SMITH & NEPHEW INSTRUMENT TRAYS

K091627 · Smith & Nephew, Inc. · KCT · Jul 2, 2009 · General Hospital

Device Facts

• Record ID: K091627
• Device Name: SMITH & NEPHEW INSTRUMENT TRAYS
• Applicant: Smith & Nephew, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Jul 2, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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.

Device Story

Smith & Nephew instrument trays are rigid containers designed to hold and organize reusable surgical instruments during sterilization, storage, and transport. Trays facilitate optimal exposure of contents to sterilant during steam sterilization cycles. Used in clinical settings by healthcare personnel; trays are not intended to maintain sterility independently and must be used with a validated sterilization wrap. Benefits include organized instrument management and protection of instruments during the sterilization process.

Clinical Evidence

Bench testing only. Performance testing was conducted in accordance with AAMI ST77:2006 Containment Devices for reusable medical device sterilization to validate sterilization parameters.

Technological Characteristics

Rigid instrument containment trays designed for prevacuum and high-temperature gravity steam sterilization. Validated for 132C (270F) sterilization cycles. Complies with AAMI ST77:2006 standards.

Indications for Use

Indicated for the containment, organized storage, sterilization, and transport of Smith & Nephew reusable surgical instruments. Suitable for use with prevacuum steam and high temperature gravity steam sterilization methods. Requires use with a validated sterilization wrap to maintain sterility.

Regulatory Classification

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.

Predicate Devices

• Smith & Nephew Instrument Tray (K073551)
• Smith & Nephew Instrument Trays (K090562)

Submission Summary (Full Text)

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KC091627

## 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. I

# Smith & Nephew Instrument Trays Date Prepared: June 2, 2009

JUL - 2 2009

## A. Submitter's Name:

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

## B. Company Contact

Christina Flores Regulatory Affairs Specialist II T: 508-261-3705 F: 508-261-3620 [e-mail]

## C. Device Name

| Trade Name: | Smith & Nephew Instrument Tray |
|------------------------|--------------------------------------------------------------------------|
| Common Name: | Sterilization Tray |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes and Other<br>Accessories |
| 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 and I and and betending beternet Nephew Instrument Tray cleared under K073551 and Smith & Nephew Instrument Trays cleared under K090562.

#### Description of Device E.

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

Page 1 of 2

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#### Intended Use F.

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-vacuum steam | 132C<br>(270F) | 4 minutes | 30 minutes |
| High Temperature<br>Gravity Steam | 132C (270F) | 15 minutes | 70 minutes |

# G. Comparison of Technological Characteristics

The subject Smith & Nephew instrument trays have 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.

### Summary Performance Data H.

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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Christina Flores Regulatory Affairs Specialist II Smith & Nephew, Incorporated Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

JUL - 2 2009

Re: K091627

Trade/Device Name: Smith & Nephew Instrument Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: June 2, 2009 Received: June 3, 2009

### Dear Ms. Flores:

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 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. Flores

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/cdrh/mdr/ 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D. Watts
Susan Duncan, DDS, M.A.

Susan Runner, D.D.S., M.A. 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

K091627 510(K) Number:

Smith & Nephew Instrument Trays Device Name:

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-vacuum<br>steam | 132C (270F) | 4 minutes | 30 minutes |
| High<br>Temperature<br>Gravity Steam | 132C (270F) | 15 minutes | 70 minutes |

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

| REF | Description |
|----------|----------------------------------------------|
| | Elite Premium II Shoulder Arthroscopy System |
| 72202042 | Tray |
| 72202044 | Elite Premium Instability System Tray |

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)

Shule A Murphy, D

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

# SECTION II

510(k) Number:

K091627 Additional Information 7/1/09