(161 days)
Not Found
No
The summary describes a physical medical device (a guide catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a guide catheter meant for access into the heart chambers and coronary vasculature, not for treating a disease or condition. It serves as a conduit, which is a diagnostic or interventional tool, not a therapeutic one itself.
No
The device is described as a guide catheter intended to serve as a conduit for access into the heart chambers and coronary vasculature. Its purpose is to facilitate access rather than to diagnose a condition.
No
The device description clearly identifies it as a "BioCardia Universal Deflectable Guide Catheter," which is a physical, hardware medical device used for accessing the heart. The summary also mentions "in-vitro and animal testing," which are typical performance studies for hardware devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "conduit for access into the chambers of the heart and coronary vasculature of the heart." This describes a device used within the body for a procedural purpose, not a device used to examine specimens outside the body to diagnose a condition.
- Device Description: The description "BioCardia Universal Deflectable Guide Catheter" further reinforces that it's a physical instrument used in a medical procedure.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information based on laboratory testing
Based on the provided information, the BioCardia Universal Guide Catheter is a medical device used for interventional procedures within the heart.
N/A
Intended Use / Indications for 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."
Product codes
74 DQO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chambers of the heart and coronary vasculature of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
"Results of in-vitro and animal testing demonstrate that the BioCardia Universal Deflectable Guide Catheter is safe and effective for its intended use."
Key Metrics
Not Found
Predicate Device(s)
SCIMED Triguide Guide Catheter (K961280), USCI Mainstay Guiding Catheter (K971034), Cardima Naviport Deflectable Tip Guiding Catheter (K974683)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
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
3
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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | R012749 |
|---|---|
| --------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-the Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)