The Needle's Eye Snare® Retrieval Set - 54cm is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides and other foreign objects.

Device Description

The Needle's Eye Snare® Retrieval Set- 54cm is a grasping device that forms a basketlike snare around the in-dwelling catheter, cardiac lead, fragment of catheter tubing, wire guide or other foreign object. The distal end is delivered to the vicinity of the lead through a long, flexible 12Fr. (O.D.) PTFE sheath placed coaxially within a 16Fr. (O.D.) PTFE Check-Flo® Introducer Sheath having a Check-Flo® Valve with stopcock at its proximal end. The device is comprised at the distal end of a nitinol wire needle's eye retrieval mechanism consisting of a "needle's eye" loop and "threader" with stainless steel sleeves housed within a PTFE protective cover sheath. The snare is activated through the forward advancement of the threader by fully depressing the plunger. The item is captured between the threader and needle's eye. The inner sheath is advanced forward closing the snare and securely capturing the lead or other foreign object. The Needle's Eye Snare® Retrieval Set - 54cm has nominal usable length of 54cm.

AI/ML Overview

The provided text describes the Needle's Eye Snare® Retrieval Set - 54cm and its substantial equivalence to a predicate device. It includes information about the device's indications for use, comparison to the predicate, device description, and a summary of test data. However, the document does not contain the detailed acceptance criteria and study information typically associated with AI/ML device performance validation.

Based on the provided text, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance (as much as can be extracted)

Acceptance Criteria	Reported Device Performance
Particulates meet USP 778 requirements.	The predetermined acceptance criteria were met.
The device is comparable to the predicate device in terms of intended use, principles of operation, basic technological characteristics, and materials of construction.	The Needle's Eye Snare® Retrieval Set - 54cm is comparable to the predicate device.

Missing Information (based on typical AI/ML device validation requests):

The document is a 510(k) submission for a medical device (a snare retrieval set), not an AI/ML diagnostic or prognostic algorithm. Therefore, the typical elements of an AI/ML study (like sample size for test/training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable and not present in this document.

Specifically, the following information is not available in the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical medical device. The "test data" mentioned refers to engineering performance tests (like particulate testing), not clinical or AI model validation data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of Device-Specific Information from the Text:

Device Name: Needle's Eye Snare® Retrieval Set - 54cm
Intended Use: For use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides and other foreign objects.
Predicate Device: Needle's Eye Snare®, cleared under K961992.
Comparison to Predicate: Identical in intended use, principles of operation, basic technological characteristics, and materials of construction. Differences are the specified length (54cm vs 94cm for predicate) and the inclusion of a 12 Fr Curved Inner Sheath as an accessory in the subject device.
Test Data Provided: Particulate Testing was performed to ensure particulates from the device are comparable to the predicate and meet USP 778 requirements. The predetermined acceptance criteria were met.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, layered on top of each other, with flowing lines beneath them.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 11, 2017

Cook Incorporated Thomas Kardos Vice President, Regulatory Affairs 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402

Re: K163353

Trade/Device Name: Needle's Eye Snare Retrieval Set - 54cm Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: June 13, 2017 Received: June 14, 2017

Dear Thomas Kardos:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv.

M.A. Willemsen
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163353

Device Name

Needle's Eye Snare® Retrieval Set - 54 cm

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is written in white, block letters in the upper portion of the logo. Below the word "COOK" is the word "MEDICAL" in smaller, white block letters.

COOK INCORPORATED

750 DANIELS WAY, P.O. BOX 489

BLOOMINGTON, IN 47402-0489 U.S.A.

PHONE: 812.339.2235 TOLL FREE: 800.457.4500

WWW.COOKMEDICAL.COM

K163353 Page 1 of 2

510(k) SUMMARY

K163353 510(k) Number: Submitted By: Thomas J. Kardos Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: (724) 845-8621 x2225 Fax: (724) 845-2848

Date Prepared: July 7, 2017

Device:

Trade Name:	Needle's Eye Snare® Retrieval Set - 54cm
Common Name:	Snare
Classification Name:	Embolectomy Catheter
	DXE (21 CFR 870.5150)
Class/Panel:	Class II, Cardiovascular

Indications for Use:

The Needle's Eye Snare® Retrieval Set – 54cm is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides and other foreign objects.

Predicate Device:

The devices, subject of this submission, are substantially equivalent to the predicate devices, the Needle's Eye Snare®, cleared on December 27, 1996 under 510(k) number K961992.

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Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in large, bold, white letters on a red background. Below the word "COOK" is the word "MEDICAL" in smaller, white letters, also on a red background. The logo is simple and clean, with a focus on the company name.

COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTOΝ, ΙΝ 47402-0489 U.S.A.
NE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM

K163353

Page 2 of 2

Comparison to Predicate Device:

It has been demonstrated that the Needle's Eye Snare® Retrieval Set - 54cm is comparable to the predicate device, the Needle's Eye Snare® (K961992) is identical in terms of intended use, principles of operation, and basic technological characteristics to the predicate devices, and also identical in materials of construction to the predicate device. The only differences between the predicate and subject device are the specified length of the proposed device, which is 54cm versus the cleared device length of 94cm, and the inclusion of a 12 Fr Curved Inner Sheath as an accessory.

Device Description:

Test Data:

The following testing was provided to support a determination of substantial equivalence to the predicate device:

. Particulate Testing - Testing was performed to show that particulates from the device are comparable to the predicate and meet the requirements of USP 778. The predetermined acceptance criteria were met.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).