ONE TRAY® Sealed Sterilization Containers are intended to be used to hold temperature tolerant medical devices, surgical supplies, single instruments or an instruments or an instrument set for immediate use following flash sterilization. This includes sterilization of lumens 3 mm in diameter or larger with lengths of up to 400 mm.

After sterilization, ONE TRAY provides for the safe transport and assured delivery for immediate use of the enclosed devices in a sealed container with tamper evident security and load record documentation according to AAMI and AORN guidelines.

Device Description

ONE TRAY® is a sealed rigid container with a rectangular patterned group of perforations forming vented areas in the lid and base. Dispossable hydrophobic SMS filters cover each vented area and are held firmly in place by a perforated stainless steel filters cover. This assembly permits the penetration of steam during the sterilization process and serves as a bacterial and fluid barrier at the conclusion of the sterilization cycle.

AI/ML Overview

The provided 510(k) summary for the "ONE TRAY® Sealed Sterilization Container" (K052567) details its intended use and performance testing relative to predicate devices. However, it does not contain specific numerical acceptance criteria or a detailed study report that would typically include the requested information for AI/ML device evaluations.

This submission is for a physical medical device (a sterilization container), not an AI/ML diagnostic or predictive device. Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "training set sample size," or "expert qualifications for ground truth," are not applicable.

The performance testing described is focused on the functional equivalence of the sterilization container to predicate devices, assessing its ability to achieve sterilization and maintain sterility.

Here's a breakdown of the information available based on your request, with a clear indication of what is not present due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicate Device	"Based on the results of laboratory tests; the ONE TRAY® is substantially equivalent to the predicate container."
Sterilization Efficacy (Steam Penetration)	Performance testing included "steam penetration." (No specific numerical criteria or results provided, implied efficacy for described cycles).
Sterilization Efficacy (Half Cycle Validation)	Performance testing included "half cycle validation." (No specific numerical criteria or results provided, implied efficacy for described cycles).
Package Integrity	Performance testing included "package integrity." (No specific numerical criteria or results provided, implied integrity).
Shelf Life	Performance testing included "shelf life." (No specific numerical criteria or results provided, implied appropriate shelf life).
Material Compatibility	Performance testing included "material compatibility." (No specific numerical criteria or results provided, implied compatibility).
Biocompatibility	Performance testing included "biocompatibility studies." (No specific numerical criteria or results provided, implied biocompatibility).
Ability to hold medical devices during steam sterilization	"The ONE TRAY® Sealed Sterilization Containers are intended to be used to hold medical devices during steam sterilization."
Rapid sterilization in flash cycles	"intended to be used for rapid sterilization of instruments or instrument sets in flash cycles."
Support 25 lb gross weight load	"been validated in all of the various size configurations listed in the following table to process a twenty five pound (25 lb) gross weight load (single container plus contents)"
Compatibility with steam pre-vacuum cycle	"in a steam pre-vacuum cycle at 132°C for 4 minutes exposure time"
Compatibility with steam gravity cycle	"in a steam gravity cycle at 132°C for 34 minutes exposure time"
Safe transport and assured delivery of enclosed devices in sealed container	"After sterilization, ONE TRAY® provides for the safe transport and assured delivery of the enclosed devices in a sealed container with tamper evident protection according to AAMI and AORN guidelines."
Sterilization of lumens 3 mm or larger, up to 400 mm length	"This includes sterilization of lumens 3 mm in diameter or larger with lengths of up to 400 mm."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document mentions "laboratory tests" but does not detail the number of containers tested, cycles performed, or specific test articles used.
Data Provenance: Not explicitly stated (e.g., country of origin). The testing would have been conducted by the manufacturer, Sterile Containment Technology, LLC, likely in a controlled laboratory environment. It is a prospective evaluation as the device was being developed and tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This information is not relevant for a physical sterilization container. "Ground truth" in this context would refer to objective measurements of sterility, steam penetration, integrity, etc., performed in a laboratory, not subjective interpretations by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, typically in diagnostic imaging or clinical trials involving human readers. This is not applicable to performance testing of a physical sterilization container.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This device is not an AI-assisted diagnostic tool, so an MRMC study and
measurement of human reader improvement with AI assistance are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device would be established through objective laboratory measurements based on recognized standards for sterilization (e.g., AAMI, AORN guidelines mentioned) and device performance (e.g., sterility indicators, microbial challenge tests, physical integrity assessments). It would not be expert consensus, pathology, or outcomes data in the typical sense applied to diagnostic tools.

8. The sample size for the training set

N/A. This device does not involve a training set as it's not an AI/ML algorithm.

9. How the ground truth for the training set was established

N/A. Not applicable, as there is no training set for this physical device.

Summary

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510(k) Summary of

K052567

Safety and Effectiveness

Submitter: Sterile Containment Technology, LLC 1301 Quarry Court Suit 204 Point Richmond, CA 94801 510-412-6383 (phone) 510-588-4699 (fax)

◆ Establishment FDA Registration No .: 3003793526

. Date Summary was prepared August 30th, 2005

Percival Banks Printed name of person submitting for 510(k)

Signature of person submitting for 510(k)

President Title of person submitting for 510(k)

Device Name and Classification

Trade Name:	ONE TRAY® Sealed Sterilization Container
Classification Name:	Sterilization Wrap
Common Name:	Sterilization, Rigid Reusable Case
Device Classification:	General Hospital, Class II, Regulation No. 880.6850
Product Code:	80FRG

Predicate Device

Case Medical SteriTite® K960738 and K022978

Additional Predicate Devices

Medin K833343 and FlashPak K871202

Device Description

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Intended Use

The ONE TRAY® Sealed Sterilization Containers are intended to be used for rapid sterilization of instruments or instrument sets in flash cycles. The containers are intended to be used to hold medical devices during steam sterilization. The complete line of ONE TRAY® Sealed Sterilization Containers can be processed in both flash steam pre-vacuum and gravity cycles.

After sterilization, ONE TRAY® provides for the safe transport and assured delivery of the enclosed devices in a sealed container with tamper evident protection according to AAMI and AORN guidelines.

Technical Characteristics

The ONE TRAY® design is rectangular in shape and has vents in the lid and floor. The ONE TRAY® design/performance concept takes advantage of the thermodynamic behavior of steam to facilitate the expeditious and complete introduction of the sterilant throughout the container. This is accomplished by incorporating a specific number of proportionate size vents in strategic locations in both the lid and base. As the sterilizing media (steam) fills up the chamber of the sterilizer, it is introduced into the container through the dedicated entry vent in the lid of ONE TRAY®. This dedicated entry port provides for displacement of the atmosphere within the container from the top to the bottom.

The vents located in the extreme lateral portions of the floor provide two dedicated exit ports that offer twice the vapor exchange capacity of the single entry vent in the lid. This relationship facilitates the complete, consistent and expeditious displacement of the atmosphere by the sterilant throughout the ONE TRAY® container,

Performance Testing

Testing was performed in order to determine the functional equivalency between the ONE TRAY® and the predicate device. Performance testing of the ONE TRAY® included, steam penetration, half cycle validation, package integrity, shelf life, material compatibility and biocompatibility studies. Based on the results of laboratory tests; the ONE TRAY® is substantially equivalent to the predicate container.

Conclusion

Supportive data has demonstrated that the ONE TRAY® is substantially equivalent to the predicate device in that they have the same intended uses and the performance attributes are the same. The use of the ONE TRAY® raises no issues related to its safety or effectiveness and therefore the ONE TRAY® should be allowed for market in the United States.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

MAR 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gage Garman Sterile Containment Technology, Limited Liability Company 1301 Quarry Court, Suite 204 Point Richmond, California 94801

Re: K052567

Trade/Device Name: ONE TRAY® Sealed Sterilization Container Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: February 11, 2006 Received: February 16, 2006

Dear Mr. Garman:

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 - Mr. Gage Garman

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 Office of Compliance at (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Saith y. Michael Oond.

Chíu 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

510(k) Number: K052567

Device Name: ONE TRAY® Sealed Sterilization Container

Indications For Use:

ONE TRAY® Sealed Sterilization Containers are available in the following sizes:

ONE TRAY System Components
Product No.	Product Name	Description
ONE 20 Model
OTS-MB2000	ONE 20ML Base	ONE 20ML Base - 20" Low Profile Base (Metal, Blue, 11.5"x20.5"x3")
OTS-MB2001	ONE 20MH Base	ONE 20MH Base - 20" High Profile Base (Metal, Blue, 11.5"x20.5"x5")
OTS-MB2010	ONE 20ML Cover	ONE 20ML Cover - 20" Low Profile Cover (Metal, Blue, 11.5"x20.5"x1")
OTS-MB2011	ONE 20MH Cover	ONE 20MH Cover - 20" High Profile Cover (Metal, Blue, 11.5"x20.5"x2.5")
OTS-MB2020	ONE 20M Deck	ONE 20M Deck -20" Deck Plate (Metal, Blue, 11.5"x20.5")
ONE 23 Model
OTS-MB2300	ONE 23ML Base	ONE 23ML Base - 23" Low Profile Base (Metal, Blue, 11.5"x23.5"x3")
OTS-MB2301	ONE 23MH Base	ONE 23MH Base - 23" High Profile Base (Metal, Blue, 11.5"x23.5"x5")
OTS-MB2310	ONE 23ML Cover	ONE 23ML Cover - 23" Low Profile Cover (Metal, Blue, 11.5"x23.5"x1")
OTS-MB2311	ONE 23MH Cover	ONE 23MH Cover - 23" High Profile Cover (Metal, Blue, 11.5"x23.5"x2.5")
OTS-MB2320	ONE 23M Deck	ONE 23M Deck -23" Deck Plate (Metal, Blue, 11.5"x23.5)

The ONE TRAY® components listed in the preceding table have been validated in all of the various size configurations listed in the following table to process a twenty five pound (25 lb) gross weight load (single container plus contents) in a steam pre-vacuum cycle at 132°C for 4 minutes exposure time; or in a steam gravity cycle at 132°C for 34 minutes exposure time.

Shule A. Murgheigh, 13/4/06
Page 1 of 2

ing, Genere

Lakes
Koszta

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ONE 20 Model			ONE 23 Model
Name	Description	Product No.	Name	Description	Product No.
ONE 20MH	High Profile Base	OTS-MB2001	ONE 23MH	High Profile Base	OTS-MB2301
	High Profile Cover	OTS-MB2011		High Profile Cover	OTS-MB2311
	Deck Plate	OTS-MB2020		Deck Plate	OTS-MB2320
ONE 20MHL	High Profile Base	OTS-MB2001	ONE 23MHL	High Profile Base	OTS-MB2301
	Low Cover	OTS-MB2010		Low Cover	OTS-MB2310
	Deck Plate	OTS-MB2020		Deck Plate	OTS-MB2320
ONE 20MLH	Low Profile Base	OTS-MB2000	ONE 23MLH	Low Profile Base	OTS-MB2300
	High Profile Cover	OTS-MB2011		High Profile Cover	OTS-MB2311
	Deck Plate	OTS-MB2020		Deck Plate	OTS-MB2320
ONE 20ML	Low Profile Base	OTS-MB2000	ONE 23ML	Low Profile Base	OTS-MB2300
	Low Profile Cover	OTS-MB2010		Low Profile Cover	OTS-MB2310
	Deck Plate	OTS-MB2020		Deck Plate	OTS-MB2320

The performance and intended use of ONE TRAY Sealed Sterilization Containers should comply at all times with the methods of use and flash sterilization guidelines as recommended by the manufacturer of the devices being sterilized, AAMI (Association for the Advance of Medical Instrumentation), AORN (Association of periOperative Nurses), ASHCSP (American Society of Healthcare Central Service Professionals), NIHSPO (National Institute for the Certification of Healthcare Sterile Processing and Distribution Personnel) and IAHCSMM (International Association of Healthcare Central Service Materiel Management)

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 2

Shiela P. Murphy, A 3/9/04

General Hos,
Dental Devices

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).