ThromCat™ Thrombectomy Catheter System is indicated for mechanical removal of thrombus from 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 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 150cm length catheter provide an infusion flow to "wash" the vessel, while simultaneously providing an extraction flow to remove thrombus.

AI/ML Overview

The provided document is a 510(k) summary for the ThromCat™ Thrombectomy Catheter System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain a study that proves the device meets specific acceptance criteria.

The "Non-Clinical Summary" section states: "Non-clinical verification has been verified through in-vitro bench testing and biocompatibility testing. Results of this testing indicate that the ThromCat design meets all specifications and intended use." This is a general statement, but no specific acceptance criteria or detailed study results are provided.

Therefore, I cannot fulfill all parts of your request as the necessary information is not present in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states that "non-clinical verification has been verified through in-vitro bench testing and biocompatibility testing" and that "results of this testing indicate that the ThromCat design meets all specifications and intended use." However, it does not provide any specific acceptance criteria (e.g., "thrombus removal efficiency > 90%") or reported device performance metrics tied to those criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document only mentions "in-vitro bench testing" and "biocompatibility testing" but does not detail sample sizes, data provenance, or whether the testing was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Cannot be provided. Since the studies mentioned are "in-vitro bench testing" and "biocompatibility testing," they are likely physical or chemical tests that do not involve human expert interpretation for establishing ground truth in the way a clinical image analysis study would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Cannot be provided. As above, this is not relevant for the type of bench and biocompatibility testing described.

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. The document does not describe any MRMC comparative effectiveness study, nor does it involve AI assistance. This device is a physical thrombectomy catheter.

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

N/A. This device is a physical medical device, not an algorithm.

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

Cannot be provided definitively for "in-vitro bench testing." For "biocompatibility testing," the ground truth would typically be established by standardized toxicological and immunological assays against established safety limits or comparison to predicate device materials, rather than expert consensus on medical images or pathology.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an algorithm that requires a "training set."

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

Not applicable. As above, this is not relevant for a physical medical device.

Summary

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510(k) Summary

510(k) Number: K07Z|95

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 AssociateTel: (484) 713-2100Fax: (484) 713-2903E-mail: Cindy.Varughese@kenseynash.com
Trade Name:	ThromCat™ Thrombectomy Catheter System
Common Name:	Thrombectomy Device
Classification Name:	Catheter, Peripheral, Atherectomy (21 CFR Section 870.4875)
Regulatory Class:	Class II
Device Product Code:	MCW
Predicate Device:	Kensey Nash Corporation's ThromCat™ ThrombectomyCatheter System (K060016)
Date Prepared:	July 30, 2007

Description of Device:

Intended Use:

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

Substantial Equivalence:

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

Non-Clinical Summarv:

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

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Public Health Service

Image /page/1/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus, with three parallel lines that curve and flow together.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2007

Kensey Nash Corp. c/o Ms. Cindy Varughese Regulatory Affairs Associate 735 Pennsylvania Drive Exton, PA 19341

Re: K072195

Trade/Device Name: ThromCat Thrombectomy Catheter System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: August 6, 2007 Received: August 7, 2007

Dear Ms. Varughese:

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. Cindy Varughese

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

ena R. bachner

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):

K072195

Device Name:

ThromCat™ Thrombectomy Catheter System

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 (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)

Duna R. belmer

(Division Sign-Off) (Division Sign-Oll)
Division of Cardiovas Jular Device

510(k) Number K072195

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).