The BioCardia Morph® Sheath Guide 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.

Device Description

The BioCardia Morph® Sheath Guide is a single lumen steerable catheter introducer. It is designed to be delivered percutaneously with the use of an internal dilator and advanced to a desired location within the vasculature to facilitate delivery of therapeutic catheters. Steering of the device is accomplished by rotation of a knob on the handle which deflects the distal tip of the catheter shaft. The BioCardia Morph Sheath Guide is supplied with a dilator and includes a hemostasis valve through which the dilator, guidewires, and devices may be passed while minimizing blood loss.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the BioCardia Morph® Sheath Guide. However, it does not contain the specific details required to complete your request regarding acceptance criteria and a study proving the device meets those criteria.

The document primarily focuses on:

Device Description: What the BioCardia Morph® Sheath Guide is.
Intended Use: What it's designed to do.
Equivalent Devices: Other similar devices on the market.
Test Results (High-level): Mentions "in-vitro and animal testing" and "biocompatibility" but provides no specific acceptance criteria or detailed study results.
Regulatory Communication: FDA's confirmation of substantial equivalence.

Therefore, I cannot populate the table or answer most of your detailed questions. The document explicitly states: "{1}------------------------------------------------ #### Test Results: #### Performance Results of in-vitro and animal testing demonstrate that the BioCardia Morph® Sheath Guide is safe and effective for its intended use." This is a summary statement, not a presentation of detailed acceptance criteria or study results.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Device Performance Study Details

Information	Description / Status
1. Acceptance Criteria Table & Reported Performance	Not provided in the text. The document states: "Results of in-vitro and animal testing demonstrate that the BioCardia Morph® Sheath Guide is safe and effective for its intended use" but offers no specific metrics, thresholds, or quantitative results against which acceptance criteria could be measured.
2. Sample size and data provenance for test set	Not provided in the text. The document mentions "in-vitro and animal testing" but gives no details on sample size, animal models, or data provenance (e.g., country of origin, retrospective/prospective).
3. Number and qualifications of experts for test set GT	Not applicable/Provided. The testing mentioned appears to be performance-based (e.g., mechanical, biocompatibility, animal-based procedural success) rather than requiring expert ground truth in the context of diagnostic interpretation. If any expert evaluation was involved (e.g., in animal studies), no details are provided.
4. Adjudication method for test set	Not applicable/Provided. See point 3.
5. MRMC comparative effectiveness study? Effect size?	No. This device is a steerable introducer sheath, not an AI or diagnostic imaging device that would typically involve a multi-reader multi-case (MRMC) comparative effectiveness study for human readers' performance with/without AI assistance.
6. Standalone (algorithm only) performance done?	No. This is a physical medical device, not a software algorithm. The performance evaluation would be of the physical device's function, not an algorithm's.
7. Type of ground truth used (test set)	Not applicable/Provided. The "ground truth" for a physical device like this relates to its mechanical performance, biocompatibility, and success in animal models (e.g., successful navigation, delivery of instruments). The specific metrics and methods for determining this are not detailed beyond "in-vitro and animal testing."
8. Sample size for training set	Not applicable/Provided. This is a physical medical device and would not typically have a "training set" in the machine learning sense. The development and design validation would involve engineering tests (e.g., fatigue, tensile strength) and early-phase animal studies, but these are not referred to as a "training set."
9. How ground truth for training set was established	Not applicable/Provided. See point 8.

Summary

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

510(K) SUMMARY 5.

APR 1 5 2009

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: March 9, 2009

K090999

Applicant Information:

BioCardia, Inc. 125 Shoreway Road, Suite B San Carlos CA 94070

Contact Person

510(k) number:

David Snow Vice President, Research and Development 650-226-0133 dsnow@biocardia.com

Device Information:

Trade Name:	BioCardia Morph® Sheath Guide
Classification:	Class II
Classification Name:	Catheter Introducer

Physical Description:

Intended Use:

The BioCardia Morph® Sheath Guide is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, quidewires, or other therapeutic devices may be introduced into the peripheral vasculature.

Equivalent Devices:

The subject device is substantially equivalent in intended use and/or method of operation to the following devices:

BioCardia Morph® Universal Deflectable Guide Catheter	K042553
Enpath / Bard® Channel Steerable Sheath	K043489
Pinnacle® Destination® Peripheral Guiding Sheath	K080415

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

Test Results:

Performance

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

Biocompatibility

The materials used in the BioCardia Morph® Sheath Guide 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 devices.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES · USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2009

BioCardia, Inc. c/o Mr. Morten Simon Christensen Staff Engineer Underwriters Laboratories, Inc. 455 E. Trimble Road San Jose, CA 95131

Re: K090999 BioCardia Morph Sheath Guide Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 1, 2009 Received: April 8, 2009

Dear Mr. Christensen:

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 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.

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

Page 2 - Mr. Morten Simon Christensen

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bram D. Zuckerman, M.D.

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

Enclosure

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

INDICATIONS FOR USE STATEMENT 4.

510(k) Number (if known):

BioCardia Morph® Sheath Guide Device Name:

Indications for Use:

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign -Off) of Clardiavascular Devices 510(k) Number Kostogy

Page of of

BioCardia, Inc.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).