(371 days)
The BH sterilization pouch is intended to provide dentists with an effective method to enclose devices intended for sterilization in steam auto claves. The recommended pre-vacuum steam sterilization cycle parameters are 4 minutes at 132°C (270°F). The sterilization pouch maintains the enclosed devices up until 180 days post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the pouch has undergone a steam sterilization process. Only one instrument can be sterilized in one pouch and only instruments that are be metal, hinged, or knurled can be sterilized in the pouch.
The pouches are made from a medical grade paper and plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the paper to the film prior to sterilization of the enclosed medical device. The medical grade paper conforms to recognized material standards and can be steam sterilized. The process indicator ink printed on the medical paper will exhibit a color change after the pouch is exposed to steam sterilization. The device is disposable, single use only.
Here's a breakdown of the acceptance criteria and the study information for the BH Sterilization Pouch, based on the provided document:
Acceptance Criteria and Device Performance
The document summarizes that the device demonstrated it met the acceptance criteria for each test performed. While specific numerical acceptance criteria are not explicitly detailed in a separate table within the document, the "Summary of Non-Clinical Testing" and "Conclusion" sections confirm that testing was conducted and passed. The criteria are implied by compliance with the referenced standards.
| Test Category | Implied Acceptance Criteria (Based on Standards) | Reported Device Performance |
|---|---|---|
| Sterility Maintenance | Maintain sterility for the specified shelf life (180 days). | Demonstrated maintenance of sterility for 180 days. |
| Thermal Profile / Sterilant Penetration | Achieve adequate sterilant penetration and maintain steady-state thermal conditions throughout the recommended sterilization cycle. | Sterilant penetration demonstrated; maintained steady-state thermal conditions. |
| Pouch Performance (Seal Integrity) | Meet specified strength and integrity requirements for seals (e.g., as per ASTM F88, F1929, F1140). | Met requirements (implied by passing tests). |
| Microbial Barrier (Packaging Material) | Provide an effective barrier against microbial penetration (as per ASTM 1608). | Met requirements (implied by passing test). |
| Steam Chemical Indicator Efficacy | Indicator must show a clear and discernible color change after exposure to steam sterilization, meeting ISO 11140-1:2014 requirements. | Indicator exhibited a color change after steam sterilization; compliant with ISO 11140-1. |
| Biocompatibility | Non-cytotoxic, non-sensitizing, and non-irritating (as per ISO 10993-5 and ISO 10993-10). | Device found to be non-cytotoxic, non-sensitizing, and non-irritating. |
| Shelf Life (Pouch & Indicator) | Pouch: Maintain usability and integrity for the specified shelf life (2 years). | |
| Indicator: Maintain efficacy for the specified shelf life (2 years). | Pouch: 2 years (implied by comparison to predicate). | |
| Indicator: 2 years (implied by comparison to predicate). | ||
| Process Type 1 Chemical Indicator Efficacy Endpoint Stability | Maintain indicator efficacy for the specified duration (180 days). | 180 days (implied by comparison to predicate). |
Study Details
The provided document describes a non-clinical testing summary for the BH Sterilization Pouch to demonstrate substantial equivalence to a predicate device (Medicom Self Sealing Sterilization Pouch, K070428).
1. Sample sizes used for the test set and data provenance:
- Sample Size: The document does not explicitly state numerical sample sizes for each test (e.g., how many pouches were tested for seal strength). It only lists the test methods used.
- Data Provenance: The studies were non-clinical performance tests conducted for regulatory submission (510(k)) in the People's Republic of China (manufacturer location). It is prospective testing designed to characterize the device's performance according to established standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This is not applicable as the studies are in vitro (non-clinical/bench testing) and do not involve human readers, clinical images, or expert interpretation for ground truth establishment. The "ground truth" is determined by established performance metrics and adherence to international technical standards (e.g., ASTM, ISO).
3. Adjudication method for the test set:
* Not applicable, as there are no human interpretations or disagreements to adjudicate. The tests have predefined pass/fail criteria based on the relevant standards.
4. 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. This is a non-clinical in vitro study of a sterilization pouch, not an AI-powered diagnostic device. MRMC studies are irrelevant in this context.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device does not involve an algorithm or AI.
6. The type of ground truth used:
* The "ground truth" for the non-clinical tests is based on objective, verifiable measurements and comparisons against established international standards and specifications. For instance:
* Seal Integrity: Measured seal strength via ASTM F88, dye penetration via ASTM F1929, and internal pressurization failure via ASTM F1140. The ground truth is the performance metric defined by these standards.
* Sterilant Penetration/Thermal Profile: Measured physical parameters against established successful sterilization conditions.
* Microbial Barrier: Measured resistance to microbial penetration against a defined metric (ASTM 1608).
* Chemical Indicator: Visual observation of color change and comparison against established criteria for a successful indicator as per ISO 11140-1.
* Biocompatibility: Laboratory assays for cytotoxicity, sensitization, and irritation interpreted against the criteria of ISO 10993-5 and ISO 10993-10.
7. The sample size for the training set:
* Not applicable. This device does not use machine learning or AI, and therefore has no "training set."
8. How the ground truth for the training set was established:
* Not applicable, for the reason stated above.
§ 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).