The ENVOY Guiding Catheters are intended for the intravascular introduction of interventional/diagnostic devices in the peripheral, coronary and neurovasculature systems.

Device Description

The 7F, 8F and 9F ENVOY Guiding Catheters are designed for the intravascular introduction of interventional/diagnostic devices into the peripheral, coronary and neurovascular systems.

AI/ML Overview

I am sorry, but the provided text does not contain information about specific acceptance criteria, a study that proves a device meets those criteria, or details regarding sample sizes, expert qualifications, or ground truth establishment.

The document is a US FDA 510(k) premarket notification letter for the ENVOY Guiding Catheter, indicating that the device has been found substantially equivalent to previously marketed devices. It confirms the intended use, classification, and states that biocompatibility tests were successfully performed. However, it does not include:

A table of acceptance criteria and reported device performance.
Details about a specific study to prove acceptance criteria.
Sample sizes for test or training sets.
Information on data provenance (country, retrospective/prospective).
Number or qualifications of experts.
Adjudication methods.
MRMC comparative effectiveness study results.
Standalone algorithm performance.
Type of ground truth used.
How ground truth for a training set was established.

Therefore, I cannot fulfill your request for this specific information based on the text provided.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

l. General Provisions:

JUL 23 1097

Catheter, Percutaneous Common Name:

ENVOY® Guiding Catheter Proprietary Name:

Name of Predicate Device: ll.

5F & 6F ENVOY Guiding Catheters a) Trade Name: Cordis Endovascular Systems, Inc. Manufacturer: K962362 - concurrence 08/08/96 510(k) Number: Predicate for design, intended use, sterilization and packaging

b)	Trade Name:	9F Brite Tip Guiding Catheter
	Manufacturer:	Cordis Corporation
	510(k) Number:	K925131 - concurrence 05/06/93
	Predicate for design

III. Classification:

Class II, Catheter, Percutaneous, 21 CFR 870.1250 (74DQY)

IV. Performance Standards:

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

Intended Use and Device Description: V.

The 7F, 8F and 9F ENVOY Guiding Catheters are designed for the intravascular introduction of interventional/diagnostic devices into the peripheral, coronary and neurovascular systems.

VI. Biocompatibility

All appropriate biocompatibility tests were successfully performed on the Cordis Endovascular Systems, Inc. 7F, 8F and 9F ENVOY Guiding Catheter.

Summary of Substantial Equivalence: VII.

The ENVOY Guiding Catheters are similar in basic design, construction, indication for use and performance characteristics to other commercially available guiding catheters.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with medicine and healthcare. The caduceus in the logo is depicted with three lines forming the shape of a staff with a snake winding around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Katherine Trevisol Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, Florida 33014

1111 23 1997

Re: K965247 ENVOY Guiding Catheter Regulatory Class: II (two) Product Code: 74 DOY Dated: April 23, 1997 Received: April 24, 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 aqainst 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumpticns. 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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Page 2 - Ms. Katherine Trevisol

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 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 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. Callehan

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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STATEMENT OF INDICATIONS FOR USE

The ENVOY Guiding Catheters are intended for the intravascular introduction of interventional/diagnostic devices in the peripheral, coronary and neurovasculature systems.

510(k) Number (if known): To be assigned by FDA

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ThA R
(Division Sign-Off)

Division of Cardiovascular, Respiratory, 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).