The Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instrumentation for convenient organized storage, sterilization and transport between usages. The instrument tray must be doubled wrapped with an FDA cleared polypropylene sterilization wrap.

The instrument wrap is suitable for use in pre-vacuum steam sterilization method. The instrument tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices. Maintenance of sterility is dependent on the sterilization wrap shelf life and not the tray. Users must follow the instructions for use supplied with the sterilization wrap and follow the manufacturer's recommended storage conditions and time frames for shelf life. The maximum number of devices that could be processed in one load is five. The maximum weight load is 8.4lbs.

Device Description

The Smith & Nephew Gynecology Instrument Tray is a stainless steel tray provided with instrument holders, internal compartment and a pin mat. The tray 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 during the sterilization process.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Smith & Nephew Gynecology Instrument Tray, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test	Acceptance Criteria	Reported Device Performance
Sterilization	Method: Pre-vacuum steam Temperature: 132° C (270° F) Exposure Time: 4 minutes Drying Time: 30 minutes Maximum Loaded Tray Weight: 8.4 lbs. Device Types and Dimensions: - Hysteroscope: Length: 334mm Max., Diameter: 8mm Max., Lumen: 3.1mm Min. - Handpiece: Length: 203mm Max., Diameter: 32mm Max., Lumen: 5.1mm Max. - Sheath: Length: 230mm Max., Diameter: 9mm Max., Lumen: 4.6mm Min. - Calibration Insert / Obturator: Length: 385mm Max., Diameter: 4.1mm Max. - Diagnostic Sheath: Length: 390mm Max., Diameter: 2.9mm Max., Lumen: 1.9mm Min. General: Must be able to contain and protect reusable surgical instruments during sterilization and allow optimal exposure to sterilant.	"Non clinical validation testing was conducted for sterilization and functional strength in order to demonstrate that the subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses." The document explicitly states the "Validated Sterilization Parameters" (which are listed as the acceptance criteria). While a detailed report of the sterilization efficacy (e.g., sterility assurance level achieved) is not provided in this summary, the statement confirms that the device was tested and found to meet these parameters. The device is also confirmed to accommodate the specified instruments at the given maximum weight.
Functional Strength	Capable of protecting reusable surgical instruments during transport, sterilization, and storage.	"Non clinical validation testing was conducted for sterilization and functional strength in order to demonstrate that the subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses." Similar to sterilization, the document asserts that functional strength testing was performed and the device met its pre-defined acceptance criteria. No specific quantitative data on strength (e.g., load capacity beyond sterilization weight, impact resistance) is detailed in this summary.

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

The document does not provide specific sample sizes for the test set used in the non-clinical validation testing. It mentions "non clinical validation testing" for sterilization and functional strength.

The data provenance is not specified beyond "non clinical validation testing." It doesn't indicate the country of origin of the data or whether it was retrospective or prospective. Given the nature of a sterilization tray, it's highly likely this testing was conducted in a laboratory setting.

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

This information is not provided in the document. For a physical device like a sterilization tray, "ground truth" would typically refer to objective measurements and observations performed by qualified laboratory personnel, rather than expert consensus on subjective interpretations (like in imaging diagnostics).

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are usually relevant for studies involving subjective interpretation by multiple human readers (e.g., radiologists reviewing images) where discrepancies need to be resolved. For a sterilization tray, the validation involves objective physical and microbiological 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 provided and not applicable. An MRMC study is relevant for diagnostic devices (often AI-based) that assist human readers. The Smith & Nephew Gynecology Instrument Tray is a physical sterilization device, not an AI diagnostic tool.

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

This information is not provided and not applicable. This concept applies to AI algorithms. The device in question is a physical instrument tray.

7. The Type of Ground Truth Used

For this device, the "ground truth" would be established through:

Objective Measurements: For dimensions, weight capacity.
Physical Testing: For functional strength (e.g., durability, integrity after repeated use/sterilization cycles).
Microbiological Testing: For sterilization efficacy (e.g., sterilization cycle validation using biological indicators to confirm sterility assurance level). This is implied by "sterilization validation."

The document states that performance testing was conducted in accordance with ANSI/AAMI ST77:2006 Containment Devices for reusable medical device sterilization, which outlines standard methods for establishing such ground truth for sterilization products.

8. The Sample Size for the Training Set

This information is not provided and not applicable. The concept of a "training set" applies to machine learning algorithms. This device is a physical product.

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

This information is not provided and not applicable, for the same reasons as point 8.

Summary

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SECTION IV

MAR 1 1 2013 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

K121904

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 Gynecology Instrument Tray

Date Prepared: June 27, 2012

A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover, MA 01810

B. Company Contact

Janice Haselton

Sr. Regulatory Affairs Specialist

T: 978-749-1494

F: 978-749-1443

Janice.haselton@smith-nephew.com

C. Device Name

Trade Name:	Smith & Nephew Gynecology Instrument Tray
Common Name:	Sterilization Tray
Classification Name:	Sterilization Wrap
Class:	2
Product Code:	KCT
Classification Number:	21 CFR §880.6850

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D. Predicate Devices

The Smith & Nephew Gynecology Instrument Tray is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution:

K090562 (cleared March 18, 2009): ELITE Premium Biceps Tenodesis System

E. Description of Device

The technological characteristics of the subject tray are identical to the predicate device. The number of instrument holders and pin mats and material of construction are similar to the predicate. The indications for use statement is unchanged from the predicate tray.

Non clinical validation testing was conducted for sterilization and functional strength in order to demonstrate that the subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.

F. Intended Use

Indications For Use

Indications For Use The Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instrumentation for convenient organized storage, sterilization and transport between usages. The instrument tray must be doubled wrapped with an FDA cleared polypropylene sterilization wrap.

The instrument wrap is suitable for use in pre-vacuum steam sterilization method. The instrument tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices. Maintenance of sterility is dependent on the sterilization wrap shelf life and not the tray. Users must follow the instructions for use supplied with the sterilization wrap and follow the manufacturer's recommended storage conditions and time frames for shelf life. The maximum number of devices that could be processed in one load is five. The maximum weight load is 8.4lbs.

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Validated Sterilization Parameters

Instrument Tray Contents	Max loaded Tray Weight 8.4 lbs.
Device Type	Dimensions
Hysteroscope	Length: 334mm Max., Diameter: 8mmMax.Lumen: 3.1mm Min.
Handpiece	Length: 203mm Max., Diameter: 32mmMax.Lumen: 5.1mm Max
Sheath	Length: 230mm Max., Diameter: 9mmMax.Lumen: 4.6mm Min.
Calibration Insert / Obturator	Length: 385mm Max., Diameter: 4.1mmMax.
Diagnostic Sheath	Length: 390mm Max., Diameter: 2.9mmMax.Lumen: 1.9mm Min.

Validated Sterilization Parameters:

Method	Temperature	Exposure Time	Drying Time
Pre-vacuumsteam	132° C(270° F)	4 minutes	30 minutes

G. Comparison of Technological Characteristics

The subject Smith & Nephew Gynecology Instrument tray has the same fundamental technological characteristics as the unmodified predicate device. The subject tray is 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 ANSI/AAMI ST77:2006 Containment Devices for reusable medical device sterilization.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 11, 2013

Ms. Janice Haselton Senior Regulatory Affairs Specialist Smith & Nephew Incorporated, Endoscopy Division 150 Minuteman Road ANDOVER MA 01810

Re: K121904

Trade/Device Name: Gynecology Instrument Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: February 25, 2013 Received: February 28, 2013

Dear Ms. Haselton:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Haselton

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): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

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Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K121904

Device Name: Smith & Nephew Gynecology Instrument Tray

Indications For Use

Validated Sterilization Parameters:

Method	Temperature	Exposure Time	Drying Time
Pre-vacuumsteam	132° C(270° F)	4 minutes	30 minutes

Instrument Tray Contents
Device Type	Dimensions
Hysteroscope	Length: 334mm Max.Diameter: 8mm MaxLumen: 3.1mm Min.
Handpiece	Length: 203mm Max.Diameter: 32mm MaxLumen: 5.1mm Min.
Sheath	Length: 230 mm Max.Diameter: 9mm MaxLumen: 4.6mm Min.
Calibration Insert/Obturator	Length: 385mm Max.Diameter: 4.1mm Max
Diagnostic Sheath	Length: 390mm Max.Diameter: 2.9mm MaxLumen: 1.9mm Min.

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Device model that is the subject of this pre-market notification:

REF	Description
72203004	Gynecology Instrument Tray

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X

Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth 2013.03.07 15:32:48 -05'00'

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121904 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).