(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."
§ 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).