THROMCAT THROMBECTOMY CATHETER SYSTEM

K072195 · Kensey Nash Corp. · MCW · Aug 23, 2007 · Cardiovascular

Device Facts

• Record ID: K072195
• Device Name: THROMCAT THROMBECTOMY CATHETER SYSTEM
• Applicant: Kensey Nash Corp.
• Product Code: MCW · Cardiovascular
• Decision Date: Aug 23, 2007
• Decision: SESE
• Submission Type: Special
• 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 removal and blood flow restoration. System components include a 5.5 Fr infusion/extraction catheter (150cm length), a DC-powered infusion/extraction pump, and an extraction line/bag. Operation involves a stainless steel helix enclosed within a radiopaque, atraumatic flexible tip/shaft to prevent vessel wall contact. The device provides simultaneous infusion to 'wash' the vessel and extraction to remove thrombus. Used in clinical settings by physicians; output is the physical removal of thrombus, which restores patency in dialysis access sites, benefiting patients by maintaining hemodialysis access.

Clinical Evidence

Bench testing only. No clinical data provided. Non-clinical verification included in-vitro bench testing and biocompatibility testing to confirm design specifications.

Technological Characteristics

Single-use, disposable catheter system. Components: 5.5 Fr infusion/extraction catheter (150cm), DC-powered pump, extraction line/bag. Features: Stainless steel helix, radiopaque atraumatic tip/shaft. Energy source: DC-powered pump. Sterilization: Not specified.

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

• ThromCat™ Thrombectomy Catheter System (K060016)

Submission Summary (Full Text)

{0}------------------------------------------------

## 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 Corporation<br>735 Pennsylvania Drive<br>Exton, PA 19341 USA |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cindy R. Varughese, RAC<br>Regulatory Affairs Associate<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| 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™ Thrombectomy<br>Catheter System (K060016) |
| Date Prepared: | July 30, 2007 |

### Description of Device:

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.

#### 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.

{1}------------------------------------------------

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.

{2}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{3}------------------------------------------------

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