The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neuro vasculature.

Device Description

• 6 French
• Single lumen catheter featuring a nylon body reinforced with a tightly wound stainless steel braid wire
• The transition segment is designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip.

AI/ML Overview

This document describes safety and effectiveness for VISTA BRITE TIP and ENVOY Guiding Catheters. However, this submission to the FDA (K982632) is for a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria for AI/ML validation studies, such as sample size for test/training sets, experts for ground truth, adjudication methods, and MRMC studies, are not applicable to this type of submission.

The primary focus of this document is to establish substantial equivalence to previously cleared predicate devices, an approach common for medical device clearances that are not software algorithms.

Here's the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria (Inferred from Substantial Equivalence) and Reported Device Performance

Since this is a substantial equivalence claim for guiding catheters, the "acceptance criteria" are implicitly met by demonstrating that the new devices perform as intended and are as safe and effective as the predicate devices. The document does not describe a formal study with quantitative performance metrics against pre-defined acceptance criteria in the way an AI/ML study would. Instead, it relies on the comparison to established predicate devices.

Acceptance Criteria (Inferred from Substantial Equivalence Principles)	Reported Device Performance (Summary from Submission)
Intended Use: Device is suitable for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neuro vasculature.	The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for this use, identical to predicate devices.
Design Characteristics: Maintained key features and specifications of predicate devices.	The new devices are 6 French, single lumen, with a nylon body reinforced with a tightly wound stainless steel braid wire, and a transition segment designed with nylons of different durometers. This description is consistent with the predicate devices.
Material Biocompatibility: Materials used are biocompatible.	"All materials used in the VISTA BRITE TIP and ENVOY Guiding Catheters are biocompatible."
Safety and Effectiveness: As safe and effective as the predicate devices.	The FDA found the device "substantially equivalent" to legally marketed predicate devices, implying comparable safety and effectiveness for the stated indications for use.

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

Not Applicable. This is a medical device submission, not an AI/ML algorithm study involving a "test set" of data in the computational sense. The "test" is more about demonstrating that the physical device's characteristics (materials, design, function) are equivalent to existing cleared devices.

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

Not Applicable. See point 2. Ground truth in this context would implicitly be the established safety and effectiveness of the predicate devices based on their prior clearance and clinical use, rather than expert annotation of a dataset.

4. Adjudication method

Not Applicable. See point 2.

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 is not an AI-assisted device.

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

Not Applicable. This is not an artificial intelligence algorithm.

7. The type of ground truth used

Predicate Device Performance/Clearance: The "ground truth" for this submission is essentially the established safety, effectiveness, and intended use of the predicate devices (Cordis Corporation VISTA BRITE TIP Guiding Catheter and Cordis Endovascular Systems, Inc. ENVOY Guiding Catheter). The submission aims to prove the new device is "substantially equivalent" to these already cleared devices, meaning it performs as well and is as safe as those established devices.

8. The sample size for the training set

Not Applicable. This is not an AI/ML algorithm that requires a "training set" of data.

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

Not Applicable. See point 8.

Summary

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Attachment 4

VG83632

Summary of Safety and Effectiveness

General Provisions	Trade Name: VISTA BRITE TIP and ENVOY Guiding CatheterCommon/Classification Name: Percutaneous Catheter
Name of Predicate Devices	• Cordis Corporation VISTA BRITE TIP Guiding Catheter• Cordis Endovascular Systems, Inc. ENVOY Guiding Catheter
Classification	Class II
Performance Standards	The FDA under section 514 of the Food, Drug and Cosmetic Act has not established performance standards.
Intended Use and Device Description	The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neuro vasculature.The device description of the VISTA BRITE TIP and ENVOY Guiding Catheters is as follows.• 6 French• Single lumen catheter featuring a nylon body reinforced with a tightly wound stainless steel braid wire• The transition segment is designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip.
Biocompatibility	All materials used in the VISTA BRITE TIP and ENVOY Guiding Catheters are biocompatible.
Summary of Substantial Equivalence	The VISTA BRITE TIP and ENVOY Guiding Catheters are substantially equivalent to the previously cleared VISTA BRITE TIP and ENVOY Guiding Catheters.

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Public Health Service

AUG 1 8 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Martine D. Schneider Sr. Regulatory Affairs Associate Cordis Corporation Cordis Endovascular 14000 N.W. 57th Court Miami Lakes, FL 33014

Re: K982632 Trade Name: Envoy and Vista Brite Tip Regulatory Class: II Product Code: DOY Dated: July 22, 1998 Received: July 23, 1998

Dear Mr. Schneider:

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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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

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Page 2 - Mr. Martine D. Schneider

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 requlations.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR 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. Callal Director Division of Cardiovascular, Respirator and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

man and the comments of the first for the first for the first for the first for the first for the first for the first for

Enclosure

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Attachment 2

Indications for Use Statement

510(k) Number(if known)	The 510(k) number has not yet been assigned.
Device Name	VISTA BRITE TIP and ENVOY Guiding Catheters
Indications forUse	The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use forintravascular introduction of interventional/diagnostic devices into the coronary,peripheral, and neuro vasculature.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tara de R

(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices G 4 510(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).