METAPAK MULTI-PURPOSE INSTRUMENT TRAY

K993535 · Riley Medical, Inc. · FRG · Dec 7, 2001 · General Hospital

Device Facts

• Record ID: K993535
• Device Name: METAPAK MULTI-PURPOSE INSTRUMENT TRAY
• Applicant: Riley Medical, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Dec 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The MetaPak Instrument Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses. The MetaPak Instrument Tray can be used in pre-vacuum steam and ethylene oxide sterilization cycles.

Device Story

MetaPak Multi-Purpose Instrument Tray is a container system for surgical instruments; consists of rectangular base and cover with latches; includes optional insert trays, protective mats, and slotted instrument bars/holders for stabilization. Used in clinical settings to organize, sterilize, transport, and store instruments between uses. Compatible with pre-vacuum steam and ethylene oxide sterilization cycles. Device protects instruments during processing and storage; facilitates efficient handling by surgical staff.

Clinical Evidence

Bench testing only. Validation testing confirmed that sterilization conditions were achieved in fully loaded MetaPak Instrument Trays of all three container base material compositions (aluminum, stainless steel, and aluminum/Radel) containing inserts, protective mats, and accessories in pre-vacuum steam and ethylene oxide sterilization processes.

Technological Characteristics

Container system consisting of rectangular base and lid with latches. Materials: Aluminum, stainless steel, and aluminum/Radel plastic combination. Accessories: Insert trays, protective mats, slotted instrument bars/holders. Compatible with pre-vacuum steam and ethylene oxide sterilization. Dimensions: Various sizes (e.g., 22"x10"x6", 26"x10"x6").

Indications for Use

Indicated for use in healthcare settings to organize, sterilize, transport, and store surgical instruments during pre-vacuum steam and ethylene oxide sterilization cycles.

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

• Riley MultiPak Surgical Instrument Tray (K944025)
• Sklar Instruments Instrument Tray

Submission Summary (Full Text)

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DEC 0 7 2001

510(k) Summary

# Kg93535

## for

# Riley Medical, Inc. MetaPak Multi-Purpose Instrument Tray

- SPONSOR 1.
Riley Medical, Inc. 27 Wrights Landing Auburn, ME 04210

Contact Person: Mr. Martin M. Moore 207-786-2775 Telephone:

November 28, 2001 Date Prepared:

#### DEVICE NAME 2.

Riley Modical, Inc. MetaPak Multi-Purpose Instrument Proprietary Name:

Tray

Tray Instrument sterilization tray Common/Usual Name: Accessory to sterilization wrap Classification Name:

#### PREDICATE DEVICES 3.

- Riley MultiPak Surgical Instrument Tray .
- Sklar Instruments Instrument Tray u

#### DEVICE DESCRIPTION 4.

The Riley Medical MetaPak Multi-Purpose Instrument Tray (MetaPak Instrument Tray) is an instrument container consisting of a rectangular box base with a cover that fastens to the base using latches on the short ends. The following sizes of bases and lids are available:

- Tall hase and lid: 22" x 10" x 6" .
- Short base and lid: 22" x 10" x 4" .
- Extra long base and lid: 26" x 10" x 6" .

Riley Medical, Inc. Additional Information for K993535

ा -

November 28, 2001

Page C-1

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Insert trays can be stacked in the container base to increase the instrument-carrying capacity of the container. The following insert sizes are available:

- . Full insert: 21" x 9.5" x 2.5"
- Small insert: 10" x 9.5" x 2.5" t

Protective mats are available that can be placed on the insert trays and in the bottom of the container base to stabilize and protect the instruments. Slotted instrument bars and holders are also available to organize, stabilize, and protect the instruments in the container.

#### INTENDED USE ર્ણ

The MetaPak Instrument Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses.

The MetaPak Instrument Tray can be used in pre-vacuum steam and ethylene oxide sterilization cycles.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The proposed MetaPak Instrument Tray and the predicate MultiPak and Sklar Instrument Trays are all used for storage, transport, and sterilization of surgical instruments between uses. Both the proposed and predicate devices are suitable for use in pre-vacuum steam and ethylene oxide sterilization processes.

The MetaPak Instrument Tray is identical to the predicate MultiPak Instrument Tray, cleared for marketing as K944025, with the exception of a modification to the materials for the container base. The original MultiPak Instrument Tray container base was constructed entirely of Radel plastic. The MetaPak Instrument Tray container base will be offered in aluminum, stainless steel, and an aluminum/Radel combination with the long sides made of aluminum and short sides made of Radel plastic.

#### PERFORMANCE TESTING 7.

Validation testing was conducted which confirmed that sterilization conditions were achieved in fully loaded MetaPak Instrument Trays of all three container base material compositions containing one full insert and two half inserts, protective mats, and accessories in prc-vacuum steam and ethylene oxide sterilization processes.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 0 7 2001

Riley Medical, Incorporated C/O Ms. Mary McNamara-Cullinane Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K993535

Trade/Device Name: Metapak Multi-Purpose Instrument Tray Regulation Number: 880.6850 Regulation Name: Instrument Sterilization Tray Regulatory Class: II Product Code: FRG Dated: October 9, 2001 Received: October 10, 2001

Dear Ms. Cullinane:

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.

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.

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### Page 2 - Ms. Cullinane

You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an all the Process of CFR Part 801); good manufacturing practice and fishing (21 CFR Part 001), abouting systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quady ion 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 This letter will and w you to oegal marketing of substantial equivalence of your device to 910(K) promative nowledge 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 If you desire specific as now as a more diagnostic devices), please contact the and additionally 27 OF FF & 1 301) 594-4618 . Additionally, for questions on the promotion and Office of Coffigur device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under nother (11 Cr Cr Cr or a from the Division of Small Manufacturers, International and the Not may be obtained its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K993535

Device Name: Riley Medical MetaPak Multi-Purpose Instrument Tray

Indications For Use:

The Riley Medical MetaPak Multi-Putpose Instrument Tray is used for loading surgical I he Teney Medical Weaks weaks organize, sterilize, transport, and store the instruments between uses.

The Riley Medical MetaPak Multi-Purpose Instrument Tray can be used in pre-vacuum steam and ethylene oxide sterilization cycles.

PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Olin S. Lim

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510(k) Number

Prescription Use (Pcr 21 CFR 801.109) ાર

Over - The - Counter Use _____________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Riley Medical, Inc. Additional Information for K993535 November 28, 2001