The Cook Vascular EVOLUTION Mechanical Dilator Sheath Set is for use in the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

Device Description

The proposed device is a polypropylene dilator with a semi-threaded stainless steel tip, This stainless steel tip is used to dilate tissue surrounding an indwelling catheter or foreign object. In addition, an ergonomic handle to be used as a "drive mechanism" will be included. The device will be made with 7.0 and 9.0 French sizes. It will be supplied sterile, intended for one-time use.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Cook Vascular EVOLUTION Mechanical Dilator Sheath Set. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study report with performance metrics. Therefore, many of the requested details are not present in the provided text.

Here is an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

The document lists various tests performed but does not specify the acceptance criteria for these tests or provide quantitative results for the device's performance against any set criteria. It merely states that the "results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use."

Since specific acceptance criteria (e.g., "Buckling force > X Newtons") and corresponding reported performance values are not provided, this table cannot be fully populated from the given text.

Test Name	Acceptance Criteria (Not provided in text)	Reported Device Performance (Not provided in text)
Buckling Test	-	-
Binding Test	-	-
Bond Strength (Connector/gun)	-	-
Pull Testing (tip)	-	-
Handle Cycling Test	-	-
Device Performance	-	-

Additional Information on the Study:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document only lists the types of tests performed (Buckling, Binding, Bond Strength, Pull Testing, Handle Cycling, Device Performance) but does not provide any details on the number of units tested for each.
- Data Provenance: Not specified. The data and testing would presumably be conducted by Cook Vascular, Inc. (Vandergrift, PA, USA) as part of their internal quality and regulatory processes, but this is not explicitly stated. It is a "Special 510(k) Premarket Submission," which often relies on internal testing to demonstrate equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not mentioned. The tests described are engineering/mechanical performance tests (e.g., buckling, bond strength), not clinical studies requiring expert interpretation of results or establishment of clinical ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. This concept is relevant for clinical studies or image interpretation tasks where human readers might disagree. For the described mechanical tests, the results would typically be objectively measured against predefined engineering specifications.
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 a conventional medical device (mechanical dilator sheath), not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a mechanical device, not an algorithm, so this concept is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the conventional sense. The "ground truth" for the mechanical tests would be the pre-defined engineering specifications and performance requirements for the device's function (e.g., "the dilator must not buckle under X force"). The tests confirm adherence to these functional requirements.
The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI model, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for a mechanical device.

Summary of what is present:

The document serves as a 510(k) summary, which aims to demonstrate "substantial equivalence" of the EVOLUTION Mechanical Dilator Sheath Set to existing predicate devices. It lists the types of tests performed (Buckling Test, Binding Test, Bond strength, Pull Testing, Handle Cycling Test, Device Performance) as evidence of reliable design and performance. However, it does not provide specific quantitative acceptance criteria or the actual test results that would illustrate the device's performance against these criteria. The approval by the FDA (K061000) indicates that the provided information was deemed sufficient to establish substantial equivalence.

Summary

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510(k) Summary

Submitted by:

MAY 1 0 11 26

Jim Ferguson Quality Systems Manager Cook Vascular, Incorporated 1186 Montgomery Lane Vandergrift, Pa 15690 724-845-8621, XT 2227 April 10, 2006

Device:

Trade name:	Cook Vascular EVOLUTION Mechanical Dilator SheathSet
Proposed Classification:	Dilator, Vessel, for Percutaneous Catheterization870.1310, DRE

Predicate Devices:

The Cook Vascular EVOLUTION Mechanical Dilator Sheath Set is similar in terms of intended use, materials of construction and technology characteristics to predicate devices reviewed as devices for dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

Device Description:

Substantial Equivalence:

This device will be manufactured to specified process controls and a Quality Assurance program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Vascular. This device will undergo sterilization similar to the devices currently marketed and distributed. Being similar with respect to indication for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

· Cook Vascular, Inc. • Special 510(k) Premarket Submission • EVOLUTION Rotary Dilator System • Confidential • ರಿ

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Test Data:

The Cook Vascular EVOLUTION Mechanical Dilator Sheath Set was subjected to the flowing tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

Buckling Test --1. 1
1. Binding Test
Bond strength (Connector/gun) 3.
1. Pull Testing (tip)
1. Handle Cycling Test
1. Device Performance

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Dilator Sheath.

· Cook Vascular, Inc. · Special 510(k) Premarket Submission · EVOLUTION Rotary Dilator System · Confidential · 10

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract eagle design, with three stylized lines forming the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2006

Cook Vascular, Inc. c/o Mr. Jim Ferguson, Jr. Quality Systems Manager 1186 Montgomery Lane Vandergrift, Pennsylvania 15690

Re: K061000

Trade/Device Name: EVOLUTION Mechanical Dilator Sheath Set Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: II Product Code: DRE Dated: April 10, 2006 Received: April 11, 2006

Dear Mr. Ferguson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Jim Ferguson, Jr.

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:

06/000

Device Name:

EVOLUTION Mechanical Dilator Sheath Set

Indications for Use:

The Cook Vascular EVOLUTION Mechanical Dilator Sheath Set is for use in the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K061000
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Prescription Use(Per 21 CFR 801 Subpart D)	OR	Over-The-Counter Use(Per 21 CFR 810 Subpart C)
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· Cook Vascular, Inc. · Special 510(k) Premarket Submission · Evolution Rotary Dilator System · Confidential ·

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).