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 segment 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 guidewire. 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

I am sorry, but based on the provided document, there is no acceptance criteria or a study described that proves the device meets specific performance criteria in the way you've outlined.

This document is a 510(k) premarket notification approval letter for the QuickCat Extraction Catheter. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through detailed clinical or statistical studies as would be required for a novel device or a PMA submission.

Here's a breakdown of why the requested information cannot be extracted from this document:

Table of acceptance criteria and reported device performance: This document does not contain any specific performance metrics (e.g., sensitivity, specificity, accuracy, success rates) or acceptance criteria for those metrics. The "Non-Clinical Summary" merely states that "Results of this testing indicate that the QuickCat design meets all specifications and intended use," which is a general statement and not a table of specific criteria and results.
Sample size used for the test set and data provenance: No information is provided about a "test set" in the context of performance evaluation. The document mentions "in-vitro bench testing and biocompatibility testing" but does not give details about the sample sizes or the origin of any data used in these tests.
Number of experts and qualifications for ground truth: Since there are no specific performance claims or clinical study results beyond the general statement of meeting specifications, there's no mention of experts establishing ground truth for a test set.
Adjudication method for the test set: Not applicable, as no information on a test set or expert evaluation is provided.
Multi-reader multi-case (MRMC) comparative effectiveness study: This document does not describe any MRMC study, nor does it refer to AI assistance. The device is a physical catheter, not an AI-powered diagnostic tool.
Standalone performance (algorithm only): Not applicable. The device is a physical medical device, not an algorithm.
Type of ground truth used: Not applicable, as detailed performance studies generating ground truth are not described. The basis for substantial equivalence is primarily the comparison of technological characteristics and intended use to a predicate device, along with verification through bench and biocompatibility testing.
Sample size for the training set: Not applicable. The device is not an AI algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided FDA 510(k) approval letter (K073519) for the QuickCat Extraction Catheter focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting detailed performance acceptance criteria and study results in the manner requested for AI/software-as-a-medical-device (SaMD) products.

Summary

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May 20, 2021

Kensey Nash Corp. Robin M. Fatzinger Regulatory Affairs Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19341

Re: K073519

Trade/Device Name: QuickCat Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ

Dear Robin M. Fatzinger:

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 March 28, 2008. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.05.20

Gregory O'Connell Assistant Director Plaque Modification Devices Team DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2008

Kensey Nash Corp. c/o Ms. Robin M. Fatzinger, RAC Vice President of Clinical and Regulatory Affairs 735 Pennsylvania Drive Exton, PA 19341

Re: K073519

Quickcat Extraction Catheter, Model 60090-01 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: March 3, 2008 Received: March 4, 2008

Dear Ms. Fatzinger:

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. Robin M. Fatzinger, RAC

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

R. Zukerman, M

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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. Indications for Use Statement

K 073519

510(k) Number (if known):

Device Name:

QuickCat™ Extraction Catheter

Indications for Use:

The OuickCat™ 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)

Ochmbe

510(k) Numbe

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510(k) Summary

MAR 2 8 2008

510(k) Number: K073519

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

Submitted By:	Kensey Nash Corporation735 Pennsylvania DriveExton, PA 19341 USA
Contact Person:	Cindy R. Varughese, RACRegulatory Affairs SpecialistTel: (484) 713-2100Fax: (484) 713-2903E-mail: Cindy.Varughese@kenseynash.com
Trade Name:	QuickCat™ Extraction Catheter
Common Name:	Embolectomy Catheter
Classification Name:	Embolectomy Catheter (21 CFR Section 870.5150)
Regulatory Class:	Class II
Device Product Code:	DXE
Predicate Device:	Kensey Nash Corporation's QuickCat™ Extraction Catheter(K060092)
Date Prepared:	December 12, 2007

Description of Device:

Intended Use:

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

Substantial Equivalence:

QuickCat is substantially equivalent to the predicate device with regard to intended use, principles of operation, and technological characteristics.

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Non-Clinical Summary:

Non-clinical verification has been verified through in-vitro bench testing and biocompatibility testing. Results of this testing indicate that the QuickCat design meets all specifications and intended use.

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).