THROMCAT THROMBECTOMY CATHETER SYSTEM

K060016 · Kensey Nash Corp. · MCW · Apr 25, 2006 · Cardiovascular

Device Facts

• Record ID: K060016
• Device Name: THROMCAT THROMBECTOMY CATHETER SYSTEM
• Applicant: Kensey Nash Corp.
• Product Code: MCW · Cardiovascular
• Decision Date: Apr 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

ThromCat Thrombectomy Catheter System is a single-use, disposable device for percutaneous thrombus maceration and removal to restore blood flow. System components include a 5.5 Fr x 4.5 Fr infusion/extraction catheter (150 cm length), a DC-powered infusion/extraction pump, and an extraction line/bag. Operation involves an internal stainless steel helix enclosed within a radiopaque, atraumatic flexible tip and shaft to prevent vessel wall contact. The pump provides simultaneous infusion to 'wash' the vessel and extraction to remove thrombus. Used in clinical settings for hemodialysis access maintenance; operated by healthcare professionals. Output is the physical removal of thrombus, facilitating restored patency in dialysis access sites.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing (biocompatibility, EMC, electrical safety, mechanical testing) and animal studies. In vitro and in vivo comparison testing was conducted against the X-Sizer Catheter predicate.

Technological Characteristics

Single-use, disposable catheter system. Components: 5.5 Fr x 4.5 Fr infusion/extraction catheter (150 cm), DC-powered pump, extraction line/bag. Materials: Stainless steel helix, radiopaque flexible tip/shaft. Principle: Mechanical maceration via internal helix with simultaneous infusion/extraction flow. Electrical safety and EMC testing performed.

Indications for Use

Indicated for mechanical removal of thrombus in synthetic hemodialysis access grafts and native vessel dialysis fistulae.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• X-Sizer® Catheter System (K021096)
• Amplatz Thrombectomy Device (K982657)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

#### 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.

#### 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Davia R. bochner

Image /page/2/Picture/5 description: The image shows a handwritten symbol or character on the left side, which appears to be a combination of curved and angular lines. To the right of this symbol, there are two lines of text. The first line contains the letter 'E', and the second line contains the letter 'D'. The text is in a simple, sans-serif font and is aligned vertically.

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