(7 days)
Not Found
No
The device description and intended use focus on mechanical steering and providing a pathway for instruments, with no mention of AI/ML, image processing, or data analysis.
No.
The device's intended use is to provide a pathway for other medical instruments and therapeutic devices, not to directly treat a condition itself.
No
The device is described as a "Sheath Guide" intended to provide a pathway for medical instruments and therapeutic devices into the peripheral vasculature. Its function is to facilitate delivery of other devices, not to diagnose medical conditions by analyzing data or images.
No
The device description clearly states it is a "single lumen steerable catheter introducer" and mentions physical components like a handle, knob, shaft, dilator, and hemostasis valve, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The BioCardia Morph® Sheath Guide is a medical device used to facilitate the introduction of other instruments into the peripheral vasculature. It is a tool used within the body for procedural purposes, not for analyzing samples outside the body.
- Intended Use: The intended use clearly states it's for providing a pathway for instruments to be introduced into the peripheral vasculature. This is a procedural function, not a diagnostic one based on analyzing biological samples.
The description and intended use align with a surgical or interventional device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of in-vitro and animal testing demonstrate that the BioCardia Morph® Sheath Guide is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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
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:
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.
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:
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.
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) |
|---|
| -------------------------------------------------------- |
(Division Sign -Off) of Clardiavascular Devices 510(k) Number Kostogy
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BioCardia, Inc.