The modified Brite Tip® Catheter Sheath Introducer is indicated for use in arterial and venous procedures requiring percutaneous introduction of catheters and other intravascular devices.
Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Device Description

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 510(k) submission describes a device modification for the Cordis Brite Tip® Catheter Sheath Introducer, not a clinical study to establish new performance criteria. Therefore, the information requested regarding acceptance criteria, study design, and ground truth for a new device's performance is not directly available in this document.

Here's a breakdown of what can be extracted and why certain requested information is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. This document is a 510(k) for a modified device. The determination of "substantial equivalence" is based on similarity to a predicate device (Brite Tip® Catheter Sheath Introducer, K954595). The acceptance criteria are implicit in showing that the modifications do not alter the fundamental safety and effectiveness of the device compared to the predicate. There are no new performance metrics or acceptance criteria explicitly defined for the modified device in this document, nor is there a study reporting new performance numbers. The FDA's letter states, "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent...". This means the acceptance criterion was "substantial equivalence" to the predicate, which implies the modified device performs comparably in its intended use.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. This submission is not a clinical study with a "test set" in the context of AI/diagnostic device performance. It's a regulatory submission for a device modification. The basis for substantial equivalence typically involves engineering analyses, bench testing (e.g., sterilization, material compatibility, functional testing), and comparison to the predicate device's design and materials. No patient data or test set in the traditional sense is described.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

Not Applicable. See point 2. There's no test set in the typical AI/diagnostic study sense, and therefore, no experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

Not Applicable. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This document is not for an AI device. It describes a conventional medical device (catheter sheath introducer). Therefore, an MRMC study related to AI performance is not relevant or included.

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

Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

Not Applicable. For a device modification submission, the "ground truth" is typically established through engineering design specifications, biocompatibility testing (as mentioned in the document), and functional testing to ensure the modified device continues to meet its intended purpose and safety profile, consistent with the predicate device. It's not about establishing diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

Not Applicable. See point 8.

Summary of what the document does convey regarding device acceptance and study (or lack thereof):

The "study" in this context is the 510(k) premarket notification process itself, where the manufacturer (Cordis Corporation) presented evidence to the FDA to demonstrate substantial equivalence to a previously cleared predicate device.

Acceptance Criteria (Implicit): The primary acceptance criterion was Substantial Equivalence to the predicate device (Cordis Brite Tip® Catheter Sheath Introducer, K954595, cleared October 02, 1995). This implies that the modified device must demonstrate:
- Same intended use.
- Similar technological characteristics (design, construction, materials).
- No new questions of safety or effectiveness.
- Performance characteristics comparable to the predicate.
"Study" That Proves Acceptance (The 510(k) Submission):
- The submission outlines that the modified device is "similar in design, construction, indication for use, and performance characteristics to other commercially available sheath introducers," specifically referencing their own predicate.
- Biocompatibility: "All appropriate biocompatibility tests were performed on the materials used in the modified Brite Tip® Catheter Sheath Introducer." This implicitly serves as evidence that the new materials (if any) or modified device components meet safety standards.
- The FDA then reviewed this information and determined that the modified device is substantially equivalent.

In essence, for this type of device modification, the "proof" is a regulatory assessment based on comparison to an already approved device, rather than a de novo clinical trial with new performance metrics.

Summary

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

JUL 21 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

General Provisions l.

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

11. Name of Predicate Devices

Brite Tip® Catheter Sheath Introducer, K 954595, October 02, 1995

lll. Classification

Class II

IV. 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

The modified Brite Tip® Catheter Sheath Introducer is indicated for use in arterial and venous procedures requiring percutaneous introduction of catheters and other intravascular devices.

VI. Biocompatibility

All appropriate biocompatibility tests were performed on the materials used in the modified Brite Tip® Catheter Sheath Introducer.

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

Summary of Substantial Equivalence VII.

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

A statement of substantial equivalence to another product is required by 21CFR 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 FOA 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. 42,520, et seg. (1977).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Elena S. Jugo, M.D. Cordis Corporation P.O. Box 025700 Miami, Florida 33102-5700

JUL 2 | 1997

Re : K971608 Brite Tip® Catheter Sheath Introducer Regulatory Class: II (two) Product Code: DYB Dated: April 30, 1997 Received: May 1, 1997

Dear Dr. Juqo:

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 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.

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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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 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. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Brite Tip Catheter Sheath Introducer

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)

Ta A'R

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

Prescription Use Y (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).