(83 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 steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C 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 user that the pouch has undergone either a steam or EO sterilization process.
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. The medical devices 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.
This document is a 510(k) Premarket Notification from Sigma Medical Supplies Corp. to the FDA regarding their SIGMA Sterilization Pouch and Roll. It seeks to prove substantial equivalence to a previously cleared device (K102158).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria here are derived from the comparison of the proposed device to the predicate device and the requirement to meet various ISO and ASTM standards. The study's "performance" is reported as "Passed" or "Meets requirements."
Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Expected Outcome) | Reported Device Performance |
|---|---|---|
| Material Composition | Same as predicate (Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam Process Indicator Print Ink) | Same as predicate (Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam Process Indicator Print Ink) |
| Steam Sterilization Cycle Parameters | 30 minutes at 121°C | Same (30 minutes at 121°C) |
| EO Gas Sterilization Cycle Parameters | 4 hours at 55°C, 50%-85% RH, 600 mg/L sterilant concentration | Same (4 hours at 55°C, 50%-85% RH, 600 mg/L sterilant concentration) |
| Pouch Types | Same as predicate (Self-sealing, Flat, Gusseted pouches; Flat, Gusseted rolls) | Same as predicate |
| Sterilant Penetration (Half-Cycle Efficacy) | Meet requirement of SAL 10^-6^ | The test meets the requirement of SAL 10^-6^ |
| Chemical Indicator (CI) Functionality & Endpoint | Sterilant penetrates and causes CI color change to endpoint color | The sterilant penetrated and affected the CI color change to the endpoint color |
| Package Integrity (Physical Properties) | Passed (based on various ASTM/ISO standards) | Passed for all listed tests (Thickness Variations, Tensile Strength of plastic film, Tensile Strength of paper, Air Permeance of paper, Tear Resistance Test, Burst Strength, Bubble Leak Test, Seal Peel Test, Dye Penetration Test, Microbial Barrier Test) |
| Toxicological Properties (Biocompatibility Test) | Passed (based on ANSI/AAMI/ISO 10993-10) | Passed. Showed "negative reaction". Meets ISO 10993-10:2010(E). EO sterilization residuals meet AAMI/ANSI/ISO 10993-7:2008 (R) 2012. |
| Durability: Accelerated Aging Test | Passed (based on ASTM F 1980; ISO 11607-1) | Passed |
| End Point / Post Processing Color Stability (Steam) | 6 months | 6 months |
| End Point / Post Processing Color Stability (EO) | 3 Years | 3 Years |
| Shelf Life (Chemical Indicator Functionality) | 3 Years | 3 Years |
| Shelf Life (Accelerated aging test - Seal Strength) | 3 Years | 3 Years |
| Class 1 Process Indicators for STEAM (Pouch & CI) | Remain stable before use, change color in presence of sterilant, maintain endpoint stability, meet ISO 11140-1:2014 requirements | Demonstrates ability to remain stable, change color, maintain endpoint stability. Meets ISO 11140-1:2014. |
| Class 1 Process Indicators for EO Gas (Pouch & CI) | Remain stable before use, change color in presence of sterilant, maintain endpoint stability, meet ISO 11140-1:2014 requirements | Demonstrates ability to remain stable, change color, maintain endpoint stability. Meets ISO 11140-1:2014. |
| Maintenance of Sterility (Steam) | Up to 6 months post Steam sterilization | Maintains up until 6 months post Steam sterilization |
| Maintenance of Sterility (EO) | Up to 3 years post EO gas sterilization | Maintains up until 3 years post EO gas sterilization |
Study Details:
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Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the exact sample sizes used for each test. It states that "The testing demonstrates the ability of the Sigma Sterilization Pouch and Roll" and "The testing results demonstrate the ability of the Sigma Sterilization Pouch and Roll."
- Data Provenance: The manufacturer is Sigma Medical Supplies Corp. located in Taiwan (R.O.C.). The testing (non-clinical) would likely have been conducted by or for this company. The document does not specify if the data is retrospective or prospective, but given it's a premarket notification for a new device (albeit similar to a predicate), it would be prospective data generated specifically for this submission.
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Number of Experts Used to Establish Ground Truth and Qualifications:
- This document describes performance testing of a medical device (sterilization pouches and rolls) against established standards (ISO, ASTM). It does not involve human interpretation of images or other data for which "ground truth" would be established by experts in a clinical sense (e.g., radiologists for diagnostic AI).
- The "ground truth" in this context is defined by the technical specifications and performance requirements of the relevant industry standards (e.g., attainment of SAL 10^-6^ for sterilization, specified physical properties, color change of chemical indicators).
- Therefore, the concept of "ground truth" established by a panel of human experts in the way it's used for AI/clinical diagnostic studies is not directly applicable here. The validity of the tests themselves is based on adherence to the referenced standards.
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Adjudication Method for the Test Set:
- Not applicable in this context. Adjudication is typically used for reconciling disagreements among human readers or evaluators in clinical studies. Here, the tests are objective measurements against defined standards.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. This type of study is relevant for assessing the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this device or its reported testing.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. All the described tests (Sterilant Penetration, Package Integrity, Biocompatibility, Chemical Indicator Efficacy, etc.) are evaluating the physical and functional properties of the device itself, independent of human interaction during its use (beyond following instructions). These are "algorithm only" in the sense that the device's performance is measured against objective criteria, not as part of a human-AI system.
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The Type of Ground Truth Used:
- The ground truth is based on industry-recognized technical standards (e.g., ISO, ASTM) for sterilant efficacy, package integrity, biocompatibility, and chemical indicator performance. For example, "SAL 10^-6^" or physical property thresholds defined by the standards.
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The Sample Size for the Training Set:
- This document describes premarket notification for a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device is manufactured based on design specifications and then tested.
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How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no "training set" for this type of device. The design and manufacturing processes are likely informed by prior engineering knowledge and adherence to quality systems for medical device production.
§ 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).