(151 days)
The Sterilization Pouches and Reels is intended to provide health care workers with an effective method to enclosed devices in a single or double pouch configuration by steam or ethylene oxide sterilization. The recommended sterilization cycle parameters are as follows:
a) Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 ℃ (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
The Sterilization Pouches and Reels is composed of medical compound film, maintains the sterility of the enclosed devices for up to 12 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 indicators are designed to indicate to the user that the pouch has undergone either a steam or EO Sterilization indicators will change color according to the sterilization method (Steam, Ethylene oxide). The color of steam sterilization indicator changes from Pink before sterilization to Cocoa after sterilization. The color of Ethylene oxide sterilization indicator changes from Blue before sterilization to Golden Brown after sterilization. The maximum validated pouch load is 1.87 lbs. (850g); The maximum validated reel load is 1.87 lbs. (850 g)
The Sterilization Pouches and Reels is composed of medical compound film. It is intended to be used to contain medical devices to be terminally sterilized by Steam or EO sterilization process. The recommended sterilization cycle parameters are as follows:
- Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. a)
- b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 °C (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
The medical devices are inserted into the Pouches/Reels, and then sterilized for the EO or Steam Sterilization Process. The heat-sealed Pouches/Reels are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouches/Reels maintain sterility of the enclosed medical devices until the seal is opened. The Sterilization Pouches and Reels maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture.
The Sterilization Pouches and Reels is printed with chemical indicator bars that changed from Pink to Cocoa(Steam) or Blue to Golden Brown (EO) when exposed to steam vapor or EO gas during process. The steam and EO chemical indicator offer an addition way to verify processing in the sterilization cycle. The chemical indicator should be used in addition to, not in place of, the biological indicator. The steam and EO chemical indicators do not signify sterilization; they only indicate that the indicators have been exposed to the Steam or EO.
Based on the provided text, the device in question is "Sterilization Pouches and Reels" (K242898), which is a medical device intended for enclosing other medical devices for sterilization. There is no mention of "AI" or "human readers" in the context of this device. The document describes a traditional 510(k) submission, primarily focusing on non-clinical performance testing and comparison to a predicate device.
Therefore, many of the requested points in your prompt that relate to AI/algorithm performance, human readers, ground truth establishment for complex data, and MRMC studies are not applicable to the information provided.
However, I can extract information related to the acceptance criteria and the study that proves the device meets them, based on the non-clinical performance testing described.
Table of Acceptance Criteria and Reported Device Performance
The document details various performance tests conducted to demonstrate the safety and effectiveness of the Sterilization Pouches and Reels. The acceptance criteria are implicitly met if the "Pass" status is achieved for each test, indicating conformity to the referenced ISO or ASTM standards.
| Acceptance Criteria (Measured Performance Aspect) | Standard (Acceptance Threshold/Method) | Reported Device Performance |
|---|---|---|
| Sterilant Penetration Efficiency | SAL10-6 (Specific threshold for sterility assurance level - not explicitly defined in text but implied by standard) | Meets the requirement of SAL10-6 |
| EO, ECH (Ethylene Oxide, Ethylene Chlorohydrin) Residue | ISO 10993-7:2008 (EO Golden Brown after EO sterilized and 24 months shelf life; Steam CI: Pink -> Cocoa after steam sterilized and 24 months shelf life) | All specified color changes and stabilities met (Pass/Similar to predicate) |
| Maintenance of Sterility | Not explicitly stated as a test, but claimed as "12 months" | 12 months (validated for effectiveness) |
| Shelf Life | Not explicitly stated as a test, but claimed as "5 years from date of manufacture" | 5 years from date of manufacture (same as predicate) |
| Biocompatibility | ISO 10993-1, -5, -7, -10, -12 (Non-cytotoxic, non-irritative, non-sensitive to skin) | Non-cytotoxic, non-irritative, and non-sensitive to skin (Pass) |
Information Not Applicable or Not Found in the Provided Text:
- Sample size used for the test set and the data provenance: The document does not specify the sample sizes (number of pouches/reels) used for the non-clinical performance and biocompatibility tests. It also does not specify the provenance (country of origin, retrospective/prospective) of any "data" beyond general testing. The tests are laboratory-based performance tests of the device itself.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of this device, is adherence to established engineering and material science standards (e.g., ISO, ASTM), rather than expert consensus on medical image interpretation.
- Adjudication method: Not applicable, as there's no expert interpretation involved in the performance testing described.
- 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/software device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm.
- The type of ground truth used: For this device, the "ground truth" is adherence to established physical, chemical, and biological performance standards (e.g., seal strength, sterility barrier, chemical indicator color change, biocompatibility). It is determined by the results of specific standardized laboratory tests, not by expert consensus, pathology, or outcomes data in the traditional sense of medical diagnostics.
- The sample size for the training set: Not applicable. There is no AI/machine learning component, so no training set is used.
- How the ground truth for the training set was established: Not applicable. There is no AI/machine learning component, so no training set or its ground truth establishment is mentioned.
Summary of Applicable Information:
The study proving the device meets its acceptance criteria is primarily based on non-clinical performance testing as outlined by various international and national standards (ASTM, ISO, DIN). The document explicitly states: "Performance testing and Biocompatibility assessment were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device meet the following standards..."
The core method of verification is demonstrating "Pass" for each of the listed tests according to the requirements of the specified standards. This type of device relies on engineering and material science validation rather than clinical trials involving human subjects or AI performance metrics.
§ 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).