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

Device Description

The Carotid Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque marker and is hydrophilically coated on the distal 15 cm. It comes packaged with a dilator, a rotating hemostatic valve (Y-connector), and a dilator retaining clip.

AI/ML Overview

The provided document describes the safety and effectiveness of the Carotid Guiding Sheath. It is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the way a clinical trial for a novel AI device would.

Therefore, many of the requested fields cannot be directly extracted from this type of regulatory submission. This document describes a medical device (a guiding sheath), not an AI/algorithm-based diagnostic device.

However, I can extract the relevant information regarding performance and equivalence.

Acceptance Criteria and Device Performance Study (as per the 510(k) document for a medical device)

This 510(k) submission demonstrates substantial equivalence to a predicate device, the Super Arrow-Flex Percutaneous Sheath Introducer Set (K924607), manufactured by Arrow International, Inc., by showing that the Carotid Guiding Sheath performs similarly. The acceptance criteria are implicit in matching the performance characteristics of the predicate device for safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For medical devices in a 510(k), "acceptance criteria" are typically defined by meeting established performance benchmarks or demonstrating equivalence to a predicate device's performance. The "reported device performance" is the results of tests aimed at demonstrating this equivalence.

Performance Characteristic	Acceptance Criteria (Implicit: Equivalent to Predicate Device)	Reported Device Performance (Carotid Guiding Sheath)
Penetration	Must demonstrate comparable penetration characteristics to the predicate device.	Performed to demonstrate substantial equivalence to the predicate device.
Kink Resistance	Must demonstrate comparable kink resistance to the predicate device.	Performed to demonstrate substantial equivalence to the predicate device.
Leakage	Must demonstrate comparable leakage characteristics to the predicate device.	Performed to demonstrate substantial equivalence to the predicate device.
Tensile Strength	Must demonstrate comparable tensile strength to the predicate device.	Performed to demonstrate substantial equivalence to the predicate device.
Tortuous Path / Durability	Must demonstrate comparable durability and performance in tortuous paths to the predicate device.	Performed to demonstrate substantial equivalence to the predicate device.
Sterility	Sterility Assurance Level (SAL) of 10-6 in accordance with ANSI / AAMI / ISO 11135-1994.	Validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide an SAL of 10-6.
Biocompatibility	Blood contacting materials must be biocompatible as per FDA G95-1 (ISO 10993).	Blood contacting materials found to be biocompatible in accordance with FDA G95-1 (ISO 10993).
Expiration Dating	Established shelf-life for safe and effective use.	30 months.

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

Sample Size for Test Set: Not explicitly stated. The document refers to "the following tests were performed," implying specific test methods were used for each characteristic, but not a patient or human-subjects test set. These are likely in vitro or bench tests.
Data Provenance: Not applicable. The tests are device performance tests, not clinical data from patients.

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. This document describes a physical medical device (guiding sheath) and its engineering performance tests, not an AI/algorithm-based diagnostic device requiring expert ground truth for imaging or clinical outcomes. The "ground truth" here is the physical measurement or outcome of the bench test (e.g., whether the device kinks, leaks, or breaks at a certain force).

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

Not Applicable. This is not a clinical study involving human readers or interpretation of results. Results are likely determined by objective measurements from engineering tests.

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 is a physical medical device, 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 a physical medical device.

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

Bench Test Results / Engineering Standards: The "ground truth" for the performance tests (Penetration, Kink Resistance, Leakage, Tensile Strength, Tortuous Path / Durability) would be the objective measurements obtained during the execution of standardized engineering tests, compared against the performance of the predicate device or established specifications. For biocompatibility and sterilization, the ground truth is compliance with specific international standards (ISO 10993, ISO 11135-1994).

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI/machine learning model. There is no concept of a "training set."

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

Not Applicable. As above, there is no training set for a physical medical device.

Summary

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KU12812

NOV 1 4 2001

SECTION II. SUMMARY OF SAFETY & EFFECTIVENESS

A. DEVICE NAME

Proprietary Name:	Has not been established yet
Classification Name:	Catheter Introducer
Common Name:	Guiding Sheath

B. PREDICATE DEVICE

The predicate device is the Super Arrow-Flex Percutaneous Sheath Introducer Set, which is manufactured by Arrow International, Inc. The Super Arrow-flex is cleared through the premarket notification process (K924607).

C. INTENDED USE

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

DESCRIPTION D.

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PRINCIPLE OF OPERATION / TECHNOLOGY E.

The Carotid Guiding Sheath and the Super Arrow-Flex Percutaneous Sheath Introducer Set are operated manually or by a manual process.

F. DESIGN / MATERIALS

The Carotid Guiding Sheath use 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

H. PERFORMANCE

The performance of the Carotid Guiding Sheath is substantially equivalent to the performance of the Super Arrow-Flex Percutaneous Sheath Introducer. The following tests were performed to demonstrate the substantial equivalence of the devices.

Penetration
Kink Resistance
Leakage
Tensile Strength A
Tortuous Path / Durability

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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 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 Carotid Guiding Sheath will be 30 months.

J. SUBSTANTIAL EQUIVALENCE

The Carotid Guiding Sheath submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the Super Arrow-Flex Percutaneous Sheath Introducer Set (K924607), which is manufactured by Arrow International, Inc. 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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K. SUBMITTER INFORMATION

Name and Address

Terumo Medical Corporation 125 Blue Ball Rd. Elkton, MD 21921

Contact Person

Mrs. Yuk-Ting Lewis Senior Regulatory Specialist Ph: 410-392-7213 Fax: 410-398-6079 Email: yukting.lewis@terumomedical.com

Date Prepared

August 1, 2001

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Image /page/4/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2001

Ms. Yuk-Ting Lewis Senior Regulatory Specialist TERUMO Medical Corporation 125 Blue Ball Road Elkton, MD 21921

Re: K012812 Carotid Guiding Sheath Regulation Number: 870.1340 Regulation Name: Catheter introducer. Regulatory Class: II (two) Product Code: 74 DYB Dated: August 21, 2001 Received: August 22, 2001

Dear Ms. Lewis:

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 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.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

the

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 1 4 2001 510(k) Number (if known):

K012812

Carotid Guiding Sheath Device Name:

Indications For Use:

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

(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

(Optional Format 1-2-96)

Division of Cardiovas
510(k) Number K012817

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).