(68 days)
Not Found
Not Found
No
The 510(k) summary describes a standard guiding catheter and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No
The device, a guiding catheter, is used to introduce other interventional devices and allows for pressure monitoring and injection of contrast agents, but it does not treat or cure a disease itself.
No
Explanation: The device, USCI® guiding catheters, is described as providing a pathway for other devices and allowing pressure monitoring and contrast injection. It is an interventional device, not a diagnostic one.
No
The device description clearly states it is a "guiding catheter," which is a physical medical device used in the cardiovascular system. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is designed for use in the cardiovascular system to provide a pathway for introducing other devices, monitoring pressure, and injecting contrast agents. This is an in vivo application (within a living organism).
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
The description of the USCI® guiding catheter aligns with a medical device used directly within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
USCI® guiding catheters are designed for use in the cardiovascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. Guiding catheters also allow pressure monitoring and injection of contrast agents.
Product codes
74 DQO
Device Description
The Mainstay catheter is a guiding catheter for use in the cardiovascular system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system
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
Safety and performance testing was performed to demonstrate that the USCI Mainstay Guiding Catheter is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Scimed Guiding Catheters, USCI Guiding Catheters
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
C.R. Bard, Inc. Regulatory Affairs 129 Concord Road P.O. Box 566 Billerica, MA 01821 508-667-2511 FAX: (508) 667-8594
B.
MAY 2 8 1997
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VI. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
- A. Submitter Information:
| Name: | USCI Division of C.R. Bard, Inc. |
|---|---|
| Address: | 129 Concord Road, Billerica, MA 01821 |
| Phone: | (508) 667-2511 extension 1065 |
| Fax: | (508) 667-8594 |
| Contact Person: | Douglas E. Ferguson |
| Senior Regulatory Affairs Coordinator | |
| Date of Preparation: | March 17, 1997 |
| Device Name | |
| Trade Name: | USCI® Mainstay Guiding Catheter |
| Common Name: | Guiding Catheter |
Classification Name: Diagnostic Intravascular Catheter/Percutaneous Catheter
| C. Predicate Device Name(s): | 1. Scimed Guiding Catheters
2. USCI Guiding Catheters |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| D. Device Description | The Mainstay catheter is a guiding
catheter for use in the cardiovascular
system. |
| E. Intended Use | Guide catheters provide a pathway
through which dilatation systems and
other interventional devices are
introduced. |
F. Technological Characteristics Summary
The USCI Mainstay Guiding Catheter is very similar to the Scimed guiding catheters regarding materials and construction, and is similar to the USCI Illumen-8 guiding catheter regarding packaging and sterilization.
Premarket Notification for USCI Mainstay Guiding Catheter
Image /page/0/Picture/13 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The word appears to be slightly tilted.
1
The indications for use are similar to both the Scimed catheters and the USCI guiding catheters. They are all indicated to provide a pathway through which dilatation systems and other interventional devices are introduced. The proposed Mainstay indications are:
USCI® guiding catheters are designed for use in the cardiovascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. Guiding catheters also allow pressure monitoring and injection of contrast agents.
Similar to both the Scimed catheters and the USCI catheters, the USCI Mainstay catheter will be available in 6 French - 9 French, and will be offered in various curve styles.
G. Performance Data
Safety and performance testing was performed to demonstrate that the USCI Mainstay Guiding Catheter is substantially equivalent to the predicate devices.
Premarket Notification for USCI Mainstay Guiding Catheter
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUM SERVICES - USA" are arranged around the caduceus in a circular fashion. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 1997
Mr.. Douglas E. Ferguson USCI Division of C.R. Bard, Inc....... 129 Concord Road " Billerica, Massachusetts 01821
Re: K971034 USCI® Mainstay Guiding Catheter Regulatory Class: II (two) Product Code: 74 DQO Dated: March 20, 1997 March 21, 1997 Received:
Dear Mr. Ferguson:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listinq of devices, qood manufacturing practice, labeling, and prohibitions against misbrandinq and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Douqlas E. Ferguson
This letter will allow you to begin marketing your device as described in your 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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, "Misbrandinq by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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D. INDICATIONS FOR USE
Device Name: USCI® Mainstay Guiding Catheter
Indications for Use:
USCI® guiding catheters are designed for use in the cardiovascular system. Their primary function is to provide a pathway through which dilatation systems and other interventional devices are introduced. Guiding catheters also allow pressure monitoring and injection of contrast agents.
Contraindications:
These devices are not intended for use in the cerebral vasculature.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Respiratory. and Neurological Devices | |
| 510(k) Number | K971034 |
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -- |
OR
Over-the-Counter UsePremarket Notification for USCI Mainstay Guiding Catheter