(71 days)
Not Found
Not Found
No
The summary describes a physical guiding catheter with material properties and construction details. There is no mention of software, algorithms, image processing, AI, or ML.
No.
The device description states it is a "guiding catheter" which is "intended for use for intravascular introduction of interventional/diagnostic devices". This indicates it is an accessory device used to deliver other devices, not a therapeutic device itself.
No
The device is a guiding catheter, intended for the introduction of other devices, not for diagnosing conditions itself.
No
The device description clearly details a physical catheter with material properties and construction, indicating it is a hardware device, not software-only.
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 for "intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems." This describes a device used within the body for delivering other devices, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details the physical construction of a catheter designed for insertion into blood vessels. This aligns with its intended use as a delivery tool within the vascular system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, this device is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vasculature.
Product codes
74 DQY
Device Description
The Vista Brite Tip Guiding Catheters are single lumen catheters which features a nylon body reinforced with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheters are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheters' tip, is pellethane with a radiopaque filler, this is the softest material in the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cordis Vista Brite Tip, Cordis Endovascular Systems, ENVOY Guiding Catheters
Reference Device(s)
Not Found
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
00-00008
PREMARKET NOTIFICATION 510(k) Cordis Corporation
Cordis Guiding Catheter
SUMMARY OF SAFETY AND EFFECTIVENESS OCT 2 ! 1097
I. General Provisions:
Common or Usual Name: Percutaneous Catheter Proprietary Name: Cordis Vista Brite Tip®
II. Name of Predicate Devices:
Cordis Vista Brite Tip Cordis Endovascular Systems, ENVOY Guiding Catheters
Classification Class II III.
- Performance standards have not been established by the FDA IV. Performance Standards: under section 514 of the Food, Drug and Cosmetic Act.
Indication For Use and Device Description V.
- Vista Brite Tip: The guiding catheter is intended for use for intravascular Indications: introduction of interventional/diagnostic devices into the coronary or peripheral vasculature.
- The Vista Brite Tip Guiding Catheters are single lumen catheters which Description: features a nylon body reinforced with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheters are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheters' tip, is pellethane with a radiopaque filler, this is the softest material in the catheter.
VI. Biocompatibility:
All appropriate biocompatibility tests for the guiding catheters were successfully completed.
VII. Summary of Substantial Equivalence:
The Cordis Guiding Catheters are similar in design, construction, indication for use and performance characteristics to other commercially available guiding catheters.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
OCT 21 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Katherine Trevisol Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, Florida 33014
Re: K972978 7F 0.078" I.D. Vista Brite Tip Guiding Catheters Regulatory Class: II (two) Product Code: 74 DQY Dated: October 9, 1997 Received: October 10, 1997
Dear Ms. Trevisol:
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, 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 aduiteration.
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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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.
2
Page 2 - Ms. Katherine Trevisol
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 leqally 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) 594-4639. 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.gov/cdrh/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
3
INDICATIONS FOR USE
510(k) Number (if known): To be assigned by FDA
Device Name: Cordis 7F 0.078" I.D. Vista Brite Tip Guiding Catheters
Indications for Use:
The guiding catheter is intended for use for intravascular introduction of
the suiding cather is a local and to the seconary and peripheral vascula The guiding catheter is intended for use for intravasoular involument wascular systems.
interventional/diagnostic devices into the coronary and peripheral vascular systems.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tre A. Pa
(Division Sign-೧೯) Division of Curce. Assentar, Respiratory, and Manrelate
510(k) Number ic977978
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_