CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE

K082930 · Cardiva Medical, Inc. · DXC · Feb 13, 2009 · Cardiovascular

Device Facts

• Record ID: K082930
• Device Name: CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE
• Applicant: Cardiva Medical, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Feb 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cardiva Catalyst™ III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva Catalyst™ III System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

Device Story

Vascular clamp system for femoral arteriotomy sites; adjunct to manual compression. Device consists of sterile wire and clip. Wire inserted through existing introducer sheath; distal tip deploys flat 'Catalyst Disc' within femoral artery lumen. Disc provides temporary hemostasis while maintaining distal perfusion. Biocompatible coating contains Protamine Sulfate to aid hemostasis in heparinized patients. After dwell, disc collapsed and wire removed; no device components left in body. Final closure achieved via manual or mechanical compression. Used in clinical settings by physicians. Benefits include reduced oozing and promoted hemostasis at access site.

Clinical Evidence

Bench testing only.

Technological Characteristics

Vascular clamp; sterile disposable wire and clip. Features biocompatible coating with Protamine Sulfate. Mechanical deployment of internal disc. Designed for 5F, 6F, 7F introducer sheaths. No software or electronic components.

Indications for Use

Indicated for patients undergoing diagnostic and/or interventional femoral artery catheterization (5F, 6F, or 7F sheaths) who are heparinized.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Cardiva Medical Boomerang™ Catalyst II System (K072297)

Submission Summary (Full Text)

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

CARDIVA MEDICAL, INC.

### Cardiva Catalyst™ III System TRADITIONAL 510(k) PREMARKET NOTIFICATION

# SECTION 6 510(k) SUMMARY

## 510(k) Notification K082930

## GENERAL INFORMATION

Applicant:

Cardiva Medical, Inc. 2585 Leghorn Street Mountain View, CA 94043 Phone: [phone] Facsimile: 650-964-8911

### Contact Person:

Kit Cariquitan Regulatory Consultant Experien Group, LLC Phone: [phone] Facsimile: 408-400-0865 Email: [e-mail]

Date Prepared: September 30, 2008

Classification: 21 CFR §870.4450, Class II

Product Code: DXC

Trade Name: Cardiva Catalyst™ III System

Generic/Common Name: Vascular Clamp

#### PREDICATE DEVICE

Cardiva Medical Boomerang™ Catalyst II System (K072297)

#### INTENDED USE

The Cardiva Catalyst™ III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva Catalyst™ III System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

FEB 1 3 2009

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

CARDIVA MEDICAL, INC.

## Cardiva Catalyst™ III System TRADITIONAL 510(k) PREMARKET NOTIFICATION

# SECTION 6 510(k) SUMMARY (CONT.)

### PRODUCT DESCRIPTION

The Cardiva Catalyst™ III System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst III system includes a design modification which involves the addition of Protamine Sulfate to the existing Boomerang Catalyst II System coating to further minimize ocze from the tissue tract and promote the hemostasis process in heparinized patients. The Cardiva Catalyst III System maintains the same indication for use as the Boomerang Catalyst System family of devices.

The Cardiva Catalyst III System consists of a sterile disposable Cardiva Catalyst III wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst III System is specifically designed for use with heparinized patients. In conjunction with manual compression, the Cardiva Catalyst III System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Cardiva Catalyst III wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Cardiva Catalyst III wire is deployed, which opens the flat, low-profile Catalyst Disc within the lumen of the femoral artery. During dwell, natural recoil of the smooth muscle of the vessel wall occurs at the arteriotomy site. A biocompatible coating on the Cardiva Catalyst III Wire aides the body's natural hemostatic process and promotes ease of removal. Specifically, the Cardiva Catalyst III System's biocompatible coating includes a minimal amount of Protamine Sulfate to further aid the body's natural hemostatic process in heparinized patients. Following the procedure, the Catalyst Disc is collapsed and the Cardiva Catalyst III wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Cardiva Catalyst III System.

### SUBSTANTIAL EQUIVALENCE

The Cardiva Catalyst III System is substantially equivalent to the predicate device with regard to function, intended use, and physical characteristics. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the Cardiva Catalyst III System is substantially equivalent to the predicate device.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION All necessary bench testing was conducted on the Cardiva Catalyst III System to support a determination of substantial equivalence to the predicate device.

#### SUMMARY

The Cardiva Catalyst III System is substantially equivalent to the predicate device.

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

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2009

Experien Group LLC c/o Mr. Kit Cariquitan Regulatory Consultant for Cardiva Medical 155 Moffett Park Drive, Suite A.2IO Sunnyvale, CA 94089

Re: K082930

Cardiva Catalyst™ III System with Protamine Sulfate Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: January 21, 2009 Received: January 22, 2009

Dear Mr. Cariquitan:

This letter corrects our substantially equivalent letter of April 23, 2009.

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 (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 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

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

Page 2 - Mr. Kit Cariquitan

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

R. Lachner

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

{4}------------------------------------------------

Page 3 - Mr. Kit Cariquitan

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,

R. Zukerman, M.D.

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