BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664

K012749 · Biocardia, Inc. · DQO · Jan 24, 2002 · Cardiovascular

Device Facts

• Record ID: K012749
• Device Name: BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664
• Applicant: Biocardia, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Jan 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The BioCardia Universal Guide Catheter is intended to serve as a conduit for access into the chambers of the heart and coronary vasculature of the heart.

Device Story

BioCardia Universal Deflectable Guide Catheter functions as a conduit for accessing heart chambers and coronary vasculature. Device features a deflectable tip to facilitate navigation within the cardiovascular system. Operated by clinicians in a clinical setting; provides physical access for diagnostic or interventional procedures. Benefits include improved maneuverability and access to target anatomy compared to standard catheters. No electronic, software, or algorithmic components involved.

Clinical Evidence

No clinical data. Evidence consists of in-vitro and animal performance testing and biocompatibility assessment per ISO 10993-1.

Technological Characteristics

Deflectable guide catheter; materials identical to predicate diagnostic catheters; meets ISO 10993-1 biocompatibility standards. Mechanical navigation via deflectable tip.

Indications for Use

Indicated for use as a conduit for access into the chambers of the heart and coronary vasculature of the heart. No specific patient population, age, or gender restrictions provided.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• SCIMED Triguide Guide Catheter (K961280)
• USCI Mainstay Guiding Catheter (K971034)
• Cardima Naviport Deflectable Tip Guiding Catheter (K974683)

Submission Summary (Full Text)

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This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: August 15, 2001

510(k) number: _ _ KO12749

## Applicant Information:

JAN 2 4 2002

BioCardia, Inc. 384 Oyster Point Blvd. #6 South San Francisco, CA 94080

| Contact Person: | Daniel C. Rosenman |
|-----------------|--------------------|
| Phone Number: | [phone] |
| Fax Number: | [phone] |

#### Device Information:

Classification: Trade Name: Classification Name: Class II BioCardia Universal Deflectable Guide Catheter Percutaneous Catheter (21 CFR 870.1250)

#### Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of operation to the SCIMED Triguide Guide Catheter (K961280), the USCI Mainstay Guiding Catheter (K971034) and the Cardima Naviport Deflectable Tip Guiding Catheter (K974683).

#### Intended Use:

The BioCardia Universal Guide Catheter is intended to serve as a conduit for access into the chambers of the heart and coronary vasculature of the heart.

## Test Results:

- Performance
Results of in-vitro and animal testing demonstrate that the BioCardia Universal Deflectable Guide Catheter is safe and effective for its intended use.

#### Biocompatibility

The materials used in the BioCardia Universal Deflectable Guide Catheter are identical to those used in other diagnostic catheters and meet the requirements of ISO 10993-1.

Summary: Based on the intended use, product, performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2002

Mr. Daniel C. Rosenman Vice President, Research & Development BioCardia, Inc. 384 Oyster Point Boulevard, Suite #4 South San Francisco, CA 94080

K012749 Re:

Trade Name: BioCardia Universal Deflectable Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: 74 DQO Dated: November 2, 2001 Received: November 5, 2001

Dear Mr. Rosenman:

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 - Mr. Daniel C. Rosenman

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,

K. Van Tull

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

Enclosure

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# Indications for Use

# K012749

510(k) Number (if known):

Device Name:

BioCardia Universal Deflectable Guide Catheter

Indications for Use:

The BioCardia Universal Deflectable Guide Catheter is intended to serve as a The Bloodiale On.Yorda. Shirorou. Shippers and coronary vasculature of the heart

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Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices

| 510(k) Number | R012749 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

(Optional Format 1-2-96)