SMITH & NEPHEW INSTRUMENT TRAYS

K073551 · Smith & Nephew Inc., Endoscopy Div. · KCT · May 21, 2008 · General Hospital

Device Facts

• Record ID: K073551
• Device Name: SMITH & NEPHEW INSTRUMENT TRAYS
• Applicant: Smith & Nephew Inc., Endoscopy Div.
• Product Code: KCT · General Hospital
• Decision Date: May 21, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The instrument tray is suitable for use in prevacuum steam and high temperature gravity steam sterilization methods. 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.

Device Story

Perforated stainless steel tray with latchable lid and handle; includes Radel organizing racks, silicone instrument holders, and protective mats. Designed to contain and protect reusable surgical instruments during transport, sterilization, and storage. Used in clinical settings to facilitate organized instrument placement and ensure optimal exposure to sterilant during steam sterilization. Requires use of validated sterilization wrap to maintain sterility post-process. Benefits include organized instrument management and protection of reusable surgical tools during sterilization cycles.

Clinical Evidence

Bench testing only. Performance testing included sterilization efficacy, thermal profile studies, and drying time studies to demonstrate conformance with AAMI ST77:2006.

Technological Characteristics

Perforated stainless steel case; Radel organizing racks; silicone instrument holders; protective mats. Latchable lid and handle. Compatible with prevacuum steam (132°C–135°C) and high temperature gravity steam (132°C) sterilization. Conforms to AAMI ST77:2006.

Indications for Use

Indicated for the containment, organized storage, sterilization, and transport of Smith & Nephew reusable surgical instruments. Suitable for use in prevacuum steam and high temperature gravity steam sterilization. Not intended to maintain sterility independently; must be used with a validated sterilization wrap.

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

• PolyVac Surgical Instrument Delivery System (K012105)
• Riley Medical, Inc. Meta-Pak Multipurpose Instrument Tray (K993535)

Submission Summary (Full Text)

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MAY 2 1 2008

# 510(k) SUMMARY K073551

# Smith & Nephew® Instrument Tray Date Prepared: May 20, 2008

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

# A. Submitter

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

# B. Company Contact

Julie Acker RAC Regulatory Affairs Specialist T: 508-261-3618 F: 508-261-3620 [e-mail]

### C. Device Name

| Trade Name: | Instrument Tray |
|----------------------|-------------------------------------------------------------------------|
| Common Name: | Instrument Tray |
| Classification Name: | Sterilization Wrap Containers, Trays Cassettes and Other<br>Accessories |
| Class: | Class 2 |
| Product Code | KCT |

#### D. Predicate Devices

The Smith & Nephew instrument tray is substantially equivalent in design, materials, and intended use to the following devices in commercial distribution: PolyVac Surgical Instrument Delivery System 510(k)# K012105 and Riley Medical, Inc. Meta-Pak Multipurpose Instrument Tray 510(k)# K993535

#### i. Description of Device

The Smith & Nephew instrument 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.

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K073551
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The instrument tray is a perforated stainless steel case with latchable lid and handle. The tray is fitted with Radel® organizing racks, silicone instrument holders and protective mats. The instrument tray is marked to facilitate organized instrument placement.

#### F. Intended Use

The Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The instrument tray is suitable for use in prevacuum steam and high temperature gravity steam sterilization methods.

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.

| Method | Temperature | Exposure Time | Drying Time |
|--------------------------------------|--------------------------------|---------------|-------------|
| Prevacuum<br>Steam | 132°C – 135°C<br>(270°F-275°F) | 4 minutes | 30 minutes |
| High<br>Temperature<br>Gravity Steam | 132°C<br>(270°F) | 10 minutes | 70 minutes |

Validated Sterilization Parameters:

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

| REF | Description |
|----------|---------------------------------------------------|
| 72201731 | Tray, ACUFEX® DIRECTOR ELITE® Drill Guide Systems |

# G. Comparison of Technological Characteristics

The Smith & Nephew instrument tray is substantially equivalent in design, materials and intended use to the predicate devices. The proposed instrument tray and predicate devices are used for storage, transport and sterilization of reusable surgical instruments between uses. Both the proposed and predicate devices are suitable for use in steam sterilization processes when used in conjunction with legally validated sterilization wrap and are not intended to maintain sterility on the own.

The Smith & Nephew instrument tray does not incorporate any new technological characteristics as compared to legally marketed devices. The Smith & Nephew instrument tray and the predicate devices are cases constructed of perforated metal with latchable lid. and utilize radel organizing racks, silicone instrument brackets and protective mats to secure encased instruments. There are no significant differences between the proposed and predicate devices.

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Performance testing including sterilization efficacy testing, thermal profile studies and drying time studies demonstrate that the Smith & Nephew instrument tray conforms to AAMI ST77:2006 Containment Devices for reusable medical device sterilization.

#### Summary and Conclusions H.

The Smith & Nephew instrument tray has the same intended use, technological characteristics and performance characteristics as the legally marketed predicate devices. The product design is in conformance with recognized consensus standards and does not raise any new issues of safety and efficacy. We consider the Smith & Nephew Instrument Tray to be substantially equivalent to the legally marketed predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 2 1 2008

Ms. Julie Acker Regulatory Affairs Smith & Nephew, Incorporated, Endoscopy Division 130 Forbes Boulevard Mansfield, Massachusetts 02766

Re: K073551

Trade/Device Name: Smith & Nephew Instrument Tray Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: April 30, 2008 Received: May 1, 2008

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 (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.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Clare

Chiu Lin. Ph.D. 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: | K073551 |
|----------------|---------|
|----------------|---------|

Smith & Nephew Instrument Tray Device Name:

The Smith & Nephew instrument tray is intended to contain Smith & Indications for Use: Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The instrument tray is suitable for use in prevacuum steam and high temperature gravity steam sterilization methods.

> 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.

Validated Sterilization Parameters:

| Method | Temperature | Exposure Time | Drying Time |
|--------------------------------------|--------------------------------|---------------|-------------|
| Prevacuum<br>Steam | 132°C – 135°C<br>(270°F–275°F) | 4 minutes | 30 minutes |
| High<br>Temperature<br>Gravity Steam | 132°C<br>(270°F) | 10 minutes | 70 minutes |

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

Description REF Tray, ACUFEX® DIRECTOR ELITE® Drill Guide Systems 72201731

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

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

(Per 21 CFR 801 Subpart D)

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Concurrence of CDRH, Office of Device Evaluati
(Division Sign-Off)
valuation DE
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Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K073577