(154 days)
The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using gravity steam sterilizers. The recommended gravity steam sterilization cycle parameters are 45 minutes exposure at 121 deg C and a 20 minute dry time. 2 metal lumens 3-mm in diameter and up to 200-mm in length were validated. The container is intended for use with non-porous materials such as stainless steel surgical instruments.
For effective sterilization and drying, the weight of the single container, basket and basket contents should not exceed the following: 16 lbs for the one-half size container, 20 Ibs for the three-quarter size container, and 25 Ibs for the full size container.
Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility for a maximum of 60 days as long as the integrity of the container has not been compromised.
Containers should not be stacked when used within gravity steam sterilizers.
The Miltex Rigid Sterilization Container System consists of a family of rigid, re-usable, sealed containers that provides an effective sterilization packaging method for medical devices. Container bottoms and lids, within a given size, are interchangeable. The system is composed of the following components:
- Container bottoms (perforated versions) .
- . Container baskets,
- . Container lids (perforated only)
The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Miltex System) |
|---|---|
| Intended Use: Contain instruments for sterilization in gravity steam sterilizers | Yes |
| Intended Use: Re-usable | Yes |
| Intended Use: Closed System | Yes |
| Intended Use: Sealed | Yes |
| Design: Incorporates a filter system to permit entry of sterilant agent | Yes |
| Design: Incorporates a filter system to prevent microbial migration during transport | Yes |
| Materials (Container): Aluminum alloy, Stainless Steel, & Silicone | Aluminum alloy, Stainless Steel, & Silicone |
| Conformance to appropriate AAMI standards | Yes, conforms to AAMI ST 77 Draft- Containment Devices for Reusable Medical Device Sterilization |
| Gravity Steam Efficacy Testing | Yes |
| Thermal Profile Study (Sterilant penetration) | Sterilant penetration can be achieved in a single layer configuration |
| Sterility Maintenance (maximum duration) | 60 days (validated for 30-day real time w/ weekly handling events) |
| Maximum Load (small container) | 16 lbs |
| Maximum Load (medium container) | 20 lbs |
| Maximum Load (large container) | 25 lbs |
| Inoculated Lumens Testing | Yes (3-mm I.D. x 200-mm, metal) |
| Inoculated Stainless Steel Medical Devices Testing | Yes (hinge area of medical pliers and knurled instruments) |
2. Sample Size and Data Provenance:
- Test Set Sample Size: The document does not specify the exact sample size for each performance test (e.g., number of sterilization cycles, number of containers tested for sterility maintenance). It only states that tests were performed for various parameters.
- Data Provenance: The document implies that the data was generated by the manufacturer, Miltex, Incorporated, as part of their 510(k) submission. The country of origin for the data is not explicitly stated but is implicitly the United States given the submission to the FDA. The study is prospective as it involves the testing and validation of the Miltex device.
3. Number of Experts and Qualifications for Ground Truth:
- The document does not provide information regarding the number of experts used to establish ground truth or their specific qualifications for the performance testing of the device (e.g., for interpreting sterilization efficacy, sterility maintenance, or thermal profiles). Performance criteria are likely based on established industry standards (AAMI) and direct laboratory measurements rather than expert consensus on individual "cases."
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method as it does not involve subjective interpretations of "cases" by multiple reviewers. The performance testing appears to involve objective measurements and adherence to predefined protocols and standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of data (e.g., medical images), not for sterilization containers whose performance is assessed through objective physical and microbiological testing.
6. Standalone Performance Study:
- Yes, a standalone performance study was done. The "Performance Data" section directly reports the performance of the Miltex System for various properties and validation tests (Gravity Steam Efficacy Testing, Thermal Profile Study, Sterility Maintenance, Load, Test Organisms/Inoculated Product). This evaluation is based on the algorithm/device's own performance against established criteria and the predicate device.
7. Type of Ground Truth Used:
- The ground truth used for the performance evaluation is based on objective experimental results and adherence to recognized industry standards. This includes:
- Microbiological testing: Efficacy of sterilization based on inactivation of test organisms (e.g., in inoculated lumens and stainless steel medical devices).
- Physical measurements: Thermal profiles to confirm sterilant penetration, weight load capacity tests.
- Time-based validation: Sterility maintenance over a specified duration (30 days in real-time with handling events).
- Conformance to standards: Meeting the requirements of AAMI ST 77 Draft.
8. Sample Size for the Training Set:
- The concept of a "training set" is relevant to machine learning or AI algorithms. As this device is a physical rigid sterilization container system, there is no training set in the context of AI or machine learning. Performance is verified through physical and microbiological validation testing.
9. How the Ground Truth for the Training Set was Established:
- Since there is no "training set" as defined in machine learning contexts, this question is not applicable. The "ground truth" for the device's performance was established through rigorous, standardized laboratory and engineering tests designed to directly measure its efficacy and adherence to performance specifications.
§ 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).