(214 days)
Winner® Self Seal Sterilization Pouch 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 ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
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 Winner® Self Seal Sterilization Pouch has the identical intended use and indication for use as the predicate devices, as well as, similar labeling.
The provided text describes a 510(k) submission for the Winner® Self Seal Sterilization Pouch, focusing on demonstrating substantial equivalence to predicate devices. It outlines the intended use, device description, and studies conducted to support the claim. However, the document does not contain the specific details required to complete your request in the format of a typical AI/ML medical device performance study.
Here's an analysis based on the available information:
This is NOT an AI/ML device. The submission is for a physical medical product (sterilization pouch), not a software algorithm or an AI-powered diagnostic tool. Therefore, many of the requested criteria related to AI/ML device performance studies (e.g., sample size for training set, number of experts for ground truth establishment, MRMC studies, standalone algorithm performance, AI vs. human improvement) are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes material and performance characteristics that were tested to establish substantial equivalence. These act as "acceptance criteria" for the physical properties of the pouch.
| Acceptance Criteria (Measured Characteristics) | Reported Device Performance (Summary) |
|---|---|
| Medical grade paper conformity to recognized material standards (pressure drop vs. flow and filtration efficiency) | Confirmed (tested for non-sterile, steam, and EtO sterilized finished devices) |
| Film characteristics (thickness, tensile strength, elongation) | Confirmed (tested for non-sterile, steam, and EtO sterilized finished devices) |
| Seal strength | Confirmed (tested for finished devices) |
| Package burst | Confirmed (tested for finished devices) |
| Dye migration | Confirmed (tested for finished devices) |
| Temperature distribution (for steam and EtO sterilization) | Confirmed (tested for finished devices) |
| Steam sterilization of biological indicators | Confirmed (tested for finished devices) |
| Ethylene Oxide sterilization of biological indicators | Confirmed (tested for finished devices) |
| Ability to maintain sterility until used (Implied) | Confirmed (Intended Use states this capability) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of pouches or samples tested for each characteristic. It only states that testing was performed on "non-sterile, steam sterilized and ethylene oxide sterilized finished devices."
- Data Provenance: The testing was presumably conducted by the manufacturer, Winner Industries Co., LTD, based in Shenzhen, China, or by a contracted lab. The document does not explicitly state the country of origin of the data beyond the manufacturer's location. The studies are prospective in the sense that they were conducted specifically to demonstrate the performance of the Winner® Self Seal Sterilization Pouch 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 concept is not directly applicable to a physical product's material and performance testing. The "ground truth" here is established by standardized testing methods and material specifications. For example, "seal strength" has a defined measurement and acceptance range, not an expert opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The testing involves objective measurements against established standards, not interpretation or adjudication by experts.
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:
Not applicable, as this is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" is based on standardized engineering and material science specifications and performance test methods relevant to sterilization packaging. For instance:
- ASTM standards for material properties (e.g., tensile strength, elongation).
- ISO or AAMI standards for package integrity (e.g., seal strength, burst testing).
- Biological indicator results demonstrating sterilization efficacy.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/ML device.
Conclusion:
The provided document describes a regulatory submission for a physical medical device (sterilization pouch) and details the physical and performance characteristics that were tested to demonstrate substantial equivalence to predicate devices. It clearly demonstrates the device meets the necessary "acceptance criteria" by showing conformity to recognized material standards and successful performance in various tests related to its intended use (sterilization and maintenance of sterility). However, the requested information format is largely geared towards AI/ML device studies, which do not apply to this product.
§ 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).