QUICKCAT EXTRACTION CATHETER

K060092 · Kensey Nash Corp. · QEZ · Mar 9, 2006 · Cardiovascular

Device Facts

• Record ID: K060092
• Device Name: QUICKCAT EXTRACTION CATHETER
• Applicant: Kensey Nash Corp.
• Product Code: QEZ · Cardiovascular
• Decision Date: Mar 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The QuickCat™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

Device Story

QuickCat™ Extraction Catheter is a single-use, disposable, dual-lumen catheter designed for arterial embolectomy. System includes 30 ml vacuum syringe, extension tubing with stopcock, and 40-micron filter basket. Catheter features 145 cm working length, compatible with 6F guiding catheters (I.D. ≥ 0.068") and 0.014" guidewires. Distal tip is atraumatic with radiopaque marker for fluoroscopic visualization; distal segment has hydrophilic coating for deliverability. Physician operates device in arterial system to extract thrombi via manual vacuum aspiration. Extracted material passes through catheter into tubing/syringe assembly; filter basket allows collection of material for analysis. Device provides structural integrity and flexibility for navigating tortuous vasculature. Benefits include effective removal of arterial obstructions.

Clinical Evidence

Bench testing only. Comparison bench testing performed against predicate devices (Diver C.E. and Export Catheter) to demonstrate equivalent performance characteristics. Biocompatibility testing conducted per ISO 10993 and FDA Memorandum #G95-1.

Technological Characteristics

Dual-lumen catheter; 145 cm length; hydrophilic coating on distal segment; radiopaque distal tip. Materials evaluated per ISO 10993. Vacuum-assisted aspiration via syringe. Compatible with 6F guiding catheters and 0.014" guidewires. Includes 40-micron filter basket for material collection.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from arterial system vessels.

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

• Diver C.E. Catheter (K050276)
• Export Catheter (K040869)
• Pronto Extraction Catheter (K032763)

Submission Summary (Full Text)

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# 510(k) Summary

**510(k) Number:** *k060092*

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR§807.92.

| Submitter Information: | Kensey Nash Corporation<br>735 Pennsylvania Drive<br>Exton, PA 19341 USA<br>Deborah L Jackson, RAC<br>Regulatory Affairs Specialist<br>Tel: [phone] |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | e-mail: [e-mail] |
| Trade Name: | QuickCat™ Extraction Catheter |
| Common Name: | Embolectomy Catheter |
| Classification Name: | Embolectomy Catheter (per 21 CFR Section 870.5150) |
| Regulatory Class: | Class II |
| Device Product Code: | DXE |
| Predicate Device: | Invatec Innovative Technologies' Diver C.E. Catheter (K050276), Medtronic Inc.'s Export Catheter (K040869), and Vascular Solution's Pronto Extraction Catheter (K032763) |
| Date Prepared: | January 11, 2006 |

#### Description of Device

The QuickCat™ Extraction Catheter is a single use, disposable, dual lumen catheter with associated accessories consisting of a 30 ml. vacuum syringe, extension tubing with stopcock, and an independent 40-micron filter basket. The 145 cm working length and is compatible with 6F guiding catheters with an inner diameter (I.D.) ≥ 0.068" (1.73 mm) and 0.014" (0.36 mm) diameter guidewires. The extraction lumen of the catheter facilitates removal of emboli and thrombi via the attached tubing assembly, stopcock and vacuum syringe. The atraumatic distal tip, which incorporates a radiopaque marker for visibility

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Kensey Nash Corporation Original Traditional 510(k) QuickCat™ Extraction Catheter

under fluoroscopy, provides for smooth passage in the arterial system. The catheter consists of three segments. The stiffer proximal seqment and more flexible distal segments provide the required structural integrity and flexibility to navigate tortuous vasculature. The distal segment consists of a dual lumen to allow for "rapid exchange" attachment to the quidewire. The catheter's distal portion has a hydrophilic coating to enhance deliverability. A 40-micron pore filter basket is supplied to assist in filtering of blood and thrombotic material for visual or laboratory analysis.

### Intended Use of Device

The QuickCat™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

### Summary of Testing

Biocompatibility: Biocompatibility testing was conducted in accordance with ISO 10993, "Biological Evaluation of Medical Devices, " and FDA Memorandum #G95-1, "Biological Evaluation of Medical Devices".

Performance Testing - Bench: Comparison bench testing was performed on the QuickCat™ Extraction Catheter and the predicate devices (Diver C.E. and Export Catheter) regarding performance characteristics to demonstrate equivalency. Design verification testing was performed on the QuickCat™ Extraction Catheter to confirm that the design inputs meet the design outputs.

#### Statement of Substantial Equivalence:

Kensey Nash Corporation considers the QuickCat™ Extraction Catheter substantially equivalent to Invatec Innovative Technologies' Diver C.E. Catheter (K050276), Medtronic Inc.'s Export Catheter (K040869), and Vascular Solution's Pronto Extraction Catheter (K032763) based on comparison of intended use, performance, technological characteristics and materials.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 9

Kensey Nash Corporation c/o Ms. Deborah L. Jackson Regulatory Affairs Specialist 735 Pennsylvania Drive Exton, PA 19341

K060092 Re: OuickCat™ Extraction Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II Product Code: DXE Dated: January 11, 2006 Received: January 12, 2006

#### Dear Ms. Jackson:

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.

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Page 2 - Ms. Deborah L. Jackson

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/cdrh/industry/support/index.html.

Sincerely yours,

Sona R. Lichtner

\ 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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Kensey Nash Corporation Original Traditional 510(k) QuickCat™ Extraction Catheter

## Indications for Use Statement

510(k) Number (if known): KO60092

: K060092

Device Name:

QuickCat™ Extraction Catheter

Indications for Use:

The QuickCat™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

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)

Duuna R. V. Jones
(Division Sign Off)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K06009Z