(242 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 ethylene oxide gas sterilizers. Metal lumens 3-mm in diameter and length up to 200-mm in length were validated. The container intended for use with non-porous materials such as stainless steel surgical instruments.
Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the medical devices within it until used.
Containers should not be stacked when used within cthylene oxide 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 (both perforated and non-perforated versions)
- Container baskets,
- Container lids (perforated only), and .
- u Container color-coding "labels."
The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated.
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 ethylene oxide gas sterilizers. The container is intended for use with non-porous materials such as stainless steel surgical instruments. Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the medical devices within it until used.
Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Standard | Miltex System Reported Performance | Predicate Device Performance
(for comparison but not direct acceptance) |
| :----------------------------------------- | :-------------------------------------------------------------------------- | :------------------------------------------------------------------------------------------- |
| Conformance to appropriate AAMI standards | Yes, conforms to AAMI ST 77 Draft- Containment Devices for Reusable Medical Device Sterilization | Yes, conforms to AAMI ST 33- Guidelines for the Selection and Use of Reusable Rigid Sterilization Container Systems for ETO Sterilization and Steam Sterilization in Health Care Facilities |
| Ethylene Oxide Sterile Efficacy Testing | Yes | Yes |
| Aeration Time and EO Residuals | 8-hours/ below maximum acceptable levels | 12-hours/ below maximum acceptable levels |
| Sterility Maintenance (Duration) | 30-day real time w/ weekly handling events | 90-day real time w/ weekly handling events. 30-day real time w/ daily handling events. |
| Load Capacity (Small container) | Up to 16-lbs. | Up to 22-lbs. |
| Load Capacity (Medium container) | Up to 20-lbs. | (Implied: up to 22-lbs for all sizes if not specified otherwise) |
| Load Capacity (Large container) | Up to 25-lbs. | (Implied: up to 22-lbs for all sizes if not specified otherwise) |
| Inoculated Lumens (Dimensions) | Yes--3-mm I.D. x 200-mm, metal | Yes-- 2.2-mm I.D. x 457-mm, metal |
| Inoculated Stainless Steel Medical Devices Location | Yes (hinge area of medical pliers and knurled instruments) | Yes (blades) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific tests. The document refers to "Validation Testing" which usually implies a pre-defined sample size for each test. However, the exact number of containers or tests performed is not detailed.
- Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective in nature, as it involves "Validation Testing" and "real-time" sterility maintenance, implying active testing of the Miltex system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies described are performance tests of the device itself (e.g., sterile efficacy, sterility maintenance, load capacity), not studies requiring human expert assessment or ground truth establishment in the way it would be for, say, an AI-powered diagnostic device. The "ground truth" for these tests would typically be established by validated laboratory methods for sterilization effectiveness and sterility.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable to the type of studies described. Adjudication methods are typically used in studies involving human interpretation or subjective assessment (e.g., medical image reading) where multiple experts might disagree. The performance tests for a sterilization container are objective and measured against pre-defined physical and biological parameters.
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. An MRMC study is relevant for evaluating diagnostic or interpretive AI systems where human readers interact with the AI. The Miltex Rigid Sterilization Container System is a physical medical device, not an AI or software-as-a-medical-device (SaMD).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. As stated above, this is a physical medical device, not an algorithm. The "standalone" performance refers to the device's ability to sterilize and maintain sterility based on its design and materials, which is what the validation testing evaluates.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the performance tests would be established through laboratory testing and microbiological methods. For example:
- Ethylene Oxide Sterile Efficacy Testing: Ground truth would be the complete kill (sterilization) of specified resistant microorganisms (e.g., Bacillus atrophaeus spores) inoculated onto test articles within the container, followed by incubation and verification of no growth.
- Aeration Time and EO Residuals: Ground truth would be the measurement of residual EO levels below acceptable safety thresholds using standardized analytical chemistry techniques.
- Sterility Maintenance: Ground truth would be the absence of microbial ingress after specified handling events and storage times, verified by microbiological culture methods.
- Load Capacity: Ground truth would be the ability of the container to hold the specified weight without structural failure or compromise to its function.
8. The sample size for the training set:
- This is not applicable. As a physical device, there is no "training set" in the context of machine learning or AI. The development of the device would involve engineering design, prototyping, and iterative testing, but not a data-driven training process in the AI sense.
9. How the ground truth for the training set was established:
- This is not applicable for the same reason as point 8.
§ 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).