The Inner-Lock Locking Introducer Sheaths are used to facilitate placing a catheter through the skin into a graft. The Inner-Lock dilator is 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.

Device Description

The Rex Medical, Inner-Lock Locking Introducer Sheaths, 6F and 7F is a vascular access device consisting of a central lumen, an angled side arm extension and a hemostasis valve. The distal tip contains a retention mechanism that is operated via a control arm on the proximal hub. The device is used in exactly the same manner as the predicate device and other substantially equivalent 510(k) cleared devices.

AI/ML Overview

The provided 510(k) summary for the "Inner-Lock Locking Introducer Sheaths" does not describe acceptance criteria, nor does it detail a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.

This document describes a traditional medical device (vascular access introducer sheaths) and its substantial equivalence to a predicate device based on non-clinical performance and material testing. The concept of acceptance criteria and performance studies in the way you've outlined for AI/ML devices (e.g., sensitivity, specificity, F1-score, MRMC studies, ground truth establishment) is not applicable to this type of submission.

Therefore, I cannot fulfill your request with the provided input. However, I can explain why this information is missing and what kind of information is provided:

Why the requested information is absent:

Device Type: The "Inner-Lock Locking Introducer Sheaths" is a physical medical device used for vascular access, not an AI/ML software device.
Regulatory Pathway: This is a 510(k) submission, which relies on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves comparing device specifications, materials, and non-clinical performance (physical testing) to ensure safety and effectiveness are comparable. It does not ordinarily involve clinical trials or performance metrics like those for AI/ML diagnostic tools.
No Clinical Study: The document explicitly states: "Discussion of Clinical Tests Performed: 8. Not applicable, as there are no new indications for use which must be supported by clinical data." This confirms that no clinical study measuring patient outcomes or diagnostic performance was conducted or required for this submission.

What the document does discuss (related to performance assessment):

Substantial Equivalence: The primary "proof" in this submission is the demonstration of substantial equivalence to predicate devices (K#954234, K#984260: PINNACLE™ R/O or RADIFOCUS® Introducer R/O device, Terumo Medical Corporation).
Non-Clinical Tests:
- Comparative functional testing: Performed against the predicate device based on ISO 10555-1, ISO 11070, and FDA's Reviewer Guidance for Short-Term and Long-Term Intravascular Catheters.
- Material testing: Included ISO 10993 Biocompatibility Testing.
- Results: "Testing results revealed the subject device to be substantially equivalent to the predicate device."

In summary, for the provided input, the following information cannot be extracted because it is not relevant to this type of medical device and regulatory submission:

Table of acceptance criteria and reported device performance: Not defined in this context.
Sample size for test set and data provenance: No clinical test set.
Number of experts used to establish ground truth: No ground truth establishment in this context.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable.
Standalone performance (algorithm only): Not applicable, as it's a physical device.
Type of ground truth used: Not applicable.
Sample size for training set: Not applicable.
How ground truth for training set was established: Not applicable.

Summary

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JAN 21 2003

EXHIBIT #1

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: KO22170

Submitter's Identification: 1.

Rex Medical 585 County Line Road Radnor, PA 19087

Contact: Mr. Paul Tashjian

Date Summary Prepared:

July 1, 2002

2. Name of the Device:

Inner-Lock Locking Introducer Sheaths

3. Predicate Device Information:

K#954234, K#984260: PINNACLE™ R/O or RADIFOCUS® Introducer R/O device, Terumo Medical Corporation, Elkton, MD

4. Device Description:

5. Intended Use:

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Comparison to Predicate Devices: 6.

Discussion of Similarities

The Inner-Lock Locking Introducer Sheaths are similar to the Terumo RADIFOCUS ® Introducer R/O device, in that both devices make use of a tapered distal tip with a central lumen to pass over a guidewire and dilator combination; both devices have an elastomer valve, side port and a radio opaque indicator and proximal hubs and extensions are similar in function and material characteristics. Both devices can be used for dialysis graft access.

Discussion of Differences

The Inner-Lock Locking Introducer Sheaths are different from the Terumo RADIFOCUS ® Introducer R/O device, by means of an angled side port and a device retention feature. The angled sidearm may reduce shear force during fluid movement. The retention feature may reduce the risk of the device accidentally being dislodged from the patient. The retention mechanism provides an alternative to suturing the device hub to the skin.

Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:

Comparative functional testing (to the predicate) was performed based on ISO 10555-1, ISO 11070 and FDA's Reviewer Guidance for Short-Term and Long-Term Intravascular Catheters. Material testing also included ISO 10993 Biocompatibility Testing. Testing results revealed the subject device to be substantially equivalent to the predicate device.

Discussion of Clinical Tests Performed: 8.

Not applicable, as there are no new indications for use which must be supported by clinical data.

9. Conclusions:

The subject device, Inner-Lock Locking Introducer Sheaths, have the same intended use and characteristics as the predicate device, the Terumo RADIFOCUS® Introducer R/O device. Moreover, bench testing contained in our submission and non-clinical testing supplied demonstrates that there are no differences in their technological characteristics, thereby not raising any new questions of safety or effectiveness. Thus, the Inner-Lock Locking Introducer

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Sheaths are substantially equivalent to the predicate device, the Terumo RADIFOCUS® Introducer R/O device.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2003

Ms. Susan D. Goldstein-Falk Rex Medical c/o MDI Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11021

Re: K022170

Rex Medical Inner-Lock Locking Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 24, 2002 Received: October 28, 2002

Dear Ms. Goldstein-Falk:

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 - Ms. Susan D. Goldstein-Falk

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.

Also, please If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

N. Harrington

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

Enclosure

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Exhibit B

Page _ 1 _ _ of _ _ 1 _

510(k) Number (if known): _ KO2Q170 __________________________________________________________________________________________________________________________________________

Device Name: Inner-Lock Locking Introducer Sheaths

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K022170
Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use (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).