The perforated base containers are part of a line of the SteriTite @ Reusable Rigid Sterilization Container system. The SteriTite® perforated base containers have been validated for use in STERRAD 100S Sterilization under the following conditions. They are intended to be used for the sterilization of surgical instruments and devices in STERRAD 100S Sterilization for a hospital or other health care facilities.

Review the sterilizer manufacturer's Instructions for Use for specific information as to the limitations of instrumentation specifications and material compatibility. Review the Steril'ite® labeling as to the limitations in regard to using a sealed container system in STERRAD 100S Sterilization.

Caution: In STERRAD 100S Stcrilization use only perforated bottom SteriTite® ● containers.
Caution: In STERRAD 100S Sterilization use only nonwoven polypropylene . disposable filters.
Caution: In STERRAD 100S Sterilization do not use materials made of cellulose . (paper filters and cotton) with SteriTite® perforated bottom containers.
Caution: In STERRAD 100S Sterilization use only luments of 3mm or . larger and a length of up to 400 mm.

The SteriTite® perforated base containers using polypropylene nonwoven Disposable Filter # SCF02 may be used for the sterilization of surgical instruments in STERRAD 100S Sterilization for a hospital or other health care facilities.

After each sterilization cycle the filters must be discarded. -
Before each sterilization cycle use new filters. -

Device Description

The SteriTite® Rigid Container System consists of a family of rigid containers that provide an effective stcrilization packaging method for operating room instruments. The SteriTite® perforated base containers include a vented base and a vented lid with filter retention plates. The SteriTite® unit consists of an anodized aluminum sealed case with a microbial barrier filltration system that allows effective penetration by the sterilant. The SteriTite® perforated base containers with baskets have been validated for surfaces and lumens in STERRAD 100S Sterilization. For STERRAD 100 and 100S Sterilization each stainless stccl filter retention plate secures a disposable round non-woven polypropylene disposable bacterial filter. Silicone gaskets are permanently attached to the filter retention plates and lid with silicone adhesive. A stainless stcel latching mechanism with handles on both ends secures the lid to the base and provides a method to incorporate tamperproof disposable locks.

The disposable filter # SCF02 is a nonwoven polypropylene material.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the SteriTite® perforated base rigid reusable sterilization container system with SCF02-polypropylene non-woven Disposable Filter.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
Effective sterilization of surgical instruments and devices in STERRAD 100S Sterilization.	The efficacy of the Case Medical container was clearly demonstrated for blades and lumens using the overkill method in the STERRAD 100S System under half-cycle conditions. Containers in combination of 10" in total height or 8" high for any one container were tested and found to be efficacious.
Ability to sterilize lumens of 3mm or larger and a length of up to 400 mm in STERRAD 100S Sterilization.	Inoculated lumens under half-cycle conditions with 3mm DIA x 400mm were tested and found to be effective.
Compatibility with STERRAD 100S Sterilization for perforated bottom containers.	Specifically stated "Caution: In STERRAD 100S Stcrilization use only perforated bottom SteriTite® ● containers," indicating it meets this requirement for its specific use.
Compatibility with STERRAD 100S Sterilization for nonwoven polypropylene disposable filters.	Specifically stated "Caution: In STERRAD 100S Sterilization use only nonwoven polypropylene . disposable filters," indicating it meets this requirement for its specific use. Testing performed demonstrated adequate sterilant penetration as well as barrier properties when used with the SteriTite® rigid reusable container system in the STERRAD 100 and 100S Sterilization process.
No use of materials made of cellulose (paper filters and cotton) with SteriTite® perforated bottom containers in STERRAD 100S.	Specifically stated "Caution: In STERRAD 100S Sterilization do not use materials made of cellulose . (paper filters and cotton) with SteriTite® perforated bottom containers," which is a usage guideline based on validated performance.
Reuse effectiveness for 100 cycles.	Reuse testing of the container and inserts was accomplished previously for 100 cycles in the STERRAD 100 Sterilization System. The product proved to be effective and compatible upon completion. (While not explicitly stated for 100S, the reuse aspect was validated with the predicate device in the 100 system, implying similar material performance. The efficacy in 100S is separately validated).
Compliance with relevant sterilization standards (AAMI, ISO, European Standard).	The SteriTite® Container was independently tested according to the following standards for its performance in STERRAD 100S Sterilization: AAMI ST 34, ANSVAAMI ST33-1996, ANSVAAMI/ISO 11134-1994, European Standard, pr EN 868-8. The comparison table also indicates compliance with various sections of AAMI ST33 Standard testing requirements (e.g., permits transfer of contaminated materials, labeling, decontamination instructions, inspections, sterility maintenance, user responsibilities, routine inspection).
Biocompatibility, non-cytotoxic, and compatibility with STERRAD System materials.	Biocompatibility validation of the SteriTite container materials (aluminum, silicone, stainless steel, polypropylene) was addressed by ASP reference to "Toxicity of Sterilant and Process By-Products" and found to be non-cytotoxic and compatible with the STERRAD System. Previously, Kimguard was extensively tested for biocompatibility (USP Acute Systemic Toxicity, Human Patch Test, Guinea Pig Sensitization Test) with negative results. The toxicity of the sterilant has not changed.
Provides a microbial barrier filtration system for effective penetration by the sterilant.	The SteriTite® unit consists of an anodized aluminum sealed case with a microbial barrier filtration system that allows effective penetration by the sterilant. Polypropylene Nonwoven Filter testing demonstrated adequate sterilant penetration as well as barrier properties.

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

The document does not explicitly state a specific "sample size" in terms of a number of cases or patients for a test set in the traditional sense of a clinical trial. Instead, the testing likely involved a series of controlled laboratory experiments and challenges.

Test Setup: Containers in combination of 10" in total height or 8" high for any one container were tested. The testing involved "blades and lumens" and "inoculated blades" and "inoculated lumens." The text mentions "STU load" which refers to a Steam Sterilization Unit test load, a standardized challenge often used in sterilization efficacy testing. It also references "occlusions were added" for STERRAD 100S testing.
Provenance: The studies were performed domestically, likely in the US, as indicated by the submission to the FDA and reference to US standards (AAMI). They were conducted as "performance testing" and "additional studies," suggesting controlled laboratory environments rather than retrospective or prospective human patient data. The independent testing was conducted by ASP.

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

This information is not provided in the document. The ground truth for sterilization efficacy is typically established through verifiable biological indicators (e.g., absence of microbial growth) and chemical indicators, observed and interpreted by microbiologists, sterilization experts, or laboratory personnel, not clinical experts like radiologists.

4. Adjudication Method for the Test Set

This information is not applicable to this type of study. Sterilization efficacy studies do not typically involve adjudication methods like 2+1 or 3+1, which are common in clinical imaging studies with human readers. The "ground truth" is determined by direct scientific measurement (e.g., biological indicator kill, chemical indicator change).

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is irrelevant for evaluating the effectiveness of a sterilization container. The device's performance is assessed based on its ability to sterilize instruments, not on how human readers interpret images or data assisted by AI.

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

Yes, in essence, a standalone performance assessment was done. The performance of the "SteriTite® Container with non-woven polypropylene filter" was evaluated directly for its ability to achieve sterilization (microbial inactivation) in the STERRAD 100S System, independent of human interaction during the sterilization cycle. The "efficacy" was "clearly demonstrated" using an "overkill method," biological indicators (Bacillus Stearothermophilus), and half-cycle conditions.

7. The Type of Ground Truth Used

The ground truth used for this study was primarily derived from biological indicators (BI) and likely chemical indicators (CI), indicative of successful microbial inactivation and sterilant penetration. Specifically:

Microbial Inactivation: The testing organism was Bacillus Stearothermophilus, and inoculated spore carriers with 1 x 10^6 B. Stearothermophilus were used. The "overkill method" also points to this. The "efficacy" for blades and lumens implies the successful killing of these organisms.
The text makes it clear that "the efficacy... was clearly demonstrated," which is the ground truth.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. The device itself (the sterilization container) is the subject of validation.

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

This information is not applicable/not provided as there is no training set for an algorithm.

Summary

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510(k) SUMMARY (21 C.F.R.§ 807.92) Case Medical, Inc. 65 Railroad Avenue Ridgefield, NJ 07657 TEL: 888.227.CASE FAX: 201-313-9090

K030853

MAR 2 1 2003

NON-CONFIDENTIAL SUMMARY OF SAFETY AND EFFECTIVENESS

Device trade or proprietary name:	SteriTite® perforated base rigid reusable sterilization containersystem with SCF02- polypropylene non-woven Disposable Filter
Device Common/ usual name:	Sterilization rigid reusable case with disposable filter.
Classification name:	Sterilization Wrap
Class of Device:	Class II device, product code 80FRG
Predicate Device:	SteriTite® System previously approved under K991023
Official contact:	Marcia Frieze, CEO, ext, 25

DEVICE DESCRIPTION

The disposable filter # SCF02 is a nonwoven polypropylene material .

INDICATIONS FOR USE

Review the sterilizer manufacturer's Instructions for Use for specific information as to the limitations of instrumentation specifications and material compatibility. Review the

Steril'ite® labeling as to the limitations in regard to using a sealed container system in STERRAD 100S Sterilization.

Caution: In STERRAD 100S Stcrilization use only perforated bottom SteriTite® ● containers.

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Caution: In STERRAD 100S Sterilization use only nonwoven polypropylene . disposable filters.
Caution: In STERRAD 100S Sterilization do not use materials made of cellulose . (paper filters and cotton) with SteriTite® perforated bottom containers.
Caution: In STERRAD 100S Sterilization use only luments of 3mm or . larger and a length of up to 400 mm.

SUMMARY OF PERFORMANCE TESTING

The SteriTite® Container with non-woven nolypropylene filter containing instrument basket and load was validated under half cycle conditions in the STERRAD 100S System. The efficacy of the Case Medical container was clearly demonstrated for blades and lumens using the overkill method. Containers in combination of 10" in total height or 8" high for any one container were tested and found to be efficacious. The same combinations were previously validated in the prior 510k K991023 for the STERRAD 100 System.

Additional studies were performed to demonstrate the effects of sterilant volume on microbial inactivation kinetics.

Reuse testing of the container and inserts was accomplished previously for 100 cycles in the STERRAD 100 Sterilization System. The product proved to be effective and compatible upon completion. Equivalency of the sealed container to a wrapped instrument tray was dcmonstrated.

The SteriTite® Container was independently tested according the following standards for its performance in STERRAD 100S Sterilization. ASP conducted testing in accordance with the following U.S. and international standards:

AAMI ST 34 " Guideline for the use of ethylene oxide and steam biological indicators in industrial sterilization processes. "

ANSVAAMI ST33-1996 " Good Hospital Practice: Guidelines for the Selection and Use of Reusuble Rigid Sterilization Container Systems."

ANSVAAMI/ISO 11134-1994 "Sterilization of heulth care products-Requirements for validation and routine control-Industrial moist heat sterilization."

European Standard, pr EN 868-8, second draft May 1995. "Packaging materials and systems for medical devices which are to be sterilized. Part 8: Re-usable sterilization containers -Requirements and test methods. "

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COMPARISON: STERITITE PERFORATED BASE CONTAINERS TO SPUNGUARD WRAP *

USE	SteriTite PerforatedContainer withpolypropylene filterSTERRAD 100	SteriTite PerforatedContainer withpolypropylene filterSTERRAD 100S	Spunguard wrap
Indicated for holding instruments to besterilized and stored	YES	YES	YES
Intended to be reused	YES	YES	NO
Methods of sterilization:
Prevacuum steam	YES	YES	YES
Gravity steam	YES	YES	YES
STERRAD 100Sterilization	YES FOR BLADES,YES FOR LUMENS		YES FORBLADES. YESFOR LUMENS
STERRAD 100S Sterilization		YES FOR BLADES,YES FOR LUMENS	YES FORBLADES. YESFOR LUMENS
DESIGN
Incorporates a filter / wrap system topermit entry of sterilant agent andprevent microbial migration duringstorage	YES	YES	YES
MATERIALS: container /basket	Aluminum, SS, silicone	Aluminum, SS, silicone
Filter / wrap	Polypropylene	Polypropylene	Polypropylene
PERFORMANCESTANDARDS/ SPECIFICATIONS
AAMI ST33 Standard testingrequirements
3.2. Permits transfer of contaminatedmaterials	YES	YES	YES
3.3.1 Removable filter assemblydisassembles	YES	YES	NO
3.3.4 Labeling	YES	YES	YES
3.4-3.5 Decontamination instructions	YES	YES	YES
3.6-4.2 Instructions for inspections	YES	YES	YES
6.2.5 Sterility maintenance-discussed inlabeling	YES	YES	YES
6.3 User responsibilities listed inlabeling	YES	YES	YES
7.3.1 Routine inspection in labeling	YES	YES	YES
VALIDATION TESTING
Testing performed using “overkill”approach	YES	YES	YES
STERRAD® half-cycle parameters	YES	YES	YES
STERRAD® half-cycle parameters -incremental	YES	YES	YES
Load	STU load	STU load	STU load
TESTING ORGANISM
Bacillus Stcarothermophilus	YES	YES	YES
Inoculated spore carriers with 1 x 10ºB. Stearothermophilus	YES	YES	YES
INOCULATED BLADES under half-cycle conditions	YES	YES	YES
INOCULATED LUMENS under halfcycle conditions with 3mm DIA x400mm	YES	YES	YES
OCCLUSION under half-cycleconditions -		YES	YES

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Note: Each container and wrap contained STU load with blades and lumens. For STERRAD 100S occlusions were added.

1. Polypropylene Nonwoven Filter: Testing performed demonstrated adequate sterilant penetration as well us barrier propertics when used with the SteriTite® rigid reusable containcr system in the STERRAD 100 and 100S Sterilization process.

BIOCOMPATIBILITY

As stated previously in the cleared 510k # K991023 Kimguard was extensively tested in the standard spectrum of biocompatibility testing.

This included USP Acute Systemic Toxicity, Human Patch Test and Guinea Pig Sensitization Test. All test results were negative,

The Biocompatibility validation of the SteriTite container matcrials was addressed by ASP reference to "Toxicity of Sterilant and Process By-Products" in which aluminum, silicone, stainless steel, polypropylene were tested and found to be non-cytoxic and found to be compatible with the STERRAD System. This was included in the STERRAD 100 510(k). The toxicity of the stcrilant has not changed.

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Image /page/4/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 representing its body and wings. The eagle is facing to the right. 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

MAR 2 1 2003

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

Re: K030853

Trade/Device Name: SteriTite® Perforated Base Rigid Sterilization Container System: SC04HG, SC06HG, SC08HG, SC04QG, SC06QG, SC08QG, SC04FG, SC06FG, SC08FG, SC03MG, SC03QG & PolyPro™ Disposable Filter # SCF02 Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: March 17, 2003 Received: March 18, 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.

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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 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

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Page

510(k) Number : K030853

Device Name : SteriTite ® Perforated Base Rigid Sterilization Container System: SC04HG, SC08HG, SC04QG, SC6QG, SC08QG, SC04FG, SC06FG, SC03MG, SC03QG & PolyPro™ Polypropylene Disposable Filter # SCF02 with MediTray product.

	DESCRIPTION
The perforated base containers are part of the SteriTite @Reusable Rigid Sterilization Container system. Product # of intended device
SC04HG	4" High Half size case perforated bottom
SC06HG	6"High Half size case perforated bottom
SC08HG	8"High Half size case perforated bottom
SC04QG, Rev. B	4"High Mid-size case perforated bottom
SC06QG, Rev. B	6"High Mid-size case perforated bottom
SC08QG, Rev.B	8"High Mid-size case perforated bottom
SC04FG	4"High Full-size case perforated bottom
SC06FG	6"High Full-size case perforated bottom
SC08G	8"High Full-size case perforated bottom
SC03MG	3"High Mini-size case perforated bottom
SC03QG	3"High ¾ Mini-size case perforated bottom

After each sterilization cycle the filters must be discarded. -
Before each sterilization cycle use new filters. -

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 OR Description Use ver- The-Counter Use

(Optional Format 1-2-96)

(Pcr 21 CFR 801.109)

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).