ThromCat™ Thrombectomy Catheter System is indicated for mechanical removal of thrombus in synthetic hemodialysis access grafts and native vessel dialysis fistulae.

Device Description

ThromCat Thrombectomy Catheter System is a single-use, disposable device that performs percutaneous maceration and removal of thrombus and restoration of blood flow. The device consists of a 5.5 Fr x 4.5 Fr infusion/extraction catheter, a DC-powered infusion/extraction pump, and an extraction line and bag. The stainless steel helix is enclosed within a radiopaque, atraumatic flexible tip and shaft, preventing direct contact with the vessel wall. The integrated pumps, tubing and 150 cm length catheter provide an infusion flow to "wash' the vessel, while simultaneously providing an extraction flow to remove thrombus.

AI/ML Overview

This document is a 510(k) summary for the Kensey Nash ThromCat™ Thrombectomy Catheter System. It describes the device, its intended use, and provides information on non-clinical testing for substantial equivalence to predicate devices.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria (e.g., performance thresholds like "achieve X% thrombus removal") or quantifiable reported device performance results for the ThromCat™ Thrombectomy Catheter System.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It asserts that "Results of bench testing and animal studies demonstrate ThromCat is as safe and effective as the legally marketed predicate devices." This is a qualitative statement of equivalence rather than a report of specific performance metrics against defined criteria.

To fully answer this question, more detailed testing reports would be needed, which are not present in this 510(k) summary. However, based on the information given, a conceptual table might look like this, with the understanding that specific numerical criteria and results are missing:

Acceptance Criterion (Implicit)	Reported Device Performance
Safety and Effectiveness Equivalence: Consistent with legally marketed predicate devices (X-Sizer® Catheter System & Amplatz Thrombectomy Device) with regard to materials, intended use, principles of operation, and technological characteristics. Any differences do not significantly affect safety and efficacy.	Demonstrated through Non-Clinical Testing:- Biocompatibility: Passed relevant tests (implied, no specific results)- EMC (Electromagnetic Compatibility): Passed relevant tests (implied, no specific results)- Electrical Safety: Passed relevant tests (implied, no specific results)- Mechanical Testing: Passed relevant tests (implied, no specific results)- Animal Studies: Demonstrated safety and effectiveness (implied, no specific results)- In vitro Comparison Testing: Conducted against X-Sizer Catheter, providing reasonable assurance of safety and effectiveness (implied, no specific results)- In vivo Comparison Testing: Conducted against X-Sizer Catheter, providing reasonable assurance of safety and effectiveness (implied, no specific results)
Mechanical Removal of Thrombus: Ability to achieve mechanical removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistulae.	This is the intended use, and the non-clinical testing (especially in vitro and in vivo comparison testing) aimed to confirm this capability and its equivalence to predicate devices. No specific "percentage of thrombus removed" or "time to removal" metrics are provided.
Prevention of direct contact with vessel wall: The stainless steel helix is enclosed within a radiopaque, atraumatic flexible tip and shaft.	This is a design feature claimed to prevent direct contact. The "animal studies" and "in vivo comparison testing" would implicitly assess the effectiveness of this design in a physiological environment, but no specific data is presented.

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

The document mentions "bench testing" and "animal studies" and "in vitro and in vivo comparison testing." However, it does not specify the sample sizes used for these test sets.

Test Set Sample Size: Not specified.
Data Provenance: The studies are described as "non-clinical testing," "in vitro," and "in vivo (animal studies)." The country of origin is not specified but implicitly would be related to the submitting company (Kensey Nash Corporation, USA). The studies are not described as retrospective or prospective in a human clinical trial sense, but rather as pre-market, non-clinical evaluations.

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

This information is not provided in the 510(k) summary. Non-clinical studies (bench and animal) typically do not involve human "experts" establishing ground truth in the same way clinical studies do (e.g., radiologist reviews). Instead, performance is measured against established scientific principles and metrics in a laboratory or animal model.

4. Adjudication Method for the Test Set

Since this relates to expert review of clinical data, and the studies mentioned are non-clinical (bench and animal), there is no information provided on an adjudication method.

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 study was done. The device described is a mechanical thrombectomy catheter system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable.

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

This question is not applicable as the device is a mechanical catheter system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "non-clinical testing" including "bench testing" and "animal studies" and "in vitro and in vivo comparison testing," the ground truth would be established by:

Quantitative measurements of performance parameters (e.g., flow rates, thrombus removal efficiency, force measurements for mechanical tests).
Histopathological analysis in animal studies to assess tissue damage or healing.
Direct observation and measurement in controlled in vitro environments.
Comparison to known performance characteristics of the predicate devices under similar conditions.

There's no mention of expert consensus, pathology in human cases, or human outcomes data for these non-clinical studies.

8. The sample size for the training set

This information is not applicable. This device is a mechanical medical device, not an AI/machine learning system that requires a "training set" in the computational sense.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as point 8.

Summary

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Kensev Nash

APS 25 2003

510(k) Summary

Jennifer J. Bosley, MBA, RAC Regulatory Affairs Specialist

735 Pennsylvania Drive

Exton, PA 19341

KENSEY NASH CORPORATION

Submitted by:

Contact Person:

Date Prepared:

510(k) #: Device Trade Name: Common/Usual Name: Proposed Classification:

March 6, 2006

K060016

ThromCat™ Thrombectomy Catheter System Thrombectomy Device Catheter, Peripheral, Atherectomy 21 CFR 870.4875, MCW, Class II

Ph: (484) 713-2100 Fax: (610) 524-5489

Device Description:

Intended Use:

ThromCat™ Thrombectomy Catheter System is indicated for mechanical removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistulae.

Predicate Devices:

Manufacturer	Device	510(k) #
ev3 Inc.	X-Sizer® Catheter System	K021096
Microvena Corporation	Amplatz Thrombectomy Device	K982657

Substantial Equivalence:

ThromCat is similar with regard to materials, intended use, principles of operation and technological characteristics to the predicate mechanical thrombectomy devices in terms of section 510(k) substantial equivalence; any differences that may exist do not significantly affect the safety and efficacy of the device. Results of bench testing and animal studies demonstrate ThromCat is as safe and effective as the legally marketed predicate devices.

Non-Clinical Testing:

ThromCat has undergone non-clinical testing, e.g., biocompatibility, EMC, electrical safety, mechanical testing and animal studies that provide reasonable assurance of safety and effectiveness for its intended use. In vitro and in vivo comparison testing was conducted on ThromCat and the predicate device, X-Sizer Catheter.

1-800 524 1984

ΚΕΝSEY ΝΑSΗ CORPORATION, 735 ΡΕΝΝSYLVANIA DRIVE, ΕΧΤΩΝ. ΡΑ 19341

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AFR 2 5 2006

Kensey Nash Corporation c/o Ms. Jennifer Bosley Regulatory Affairs Specialist 735 Pennsylvania Drive Exton, PA 19341

Re: K060016

Trade Name: ThromCat™ Thrombectomy Catheter System Regulation Number: 21 CFR 870.4875 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MCW Dated: April 6. 2006 Received: April 7. 2006

Dear Ms. Bosley:

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, Drue. 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. Ilisting 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 max publish further announcements concerning vour device in the Federal Register.

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Page 2 - Mr. Alex Kou

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/cdrl/industry/support/index.html.

Sincerely yours,

Davia R. bochner

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A 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

510(k) Number (if known): K 6660 م ا

ThromCat™ Thrombectomy Catheter System Device Name:

Indications For Use:

ThromCat™ Thrombectomy Catheter System is indicated for mechanical removal of thrombus in synthetic hemodialysis access grafts and native vessel dialysis fistulae.

Prescription Use X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Bruce W. Hunnell

Division . S. . Off) (Division of Cardiovascular Devices

510(k) number

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).