(187 days)
Cordis Vista brite tip™ guiding catheter
No
The 510(k) summary describes a physical medical device (guiding catheter) and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is designed to facilitate the placement of interventional devices, not to provide therapy itself. It acts as a guide for other devices.
No
The device is a guiding catheter designed to facilitate the introduction of other interventional devices, not to diagnose a condition. Its function is purely procedural, enabling the placement of therapeutic tools.
No
The device description clearly states it is a physical catheter available in different sizes and configurations, which is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed for the "introduction of interventional devices" into the peripheral, coronary, and neurovascular systems. This describes a device used in vivo (within the body) for a medical procedure, not a device used in vitro (outside the body) to examine specimens like blood or tissue.
- Device Description: The description focuses on the physical characteristics of a catheter used for guiding other devices within the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device's function is procedural, not diagnostic.
N/A
Intended Use / Indications for Use
The SCHNEIDER GUIDER Softip® Guiding Catheters are designed for the introduction of interventional devices. They are intended to facilitate the placement of interventional devices into the peripheral and coronary systems and, in addition for the XF models, into the neurovascular system.
Product codes
74 DQY
Device Description
The SCHNEIDER GUIDER Softip® Guiding Catheter in this 510(k) is available in four French sizes (6 through 9 Fr) with multiple distal stem configurations and lengths. SCHNEIDER GUIDER Softip® Guiding Catheters are designed for the introduction of interventional devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary systems, neurovascular 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Cordis Vista brite tip™ guiding catheter
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
1980453
AUG 1 1 1998
510(k) Summary
Date Prepared
August 7, 1998
Submitter
Address:
Schneider (USA) Inc 5905 Nathan Lane Minneapolis, MN 55442
| Phone: | (612) 550-5500 |
|---|---|
| Fax: | (612) 550-5771 |
Contact Person
Ronald W. Bennett Senior Regulatory Affairs Specialist
Device Name and Classification
| Trade Name | SCHNEIDER GUIDER Softip® Guiding Catheters |
|---|---|
| Classification | Class II |
| Predicate Devices | SCHNEIDER GUIDER Softip® Guiding Catheters |
| (K961999) | |
| Cordis Vista brite tip™ guiding catheter |
Device Description
The SCHNEIDER GUIDER Softip® Guiding Catheter in this 510(k) is available in four French sizes (6 through 9 Fr) with multiple distal stem configurations and lengths. SCHNEIDER GUIDER Softip® Guiding Catheters are designed for the introduction of interventional devices.
Indication
SCHNEIDER GUIDER Softip® Guiding Catheters are intended to facilitate the placement of interventional devices into the peripheral and coronary systems and, in addition for the XF models, into the neurovascular system.
Technological Characteristics
The design of the SCHNEIDER GUIDER Softip® Guiding Catheter remains the same as for the previous cleared devices. These have been tested in simulated aortic and carolid anatomy with appropriate interventional devices to test that the force needed for insertion is acceptable.
1
Summary
In summary Schneider (USA) Inc has demonstrated that the SCHNEIDER GUIDER Softip® Guiding Catheters are substantially equivalent based on design, test results, and indications for use to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with overlapping lines creating a sense of depth.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 1998
Mr. Ronald W. Bennett Schneider (USA) Inc. Pfizer Medical Technology Group 5905 Nathan Lane Minneapolis, MN 55442
Re: K980453 SCHNEIDER GUIDER Softip® Guiding Catheter Requlatory Class: II (two) Product Code: 74 DQY Dated: May 26, 1998 Received: May 28, 1998
Dear Mr. Bennett:
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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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.
3
Paqe 2 - Mr. Ronald W. Bennett
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 labeling requlation (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, "Misbranding 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page
510(k) Number (if known):
Device Name: SCHNEIDER GUIDER Softip® Guiding Catheter
Indications for Use:
The SCHNEIDER GUIDER Softip® Guiding Catheters are designed for the introduction of interventional devices. They are intended to facilitate the placement of interventional devices into the peripheral and coronary systems and, in addition for the XF models, into the neurovascular system.
Tara A. Re
(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices 980453 510(k) Number
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)