proximal to the | |||
| thrombus to aspirate. | Same as subject device | Same as subject device | |
| Accessory Devices | |||
| Provided | Introducer sheath | Peelable sheath, rotating | |
| hemostasis valve, shaping | |||
| mandrel | Introducer sheath, | ||
| shaping mandrel | |||
| Materials | |||
| Hub | Polycarbonate | Nylon (Grilamid) | Nylon (Grilamid) |
| Strain Relief | Santoprene (thermoplastic | ||
| elastomer) | Nylon (Grilamid) / 304 | ||
| stainless steel | Polyurethane | ||
| Liner | Polytetrafluoroethylene | ||
| (PTFE)/Tecoflex composite | Not described | Polytetrafluoroethylene/ | |
| polyolefin elastomer | |||
| Shaft Coil and | |||
| Braid | 304V stainless steel braid | ||
| 304V stainless steel coil | 304V stainless steel braid | ||
| nitinol coil | Stainless steel braid | ||
| Stainless 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 | Thermoplastic | ||
| polyurethane (Pellethane | |||
| and Tecoflex), polyether | |||
| block 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 Outer | |||
| Diameter (OD) | 0.083 inch | 0.084 inch max | Same as subject device |
| Proximal Inner | |||
| Diameter (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, 132 | |
| cm | 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 sulfate | ||
| paperboard | 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 length | ||
| Tubing ID = 0.110 inch | 112 inch length | ||
| Tubing ID=0.110 inch | 112 inch length | ||
| Tubing 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 the | |||
| Instructions for Use with | |||
| accessory devices in an | |||
| anatomical neurovascular model | |||
| and compared to a predicate. | 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. |
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 sensitization | |
| Response. | 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/Intracutaneous | ||
| Reactivity | The APRO Catheter demonstrated no evidence of irritation. | Non-Irritant |
| The Alembic Aspiration Tubing demonstrated no evidence of irritation. | Non-Irritant | |
| Cytotoxicity | ||
| (MEM Elution, L929 | ||
| cells) | 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 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 |