The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or 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 after removal of a catheter.

Device Description

The Glidesheath is comprised of an introducer sheath and a dilator.

The Glidesheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the Glidesheath. The Inserter docs not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer.

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 The Mini Guide Wire is then withdrawn from the vessel.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 RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The Obturator also provides support to the indwelling Sheath after the catheter is removed.

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

AI/ML Overview

Here's an analysis of the provided text regarding the Glidesheath device, focusing on acceptance criteria and the study proving its compliance:

The provided text describes a 510(k) premarket notification for a new device, the Glidesheath, and its substantial equivalence to a previously cleared device, the RADIFOCUS® Introducer II (K954234). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are not focused on a strict performance threshold for the Glidesheath itself, but rather on demonstrating that the Glidesheath performs as well as or is substantially equivalent to the predicate device.

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Demonstrates Substantial Equivalence)	Reported Device Performance (Glidesheath vs. RADIFOCUS® Introducer II)
Leakage/clogging	No new issues of safety and effectiveness raised.
Tensile strength of connections	No new issues of safety and effectiveness raised.
Separation force of dilator and sheath	No new issues of safety and effectiveness raised.
Internal sliding resistance	No new issues of safety and effectiveness raised.
External sliding resistance	No new issues of safety and effectiveness raised.
Penetration force	No new issues of safety and effectiveness raised.
Overall Substantial Equivalence (Summary of Performance)	Performance of the Glidesheath is substantially equivalent to the performance of the RADIFOCUS® Introducer II.

Note: The document explicitly states, "None of the data raises any new issues of safety and effectiveness." This implies that the Glidesheath's performance in these categories met the acceptable levels established by the predicate device and did not introduce new risks or deficiencies. The "acceptance criteria" for each test would have been defined by the performance characteristics of the predicate device, K954234.

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

Sample Size: The document does not specify the sample sizes used for the verification tests (Leakage/clogging, Tensile strength, etc.).
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given these are physical/mechanical property tests, they would be conducted in a laboratory setting.

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

This is not applicable in this context. The "ground truth" for these performance tests is typically established through direct measurement against pre-defined engineering and material specifications, and comparison to the predicate device's performance. It does not involve human experts establishing a subjective "ground truth" in the way a diagnostic imaging study would.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, often in clinical studies or image interpretation. For engineering verification tests, results are typically objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic accuracy, especially of AI/CAD systems, and involves human readers interpreting cases. The Glidesheath is a physical medical device (introducer sheath, dilator, guide wire) and its performance is assessed via engineering and material properties, not diagnostic interpretation.

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

This is not applicable. The Glidesheath is a physical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the verification tests was based on objective measurements of physical and mechanical properties (e.g., force, resistance, leak rates) compared against the performance characteristics of the predicate device, RADIFOCUS® Introducer II. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific tests.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The "study" here refers to verification testing of a physical device.

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

This is not applicable, as there is no training set for this type of device.

Summary

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SECTION II. SUMMARY AND CERTIFICATION

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Device Name A.

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

B. Intended Use

Note: This is the same intended use as the RADIFOCUS® Introduccr II Kit , K954234.

C. Device Description

The Glidesheath is comprised of an introducer sheath and a dilator.

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Obturator also provides support to the indwelling Sheath after the catheter is removed.

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

Principle Of Operation / Technology D.

and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of

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

Design / Materials E.

Differences in materials between the Glidesheath and the RADIFOCUS® Introducer II Kit, K954234 raise no new issues of safety and effectiveness.

Part	Glidesheath	RADIFOCUS® Introducer II,K954234
Introducer SheathSizeLength	5 & 6 French10-25 cm	4 – 11 French5 - 110 cm
DilatorLength	15.5 - 30.5 cm	6 - 110 cm
Guide Wire OD	0.021" – 0.038"	0.021" – 0.038"

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G. Performance

ﻧﮯ ﭘﺮ ﺳﻤ

The Glidesheath is comprised of an introducer sheath and a dilator. Only the introducer sheath was modified. The dilator was not modified.

The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Glidesheath) to the unmodified device (RADIFOCUS® Introducer II).

Leakage/clogging .
Tensile strength of connections .
Separation force of dilator and sheath .
Internal sliding resistance .
External sliding resistance .
Penetration force .

None of the data raises any new issues of safety and effectivencss. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.

Therefore the performance of the Glidesheath is substantially equivalent to the performance of the RADIFOCUS® Introducer II, cleared under K954234.

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 ANSI / AAMI / ISO 11135-1994, Medical Devices -- Validation and routine control of ethylene oxide sterilization and EN 550. The device is sterilized to a SAL of 106.

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I. Substantial Equivalence

The Glidesheath is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the RADIFOCUS® Introducer II, cleared under K954234. Differences between the two devices do not raise any significant issues of safety or effectiveness.

Submitter Information J.

Prepared By:	Mr. Mark UnterreinerRegulatory Affairs Specialist
Prepared For:	Terumo Medical Corporation125 Blue Ball RoadElkton, MD 21921Phone: (410) 392-7213Fax: (410) 398-6079Email: mark.unterreiner@terumomedical.com
Date Prepared:	November 21, 2003

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2003

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

K033681 Re: Trade Name: Glidesheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer. Regulatory Class: II Product Code: 74 DYB Dated: November 21, 2003 Received: November 23, 2003

Dear Mr. Unterreiner:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 iQ(x) premaince is substantially equivalent (for the indications
referenced above and have determined the device as againers in interstate referenced above and have detellimbed the devices marketed in interstate for use stated in the enclosure) to tegally markets the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment the of the Federal Food. Drug. commerce prior to May 28, 1976, the enactiven and of the Federal Food, Drug, devices that have been reclassined in accondice was are archarded application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The Act. The You may, therefore, market the device, subject to the general sommal registration, listing of
general controls provisions of the Act include requirements for amount misbrandi general controls provisions of the Act mender requirements on the 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
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controlis. Existing major regalato of the Marketion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 . In a be found in the Code of I cacral regarations, your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a subscribed with other requirements of the Act
that FDA has made a determination that your device coderal econoise. You must that FDA has made a delerimilations administered by other Federal agencies. You must a or any Federal statutes and regulations and united to registration and listing (21
comply with all the Act's requirements, including, but not limited to: registration and lis comply with all the Act s requirements, meridants, out how man and one of the many of the many

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Page 2 - Mr. Mark Unterreiner

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (QD) regalantis (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 premarked notification: "The PDF intrailigstification 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 If you desire specific acrison. I for in vitro diagnostic devices), please contact the Office of additionally 21 Of I Creat 586. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-4639. Iffice of Compliance at (301) 594-4639. Also, please note the your de roo, prease ochabranding by reference to premarket notification" (21 CFR Part 807.97). Tegulation on thinked, "Thisorians on your responsibilities under the Act may be obtained from the Other general mionmation on Jose, 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,

Jessa D. Harrison

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

Enclosure

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Note: This is the same intended use as the predicate device, K954234

510(k) Number (if known):	K033681
Device Name:	Glidesheath

Indications For Use:

(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)

Over-The-Counter Use

Qlar 12/11/03

vision Sign-off Division of Cardio 510(K) Numbe

(Optional Format 1-2-96)

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).