(137 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, Non-Lumen and Flexible cycle) -
- -STERIS V-Pro maX (Lumen, Non-Lumen and Flexible cycle)
- STERRAD 100NX ALLCLEAR (Standard, Flexible,DUO and Express 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 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) |
The SteriTite® Universal Container is a rigid, reusable, sealed sterilization packaging system that is compatible with steam, hydrogen peroxide, ethylene oxide, and ozone sterilizers. 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 does not contain information about an AI device. Instead, it describes a medical device, the "SteriTite Container System with MediTray Parts," which is a reusable sterilization container system. The document outlines its indications for use, compatibility with various sterilizers and accessories, maximum load weight recommendations, and non-clinical performance testing.
Therefore, I cannot provide details on the acceptance criteria and study for an AI device as requested by your prompt.
However, if you are interested in the acceptance criteria and study for the SteriTite Container System with MediTray Parts, I can extract that information:
Description of Acceptance Criteria and Study for SteriTite Container System with MediTray Parts:
The SteriTite Container System with MediTray Parts is a reusable sterilization container system. The device was evaluated through non-clinical performance testing to demonstrate its safety, effectiveness, and performance. The testing followed established ANSI/AAMI standards and FDA guidance.
1. Table of Acceptance Criteria and Reported Device Performance:
| 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 bacteria spores. | Pass |
| Biocompatibility | ANSI AAMI ISO10993-1 | 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. | Pass |
2. Sample size used for the test set and the data provenance:
The document states that "All SteriTite containers were tested with inner baskets or trays representative of the products." It does not specify the exact sample size (number of containers, baskets, or trays) used for each test. The provenance of the data is that the "validation testing was conducted at qualified independent laboratories." The data is thus prospective testing specifically for this device's validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a sterilization container system, and its performance is evaluated against physical and biological challenges, not against expert interpretation of data. "Ground truth" in this context refers to established scientific and regulatory standards for sterilization efficacy and device material compatibility.
4. Adjudication method for the test set:
Not applicable in the context of device performance testing against established standards. The results are objective "Pass" or "Fail" based on whether the device meets the criteria outlined in the referenced standards.
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:
Not applicable. This is not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI device.
7. The type of ground truth used:
The ground truth for this device's performance is based on established industry standards for sterilization, biocompatibility, and material compatibility. Specifically, the standards cited are:
- ANSI/AAMI ST77:2013 (R)2018 (Sterility Maintenance, Whole Package Microbial Challenge, Material Compatibility / Re-Use Testing)
- ANSI AAMI ISO10993-1 (Biocompatibility)
- ANSI AAMI ISO 14937:2009/(R)2013 (Simulated Use Testing/Sterilization Efficacy)
- FDA guidance (not specifically named, but implied for regulatory compliance)
- AAMI TIR 12 and ANSI/AAMI ST-79 (additional relevant standards mentioned)
The efficacy testing followed the "overkill method" of sterility assurance and used the bacterial strain G. stearothermophilus as a biological challenge.
8. The sample size for the training set:
Not applicable. This is not an AI device, so there is no training set in the AI sense.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI device.
§ 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).