Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Device Description

The line extensions for Brite Tip® Catheter Sheath Introducer System is indicated for use in arterial and venous procedures requiring percutaneous introduction of catheters and other intravascular devices. As with other currently marketed Cordis CSIs mentioned in this submission, these devices provide vascular access for various intravascular devices through the valve while simultaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.

AI/ML Overview

This appears to be a 510(k) premarket notification for a medical device (Cordis Brite Tip® Catheter Sheath Introducer System), and the provided text primarily focuses on regulatory information, intended use, and substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-based devices or studies requiring performance data.

The document states:

"Performance standards have not been established by the FDA under section 514 of the Food, Drug and and Cosmetic Act." This indicates there are no pre-defined FDA performance standards this device needs to meet.
The re-submission (K974448) is a "Modification" (K971608) and a "line extension." This suggests that the substantial equivalence is based on the previously cleared device, and the modifications are likely minor enough not to require new significant performance studies.
"All materials used in the line extensions for Cordis Brite Tip® Catheter Sheath Introducer System had been successfully tested on previously concurred devices. Since all appropriate biocompatibility tests were previously performed on these materials, testing was not repeated." This further emphasizes reliance on previous testing.
"The modified Cordis Brite Tip® Catheter Sheath Introducer System is similar in design, constructions, indication for use, and performance characteristics to other commercially available sheath introducers." This is the core argument for substantial equivalence, implying that its performance is implicitly accepted because it's similar to already cleared devices.

Therefore, many of the requested fields cannot be filled from the provided text as they relate to performance studies, which are not detailed here.

Here's the breakdown based on the provided text, indicating where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified. The document focuses on substantial equivalence to a predicate device rather than specific performance metrics or acceptance criteria for a new study.	The device is deemed "substantially equivalent" to the predicate device (Brite Tip® Catheter Sheath Introducer System, K971608) in design, construction, indication for use, and performance characteristics. No specific performance data are reported.

Regarding the study proving the device meets acceptance criteria:

The provided document does not describe a specific study designed to prove the device meets acceptance criteria in the way one would for a novel AI/ML device or a device requiring new clinical performance data. Instead, the substantial equivalence relies on:

Similarity to a predicate device: The modified device is stated to be similar in design, construction, indication for use, and performance characteristics to the already cleared predicate device (K971608).
Prior testing of materials: Biocompatibility tests were previously performed on the materials used in the line extensions and successfully cleared, so no new biocompatibility testing was repeated for this submission.

Therefore, the following points address what can be inferred or what is explicitly not present in the provided text:

2. Sample size used for the test set and the data provenance: Not applicable/Not provided. No new test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No new test set requiring expert-established ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided. No new test set requiring adjudication is described.
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: No. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. No new ground truth establishment is described. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device and its materials.
8. The sample size for the training set: Not applicable/Not provided. This is not an AI/ML device; no training set described.
9. How the ground truth for the training set was established: Not applicable/Not provided. This is not an AI/ML device; no training set described.

Summary

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

00-00026 K9174448

PREMARKET NOTIFICATION 510(k) Cordis, a Johnson and Johnson company Brite Tip® Catheter Sheath Introducer (Modification K971608)

6 1008 구 3

SUMMARY OF SAFETY AND EFFECTIVENESS

General Provisions l.

Common or Usual Name: Catheter Sheath Introducer or Sheath Introducer System. Proprietary Name: Cordis Brite Tip® Catheter Sheath Introducer System.

.. Name of Predicate Device

Brite Tip® Catheter Sheath Introducer System, K971608.

III. Classification

Class II

N. Performance Standards

Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.

V. Intended Use and Device Description

As with other currently marketed Cordis CSIs mentioned in this submission, these devices provide vascular access for various intravascular devices through the valve while simultaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.

VI. Biocompatibility

All materials used in the line extensions for Cordis Brite Tip® Catheter Sheath Introducer System had been successfully tested on previously concurred devices. Since all appropriate biocompatibility tests were previously performed on these materials, testing was not repeated.

VII. Summary of Substantial Equivalence

The modified Cordis Brite Tip® Catheter Sheath Introducer System is similar in design, constructions, indication for use, and performance characteristics to other commercially available sheath introducers.

{1}------------------------------------------------

Rockville MD 20857

First e 1998

Ms, Ariel MacTavish Sr. Requlatory Affairs Associate Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700

K974448 Re: Brite Tip® Catheter Sheath Introducer System Regulatory Class: II (two) Product Code: 74 DYB Dated: November 24, 1997 Received: November 25, 1997

Dear Ms. MacTavish:

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 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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.

{2}------------------------------------------------

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) 594-4648. 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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}------------------------------------------------

00-00051

PREMARKET NOTIFICATION 510(k) Cordis Corporation Brite Tip® Catheter Sheath Introducer

510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

T.A.V.

(D. Off)
[ ardiovascular, Respiratory,
2. :ical Devices K974448
5. Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).