The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a guiding catheter, and it does not contain the level of detail typically found in a clinical study report or a performance study. Guiding catheters are Class II devices, and their 510(k) clearances often rely on demonstrating substantial equivalence to a predicate device rather than extensive new clinical trials with detailed performance metrics.

Based on the provided text, here's an analysis of what can be extracted and what cannot:

Table of acceptance criteria and the reported device performance:
The document does not report specific quantitative acceptance criteria or detailed device performance data against such criteria. The clearance is based on substantial equivalence. It notes "All appropriate biocompatibility tests for the guiding catheters were successfully completed" but doesn't provide the criteria for "appropriate" or the specific results. The summary states, "The Cordis Guiding Catheters are similar in design, construction, indication for use and performance characteristics to other commercially available guiding catheters," implying that its performance is presumed to be similar to its predicates without presenting new direct performance measurements in this document.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not mention any specific test set, sample size for testing, or data provenance related to a performance study. The 510(k) process for this type of device often relies on engineering bench testing, biocompatibility testing, and comparison to predicate devices, rather than a prospective clinical study with a defined test set of patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
The document does not describe any expert-based ground truth establishment, as it doesn't detail a clinical study where such ground truth would be necessary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no described test set requiring adjudication is present.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical medical instrument (guiding catheter), not an AI diagnostic tool. Therefore, an MRMC study or AI-related performance metrics are irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no described clinical study with ground truth data is presented. The "ground truth" for showing substantial equivalence here would be the established safe and effective performance of the predicate devices based on their historical use and regulatory clearances.
The sample size for the training set:
Not applicable, as this device does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
Not applicable, for the same reason as point 8.

Summary of Information from the Provided Document:

This 510(k) submission for the Cordis Guiding Catheter primarily focuses on demonstrating substantial equivalence to existing predicate devices (Cordis Vista Brite Tip and Cordis Endovascular Systems, ENVOY Guiding Catheters). The pathway for clearance relies on showing that the new device has similar design, construction, indications for use, and performance characteristics to legally marketed devices.

The key points from the document regarding performance and acceptance are:

Biocompatibility: "All appropriate biocompatibility tests for the guiding catheters were successfully completed." (Specific criteria or results are not provided.)
Substantial Equivalence: The device's "performance characteristics" are deemed "similar" to predicate devices, which implies that the predicate devices' established safety and efficacy serve as the "acceptance criteria" through comparison. No new, independent performance study with defined criteria and measurements is detailed in this summary.

In essence, for this type of medical device 510(k), the "study that proves the device meets the acceptance criteria" is often the comprehensive comparison to predicate devices, supported by bench testing and biocompatibility data. Detailed clinical performance criteria, as might be seen for a novel diagnostic or therapeutic device, are not typically part of this type of submission summary.

Summary

{0}------------------------------------------------

00-00008

PREMARKET NOTIFICATION 510(k) Cordis Corporation

K972978

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)

Over-The-Counter Use_

Regulation Number and Section

§ 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).