(239 days)
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam Sterilizer and via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:
- · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 30 minutes.
- · Gravity steam at 132°C (270°F) for 15 minutes; Drying time of 30 minutes.
- · Gravity steam at 135°C (275°F) for 10 minutes; Drying time of 30 minutes.
- · Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
- · Pre-vacuum steam at 135°C (275°F) for 3 minutes; Drying time of 16 minutes.
· EO sterilization cycle is 4 hours at 55°C (131°F) with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L.
Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the pouch has undergone either a steam or EO sterilization process.
The SIGMA sterilization pouches and rolls are inserted into the Pouch/Roll, sealed, and then sterilized in the Sterilization System. 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 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization.
The Self-seal pouch permits sealing of the pouch without need of heat- sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the steam/or EO Sterilization cycles.
The chemical indicators ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas. The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam. And the color changes from red to yellow, when exposed to EO gas.
The 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 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.
The provided document is a 510(k) premarket notification for the SIGMA Sterilization Pouch and Roll. It does not describe an AI/ML medical device, but rather a sterilization packaging product. Therefore, the questions related to AI/ML device performance metrics such as sample size for test set, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device (K180661) through non-clinical performance testing.
Here's an analysis of the acceptance criteria and study as presented for this non-AI/ML medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are extensively detailed across multiple tables, primarily Table 2 ("Summary of the Proposed and Predicate Devices Technological Characteristics") and Table 3 ("Summary of Non-Clinical Testing"). I will extract the key information from these tables.
| Feature | Test/Standard | Acceptance Criteria | Reported Device Performance (Proposed Device) | Result |
|---|---|---|---|---|
| Sterilant Penetration / Drying Time / Aeration | ||||
| Steam Sterilization - SAL | ANSI/AAMI/ISO 17665-1:2006/(R)2013, ANSI/AAMI/ISO TIR 17665-2:2009 (R2016) | Meet the requirement of SAL 10-6, test BI (Steam processed): No bacterial growth | Using half-cycle and full-cycle analysis. Test BI: No bacterial growth | Pass |
| Steam Sterilization - Drying Time | ANSI/AAMI/ISO 17665-1:2006/(R)2013, ANSI/AAMI/ISO TIR 17665-2:2009 (R2016) | Weight difference before sterilization and after drying shall not exceed 0% | Weight difference = 0% | Pass |
| Steam Sterilization - Visual Drying | (Standard not explicitly listed for this specific bullet, but falls under the general standards above) | (Implied visual dryness) | Visual are drying. | Pass |
| EO Gas Sterilization - SAL | AAMI / ANSI / ISO 11135:2014 | Meet the requirement of SAL 10-6, test BI (EO processed): No bacterial growth | Using half-cycle analysis. Test BI: No bacterial growth | Pass |
| EO Gas Sterilization - Residuals | ISO 10993-7:2008 (R) 2012 | EO 400 (kgf/mm2), MD > 450 (kgf/mm2) | CD = 458, MD = 462 (min. value after Steam Sterilization) | Pass |
| Tear Resistance Test (Plastic Film) | ASTM D 1004 -13 | CD > 300 (kgf/mm2), MD > 350 (kgf/mm2) | CD = 443, MD = 453 (min. value after Steam Sterilization) | Pass |
| Thickness Variation | ASTM F 2251-13 | ±0.02 | ±0.003 | Pass |
| Internal Pressurization Failure Resistance | ASTM F1140/F1140M-13 | Pressurize to 80% of burst value and hold for 30s. Burst value > 5.0 (kPa) | Average Burst pressure = 5.8 (kPa) (after Accelerated Aging) | Pass |
| Dye Penetration Test (Seal Leaks) | ASTM F1929-15 | No leakage across the seal width of sterile barrier system | No Channels identified on package | Pass |
| Seal Strength | ASTM F88/F88M-15 | Strength > 356 (gf /25.4mm) | Site 1= 588, Site 2= 598, Site 3= 909, Site 4= 1016 (min. value of test results) | Pass |
| Accelerated Aging (Steam) | ASTM F 1980-07 | Incubated for 22.5 days under controlled conditions (Temp: 55°C / RH: 50%) simulating 6 months post-steam sterilization storage. | a. Test articles (no product included and steam sterilized 135°C/15min) were accelerated aged at 55°C and 50% R.H to simulate the real time aging of 6 months. b. Test articles (product included and steam sterilized 135°C/15min) were accelerated aged at 55°C and 50% R.H to simulate the real time aging of 6 months. (Implied that package integrity was maintained after aging, as it "Pass"ed) | Pass |
| Accelerated Aging (EO Gas, Sterility) | ASTM F 1980-07 | Incubated for 137 days under controlled conditions (Temp: 55°C / RH: 50%) simulating 3 years post-EO gas sterilization storage. | a. Test articles (no product included) were accelerated aged at 55°C and 50% R.H to simulate the real time aging of 3 years. b. Test articles (product included and EO sterilized) were accelerated aged at 55°C and 50% R.H to simulate the real time aging of 3 years. (Implied that package integrity was maintained after aging, as it "Pass"ed) | Pass |
| Accelerated Aging (General Shelf Life) | ASTM F 1980-07 | Incubated for 137 days under controlled conditions (Temp: 55°C / RH: 50%) simulating 3 years storage. | a. Test articles (no product included) were accelerated aged at 55°C, and 75% RH to simulate the real time aging of 3 years. b. Test articles (product included) were accelerated aged at 55°C, and 75% RH to simulate the real time aging of 3 years. (Implied that package integrity was maintained after aging, as it "Pass"ed) | Pass |
| Bubble Emission (Gross Leaks) | ASTM D3078-02(R2013) | No Leakage | No Leakage | Pass |
| Internal Pressurization (Gross Leaks) | ASTM F2096-11 | No Leakage | No Leakage | Pass |
| Microbial Barrier Test | DIN 58953-6 | CFU 1.7 | Average LRV = 3.31 | Pass |
| Chemical Indicator Efficacy Testing (Type 1 Process Indicators) | ||||
| Steam CI Color Change (Low Exposure) | AAMI/ANSI/ISO 11140-1:2014 | 121°C / 3.0 min & 134°C / 0.5 min: Unacceptable result (Color should not change significantly) | 121°C / 3.0 min & 134°C / 0.5 min: the result of color is Blue (No change) | Pass |
| Steam CI Color Change (High Exposure) | AAMI/ANSI/ISO 11140-1:2014 | 121°C / 10.0 min & 134°C / 2.0 min: Acceptable result (Color should change to endpoint color) | 121°C / 10.0 min & 134°C / 2.0 min: the result of color is from Blue to Greenish Black (Endpoint color) | Pass |
| Steam CI Color Change (Dry Heat Control) | AAMI/ANSI/ISO 11140-1:2014 | Dry heat 140°C / 30 min: Unacceptable result (Color should not change significantly) | Dry heat 140°C / 30 min: the result of color is Blue (No change) | Pass |
| EO Gas CI Color Change (Absence of EO) | AAMI/ANSI/ISO 11140-1:2014 | Absence of EO gas / 90 min: Unacceptable result (Color should not change significantly) | Absence of EO gas / 90 min: the result of color is Red (No change) | Pass |
| EO Gas CI Color Change (Low Exposure) | AAMI/ANSI/ISO 11140-1:2014 | EO gas Teat / 2 min: Unacceptable result (Color should not change significantly) | EO gas Teat / 2 min: the result of color is Red (No change) | Pass |
| EO Gas CI Color Change (High Exposure) | AAMI/ANSI/ISO 11140-1:2014 | EO gas Teat / 20 min: Acceptable result (Color should change to endpoint color) | EO gas Teat / 20 min: the result of color is Yellow (Endpoint color) | Pass |
| Chemical Indicator Shelf Life | AAMI/ANSI/ISO 11140-1:2014 | All performance attributes should maintain the original color: 3 years shelf life | The real-time test was carried out from October 15, 2007 to December 15, 2010. Test group exposed to Steam maintained Dark Green; test group exposed to EO maintained Yellow; Control group maintained original color. | Pass |
Regarding the sections that are not applicable to non-AI/ML devices (points 2-9):
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this is a physical medical device. The testing involves laboratory evaluations of material properties and sterilization efficacy, not interpretation of data. The document does not specify general "sample sizes" in terms of number of patients/cases, but rather the number of units tested for specific physical and chemical properties. The provenance is likely from the manufacturer's testing facilities in Taiwan.
-
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): Not applicable. "Ground truth" in the context of AI/ML refers to expert-labeled data. For this device, "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO, AAMI) and their specified pass/fail criteria for physical and chemical properties.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling of AI/ML data. The "acceptance criteria" here are objective measurements against defined standards.
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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 a standalone physical product, not an AI-assisted diagnostic or therapeutic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no AI algorithm. The device's performance is inherently standalone in its function as a sterilization pouch.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI device. For this physical device, the "ground truth" for its performance is determined by adherence to established international and national standards for sterilization packaging, material science, and chemical indicators (e.g., microbial barrier, tensile strength, peel strength, chemical indicator color change).
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The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML model for which a training set would be required.
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How the ground truth for the training set was established: Not applicable. Same reason as point 8.
§ 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).