Smith & Nephew instrument trays are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument trays are suitable for use in prevacuum steam and high temperature gravity steam sterilization methods. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.

Device Description

The Smith & Nephew instrument trays are designed to contain and protect reusable surgical instruments during transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process.

AI/ML Overview

This document describes the Smith & Nephew Instrument Trays, which are sterilization trays. The information provided is a 510(k) summary for regulatory approval, focusing on demonstrating substantial equivalence to a predicate device. Therefore, a study meeting the specific criteria for AI/ML device evaluation (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable or present in this submission.

Here's an analysis based on the provided text, focusing on what is available about acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Smith & Nephew Instrument Trays are based on their ability to contain and protect surgical instruments and allow for effective sterilization according to specific parameters. The reported performance confirms that the trays meet these parameters.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Intended Use	Contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization, and transport between usages. Suitable for use in prevacuum steam and high-temperature gravity steam sterilization methods. Not intended to maintain sterility; requires a validated sterilization wrap.	The device meets the intended use. It is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage, and to allow optimal exposure of the tray's contents to sterilant. It is suitable for prevacuum steam and high-temperature gravity steam sterilization methods when used with a validated wrap.
Sterilization Parameters	Pre-vacuum steam:- Temperature: 132 - 135 C (270 F - 275F)- Exposure Time: 4 minutes- Drying Time: 30 minutesHigh Temperature Gravity Steam:- Temperature: 132C (270F)- Exposure Time: 15 minutes- Drying Time: 70 minutes	The trays were successfully validated with these sterilization parameters. (Implied by the "Validated Sterilization Parameters" table in the Indications for Use and the statement "Performance testing was conducted in accordance with AAMI ST77:2006").
Regulatory Compliance	Substantially equivalent to a legally marketed predicate device (Smith & Nephew Instrument Tray 510(k)# K073551) in Intended Use and Fundamental Scientific Technology, with no significant differences raising new questions of safety or efficacy.	The FDA determined the device is substantially equivalent to the predicate device, allowing it to be legally marketed.
Performance Standard	Conformity to AAMI ST77:2006 Containment Devices for reusable medical device sterilization.	Performance testing was conducted in accordance with AAMI ST77:2006. (Implies successful adherence to the standard's requirements for containment and sterilant exposure.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The filing is for a physical medical device (sterilization trays), not an AI/ML diagnostic or predictive algorithm. Performance testing details like specific sample sizes for physical testing, data provenance, or whether it was retrospective/prospective (in the context of clinical data) are not typically included in a 510(k) summary for such devices. The performance testing refers to engineering and sterilization validation, likely in a lab setting rather than with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. Ground truth in the context of expert consensus is relevant for diagnostic or image interpretation AI/ML devices. For a sterilization tray, "ground truth" would relate to successful sterilization as determined by validated laboratory methods (e.g., biological indicators, chemical indicators) and engineering tests. The document mentions testing was done according to AAMI ST77:2006, which implies adherence to established scientific protocols, not expert clinical consensus.

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

This information is not applicable/not provided. Adjudication methods are typically used when multiple human readers interpret data to resolve disagreements or establish ground truth for AI/ML performance evaluation. For a physical device like a sterilization tray, performance is assessed through objective, instrument-based measurements and validated protocols (e.g., sterility testing).

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

This information is not applicable/not provided. MRMC studies are specific to AI/ML devices that assist human readers in tasks like image interpretation. This device is a physical sterile processing accessory and does not involve human readers interpreting data assisted by AI.

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

This information is not applicable/not provided. This device is not an algorithm.

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

The "ground truth" for this device's performance is based on validated sterilization parameters and engineering tests according to the AAMI ST77:2006 standard. This involves objective measures of sterilant penetration and maintenance of physical integrity, rather than clinical outcomes or expert subjective assessment, as it is a device intended to facilitate sterilization, not diagnose or treat.

8. The sample size for the training set

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

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

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

Summary

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090562

SECTION IV

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Smith & Nephew Instrument Trays Date Prepared: February 27, 2009

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

B. Company Contact

Julie Acker RAC Senior Regulatory Specialist T: 508-261-3618 F: 508-261-3620 Julie.acker@smith-nephew.com

C. Device Name

Trade Name:	Smith & Nephew Instrument Tray
Common Name:	Sterilization Tray
Classification Name:	Sterilization Wrap Containers, Trays, Cassettes and OtherAccessories
Class:	II
Product Code:	KCT
Classification Number:	21 CFR §880.6850

D. Predicate Devices

The subject Smith & Nephew Instrument Trays are substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew Instrument Tray 510(k)# K073551

Description of Device E.

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F. Intended Use

Validated Sterilization Parameters:

Method	Temperature	Exposure Time	Drying Time
Pre-vacuum steam	132 - 135 C(270 F - 275F)	4 minutes	30 minutes
High TemperatureGravity Steam	132C (270F)	15 minutes	70 minutes

G. Comparison of Technological Characteristics

The subject Smith & Nephew instrument trays have the same fundamental technological characteristics as the unmodified predicate device. The subject trays are substantially equivalent in design, materials and intended use to the predicate device. There are no significant differences between the proposed and predicate devices that raise new questions of safety or efficacy.

H. Summary Performance Data

Performance testing was conducted in accordance with AAMI ST77:2006 Containment Devices for reusable medical device sterilization.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Public Health Service

MAR 1 8 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Incorporated Ms. Julie Acker Senior Regulatory Specialist Endoscopy, Division 130 Forbes Boulevard Mansfield, Massachusetts 02048

Re: K090562

Trade/Device Name: Smith & Nephew Instrument Trays Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: February 27, 2009 Received: March 2, 2009

Dear Ms. Acker:

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. Acker

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 Biometric's (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 vours.

Sujata Y. Michan MD.

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(K) Number:

K090562

Device Name:

Smith & Nephew Instrument Trays

Indications for Use: Smith & Nephew instrument trays are intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument trays are suitable for use in prevacuum steam and high temperature gravity steam sterilization methods. The subject instrument trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.

Validated Sterilization Parameters:

Method	Temperature	Exposure Time	Drying Time
Pre-vacuumsteam	132 - 135 C(270 F - 275F)	4 minutes	30 minutes
HighTemperatureGravity Steam	132C (270F)	15 minutes	70 minutes

Device models that are the subject of this pre-market notification:

REF	Description
72201939	Tray, BIOSURE™ Easy -Taps
72201940	Tray, BIOSURE™ Notchers
72201938	Tray, BIOSURE™ Taps
72201847	Tray, CROSSTRAC™ Hip Access System
72202202	Tray, ELITE Premium Biceps Tenodesis System

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(Per 21 CFR 801 Subpart D)

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

Shula M. Murphy, MS
(Division Sign-Off)

(Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Kog0562

510(k) Number:

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).