The XTD™ Thrombectomy Catheter is a sterile, single-use, disposable catheter designed to simultaneously fragment and remove thrombus from clotted hemodialysis access grafts. The catheter consists of a flexible, spiral-conveyor shaft rotating within a plastic sheath. The shaft has a small, flexible, curved agitator which extends out of the sheath. As the agitator rotates it breaks the thrombus to particles are aspirated into the sheath and are conveyed by the rotating spiral shaft through the sheath to a collection line connected to a disposable vacuum syringe. A pinch clamp on the collection line isolates the svringe and allows the operator to manually control the delivery of suction to the catheter tip. The battery supply and a luer connection for the syringe are incorporated directly onto the catheter.

AI/ML Overview

This document is a 510(k) premarket notification for the XTD™ Thrombectomy Catheter, issued by the FDA. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting formal acceptance criteria and a detailed study proving the device meets them in the way clinical studies for AI/software devices typically do.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth establishment for this specific device (a physical medical device, not an AI/software product) is not directly present in the provided text.

However, I can extract the relevant information from the document as it pertains to the safety and effectiveness testing conducted for this device.

Here's a breakdown based on the provided text, addressing what can be inferred and what is not applicable:

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

The document does not provide a table of acceptance criteria with specific numerical thresholds for performance. Instead, it states that "Test results have demonstrated conformance of the XTD™ Thrombectomy Catheter to its specification requirements." The general acceptance criterion is demonstrating substantial equivalence to the predicate device and meeting its own specifications.

Acceptance Criterion (Inferred)	Reported Device Performance
Conformance to Specification Requirements	Test results demonstrated conformance of the XTD™ Thrombectomy Catheter to its specification requirements.
Safety and Effectiveness	The XTD™ Thrombectomy Catheter is as safe and effective as the legally marketed predicate device (XTD™ Thrombectomy System, K013473).
Material Suitability	All materials used are suitable for their intended use and commonly used in previously cleared products.
Mechanical Bench Testing	Testing was performed; results demonstrated conformance to specification requirements.
Battery Life Testing	Testing was performed; results demonstrated conformance to specification requirements.
Electrical Safety Testing	Testing was performed; results demonstrated conformance to specification requirements.
Electrical Emissions Testing	Testing was performed; results demonstrated conformance to specification requirements.
Ship Testing	Testing was performed; results demonstrated conformance to specification requirements.

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

This information is not provided in the document. The testing described (mechanical bench, battery life, electrical safety, electrical emissions, ship testing) refers to physical device characteristic testing, not clinical data or a "test set" in the context of an AI/software evaluation.

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)

This is not applicable as the device is a physical thrombectomy catheter, not an AI/software product requiring expert-established ground truth on clinical images or data. The "ground truth" here would be the physical specifications and performance under various engineering tests.

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

This is not applicable for the type of device and 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

This is not applicable. An MRMC study is relevant for AI-assisted diagnostic or interpretative devices. The XTD™ Thrombectomy Catheter is a therapeutic surgical tool.

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

This is not applicable. The device is a physical catheter used by a human operator, not an algorithm.

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

For this physical device, the "ground truth" or reference standards for the performance testing would be:

Engineering specifications and validated test methods for mechanical, electrical, and battery performance.
Established regulatory standards for electrical safety and emissions.
Industry standards for ship testing (packaging integrity).
The performance characteristics of the legally marketed predicate device against which substantial equivalence is claimed.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI/software product that requires a training set.

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

This is not applicable.

Summary

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October 8, 2021

Xtrak Medical Inc. Debbie Iampietro President 7 Tiffany Trail Hopkinton, Massachusetts 01748

Re: K021641

Trade/Device Name: XTD Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW

Dear Debbie Iampietro:

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 July 26, 2002. Specifically, FDA is updating this SE Letter 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,

Digitally signed by Gregory W. Gregory W. O'connell -5 O'connell -S Date: 2021.10.08 10:19:03 -04'00'

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 seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 6 2002

XTRAK Medical, Inc. Ms. Debbie Iampietro c/o QRC Consulting Associates 7 Tiffany Trail Hopkinton, MA 01748

K021641 Re:

Device Name: XTDTM Thrombectomy Cathater Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: July 2, 2002 Received: July 2, 2002

Dear Ms. Iampietro:

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.

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

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Page 2 - Ms. Debbie Iampietro

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Nole Tuch

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Verl 3 - 4/24/96

Applicant: XTRAK MEDICAL, INC.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: XTD™ Thrombectomy Catheter

Indications For Use:

For breaking apart and removing thrombus from hemodialysis access grafts.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K021641

Prescription Use
(Per 21 CFR 801.109)

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JUL 2 6 2002

K021641 response

ﭘﻪ

K021641
Attachment 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS XTD™ Thrombectomy Catheter July 1, 2002

General Information

Classification: Trade Name:

Trade Name

Sponsor:

Class II

XTD™ Thrombectomy Catheter

Xtrak Medical, Inc. 26H Keewaydin, Dr. Salem, NH 03079 Tel: (603) 896-6416 Fax: (603) 893-7708

Contact:

Gary Boseck, Ph.D. President

Identification of Predicate or Legally Marketed Devices

The XTD™ Thrombectomy System (K013473) manufactured by Xtrak Medical, Inc.

Intended Use

For breaking apart and removing thrombus from hemodialysis access grafts.

Device Description

Materials

All materials used in the manufacture of the XTD™ Thrombectomy Catheter are suitable for their intended use and are used commonly in the manufacture of previously cleared products.

Performance Testing

The XTD™ Thrombectomy Catheter components have been tested to assess compliance with their specifications and to support claims of substantial equivalence to the predicate device. This testing includes the following:

Mechanical Bench Testing Battery Life Testing Electrical Safety Testing Electrical Emissions Testing Ship Testing

Test results have demonstrated conformance of the XTD™ Thrombectomy Catheter to its specification requirements, and that the XTD™ Thrombectomy Catheter is as safe and effective as the legally marketed predicate device.

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K021641 response

Summary of Substantial Equivalence

Xtrak Medical believes that the XTD™ Thrombectomy Catheter is substantially equivalent to the legally marketed predicate device. This claim of equivalence is supported by the identical intended use of the devices and their common fundamental scientific characteristics.

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).