The QuickCat™ Extraction Catheter is a single use, disposable, dual lumen catheter with associated accessories consisting of a 30 ml. vacuum syringe, extension tubing with stopcock, and an independent 40-micron filter basket. The 145 cm working length and is compatible with 6F guiding catheters with an inner diameter (I.D.) ≥ 0.068" (1.73 mm) and 0.014" (0.36 mm) diameter guidewires. The extraction lumen of the catheter facilitates removal of emboli and thrombi via the attached tubing assembly, stopcock and vacuum syringe. The atraumatic distal tip, which incorporates a radiopaque marker for visibility under fluoroscopy, provides for smooth passage in the arterial system. The catheter consists of three segments. The stiffer proximal seqment and more flexible distal segments provide the required structural integrity and flexibility to navigate tortuous vasculature. The distal segment consists of a dual lumen to allow for "rapid exchange" attachment to the quidewire. The catheter's distal portion has a hydrophilic coating to enhance deliverability. A 40-micron pore filter basket is supplied to assist in filtering of blood and thrombotic material for visual or laboratory analysis.

AI/ML Overview

This document, a 510(k) summary for the QuickCat™ Extraction Catheter, details the device's characteristics and its substantial equivalence to predicate devices, but it does not provide specific acceptance criteria or an explicit study proving performance against those criteria in the way a clinical trial or performance study report would. It focuses on establishing equivalence for regulatory clearance.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is NOT explicitly provided in the 510(k) summary. The document states that "Design verification testing was performed on the QuickCat™ Extraction Catheter to confirm that the design inputs meet the design outputs," and "Comparison bench testing was performed... regarding performance characteristics to demonstrate equivalency." However, it does not list specific quantitative acceptance criteria (e.g., "Device must extract X% of emboli") or the specific performance results against such criteria. It only asserts that equivalency was demonstrated.

2. Sample Size for the Test Set and Data Provenance

This information is NOT explicitly provided. The summary mentions "Performance Testing - Bench" and "Comparison bench testing," but does not specify the sample sizes (e.g., number of catheters tested, number of simulated emboli used) or the data provenance (e.g., country of origin, retrospective/prospective). This type of detail would typically be in a separate, more comprehensive test report, not usually in a 510(k) summary.

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

This information is NOT applicable/provided. The testing mentioned (biocompatibility and bench testing) does not involve human expert assessment for establishing "ground truth" in the way a clinical study using diagnostic imaging would. Ground truth in this context would likely refer to objective measurements of device performance (e.g., extraction force, flow rate, navigability).

4. Adjudication Method for the Test Set

This information is NOT applicable/provided. As the document describes bench testing and biocompatibility, there is no expert adjudication method like 2+1 or 3+1 typically used in clinical imaging studies.

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

No, a MRMC comparative effectiveness study was NOT done/reported in this document. The document discusses "Comparison bench testing" to demonstrate equivalency to predicate devices, but this refers to comparing physical performance characteristics, not comparing human reader performance with and without AI assistance. This device is a physical medical device (catheter), not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study was NOT done/reported in this document. This is a physical medical device, not an algorithm. Therefore, "algorithm only" performance is not relevant.

7. Type of Ground Truth Used for the Test Set

For the bench testing, the "ground truth" would likely be objective measurements and engineering specifications of the catheter's performance characteristics (e.g., successful extraction of simulated thrombi, navigability, guidewire compatibility, lumen integrity, material properties). For biocompatibility, the ground truth is established through adherence to ISO 10993 standards and FDA guidelines, indicating the absence of adverse biological reactions.

8. Sample Size for the Training Set

This information is NOT applicable/provided. As this is a physical medical device, not an AI or machine learning model, there is no "training set" in the computational sense. The design and validation of the catheter would involve engineering principles, material science, and physical testing, not data training.

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

This information is NOT applicable/provided. No training set exists for this type of device. The "ground truth" for the device's design and manufacturing would be established through engineering design specifications, material standards, and quality control processes.

In summary:

The provided 510(k) summary for the QuickCat™ Extraction Catheter is for a physical medical device and primarily focuses on demonstrating "substantial equivalence" to predicate devices through biocompatibility and bench testing. It clearly lacks the specific details about acceptance criteria, quantifiable performance results against those criteria, sample sizes for test sets, and the methodologies related to expert review or AI model validation that would be found in a performance study for a diagnostic algorithm or a clinical trial report. The context of the questions (e.g., "number of experts," "MRMC study," "training set," "algorithm only performance") strongly suggests inquiry into an AI/ML powered device, which this catheter is not.

Summary

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510(k) Summary

510(k) Number: K060092

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR§807.92.

Submitter Information:	Kensey Nash Corporation735 Pennsylvania DriveExton, PA 19341 USADeborah L Jackson, RACRegulatory Affairs SpecialistTel: (484) 713-2100
	e-mail: Debbie.Jackson@kenseynash.com
Trade Name:	QuickCat™ Extraction Catheter
Common Name:	Embolectomy Catheter
Classification Name:	Embolectomy Catheter (per 21 CFR Section 870.5150)
Regulatory Class:	Class II
Device Product Code:	DXE
Predicate Device:	Invatec Innovative Technologies' Diver C.E. Catheter (K050276), Medtronic Inc.'s Export Catheter (K040869), and Vascular Solution's Pronto Extraction Catheter (K032763)
Date Prepared:	January 11, 2006

Description of Device

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Kensey Nash Corporation Original Traditional 510(k) QuickCat™ Extraction Catheter

under fluoroscopy, provides for smooth passage in the arterial system. The catheter consists of three segments. The stiffer proximal seqment and more flexible distal segments provide the required structural integrity and flexibility to navigate tortuous vasculature. The distal segment consists of a dual lumen to allow for "rapid exchange" attachment to the quidewire. The catheter's distal portion has a hydrophilic coating to enhance deliverability. A 40-micron pore filter basket is supplied to assist in filtering of blood and thrombotic material for visual or laboratory analysis.

Intended Use of Device

The QuickCat™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Summary of Testing

Biocompatibility: Biocompatibility testing was conducted in accordance with ISO 10993, "Biological Evaluation of Medical Devices, " and FDA Memorandum #G95-1, "Biological Evaluation of Medical Devices".

Performance Testing - Bench: Comparison bench testing was performed on the QuickCat™ Extraction Catheter and the predicate devices (Diver C.E. and Export Catheter) regarding performance characteristics to demonstrate equivalency. Design verification testing was performed on the QuickCat™ Extraction Catheter to confirm that the design inputs meet the design outputs.

Statement of Substantial Equivalence:

Kensey Nash Corporation considers the QuickCat™ Extraction Catheter substantially equivalent to Invatec Innovative Technologies' Diver C.E. Catheter (K050276), Medtronic Inc.'s Export Catheter (K040869), and Vascular Solution's Pronto Extraction Catheter (K032763) based on comparison of intended use, performance, technological characteristics and materials.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 9

Kensey Nash Corporation c/o Ms. Deborah L. Jackson Regulatory Affairs Specialist 735 Pennsylvania Drive Exton, PA 19341

K060092 Re: OuickCat™ Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II Product Code: DXE Dated: January 11, 2006 Received: January 12, 2006

Dear Ms. Jackson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms. Deborah L. Jackson

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sona R. Lichtner

\ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Kensey Nash Corporation Original Traditional 510(k) QuickCat™ Extraction Catheter

Indications for Use Statement

510(k) Number (if known): KO60092

: K060092

Device Name:

QuickCat™ Extraction Catheter

Indications for Use:

The QuickCat™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duuna R. V. Jones
(Division Sign Off)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K06009Z

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).