(230 days)
The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
• Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• Ethylene Oxide (EO) with a concentration of 800 mg/L at 55° C (131° F) and 40% to 90% relative humidity for 6 hour. Aeration time of 7 days at 20℃).
The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintains the sterility of the enclosed devices for up to 24 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from prink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark grey after sterilization.
The maximum validated pouch load is 1.1 lbs (0.5kg); The maximum validated roll load is 1.1 lbs (0.5kg).
The Sterilization pouch and roll is composed of medical grade paper(60g/m²) and medical compound film(52um), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is:
Steam: 4 minutes at 132°C (270°F); 20 minutes dry time.
Ethylene oxide: 6 hours at 55 ℃; relative humidity between 40%- 90%; ethylene oxide concentration is 800 mg/L, 7 days aeration time at 20 ℃.
The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.
The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 24 months post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to Yellow (EtO) or Blue to Dark grey (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.
Based on the provided text, the device in question is a "Sterilization Pouch and Roll" and the document describes non-clinical performance testing rather than a study involving human subjects or AI algorithms. Therefore, many of the typical acceptance criteria and study design elements for AI/ML-based medical devices (like MRMC studies, expert adjudication for ground truth for training/test sets, effect sizes of human performance improvement with AI, etc.) are not applicable to this document.
The document discusses the physical and chemical performance of a sterilization packaging product. The studies described are bench testing and laboratory validation against established ISO and ASTM standards.
Here's the breakdown based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization Process Validation (EO) | ISO 11135:2014 | Ethylene oxide: 6 hours at 55 °C; relative humidity between 40%- 90%; ethylene oxide concentration is 800 mg/L, 7 days aeration time at 20°C. SAL=10-6 | SAL=10-6 (Pass) |
| Sterilization Process Validation (Steam) | ISO 17665-1:2006; ISO TS 17665-2:2009 | Steam: 8 minutes at 134°C; 8 minutes dry time. SAL=10-6 | SAL=10-6 (Pass) |
| EO/ECH Residuals | ISO 10993-7:2008 | EO 3 Kpa or No Burst | Minimum of Burst pressure = 6.4 (kPa) (Pass) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Dye Penetration) | ASTM F1929-15 | The dye solution is no any leakage across the seal width of sterile barrier system. (No Infiltration) | No Infiltration (Pass) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Seal Strength) | ASTM F88/F88M-15 | Seal strength > 2.5 (N/15mm) | Minimum of Seal strength = 2.9 (Pass) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Tensile Strength) | ISO 1924-2:2008 | Tensile strength: CD ≥ 2.2KN/m, MD ≥ 4.4KN/m | Pass |
| Package Integrity / Material Compatibility / Sterility Maintenance (Aging - Shelf Life) | Real time aging | 5 years real time aging (Incubation for empty pouch); 24 months real time aging Incubation for post steam/EO sterilization storage | The test results of all samples meet the requirements. (Pass) (Real-time test for empty pouch: Jan. 08, 2017 to Jan. 28, 2022. Real-time test for exposed pouch: Jan. 08, 2020 to Jan. 20, 2022). |
| Package Integrity / Material Compatibility / Sterility Maintenance (Leakage) | ASTM F2096-11 | No Leakage | No Leakage (Pass) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Microbial Barrier) | DIN 58953-6 | CFU = 0 | CFU = 0 (Pass) |
| Chemical Indicator Efficacy Testing (Steam) | ISO 11140-1:2014 | The color of CI changes from Blue to Dark Grey, when exposed to Steam; Change the color: Color of indicator changes from blue to dark grey after Steam sterilization. Should remain stable before use (5 years shelf life) and maintain endpoint stability (24 months post-sterilization). | Color of indicator changes from blue to dark grey under indicated condition and no changed under other condition. (Pass). (Empty pouch: Original color maintained Jan. 08, 2017 to Jan. 28, 2022. Exposed pouch: Dark Grey color maintained Jan. 08, 2020 to Jan. 20, 2022). |
| Chemical Indicator Efficacy Testing (EO) | ISO 11140-1:2014 | The color of CI changes from Pink to Yellow, when exposed to EO gas. Color of indicator changes from pink to yellow after EO sterilization. Should remain stable before use (5 years shelf life) and maintain endpoint stability (24 months post-sterilization). | Color of indicator changes from pink to yellow under indicated condition and no changed under other condition. (Pass). (Empty pouch: Original color maintained Jan. 08, 2017 to Jan. 28, 2022. Exposed pouch: Yellow color maintained Jan. 08, 2020 to Jan. 20, 2022). |
Since this is a non-clinical device (sterilization pouch), the following points are not applicable as they relate to clinical studies, AI/ML models, and human expert evaluations of diagnostic imaging.
- Sample size used for the test set and the data provenance: Not applicable. This refers to physical samples of the sterilization pouches and rolls tested in a laboratory setting, not a "test set" in the context of an AI/ML model. The provenance would be the manufacturing site (China) and the tests are prospective lab tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is established by physical measurements and compliance with international standards (ISO, ASTM), not by human expert opinion.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Ground truth is determined by standardized test methods.
- 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. This is not an AI/ML diagnostic device for human interpretation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on the specified performance criteria defined by international standards (ISO, ASTM) and physical/chemical properties.
- The sample size for the training set: Not applicable. This device does not involve a training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.
§ 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).