The SteriTite universal container system with MediTray products is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The SteriTite container system is intended for use in Steris Amsco V-PRO 1 low temperature Sterilization System Lumen Cycle.

SteriTite Sealed Container system is recommended for surface and stainless steel lumens (process up to 20 stainless steel lumened instruments of 3mm diameter or larger and a length up to 400 mm or shorter).

Device Description

The SteriTite universal container system consists of a family of rigid reusable containers and inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Stainless steel latching mechanism with handles on both ends secures the lid to the base and provides a method to incorporate tamper evident seals. A filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts are available for instrument management. The lids and bases as well as retention plates of the same model and size are compatible and interchangeable throughout its useful life. Vent holes are offset to prevent strike through. All components may be easily disassembled for cleaning.

AI/ML Overview

Please note that the provided text is a 510(k) Summary for a medical device approval, not a detailed study report. As such, it focuses on demonstrating substantial equivalence to an already cleared device rather than presenting a comprehensive clinical trial or acceptance testing study against pre-defined performance criteria for a novel device. Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test/training, number/qualifications of experts, adjudication methods, MRMC studies, effect sizes, and ground truth establishment details) is not present in this document because it's typically not required for a 510(k) submission based on substantial equivalence.

However, I can extract the information that is present and indicate where the requested details are not available or applicable based on the nature of this document.

Acceptance Criteria and Device Performance (Interpreted from the document's claims about sterility assurance)

The document implicitly defines acceptance criteria based on the ability to achieve sterility (elimination of a biological challenge) using the "overkill method." The performance stated is that this method was followed and successfully demonstrated.

Acceptance Criterion (Implicit)	Reported Device Performance
Sterility Assurance (elimination of a biological challenge) via "overkill method"	Microbial challenge testing showed successful elimination of a biological challenge.
Sterilization of specific lumens (3mm x 400mm)	Lumens of 3mm diameter x 400mm length were successfully tested.
Compatibility with MediTray products and various container sizes	All listed MediTray products and container sizes (SC03MG to SC05WG) are compatible and underwent testing.
Use in Steris Amsco V-PRO 1 low temperature Sterilization System Lumen Cycle	The system is indicated and tested for use in this specific sterilization system.
Ability to prevent strike-through	Vent holes are offset to prevent strike-through.

1. Sample sized used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated. The document mentions "All containers were tested" and "Furthermore, sample containers were validated," but specific numbers are not provided.
Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by or on behalf of Case Medical, Inc. based in Ridgefield, NJ, USA. It is prospective testing designed to support the 510(k) submission.

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

Number of Experts: Not applicable or not stated. This type of testing (microbial challenge) typically relies on laboratory methods and established sterility assurance levels rather than expert consensus on imaging or clinical outcomes.
Qualifications of Experts: Not applicable or not stated.

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

Adjudication Method: Not applicable. Sterility testing by biological indicators and inoculated products follows laboratory protocols for pass/fail criteria, not a consensus-based adjudication process.

4. 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:

MRMC Study: No, an MRMC comparative effectiveness study was explicitly not done. This device is a sterilization container, not an AI-assisted diagnostic tool.

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

Standalone Performance: Not applicable. This device is a passive sterilization container; it does not involve algorithms or human-in-the-loop processing in the context of AI. The performance demonstrated is the efficacy of the container system in achieving sterility.

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

Type of Ground Truth: The ground truth for sterility was established using microbial challenge testing with biological indicators and inoculated products. This is a scientific and standardized method for assessing sterilization efficacy, aiming for the "elimination of a biological challenge," indicating a certain sterility assurance level (SAL).

7. The sample size for the training set:

Sample Size for Training Set: Not applicable. This submission is for a physical medical device (sterilization container), not an AI/machine learning algorithm requiring a "training set."

8. How the ground truth for the training set was established:

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

K090068

FEB 2 4 2010

510(k) Summary of Safety and Effectiveness

SteriTite Universal Container System with MediTray Products for Steris Amsco V-PRO 1 low temperature Sterilization System

Date Prepared: February 22, 2010

Company Name: Case Medical, Inc. 65 Railroad Avenue Ridgefield, NJ 07657

Contact: Tania Lupu Phone: 201-313-1999 ext.229 Fax: 201-313-9090

Trade Name:	SteriTite® universal container system
Common Name:	Sterilization container with disposable filter.
Establishment registration number:	2248608
Classification name:	Sterilization Wrap
Class of Device:	Class II device,
Product Code:	80FRG
Review Panel:	General Hospital
Legally Marketed Predicate:	SteriTite universal container system previously cleared forSTERRAD 200 and STERRAD NX, 510k # K080558

Indications for Use:

The SteriTite universal container system with MediTray products is a reusable sterilization The Sterrific universal container of other medical devices, which are to be sterilized, transported container system used to cheriTite container system is intended for use in Steris Amsco V-PRO 1 low temperature Sterilization System Lumen Cycle.

Description of the Device:

The SteriTite universal container system consists of a family of rigid reusable containers and inserts that provide an effective sterilization packaging method for operating The SteriTite® container is made out of anodized aluminum with room instruments. passivated stainless steel hardware and silicone gaskets. Stainless steel latching mechanism with handles on both ends secures the lid to the base and provides a method to incorporate with handles on bour chus secures as filter retention plate secures a disposable filter for Various instrument trays as well as stacked baskets and inserts a bacterial barrier filtration. bacterial barrier intration. - Various morement anys as were manager. The

{1}------------------------------------------------

lids and bases as well as retention plates of the same model and size are compatible and interchangeable throughout its useful life. Vent holes are offset to prevent strike through. All components may be easily disassembled for cleaning.

Performance Data

ﻨﻨ

Case Medical, Inc. follows the "overkill method" of sterility assurance to show an elimination of a biological challenge. Microbial challenge testing included placement of biological indicators and inoculated products in the most difficult-to-sterilize areas of the container in opposing corners, under the lid, inside of lumens, within insert boxes, and under occlusion within the slot of an instrument bracket securing a surgical instrument. The lumens tested were stainless steel lumens of 3 mm diameter x 400mm length.

All containers were tested with inner baskets or trays representative of the MediTray line of products.

Furthermore, sample containers were validated in worst-case scenarios.

Substantial Equivalence:

Case Medical's SteriTite container system is substantially equivalent to the company's previously cleared device for STERRAD 200. All containers are of equivalent sizes, have gasketed lids that latch, and offer tamper evident features.

References:

ANSVAAMI ST 77:2006 - Containment Devices for Reusable Medical Devices Sterilization ANSVAAMI ST 79:2006 - Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number_K090068

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a bird-like figure, possibly representing an eagle or other national symbol. The figure is composed of three curved lines that suggest movement or flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Tania Lupu Quality Assurance Quality Consultant Director Case Medical, Incorporated 65 Railroad Avenue Ridgefied, New Jersey 07657

FEB 2 4 2010

Re: K090068

Trade/Device Name: SteriTite Universal Container System and MediTray Products Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: February 11, 2010 Received: February 16, 2010

Dear Ms. Lupu:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{3}------------------------------------------------

Page 2- Ms. Lupu

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/A.boutlFDA/CentersOffices/ CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Runne

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K090068

Device Name: SteriTite Universal Container System and MediTray products

Indications for Use:

The table below identifies the SteriTite Sealed Containers with disposable filter , which may be sterilized in Steris Amsco V-PRO 1 low temperature Sterilization System:

Over-The-Counter Use_ Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 2
Elisut Б.Саши шел
(Division Sign-Off)
Division of Anesthesiology, General Hospital
infection Control, Dental Devices

{5}------------------------------------------------

PartNumber	Description	Steris AmscoV-PRO 1 w/polypropylenedisposablefilter	Maximum load(lbs) inclusiveof sealedcontainerweight
SC03MG	3" high Endo mini-size w/ perforated base	X	5.63
SC03QG	3" high Endo mid-size w/ perforated base	X	8.85
SC04FG	4" high Full-size w/ perforated base	X	19.97
SC04HG	4" high Half-size w/ perforated base	X	9.90
SC04QG	4" high Mid-size w/ perforated base	X	15.70
SC06FG	6" high Full-size w/ perforated base	X	19.97
SC06HG	6" high Half-size w/ perforated base	X	13.16
SC06QG	6" high Mid-size w/ perforated base	X	19.97
SC08FG	8" high Full-size w/ perforated base	X	19.97
SC08HG	8" high Half-size w/ perforated base	X	15.92
SC08QG	8" high Mid-size w/ perforated base	X	19.97
SC05WG	5" high Extra Wide w/ perforated base	X	19.97

Note: All containers for Steris Amsco V-PRO 1 low temperature Sterilization System Note. An containers for Steners, which must be used with single-use non-woven Polypro filter.

MediTray Products Compatibility Table

MEDITRAY PRODUCT	Steris Amsco V-PRO 1
Baskets	X
Trays	X
Insert Boxes	X
Metal Brackets	X
Metal Partitions	X
Posts	X
Silicone Brackets	X
Racks	X
Stringers	X

Over-The-Counter Use X Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Conalityence (Mish Rightighting of Device Evaluation (ODE) Division of Anesthesiology, General Hospital - Page 2 of _2 _________ Paral Hospital ్రగా Infection Control, Dental Devices Infection Control, Demai Devices

K090068 510(k) Number: _KO 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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).