The APRO 55 Catheter with an aspiration pump and the Alembic Aspiration Tubing is intended for use in the revascularization of patients with acute 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.

Device Description

The APRO 55 Catheter is a single-lumen, braid and coil reinforced catheter. The APRO 55 Catheter is designed to remove thrombus from the vasculature using aspiration. The APRO 55 Catheter targets aspiration from a suction pump directly to the thrombus to remove thrombus from an occluded vessel. The APRO 55 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 55 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 55 Catheter is available in lengths of 125 cm and 137 cm and is provided with an introducer sheath.

The Alembic Aspiration Tubing connects the APRO 55 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

Here's a summary based on the provided FDA 510(k) document, focusing on acceptance criteria and study details:

Device: APRO 55 Catheter and Alembic Aspiration Tubing

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria listed are primarily for non-clinical bench tests. The reported device performance uniformly states that the APRO 55 Catheter (and Alembic Aspiration Tubing where applicable) met the acceptance criteria.

Test	Acceptance Criteria	Reported Device Performance
Visual and Dimensional Characteristics	Catheter meets the visual and dimensional specifications. Introducer Sheath meets the visual and dimensional specifications.	The APRO 55 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 55 Catheter met the acceptance criteria.
Vacuum Integrity	Catheter is free from collapse and loss of vacuum between aspiration source and catheter tip.	The APRO 55 Catheter met the acceptance criteria.
Kink Resistance	Catheter shaft shall not kink at clinically relevant radii.	The APRO 55 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 55 Catheter met the acceptance criteria.
Hub Compatibility	Hub meets the requirements per EN ISO 80369-7.	The APRO 55 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 55 Catheter met the acceptance criteria.
Dynamic Burst Pressure	No damage to catheter with dynamic pressure.	The APRO 55 Catheter met the acceptance criteria.
Fluid Leakage	Catheter must withstand pressure with methods per ISO 10555-1 Annex C.	The APRO 55 Catheter met the acceptance criteria.
Static Burst	Catheter must withstand pressures anticipated for clinical use.	The APRO 55 Catheter met the acceptance criteria.
Tensile Strength of Catheter Hub and Shaft	Catheter hub and shaft must meet tensile strength specification.	The APRO 55 Catheter met the acceptance criteria.
Tensile Strength of Catheter Tip	Catheter tip must meet tip tensile strength specification.	The APRO 55 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 55 Catheter met the acceptance criteria.
Tip Buckling Force	Catheter tip buckling force must be acceptable. Forces were compared to a predicate.	The APRO 55 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 55 Catheter and Alembic Aspiration Tubing met the acceptance criteria.

Biocompatibility Tests:

Test	Results	Conclusions
Sensitization (Guinea Pig Maximization)	The APRO 55 Catheter did not elicit a sensitization response.	Non-sensitizing
Irritation/Intracutaneous Reactivity	The APRO 55 Catheter demonstrated no evidence of irritation.	Non-Irritant
Cytotoxicity (MEM Elution, L929 cells)	The APRO 55 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
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	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 < 0.5 °C 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 a sample size for the "test set" in terms of patient data. All testing described is non-clinical bench testing and biocompatibility testing.

Data Provenance: Not applicable as no human patient data was used for effectiveness evaluation. The studies were laboratory-based bench tests and animal biocompatibility studies.

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

This information is not provided as the studies were non-clinical bench tests and biocompatibility testing, which do not typically involve human expert ground truth for performance evaluation in the way imaging AI or diagnostic devices do. Standardized test methods and acceptance criteria are used.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable, as there was no test set requiring human adjudication for performance evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Substantial equivalence was established based on non-clinical performance data. Human clinical data were not deemed necessary."

6. Standalone (Algorithm only without human-in-the-loop) Performance

This is not applicable. The APRO 55 Catheter and Alembic Aspiration Tubing is a physical medical device (catheter for thrombus retrieval) and not an AI algorithm or software-only device. Therefore, standalone algorithm performance is not a relevant concept for this submission.

7. Type of Ground Truth Used

For non-clinical bench testing, the "ground truth" is defined by the specifications, industry standards (e.g., ISO 10555-1, EN ISO 80369-7), and acceptable ranges or comparisons to predicate devices outlined in the acceptance criteria. For example, for "Kink Resistance," the ground truth is "Catheter shaft shall not kink at clinically relevant radii."
For biocompatibility testing, the ground truth is established by standardized biological response criteria (e.g., non-sensitizing, non-irritant, non-cytotoxic) defined by ISO 10993-1.

8. Sample Size for the Training Set

This information is not applicable as this is a physical medical device and not an AI/ML device that requires a training set.

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

This information is not applicable as this is a physical medical device and not an AI/ML device.

Summary

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August 29, 2024

Image /page/0/Picture/1 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 FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" in a larger font size and "ADMINISTRATION" in a smaller font size below.

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

Re: K232971

Trade/Device Name: APRO 55 Catheter and Alembic Aspiration Tubing Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY

Dear Lisa Yen:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 29, 2024. Specifically, FDA is updating this SE Letter as an administrative correction to update the 510(k) Summary to reflect the biocompatibility testing conducted in support of the APRO 55 Catheter.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Naira Muradyan, Ph.D., OHT5: Office of Neurological and Physical Medicine Devices, 240-402-4918, Naira.Muradyan@fda.hhs.gov.

Sincerely,

Naira Muradyan -S

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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February 29, 2024

Image /page/1/Picture/1 description: The image shows the logo for 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 acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure. The FDA acronym is in a blue square, and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue text.

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

Re: K232971

Trade/Device Name: APRO 55 Catheter and Alembic Aspiration Tubing Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: January 26, 2024 Received: January 29, 2024

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 (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/cdrb/cfdocs/cfpm/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/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 Ouality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232971

Device Name

APRO 55 Catheter and Alembic Aspiration Tubing

Indications for Use (Describe)

The Alembic Aspiration Tubing is intended to connect the APRO 55 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: K232971

This 510(k) Summary is provided in accordance with the requirements of 21 CFR §807.92.

1) Submitter information

Submitter:	Alembic, LLC627 National Ave.Mountain View, CA 94043
Contact:	Lisa YenDirector of Regulatory and QualityTelephone Number: (650) 388-5087Fax: (650) 390-0107Email: lyen@alembicllc.com
Date Prepared:	Mar 05, 2024

2) Device Name and Classification

Trade/Proprietary Name:	APRO® 55 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:	K173841 AXS Catalyst Distal Access Catheter as part of the AXSUniversal Aspiration System
Reference Device:	K223545 APRO® 70 Catheter and Alembic Aspiration Tubing

4) Device Description

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aspiration source, the APRO 55 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 55 Catheter is available in lengths of 125 cm and 137 cm and is provided with an introducer sheath.

The Alembic Aspiration Tubing connects the APRO 55 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 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.

6) Technological Characteristics Comparison

Alembic has demonstrated the APRO 55 Catheter and Alembic Aspiration Tubing are substantially equivalent to the predicate AXS Catalyst Distal Access Catheter based on the similarity in materials, similarity in design concept, and the same fundamental operating principles. A comparison of the APRO 55 Catheter with the predicate device is summarized in Table 1 below. There are no changes to the Alembic Aspiration Tubing compared to that included as part of the K223545 submission.

		Table 1 - APRO 55 Catheter Comparison with the Predicate Device and Reference Device

Category	Subject DeviceAPRO 55 Catheter andAlembic Aspiration Tubing	Predicate DeviceAXS Catalyst DistalAccess Catheter as part ofthe AXS UniversalAspiration System	Reference DeviceAPRO 70 Catheter andAlembic Aspiration Tubing
510(k) Number	K232971	K173841	K223545
Regulatory Class	Identical to predicate	Class II, 21 CFR 870.1250,NRY	Class II, 21 CFR 870.1250,NRY
Indications for Use	The APRO 55 Catheter withan aspiration pump and theAlembic Aspiration Tubing isintended for use in therevascularization of patientswith acute ischemic strokesecondary to intracranial largevessel occlusive disease(within the internal carotid,middle cerebral - M1 and M2segments, basilar, andvertebral arteries) within 8	The AXS Catalyst DistalAccess Catheter as part ofthe AXS UniversalAspiration System isindicated for use in therevascularization of patientswith acute ischemic strokesecondary to intracraniallarge vessel occlusivedisease (in theinternal carotid, middlecerebral - M1 and M2	The APRO 70 Catheter withan aspiration pump and theAlembic Aspiration Tubing isintended for use in therevascularization of patientswith acute ischemic strokesecondary to intracraniallarge vessel occlusive disease(within the internal carotid,middle cerebral - M1 and M2segments, basilar, andvertebral arteries) within 8
Category	Subject DeviceAPRO 55 Catheter andAlembic Aspiration Tubing	Predicate DeviceAXS Catalyst DistalAccess Catheter as part ofthe AXS UniversalAspiration System	Reference DeviceAPRO 70 Catheter andAlembic Aspiration Tubing
	hours of symptom onset.Patients who are ineligible forintravenous tissueplasminogen activator (IV t-PA) or who fail IV t-PAtherapy are candidates fortreatment.The Alembic AspirationTubing is intended to connectthe APRO 55 Catheter to theaspiration pump.	hours of symptom onset.segments, basilar, andvertebral arteries) within 8hours of symptom onset.Patients who are ineligiblefor intravenous tissueplasminogen activator (IVt-PA) or who failed IV t-PAare candidatesfor treatment.	hours of symptom onset.Patients who are ineligible forintravenous tissueplasminogen activator (IV t-PA) or who fail IV t-PAtherapy are candidates fortreatment.The Alembic AspirationTubing is intended to connectthe APRO 70 Catheter to theaspiration pump.
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 reference	None	Cyanoacrylate
Strain Relief	Same as reference	Thermoplastic rubber	Santoprene (thermoplasticelastomer)
Liner	Same as reference	Polytetrafluoroethylene(PTFE)	PTFE/Tecoflex composite
Shaft Coil orBraid	Same as reference	Stainless steel with nitinolwire and polymer fiber	304V stainless steel braid304V stainless steel coil
Extrusions	Same as reference	Pebax, Nylon	Thermoplastic polyurethanes,thermoplastic elastomer
Marker Band	Same as predicate, reference	Platinum/ iridium	Platinum/ iridium
Coating	Same as predicate, reference	Hydrophilic coating	Hydrophilic coating
Dimensions
Proximal OuterDiameter	0.066 inch	5.6 F (0.073 inch)6.0 F (0.078 inch)	0.083 inch
Distal OuterDiameter	0.066 inch	5.3 F (0.069 inch)5.4 F (0.070 inch)	0.083 inch
Inner Diameter (ID)	0.055 inch	0.058 inch, 0.060 inch	0.070 inch
Effective Length	125, 137 cm	115, 132 cm	125, 132, 135 cm
Coated Length	90, 102 cm	65, 82 cm	90, 97, 100 cm
Tip Shape	Same as predicate, reference	Straight	Straight
Accessories
Introducer Sheath	Same as predicate, reference	Yes	Yes
RotatingHemostasis Valve	Same as reference	Yes	None
Category	Subject DeviceAPRO 55 Catheter andAlembic Aspiration Tubing	Predicate DeviceAXS Catalyst DistalAccess Catheter as part ofthe AXS UniversalAspiration System	Reference DeviceAPRO 70 Catheter andAlembic Aspiration Tubing
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	Yes	Polyethylene
Shelf Carton	Same as predicate, reference	Solid bleached sulfatepaperboard	Solid bleached sulfatepaperboard
Other
Sterilization	Same as predicate, reference	Ethylene oxide	Ethylene oxide
Shelf Life	Same as reference	2 years	6 months
Use	Same as predicate, reference	Sterile, single use,disposable	Sterile, single use, disposable
Alembic Aspiration Tubing
Aspiration Tubing	Same as reference	300 cm lengthTubing ID = 0.218 inch	110 inch lengthTubing ID = 0.110 inch

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7) Performance Data

Alembic performed non-clinical bench testing in accordance with the same design controls, protocols, and test methods as for the reference device APRO 70 Catheter (K223545). The results demonstrate substantial equivalence of the subject APRO 55 Catheter and Alembic Aspiration Tubing to the legally marketed predicate device.

A. Design Verification Testing – Non-Clinical Bench

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 55 Catheter met theacceptance 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 55 Catheter met theacceptance criteria.
Vacuum Integrity	Catheter is free from collapse and loss ofvacuum between aspiration source andcatheter tip.	The APRO 55 Catheter met theacceptance criteria.
Kink Resistance	Catheter shaft shall not kink at clinicallyrelevant radii.	The APRO 55 Catheter met theacceptance criteria.
Catheter Hub Leakage	Catheter does not leak into hub assemblyduring aspiration, with methods specifiedin ISO 10555-1, Annex D.	The APRO 55 Catheter met theacceptance criteria.
Hub Compatibility	Hub meets the requirements per EN ISO80369-7	The APRO 55 Catheter met theacceptance criteria.

Table 2 – Summary of Non-Clinical Bench Test Results

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Test	Acceptance Criteria	Conclusion
Catheter Torque Strength	Catheter must withstand the minimumrequired number of rotations withoutbreakage and without kinking compared tolegally marketed devices.	The APRO 55 Catheter met theacceptance criteria.
Dynamic Burst Pressure	No damage to catheter with dynamicpressure.	The APRO 55 Catheter met theacceptance criteria.
Fluid Leakage	Catheter must withstand pressure withmethods per ISO 10555-1 Annex C.	The APRO 55 Catheter met theacceptance criteria.
Static Burst	Catheter must withstand pressuresanticipated for clinical use.	The APRO 55 Catheter met theacceptance criteria.
Tensile Strength ofCatheter Hub and Shaft	Catheter hub and shaft must meet tensilestrength specification.	The APRO 55 Catheter met theacceptance criteria.
Tensile Strength ofCatheter Tip	Catheter tip must meet tip tensile strengthspecification.	The APRO 55 Catheter met theacceptance criteria.
Delivery and RetrievalForce	Catheter delivery and retrieval force mustbe acceptable. Forces were compared to apredicate.	The APRO 55 Catheter met theacceptance criteria.
Tip Buckling Force	Catheter tip buckling force must beacceptable. Forces were compared to apredicate.	The APRO 55 Catheter met theacceptance criteria.
Simulated Use includingClot Retrieval	When used per the Instructions for Usewith accessory devices in an anatomicalneurovascular model, the Catheter andAspiration Tubing must meetfunctionality specifications. Clot retrievalfrom various locations of the anatomicalmodel was performed using the subjectdevice system.	The APRO 55 Catheter andAlembic Aspiration Tubing metthe acceptance criteria.

B. Design Verification Testing - Animal

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

C. Sterilization and Shelf-Life

The APRO 55 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 55 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. Biocompatibilitv

Biocompatibility testing has been completed for the APRO 55 Catheter in accordance with ISO 10993-1 and the device is deemed non-toxic (local or systemic), nonsensitizing, not locally irritating or otherwise harmful. Test results obtained were acceptable for the intended use as shown in Table 3. The thrombogenicity evaluation of the APRO 55 Catheter was supplemented by the prior in vivo thrombogenicity evaluation of the reference device, APRO 70 Catheter, in a good laboratory practice animal study.

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Biocompatibility studies for the Alembic Aspiration Tubing, that is unchanged from K223545, have previously established that it is biocompatible.

Test	Results	Conclusions
Sensitization(Guinea PigMaximization)	The APRO 55 Catheter did not elicit asensitization response.	Non-sensitizing
Irritation/IntracutaneousReactivity	The APRO 55 Catheter demonstrated no evidenceof irritation.	Non-Irritant
Cytotoxicity (MEMElution, L929 cells)	The APRO 55 Catheter did not elicit a cytotoxicresponse at 24 hours and 48 hours.	Non-cytotoxic
Hemolysis – Indirect	There were no significant differences between thetest article extract and negative control articleresults.	Non-hemolytic
Hemolysis – Direct	There were no differences between the hemolyticindex of the test article and the negative control.	Non-hemolytic
Partial ThromboplastinTime (PTT)	The average clotting time of the test article wasgreater than vehicle control and negative control.	Acceptable clottingtimes
SC5b9 ComplementActivation	The Sc5b9 concentration of the test article wasstatistically less than the positive control andwas not statistically higher than the negativecontrol.	Acceptable
Acute SystemicToxicity	No weight loss, mortality, or evidence ofsystemic toxicity from the extract exposure tothe mice.	Non-toxic
Material-MediatedPyrogenicity	All individual rabbits for both the test article andnegative control showed a total rise intemperature of < 0.5 °C and were determined tobe nonpyrogenic.	Non-pyrogenic

Table 3 – Biocompatibility Test Results

E. Clinical Testing

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

8) Conclusion

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

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).