Used for the delivery of PTCA balloons and other various types of interventional cardiology devices. They are intended for use by physicians trained and experienced in PTCA and interventional cardiology techniques. Not intended for cerebral vascular use.

Device Description

The Envy™ Guiding Catheter is manufactured using an inner layer of nylon tubing with stainless steel braiding and laminated with an outer layer of TFE tubing. This tubing is coated with a hydrophilic coating to enhance lubricity. This catheter is available in 4.0, 7.0 and 8.0 French outer diameter, various lengths and various curves to accommodate interventional cardiology procedures. This device can also be used with an inner catheter used for introduction. The inner catheter is manufactured using polyethylene tubing tapered to an .038-inch endhole with a hydrophilic coated distal tip. The length of the inner catheter corresponds to the guiding catheter length. The inner catheter is designed to introduce the guiding catheter over an 0.038-inch wire guide or through an appropriately sized sheath introducer.

AI/ML Overview

This filing pertains to a Special 510(k) Premarket Notification for the Envy™ Guiding Catheter, specifically the 4.0, 7.0, and 8.0 French sizes. The submission indicates that these new sizes are substantially equivalent to the previously cleared Envy™ Guiding Catheter, 6.0 French (K974774). As a Special 510(k), it relies on substantial equivalence and does not typically include new independent studies with acceptance criteria or detailed performance data beyond what's needed to demonstrate equivalence.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly available or applicable in the provided document, which focuses on demonstrating substantial equivalence rather than presenting an independent performance study.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed performance data for the Envy™ Guiding Catheter (4.0, 7.0, 8.0 French). The basis for clearance is substantial equivalence to an existing predicate device (Envy™ Guiding Catheter, 6.0 French). The "performance" in this context is the assertion that the new sizes have the "same intended use, materials of construction, and technological characteristics" as the predicate device.

Acceptance Criteria	Reported Device Performance
Intended Use Equivalence: Same indications for use as predicate.	"Used for the delivery of PTCA balloons and other various types of interventional cardiology devices." Identical to the predicate device.
Technological Characteristics Equivalence: Similar materials, design, and physical properties to predicate.	"Manufactured using an inner layer of nylon tubing with stainless steel braiding and laminated with an outer layer of TFE tubing. This tubing is coated with a hydrophilic coating to enhance lubricity." Inner diameter specifications provided for each French size (4.0: .040-inch, 7.0: .078-inch, 8.0: .092-inch). These characteristics are stated to be "identical to the currently marketed Envy™ Guiding Catheter, 6.0 French."
Safety and Effectiveness Equivalence: No new questions of safety or effectiveness compared to predicate.	Not explicitly stated with specific metrics, but the FDA's clearance (K990726) implies this determination based on the provided information.

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

Not applicable. This is a Special 510(k) based on substantial equivalence, not a new performance study requiring a dedicated test set with patients/data. The "test set" implicitly refers to the design and material evaluations performed to demonstrate similarity to the predicate, but these details are not provided in this regulatory summary.

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

Not applicable. There is no specific "ground truth" establishment process described for a test set in this substantial equivalence submission.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring expert adjudication is described in this filing.

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-powered diagnostic or interpretive device. Therefore, a MRMC study involving human readers and AI assistance is irrelevant.

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

Not applicable. This device is a guiding catheter, a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used:

Not applicable. The "ground truth" in this context is the established safety and effectiveness of the existing predicate device, backed by its prior clearance (K974774), and the manufacturer's assertion of equivalence in design, materials, and intended use.

8. The Sample Size for the Training Set:

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no training set for this device.

Summary

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APR 2 1995

K990726

Special 510(k) Premarket Notification EnvyTM Guiding Catheter COOK INCORPORATED

510(k) Summary 0

Submitted By:	April Lavender, RACVice President, Regulatory AffairsCOOK INCORPORATED925 South Curry PikeP.O. Box 489Bloomington, IN 47402(812) 339-2235
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Device:

Trade Name:	Envy™ Guiding Catheter
Proposed Classification Name:	Catheter, Intravascular, Diagnostic
	21 CFR Part 876.1200 (74DO)

Predicate Devices:

The Envy™ Guiding Catheter, 4.0, 7.0 and 8.0 French, has the same intended use, materials of construction, and technological characteristics as the Envy™ Guiding Catheter, 6.0 French.

Device Description:

French Size	Inside diameter
4.0	.040-inch
7.0	.078-inch
8.0	.092-inch

This device can also be used with an inner catheter used for introduction. The inner catheter is manufactured using polyethylene tubing tapered to an .038-inch endhole with a hydrophilic coated distal tip. The length of the inner catheter corresponds to the guiding catheter length. The inner catheter is designed to introduce the guiding catheter over an 0.038-inch wire guide or through an appropriately sized sheath introducer.

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Special 510(k) Premarket Notification EnvyTM Guiding Catheter COOK INCORPORATED

D 510(k) Summary

Substantial Equivalence:

The Envy™ Guiding Catheter, 4.0, 7.0 and 8.0 French, is similar to many devices in commercial distribution for delivery of PTCA balloons and other various types of interventional cardiology devices. It is identical to the currently marketed Envy™ Guiding Catheter, 6.0 French, in overall configuration and indications. The Envy™ Guiding Catheter, 6.0 French, was cleared for commercial distribution on October 16, 1998, D.C.#K974774. The identical indications for use and technological characteristics of the Envy™ Guiding Catheter supports a determination of substantial equivalency.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the Department of Health & Human Services logo and the date April 2, 1999. The logo is a stylized image of three human profiles. The text is in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. April Lavender, RAC Vice President Requlatory Affairs Cook Incorporated 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402

Re : K990726 Envy™ Guiding Catheter, 4.0, 7.0 and 8.0 French Regulatory Class: II (Two) Product Code: 74 DQY Dated: March 3, 1999 Received: March 5, 1999

Dear Ms. Lavender:

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 regulation (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 In addition, FDA may publish further regulatory action. 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. April Lavender, RAC

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding described in your srown promazion and 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) 594-4648. Additionally, for questions on the promotion and (501) 591 1010. Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Other general information on your (21CFR 807.97). 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 Radioloqical Health

Enclosure

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510(k) Number (if known):_

Device Name:

Envy™ Guiding Catheter

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	OR Over-the-Counter Use

for TJC
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

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).