The Destination Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.

Device Description

The Destination® Carotid Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Carotid Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (dilator retaining clip is only available with codes containing the touhy-borst valve).

AI/ML Overview

This document is a 510(k) summary for the Destination® Carotid Guiding Sheath, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against predefined acceptance criteria for a novel AI device. Therefore, most of the requested information regarding acceptance criteria, study design, and AI-specific details cannot be extracted from this document.

However, I can extract information relevant to the performance section as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined as a numerical threshold for a novel AI/diagnostic device.	Substantially equivalent to the predicate device (Carotid Guiding Sheath cleared under K012812). Equivalence shown through bench and cadaver testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not specified.
Data Provenance: Not specified, but the testing involved "bench and cadaver testing." This suggests a mix of laboratory and pre-clinical data. No mention of human clinical data or country of origin.
Retrospective or Prospective: Not indicated.

3. 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 as this is not a diagnostic AI device requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document describes physical device testing.

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 sheath, not an AI diagnostic tool.

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

Not applicable. This is not an algorithm. The device "is operated manually or by a manual process."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the typical sense for an AI device. The "ground truth" here would relate to the successful performance of the device in bench and cadaver testing, likely against established engineering and physiological parameters for catheter introducers.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device.

Summary

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Terumo Medical Corporation Special 510(k) Premarket Notification - Destination® Carotid Guiding Sheath Section II: 510(k) Summary

SECTION II. 510(k) SUMMARY

A. DEVICE NAME

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Destination® Carotid Guiding Sheath Proprietary Name: Classification Name: Catheter Introducer Common Name: Guiding Sheath

B. PREDICATE DEVICE

The predicate device is the Carotid Guiding Sheath, which is manufactured by Terumo Medical Corporation. The Carotid Guiding Sheath is cleared through the premarket notification process (K012812).

C. INTENDED USE

The Destination® Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.

Note: This is the same intended use as the Carotid Guiding Sheath, K012812.

D. DESCRIPTION

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Principle of Operation / Technology E.

The Destination® Carotid Guiding Sheath is operated manually or by a manual process.

F. Design / Materials

The Destination® Carotid Guiding Sheath uses similar materials as the predicate device. Differences in materials between the two devices do not raise any new issues of safety and effectiveness.

G. SPECIFICATIONS

Sheath Size:	6-7Fr.
Nominal ID / OD:	6Fr.: 0.087" / 0.112"7Fr.: 0.100" / 0.122"
Sheath Length:	80-110 cm
Hydrophilic Coating:	Distal 15 cm
Distal Shape Configurations:	Straight, Angled

H. PERFORMANCE

The performance of the Destination® Carotid Guiding Sheath.is substantially equivalent to the performance of the predicate device K012812. The equivalence was shown through bench and cadaver testing.

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I. ADDITIONAL SAFETY INFORMATION

Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide a Sterility Assurance Level of 10-6.

Blood contacting materials were tested in accordance with the test recommendations in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices – Part I: Evaluation and Testing." The Destination® Carotid Guiding Sheath is categorized as "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)". The blood contacting materials were found to be biocompatible.

Expiration dating for the Destination® Carotid Guiding Sheath will be 30 months.

J. SUBSTANTIAL EQUIVALENCE

The Destination® Carotid Guiding Sheath submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the Carotid Guiding Sheath (K012812), which is manufactured by Terumo Medical Corporation. Differences between the devices do not raise any issues of safety or effectiveness.

Terumo's statement of substantial equivalence is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended whatsoever to be the basis for a patent infringement action.

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K052185
p. 4 of 4

K. SUBMITTER INFORMATION

Name and Address

Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921

Contact Person

Mr. Mark Unterreiner Regulatory Affairs Specialist Ph: 410-392-7213 Fax: 410-398-6079 Email: mark.unterreiner@terumomedical.com

Date Prepared

August 10, 2005

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

SEP - 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Terumo Medical Corporation c/o Mr. Mark Unterreiner Regulatory Affairs Specialist 125 Blue Ball Road Elkton, MD 21921

Re: K052185

Destination® Carotid Guiding Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DYB Dated: August 10, 2005 Received: August 11, 2005

Dear Mr. Unterreiner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bection 910(x) presidentially equivalent (for the indications for relerenced above and nave decemined and seed predicate devices marketed in interstate commerce use stated in the encrosure/ to regary interest date of the Medical Device Amendments, or to devices that proof to May 26, 1770, the onecthers and the provisions of the Federal Food, Drug, and Cosmetic have occh recuired in asserval of a premarket approval application (PMA). You may, Act (Act) that do not require apprect to the general controls provisions of the Act. The general therefore, mailier the defree, backed we annual registration, listing of devices, good Controls provisions or allabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may be subject to sam adon Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Mark Unterreiner

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 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) 276-0120. 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/industry/support/index.html.

Sincerely yours.

Durna R. Valumer

\ 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):_____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

ﺎ

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

P. vochner

vision Sign-Off) ivision of Cardiovascular Devices

10(k) Number K052185

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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).