The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery.

The Radifocus Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery, including but not limited to the radial artery, after removal of a catheter.

Device Description

The Glidesheath is comprised of an introducer sheath and a dilator. The Glidesheath is coated with a hydrophilic coating to reduce the frictional resistance of the sheath when inserting or removing the sheath from the patient's blood vessel. The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery. The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The Glidesheath is then inserted over the Mini Guide Wire and into the blood vessel. The Mini Guide Wire is then withdrawn from the vessel. The Dilator maintains the integrity of the Sheath and dilates the blood vessel while the Glidesheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted.

The Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery, including but not limited to the radial artery, after removal of a catheter. The Obturator is sold separately.

The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.

Accessories to the Glidesheath are the mini guide wire, Surflo IV catheter, Syringe, and Scalpel, and the RADIFOCUS Obturator. Depending on the product code, these accessories may or may not be contained within the kit. All of the accessories are packaged with the Glidesheath in a pouch prior to sterilization.

AI/ML Overview

The provided text is a 510(k) summary for the Glidesheath, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with performance metrics in the way, for example, an AI/ML algorithm would be evaluated for accuracy.

Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth) are not applicable to this type of device submission based on the provided information.

Here's an analysis based on the information provided, highlighting what is included and what is not:

Acceptance Criteria and Device Performance Summary

Since this is a 510(k) submission for substantial equivalence for a medical device (introducer sheath, dilator, guide wire, obturator), the "acceptance criteria" and "device performance" are primarily focused on meeting regulatory requirements for safety and effectiveness through comparison to already marketed predicate devices, rather than quantitative performance metrics like sensitivity, specificity, or accuracy for a diagnostic or AI device.

The "study" that proves the device meets the "acceptance criteria" is essentially the comparison to predicate devices and adherence to relevant standards/tests.

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Implied from 510(k) goals)	Reported Device Performance (as demonstrated by comparison/testing)
Intended Use	Substantially equivalent to predicate devices (Glidesheath K062858, Cordis Avanti K962746)	Used to facilitate catheter placement into veins/arteries, including radial artery. Mini Guide Wire and Obturator as accessories.
Design / Materials	No new issues of safety and effectiveness compared to predicate devices	Differences in materials between modified and predicate device raise no new safety/effectiveness issues. Includes hydrophilic coating.
Biological Safety (Biocompatibility)	Biocompatible for prolonged contact (24 hrs to 30 days) with circulating blood.	Blood contacting materials tested per ISO 10993-1, results demonstrate biocompatibility.
Sterilization	Sterilized to a Sterility Assurance Level (SAL) of 10^-6.	Validated according to EN ISO 11135-1, device sterilized to SAL of 10^-6.
Risk Management	Conducted according to EN ISO 14971.	A risk/hazard analysis was conducted according to EN ISO 14971.
Manufacturing Controls	Includes visual, functional, dimensional, and sterility tests.	Manufacturing controls include visual, functional, dimensional and sterility tests.
Overall Safety and Effectiveness (SE)	Substantially equivalent to predicate devices.	"Differences between the devices do not raise any significant issues of safety or effectiveness."
Physical Specifications	Meet specified ranges for sheath sizes, lengths, guide wire OD, and Surflo IV catheter.	Ranges: Sheath 4, 5, 6 Fr; Sheath Length 10-25 cm; Dilator Length 15.5-30.5 cm; Guide Wire OD 0.021"-0.038", 10-180cm; Surflo IV Catheter 16G-22G, 1"-2.5" length.

2. Sample Size used for the test set and the data provenance

Not Applicable. This is a 510(k) submission for a physical medical device, not a data-driven device (like an AI/ML algorithm) that typically relies on a "test set" in the conventional sense of machine learning. The "testing" involves biocompatibility tests, sterilization validations, and performance characteristic determinations based on engineering principles and comparisons to predicate devices, not data sets of patient information.
The provenance of data is not specified in terms of country of origin or retrospective/prospective, as typical for clinical data studies. The testing is laboratory and bench-top oriented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth in the context of diagnostic performance metrics is not established for this type of device. The verification and validation activities are based on engineering standards, material science, and regulatory compliance.

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

Not Applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert consensus for ground truth. This is not the type of evaluation described.

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. An MRMC study is relevant for diagnostic imaging devices, particularly with AI assistance. This device is an introducer sheath for facilitating catheter placement, not an imaging or diagnostic interpretation device.

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

Not Applicable. This is not an algorithm-based device.

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

Not Applicable in the sense of clinical ground truth for diagnostic accuracy. For physical device testing, "ground truth" equates to established engineering specifications, validated test methods (e.g., ISO standards for biocompatibility and sterilization), and objective measurements.

8. The sample size for the training set

Not Applicable. This device does not involve a "training set" like an AI/ML algorithm.

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

Not Applicable. This device does not involve a "training set" or "ground truth" in the context of data-driven learning.

Summary

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Korzuyy

SEP 1 8 2008

SECTION II. 510(K) SUMMARY

A. Device Name

Proprietary Name	Glidesheath
Classification Name	Introducer, Catheter
Common Name	Introducer Sheath

B. Intended Use

The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery.

C. Device Description

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The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.

D. Principle Of Operation / Technology

The Glidesheath and its accessories are operated manually or by a manual process.

E. Design / Materials

Differences in materials between the modified device and the predicate device the Glidesheath cleared under K062858 and the Cordis Avanti™ cleared under K962746 raise no new issues of safety and effectiveness.

F. Specifications

Sheath Sizes:	4, 5 & 6 French
Sheath Length:	10-25 cm
Dilator Length:	15.5 - 30.5 cm
Guide Wire OD:	0.021"-0.038"10 - 180cm
Surflo IV Catheter:	16G-22G1" – 2.5" length

Hydrophilic Coating: 10-25cm (entire length of Sheath)

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G. Performance

A risk/hazard analysis was conducted according to EN ISO 14971 Medical Devices -Application of risk management to medical devices. Performance characteristics for this new indication for use were determined. Then it was justified that the performance of the Glidesheath is substantially equivalent to the performance of the Glidesheath cleared under K062858 and the Cordis Avanti™ cleared under K962746.

H. Additional Safety Information

Manufacturing controls include visual, functional, dimensional and sterility tests.

Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".

The introducer sheath is classified as Externally Communicating Devices, Circulating Blood. Prolonged Contact (24 hrs to 30 days). Results of the testing demonstrate that the blood contacting materials are biocompatible.

Sterilization conditions have been validated in accordance with EN ISO 11135-1, Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices. The device is sterilized to a SAL of 10-6.

Substantial Equivalence H.

The Glidesheath is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device the Glidesheath, cleared under K062858 and the Cordis Avanti™ cleared under K962746. Differences between the devices do not raise any significant issues of safety or effectiveness.

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I. Submitter Information

Prepared By:	Mr. Mark UnterreinerSr. Regulatory Affairs Specialist
Prepared For:	Terumo Medical Corporation950 Elkton Blvd.Elkton, MD 21921Phone: (410) 392-7213Fax: (410) 398-6079Email: mark.unterreiner@terumomedical.com
Date Prepared:	August 21, 2008

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 2008

Terumo Corporation c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Rc: K082644 Glidesheath Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Introducer Regulatory Class: Class II Product Code: DYB Dated: September 10, 2008 Received: September 11, 2008

Dear Mr. Job:

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.

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Page 2 - Mr. Mark Job

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 clectronic 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

R. Vuhmer

A 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):	K082644
Device Name:	Glidesheath™

Indications For Use:

The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery.

The Radifocus Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the indwelling sheath while it remains in place within the vein or artery, including but not limited to the radial artery, after removal of a catheter.

Prescription Use (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)

uma P. Vachner

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number_Ko 8 264 4

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).