Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories

K173259 · Case Medical, Inc. · KCT · Jun 13, 2018 · General Hospital

Device Facts

• Record ID: K173259
• Device Name: Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories
• Applicant: Case Medical, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Jun 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

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 base, 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 Story

Rigid reusable sterilization container system; encloses medical instruments for steam sterilization, transport, and storage. Composed of anodized aluminum, stainless steel hardware, and silicone gaskets; features lid/base with filter retention plates for disposable filters. Operates by providing a bacterial barrier while allowing steam penetration during prevacuum sterilization cycles. Used in clinical settings by healthcare staff. Output is a sterile, dry, protected instrument set. Benefits include maintained sterility for up to one year, reduced dry times, and compatibility with tabletop dynamic air removal autoclaves.

Clinical Evidence

Bench testing only. Validated one-year shelf life via accelerated aging and whole-package microbial aerosol challenge. Reduced dry time validated via laboratory testing (5 minutes for perforated, 8 minutes for solid bottom units). Sterilization efficacy (lethality) for tabletop autoclaves confirmed via half-cycle studies using worst-case loads (stainless steel lumens) in accordance with AAMI standards.

Technological Characteristics

Rigid container system; anodized aluminum body, passivated stainless steel hardware, silicone gaskets. Features: recessed gasket, knife-edge fit, offset vent pattern, interchangeable filter retention plates. Energy source: steam sterilization (prevacuum). Connectivity: none. Sterilization: steam. Software: none.

Indications for Use

Indicated for use by healthcare providers to enclose, sterilize, transport, and store medical devices, including full instrument sets, stacked trays, and mixed loads, via prevacuum steam sterilization.

Regulatory Classification

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.

Predicate Devices

• SteriTite Rigid sterilization Containers System with FlashTite valve plate & MediTray Products (K022978)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 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. 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: [phone] ext.229 |
| | Fax: [phone] |
| | Email: [e-mail] |
| 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:

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.

# 5.3 Indications for Use:

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 base, perforated lid with filter

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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 x 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. Please see tables 1 and 2 below for the recommended total weight of SteriTite® containers with contents 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) |
| 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 with<br>MediTray® products is a rigid reusable sealed<br>sterilization container system used to enclose<br>other medical devices, which are to be<br>sterilized, transported, and stored by a health<br>care provider. The container consists of a solid<br>or a perforated base, perforated lid with filter<br>retention plates, and disposable filters. Case<br>Medical endorses a dry outcome for<br>sterilization, transport, storage, and subsequent<br>use. | The SteriTite containers with FlashTite<br>valve plate(s) are intended to be used in<br>conjunction with MediTray basic tray for<br>the flash sterilization of one instrument or<br>instrument set. | |
| | The SteriTite® container has been validated<br>for prevacuum sterilization at 132°C for 4<br>minutes. with 3 stainless steel (3mm inner<br>diameter × 400mm length) and 3 porous<br>lumens (2mm inner diameter × 400mm<br>length), and representative products of the<br>MediTray line of accessories such as: insert<br>boxes, multilevel tray systems, instrument<br>baskets (stacked and single level) with various<br>inserts including brackets, posts, and<br>partitions. The container may be used for<br>sterilization of medical devices including full<br>instrument sets, stacked trays, and mixed<br>loads. | The SteriTite container system with<br>MediTray product are intended to be used to<br>contain medical devices for steam<br>sterilization. The full line of MediTray<br>product is intended for complex<br>customization in pre- Vacuum steam<br>sterilization. MediTray basic trays are<br>intended to be used in the sealed container<br>for sterilization in steam pre-vacuum and<br>gravity sterilization. MediTray products<br>may be used separately for sterilization<br>when wrapped in FDA cleared medical<br>grade wrappers. | |
| | Additionally, the SteriTite® container has been<br>validated for prevacuum sterilization at 134°C<br>for 4 minutes using tabletop autoclaves for<br>metal instrument loads with 5 stainless steel<br>lumen (2mm ID × 250mm length). | The MediTray products include case/trays<br>with lid and base, insert boxes, cassettes,<br>trays, baskets, instrument racks, silicone<br>mats, brackets, posts, partitions. | |
| | The following claims have been validated for<br>this device:<br>• One (1) Year sterile shelf life/maintenance of<br>sterility claim:<br>• Reduced Dry Time Claim for Pre-Vacuum<br>Steam Sterilization: SteriTite® containers<br>previously cleared for terminal and IUSS<br>(flash) steam sterilization may be used for<br>storage and transport after steam sterilization<br>with a reduced dry time. Dry loads will be<br>achieved using a minimum of 5 minutes dry<br>time when using perforated bottom units and a<br>minimum of 8 minutes dry time when using<br>solid bottom units.<br>• Compatibility with Table Top Pre-Vacuum<br>Steam Sterilization: SteriTite® containers<br>previously cleared for steam sterilization may<br>be used in small table top sterilizers with | | |
| | dynamic air removal. Container sizes are<br>limited due to the small chamber of the table<br>top sterilizer. | | |
| Materials of construction | anodized aluminum<br>stainless steel hardware<br>silicone gaskets. | same | |
| Device Design | • off set vent pattern<br>• disposable filter in lid<br>• interchangeable filter retention plates<br>• 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.