XTD THROMBECTOMY CATHETER, XX CM

K021641 · Xtrak Medical, Inc. · QEW · Jul 26, 2002 · Cardiovascular

Device Facts

• Record ID: K021641
• Device Name: XTD THROMBECTOMY CATHETER, XX CM
• Applicant: Xtrak Medical, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Jul 26, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For breaking apart and removing thrombus from hemodialysis access grafts.

Device Story

XTD Thrombectomy Catheter is a sterile, single-use, disposable device for fragmenting and removing thrombus from clotted hemodialysis access grafts. Device features a flexible, spiral-conveyor shaft rotating within a plastic sheath; a small, flexible, curved agitator extends from the sheath tip. During operation, the rotating agitator breaks thrombus into particles; particles are aspirated into the sheath and conveyed by the rotating spiral shaft to a collection line connected to a disposable vacuum syringe. A pinch clamp on the collection line allows the operator to manually control suction delivery. The device includes an integrated battery supply and luer connection. Used in clinical settings by healthcare providers to restore graft patency, potentially benefiting patients by avoiding more invasive surgical interventions.

Clinical Evidence

Bench testing only. Testing included mechanical bench testing, battery life testing, electrical safety testing, electrical emissions testing, and ship testing to assess compliance with specifications and support substantial equivalence.

Technological Characteristics

Sterile, single-use, disposable catheter. Features a rotating spiral-conveyor shaft within a plastic sheath and a curved agitator. Powered by an integrated battery. Includes a luer connection for a vacuum syringe and a manual pinch clamp for suction control.

Indications for Use

Indicated for patients requiring removal of thrombus from hemodialysis access grafts.

Regulatory Classification

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.

Predicate Devices

• XTD Thrombectomy System (K013473)

Submission Summary (Full Text)

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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, [phone], [e-mail].

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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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: [phone] Fax: [phone]

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

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.

## 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.