(246 days)
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 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.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the SteriTite Container System with MediTray Products (K212711).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Testing) | Standard | Purpose | Reported Device Performance |
|---|---|---|---|
| Sterility Maintenance | ANSI/AAMI ST77:2013 (R)2018 | Demonstrate the integrity of the container to maintain sterility of contents over time and with multiple handling events after sterilization | Pass |
| Whole Package Microbial Challenge | ANSI/AAMI ST77:2013 (R)2018 | Demonstration of whole package integrity following exposure to aerosolized bacterial spores. | Pass |
| Biocompatibility | ANSI AAMI ISO 10993-1 | Acute systemic toxicity, primary irritation and sensitization of the subject device. | Pass |
| Material Compatibility / Re-Use Testing | ANSI/AAMI ST77:2013 (R)2018 | Demonstration that the subject device materials are compatible with the intended sterilization cycles | Pass |
| Simulated Use Testing / Sterilization Efficacy | ANSI AAMI ISO 14937:2009/(R)2013 | 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. This included simulating worst-case scenarios with half cycles and end-of-shelf-life concentrations of hydrogen peroxide for low temperature sterilization, and using G. stearothermophilus as the bacterial challenge. | Pass |
| Lumen Sterilization Claims (Specific to Sterilizer and Cycle) | (Implied by compatibility with standards and specific claims) | To confirm the ability of the container system to effectively sterilize lumens of specified internal diameter and length when used with compatible sterilizers and cycles. | Varies by Sterilizer/Cycle (see Table 1 / Table 12):- 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) / V-Pro maX (Flexible): ≥1mm x ≤1050mm (Single Lumen)- STERIS V-Pro maX 2 (Lumen) / 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) and ≥1.45mm x ≤3500mm (Flexible Lumens)- Steam (Pre-Vac): ≥2mm x ≤400mm (Stainless Steel Lumen) and ≥1.2mm x ≤400mm (Flexible Lumen) |
| Maximum Load Weight Recommendations | (Implied by manufacturer's specifications and validation) | To define the safe and effective maximum weight of instruments and the container system for various sterilizers and cycles. | Varies by Sterilizer/Cycle/Container Type (see Tables 5-11):e.g., SC02MG in V-Pro s2/60 Lumen Cycle: 25 lbs; SC02MG in STERRAD NX Standard Cycle: 10.7 lbs; SC02MG in Steam Sterilization Pre-Vacuum Cycle: 35 lbs. |
| Compatibility with MediTray Products and Accessories | (Implied by manufacturer's specifications and validation) | To confirm that various MediTray components (baskets, trays, etc.) and SteriTite accessories (filters, seals, load cards) are compatible with the indicated sterilizers. | All listed MediTray products and SteriTite accessories are compatible with all listed sterilizers. (See Table 3 and Table 4 for "Yes" for all) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "sample size" for a test set in terms of cases or individual devices for the sterilization efficacy study. However, the testing was conducted to prove the efficacy of the device (SteriTite Container System with MediTray Products) itself under a representative "worst-case scenario." This typically involves multiple runs and replicates to demonstrate sterility assurance.
- Data Provenance: The testing was conducted at "qualified independent laboratories." The document does not specify the country of origin of the data directly, nor does it explicitly state whether the study was retrospective or prospective. Given the nature of sterilization validation, it would be a prospective study where the device is subjected to controlled sterilization cycles and then tested for sterility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth for sterilization efficacy is typically established through microbiological testing (e.g., biological indicators, microbial challenges) and physical/chemical indicators, not through expert consensus on images or diagnoses. The expertise involved would be in microbiology, sterilization science, and engineering to design and execute the validation studies.
4. Adjudication Method for the Test Set
This concept (e.g., 2+1, 3+1) is typically relevant to diagnostic studies involving human readers and ground truth established by multiple experts. For this type of device (sterilization container), the "ground truth" is determined by objective scientific testing (e.g., presence or absence of microbial growth, physical integrity of the container). Therefore, an adjudication method in the human-reader sense is not applicable and not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable to the SteriTite Container System with MediTray Products. This device is a medical device for sterilization, not an AI or diagnostic imaging tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable to the SteriTite Container System with MediTray Products. This device does not involve an algorithm. The performance is the standalone performance of the physical container system in maintaining sterility and enabling sterilization.
7. The Type of Ground Truth Used
For the sterilization efficacy testing and other performance tests, the ground truth was primarily established through:
- Microbiological testing: Using a bacterial strain (G. stearothermophilus) as a biological challenge, and assessing its elimination to demonstrate sterility assurance.
- Physical and Chemical testing: To verify container integrity, biocompatibility, and material compatibility under simulated use and sterilization conditions.
- Engineering specifications: Lumen claims (ID x length) and maximum load weights are based on engineering design and validated performance through rigorous testing.
8. The Sample Size for the Training Set
This is not applicable as this device does not involve AI or machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as this device does not involve AI or machine learning algorithms that require a "training set."
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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
{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
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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)≥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 s2/60LumenFlex | V-Pro 1Lumen Cycle | V-Pro maX/2LumenFlex | Sterizone VP4Cycle 1 | STERRAD 100NXDUO | STERRAD 100NXStandardFlex |
|---|---|---|---|---|---|
| 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-PromaX/2 | V-Pro 1 | V-Pros2/60 | STERRAD100NX | STERRAD100s/200 | STERRADNX | STERIZONEVP4 | 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-PromaX/2 | V-Pro 1 | V-Pros2/60 | STERRAD100NX | STERRAD100s | STERRADNX | STERIZONEVP4 | 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 inV-Pro s2/60Lumen Cycle | Total Load Weight inV-Pro s2/60Flexible 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 inNX Standard Cycle | Total Load Weight inNX 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 inV-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 theSTERRAD 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 in100NX Standard Cycle | Total Load Weight in100NX Flex Cycle | Total Load Weight in100NX 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-PromaX/maX 2 Lumen Cycle | Total Load Weight in V-PromaX/maX 2 Flex Cycle | Total Load Weight in V-PromaX/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 inSteam Sterilization Pre-Vacuum Cycle | Total Load Weight inSteam 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, Inc50 West StreetBloomfield 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 |
| EstablishmentRegistration 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 andinserts that provide an effective reusable sterilization packaging system foroperating room instruments. The SteriTite container as previously cleared isavailable with solid or perforated base. The container is made of anodizedaluminum with passivated stainless-steel hardware and silicone gaskets. Eachfilter retention plate with gaskets and off set vent pattern secures a disposablefilter for bacterial barrier filtration. Filter retention plates in lid and base areinterchangeable for universal use. A recessed gasket contributes to a knife edge fitbetween lid and base. Various instrument trays as well as stacked baskets andinserts including insert boxes, brackets, posts, partitions, and racks provideinstrument protection and secure devices for sterilization within the container. |
{12}------------------------------------------------
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 LumenCharacteristics |
|---|---|---|---|
| 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
{13}------------------------------------------------
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 s2/60LumenFlex | V-Pro 1Lumen | V-Promax/maX2LumenFlex | SterizoneVP4Cycle 1 | STERRAD100NXDUO | STERRAD100NXStandardFlex | STERRAD100S/200Standard | NXAdvancedStandard | SteamPre-vacGravityIUSS |
| 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-PromaX/2 | V-Pro 1 | V-Pros2/60 | STERRAD100NX | STERRAD100S/200 | STERRADNX | STERIZONEVP4 | 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
{14}------------------------------------------------
The following table identifies which SteriTite accessories are compatible with low temperature sterilizers and steam sterilization:
| SteriTite Accessories | V-PromaX/2 | V-Pro 1 | V-Pros2/60 | STERRAD100NX | STERRAD100S | STERRADNX | STERIZONEVP4 | 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
| PartNumber | Total Load Weight in V-Pros2/60 Lumen Cycle | Total Load Weight in V-Pros2/60 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
| PartNumber | Total Load Weightin NXStandard Cycle | Total Load Weightin NXAdvanced 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 |
{15}------------------------------------------------
Table 7. SteriTite Container in V-Pro 1 Maximum Load Weight Recommendations Including Weight of Container
| PartNumber | Total Load Weight in V-Pro 1Lumen 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 inthe STERRAD 100s/200Standard 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
| PartNumber | Total Load Weight in100NXStandard Cycle | Total Load Weight in100NXFlex Cycle | Total Load Weight in100NXDUO 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 |
{16}------------------------------------------------
| PartNumber | Total Load Weight inV-Pro maX/maX2Lumen Cycle | Total Load Weight inV-Pro maX/maX2 FlexCycle | Total Load Weight in V-Pro maX/maX2 Non-Lumen Cycle |
|---|---|---|---|
| SC02MG | 19.65lbs | 24lbs | 50lbs |
| SC03MG | 19.65lbs | 24lbs | 50lbs |
| SC04MG | 19.65lbs | 24lbs | 50lbs |
| SC02NG | 19.65lbs | 24lbs | 50lbs |
| SC03NG | 19.65lbs | 24lbs | 50lbs |
| SC04NLG | 19.65lbs | 24lbs | 50lbs |
| SC05NLG | 19.65lbs | 24lbs | 50lbs |
| SC04HG | 19.65lbs | 24lbs | 50lbs |
| SC05HG | 19.65lbs | 24lbs | 50lbs |
| SC06HG | 19.65lbs | 24lbs | 50lbs |
| SC08HG | 19.65lbs | 24lbs | 50lbs |
| SC04QG | 19.65lbs | 24lbs | 50lbs |
| SC05QG | 19.65lbs | 24lbs | 50lbs |
| SC06QG | 19.65lbs | 24lbs | 50lbs |
| SC08QG | 19.65lbs | 24lbs | 50lbs |
| SC04FG | 19.65lbs | 24lbs | 50lbs |
| SC05FG | 19.65lbs | 24lbs | 50lbs |
| SC06FG | 19.65lbs | 24lbs | 50lbs |
| SC08FG | 19.65lbs | 24lbs | 50lbs |
| SC04LG | 19.65lbs | 24lbs | 50lbs |
| SC06LG | 19.65lbs | 24lbs | 50lbs |
| SC08LG | 19.65lbs | 24lbs | 50lbs |
| SC05WG | 19.65lbs | 24lbs | 50lbs |
Table 10. SteriTite Container in V-Pro maX/maX 2 Maximum Load Weight Recommendations Including Weight of Container
Table 11. SteriTite Container in Steam Sterilization/IUSS Maximum Load Weight Recommendations Including Weight of Container
| PartNumber | Total Load Weight inSteam SterilizationPre-Vacuum Cycle | Total Load Weight inSteam SterilizationGravity Cycle |
|---|---|---|
| SC02MG | 35lbs | 35lbs |
| SC03MG | 35lbs | 35lbs |
| SC04MG | 35lbs | 35lbs |
| SC02NG | 35lbs | 35lbs |
| SC03NG | 35lbs | 35lbs |
| SC04NLG | 35lbs | 35lbs |
| SC05NLG | 35lbs | 35lbs |
| SC04HG | 35lbs | 35lbs |
| SC05HG | 35lbs | 35lbs |
| SC06HG | 35lbs | 35lbs |
| SC08HG | 35lbs | 35lbs |
| SC04QG | 35lbs | 35lbs |
| SC05QG | 35lbs | 35lbs |
| SC06QG | 35lbs | 35lbs |
| SC08QG | 35lbs | 35lbs |
| SC04FG | 35lbs | 35lbs |
| SC05FG | 35lbs | 35lbs |
| SC06FG | 35lbs | 35lbs |
| SC08FG | 35lbs | 35lbs |
| SC04LG | 35lbs | 35lbs |
| SC06LG | 35lbs | 35lbs |
| SC08LG | 35lbs | 35lbs |
| SC05WG | 35lbs | 35lbs |
{17}------------------------------------------------
Technological Characteristics Comparison
All functional and design characteristics are the same as the previously cleared and show effective performance characteristics. The SteriTite container system is the same container system previously cleared and demonstrated the same technical and performance characteristics previously. Sterilization efficacy testing has been conducted to support new indications.
Summary of Non-Clinical Performance Testing
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.
| Performance Testing | Standard | Purpose | Results |
|---|---|---|---|
| Sterility Maintenance | ANSI/AAMI ST77:2013 (R)2018 | Demonstrate the integrity ofthe container to maintainsterility of contents over timeand with multiple handlingevents after sterilization | Pass |
| Whole Package MicrobialChallenge | ANSI/AAMI ST77:2013 (R)2018 | Demonstration of wholepackage integrity followingexposure to aerosolizedbacterial spores. | Pass |
| Biocompatibility | ANSI AAMI ISO 10993-1 | Acute systemic toxicity, primaryirritation and sensitization ofthe subject device. | Pass |
| Material Compatibility / Re-UseTesting | ANSI/AAMI ST77:2013 (R)2018 | Demonstration that the subjectdevice materials arecompatible with the intendedsterilization cycles | Pass |
| Simulated Use Testing /Sterilization Efficacy | ANSI AAMI ISO14937:2009/(R)2013 | Testing was completed todemonstrate sterilizationefficacy of the subject devicefor processing of medicaldevices with the indicatedclaims using the identifiedsterilization processes. | Pass |
| Table 12: Summary of Non-Clinical Performance Testing | |
|---|---|
| ------------------------------------------------------- | -- |
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K212711, the SteriTite Universal Container System and MediTray Products, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K173259.
§ 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).