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

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.

AI/ML Overview

This document is a 510(k) summary for the Cordis Vista Brite Tip Guiding Catheter. It establishes substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in the manner of a clinical trial for a new therapeutic device.

Therefore, many of the requested sections regarding acceptance criteria and a study proving their fulfillment, especially those involving expert reviews, ground truth, and statistical analyses (like MRMC studies) are not applicable or extractable from this type of regulatory submission. The document focuses on performance characteristics and biocompatibility to demonstrate equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of specific, quantifiable acceptance criteria (e.g., specific thresholds for success, safety endpoints) with corresponding device performance results from a dedicated study. Instead, it relies on demonstrating substantial equivalence to a previously approved predicate device.

The performance characteristics mentioned are general design features and biocompatibility.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
Similar Design	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. Similar in design, construction... to other commercially available Cordis guiding catheters.
Similar Construction	(See "Similar Design" above)
Biocompatibility	All appropriate biocompatibility tests were successfully performed on the materials used for the Cordis Vista Brite Tip Catheter.
Intended Use	The Cordis Vista Brite Tip Guiding Catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary, peripheral, and neurovasculature. Similar in... indication for use... to other commercially available Cordis guiding catheters.
Performance Characteristics	(Implicitly similar to predicate device) Similar in... performance characteristics to other commercially available Cordis guiding catheters. Performance standards have not been established by the FDA under Section 514 of the Food, Drug, and Cosmetic Act for this device type.

2. Sample size used for the test set and the data provenance

Not applicable. This is a 510(k) submission demonstrating substantial equivalence, not a clinical study involving a test set of data or patient samples. The review is based on device design, materials, and comparison to a predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "ground truth" for a test set was established by external experts in the context of this submission. The FDA reviews the provided information to determine substantial equivalence.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There was no test set requiring expert adjudication.

5. 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 guiding catheter, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (guiding catheter), not an algorithm or software requiring standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. There was no "ground truth" in the context of a clinical study or diagnostic performance evaluation. The "truth" in this submission is that the device is demonstrably equivalent in design, materials, indications, and performance to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device where a training set would be used.

9. How the ground truth for the training set was established

Not applicable. There was no training set.

Summary

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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.

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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).

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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 intravascularintroduction of interventional / diagnostic devices into thecoronary, 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.

(Division Sign-Off) Division of Cardiovascular, Re and Neurological Devices 510(k) Number

× 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).