The Glidewire® guide wire is designed to direct a catheter to the desired anatomical location, including but not limited to the carotid arteries, during diagnostic or interventional procedures.

The GlideCath® XP catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system, including but not limited to the carotid arteries.

The Destination® 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 Access Kit is designed to be used for the introduction of devices during carotid intravascular procedures. The kit consists of a Glidewire® guide wire, GlideCath® XP catheter, Tuohy-Borst Valve (TBV), Destination® Carotid Guiding Sheath and inner sheath. The inner sheath is composed of PTFE and the distal end is tapered to provide a smooth transition from the GlideCath XP to the Destination Carotid Guiding Sheath. All components are STERILE. They are sterilized using Ethylene Oxide (EtO) gas.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Carotid Access Kit (K060666) based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance	Comments
Performance Equivalence	Substantial equivalence to predicate device performance	"The performance of the Carotid Access Kit is substantially equivalent to the performance of the predicate devices."	Equivalence was shown through bench testing. The document does not provide specific quantitative performance metrics or acceptance thresholds; it relies on the concept of substantial equivalence to existing devices.
Sterilization	Sterility Assurance Level (SAL)	"Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide a Sterility Assurance Level of 10-6."	This meets the standard SAL for sterile medical devices.
Biocompatibility	Compliance with ISO 10993 for blood-contacting materials	"The blood contacting materials were found to be biocompatible."	Tested according to FDA General Program Memorandum #G95-1 (5/1/95) and ISO 10993. Device categorized as "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)".
Shelf-life	Maximum shelf-life determination	"The maximum shelflife for the kit is 24 months."	Dependent on the shelf-life remaining on individual kit components.
Materials	Similar materials to predicate devices; no new safety issues	"The Carotid Access Kit uses similar materials as the predicate device. Differences in materials between the devices do not raise any new issues of safety and effectiveness."	Qualitative assessment.
Design/Technology	Similar design and principle of operation/technology to predicate devices	"The Carotid Access kit submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the predicate devices..."	Qualitative assessment.
Indications for Use	Consistent intended use with predicate devices	"The Carotid Access kit submitted in this 510(k) is substantially equivalent in intended use..."	The intended uses are clearly stated for each component and align with the functions of the predicate devices.

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

The document explicitly states that performance equivalence was shown through bench testing. It does not provide information on specific sample sizes for this bench testing, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). Bench testing typically involves laboratory-controlled experiments rather than patient data.

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

This information is not applicable or provided. The "study" described is bench testing for mechanical and material properties, sterilization, and biocompatibility, not a clinical study involving human patients where "ground truth" would be established by experts for diagnostic or interventional outcomes.

4. Adjudication Method for the Test Set

This information is not applicable or provided. Since the performance evaluation was based on bench testing of physical and material properties, there would be no need for an adjudication method in the context of clinical expert review.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a manual medical instrument (guide wire, catheter, sheath), not an AI-powered diagnostic or interventional system. Therefore, assessing human reader improvement with AI assistance is not relevant.

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

No, a standalone (algorithm only) performance study was not done. This device has no algorithmic component. Its operation is "manual or by a manual process."

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

The document describes bench testing, which implies that "ground truth" was established by defined engineering specifications, material standards, and validated laboratory methodologies (e.g., tensile strength tests, flow rate measurements, sterility testing protocols compliant with ISO standards, biocompatibility testing according to ISO 10993). It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This information is not applicable or provided. There is no "training set" as this device is not an AI/machine learning system.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or provided. As there is no training set, there is no ground truth establishment for one.

Summary

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K060666
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JUN 2 9 2006

SECTION V. 510(k) SUMMARY

DEVICE NAME A.

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Proprietary Name: Carotid Access Kit Classification Name: Percutaneous Catheter Common Name: Guide Wire, Catheter, and Introducer

B. PREDICATE DEVICE

The predicate device are:

Product Name: Terumo Radifocus® Guide Wire 510k #: K863138 Manufacaturer: Terumo Corporation

Product Name: Terumo Angiographic Catheter 510k #: K915414 Manufacaturer: Terumo Corporation

Product Name: Pinnacle Destination Carotid Guiding Sheath 510k #: K012812 Manufacaturer: Terumo Medical Corporation

C. INDICATIONS FOR USE

The Glidewire® guide wire is designed to direct a catheter to the desired anatomical location, including but not limited to the carotid arteries, during diagnostic or interventional procedures.

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The Destination® 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.

D. DESCRIPTION

and the control of the contraction of the control of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of t

E. PRINCIPLE OF OPERATION / TECHNOLOGY

The devices in the Carotid Access Kit are operated manually or by a manual process.

F. DESIGN / MATERIALS

The Carotid Access Kit uses similar materials as the predicate device. Differences in materials between the devices do not raise any new issues of safety and effectiveness.

். SPECIFICATIONS

Glidewire Specifications: 180 to 300 cm length GlideCath XP Specifications: 180 to 300 cm length with H1 and Vitek shaped distal end Destination Carotid Guiding Sheath Specifications: 6 & 7Fr, 90 cm length, Straight and Multipurpose shaped distal end, with Tuohy-Borst Valve and Inner sheath

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K060666
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PERFORMANCE H.

The performance of the Carotid Access Kit is substantially equivalent to the performance of the predicate devices. The equivalence was shown through bench testing.

Additional Safety Information I.

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 Access Kit 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 Access Kit will be dependent on the selflife remaining on the kit components. The maximum shelflife for the kit is 24 months.

SUBSTANTIAL EQUIVALENCE J.

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

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K060666
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K. SUBMITTER INFORMATION

Name and Address

Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921

Contact Person

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

Date Prepared

March 13, 2006

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2006

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

Rc: K060666 Carotid Access Kit Regulation Number: 21 CFR 870.1250 Regulation Name: Perculaneous Catheter Regulatory Class: Class II (Two) Product Code: DYB Dated: May 31. 2006 Received: June 1, 2006

Dear Mr. Unterreiner:

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. 1)rug. 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. Iisting 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.

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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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl.industry/support/index.html.

Sincerely yours.

Dma R. Valmer

Image /page/5/Picture/5 description: The image contains a handwritten symbol or character that appears to be a combination of a cursive letter and a simple line drawing. The symbol has a loop at the top, a downward stroke, and a curved line at the bottom. To the right of the symbol are the letters 'E' and 'R', which are likely part of a word or abbreviation.

CA 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): K060666

Device Name: Carotid Access Kit

Indications For Use:

The Glidewire® guide wire is designed to direct a catheter to the desired anatomical location, including but not limited to the carotid arteries, during diagnostic or interventional procedures.

The Destination® 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

R. V. Jones

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K0666666

00011

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).