The BioCardia Morph Universal Deflectable Guide Catheter is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.

Device Description

Not Found

AI/ML Overview

This device, the BioCardia Morph Universal Deflectable Guide Catheter, is a medical device and not an AI/ML product. Therefore, the questions related to AI/ML product evaluation (such as acceptance criteria for AI performance, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, MRMC studies, and standalone performance) are not applicable.

The submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria in the way an AI/ML product would.

Here’s the information gleaned from the provided text, focusing on the equivalence determination for a medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

For a traditional medical device 510(k), specific numerical "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC are typically not established in the same way as for an AI/ML device. Instead, the performance is demonstrated through comparison to a predicate device and adherence to recognized standards.

Acceptance Criteria (Implicit for 510(k) Equivalence)	Reported Device Performance (from "Test Results" section)
Performance for Intended Use: Device is safe and effective for its intended use.	"Results of in-vitro and animal testing demonstrate that the BioCardia Morph Universal Deflectable Guide Catheter is safe and effective for its intended use."
Biocompatibility: Materials meet requirements for biological safety.	"The materials used in the BioCardia Morph Universal Deflectable Guide Catheter are identical to those used in other diagnostic catheters and meet the requirements of ISO 10993-1."
Substantial Equivalence: Device is substantially equivalent to legally marketed predicate devices in intended use and/or method of operation.	The FDA determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.

2. Sample size used for the test set and the data provenance:

The document mentions "in-vitro and animal testing."
Sample Size: Specific numbers for samples used in in-vitro or animal testing are not provided in this summary.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as there is no mention of human expert-based ground truth establishment for this type of medical device evaluation. Performance is assessed through engineering tests and animal studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for the evaluation of this traditional medical device.

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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this medical device would be based on engineering measurements for in-vitro performance (e.g., deflection force, torque transmission, guidewire passage) and physiological/anatomical observations and safety assessments in animal models. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" in the AI/ML sense.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. There is no "training set" or corresponding ground truth for this traditional medical device.

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: 2/1/05

510(k) number: K042553

Applicant Information:

BioCardia, Inc. 384 Ovster Point Blvd. #5 South San Francisco, CA 94080

Contact Person:	Daniel C. Rosenman
Phone Number:	(650) 624-0900 main
Direct Number:	(650) 624-0122
Fax Number:	(650) 624-0099
Email:	drosenman@biocardia.com

Device Information:

Classification:
Trade Name:
Classification Name:

Class II BioCardia Morph Universal Deflectable Guide Catheter Percutaneous Catheter (21 CFR 870.1250)

Equivalent Device:

Equivalions Dovice is substantially equivalent in intended use and/or method of operation to the BioCardia Universal Deflectable Guide Catheter (K012749), SCIMED Triguide Guide Catheter (K961280), the USCI Mainstay Guiding Catheter (K971034) and the Cardima Naviport Deflectable Tip Guiding Catheter (K974683).

Intended Use:

Test Results:

Performance

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

Biocompatibility

The materials used in the BioCardia Morph 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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2005

Mr. Daniel C. Rosenman Vice President, Research and Development BioCardia, Inc. 384 Oyster Point Blvd, #5 South San Francisco, CA 94080

K042553 Re:

Trade/Device Name: BioCardia Morph Universal Deflectable Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: February 1, 2005 Received: February 2, 2005

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
s (21 CFR) (2008) (2006) (2005) (2005) (21 (2) (2) (2) 1000-1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Actived in your Section product radiation control provisions (Scellons 35 described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin harksting your correst of your device to a legally
premarket notification. The FDA finding of substantial equirales of your device to a le premarket notification. The FDA imuling of subsalinal equive 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 81), please
rs of the many of the may on 10, 2019 - Aber whices mate the regulation enti If you desire specific advice for your de vice of on Also, please note the regulation entitled, and the move obtain contact the Office of Compliance at (210) 276 - 17 (21CFR Part 807.97). You may obtain "Misbranding by reference to premation is the Act from the Division of Small
other general information on your responsibilities under the Act from worker (800) 638-200 other general information on your responsions at its toll-free number (800) 638-2041 or 1 Manufacturers, International and Consumer : 1/10/14/2017 : 1/10/10/10/10/11/10/1511/11/11/1

Sincerely yours,

Dana R. Varner

(a) 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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Indications for Use

510(k) Number (if known):	K042553
Device Name:	BioCardia Morph Universal Deflectable Guide Catheter
Indications For Use:	The BioCardia Morph Universal Deflectable Guide Catheter isintended to provide a pathway through which medical instruments,such as balloon dilatation catheters, guidewires, or othertherapeutic devices may be introduced into the peripheralvasculature or chambers and coronary vasculature of the heart.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dhuna R. Vaclunes

(Division & Off) Division of Cardiovascular Devices

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510(k) number K042553

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).