(28 days)
Not Found
No
The document describes a physical medical device (catheter and tubing) for aspiration, and there is no mention or indication of any software, algorithms, or intelligent processing being part of the device itself. The device relies on a physical aspiration pump.
Yes
The device is intended for the revascularization of patients with acute ischemic stroke by removing thrombus, which directly treats a medical condition.
No
This device is intended for the revascularization of patients with acute ischemic stroke by removing thrombus through aspiration with a catheter, not for diagnosing medical conditions.
No
The device is a physical medical device (catheter and tubing) intended for use in revascularization procedures. The description clearly details hardware components, physical properties, and bench/animal testing, none of which are characteristic of a software-only medical device.
No.
The device is an interventional medical device used for revascularization in acute ischemic stroke, indicated for direct interaction with the human circulatory system (intracranial vessels) to remove thrombus. IVDs are used for in-vitro examination of specimens derived from the human body, not for direct therapeutic intervention within the body.
N/A
Intended Use / Indications for Use
The APRO 45 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Alembic Aspiration Tubing is intended to connect the APRO 45 Catheter to the aspiration pump.
Product codes
NRY
Device Description
The APRO 45 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 45 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 45 Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 45 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 45 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 45 Catheter is available in lengths of 115, 125, 146, and 160 cm and is provided with an introducer sheath. The APRO 45 Catheter contains animal derived materials made from tallow derivatives.
The Alembic Aspiration Tubing connects the APRO 45 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
Alembic performed non-clinical bench, sterility, shelf-life, and biocompatibility testing. The results demonstrate substantial equivalence of the subject APRO 45 Catheter and Alembic Aspiration Tubing to the legally marketed predicate device.
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 performs as intended. Tests included Visual and Dimensional Characteristics, Particulate, Vacuum Integrity, Kink Resistance, Catheter Hub Leakage, Hub Compatibility, Catheter Torque Strength, Dynamic Burst Pressure, Liquid Leakage, Static Burst, Tensile Strength of Catheter Hub and Shaft, Tensile Strength of Catheter Tip, Delivery and Retrieval Force, 3-Point Bend, Simulated Use including Clot Retrieval, and Corrosion Resistance. The APRO 45 Catheter and Alembic Aspiration Tubing met all acceptance criteria.
Design Verification Testing – Animal: Substantial equivalence was established based on non-clinical bench performance data. Animal testing data were not deemed necessary.
Sterilization and Shelf-Life: The APRO 45 Catheter and 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 45 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 the device functionality were performed and met the acceptance criteria.
Biocompatibility: Biocompatibility testing has been completed for the APRO 45 Catheter as an externally communicating device with circulating blood contact for a limited (≤ 24 hours) duration in accordance with ISO 10993-1 and the FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"." Tests included Sensitization (Guinea Pig Maximization - Non-sensitizing), Irritation/Intracutaneous Reactivity (Non-irritant), Cytotoxicity (MEM Elution, L929 cells - Non-cytotoxic), Hemolysis - Indirect (Non-hemolytic), Hemolysis - Direct (Non-hemolytic), Thrombogenicity – Partial Thromboplastin Time (PTT - Non-thrombogenic), Thrombogenicity – Platelet Leukocyte Count, Thrombogenicity – Comparative Surface and Geometry Assessment (similar surface morphology to predicate), SC5b9 Complement Activation (Acceptable), Acute Systemic Toxicity (Non-toxic), and Material-Mediated Pyrogenicity (Non-pyrogenic).
Clinical Testing: Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
FDA 510(k) Clearance Letter - APRO 45 Catheter and Alembic Aspiration Tubing
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 30, 2025
Alembic, LLC
Stina Almaleh
Regulatory and Quality Engineer
627 National Avenue
Mountain View, California 94043
Re: K251015
Trade/Device Name: APRO 45 Catheter and Alembic Aspiration Tubing
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: NRY
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.
Page 2
K251015 - 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-
Page 3
K251015 - 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
Page 4
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): K251015
Device Name: APRO 45 Catheter and Alembic Aspiration Tubing
Indications for Use (Describe)
The APRO 45 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Alembic Aspiration Tubing is intended to connect the APRO 45 Catheter to the aspiration pump.
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."
Page 5
APRO® 45 Catheter and Alembic Aspiration Tubing 510(k) Summary
510(k) Number: K251015
Page 1 of 6
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) 388-5088
Date Prepared: April 28, 2025
2) Device Name and Classification
Trade/Proprietary Name: APRO® 45 Catheter and Alembic Aspiration Tubing
Common Name: Catheter, Thrombus Retriever
Classification Name: Percutaneous Catheter, 21 CFR 870.1250
Regulatory Class: Class II
Product Codes: NRY
Review Panel: Neurology
3) Legally Marketed Predicate Device
Predicate Device: K232971 APRO® 55 Catheter and Alembic Aspiration Tubing
4) Device Description
The APRO 45 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 45 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 45 Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 45 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 45 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 45 Catheter is available in lengths of 115, 125, 146, and 160 cm and is provided with an introducer sheath. The APRO 45 Catheter contains animal derived materials made from tallow derivatives.
The Alembic Aspiration Tubing connects the APRO 45 Catheter to the aspiration pump. The
Page 6
APRO® 45 Catheter and Alembic Aspiration Tubing
510(k) Number: K251015
Page 2 of 6
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 45 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Alembic Aspiration Tubing is intended to connect the APRO 45 Catheter to the aspiration pump.
6) Technological Characteristics Comparison
Alembic has demonstrated that the APRO 45 Catheter and Alembic Aspiration Tubing are substantially equivalent to the predicate device APRO 55 Catheter and Alembic Aspiration Tubing 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. There are no changes to the Alembic Aspiration Tubing compared to that included as part of the K232971 submission.
Table 1. APRO 45 Catheter and Alembic Aspiration Tubing Comparison with the Predicate Device
| Category | Subject Device
APRO 45 Catheter and Alembic Aspiration Tubing | Predicate Device
APRO 55 Catheter and Alembic Aspiration Tubing |
|----------|-------------------------------------------------------------------|---------------------------------------------------------------------|
| 510(k) Number | K251015 | K232971 |
| Regulatory Class | Identical to predicate. | Class II, 21 CFR 870.1250, NRY |
| Indications for Use | The APRO 45 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Alembic Aspiration Tubing is intended to connect the APRO 45 Catheter to the aspiration pump. | The APRO 55 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 55 Catheter to the aspiration pump. |
| Principles of Operation | Same as predicate. | Using conventional catheterization techniques under fluoroscopic guidance, the catheter is advanced into the target vessel over an appropriate neurovascular guidewire. The catheter is positioned proximal to the thrombus to aspirate. |
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APRO® 45 Catheter and Alembic Aspiration Tubing
510(k) Number: K251015
Page 3 of 6
Table 1. APRO 45 Catheter and Alembic Aspiration Tubing Comparison with the Predicate Device
| Category | Subject Device
APRO 45 Catheter and Alembic Aspiration Tubing | Predicate Device
APRO 55 Catheter and Alembic Aspiration Tubing |
|----------|-------------------------------------------------------------------|---------------------------------------------------------------------|
| Materials | | |
| Hub | Same as predicate. | Nylon |
| Adhesive | Same as predicate. | Cyanoacrylate |
| Strain Relief | Same as predicate. | Santoprene (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 |
| Alembic Aspiration Tubing | | |
| Aspiration Tubing | Same as predicate. | 110-inch length
Tubing ID = 0.110 inch |
7) Performance Data
Alembic performed non-clinical bench, sterility, shelf-life, and biocompatibility testing. The results demonstrate substantial equivalence of the subject APRO 45 Catheter and Alembic Aspiration Tubing 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 performs as intended. Included in Table 2 is a description of bench performance tests that were conducted to support
Page 8
APRO® 45 Catheter and Alembic Aspiration Tubing
510(k) Number: K251015
Page 4 of 6
substantial equivalence determination.
Table 2. Summary of Non-Clinical Bench Test Results
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Visual and Dimensional Characteristics | Catheter meets the visual and dimensional specifications. |
Introducer Sheath meets the visual and dimensional specifications. | The APRO 45 Catheter met the acceptance criteria.
The Introducer Sheath 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. |
| Vacuum Integrity | Catheter is free from collapse and loss of vacuum between aspiration source and catheter tip. | 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. |
| Catheter Hub 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. |
| Catheter 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. |
| Tensile Strength of Catheter Hub and Shaft | Catheter hub and shaft must meet tensile strength specification. | The APRO 45 Catheter met the acceptance criteria. |
| Tensile Strength of Catheter Tip | Catheter tip must meet tip tensile strength specification. | The APRO 45 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 45 Catheter met the acceptance criteria. |
| 3-Point Bend | Catheter 3-Point Bend force must be acceptable. Forces were compared to a predicate | The APRO 45 Catheter met the acceptance criteria. |
| Simulated Use including Clot Retrieval | When used per the Instructions for Use with accessory devices in an anatomical neurovascular model, the Catheter and Aspiration Tubing must meet functionality specifications. Clot retrieval from various locations of the anatomical model was performed using the subject device system. | The APRO 45 Catheter and Alembic Aspiration Tubing 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. |
B. Design Verification Testing – Animal
Substantial equivalence was established based on non-clinical bench performance data. Animal testing data were not deemed necessary.
Page 9
APRO® 45 Catheter and Alembic Aspiration Tubing
510(k) Number: K251015
Page 5 of 6
C. Sterilization and Shelf-Life
The APRO 45 Catheter and 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 45 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 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 (≤ 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 |
| Material-Mediated Pyrogenicity | All individual rabbits for both the test article and negative control showed a total rise in temperature of |