SMITH & NEPHEW INSTRUMENT TRAYS

K090562 · Smith & Nephew, Inc. · KCT · Mar 18, 2009 · General Hospital

Device Facts

• Record ID: K090562
• Device Name: SMITH & NEPHEW INSTRUMENT TRAYS
• Applicant: Smith & Nephew, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Mar 18, 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

Instrument trays designed to house and protect reusable surgical instruments during sterilization, storage, and transport. Trays facilitate sterilant exposure to contents during steam sterilization cycles. Used in clinical settings by healthcare personnel. Trays are not sterile barriers; must be used with validated sterilization wraps. Benefits include organized instrument management and protection of devices during processing.

Clinical Evidence

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

Technological Characteristics

Sterilization tray for reusable surgical instruments. Compatible with pre-vacuum steam (132-135°C) and high-temperature gravity steam (132°C) sterilization. Designed for use with validated sterilization wraps. No software or electronic components.

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)

Submission Summary (Full Text)

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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 [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 commercial distribution: Smith & Nephew Instrument Tray 510(k)# K073551

#### Description of Device E.

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.

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#### F. 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.

Validated Sterilization Parameters:

| Method | Temperature | Exposure Time | Drying Time |
|-----------------------------------|-------------------------------|---------------|-------------|
| Pre-vacuum steam | 132 - 135 C<br>(270 F - 275F) | 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 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 [phone]. 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 [phone] or [phone] 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-vacuum<br>steam | 132 - 135 C<br>(270 F - 275F) | 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 |
|----------|---------------------------------------------|
| 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: