The APRO 70 Swift 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 70 Swift Catheter to the aspiration pump.

Device Description

The APRO 70 Swift Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 70 Swift Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 70 Swift Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 70 Swift 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 Swift 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 Swift Catheter is available in lengths of 125 cm. 132 cm, and 135 cm and is provided with an introducer sheath.

The Alembic Aspiration Tubing connects the APRO 70 Swift 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.

AI/ML Overview

The provided text describes the acceptance criteria and the study results for the APRO 70 Swift Catheter and Alembic Aspiration Tubing. It is important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance data, rather than a clinical trial report. Therefore, some of the requested information, particularly regarding clinical studies, human readers, and effect sizes, is not applicable or available in this document.

Here's the breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance data are primarily from non-clinical bench testing.

Test Category	Acceptance Criteria	Reported Device Performance
Visual and Dimensional Characteristics	Catheter meets visual and dimensional specifications.Introducer Sheath meets visual and dimensional specifications.	The APRO 70 Swift 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 70 Swift Catheter particulates were comparable to the predicate device.
Vacuum Integrity	Catheter is free from collapse and loss of vacuum between aspiration source and catheter tip.	The APRO 70 Swift Catheter met the acceptance criteria.
Kink Resistance	Catheter shaft shall not kink at clinically relevant radii.	The APRO 70 Swift 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 Swift Catheter met the acceptance criteria.
Hub Compatibility	Hub meets the requirements per EN ISO 80369-7.	The APRO 70 Swift 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 70 Swift Catheter met the acceptance criteria.
Dynamic Burst Pressure	No damage to catheter with dynamic pressure.	The APRO 70 Swift Catheter met the acceptance criteria.
Fluid Leakage	Catheter must withstand pressure with methods per ISO 10555-1 Annex C.	The APRO 70 Swift Catheter met the acceptance criteria.
Static Burst	Catheter must withstand pressures anticipated for clinical use.	The APRO 70 Swift Catheter met the acceptance criteria.
Tensile Strength of Catheter Hub and Shaft	Catheter hub and shaft must meet tensile strength specification.	The APRO 70 Swift Catheter met the acceptance criteria.
Tensile Strength of Catheter Tip	Catheter tip must meet tip tensile strength specification.	The APRO 70 Swift 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 Swift Catheter met the acceptance criteria.
Tip Buckling Force	Catheter tip buckling force must be acceptable. Forces were compared to a predicate.	The APRO 70 Swift 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 70 Swift Catheter and Alembic Aspiration Tubing met the acceptance criteria.
Biocompatibility (Sensitization)	Did not elicit a sensitization response.	Non-sensitizing
Biocompatibility (Irritation)	Demonstrated no evidence of irritation.	Non-irritant
Biocompatibility (Cytotoxicity)	Did not elicit a cytotoxic response at 24 hours and 48 hours.	Non-cytotoxic
Biocompatibility (Hemolysis – Indirect)	No significant differences between the test article extract and negative control article results.	Non-hemolytic
Biocompatibility (Hemolysis - Direct)	No differences between the hemolytic index of the test article and the negative control.	Non-hemolytic
Biocompatibility (Thrombogenicity - PTT)	Average clotting time of the test article was greater than vehicle control and negative control.	Acceptable clotting times
Biocompatibility (Thrombogenicity - Platelet Leukocyte Count)	Performed similar to comparator and negative controls.	Non-thrombogenic
Biocompatibility (Thrombogenicity - Comparative Surface and Geometry Assessment)	Comparative surface assessment using 40X optical microscopy at representative locations of the subject device and the reference device APRO 70 Catheter did not find any differences in roughness or presence of any defects. The subject device has the same geometry as the reference device APRO 70 Catheter.	Acceptable results
Biocompatibility (SC5b9 Complement Activation)	Sc5b9 concentration of the test article was statistically less than the positive control and was not statistically higher than the negative control.	Acceptable
Biocompatibility (Acute Systemic Toxicity)	No weight loss, mortality, or evidence of systemic toxicity from the extract exposure to the mice.	Non-toxic
Biocompatibility (Material-Mediated Pyrogenicity)	All individual rabbits for both the test article and negative control showed a total rise in temperature of < 0.5 ℃ and were determined to be nonpyrogenic.	Non-pyrogenic

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state specific sample sizes for each non-clinical bench test. The testing involved various repetitions per test to demonstrate meeting acceptance criteria. The data provenance is non-clinical bench testing performed by Alembic, LLC. No human (clinical) test set is mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable (N/A) as the studies described are non-clinical bench tests and do not involve expert interpretation or ground truth establishment in the context of medical imaging or diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for non-clinical bench testing. Adjudication methods are typically relevant for human reader studies or clinical trials where expert consensus is needed to establish ground truth for complex interpretations.

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

No MRMC comparative effectiveness study was done. The document states: "Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary." This device is a physical catheter, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable (N/A). This is a 510(k) submission for a physical medical device (catheter and tubing), not a software algorithm.

7. The Type of Ground Truth Used

For the non-clinical bench tests, the "ground truth" or reference for performance was established by predefined engineering specifications, international standards (e.g., ISO 10555-1, EN ISO 80369-7, ISO 11135, ISO 10993-1), and comparisons to predicate devices. For example, particulate levels were compared to predicate devices, and clot retrieval was assessed against "functionality specifications" using an anatomical neurovascular model. Biocompatibility tests followed established methodologies like those in ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable (N/A). This submission is for a physical medical device, not a machine learning or AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable (N/A). As there is no training set for an algorithm, there is no ground truth established for it in this context.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

February 24, 2025

Alembic, LLC Lisa Yen Vice President of Regulatory and Quality 627 National Avenue Mountain View. California 94043

Re: K243287

Trade/Device Name: APRO 70 Swift Catheter and Alembic Aspiration Tubing Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: January 27, 2025 Received: January 27, 2025

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 (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.

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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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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-device-advicecomprehensive-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-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-regulatory

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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

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Indications for Use

510(k) Number (if known) K243287

Device Name

APRO 70 Swift Catheter and Alembic Aspiration Tubing

Indications for Use (Describe)

The APRO 70 Swift 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

The Alembic Aspiration Tubing is intended to connect the APRO 70 Swift 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)

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510(k) Summary

510(k) Number: K243287

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 YenVP of Regulatory and QualityTelephone Number: (650) 388-5087Email: lyen@alembicllc.com
Date Prepared:	February 21, 2025

2) Device Name and Classification

Trade/Proprietary Name:	APRO® 70 Swift 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 Device and Reference Device

Predicate Device:	K232971 APRO 55 Catheter and Alembic Aspiration Tubing
Reference Device:	K223545 APRO 70 Catheter and Alembic Aspiration Tubing

4) Device Description

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connected using the Alembic Aspiration Tubing, along with a legally marketed canister and accessories kit. The APRO 70 Swift Catheter is available in lengths of 125 cm. 132 cm, and 135 cm and is provided with an introducer sheath.

5) Indications for Use

The Alembic Aspiration Tubing is intended to connect the APRO 70 Swift Catheter to the aspiration pump.

6) Technological Characteristics Comparison

Alembic has demonstrated the APRO 70 Swift Catheter and Alembic Aspiration Tubing are substantially equivalent to the predicate 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 70 Swift Catheter with the predicate and reference devices 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.

Category	Subject Device	Predicate Device	Reference Device
510(k) Number	APRO 70 Swift Catheter and Alembic Aspiration TubingK243287	APRO 55 Catheter and Alembic Aspiration TubingK232971	APRO 70 Catheter and Alembic Aspiration TubingK223545
Regulatory Class, Product Code	Identical to predicate	Class II, 21 CFR 870.1250, NRY	Class II, 21 CFR 870.1250, NRY
Indications for Use	The APRO 70 Swift 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.	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	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
	Subject DeviceAPRO 70 Swift Catheterand Alembic AspirationTubing	Predicate DeviceAPRO 55 Catheter andAlembic AspirationTubing	Reference DeviceAPRO 70 Catheter andAlembic AspirationTubing
Category	Patients who are ineligible forthrombolytic drug therapy orwho failed thrombolytic drugtherapy are candidates fortreatment.The Alembic AspirationTubing is intended to connectthe APRO 70 Swift Catheterto the aspiration pump.	who are ineligible forintravenous tissueplasminogen activator (IV t-PA) or who fail IV t-PAtherapy are candidates fortreatment.The Alembic AspirationTubing is intended toconnect the APRO 55Catheter to the aspirationpump.	who are ineligible forintravenous tissueplasminogen activator (IV t-PA) or who fail IV t-PAtherapy are candidates fortreatment.The Alembic AspirationTubing is intended toconnect the APRO 70Catheter to the aspirationpump.
Principles ofOperation	Same as predicate, reference	Using conventionalcatheterization techniquesunder fluoroscopic guidance,the catheter is advanced intothe target vessel over anappropriate neurovascularguidewire. The catheter ispositioned proximal to thethrombus to aspirate.	Using conventionalcatheterization techniquesunder fluoroscopic guidance,the catheter is advanced intothe target vessel over anappropriate neurovascularguidewire. The catheter ispositioned proximal to thethrombus to aspirate.
Materials
Hub	Same as predicate	Nylon	Polycarbonate
Adhesive	Same as predicate, reference	Cyanoacrylate	Cyanoacrylate
Strain Relief	Same as predicate, reference	Santoprene (thermoplasticelastomer)	Santoprene (thermoplasticelastomer)
Liner	Same as predicate, reference	PTFE/Tecoflex composite	PTFE/Tecoflex composite
Shaft Coil or Braid	Same as predicate, reference	304V stainless steel braid304V stainless steel coil	304V stainless steel braid304V stainless steel coil
Extrusions	Same as predicate, reference	Thermoplasticpolyurethanes, thermoplasticelastomer	Thermoplasticpolyurethanes, thermoplasticelastomer
Marker Band	Same as predicate, reference	Platinum/ iridium	Platinum/ iridium
Coating	Same as predicate, reference	Hydrophilic coating	Hydrophilic coating
Dimensions
Proximal OuterDiameter	Same as reference	0.066 inch	0.083 inch
Distal OuterDiameter	Same as reference	0.066 inch	0.083 inch
Inner Diameter (ID)	Same as reference	0.055 inch	0.070 inch
Effective Length	Same as reference	125, 137 cm	125, 132, 135 cm
Coated Length	Same as reference	90, 102 cm	90, 97, 100 cm
Tip Shape	Same as reference	Straight	Straight
Accessories
Introducer Sheath	Same as predicate, reference	Yes	Yes
Packaging Materials
Pouch	Same as predicate, reference	Nylon/polyethylene/Tyvek	Nylon/polyethylene/Tyvek
Packaging Tube	Same as predicate, reference	Polyethylene	Polyethylene
Packaging Card	Same as predicate, reference	Polyethylene	Polyethylene
Category	Subject DeviceAPRO 70 Swift Catheterand Alembic AspirationTubing	Predicate DeviceAPRO 55 Catheter andAlembic AspirationTubing	Reference DeviceAPRO 70 Catheter andAlembic AspirationTubing
Shelf Carton	Same as predicate, reference	Solid bleached sulfatepaperboard	Solid bleached sulfatepaperboard
Other	Same as predicate, reference	Ethylene oxide	Ethylene oxide
Shelf Life	1 year	6 months	6 months
Use	Same as predicate, reference	Sterile, single use,disposable	Sterile, single use,disposable
Alembic Aspiration Tubing	Same as predicate, reference	110 inch lengthTubing ID = 0.110 inch	110 inch lengthTubing ID = 0.110 inch

Table 1 - APRO 70 Swift Catheter Comparison with the Predicate Device and Reference Device

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7) Performance Data

Alembic performed non-clinical bench, sterility, shelf-life, and biocompatibility testing. The results demonstrate substantial equivalence of the subject APRO 70 Swift Catheter and Alembic Aspiration Tubing to the legally marketed predicate device.

A. Design Verification Testing – Non-Clinical Bench

Performance testing was conducted to support the APRO 70 Swift Catheter submission. The results of the design verification and validation testing confirm that the APRO 70 Swift Catheter conforms to the predefined specifications and performs as intended. Included in Table 2 is the description of bench performance tests that were conducted to support substantial equivalence determination.

Test	Acceptance Criteria	Conclusion
Visual and DimensionalCharacteristics	Catheter meets the visual and dimensionalspecifications.Introducer Sheath meets the visual anddimensional specifications.	The APRO 70 Swift Catheter metthe acceptance criteria.The Introducer Sheath met theacceptance criteria.
Particulate	Catheter meets the acceptance criteria.Subject device was evaluated with apredicate device under the same testconditions.	The APRO 70 Swift Catheterparticulates were comparable tothe predicate device.
Vacuum Integrity	Catheter is free from collapse and loss ofvacuum between aspiration source andcatheter tip.	The APRO 70 Swift Cathetermet the acceptance criteria.
Kink Resistance	Catheter shaft shall not kink at clinicallyrelevant radii.	The APRO 70 Swift Catheter metthe acceptance criteria.
Catheter Hub Leakage	Catheter does not leak into hub assemblyduring aspiration, with methods specifiedin ISO 10555-1, Annex D.	The APRO 70 Swift Catheter metthe acceptance criteria.
Hub Compatibility	Hub meets the requirements per EN ISO80369-7.	The APRO 70 Swift Catheter metthe acceptance criteria.
Catheter Torque Strength	Catheter must withstand the minimumrequired number of rotations withoutbreakage and without kinking compared tolegally marketed devices.	The APRO 70 Swift Catheter metthe acceptance criteria.

Table 2 – Summary of Non-Clinical Bench Test Results

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Test	Acceptance Criteria	Conclusion
Dynamic Burst Pressure	No damage to catheter with dynamic pressure.	The APRO 70 Swift Catheter met the acceptance criteria.
Fluid Leakage	Catheter must withstand pressure with methods per ISO 10555-1 Annex C.	The APRO 70 Swift Catheter met the acceptance criteria.
Static Burst	Catheter must withstand pressures anticipated for clinical use.	The APRO 70 Swift Catheter met the acceptance criteria.
Tensile Strength ofCatheter Hub and Shaft	Catheter hub and shaft must meet tensile strength specification.	The APRO 70 Swift Catheter met the acceptance criteria.
Tensile Strength ofCatheter Tip	Catheter tip must meet tip tensile strength specification.	The APRO 70 Swift Catheter met the acceptance criteria.
Delivery and RetrievalForce	Catheter delivery and retrieval force must be acceptable. Forces were compared to a predicate.	The APRO 70 Swift Catheter met the acceptance criteria.
Tip Buckling Force	Catheter tip buckling force must be acceptable. Forces were compared to a predicate.	The APRO 70 Swift Catheter met the acceptance criteria.
Simulated Use includingClot 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 70 Swift Catheter and Alembic Aspiration Tubing met the acceptance criteria.

B. Design Verification Testing - Animal

Substantial equivalence was established based on non-clinical performance data. Animal data was not deemed necessary.

C. Sterilization and Shelf-Life

The APRO 70 Swift 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° in accordance with ISO 11135. Aging studies for the APRO 70 Swift 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.

D. Biocompatibility

Biocompatibility testing has been completed for the APRO 70 Swift 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"."

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Test	Results	Conclusions
Sensitization(Guinea PigMaximization)	The APRO 70 Swift Catheter did not elicit asensitization response.	Non-sensitizing
Irritation/IntracutaneousReactivity	The APRO 70 Swift Catheter demonstrated noevidence of irritation.	Non-irritant
Cytotoxicity (MEMElution, L929 cells)	The APRO 70 Swift Catheter did not elicit a cytotoxicresponse at 24 hours and 48 hours.	Non-cytotoxic
Hemolysis – Indirect	There were no significant differences between the testarticle extract and negative control article results.	Non-hemolytic
Hemolysis - Direct	There were no differences between the hemolyticindex of the test article and the negative control.	Non-hemolytic
Thrombogenicity - PartialThromboplastinTime (PTT)	The average clotting time of the test article wasgreater than vehicle control and negative control.	Acceptable clottingtimes
Thrombogenicity -Platelet Leukocyte Count	The test article performed similar to comparator andnegative controls.	Non-thrombogenic
Thrombogenicity -Comparative Surface andGeometry Assessment	Comparative surface assessment using 40X opticalmicroscopy at representative locations of the subjectdevice and the reference device APRO 70 Catheter didnot find any differences in roughness or presence ofany defects. The subject device has the same geometryas the reference device APRO 70 Catheter.	Acceptable results
SC5b9 ComplementActivation	The Sc5b9 concentration of the test article wasstatistically less than the positive control and was notstatistically higher than the negative control.	Acceptable
Acute Systemic Toxicity	No weight loss, mortality, or evidence of systemictoxicity from the extract exposure to the mice.	Non-toxic
Material-MediatedPyrogenicity	All individual rabbits for both the test article andnegative control showed a total rise in temperature of< 0.5 ℃ and were determined to be nonpyrogenic.	Non-pyrogenic

Table 3 - Biocompatibility Test Results

E. Clinical Testing

Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary.

8) Conclusion

Based on the comparison of the technological characteristics and the non-clinical testing, the subject device is found to be substantially equivalent to the predicate device. The differences in technological characteristics do not raise new questions of safety and effectiveness. Testing was conducted to demonstrate that the subject device meets the specifications and performs as intended.

Regulation Number and Section

§ 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).