The OrthoGuard AB Antimicrobial Sleeve is intended to be used as an accessory surrounding orthopaedic pins and wires during external fixation of bones. The OrthoGuard AB Antimicrobial Sleeve is indicated to inhibit bacterial colonization on the pin/wire.

Device Description

The OrthoGuard AB Antimicrobial Sleeve consists of polyurethane tubing coated on the inner and outer surfaces with an antimicrobial coating of gentamicin complexed with lauryl sulfate in a matrix of nitrocellulose and polyurethane.

AI/ML Overview

This 510(k) submission for the OrthoGuard AB Antimicrobial Sleeve does not contain specific acceptance criteria or a detailed study description that proves the device meets such criteria. Instead, it relies on the concept of substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

No explicit acceptance criteria or a table of performance metrics are provided in the document. The submission states: "The technological and performance characteristics of the OrthoGuard AB Antimicrobial Sleeve were compared to the predicate device. The results of this comparison support the safety and effectiveness of the device and substantial equivalence to legally marketed devices." This implies that the performance was considered "equivalent enough" to the predicate, but specific quantitative acceptance criteria or performance numbers are not given.

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

No information regarding a "test set" or specific study data is provided. The document relies on comparison to a predicate device rather than a new standalone clinical or performance study with a distinct test set.

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

Not applicable. No new test set requiring expert ground truth establishment is described. The submission focuses on substantial equivalence to a previously approved device.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring an adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study would be relevant for devices involving human interpretation of medical images or data, which is not the case for an antimicrobial sleeve.

6. If a Standalone (Algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical product (an antimicrobial sleeve), not an algorithm or AI system. Therefore, an "algorithm only" performance study is irrelevant.

7. The Type of Ground Truth Used:

The "ground truth" here is effectively established by the predicate device's prior approval and its demonstrated safety and effectiveness in its intended use. The new device is deemed substantially equivalent to that established "ground truth." There is no new, independent establishment of ground truth for bacterial colonization inhibition mentioned for the OrthoGuard AB Antimicrobial Sleeve itself in this document, beyond its comparison to the predicate.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. As above, this is not an AI/ML device.

Summary of Approach in this 510(k) Submission:

This 510(k) submission for the OrthoGuard AB Antimicrobial Sleeve is based entirely on substantial equivalence to a previously cleared predicate device (OrthoGuard AB Antimicrobial Pin Sleeves, K012193). The rationale for equivalence is that the new wire sleeve has the "same" intended use, material, coating formulation, manufacturing, coating method, labeling, and sterilization method as the predicate. Any differences were deemed not to significantly affect safety or effectiveness.

Therefore, the "acceptance criteria" were implicitly met by demonstrating that the new device is functionally and materially similar enough to a device already accepted by the FDA. The "study" proving this is essentially the comparison analysis outlined in the "Technological and Performance Characteristics" section, which concluded that the differences were not significant. No new, independent studies with specific performance endpoints, test sets, or ground truth establishment are detailed in this summary.

Summary

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510(k) Summary of Safety and Effectiveness OrthoGuard AB Antimicrobial Sleeve

Ka226 76

Submitted By:	Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116
Date:	August 7, 2002
Contact Person:	Janet Johnson GreenDirector, Regulatory Affairs
Proprietary Name:	OrthoGuard AB Antimicrobial Sleeve
Common Name:	Antimicrobial Pin/Wire Sleeve
Classification Name and Reference:	Smooth or threaded metallic bone fixationfastener (21 CFR 888.3040)
Device Product Code and Panel Code:	JEC / NJA - Orthopedics/87

Predicate Device / Substantial Equivalence Information

The OrthoGuard AB Antimicrobial Wire Sleeve is similar to the OrthoGuard AB Antimicribial Pin Sleeves included in 510(k) K012193. The following properties of the wire sleeve are the same as for the pin sleeves currently offered: intended use, material and coating formulation, manufacturing and coating method, labeling, and sterilization method. While the OrthoGuard AB Antimicrobial Wire Sleeve is not identical to the predicates, any differences that may exist do not significantly affect the safety or effectiveness. Therefore, the OrthoGuard AB Antimicrobial Wire Sleeve is substantially equivalent to the predicate devices.

Device Description

Intended Use

Technological and Performance Characteristics

The technological and performance characteristics of the OrthoGuard AB Antimicrobial Sleeve were compared to the predicate device. The results of this comparison support the safety and effectiveness of the device and substantial equivalence to legally marketed devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the three branches of government. The logo is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2002

Ms. Janet Johnson Green Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K022676

Trade/Device Name: OrthoGuard AB Antimicrobial Sleeve Regulation Number: 21 CFR §888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JEC and NJA Dated: August 8, 2002 Received: August 12, 2002

Dear Ms. Green:

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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Page 2 -- Ms. Janet Johnson Green

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) 594-4659. 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.

Mark n Millan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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OrthoGuard AB Antimicrobial Sleeve Indications Statement

Mark N. Mulkeron

Mivicia al. Restorative Division C and Neurological L evices

510(k) Number: K022676

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.