(270 days)
Winner® Self Seal Sterilization Pouch with Steam and Ethylene Oxide Process Indicators is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam 121°C for 15 minutes or greater than or equal to 600 mg/l of ethylene oxide (EtO) for 1 hour at 55° C and 70%RH. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The process indicators on the pouches are intended to demonstrate that the device has been exposed to the steam or EtO sterilization process and to distinguish between processed and unprocessed devices.
These pouches are manufactured from a medical grade paper and plastic film that are heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Sterilization Pouch with indicators has the identical intended use, components, and manufacturing methods as our previous Self Seal Sterilization Pouch.
The provided text is a 510(k) summary for the "Winner® Self Seal Sterilization Pouch with Steam and Ethylene Oxide Process Indicators." This type of document is for medical device approval and focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria for a new, innovative AI/software device.
Therefore, much of the requested information (like sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance of an algorithm, etc.) is not applicable or available in this document because it describes a physical sterilization pouch, not a software or AI-driven diagnostic device.
Here's an analysis based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "The process indicators meet the performance requirements of ANSI/AAMI ST60:1996 standard entitled "Sterilization of health care products - Chemical indicators -Part 1: General requirements"." However, the specific quantitative acceptance criteria defined within ANSI/AAMI ST60:1996 and the detailed reported device performance against those criteria are not provided in this summary. Instead, a general statement of compliance is made.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Standards (Paper) | Conforms to recognized material standards (details not specified) |
| Material Standards (Film) | Conforms to recognized material standards (details not specified) |
| Physical Testing (Paper) | Pressure drop vs. flow, filtration efficiency from non-sterile, steam sterilized, and EtO sterilized devices (details not specified) |
| Physical Testing (Film) | Thickness, tensile strength, and elongation from non-sterile, steam sterilized, and EtO sterilized devices (details not specified) |
| Finished Device Performance | Seal strength, package burst, dye migration, temperature distribution for steam and EtO sterilization, steam and EtO sterilization of biological indicators (details not specified) |
| Process Indicators | Meets the performance requirements of ANSI/AAMI ST60:1996 standard entitled "Sterilization of health care products - Chemical indicators -Part 1: General requirements." (Specific quantitative criteria and measured performance not detailed) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "physical testing of the medical grade paper... and film... as well as, performance of these finished devices." The number of units tested is not specified.
- Data Provenance: The testing was conducted as part of the submission process, likely by the manufacturer (Winner Industries Co., LTD & Winner Medical USA, Inc.). The country of origin of the data is not specified beyond where the company is based (Shenzhen, China, and Pomona, CA, USA). The testing is prospective in nature, as it relates to evaluating the newly manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a physical sterilization pouch, not an AI/software diagnostic device requiring expert interpretation for ground truth. Performance is assessed against physical and chemical standards.
4. Adjudication method for the test set:
This information is not applicable for the same reasons as above.
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. The device is not an AI product and does not involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's performance is based on established material standards (e.g., medical grade paper and plastic film standards) and performance standards (e.g., ANSI/AAMI ST60:1996 for chemical indicators). It also involves demonstrating the ability to maintain sterility and allow sterilization, which would be verified through microbiology (sterilization of biological indicators) and physical integrity testing.
8. The sample size for the training set:
This is not applicable as the device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reasons as 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).