The SteriTite® container system is designed for use in hospitals and health care facilities to contain medical devices for sterilization, storage, transportation, and aseptic presentation of contents. It is intended to be used to sterilize medical devices including surfaces and lumens in steam, gas (EO) and gas plasma (STERRAD Sterilization). The SteriTite container is designed to maintain sterility of the contents until it is used.

The SteriTite container system and MediTray product is intended to be used to contain medical devices for sterilization, storage, transportation and aseptic presentation of contents in health care facilization of surfaces and lumented dev in EO. Metal lumens 2.2mm diameter or larger and length up to 45.7 cm and porous (silicone) lumened devices 3 mm diameter or larger and length up to 40 cm were validated. The SterTite container is designed to maintain sterility of the contents until it is used

Device Description

The SteriTite container system consists of a family of rigid reusable scaled containers that provide an effective sterilization packaging method for medical devices. Cases and lids are interchangeable. A part number and lot number identify each component of the container, including lid, base, retaincr/valve plate and insert basket or tray. The SteriTite system is designed for sterilant penetration through vents/perforations in the lid and in perforated bottom models in the base of SteriTite sealed containers as well. MedifFray case trays, baskets and insert boxes may be placed within sealed containers or wrapped.

AI/ML Overview

The provided text is a 510(k) summary for the SteriTite® rigid reusable sterilization container system. It describes the device and explicitly states its substantial equivalence to a predicate device, the Genesis™ container (K012931), based on a comparison of properties, specifications, and performance.

However, the document does not describe the outcome of a study proving the device meets acceptance criteria. Instead, it presents a comparison table showing that the SteriTite® container has similar characteristics and has undergone similar validation testing as its predicate device. This is a common approach in 510(k) submissions to demonstrate substantial equivalence, rather than providing the detailed results of a specific study against predefined acceptance criteria.

Therefore, many of the requested fields cannot be directly extracted from the provided text because it focuses on a comparative assessment rather than a detailed study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria as pass/fail thresholds with specific numerical or qualitative targets. Instead, it compares the SteriTite® device's properties and validation testing to those of the predicate device. The "performance" is implicitly deemed acceptable if it matches or exceeds the predicate's performance.

Property/Specification	Acceptance Criteria (Implicit: Similar to Predicate)	SteriTite® Performance (Reported)	Predicate (Genesis™) Performance (for comparison)
Indicated for containing instruments for EO and transport	YES	YES	YES
Intended to be reused	YES	YES	YES
Closed System	YES	YES	YES
Sealed	YES	YES	YES
Incorporates a filter system to permit entry of sterilant agent	YES	YES	YES
Incorporates a filter system to prevent microbial migration during transport	YES	YES	YES
Conformance to AAMI ST33 Standard testing requirements	YES	YES	YES
Pre-vacuum steam validation testing	YES	YES	YES
Gravity Displacement steam validation testing	YES	YES	YES
EO Sterilization validation testing	YES (perforated bottom containers)	YES (solid and perforated bottom containers)	YES (perforated bottom containers)
STERRAD Sterilization validation testing	YES	YES	YES
Load capacity	Up to 11 Lbs.	STU load up to 22 lbs.	Up to 11 Lbs.
Sterility Maintenance - Barrier properties	Event Related Sterility Maintenance: 180-day (30-day) real time	Event Related Sterility Maintenance: 90-day real time w/weekly handling events. 30-day real time with daily handling events	Event Related Sterility Maintenance: 180-day (30-day) real time
Aeration Time	24 Hours	12 Hours	24 Hours
Test organism/inoculated product	Inoculated spore carriers with 1 x 10^6^ Bacillus Subtilis var. niger	YES	YES
Inoculated Blades	YES	YES	YES
Inoculated Lumens	YES (3mm diameter metal)	YES (2.2mm diameter metal)	YES (3mm diameter metal)
Inoculated Nylon	N/A (for predicate)	YES	N/A
Inoculated Silicone	N/A (for predicate)	YES	N/A
Inoculated Radel	N/A (for predicate)	YES	N/A

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

The document mentions "validation testing" but does not specify the sample sizes used for these tests for either the SteriTite® device or the predicate. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The implication is that these are laboratory validation tests.

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

This information is not provided in the document. The validation testing described appears to be laboratory-based performance testing rather than expert-based adjudication of results.

4. Adjudication method

This information is not provided. Given the nature of the validation tests (e.g., sterilization effectiveness, sterility maintenance), it's likely they involve objective measurements rather than expert adjudication.

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

Not applicable. This document describes a medical device for sterilization, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable. This document describes a physical medical device. It is not an algorithm or software.

7. The type of ground truth used

For the validation testing mentioned (e.g., EO sterilization, sterility maintenance), the "ground truth" would likely be based on microbiological assays/indicators to confirm sterility and physical integrity testing for sterility maintenance. For load capacity, it's weight measurement. The document implies objective, measurable outcomes.

8. The sample size for the training set

Not applicable. This section refers to data used to train algorithms, which is not relevant for a physical medical device like a sterilization container.

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

Not applicable. As above, this pertains to algorithm training, which is not relevant here.

Summary

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

K023614

510(k) SUMMARY

(21 C.F.R.S 807.92) Casc Medical, Inc. 65 Railroad Avenue Ridgefield, NJ 07657 TEL: 888.227.CASE FAX: 201-313-9090

APR 0 7 2003

NON-CONFIDENTIAL SUMMARY OF SAFETY AND EFFECTIVENESS

Device trade or proprietary name:	SteriTite ® rigid reusable sterilization container system.
Device Common/ usual name:	Sterilization, rigid reusable case.
Establishment registration number:	2248608
Classification name:	Sterilization Wrap
Class of Device:	Class II device, product code 80FRG
Predicate	Genesis ™ - 510k # K012931
Official contact:	Marcia A. Frieze, CEO, 201-313-1999 ext. 225

INTENDED USE

ﮯ۔

It is intended to be used to sterilize medical devices including surfaces and lumens in steam, gas (EO) and gas plasma (STERRAD Sterilization). The SteriTite container is designed to maintain sterility of the contents until it is used.

DEVICE DESCRIPTION

The SteriTite system is designed for sterilant penetration through vents/perforations in the lid and in perforated bottom models in the base of SteriTite sealed containers as well. MedifFray case trays, baskets and insert boxes may be placed within sealed containers or wrapped.

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

EQUIVALENCE STATEMENT FOR STERITITE® CONTAINER WITH FILTER IN EO STERILIZATION

Case Medical, Inc.'s SteriTitc filtered container is substantially equivalent to the Genesis (510k # K012931) container with disposable filter.

Comparison of SteriTite® Rigid Reusable Containers with disposable filter to Predicate
	A CONTRACT A LAW - LAW - LAW LINE LE - CAR FREE - CAR FREE - CAR FREE - CAR FREE - C

PROPERTIES/SPECIFICATIONS	STERITITE CASEW/ FILTER	GENESIS CASE W/FILTER
Indicated for containing instruments tobe sterilized in EO, and be transported	YES	YES
Intended to be reused	YES	YES
Closed System	YES	YES
Sealed	YES	YES
DESIGN
Incorporates a filter system to permitentry of sterilant agent	YES	YES
Incorporates a filter system to preventmicrobial migration during transport	YES	YES
MATERIALS
Container	Aluminum, SS, silicone	Aluminum, SS,silicone
Filter	Disposable filter	Disposable filter
PERFORMANCE STANDARDS
Conformance to AAMI ST33Standard testing requirements	YES	YES
VALIDATION TESTING
Pre-vacuum steam	YES	YES
Gravity Displacement steam	YES	YES
EO Sterilization	YES (solid andperforated bottomcontainers)	YES (perforatedbottom containers)
STERRAD Sterilization	YES	YES
Load	STU load up to 22 lbs.	Up to 11 Lbs.
Sterility Maintenance - Barrierproperties	Event Related SterilityMaintenance: 90-dayreal time w/weeklyhandling events. 30-dayreal time with dailyhandling events	Event Related SterilityMaintenance: 180-day(30-day) real time
PROPERTIES/SPECIFICATIONS	STERITITE® CASEW/ FILTER	GENESIS CASE W/FILTER
Aeration Time	12 Hours	24 Hours
TEST organism/inoculated product
Inoculated spore carriers with 1 x 106Bacillus Subtilis var. niger	YES	YES
INOCULATED BLADES	YES	YES
INOCULATED LUMENS	YES - 2.2mm diametermetal	YES - 3mm diametermetal
INOCULATED NYLON	YES	N/A
INOCULATED SILICONE	YES	N/A
INOCULATED RADEL	YES -	N/A

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

and the comments of the comments of

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wing. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 0 7 2003

Ms. Marcia Frieze CEO Case Medical, Incorporated 65 Railroad Avenue Ridgefield, New Jersey 07657

Re: K023614

Trade/Device Name: SteriTite® Rigid Sterilization Container System with MediTray Products Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 6, 2003 Received: January 7, 2003

Dear Ms. Frieze:

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.

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

Page 2 - Ms. Frieze

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 (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,

Susan Runge-

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Page

510(K) Number: KO23614

Device Name: SteriTite® Rigid Sterilization Container System with MediTray Products

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
And General Hospital Devices
510(k) Number
Description Use	OR Over-The-Counter Use
(Per 21 CFR 801.109)	(Optional Format 1-2-96)

(Division Sign-Off)

Division of Anesthesiology, General Hospital,

Infection Control, Dental Devices

510(k) Number	K023614
---------------	---------

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).