SteriTite Container System with MediTray Products
Device Facts
| Record ID | K212711 |
|---|---|
| Device Name | SteriTite Container System with MediTray Products |
| Applicant | Case Medical, Inc. |
| Product Code | KCT · General Hospital |
| Decision Date | Apr 29, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Intended Use
The SteriTite container and MediTray products are a reusable sterilization container system to be used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. It is intended to allow sterilization of the enclosed devices and maintain sterility of the enclosed device until it is used. This container system is compatible for use with the following low temperature sterilizers and cycles identified below: - STERIS V-Pro 60 (Flexible and Lumen cycle) - -STERIS V-Pro s2 (Flexible and Lumen cycle) - STERIS V-Pro maX 2 (Lumen and Flexible cycle) - -STERIS V-Pro maX (Lumen and Flexible cycle) - STERRAD 100NX (ALLCLEAR-DUO cycle) - -Sterizone VP4 (Cycle 1)
Device Story
SteriTite container system is a family of rigid, reusable containers and inserts (MediTray products) used to house medical instruments during sterilization, transport, and storage. The system consists of anodized aluminum containers with passivated stainless-steel hardware and silicone gaskets. It utilizes a filter retention plate system with disposable bacterial barrier filters. The device is used in clinical settings (e.g., hospitals, surgical centers) by healthcare personnel. It functions as a protective, sterile barrier for instruments processed in low-temperature (hydrogen peroxide gas plasma/vapor) or steam sterilizers. By maintaining the sterility of enclosed instruments until point-of-use, the system helps prevent surgical site infections and ensures instrument readiness. Healthcare providers load instruments into the container, process them through validated sterilization cycles, and store them until needed for procedures.
Clinical Evidence
Bench testing only. Testing included sterility maintenance, whole package microbial challenge, biocompatibility, material compatibility, and sterilization efficacy (simulated use) conducted in accordance with ANSI/AAMI ST77, AAMI TIR 12, ANSI/AAMI ST79, and ISO 14937. All tests passed.
Technological Characteristics
Materials: Anodized aluminum, passivated stainless-steel hardware, silicone gaskets. Design: Rigid, reusable container with filter retention plates and recessed gasket for knife-edge seal. Connectivity: None. Sterilization: Low-temperature (H2O2) and steam. Standards: ANSI/AAMI ST77, ISO 10993-1, ISO 14937.
Indications for Use
Indicated for use by healthcare providers to enclose, sterilize, transport, and store medical devices. Compatible with specific low-temperature sterilizers (STERIS V-Pro series, STERRAD 100NX, Sterizone VP4) and steam sterilization cycles. Validated for specific lumen dimensions and load weights.
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 Container System with MediTray Products (K173259)
Related Devices
- K112904 — STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS · Case Medical, Inc. · Jan 24, 2012
- K221492 — SteriTite Container System with MediTray Parts · Case Medical, Inc. · Oct 7, 2022
- K161415 — SteriTite Containers System & MediTray Products · Case Medical, Inc. · Feb 10, 2017
- K080558 — STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS · Case Medical, Inc. · Dec 5, 2008
- K030853 — STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI · Case Medical, Inc. · Mar 21, 2003
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 29, 2022
Case Medical, Inc. Michael Polozani Regulatory Affairs 50 West Street Bloomfield, New Jersey 07003
Re: K212711
Trade/Device Name: SteriTite Container System with MediTray Products Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: April 12, 2022 Received: April 13, 2022
Dear Michael Polozani:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Clarence W. Murray, III, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K212711
#### Device Name
SteriTite Container System with MediTray Products
#### Indications for Use (Describe)
The SteriTite container and MediTray products are a reusable sterilization container system to be used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. It is intended to allow sterilization of the enclosed devices and maintain sterility of the enclosed device until it is used. This container system is compatible for use with the following low temperature sterilizers and cycles identified below:
- STERIS V-Pro 60 (Flexible and Lumen cycle) -
- -STERIS V-Pro s2 (Flexible and Lumen cycle)
- STERIS V-Pro maX 2 (Lumen and Flexible cycle) -
- -STERIS V-Pro maX (Lumen and Flexible cycle)
- STERRAD 100NX (ALLCLEAR-DUO cycle) -
- -Sterizone VP4 (Cycle 1)
Refer to the specific Sterilizer user manual and vendor provided information regarding of appropriate devices and device type. See the following pages for tables of compatible devices and description of the validated loads.
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The following table (Table 1) identifies the validated lumen claims of the SteriTite container with MediTray parts in low temperature and pre-vacuum steam sterilizers:
| | | Table 1. SteriTite Container System with MediTray Parts Lumen Claims: |
|--|--|-----------------------------------------------------------------------|
| | | |
| Sterilizer | Cycle | Lumen Sterilization Claims (I.D. x Length) |
|--------------------|----------|---------------------------------------------------------------------------|
| STERIS V-Pro 60 | Flexible | ≥1mm x ≤990mm (Single or Dual Lumen) |
| STERIS V-Pro 60 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) |
| STERIS V-Pro s2 | Flexible | ≥1mm x ≤990mm (Single or Dual Lumen) |
| STERIS V-Pro s2 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) |
| STERIS V-Pro maX 2 | Flexible | ≥1mm x ≤1050mm (Single Lumen) |
| STERIS V-Pro maX 2 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) |
| STERIS V-Pro maX | Flexible | ≥1mm x ≤1050mm (Single Lumen) |
| STERIS V-Pro maX | Lumen | ≥0.77mm x ≤527mm (Dual Channel) |
| STERRAD 100NX | DUO | ≥1mm x ≤875mm (Single Lumen) |
| Sterizone VP4 | Cycle 1 | ≥1.2mm x ≤1955mm (Flexible Lumens) |
| Sterizone VP4 | Cycle 1 | ≥1.45mm x ≤3500mm (Flexible Lumens) |
| Steam | Pre-Vac | ≥2mm x ≤400mm (Stainless Steel Lumen)<br>≥1.2mm x ≤400mm (Flexible Lumen) |
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The following table (Table 2) displays the SteriTite part numbers and the sterilizers they are compatible with.
| V-Pro s2/60<br>Lumen<br>Flex | V-Pro 1<br>Lumen Cycle | V-Pro maX/2<br>Lumen<br>Flex | Sterizone VP4<br>Cycle 1 | STERRAD 100NX<br>DUO | STERRAD 100NX<br>Standard<br>Flex |
|------------------------------|------------------------|------------------------------|--------------------------|----------------------|-----------------------------------|
| SC02MG | SC02MG | SC02MG | SC02M(G)* | SC02MG | SC02MG |
| SC03MG | SC03MG | SC03MG | SC03M(G)* | SC03MG | SC03MG |
| SC04MG | SC02NG | SC04MG | SC04M(G)* | SC04MG | SC04MG |
| SC02NG | SC03NG | SC02NG | SC02N(G)* | SC02NG | SC02NG |
| SC03NG | SC04FG | SC03NG | SC03N(G)* | SC03NG | SC03NG |
| SC04NLG | SC05FG | SC04NLG | SC04NL(G)* | SC04NLG | SC04NLG |
| SC05NLG | SC06FG | SC05NLG | SC05NL(G)* | SC05NLG | SC05NLG |
| SC04HG | SC08FG | SC04HG | SC04H(G)* | SC04HG | SC04HG |
| SC05HG | SC04HG | SC05HG | SC05H(G)* | SC05HG | SC05HG |
| SC04QG | SC05HG | SC06HG | SC06H(G)* | SC06HG | SC06HG |
| SC05QG | SC06HG | SC08HG | SC08H(G)* | SC08HG | SC08HG |
| SC04FG | SC08HG | SC04QG | SC04Q(G)* | SC04QG | SC04QG |
| | SC04QG | SC05QG | SC05Q(G)* | SC05QG | SC05QG |
| | SC05QG | SC06QG | SC06Q(G)* | SC04FG | SC06QG |
| | SC06QG | SC08QG | SC08Q(G)* | SC05FG | SC08QG |
| | SC08QG | SC04FG | SC04F(G)* | SC04LG | SC04FG |
| | SC04LG | SC05FG | SC04L(G)* | SC05WG | SC05FG |
| | SC06LG | SC06FG | SC06L(G)* | | SC06FG |
| | SC08LG | SC08FG | SC08L(G)* | | SC08FG |
| | SC05WG | SC04LG | | | SC04LG |
| | | SC06LG | | | SC06LG |
| | | SC08LG | | | SC08LG |
| | | SC05WG | | | SC05WG |
Table 2. SteriTite Container Compatibility with Low Temperature and Steam Sterilizers
*Please note that the SteriTite perforated bottom containers are compatible with the Sterizone VP4 Sterilizer.
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Table 2 (Continued). SteriTite Container Compatibility with Low Temperature and Steam Sterilizers
| STERRAD 100S/200 | NX | Steam |
|------------------|----------|---------|
| Standard | Standard | Pre-Vac |
| | Advanced | Gravity |
| | | IUSS |
| SC02MG | SC02MG | SC02MG |
| SC03MG | SC03MG | SC03MG |
| SC04MG | SC04MG | SC04MG |
| SC02NG | SC02NG | SC02NG |
| SC03NG | SC03NG | SC03NG |
| SC04NLG | SC04HG | SC04NLG |
| SC05NLG | SC05HG | SC05NLG |
| SC04HG | SC04QG | SC04HG |
| SC05HG | SC05QG | SC05HG |
| SC06HG | SC04FG | SC06HG |
| SC08HG | | SC08HG |
| SC04QG | | SC04QG |
| SC05QG | | SC05QG |
| SC06QG | | SC06QG |
| SC08QG | | SC08QG |
| SC04FG | | SC04FG |
| SC05FG | | SC05FG |
| SC06FG | | SC06FG |
| SC08FG | | SC08FG |
| | | SC04LG |
| | | SC06LG |
| | | SC08LG |
| | | SC05WG |
The following table (Table 3) identifies which MediTray products are compatible with low temperature sterilizers and steam sterilization:
Table 3. MediTray Products Sterilizer Compatibility Table
| MediTray Product | V-Pro<br>maX/2 | V-Pro 1 | V-Pro<br>s2/60 | STERRAD<br>100NX | STERRAD<br>100s/200 | STERRAD<br>NX | STERIZONE<br>VP4 | STEAM |
|-------------------|----------------|---------|----------------|------------------|---------------------|---------------|------------------|-------|
| Baskets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Trays | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Insert Boxes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Metal Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Metal Partitions | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Posts | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Silicone Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Racks | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Stringers | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
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The following table (Table 4) identifies which SteriTite accessories are compatible with low temperature sterilizers and steam sterilization:
| SteriTite Accessories | V-Pro<br>maX/2 | V-Pro 1 | V-Pro<br>s2/60 | STERRAD<br>100NX | STERRAD<br>100s | STERRAD<br>NX | STERIZONE<br>VP4 | Steam |
|-----------------------|----------------|---------|----------------|------------------|-----------------|---------------|------------------|-------|
| Baskets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Trays | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Insert Boxes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Metal Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Metal Partitions | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Posts | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Silicone Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Racks | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Stringers | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Table 4. SteriTite Accessories Sterilizer Compatibility Table
The following tables (5-11) identify the sterilizer maximum load weight recommendations with the SteriTite containers:
Table 5. SteriTite Container in V-Pro 60 Maximum Load Weight Recommendations Including Weight of Container
| Part Number | Total Load Weight in<br>V-Pro s2/60<br>Lumen Cycle | Total Load Weight in<br>V-Pro s2/60<br>Flexible Cycle |
|-------------|----------------------------------------------------|-------------------------------------------------------|
| SC02MG | 25 lbs | 11 lbs |
| SC03MG | 25 lbs | 11 lbs |
| SC04MG | 25 lbs | 11 lbs |
| SC02NG | 25 lbs | 11 lbs |
| SC03NG | 25 lbs | 11 lbs |
| SC04NLG | 25 lbs | 11 lbs |
| SC05NLG | 25 lbs | 11 lbs |
| SC04HG | 25 lbs | 11 lbs |
| SC05HG | 25 lbs | 11 lbs |
| SC04QG | 25 lbs | 11 lbs |
| SC05QG | 25 lbs | 11 lbs |
| SC04FG | 25 lbs | 11 lbs |
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Table 6. SteriTite Container in STERRAD NX Maximum Load Weight Recommendations Including Weight of Container
| Part Number | Total Load Weight in<br>NX Standard Cycle | Total Load Weight in<br>NX Advanced Cycle |
|-------------|-------------------------------------------|-------------------------------------------|
| SC02MG | 10.7 lbs | 10.7 lbs |
| SC03MG | 10.7 lbs | 10.7 lbs |
| SC04MG | 10.7 lbs | 10.7 lbs |
| SC02NG | 10.7 lbs | 10.7 lbs |
| SC03NG | 10.7 lbs | 10.7 lbs |
| SC04HG | 10.7 lbs | 10.7 lbs |
| SC05HG | 10.7 lbs | 10.7 lbs |
| SC04QG | 10.7 lbs | 10.7 lbs |
| SC05QG | 10.7 lbs | 10.7 lbs |
| SC04FG | 10.7 lbs | 10.7 lbs |
Table 7. SteriTite Container in V-Pro 1 Maximum Load Weight Recommendations Including Weight of Container
| Part Number | Total Load Weight in<br>V-Pro 1 Lumen Cycle |
|-------------|---------------------------------------------|
| SC02MG | 19.65 lbs |
| SC03MG | 19.65 lbs |
| SC02NG | 19.65 lbs |
| SC03NG | 19.65 lbs |
| SC04FG | 19.65 lbs |
| SC05FG | 19.65 lbs |
| SC06FG | 19.65 lbs |
| SC08FG | 19.65 lbs |
| SC04HG | 19.65 lbs |
| SC05HG | 19.65 lbs |
| SC06HG | 19.65 lbs |
| SC08HG | 19.65 lbs |
| SC04QG | 19.65 lbs |
| SC05QG | 19.65 lbs |
| SC06QG | 19.65 lbs |
| SC08QG | 19.65 lbs |
| SC04LG | 19.65 lbs |
| SC06LG | 19.65 lbs |
| SC08LG | 19.65 lbs |
| SC05WG | 19.65 lbs |
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Table 8. SteriTite Container in STERRAD 100s/200 Maximum Load Weight Recommendations Including Weight of Container
| Part Number | Total Load Weight in the<br>STERRAD 100s Standard Cycle |
|-------------|---------------------------------------------------------|
| SC02MG | 22 lbs |
| SC03MG | 22 lbs |
| SC04MG | 22 lbs |
| SC02NG | 22 lbs |
| SC03NG | 22 lbs |
| SC04NLG | 22 lbs |
| SC05NLG | 22 lbs |
| SC04HG | 22 lbs |
| SC05HG | 22 lbs |
| SC06HG | 22 lbs |
| SC08HG | 22 lbs |
| SC04QG | 22 lbs |
| SC05QG | 22 lbs |
| SC06QG | 22 lbs |
| SC08QG | 22 lbs |
| SC04FG | 22 lbs |
| SC05FG | 22 lbs |
| SC06FG | 22 lbs |
| SC08FG | 22 lbs |
Table 9. SteriTite Container in 100NX Maximum Load Weight Recommendations Including Weight of Container.
| Part Number | Total Load Weight in<br>100NX Standard Cycle | Total Load Weight in<br>100NX Flex Cycle | Total Load Weight in<br>100NX DUO Cycle |
|-------------|----------------------------------------------|------------------------------------------|-----------------------------------------|
| SC02MG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC03MG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC04MG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC02NG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC03NG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC04NLG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC05NLG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC04HG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC05HG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC06HG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC08HG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC04QG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC05QG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC06QG | 21.4 lbs | 21.4 lbs | NA |
| SC08QG | 21.4 lbs | 21.4 lbs | NA |
| SC04FG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC05FG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC06FG | 21.4 lbs | 21.4 lbs | NA |
| SC08FG | 21.4 lbs | 21.4 lbs | NA |
| SC04LG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
| SC06LG | 21.4 lbs | 21.4 lbs | NA |
| SC08LG | 21.4 lbs | 21.4 lbs | NA |
| SC05WG | 21.4 lbs | 21.4 lbs | 13.2 lbs |
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| Part Number | Total Load Weight in V-Pro<br>maX/maX 2 Lumen Cycle | Total Load Weight in V-Pro<br>maX/maX 2 Flex Cycle | Total Load Weight in V-Pro<br>maX/maX 2 Non-Lumen Cycle |
|-------------|-----------------------------------------------------|----------------------------------------------------|---------------------------------------------------------|
| SC02MG | 19.65 lbs | 24 lbs | 50 lbs |
| SC03MG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04MG | 19.65 lbs | 24 lbs | 50 lbs |
| SC02NG | 19.65 lbs | 24 lbs | 50 lbs |
| SC03NG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04NLG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05NLG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04HG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05HG | 19.65 lbs | 24 lbs | 50 lbs |
| SC06HG | 19.65 lbs | 24 lbs | 50 lbs |
| SC08HG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04QG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05QG | 19.65 lbs | 24 lbs | 50 lbs |
| SC06QG | 19.65 lbs | 24 lbs | 50 lbs |
| SC08QG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04FG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05FG | 19.65 lbs | 24 lbs | 50 lbs |
| SC06FG | 19.65 lbs | 24 lbs | 50 lbs |
| SC08FG | 19.65 lbs | 24 lbs | 50 lbs |
| SC04LG | 19.65 lbs | 24 lbs | 50 lbs |
| SC06LG | 19.65 lbs | 24 lbs | 50 lbs |
| SC08LG | 19.65 lbs | 24 lbs | 50 lbs |
| SC05WG | 19.65 lbs | 24 lbs | 50 lbs |
Table 10. SteriTite Container in V-Pro maX/maX 2 Maximum Load Weight Recommendations Including Weight of Container
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| Part Number | Total Load Weight in<br>Steam Sterilization Pre-Vacuum Cycle | Total Load Weight in<br>Steam Sterilization Gravity Cycle |
|-------------|--------------------------------------------------------------|-----------------------------------------------------------|
| SC02MG | 35 lbs | 35 lbs |
| SC03MG | 35 lbs | 35 lbs |
| SC04MG | 35 lbs | 35 lbs |
| SC02NG | 35 lbs | 35 lbs |
| SC03NG | 35 lbs | 35 lbs |
| SC04NLG | 35 lbs | 35 lbs |
| SC05NLG | 35 lbs | 35 lbs |
| SC04HG | 35 lbs | 35 lbs |
| SC05HG | 35 lbs | 35 lbs |
| SC06HG | 35 lbs | 35 lbs |
| SC08HG | 35 lbs | 35 lbs |
| SC04QG | 35 lbs | 35 lbs |
| SC05QG | 35 lbs | 35 lbs |
| SC06QG | 35 lbs | 35 lbs |
| SC08QG | 35 lbs | 35 lbs |
| SC04FG | 35 lbs | 35 lbs |
| SC05FG | 35 lbs | 35 lbs |
| SC06FG | 35 lbs | 35 lbs |
| SC08FG | 35 lbs | 35 lbs |
| SC04LG | 35 lbs | 35 lbs |
| SC06LG | 35 lbs | 35 lbs |
| SC08LG | 35 lbs | 35 lbs |
| SC05WG | 35 lbs | 35 lbs |
Table 11. SteriTite Container in Steam Sterilization/IUSS Maximum Load Weight Recommendations Including Weight of Container.
## Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510K Summary
## SteriTite Container System with MediTray Products
| Date Prepared : | 04/28/2022 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name : | Case Medical, Inc<br>50 West Street<br>Bloomfield NJ 07003 |
| Contact: | Michael Polozani |
| Email | MPolozani@casemed.com |
| Office | 201-313-1999 x 633 |
| Fax | 201-373-9090 |
| Trade Name | SteriTite Container System with MediTray Products |
| Common Name | Sterilization Wrap Containers, Trays, Cassettes, and Other Accessories |
| Class of Device | Class II |
| Product Code | KCT |
| Regulation | 21CFR880.6850 |
| Review Panel | General Hospital |
| Establishment<br>Registration Number | 2248608 |
| Predicate Device | K173259-SteriTite Rigid Container System with MediTrayProducts |
| Description of Device | The SteriTite container system consists of a family of rigid reusable containers and<br>inserts that provide an effective reusable sterilization packaging system for<br>operating room instruments. The SteriTite container as previously cleared is<br>available with solid or perforated base. The container is made of anodized<br>aluminum with passivated stainless-steel hardware and silicone gaskets. Each<br>filter retention plate with gaskets and off set vent pattern secures a disposable<br>filter for bacterial barrier filtration. Filter retention plates in lid and base are<br>interchangeable for universal use. A recessed gasket contributes to a knife edge fit<br>between lid and base. Various instrument trays as well as stacked baskets and<br>inserts including insert boxes, brackets, posts, partitions, and racks provide<br>instrument protection and secure devices for sterilization within the container. |
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## Indications for Use
The SteriTite container and MediTray products are a reusable sterilization container system to be used to enclose other medical devices, which are to be sterilized, transported, and stored by a health careprovider. It is intended to allow sterilization of the enclosed devices and maintain sterility of the enclosed device until it is used. This container system is compatible for use with the following low temperature sterilizers and cycles identified below:
- -V-Pro 60 (Flexible and Lumen cycle).
- -V-Pro s2 (Flexible and Lumen cycle).
- -V-Pro maX 2 (Flexible and Lumen cycle)
- -V-Pro maX (Flexible and Lumencycle)
- -STERRAD 100NX (ALLCLEAR-DUO Cycle)
- -Sterizone VP4 (Cycle 1)
The SteriTite container with MediTray accessories has the following validated lumen claims in low temperature and pre-vacuum steam sterilization:
The following table (Table 1) identifies the lumen claims of the SteriTite container with MediTray parts in low temperature and steam sterilizers:
| Sterilizer | Cycle | Lumen Sterilization Claims<br>(I.D. x Length) | Validated Lumen<br>Characteristics |
|--------------------|----------|-----------------------------------------------|------------------------------------|
| STERIS V-Pro 60 | Flexible | ≥1mm x ≤990mm | Single or Dual Lumen |
| | Lumen | ≥0.77mm x ≤527mm | Dual Channel |
| STERIS V-Pro s2 | Flexible | ≥1mm x ≤990mm | Single or Dual Lumen |
| | Lumen | ≥0.77mm x ≤527mm | Dual Channel |
| STERIS V-Pro max 2 | Flexible | ≥1mm x <1050mm | Single Lumen |
| STERIS V-Pro max | Flexible | ≥1mm x <1050mm | Single Lumen |
| | Lumen | ≥0.77mm x ≤527mm | Dual Channel |
| STERRAD 100NX | DUO | ≥1mm x ≤875mm | Single Lumen |
| Sterizone VP4 | Cycle 1 | ≥1.2mm x <1955mm | Flexible Lumens |
| | | ≥1.45mm x <3500mm | Flexible Lumens |
| Steam | Pre-Vac | ≥2mm x <400mm | Stainless Steel Lumen |
| | | ≥1.2mm x <400mm | Flexible Lumen |
Table 1. SteriTite Container System with MediTray Parts Lumen Claims
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The following table (Table 2) displays the SteriTite part numbers and the sterilizers they are compatible with:
| Table 2. Sterilite Container Compatibility with Low Temperature and Steam Sterilizers | | | | | | | | |
|---------------------------------------------------------------------------------------|------------------|------------------------------------|-----------------------------|-------------------------|--------------------------------------|---------------------------------|----------------------------|-------------------------------------|
| V-Pro s2/60<br>Lumen<br>Flex | V-Pro 1<br>Lumen | V-Pro<br>max/maX2<br>Lumen<br>Flex | Sterizone<br>VP4<br>Cycle 1 | STERRAD<br>100NX<br>DUO | STERRAD<br>100NX<br>Standard<br>Flex | STERRAD<br>100S/200<br>Standard | NX<br>Advanced<br>Standard | Steam<br>Pre-vac<br>Gravity<br>IUSS |
| SC02MG | SC02MG | SC02MG | SC02M(G)* | SC02MG | SC02MG | SC02MG | SC02MG | SC02MG |
| SC03MG | SC03MG | SC03MG | SC03M(G)* | SC03MG | SC03MG | SC03MG | SC03MG | SC03MG |
| SC04MG | SC02NG | SC04MG | SC04M(G)* | SC04MG | SC04MG | SC04MG | SC04MG | SC04MG |
| SC02NG | SC03NG | SC02NG | SC02N(G)* | SC02NG | SC02NG | SC02NG | SC02NG | SC02NG |
| SC03NG | SC04FG | SC03NG | SC03N(G)* | SC03NG | SC03NG | SC03NG | SC03NG | SC03NG |
| SC04NLG | SC05FG | SC04NLG | SC04NL(G)* | SC04NLG | SC04NLG | SC04NLG | SC04HG | SC04NLG |
| SC05NLG | SC06FG | SC05NLG | SC05NL(G)* | SC05NLG | SC05NLG | SC05NLG | SC05HG | SC05NLG |
| SC04HG | SC08FG | SC04HG | SC04H(G)* | SC04HG | SC04HG | SC04HG | SC04QG | SC04HG |
| SC05HG | SC04HG | SC05HG | SC05H(G)* | SC05HG | SC05HG | SC05HG | SC05QG | SC05HG |
| SC04QG | SC05HG | SC06HG | SC06H(G)* | SC06HG | SC06HG | SC06HG | SC04FG | SC06HG |
| SC05QG | SC06HG | SC08HG | SC08H(G)* | SC08HG | SC08HG | SC08HG | | SC08HG |
| SC04FG | SC08HG | SC04QG | SC04Q(G)* | SC04QG | SC04QG | SC04QG | | SC04QG |
| | SC04QG | SC05QG | SC05Q(G)* | SC05QG | SC05QG | SC05QG | | SC05QG |
| | SC05QG | SC06QG | SC06Q(G)* | SC04FG | SC06QG | SC06QG | | SC06QG |
| | SC06QG | SC08QG | SC08Q(G)* | SC05FG | SC08QG | SC08QG | | SC08QG |
| | SC08QG | SC04FG | SC04F(G)* | SC04LG | SC04FG | SC04FG | | SC04FG |
| | SC04LG | SC05FG | SC04L(G)* | SC05WG | SC05FG | SC05FG | | SC05FG |
| | SC06LG | SC06FG | SC06L(G)* | | SC06FG | SC06FG | | SC06FG |
| | SC08LG | SC08FG | SC08L(G)* | | SC08FG | SC08FG | | SC08FG |
| | SC05WG | SC04LG | | | SC04LG | | | SC04LG |
| | | SC06LG | | | SC06LG | | | SC06LG |
| | | SC08LG | | | SC08LG | | | SC08LG |
| | | SC05WG | | | SC05WG | | | SC05WG |
Table 2. SteriTite Container Compatibility with Low Temperature and Steam Sterilizers
*Please note that the SteriTite perforated bottom containers are compatible with the Sterizone VP4 Sterilizer.
The following table identifies which MediTray products are compatible with low temperature sterilizers and steam sterilization:
| MediTray Product | V-Pro<br>maX/2 | V-Pro 1 | V-Pro<br>s2/60 | STERRAD<br>100NX | STERRAD<br>100S/200 | STERRAD<br>NX | STERIZONE<br>VP4 | Steam |
|-------------------|----------------|---------|----------------|------------------|---------------------|---------------|------------------|-------|
| Baskets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Trays | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Insert Boxes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Metal Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Metal Partitions | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Posts | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Silicone Brackets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Racks | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Stringers | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
#### Table 3. MediTray Products Sterilizer Compatibility Table
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The following table identifies which SteriTite accessories are compatible with low temperature sterilizers and steam sterilization:
| SteriTite Accessories | V-Pro<br>maX/2 | V-Pro 1 | V-Pro<br>s2/60 | STERRAD<br>100NX | STERRAD<br>100S | STERRAD<br>NX | STERIZONE<br>VP4 | Steam |
|-----------------------------|----------------|---------|----------------|------------------|-----------------|---------------|------------------|-------|
| SCF02 Round filter | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SCFM02 Rectangular filter | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SCS01W Tamper Evident Seals | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SCLH2023 Load Card Large | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SCLH2024 Load Card Small | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
#### Table 4. SteriTite Accessories Sterilizer Compatibility Table
The following tables (5-11) identify the sterilizer maximum load weight recommendations with the SteriTite containers:
## Table 5. SteriTite Container in V-Pro 60 Maximum Load Weight Recommendations Including Weight of Container
| Part<br>Number | Total Load Weight in V-Pro<br>s2/60 Lumen Cycle | Total Load Weight in V-Pro<br>s2/60 Flexible Cycle |
|----------------|-------------------------------------------------|----------------------------------------------------|
| SC02MG | 25lbs | 11lbs |
| SC03MG | 25lbs | 11lbs |
| SC04MG | 25lbs | 11lbs |
| SC02NG | 25lbs | 11lbs |
| SC03NG | 25lbs | 11lbs |
| SC04NLG | 25lbs | 11lbs |
| SC05NLG | 25lbs | 11lbs |
| SC04HG | 25lbs | 11lbs |
| SC05HG | 25lbs | 11lbs |
| SC04QG | 25lbs | 11lbs |
| SC05QG | 25lbs | 11lbs |
| SC04FG | 25lbs | 11lbs |
# Table 6. SteriTite Container in STERRAD NX Maximum Load Weight Recommendations Including Weight of
Container
| Part<br>Number | Total Load Weight<br>in NX<br>Standard Cycle | Total Load Weight<br>in NX<br>Advanced Cycle |
|----------------|----------------------------------------------|----------------------------------------------|
| SC02MG | 10.7lbs | 10.7lbs |
| SC03MG | 10.7lbs | 10.7lbs |
| SC04MG | 10.7lbs | 10.7lbs |
| SC02NG | 10.7lbs | 10.7lbs |
| SC03NG | 10.7lbs | 10.7lbs |
| SC04HG | 10.7lbs | 10.7lbs |
| SC05HG | 10.7lbs | 10.7lbs |
| SC04QG | 10.7lbs | 10.7lbs |
| SC05QG | 10.7lbs | 10.7lbs |
| SC04FG | 10.7lbs | 10.7lbs |
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Table 7. SteriTite Container in V-Pro 1 Maximum Load Weight Recommendations Including Weight of Container
| Part<br>Number | Total Load Weight in V-Pro 1<br>Lumen Cycle |
|----------------|---------------------------------------------|
| SC02MG | 19.65lbs |
| SC03MG | 19.65lbs |
| SC02NG | 19.65lbs |
| SC03NG | 19.65lbs |
| SC04FG | 19.65lbs |
| SC05FG | 19.65lbs |
| SC06FG | 19.65lbs |
| SC08FG | 19.65lbs |
| SC04HG | 19.65lbs |
| SC05HG | 19.65lbs |
| SC06HG | 19.65lbs |
| SC08HG | 19.65lbs |
| SC04QG | 19.65lbs |
| SC05QG | 19.65lbs |
| SC06QG | 19.65lbs |
| SC08QG | 19.65lbs |
| SC04LG | 19.65lbs |
| SC06LG | 19.65lbs |
| SC08LG | 19.65lbs |
| SC05WG | 19.65lbs |
Table 8. SteriTite Container in STERRAD 100s/200 Maximum Load Weight Recommendations Including Weight of Container
| Part Number | Total Load Weight in<br>the STERRAD 100s/200<br>Standard Cycle |
|-------------|----------------------------------------------------------------|
| SC02MG | 22lbs |
| SC03MG | 22lbs |
| SC04MG | 22lbs |
| SC02NG | 22lbs |
| SC03NG | 22lbs |
| SC04NLG | 22lbs |
| SC05NLG | 22lbs |
| SC04HG | 22lbs |
| SC05HG | 22lbs |
| SC06HG | 22lbs |
| SC08HG | 22lbs |
| SC04QG | 22lbs |
| SC05QG | 22lbs |
| SC06QG | 22lbs |
| SC08QG | 22lbs |
| SC04FG | 22lbs |
| SC05FG | 22lbs |
| SC06FG | 22lbs |
| SC08FG | 22lbs |
#### Table 9. SteriTite Container in 100NX Maximum Load Weight Recommendations Including Weight of Container
| Part<br>Number | Total Load Weight in<br>100NX<br>Standard Cycle | Total Load Weight in<br>100NX<br>Flex Cycle | Total Load Weight in<br>100NX<br>DUO Cycle |
|----------------|-------------------------------------------------|---------------------------------------------|--------------------------------------------|
| SC02MG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC03MG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC04MG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC02NG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC03NG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC04NLG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC05NLG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC04HG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC05HG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC06HG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC08HG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC04QG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC05QG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC06QG | 21.4lbs | 21.4lbs | NA |
| SC08QG | 21.4lbs | 21.4lbs | NA |
| SC04FG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC05FG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC06FG | 21.4lbs | 21.4lbs | NA |
| SC08FG | 21.4lbs | 21.4lbs | NA |
| SC04LG | 21.4lbs | 21.4lbs | 13.2lbs |
| SC06LG | 21.4lbs | 21.4lbs | NA |
| SC08LG | 21.4lbs | 21.4lbs | NA |
| SC05WG | 21.4lbs | 21.4lbs | 13.2lbs |
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| Part<br>Number | Total Load Weight in<br>V-Pro maX/maX2<br>Lumen Cycle | Total Load Weight in<br>V-Pro maX/maX2 Flex<br>Cycle | Total Load Weight in V-<br>Pro maX/maX2 Non-<br>Lumen Cycle |
|----------------|-------------------------------------------------------|------------------------------------------------------|-------------------------------------------------------------|
| SC02MG | 19.65lbs | 24lbs | 50lbs…
