(143 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 high vacuum steam sterilizers. The containers have been validated for sterilization of instruments with lumens up to 3 mm I.D. by 400 mm length, for the Full (large) size container and up to 3mm I.D. by 200mm length for the ½ (small) and ¼ (medium) size containers. Sterilized devices may be stored and transported within the container.
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
- 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 provided text describes a 510(k) premarket notification for the Miltex Rigid Sterilization Container System. It does not describe an AI or algorithm-based device, but rather a medical device designed for sterilizing other medical instruments. Therefore, many of the requested details, such as those related to AI performance, ground truth, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes, are not applicable to this document.
However, I can extract information related to the device's performance against relevant standards and the nature of the study conducted, which is a validation study demonstrating the device's sterilization capabilities.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Miltex Rigid Sterilization Container System are based on conformance to AAMI standards and successful validation testing for steam sterilization.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance for Miltex System |
|---|---|---|
| Performance Standards | Conformance to appropriate AAMI standards for containment devices for reusable medical device sterilization. | Yes, conforms to AAMI ST 77 Draft- Containment Devices for Reusable Medical Device Sterilization. |
| Validation Testing - Sterilization | Demonstrated effectiveness in pre-vacuum steam sterilization. | Yes, validated through pre-vacuum steam sterilization testing. |
| Validation Testing - Load Capacity | Ability to accommodate specified weights of instruments for different container sizes. | Up to 16-lbs. (small) |
| Up to 20-lbs. (medium) | ||
| Up to 25-lbs. (large) | ||
| Validation Testing - Lumens | Effective sterilization of instruments with lumens of specific internal diameter and length. This is a critical performance aspect for sterilization containers, demonstrating sterilant penetration. | Up to 3-mm I.D. x 400-mm length (Full/large size container) for metal instruments. |
| Up to 3-mm I.D. x 200-mm length (½ /small and ¼ /medium size containers) for metal instruments. | ||
| (Tested with inoculated lumens—the document implies successful sterilization, as it's presented as a performance characteristic meeting the intended use). | ||
| Validation Testing - Medical Devices | Effective sterilization of inoculated medical devices. | Yes, testing was conducted with inoculated stainless steel medical devices (implied successful sterilization based on context). |
| Functional Characteristics | Intended for use with instruments to be sterilized in pre-vacuum (Hi-Vac) steam sterilizers, reusable, closed system, sealed, incorporates a filter system to permit entry of sterilant agent, incorporates a filter system to prevent microbial migration during transport. These are design and functional requirements for a rigid sterilization container to ensure safe and effective use. | Yes (Indicated for use in Hi-Vac steam sterilizers) |
| Yes (Reusable) | ||
| Yes (Closed System) | ||
| Yes (Sealed) | ||
| Yes (Incorporates a filter system to permit entry of sterilant agent) | ||
| Yes (Incorporates a filter system to prevent microbial migration during transport) |
(These are fundamental design and functional requirements inherent to the product category, and the "Yes" confirms they are met for the Miltex system). |
Study Information (as applicable for a non-AI medical device):
-
Sample size used for the test set and the data provenance:
- The document does not explicitly state a sample size in terms of number of containers or tests in a statistical sense for the validation. Rather, it describes the conditions and types of loads tested.
- The "test set" in this context refers to the conditions and materials used during the validation testing: "inoculated lumens" (3-mm I.D. x 400-mm, metal, and 3-mm I.D. x 200-mm, metal) and "inoculated stainless steel medical devices."
- Data provenance: Not specified, but likely laboratory-based (in-vitro) testing conducted by the manufacturer or a contracted lab to demonstrate efficacy for regulatory submission. It is prospective in the sense that the testing was performed specifically to validate the device's performance prior to market approval.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable to this type of device validation. Ground truth for sterilization efficacy is established through scientific methods like spore-kill assays and sterility testing, not expert consensus interpretation. The "ground truth" here is the absence of viable microorganisms after the sterilization cycle.
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Adjudication method for the test set:
- Not applicable. Sterilization efficacy is typically determined by objective biological and physical indicators (e.g., biological indicators showing no growth, chemical indicators showing proper sterilant exposure, physical parameters like temperature and pressure).
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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 study is for a physical medical device (sterilization container), not an AI algorithm.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used:
- The ground truth for adequate sterilization is based on microbiological sterility (absence of viable microorganisms) for the inoculated test pieces (lumens and stainless steel devices), confirmed by appropriate biological indicators and sterility testing methods. This aligns with scientific and regulatory standards (like AAMI) for sterilization efficacy.
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The sample size for the training set:
- Not applicable. This is not an AI or algorithm-based device that requires a training set. The "training" here would refer to the developmental process of the container design and manufacturing.
-
How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document details the conformance and validation testing of a physical medical device (sterilization container) against established performance standards and functional requirements. It does not pertain to software, AI, or diagnostic algorithms, and therefore, many of the requested categories related to such technologies are not relevant.
§ 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).