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 Description

BioCardia Universal Deflectable Guide Catheter

AI/ML Overview

The provided text describes the 510(k) premarket notification for the BioCardia Universal Deflectable Guide Catheter, submitted in 2001. The information focuses on demonstrating substantial equivalence to existing devices rather than a detailed study with acceptance criteria and device performance metrics in the way a modern AI/ML device submission would.

Therefore, many of the requested fields cannot be directly populated from the provided text. I will fill in what is available and indicate when information is not present.

Acceptance Criteria and Study Details for BioCardia Universal Deflectable Guide Catheter

This submission demonstrates substantial equivalence of the BioCardia Universal Deflectable Guide Catheter to predicate devices rather than proving performance against specific acceptance criteria for a novel device. The "acceptance criteria" can be inferred as meeting the safety and effectiveness requirements for its intended use, as demonstrated through in-vitro and animal testing and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred)	Reported Device Performance
Safety and Effectiveness for Intended Use: To serve as a conduit for access into the chambers of the heart and coronary vasculature.	Results of in-vitro and animal testing demonstrate that the BioCardia Universal Deflectable Guide Catheter is safe and effective for its intended use.
Biocompatibility: Materials meet requirements of ISO 10993-1.	The materials used are identical to those in other diagnostic catheters and meet the requirements of ISO 10993-1.
Substantial Equivalence: Equivalent in intended use and/or method of operation to predicate devices (SCIMED Triguide Guide Catheter (K961280), USCI Mainstay Guiding Catheter (K971034), Cardima Naviport Deflectable Tip Guiding Catheter (K974683)).	The device was found substantially equivalent to the legally marketed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified. The document mentions "in-vitro and animal testing," but doesn't provide the number of samples or animals used.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The nature of "in-vitro and animal testing" suggests controlled lab environments.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable/Not specified. The assessment appears to be based on physical testing and material compliance rather than expert image interpretation or clinical consensus.

4. Adjudication Method for the Test Set:

Not applicable/Not specified. This type of adjudication is typically for clinical or image-based studies where expert consensus on a diagnosis is required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/ML device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML device. The "standalone" performance here relates to the physical and functional testing of the catheter itself, as indicated by "in-vitro and animal testing."

7. The Type of Ground Truth Used:

For Performance and Safety: Results from "in-vitro and animal testing." This would typically involve objective measurements of device function, durability, and biological response.
For Biocompatibility: Compliance with ISO 10993-1 standards, likely through laboratory tests and material composition analysis.

8. The Sample Size for the Training Set:

Not applicable in the context of this device. This is a traditional medical device, not an AI/ML product that utilizes a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary

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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:	(650) 624-0120
Fax Number:	(650) 624-0125

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 (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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Prescription Use(Per 21 CFR 801.109)	OR	Over-the Counter Use
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(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).