The Riley Medical MetaPak Multi-Purpose Instrument Tray is used for loading surgical instruments in order to conveniently 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.

Device Description

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" .

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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Riley Medical, Inc. MetaPak Multi-Purpose Instrument Tray:

Analysis of Acceptance Criteria and Performance Study for Riley Medical, Inc. MetaPak Multi-Purpose Instrument Tray

This submission describes a medical device, the MetaPak Multi-Purpose Instrument Tray, which is intended for organizing, sterilizing, transporting, and storing surgical instruments. The key performance aspect is the ability to achieve sterilization conditions within the tray using pre-vacuum steam and ethylene oxide sterilization cycles.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Sterilization Conditions Achieved	Confirmed that sterilization conditions were achieved in fully loaded MetaPak Instrument Trays using pre-vacuum steam and ethylene oxide sterilization processes.
Sterilization Compatibility (Pre-vacuum Steam)	Confirmed compatible with pre-vacuum steam sterilization cycles.
Sterilization Compatibility (Ethylene Oxide)	Confirmed compatible with ethylene oxide sterilization cycles.
Functionality with fully loaded trays	Sterilization conditions were achieved in fully loaded MetaPak Instrument Trays, including one full insert and two half inserts, protective mats, and accessories.
Functionality across material compositions	Sterilization conditions were achieved in trays of all three container base material compositions (aluminum, stainless steel, and aluminum/Radel combination).

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

The document does not explicitly state a numerical "sample size" for the performance testing in terms of individual trays tested or the number of sterilization cycles performed. It broadly states "Validation testing was conducted."

Test Set Size: Not explicitly stated as a numerical value for individual test units or cycles. It refers to "MetaPak Instrument Trays of all three container base material compositions containing one full insert and two half inserts, protective mats, and accessories." This implies at least one of each material composition, fully loaded.
Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal validation by Riley Medical, Inc. The study is retrospective in the sense that the testing was performed, and then the results were submitted for clearance.

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

This type of information is generally not applicable to functional performance testing of a sterilization tray, as "ground truth" here is objective (i.e., whether sterilization was achieved or not). The assessment would typically involve laboratory analysis (e.g., biological indicators, chemical indicators) rather than expert human interpretation of complex images or clinical data. Therefore, no information is provided on "experts" in this context.

4. Adjudication Method for the Test Set

Not applicable. The determination of whether sterilization conditions were achieved would be based on objective laboratory methods, not subjective adjudication by human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is not relevant for this device. This study focuses on the physical performance of a sterilization tray, not the diagnostic accuracy or effectiveness of human readers using an AI component.

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

Not applicable. This device is a physical instrument tray, not an algorithm or AI system. Its performance is entirely "standalone" in the sense that it functions based on its design and material properties, undergoing sterilization processes.

7. The Type of Ground Truth Used

The ground truth used for assessing sterilization achievement would be based on objective biological and/or chemical indicators used within the sterilization cycles. While not explicitly detailed, standard sterilization validation protocols involve placing biological indicators (e.g., spores of highly resistant microorganisms) and chemical indicators within the device and then testing for the inactivation of these organisms or changes in the chemical indicators after the sterilization cycle. The text states "confirmed that sterilization conditions were achieved," which implies such objective methods were employed.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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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.

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

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.

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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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).