The XTD™ Thrombectomy System consists of the XTD™ Thrombectomy Catheter has a flexible, rotating spiral conveyor shaft contained within a plastic sheath, a Control Console, and a disposable Collection Bottle. As the agitator rotates it macerated thrombus within the graft and the rotating spiral conveyor shaft conveys the macerated thrombus through the sheath, assisted by negative pressure, to a disposable Collection Bottle. The Control Console provides power and control of the catheter operation.

AI/ML Overview

The provided text describes the XTD™ Thrombectomy System and its 510(k) summary for FDA clearance. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, device performance metrics, study design specifics (sample sizes, data provenance, expert details, adjudication methods), or comparative effectiveness studies.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in the document. The document generally refers to "specifications" and "claims of substantial equivalence."
Reported Device Performance:
- "Test results have demonstrated conformance of the XTD™ components to their specification."
- "Performance testing has demonstrated that the XTD™ Thrombectomy System is as safe and effective as the legally marketed predicated devices."
- These are qualitative statements, not quantitative performance metrics against specific acceptance criteria.

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

Sample Size: Not mentioned. The document states "Human Clinical Testing" was performed but gives no details about the number of subjects or cases.
Data Provenance (country of origin, retrospective/prospective): Not mentioned.

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

Not mentioned.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not mentioned. The document only states the device is "as safe and effective as the legally marketed predicated devices," implying a comparison, but it doesn't describe an MRMC study or quantify any effect size.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a physical medical device (thrombectomy system), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" is not applicable here. Performance testing would refer to the device's mechanical, electrical, and biological safety and efficacy when used by an operator.

7. The Type of Ground Truth Used

Not explicitly stated for clinical trials. For in-vitro and in-vivo (animal) testing, "specifications" are mentioned, which would serve as a form of ground truth for those tests (e.g., efficacy in removing thrombus in a controlled setting). For "Human Clinical Testing," the ground truth likely involved clinical outcomes (e.g., successful thrombus removal, complication rates) compared to the predicate device, but this is not detailed.

8. The Sample Size for the Training Set

Not applicable as this is a physical medical device, not an AI model that requires a training set.

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

Not applicable as this is a physical medical device.

Summary of Conducted Performance Testing (from the document):

Mechanical Strength Testing
Fatigue Strength Testing
Electrical Safety Testing
Biocompatibility Testing
In-vitro Performance Testing
In-vivo (animal) Testing
Human Clinical Testing

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through various types of testing, but it lacks the detailed quantitative performance metrics, study design specifics, and expert-related information that your prompt requests. This level of detail is typically found in full study reports or more comprehensive regulatory submissions, not usually in a high-level 510(k) summary.

Summary

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6 2002 MAR

K013473

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

XTD™ Thrombectorny System Xtrak Medical, Inc. January 17, 2002

General Information

Classification:

Class II

XTD™ Thrombectomy System Trade Name: Xtrak Medical, Inc. Sponsor: 26H Keewaydin, Dr. Salem, NH 03079 (603) 896-6416 Tel: (603) 893-7708 Fax: Gary Boseck, Ph.D. Contact: President

Identification of Predicate or Legally Marketed Devices

ldentification of Predicate of Legally Manufactured by Possis Medical, Possis Anglosel Rapid Thrombecomy Oystem (RSC61-9), Manufactured by Arrow International, Inc.

Intended Use

mtended Use

Device Description

Device Description
The XTD™ Thrombectomy System consists of the XTD™ Thrombectomy Catheter has a flexible , rd The XTD™ Thrombectorly System Consists of the XTD™ catheter has a flexible, rotating Control Console, and ATD - Oollection BF plastic sheatist end of the spiral shaft spiral conveyor shart contained within a chipitator. As the agitator rotates it macerated thrombus within the graft and the rotating spiral conveyor shaft conveys the macerated thrombus within the gran and the rolating spiral of researc, to a disposable Collection Bottle.
thrombus through the sheath, assisted by negative pressure, to a disposation thromous inrough the sheath, assisted by nogative process. It as a many of the catheter operation.

Materials

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

Performance Testing

Perrormance Testing The ATD™ Thrombectonly Oystem oumponents nave been to the predicate devices.
their specifications and to support claims of substantial equivalence to the predicate devices. This testing includes the following:

Mechanical Strength Testing .
Fatigue Strength Testing .
Electrical Safety Testing ●
Biocompatibility Testing ●
In-vitro Performance Testing ●
In-vivo (animal) Testing ●
Human Clinical Testing .

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Test results have demonstrated conformance of the XTD™ components to their specification Test results have demonstrated confidmance of the ATD - compensent is the results and effective as the legally marketed predicated devices.

Summary of Substantial Equivalence

Sammary of Gubountial Equiv Thrombectomy System is substantially equivalent to the legally marketed predicate devices. This claim of equivalence is supported by the identical intended use of the devices and their common technological characteristics.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 2002 MAR

Xtrak Medical, Inc. c/o Gary Boseck, Ph.D. 26H Keewaydin Dr Salem, NH 03079

Re: K013473

XTD™ Thrombectomy System Regulation Number: 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: II (two) Product Code: MCW Dated: January 17, 2002 Received: January 18, 2002

Dear Dr. Boseck:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bection of the device is substantially equivalent (for the indications felerenced above and nave acterimentaly marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manat date of the Medical Device Amendments, or to connine.co. phor to May 20, 1978, as can and and and the Federal Food, Drug, devices mat have occh reclassinod in assess approval of a premarket approval application (PMA). and Costicule Act (71ct) that to novice, subject to the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (500 a00 ro) as . Existing major regulations affecting your device can may oc subject to suen additions, 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 I least be advised that I Dri 3 lisualite of our device complies with other requirements of the Act that I Dri has made a acterimalistions administered by other Federal agencies. You must

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Page 2 - Gary Boseck, Ph.D.

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 CFK Fart 807), fabeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maxioning your maxicant of your device to a legally prematication. The PDA mixing of cassification 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 If you desire specific advice to: your witto diagnostic devices), please contact the Office of additionally 21 CTTC Far 009.10 Additionally, for questions on the promotion and advertising of Compliance at (301) 594-1500. Traditions) , 1977-194-4639. Also, please note the your devices, prease commonding by reference to premarket notification" (21CFR Part 807.97). I guilation chitited, "Misolanants of responsibilities under the Act may be obtained from the Other general miormation on your responsional 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,

Dork Tills

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ver/ 3 - 4/24/96

Applicant: XTRAK MEDICAL, INC.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: XTD™ Thrombectomy System

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)

Division of Cardiovascular & Respiratory Devige (Per 21 CFR 801.109)
510(k) Number K013473

(Optional Format 1-2-96)

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).