(63 days)
Not Found
No
The device description focuses on the physical construction and materials of a guiding catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
The device is a guiding catheter intended for the introduction of other diagnostic or interventional devices, not for direct therapeutic action itself.
No
The device, a guiding catheter, is intended for the "intravascular introduction of interventional / diagnostic devices," meaning it facilitates the use of other devices, but it does not perform diagnostic functions itself.
No
The device description clearly describes a physical catheter with material components (nylon body, stainless steel braid wire, polyurethane tip with radiopaque filler), indicating it is a hardware medical 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, peripheral, and neufosvasculature." This describes a device used within the body to facilitate procedures, 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 the intended use and is not characteristic of an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect analytes, or provide diagnostic information based on in vitro testing.
Therefore, the Cordis Vista Brite Tip Catheter is a medical device used for guiding other devices within the vascular system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cordis Vista Brite Tip Guiding Catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary, peripheral, and neorovasculature.
Product codes
DOY
Device Description
The Cordis Vista Brite Tip Catheters are single lumen catheters which feature a nylon body with a tightly wound stainless steel braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheter are designed with nylons of different stiffness to provide gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheter's tip, is polyurethane 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, peripheral, and neorovasculature
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)
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
Summary Of Safety And Effectiveness
K942673 The name of the device is: General Provisions Common or Usual Name Proprietary Name Percutaneous Catheter Cordis Vista Brite Tip Guiding Catheter The name of the predicate devices are: Predicate Device · Cordis Vista Brite Tip · Cordis Endovascular Systems, ENVOY Guiding Catheters Classification The FDA has classified guiding catheters as: · Class II, 21CFR 870.1250, 74 DQY Performance Performance standards have not been established by the FDA under Section Standards 514 of the Food, Drug, and Cosmetic Act. Indications for The Cordis Vista Brite Tip Guiding Catheter is intended for use for Use intravascular introduction of interventional / diagnostic devices into the coronary, peripheral, and neorovasculature. The Cordis Vista Brite Tip Catheters are single lumen catheters which feature Device Description a nylon body with a tightly wound stainless steel braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheter are designed with nylons of different stiffness to provide gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheter's tip, is polyurethane with a radiopaque filler; this is the softest material in the catheter.
Continued on next page
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Summary Of Safety And Effectiveness, Continued
All appropriate biocompatibility tests were successfully performed on the Biocompatibility materials used for the Cordis Vista Brite Tip Catheter. The Cordis Vista Brite Tip Catheter is similar in design, construction, Summary of indication for use and performance characteristics to other commercially Substantial Equivalence available Cordis guiding catheters. 1
Any statement of substantial equivalence to another product is required by 21 CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, "... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits." 42 Fed. Reg. (1977).
2
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 often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 2 1999
Mr. Dennis Griffin Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014
Re: K992673 .9F Cordis Vista Brite Tip Guiding Catheter Requlatory Class: II (two) Product Code: DOY Dated: August 6, 1999 Received: August 10, 1999
Dear Mr. Griffin:
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 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 requlatory 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. Dennis Griffin
This letter will allow you to beqin 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 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 requlation 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/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
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INDICATIONS FOR USE
| 510(K) Number (if known): [To be assigned by the FDA] | |
|---|---|
| Device Name: | Vista Brite® Tip Guiding Catheter |
| Indications for Use: | The guiding catheter is intended for use for intravascular |
| introduction of interventional / diagnostic devices into the | |
| coronary, peripheral, and neufosvasculature. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Christopher for Callahan.
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(Division Sign-Off) Division of Cardiovascular, Re and Neurological Devices 510(k) Number
× Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use _