(99 days)
The Oticon Medical Sterilization Cassette is intended to organize and protect non-disposable medical device instrumentation during handling and use in hearing health care surgery. It is intended to be sterilized and stored with non-disposable medical device instrumentation. The Sterilization Cassette is intended to be used in conjunction with a legally marketed sterilization wrap in order to maintain sterility of the enclosed instruments until use.
The sterilization cassette is intended for washing, either manually or in an automated process in a washer disinfector, and for sterilization in a pre-vacuum steam sterilizer (min. three pulse, standard) utilizing either of the following cycles:
| Cycle alt 1 | Cycle alt 2 | Cycle alt 3 | |
|---|---|---|---|
| Temperature | 132°C (270°F) | 134°C (273°F) | 135°C (275°F) |
| Exposure time | 4 Minutes | 3 Minutes | 3 Minutes |
| Drying time (wrapped) | 20 Minutes | 16 Minutes | 16 Minutes |
The Oticon Medical Sterilization Cassette is a stainless steel cassette consisting of a base tray, a lid and an insert with instrument holders made of silicone. The lid is locked to the base tray by a locking tab. Once the lid is closed and locked, enclosed instruments are kept in place by the holders and a silicone rail in the lid.
The Sterilization Cassette is designed using materials that can be reused with steam sterilization methods. The base tray, lid and insert have evenly distributed perforations to allow for penetration of sterilant during steam sterilization. For the sterilization process, the cassette is to be used in conjunction with a legally marketed sterilization wrap.
This document is a 510(k) summary for the Oticon Medical Sterilization Cassette, demonstrating its substantial equivalence to predicate devices. It focuses on the device's intended use and performance in cleaning and sterilization.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance and Outcomes |
|---|---|---|
| Cleaning and Disinfection | Verification of automated cleaning and disinfection. Verification of manual and ultrasonic cleaning. | Demonstrated efficiency of the cleaning and disinfection procedures. |
| Sterilization Validation | Validation for pre-vacuum steam sterilizer (min. three pulse, standard) utilizing specified cycles: |
- 132°C (270°F) for 4 minutes exposure, 20 minutes drying
- 134°C (273°F) for 3 minutes exposure, 16 minutes drying
- 135°C (275°F) for 3 minutes exposure, 16 minutes drying. | Showed that under the selected processing parameters, excellent steam penetration was achieved within the wrapped cassettes. Sterilization testing further demonstrated a sterility assurance level (SAL) of 10⁻⁶ of the cassette and its contents when handled according to the recommended instructions. |
| Wear Following Re-use and Processing | Testing for wear following re-use and repeated processing (no specific quantitative criteria mentioned, but implied satisfactory performance). | The Sterilization Cassette functioned as intended, and the performance observed was as expected. The document concludes that "further testing will not raise new issues of safety or efficacy," implying acceptable wear characteristics over repeated use. |
| Material Compatibility | Material compatibility with sterilization process (based on comparison table). | "Yes" (stated in the comparison table, indicating compatibility). |
| Microbial Barrier Properties | To be used in conjunction with a legally marketed sterilization wrap to maintain sterility (based on comparison table). | Confirmed that for the sterilization process, the cassette is to be used in conjunction with a legally marketed sterilization wrap. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of cassettes, number of cleaning cycles, number of sterilization cycles) used for the performance testing. It generally refers to "Testing... includes" and "The testing demonstrated."
The data provenance is from Oticon Medical AB, Sweden, as indicated by the submitter's address and manufacturer information. The testing is prospective, conducted specifically for the purpose of demonstrating the device's performance for this 510(k) submission.
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 performance data section describes the outcomes of the tests (efficiency, steam penetration, SAL of 10⁻⁶), but does not detail the methodology for establishing ground truth or the involvement of experts in that process. For a sterilization cassette, the "ground truth" would typically be established by validated test methods (e.g., biological indicators for sterility assurance) rather than expert consensus on subjective observations.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or subjective assessments by multiple readers. For performance testing of a sterilization cassette, the results are derived from objective physical and microbiological measurements/assays, not from human interpretation that requires adjudication.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for a sterilization cassette. The document does not describe any AI component in this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (sterilization cassette), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply. The device's performance is inherently tied to its physical design and the validated processes it enables.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests would be based on objective scientific measurements and validated industry standards. For example:
- Cleaning and Disinfection: Ground truth would be the reduction of specific microbial loads or removal of simulated soil to predefined levels, typically measured quantitatively in a lab setting according to standards (e.g., ASTM, ISO).
- Sterilization Validation: Ground truth is achieved when test results (e.g., from biological indicators or physical monitoring) demonstrate a sterility assurance level (SAL) of 10⁻⁶, meaning a one-in-a-million chance of a non-sterile unit, as per relevant sterilization standards (e.g., ANSI/AAMI ST79).
- Wear Testing: Ground truth would be the maintenance of physical integrity and functionality after a specified number of reprocessing cycles, conforming to design specifications or acceptable wear limits.
The document states "sterilization testing further demonstrated a sterility assurance level (SAL) of 10⁻⁶," which is a key ground truth metric for sterilization.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As mentioned above, there is no AI/ML algorithm or training set for this 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).