(246 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization efficacy of a reusable container system, with no mention of AI or ML technologies.
No
This device is a reusable sterilization container system used to enclose other medical devices for sterilization, transport, and storage, not to treat a disease or condition in a patient.
No
The device is a reusable sterilization container system for medical devices, not a diagnostic tool. Its purpose is to prepare and maintain sterility of other medical devices, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical components made of anodized aluminum, stainless-steel hardware, and silicone gaskets, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is 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." This describes a device used in the process of sterilizing and handling medical instruments, not a device used to perform tests on samples taken from the human body to diagnose diseases or conditions.
- Device Description: The description details the physical components of the container system (aluminum, stainless steel, gaskets, filters, trays, etc.). This aligns with a sterilization container, not an IVD which would typically involve reagents, test strips, or analytical components.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on sterility maintenance, microbial challenge, biocompatibility, material compatibility, and sterilization efficacy – all related to the function of a sterilization container.
Therefore, this device falls under the category of a medical device used for sterilization and storage, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
The SteriTite container with MediTray accessories has the following validated lumen claims in low temperature and pre-vacuum steam sterilization:
Product codes
KCT
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Case Medical, Inc. follows the "overkill method" of sterility assurance to show an elimination of a biological challenge. All SteriTite containers were tested with inner baskets or trays representative of the MediTray line of products. Testing was designed to simulate worst-case scenarios with half cycles utilized with end of shelf-life concentrations of hydrogen peroxide for low temperature sterilization. The bacterial strain G. stearothermophilus was used in all testing due to its resistance to moist heat and hydrogen peroxide. The validation testing was conducted at qualified independent laboratories in accordance with FDA guidance and available ANSI/AAMI standards such as ANSI/AAMI ST77, AAMI TIR 12 and ANSI/AMMI ST79.
Based on the testing performed on the SteriTite container and MediTray parts, the device has demonstrated compatibility with the sterilizers indicated above. Results are summarized in Table 12.
Table 12: Summary of Non-Clinical Performance Testing
Performance Testing: Sterility Maintenance; Standard: ANSI/AAMI ST77:2013 (R)2018; Purpose: Demonstrate the integrity of the container to maintain sterility of contents over time and with multiple handling events after sterilization; Results: Pass
Performance Testing: Whole Package Microbial Challenge; Standard: ANSI/AAMI ST77:2013 (R)2018; Purpose: Demonstration of whole package integrity following exposure to aerosolized bacterial spores.; Results: Pass
Performance Testing: Biocompatibility; Standard: ANSI AAMI ISO 10993-1; Purpose: Acute systemic toxicity, primary irritation and sensitization of the subject device.; Results: Pass
Performance Testing: Material Compatibility / Re-Use Testing; Standard: ANSI/AAMI ST77:2013 (R)2018; Purpose: Demonstration that the subject device materials are compatible with the intended sterilization cycles; Results: Pass
Performance Testing: Simulated Use Testing / Sterilization Efficacy; Standard: ANSI AAMI ISO 14937:2009/(R)2013; Purpose: Testing was completed to demonstrate sterilization efficacy of the subject device for processing of medical devices with the indicated claims using the identified sterilization processes.; Results: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K173259-SteriTite Rigid Container System with MediTrayProducts
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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.
3
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) |
| ≥1.2mm x ≤400mm (Flexible Lumen) |
4
The following table (Table 2) displays the SteriTite part numbers and the sterilizers they are compatible with.
| V-Pro s2/60
Lumen
Flex | V-Pro 1
Lumen Cycle | V-Pro maX/2
Lumen
Flex | Sterizone VP4
Cycle 1 | STERRAD 100NX
DUO | STERRAD 100NX
Standard
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.
5
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
maX/2 | V-Pro 1 | V-Pro
s2/60 | STERRAD
100NX | STERRAD
100s/200 | STERRAD
NX | STERIZONE
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 |
6
The following table (Table 4) identifies which SteriTite accessories are compatible with low temperature sterilizers and steam sterilization:
| SteriTite Accessories | V-Pro
maX/2 | V-Pro 1 | V-Pro
s2/60 | STERRAD
100NX | STERRAD
100s | STERRAD
NX | STERIZONE
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
V-Pro s2/60
Lumen Cycle | Total Load Weight in
V-Pro s2/60
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 |
7
Table 6. SteriTite Container in STERRAD NX Maximum Load Weight Recommendations Including Weight of Container
| Part Number | Total Load Weight in
NX Standard Cycle | Total Load Weight in
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
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 |
8
Table 8. SteriTite Container in STERRAD 100s/200 Maximum Load Weight Recommendations Including Weight of Container
| Part Number | Total Load Weight in the
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
100NX Standard Cycle | Total Load Weight in
100NX Flex Cycle | Total Load Weight in
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 |
9
| Part Number | Total Load Weight in V-Pro
maX/maX 2 Lumen Cycle | Total Load Weight in V-Pro
maX/maX 2 Flex Cycle | Total Load Weight in V-Pro
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
10
| Part Number | Total Load Weight in
Steam Sterilization Pre-Vacuum Cycle | Total Load Weight in
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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11
510K Summary
SteriTite Container System with MediTray Products
| Date Prepared : | 04/28/2022 |
|---|---|
| Company Name : | Case Medical, Inc |
| 50 West Street | |
| Bloomfield NJ 07003 | |
| Contact: | Michael Polozani |
| 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 | |
| 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 |
| 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 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. |
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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
(I.D. x Length) | Validated Lumen
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