The SteriTite® container system with MediTray® products is a rigid reusable sealed sterilization container system used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. The container consists of a solid or a perforated lid with filter retention plates, and disposable filters. Case Medical endorses a dry outcome for sterilization, transport, storage, and subsequent use.

The SteriTite® container has been validated for prevacuum sterilization at 132°C for 4 minutes. with 3 stainless steel (3mm inner diameter × 400mm length) and 3 porous lumens (2mm inner diameter × 400mm length), and representative products of the MediTray line of accessories such as: insert boxes, multilevel tray systems, instrument baskets (stacked and single level) with various inserts including brackets, posts, and partitions. The container may be used for sterilization of medical devices including full instrument sets, stacked trays, and mixed loads.

Additionally, the SteriTite® container has been validated for prevacuum sterilization at 134℃ for 4 minutes using tabletop autoclaves for metal instrument loads with 5 stainless steel lumen (2mm ID × 250mm length).

The following claims have been validated for this device:
· One (1) Year sterile shelf life/maintenance of sterility claim:
· Reduced Dry Time Claim for Pre-Vacuum Steam Sterilization: SteriTite® containers previously cleared for terminal and IUSS (flash) steam sterilization may be used for storage and transport after steam sterilization with a reduced dry time. Dry loads will be achieved using a minimum of 5 minutes dry time when using perforated bottom units and a minimum of 8 minutes dry time when using solid bottom units.
· Compatibility with Table Top Pre-Vacuum Steam SteriTite® containers previously cleared for steam sterilization may be used in small table top sterilizers with dynamic air removal. Container sizes are limited due to the small chamber of the table top sterilizer.

The SteriTite® container system is recommended to be used for sterilization of medical devices.

Device Description

The SteriTite® container system consists of a family of rigid reusable containers and inserts that provide an effective reusable sterilization packaging system for operating room instruments. The SteriTite® container as previously cleared is available with solid or perforated base. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Each filter retention plate with gaskets and off set vent pattern secures a disposable filter for bacterial barrier filtration. Filter retention plates in lid and base are interchangeable for universal use. A recessed gasket contributes to a knife edge fit between lid and base. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions, and racks provide instrument protection and secure devices for sterilization within the container.

AI/ML Overview

The provided text describes the acceptance criteria and supporting studies for the Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories. However, it is primarily focused on the validation of the container system itself and its ability to maintain sterility and achieve a dry outcome.

The concept of "device performance" in this context refers to the container's ability to:

Maintain sterility for a specified shelf life.
Achieve a dry load after sterilization with reduced dry times.
Be compatible with various sterilization methods, including tabletop pre-vacuum steam sterilization.

The text does not describe an AI/ML-enabled device or a study involving human readers or comparative effectiveness for diagnostic or screening purposes. Therefore, questions related to test sets, data provenance, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.

Here's an attempt to answer the relevant questions based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Claim	Reported Device Performance
One (1) Year Sterile Shelf Life/Maintenance of Sterility	Accelerated time study to demonstrate equivalence to a one-year shelf life. Verified with a whole package aerosol microbial challenge performed in a qualified independent laboratory. Challenged containers were negative for growth, supporting the 1-year shelf life claim.
Reduced Dry Time for Pre-Vacuum Steam Sterilization	Demonstrated dry loads with a minimum of 5 minutes dry time using perforated bottom units (with paper filter) and a minimum of 8 minutes dry time using solid bottom units (with paper filter). Independent laboratory validation confirmed no residual moisture after sterilization with these dry times.
Compatibility with Tabletop Pre-Vacuum Steam Sterilization	Successful half-cycle Steam Sterilization Efficacy (Lethality) Study in a tabletop sterilizer. The study included two solid bottom containers with contents (4.4 lbs, including 2x250mm rigid lumens, knurled and hinged devices) and proved effective sterilization of instrumentation.
Pre-vacuum sterilization at 132°C for 4 minutes.	Validated with 3 stainless steel (3mm ID × 400mm length) and 3 porous lumens (2mm ID × 400mm length), and representative MediTray accessories.
Pre-vacuum sterilization at 134°C for 4 minutes (tabletop)	Validated for metal instrument loads with 5 stainless steel lumens (2mm ID × 250mm length).
Recommended Load (General Steam Sterilization)	Varies by container part number and size, ranging from 6 lbs (2.7 kg) for mini sizes to 30 lbs (13.6 kg) for long sizes. (See Tables 1 in original document for full details).
Recommended Load (Tabletop Sterilizers)	Varies by container part number and size, ranging from 6 lbs (2.7 kg) for mini sizes to 10 lbs (4.5 kg) for ¾ mini sizes. (See Tables 2 in original document for full details).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This device is a physical sterilization container, not a data-driven device. Therefore, the concept of a "test set" for data provenance as it applies to AI/ML devices is not applicable. The studies performed are physical validation tests.

For the shelf-life study, "Containers representative of SteriTite line of product" were challenged, but the exact number is not specified in the provided text. The reduced dry time study also refers to "numerous shorter dry time studies" in-house and subsequent "independent laboratory validated the outcome." For tabletop sterilization, the study used "two solid bottom containers."

The data provenance is from laboratory studies conducted by Case Medical, Inc. and subsequently validated by a qualified independent laboratory. The country of origin of the labs is not explicitly stated, but the submission is to the U.S. FDA. These are prospective validation studies designed to test the specific claims.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an image-based diagnostic or AI/ML device where expert consensus is used to establish ground truth for a test set. The validation relies on scientific and engineering tests (e.g., microbial challenge, moisture detection, lethality studies) conducted by qualified laboratory personnel and based on established standards (ASTM, AAMI, FDA guidance).

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

Not applicable for a physical device validation. The "ground truth" for sterility is determined by microbial growth (or lack thereof) and for dryness by the absence of residual moisture. These are objective, measurable outcomes, not subjective interpretations requiring 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 is not an AI-assisted diagnostic device.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The ground truth for the validation studies is based on:

Absence of Microbial Growth: For the sterile shelf-life claim, the ground truth is established by the lack of microbial growth after a whole package microbial aerosol challenge, indicating sterility maintenance.
Absence of Residual Moisture: For the reduced dry time claim, the ground truth is the confirmed absence of residual moisture after the sterilization and drying cycle.
Sterilization Efficacy (Lethality): For the compatibility with tabletop sterilizers, the ground truth relates to the effective sterilization of challenge devices (e.g., lumens) within the container, indicating that the sterilization process achieved its intended lethality.

These ground truths are determined through established laboratory testing protocols and standards (ASTM, AAMI, FDA guidance).

8. The sample size for the training set

Not applicable. There is no AI/ML model for this device, and thus no "training set."

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

Not applicable, as there is no training set for an AI/ML model.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 13, 2018

Case Medical, Inc Tania Lupu QA-QC Director 19 Empire Blvd South Hackensack, New Jersey 07606

Re: K173259

Trade/Device Name: Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 26, 2018 Received: March 28, 2018

Dear Tania 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.

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

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801); medical device 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elizabeth F. Claverie -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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 (if known) K173259

Device Name

SteriTite® Container System with MediTray® Products

Indications for Use (Describe)

The following claims have been validated for this device:

· One (1) Year sterile shelf life/maintenance of sterility claim:

· Reduced Dry Time Claim for Pre-Vacuum Steam Sterilization: SteriTite® containers previously cleared for terminal and IUSS (flash) steam sterilization may be used for storage and transport after steam sterilization with a reduced dry time. Dry loads will be achieved using a minimum of 5 minutes dry time when using perforated bottom units and a minimum of 8 minutes dry time when using solid bottom units.

· Compatibility with Table Top Pre-Vacuum Steam SteriTite® containers previously cleared for steam sterilization may be used in small table top sterilizers with dynamic air removal. Container sizes are limited due to the small chamber of the table top sterilizer.

The SteriTite® container system is recommended to be used for sterilization of medical devices. Please see tables 1 and 2 below for the recommended total weight of SteriTite® containers with contents in steam sterilization:

Table 1: Recommended Load for SteriTite® Containers in Steam Sterilization:

Part Number	Description	Total weight load including container
SC02M	Mini Size 2"H - Solid Bottom	6 lbs. (2.7 kg)
SC02MG	Mini Size 2"H - Perforated Bottom	6 lbs. (2.7 kg)
SC03M	Mini Size 3"H - Solid Bottom	8 lbs. (3.6 kg)
SC03MG	Mini Size 3"H - Perforated Bottom	8 lbs. (3.6 kg)
SC04M	Mini Size 4"H - Solid Bottom	8 lbs. (3.6 kg)
SC04MG	Mini Size 4"H - Perforated Bottom	8 lbs. (3.6 kg)
SC02N	3/4 Mini Size 2"H - Solid Bottom	8 lbs. (3.6 kg)
SC02NG	3/4 Mini Size 2"H - Perforated Bottom	8 lbs. (3.6 kg)
SC03N	3/4 Mini Size 3"H - Solid Bottom	10 lbs. (4.5 kg)
SC03NG	3/4 Mini Size 3"H - Perforated Bottom	10 lbs. (4.5 kg)
SC04H	1/2 Size 4"H - Solid Bottom	12 lbs. (5.4 kg)
SC04HG	1/2 Size 4"H - Perforated Bottom	12 lbs. (5.4 kg)
SC05H	Half Size 5"H - Solid Bottom	12 lbs. (5.4 kg)

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SC05HG	Half Size 5"H - Perforated Bottom	12 lbs. (5.4 kg)
SC06H	½ Size 6"H - Solid Bottom	14 lbs. (6.4 kg)
SC06HG	½ Size 6"H - Perforated Bottom	14 lbs. (6.4 kg)
SC08H	½ Size 8"H - Solid Bottom	16 lbs. (7.3 kg)
SC08HG	½ Size 8"H - Perforated Bottom	16 lbs. (7.3 kg)
SC04Q	¾ Size 4"H - Solid Bottom	18 lbs. (8.2 kg)
SC04QG	¾ Size 4"H - Perforated Bottom	18 lbs. (8.2 kg)
SC05Q	¾ Size 5"H - Solid Bottom	22 lbs. (10.0 kg)
SC05QG	¾ Size 5"H - Perforated Bottom	22 lbs. (10.0 kg)
SC06Q	¾ Size 6"H - Solid Bottom	22 lbs. (10.0 kg)
SC06QG	¾ Size 6"H - Perforated Bottom	22 lbs. (10.0 kg)
SC08Q	¾ Size 8"H - Solid Bottom	25 lbs. (11.3 kg)
SC08QG	¾ Size 8"H - Perforated Bottom	25 lbs. (11.3 kg)
SC04F	Full Size 4"H - Solid Bottom	25 lbs. (11.3 kg)
SC04FG	Full Size 4"H - Perforated Bottom	25 lbs. (11.3 kg)
SC05F	Full Size 5"H - Solid Bottom	25 lbs. (11.3 kg)
SC05FG	Full Size 5"H - Perforated Bottom	25 lbs. (11.3 kg)
SC06F	Full Size 6"H - Solid Bottom	25 lbs. (11.3 kg)
SC06FG	Full Size 6"H - Perforated Bottom	25 lbs. (11.3 kg)
SC08F	Full Size 8"H - Solid Bottom	25 lbs. (11.3 kg)
SC08FG	Full Size 8"H - Perforated Bottom	25 lbs. (11.3 kg)
SC04L	Long Size 4"H – Solid Bottom	30 lbs. (13.6 kg)
SC04LG	Long Size 4"H - Perforated Bottom	30 lbs. (13.6 kg)
SC06L	Long Size 6"H – Solid Bottom	30 lbs. (13.6 kg)
SC06LG	Long Size 6"H - Perforated Bottom	30 lbs. (13.6 kg)
SC08L	Long Size 8"H – Solid Bottom	30 lbs. (13.6 kg)
SC08LG	Long Size 8"H - Perforated Bottom	30 lbs. (13.6 kg)

Table 2. Recommended Load and Sizing for SteriTite® Containers for Table Top Sterilizers

Part Number	Description	Total weight load including container
SC02M	Mini Size 2"H - Solid Bottom	6 lbs. (2.7 kg)
SC02MG	Mini Size 2"H - Perforated Bottom	6 lbs. (2.7 kg)
SC03M	Mini Size 3"H - Solid Bottom	8 lbs. (3.6 kg)
SC03MG	Mini Size 3"H - Perforated Bottom	8 lbs. (3.6 kg)
SC04M	Mini Size 4"H – Solid Bottom	8 lbs. (3.6 kg)
SC04MG	Mini Size 4"H - Perforated Bottom	8 lbs. (3.6 kg)
SC02N	¾ Mini Size 2"H - Solid Bottom	8 lbs. (3.6 kg)
SC02NG	¾ Mini Size 2"H - Perforated Bottom	8 lbs. (3.6 kg)
SC03N	¾ Mini Size 3"H - Solid Bottom	10 lbs. (4.5 kg)
SC03NG	¾ Mini Size 3"H - Perforated Bottom	10 lbs. (4.5 kg)

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

区 Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) Summary

SteriTite® Container System with MediTray Products

Date Prepared:	6/05/2018
Company Name:	Case Medical, Inc.
	19 Empire Blvd
	South Hackensack, NJ 07606
Contact:	Tania Lupu
	Phone: 201-313-1999 ext.229
	Fax: 201-373-9090
	Email: tlupu@casemed.com
Trade Name:	SteriTite® Container System with MediTray Products
Common Name:	Sterilization container with disposable filter
Regulation number:	21 CFR 880.6850
Classification name:	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Class of Device:	Class II
Product Code:	KCT
Review Panel:	General Hospital
Establishment Registration Number:	2248608

Predicate device: K022978 - SteriTite Rigid sterilization Containers System with FlashTite valve plate & MediTray Products

5.2 Description of the Device:

5.3 Indications for Use:

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retention plates, and disposable filters. Case Medical endorses a dry outcome for sterilization, transport. storage, and subsequent use.

The following claims have been validated for this device:

· One (1) Year sterile shelf life/maintenance of sterility claim:

for steam sterilization may be used in small table top sterilizers with dynamic air removal. Container sizes are limited due to the small chamber of the table top sterilizer.

Part Number	Description	Total weight load including container
SC02M	Mini Size 2"H - Solid Bottom	6 lbs. (2.7 kg)
SC02MG	Mini Size 2"H - Perforated Bottom	6 lbs. (2.7 kg)
SC03M	Mini Size 3"H - Solid Bottom	8 lbs. (3.6 kg)
SC03MG	Mini Size 3"H - Perforated Bottom	8 lbs. (3.6 kg)
SC04M	Mini Size 4"H - Solid Bottom	8 lbs. (3.6 kg)
SC04MG	Mini Size 4"H - Perforated Bottom	8 lbs. (3.6 kg)
SC02N	3/4 Mini Size 2"H - Solid Bottom	8 lbs. (3.6 kg)
SC02NG	3/4 Mini Size 2"H - Perforated Bottom	8 lbs. (3.6 kg)
SC03N	3/4 Mini Size 3"H - Solid Bottom	10 lbs. (4.5 kg)
SC03NG	3/4 Mini Size 3"H - Perforated Bottom	10 lbs. (4.5 kg)
SC04H	1/2 Size 4"H - Solid Bottom	12 lbs. (5.4 kg)
SC04HG	1/2 Size 4"H - Perforated Bottom	12 lbs. (5.4 kg)
SC05H	Half Size 5"H - Solid Bottom	12 lbs. (5.4 kg)
SC05HG	Half Size 5"H - Perforated Bottom	12 lbs. (5.4 kg)
SC06H	1/2 Size 6"H - Solid Bottom	14 lbs. (6.4 kg)
SC06HG	1/2 Size 6"H - Perforated Bottom	14 lbs. (6.4 kg)
SC08H	1/2 Size 8"H - Solid Bottom	16 lbs. (7.3 kg)

Table 1: Recommended Load for SteriTite® Containers in Low Temperature and Steam Sterilization:

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SC08HG	½ Size 8"H – Perforated Bottom	16 lbs. (7.3 kg)
SC04Q	¾ Size 4"H – Solid Bottom	18 lbs. (8.2 kg)
SC04QG	¾ Size 4"H – Perforated Bottom	18 lbs. (8.2 kg)
SC05Q	¾ Size 5"H – Solid Bottom	22 lbs. (10.0 kg)
SC05QG	¾ Size 5"H – Perforated Bottom	22 lbs. (10.0 kg)
SC06Q	¾ Size 6"H – Solid Bottom	22 lbs. (10.0 kg)
SC06QG	¾ Size 6"H – Perforated Bottom	22 lbs. (10.0 kg)
SC08Q	¾ Size 8"H – Solid Bottom	25 lbs. (11.3 kg)
SC08QG	¾ Size 8"H – Perforated Bottom	25 lbs. (11.3 kg)
SC04F	Full Size 4"H – Solid Bottom	25 lbs. (11.3 kg)
SC04FG	Full Size 4"H – Perforated Bottom	25 lbs. (11.3 kg)
SC05F	Full Size 5"H – Solid Bottom	25 lbs. (11.3 kg)
SC05FG	Full Size 5"H – Perforated Bottom	25 lbs. (11.3 kg)
SC06F	Full Size 6"H – Solid Bottom	25 lbs. (11.3 kg)
SC06FG	Full Size 6"H – Perforated Bottom	25 lbs. (11.3 kg)
SC08F	Full Size 8"H – Solid Bottom	25 lbs. (11.3 kg)
SC08FG	Full Size 8"H – Perforated Bottom	25 lbs. (11.3 kg)
SC04L	Long Size 4"H – Solid Bottom	30 lbs. (13.6 kg)
SC04LG	Long Size 4"H – Perforated Bottom	30 lbs. (13.6 kg)
SC06L	Long Size 6"H – Solid Bottom	30 lbs. (13.6 kg)
SC06LG	Long Size 6"H – Perforated Bottom	30 lbs. (13.6 kg)
SC08L	Long Size 8"H – Solid Bottom	30 lbs. (13.6 kg)
SC08LG	Long Size 8"H – Perforated Bottom	30 lbs. (13.6 kg)

		Table 2. Recommended Load and Sizing for SteriTite® Containers for Table Top Sterilizer
--	--	-----------------------------------------------------------------------------------------	--	--	--	--	--	--

Part Number	Description	Total weight load including container
SC02M	Mini Size 2"H - Solid Bottom	6 lbs. (2.7 kg)
SC02MG	Mini Size 2"H - Perforated Bottom	6 lbs. (2.7 kg)
SC03M	Mini Size 3"H - Solid Bottom	8 lbs. (3.6 kg)
SC03MG	Mini Size 3"H - Perforated Bottom	8 lbs. (3.6 kg)
SC04M	Mini Size 4"H - Solid Bottom	8 lbs. (3.6 kg)
SC04MG	Mini Size 4"H - Perforated Bottom	8 lbs. (3.6 kg)
SC02N	3/4 Mini Size 2"H - Solid Bottom	8 lbs. (3.6 kg)
SC02NG	3/4 Mini Size 2"H - Perforated Bottom	8 lbs. (3.6 kg)
SC03N	3/4 Mini Size 3"H - Solid Bottom	10 lbs. (4.5 kg)
SC03NG	3/4 Mini Size 3"H - Perforated Bottom	10 lbs. (4.5 kg)

Comparison with the predicate device:

The SteriTite® container system is the same SteriTite® container system previously cleared for prevacuum, gravity displacement, and IUSS steam sterilization.

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All SteriTite containers are the same units as previously cleared, containing the same characteristics, such as knife edge fit between lid and base, anodized aluminum and passivated stainless-steel materials of construction, offset vent pattern, gasketed lids with latching mechanism, tamper evident features, and external labeling, seals and indicators. The SteriTite® sealed container in this submission is the same container previously cleared in the predicate submission. The subject device includes additional claims for extended maintenance of sterility, reduced dry time and table-top steam sterilization claims.

Indications for Use:	Subject device (K173259)	Predicate (K022978)
	The SteriTite® container system withMediTray® products is a rigid reusable sealedsterilization container system used to encloseother medical devices, which are to besterilized, transported, and stored by a healthcare provider. The container consists of a solidor a perforated base, perforated lid with filterretention plates, and disposable filters. CaseMedical endorses a dry outcome forsterilization, transport, storage, and subsequentuse.	The SteriTite containers with FlashTitevalve plate(s) are intended to be used inconjunction with MediTray basic tray forthe flash sterilization of one instrument orinstrument set.
	The SteriTite® container has been validatedfor prevacuum sterilization at 132°C for 4minutes. with 3 stainless steel (3mm innerdiameter × 400mm length) and 3 porouslumens (2mm inner diameter × 400mmlength), and representative products of theMediTray line of accessories such as: insertboxes, multilevel tray systems, instrumentbaskets (stacked and single level) with variousinserts including brackets, posts, andpartitions. The container may be used forsterilization of medical devices including fullinstrument sets, stacked trays, and mixedloads.	The SteriTite container system withMediTray product are intended to be used tocontain medical devices for steamsterilization. The full line of MediTrayproduct is intended for complexcustomization in pre- Vacuum steamsterilization. MediTray basic trays areintended to be used in the sealed containerfor sterilization in steam pre-vacuum andgravity sterilization. MediTray productsmay be used separately for sterilizationwhen wrapped in FDA cleared medicalgrade wrappers.
	Additionally, the SteriTite® container has beenvalidated for prevacuum sterilization at 134°Cfor 4 minutes using tabletop autoclaves formetal instrument loads with 5 stainless steellumen (2mm ID × 250mm length).	The MediTray products include case/trayswith lid and base, insert boxes, cassettes,trays, baskets, instrument racks, siliconemats, brackets, posts, partitions.
	The following claims have been validated forthis device:• One (1) Year sterile shelf life/maintenance ofsterility claim:• Reduced Dry Time Claim for Pre-VacuumSteam Sterilization: SteriTite® containerspreviously cleared for terminal and IUSS(flash) steam sterilization may be used forstorage and transport after steam sterilizationwith a reduced dry time. Dry loads will beachieved using a minimum of 5 minutes drytime when using perforated bottom units and aminimum of 8 minutes dry time when usingsolid bottom units.• Compatibility with Table Top Pre-VacuumSteam Sterilization: SteriTite® containerspreviously cleared for steam sterilization maybe used in small table top sterilizers with
	dynamic air removal. Container sizes arelimited due to the small chamber of the tabletop sterilizer.
Materials of construction	anodized aluminumstainless steel hardwaresilicone gaskets.	same
Device Design	• off set vent pattern• disposable filter in lid• interchangeable filter retention plates• recessed gasket	Same
	Reusable	yes	yes
	Patient contact	No direct patient contact	Same

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Non Clinical Performance Data:

One (1) Year Shelf Life Claim

The SteriTite® container has been challenged under event related conditions in real time. An accelerated time study was conducted to demonstrate equivalence to a one-year shelf life. Subsequently, we verified these claims with a whole package aerosol microbial challenge performed in a qualified independent laboratory. The challenged containers were negative for growth.

One (1) year shelf life is claimed based on the following rationale and test data.

Rationale: Event related sterility maintenance is crucial for determining sterility maintenance of contents. Criteria, such as compromised filters, tampered seals, environmental conditions, and accidental opening of the device, will indicate whether the set needs to be reprocessed. Simulated handling events will indicate whether the package can maintain its' integrity when transported, rotated on shelves, and can withstand environmental contamination and stresses. In addition to handling events, the SteriTite container system has undergone real time shelf life studies in the past.

The following studies have been performed to simulate a one (1) year shelf life claim with whole package microbial challenge to validate the claim, and are now included in the IFU:

Time Study:

One (1) year Accelerated Shelf Life Test / Sterility Maintenance Study

Containers representative of SteriTite line of product were processed in steam sterilization followed be an aging study per ASTM guidelines. The outcome was verified by a Whole Package Microbial Aerosol Challenge conducted at a qualified independent laboratory in accordance with FDA guidance and available ASTM standards.

Reduced Dry Time

Case Medical endorses a dry outcome for sterilization, transport, storage, and subsequent use. The SteriTite container has successfully demonstrated dry loads using a shortened dry time of five (5) minutes in pre-vacuum steam sterilization, using paper filter and perforated bottom units. Eight (8) minutes was successfully demonstrated with solid bottom units and paper filters.

We conducted numerous shorter dry time studies in our laboratory using single and multiple units in the autoclave chamber using pre-vacuum steam sterilization cycles. Subsequently, an independent laboratory validated the outcome. The Reduced Dry Time Study was successfully conducted at a qualified independent laboratory in accordance with FDA guidance and available AAMI standards using perforated and solid base containers. No residual moisture was present after sterilization with dry times of 5 and 8 minutes respectively.

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Conclusion: The successful Reduced Dry Time Validation Study indicates that the SteriTite® container system with paper (cellulosic) filter processed in pre-vacuum steam sterilization with a reduced dry time shows no moisture, resulting in dry loads that are safe for terminal sterilization and subsequent storage for later use.

Compatibility with Pre-Vacuum Table Top Steam Sterilization

The same SteriTite containers previously cleared for steam sterilization is compatible with table top dynamic air removal autoclaves. The Steam Sterilization Efficacy Validation (Lethality) Study of the SteriTite® sealed containers with contents of 4.4 1bs. including 2x250 mm rigid lumens, knurled and hinged devices in a half cycle of a table-top sterilizer was successfully conducted at a qualified independent laboratory in accordance with FDA guidance and available AAMI standards. The sterilization load contained two solid bottom containers (as a worst-case scenario), one on each shelf.

Conclusion: The SteriTite container System is compatible with steam sterilization including table top dynamic air removal (pre-vacuum sterilizers). The successful half cycle Steam Sterilization Efficacy (Lethality) Study in a table top sterilizer proves that the SteriTite container system effectively sterilizes instrumentation in Table Top steam sterilizers.

Conclusion:

Based on the performed nonclinical tests, the device is as safe, as effective, and performs as well as the legally marketed predicate device, K022978.

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).