(120 days)
PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization with steam or ethylene oxide (EO) applying the below validated sterilization cycle parameters. The indicated sterilization parameters for either steam or EO are the only validated sterilization parameters to be used/applied.
The recommended (and validated) sterilization cycle parameters are;
· For steam sterilization pre-vacuum cycle at 132 degrees C for 4 minutes.
· For EO sterilization: 100% ethylene oxide (EO) with a concentration of 725mg/l at 55 degrees C and 50-80% relative humidity for 60 minutes. Aeration time is 8 hours.
Chemical process indicator on the exterior of the pouch indicates by color change that the pouch has undergone either a steam or ethylene oxide sterilization process.
After the sterilization process is completed the sterility of the enclosed medical device is maintained for 30 days.
PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are manufactured from medical grade paper/plastic film that are heat sealed on 3 sides, the fourth side has a self-seal adhesive strip and left opened. This side is manually sealed by the user with the self-seal adhesive strip. Triple band seal provides three independent barriers to contamination, while reducing the risk of fibre tear. PMSSteripack Self Seal Sterilization Pouches with Chemical Indicator (KP); are presented as 60 gsm model.
The provided text describes the acceptance criteria and performance data for a medical device called "PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP)". However, it does not contain the level of detail requested for AI/ML device studies (e.g., number of experts, adjudication methods, training/test set sample sizes, ground truth provenance for training set). This is because the document is a 510(k) premarket notification for a sterilization pouch, which is a physical medical device, not an AI/ML algorithm. Therefore, the questions related to AI/ML device performance are not applicable.
Here's the information that can be extracted from the document, presented in a format that aligns with the request where possible:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria / Requirement | Reported Device Performance (PMSSteripack Self Seal Sterilization Pouch with Chemical Indicator (KP)) | Substantial Equivalence to Predicate Device (SIGMA Sterilization Pouch and Roll (K102158)) |
|---|---|---|---|
| Intended Use | Single use device to enclose medical devices for sterilization by Steam and EO sterilization methods. Specific validated cycle parameters for Steam (132°C for 4 min) and EO (100% EO, 725mg/L, 55°C, 50-80% RH for 60 min, 8hr aeration). Chemical indicators show exposure to sterilization process. Sterility maintained for 30 days. | Functions as a single-use device for enclosing medical devices for sterilization. Conforms to specified validated Steam and EO sterilization cycle parameters. Chemical indicators change color to indicate exposure. Sterility maintained for 30 days. | YES (Similar intended use, though specific cycle parameters and sterility maintenance duration) |
| Design and Construction & Material Composition | Medical grade paper and heat-sealed laminated PET/PP plastic film. Externally printed Steam and EO process indicator ink. Heat-sealed on 3 sides, self-seal adhesive strip on 4th side. | Medical grade paper and heat-sealed laminated PET/PP plastic film. Externally printed Steam and EO process indicator ink. Heat-sealed on 3 sides, self-seal adhesive strip for manual closure. | YES |
| Sterilization Properties (Validated Parameters) | Steam: Pre-vacuum cycle at 132 °C for 4 minutes. EO: 100% ethylene oxide (EO) with a concentration of 725 mg/L at 55 °C and 50-80% relative humidity for 60 minutes. Aeration time is 8 hours. | Steam: Validated for pre-vacuum cycle at 132 °C for 4 minutes. EO: Validated for 100% ethylene oxide (EO) with a concentration of 725 mg/L at 55 °C and 50-80% relative humidity for 60 minutes. Aeration time is 8 hours. | YES (Different specific parameters than predicate, but still considered substantially equivalent for the capability of sterilization, with its own validated parameters). |
| Principle of Operation | Medical device placed in pouch, manually sealed with adhesive strip. Subjected to validated Steam & EO sterilization. Sterilant penetration through medical grade paper destroys microorganisms. Chemical process indicator changes color. Sterility maintained for 30 days. | Operates as described: device placed in pouch, sealed, sterilized (Steam/EO), sterilant penetrates paper. Chemical indicator changes color. Sterility maintained for 30 days. | YES |
| Principles of Operation for Chemical Indicators | Process Indicator Ink on medical grade paper changes color when exposed to sterilant vapor. Steam: pink to brown. EO: turquoise to yellow. | Steam indicator changes from pink to brown. EO indicator changes from turquoise to yellow. | YES |
| Shelf Life | 5 years | 5 years | YES (Longer than predicate's 3 years, but considered substantially equivalent as it meets or exceeds requirements). |
| Configurations & Dimensions | Various sizes (width and height) | Various sizes (width and height) | YES |
| Sterilant Penetration | Sterility assurance level (SAL) of 10^-6 achieved. | Sterility assurance level (SAL) of 10^-6 achieved for both steam and EO. | YES |
| Microbial Barrier Properties | Sterility maintained for at least 30 days after processing. | Sterility maintained for at least 30 days after processing in Steam and EO sterilizer. | YES |
| Material Compatibility | Suitability for use in Steam and EO sterilization processes and cycle parameters. | Suitable for use in Steam and EO sterilization processes and cycle parameters. | YES |
| Biocompatibility | Non-direct patient-contacting devices; materials non-toxic and meet ISO 10993-1. | Not direct patient-contacting devices; materials non-toxic and meet ISO 10993-1 requirements. | YES |
| Package Integrity | Porous material providing a microbial barrier. | Porous material providing a microbial barrier. | YES |
| Compliance with Standards | ANSI/AAMI/ISO 11140-1:2005 (for chemical indicators) and ANSI/AAMI/ISO 11607-1:2006 (for packaging) | Meets the requirements of ANSI/AAMI/ISO 11140-1:2005 and ANSI/AAMI/ISO 11607-1:2006. | YES |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document is for a physical medical device (sterilization pouch), not an AI/ML device. Therefore, a "test set" in the context of an AI/ML algorithm is not applicable. The performance data is based on various standard tests for sterilization packaging and indicators. The provenance mentioned is PMS Tıp Teknolojileri Sanayi ve Ticaret Limited Şirketi, located in Mersin, Turkey. The testing would have been conducted as part of the device's development and validation, which is prospective in nature, but specific sample sizes for each test are not detailed in this summary document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to a physical medical device like a sterilization pouch, as "ground truth" established by experts in the context of AI/ML algorithms does not apply here. Performance is evaluated against established physical, chemical, and microbiological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to a physical medical device. Performance is evaluated against objective, measurable criteria and standards, not expert adjudication of complex interpretations.
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 question is not applicable to a physical medical device. MRMC studies are relevant for imaging or diagnostic AI where human readers interact with the AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to a physical medical device. There is no AI algorithm involved. The device operates independently of human interpretation in terms of its core function (sterilization and indication).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" used for testing would be based on:
- Physical/Chemical Standards: Adherence to material specifications, seal strength, and indicator color change criteria as defined by international standards (e.g., ISO 11140-1, ISO 11607-1).
- Microbiological Standards: Demonstrated sterility assurance level (SAL) of 10^-6, typically confirmed through biological indicator tests and sterility testing after exposure to validated sterilization cycles.
- Performance Standards: Ability to maintain sterility for the stated shelf life (30 days in this case).
8. The sample size for the training set
This question is 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
This question is not applicable, as this is not an AI/ML device that requires a training set or its associated ground truth establishment.
§ 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).