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 100 Sterilization under the following conditions. They are intended to be used for the sterilization of surgical instruments and devices in STERRAD 100 Sterilization for a hospital or other health care facilities.

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

Device Description

The SteriTite® Rigid Container System consists of a family of rigid containers that provide an effective sterilization 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 filtration system that allows effective penetration by the sterilant steam previously cleared K960738. In addition the SteriTite® perforated base containers have been validated for blades and lumens in STERRAD 100 Sterilization. For STERRAD 100 Sterilization each stainless steel 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 steel latching mechanism with handles on both ends secures the lid to the base and provides a method to incorporate tamperproof disposable locks.

The polypropylene non-woven disposable filter # SCF02 is cut from Kimguard ® wrap. Kimguard ® wrap is manufactured from a hydrophobic nonwoven polypropylene material as is Spunguard wrap, the previously cleared device.

AI/ML Overview

The provided document is a 510(k) summary for the SteriTite® perforated base rigid reusable sterilization container system with SCF02- polypropylene non-woven Disposable Filter. It describes the device, its intended use, and performance testing to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with pass/fail thresholds. Instead, it compares the performance of the SteriTite® container with its polypropylene filter to the predicate device (Spunguard wrap/SteriTite® Container System) and established standards. The acceptance criteria are implicitly defined by demonstrating equivalence or superior performance to the predicate and compliance with relevant standards.

Here's a table summarizing the comparison, effectively acting as an implicit acceptance criteria fulfillment:

Acceptance Criteria (Implicit from Predicate & Standards)	SteriTite Perforated Container with Polypropylene Filter Performance	Predicate (Spunguard wrap) Performance	Notes / Confirmation
Intended Use
Holding instruments for sterilization & storage	YES	YES	Confirmed
Reusability	YES	NO	SteriTite is reusable, predicate is not
Methods of Sterilization
Prevacuum steam	YES	YES	Confirmed
Gravity steam	YES	YES	Confirmed
STERRAD 100 Sterilization (Blades)	YES	YES	Confirmed
STERRAD 100 Sterilization (Lumens)	YES FOR LUMENS	YES FOR LUMENS	Confirmed for lumens ≥3mm x 400mm
Design
Filter/wrap system for sterilant entry & microbial barrier	YES	YES	Confirmed
Materials (Container/Basket)	Aluminum, SS, silicone	Aluminum, SS, silicone	Confirmed as equivalent
Materials (Filter/Wrap)	Polypropylene (Kimguard)	Polypropylene (Spunguard)	Confirmed as equivalent
Performance Standards/Specifications (AAMI ST33)
Permits transfer of contaminated materials	YES	YES	Confirmed
Removable filter assembly disassembles	YES	NO	SteriTite has this feature, predicate does not
Labeling	YES	YES	Confirmed
Decontamination instructions	YES	YES	Confirmed
Instructions for inspections	YES	YES	Confirmed
Sterility maintenance - discussed in labeling	YES	YES	Confirmed
User responsibilities listed in labeling	YES	YES	Confirmed
Routine inspection in labeling	YES	YES	Confirmed
Validation Testing
Overkill approach	YES	YES	Confirmed
STERRAD® half-cycle parameters	YES	YES	Confirmed
STERRAD® increments below half-cycle parameters	YES	YES	Confirmed
Incremental Testing - diffusion time	10 minute kill	10 minute kill	Confirmed as equivalent
Incremental Testing - diffusion H2O2	720 μl	360 μl	SteriTite used a higher concentration, implying robustness
Load	STU load + basket	STU load + basket	Confirmed as equivalent
Testing Organism
Bacillus stearothermophilus	YES	YES	Confirmed
Inoculated spore carriers with 1 x 10^6^ B. Stearothermophilus	YES	YES	Confirmed
Inoculated blades under half-cycle conditions	YES	YES	Confirmed
Inoculated lumens (3mm DIA x 400mm) under half-cycle conditions	YES	YES	Confirmed
Filter Performance (Kimguard vs. Spunguard)
Filtration Efficiency / Bacteria (3-regular)	3 (equal to heavy-duty Spunguard)	3-heavy duty	Confirmed as equivalent or superior for regular Kimguard
Water Resistance (55cms-regular)	55cms (better than heavy-duty Spunguard)	44cms.-heavy duty	Kimguard is better.
Strength (Tensile load / lbs.)	14.5-regular	18-heavy duty	Spunguard is stronger, but "Not important due to the offset hole design of the SteriTite container."
Peak energy absorption / in-lbs.	14.5-regular	20-heavy duty	Spunguard is better, but "Not important due to the offset hole design of the SteriTite container."
Resistance to Linting / no. of lint particles >10μ	21-regular (better than heavy-duty Spunguard)	28-heavy duty	Kimguard is better.
Bio-compatibility	Kimguard: Negative (USP Acute Systemic Toxicity, Human Patch, Guinea Pig Sensitization) SteriTite components: Non-cytotoxic, compatible with STERRAD System.	Not explicitly detailed for Spunguard here, but generally accepted for predicate.	Confirmed as safe.

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

Test Set Description: The "test set" primarily refers to the biological indicator (BI) challenge performed during sterilization efficacy validation.
Sample Size: The efficacy testing was conducted "in triplicate" for both the SteriTite® Container and for comparison against the wrapped tray. This means 3 runs were performed for each test condition.
Data Provenance: The studies were conducted by ASP (a company, likely supporting the STERRAD system) and were independent. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, implying compliance with U.S. regulatory standards and likely conducted within the U.S. or by organizations adhering to U.S./international best practices. The data is prospective as it involves controlled experiments to validate the device's performance.
Reuse Testing: The container and inserts were subjected to "100 cycles" of reuse testing.

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

The document does not mention the use of human experts to establish "ground truth" for the sterilization efficacy tests in the way one might for diagnostic imaging.
Instead, the "ground truth" for sterilization efficacy is established by biological indicators (BIs), specifically Bacillus stearothermophilus spores. The absence of microbial growth after sterilization is the definitive indicator of successful sterilization (a "kill").
The tests were conducted by ASP, an entity specializing in sterilization and likely possessing qualified microbiologists and technicians to perform and interpret these tests accurately. The standards cited (AAMI ST 34, ANSI/AAMI ST33-1996, ANSI/AAMI/ISO 11134-1994, pr EN 868-8) imply that the methodologies and interpretations follow established scientific and industry best practices.

4. Adjudication Method for the Test Set

Not applicable in the human expert sense. The "adjudication" for the sterilization efficacy test results (i.e., whether sterilization was achieved) is based on the objective outcome of the biological indicator (BI) tests: growth or no growth of Bacillus stearothermophilus.
The "triplicate" testing provides a form of internal verification, where consistent results across the three runs confirm efficacy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was done. This device is a medical device (sterilization container) and not a diagnostic AI system. Therefore, the concept of "human readers" or "AI assistance" does not apply to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device, not an algorithm. The performance tested is the device's ability to achieve sterilization, which is inherently a "standalone" performance of the container system under specific sterilization conditions. The sterilizer itself is the "algorithm," and the container facilitates its function.

7. The Type of Ground Truth Used

Biological Ground Truth: For the sterilization efficacy studies, the ground truth was the viability of microorganisms. Specifically, the ground truth for successful sterilization was the complete inactivation of a high concentration of Bacillus stearothermophilus spores as indicated by the absence of growth of the biological indicators after exposure to the sterilization process within the device.
Benchmarking/Standards Conformity: Other aspects of "ground truth" relate to compliance with established industry standards (AAMI ST33) and comparison to the physical and barrier properties of the legally marketed predicate device (Spunguard wrap).

8. The Sample Size for the Training Set

Not applicable in the context of an AI/ML training set. This is a physical device. "Training" for this device would refer to its manufacturing process and quality control, not an AI model.

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

Not applicable. As this is not an AI/ML device, there is no "training set" in that sense. The "ground truth" for the performance of the materials and design are established through established engineering principles, material science, and prior regulatory clearances for similar components (e.g., Kimguard being approved for other container systems).

Summary

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510(k) SUMMARY K991023

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

NON-CONFIDENTIAL SUMMARY OF SAFETY AND EFFECTIVENESS

Device trade or proprietary name:	SteriTite® perforated base rigid reusable sterilizationcontainer system 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:	Spunguard wrap/SteriTite® Container System
Official contact:	Marcia Frieze, CEO, ext. 25

DEVICE DESCRIPTION

INDICATIONS FOR USE

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

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

SUMMARY OF PERFORMANCE TESTING

The SteriTite® Container with non-woven polypropylene filter containing instrument basket and load was validated under half cycle conditions in triplicate in the STERRAD 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.

Further, in order to demonstrate adequate sterilant penetration, the SteriTite® Container was validated for efficacy in the STERRAD System by comparing it against a tray wrapped in Spunguard, as the predicate. This study was done in triplicate and conducted in increments below the half cycle in diffusion time and concentration of sterilant. The objective was to compare a lidded container with basket versus a wrapped tray.

Reuse testing of the container and inserts for 100 cycles in the STERRAD 100 Sterilization System proved to be effective and compatible upon completion.

1. The SteriTite® Container was independently tested according the following standards for its performance in STERRAD 100 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 Reusable Rigid Sterilization Container Systems."

ANSVAAMI/ISO 11134-1994 "Sterilization of health 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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USE	SteriTite Perforated Containerwith polyproplyene filter	Spunguard wrap
Indicated for holding instruments tobe sterilized and stored	YES	YES
Intended to be reused	YES	NO
Methods of sterilization:
Prevacuum steam	YES	YES
Gravity steam	YES	YES
STERRAD 100 Sterilization	YES FOR BLADES, YES FORLUMENS	YES FOR BLADES. YES FORLUMENS
DESIGN
Incorporates a filter / wrap system topermit entry of sterilant agent andprevent microbial migration duringstorage	YES	YES
MATERIALS: container /basket	Aluminum, SS, silicone	Aluminum, SS, silicone
Filter / wrap	Polypropylene	Polypropylene
PERFORMANCE STANDARDS/SPECIFICATIONS
AAMI ST33 Standard testingrequirements
3.2. Permits transfer of contaminatedmaterials	YES	YES
3.3.1 Removable filter assemblydisassembles	YES	NO
3.3.4 Labeling	YES	YES
3.4 -3.5 Decontaminationinstructions	YES	YES
3.6-4.2 Instructions for inspections	YES	YES
6.2.5 Sterility maintenance-discussedin labeling	YES	YES
6.3 User responsibilities listed inlabeling	YES	YES
7.3.1 Routine inspection in labeling	YES	YES
VALIDATION TESTING
Testing performed using "overkill"approach	YES	YES
STERRAD® half-cycle parameters	YES	YES
STERRAD® increments below half-cycle parameters	YES	YES
Incremental Testing -diffusion time	10 minute kill	10 minute kill
Incremental Testing -diffusion H2O2	720 μl	360 μl
Load	STU load + basket	STU load + basket
TESTING ORGANISM
Bacillus stearothermophilus	YES	YES
Inoculated spore carriers with 1 x 106B. stearothermophilus	YES	YES
INOCULATED BLADES underhalf-cycle conditions	YES	YES
INOCULATED LUMENS underhalf cycle conditions with 3mm DIAx 400mm	YES	YES

COMPARISON: STERITITE PERFORATED BASE CONTAINERS TO SPUNGUARD WRAP *

Note: Each container and wrap contained STU load with blades and lumens.

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Polypropylene Nonwoven Filter: Testing performed demonstrated adequate sterilant 2. penetration as well as barrier properties when used with the SteriTite® rigid reusable container system in the STERRAD 100 Sterilization process.
The previously cleared and tested wrap was Spunguard. Kimguard is the selected filter material and is currently used with Genesis and Aesculap containers for steam sterilization. See Spunguard/Kimguard Equivalence Chart below.

BIOCOMPATIBILITY

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 materials 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 noncytoxic and found to be compatible with the STERRAD System. This was included in the STERRAD 50 510(k). The toxicity of the sterilant has not changed. See Attachment # P-1199.

COMPARISON TO LEGALLY MARKETED DEVICE

	SPUNGUARD WRAP	KIMGUARD WRAP
Construction	3 layer construction	3 layer construction
Tear / Punctureresistance	Tear resistance	Tear resistance
Hydrophobic properties	Resist penetration of particles andliquids.	Resist penetration of particles andliquids.
Material	100% non-woven Polypropylene	100% non-woven Polypropylene
Drapeability	Drapeable, soft	Drapeable, soft
Weights	Super dutyHeavy dutyRegular	UltraHeavy dutyMidweightRegular
STERRADpenetration study	Efficacious - Validated by ASP	Efficacious - Validated by ASP
Event related sterilitymaintenance study*	Higher sterility assurance than MuslinSpun.:1.1% / Mus.22.8%	Higher sterility assurance than Muslinor Spunguard. Excellent.Kim.:0% / Mus.:10%

SPUNGUARD / KIMGUARD EQUIVALENCE

*The weight of Spunguard and Kimguard used for the above studies was the weight posing the greatest challenge to sterilant penetration or sterility maintenance.

Reference Kimberly-Clark Spunguard Sterilization Wrap Technical Data and Kimguard Sterilization Wrap Technical Data.

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BARRIER PROPERTIES

For KIMGUARD® bacterial filtration efficiency tests refer to equivalence Spunguard / Kimguard chart. Filtration Efficiency is equal for both. Water resistance is better in Kimguard®.

	SPUNGUARD WRAP	KIMGUARD WRAP
Filtration Efficiency / Bacteriaper 1000 dry spore penetration	3-heavy duty	3-regular
Water Resistance / water repelledbefore leakage cms.	44cms.-heavy duty	55cms-regular

PHYSICAL AND MECHANICAL SPECIFICATIONS

For KIMGUARD® physical and mechanical properties refer to the following equivalence Spunguard / Kimguard chart.

Strength: better in Spunguard. Not important due to the offset hole design of the SteriTite container.

Resistance to Linting is better in KIMGUARD®

	SPUNGUARD WRAP	KIMGUARD WRAP
Strength :Tensile load / lbs.	18-heavy duty	14.5-regular
Peak energy absorption / in-lbs.	20-heavy duty	14.5-regular
Resistance to Linting /no. of lint particles >10μ	28-heavy duty	21-regular

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 2000

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

K991023 Re:

SteriTite® Perforated Base Rigid Reusable Trade Name: Sterilization Container System With SCF02 - Polypropylene Non-Woven Disposable Filter Requlatory Class: II Product Code: FRG Dated: November 23, 1999 November 23, 1999 Received:

Dear Ms. Frieze:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Frieze

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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 : K991023

Device Name : SteriTite ® Perforated Base Rigid Sterilization Container System: SC04HG, SC06HG, SC08HG, SC04OG, SC6QG, SC08QG, SC04FG, SC06FG, SC08FG & Kimguard ® Disposable Filter # SCF02

INDICATIONS FOR USE

The perforated base containers are part of the SteriTite® Reusable Rigid Sterilization Container system.

Product # of intendeddevice	DESCRIPTION
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
SC08FG	8" High Full-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	K991023
Description Use	OR Over-The-Counter Use
(Per 21 CFR 801.109)	(Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
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).