(368 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 ℃. 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 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 is offered in the following 5 types:
- Self-sealing sterilization pouches .
- . Sterilization pouches, Flat
- . Sterilization pouches, Gusseted
- . Sterilization rolls, Flat
- . Sterilization rolls, Gusseted
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 ℃. 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 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 is offered in the following 5 types:
- Self-sealing sterilization pouches: These pouches are made from a medical grade plastic film that . 0 is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.
- Sterilization pouches, Flat: These pouches has the same components with the Self-sealing . sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using.
- Sterilization pouches, Gusseted: These pouches are the same with the Sterilization pouches, flat, . except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
- Sterilization rolls, Flat: These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
- Sterilization rolls, Gusseted: These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
The SIGMA Sterilization Pouch and Roll underwent numerous validation studies to demonstrate its effectiveness and safety, confirming its substantial equivalence to predicate devices. These studies adhered to recommended practices, standards, and guidelines from organizations such as AAMI, ISO, and ASTM.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Sterilant Penetration | AAMI / ANSI / ISO 17665-1:2006, ISO TS 17665-2:2009, AAMI / ANSI / ISO 11135-1:2007 | Effectively adequate sterilant penetration to most difficult areas. Confirmed sterilant able to penetrate and sustain direct contact with instruments. |
| Drying Time | AAMI / ANSI / ISO 17665-1:2006, ISO TS 17665-2:2009, AAMI / ANSI / ISO 11135-1:2007 | Testing performed as described. Results confirm effective performance (specific quantitative result not detailed, but implied by meeting standard). |
| Aeration | AAMI / ANSI / ISO 10993-7:2008 | Aeration time validation test meets requiremeAAMI / ANSI / ISO 10993-7:2008. |
| Biocompatibility | ISO 10993-10:2010(E), ISO 10993-1:2009/Cor. 1:2010(E), ISO 10993-12:2007(E), ISO/IEC 17025:2005 | Showed "negative reaction." Meets requirements of ISO 10993-10:2010(E). |
| Package Integrity | AAMI / ANSI / ISO 11607-1:2006, ISO 1924-2, ISO 5636-3, ASTM D 3078-02, ASTM D882, ASTM F 2251-03, ASTM D 1004, ASTM E 1140-07, ASTM E 1929-98 (04), ASTM E 88-2007, ASTM F 1980-2007, ASTM F 1608-00 | Effectively adequate Package Integrity. |
| Material Compatibility | AAMI / ANSI / ISO 11607-1:2006, ISO 1924-2, ISO 5636-3, ASTM D 3078-02, ASTM D882, ASTM F 2251-03, ASTM D 1004, ASTM E 1140-07, ASTM E 1929-98 (04), ASTM E 88-2007, ASTM F 1980-2007, ASTM F 1608-00 | Testing performed as described. Results confirm effective performance (specific quantitative result not detailed, but implied by meeting standard). |
| Sterility Maintenance | AAMI / ANSI / ISO 11607-1:2006, ISO 1924-2, ISO 5636-3, ASTM D 3078-02, ASTM D882, ASTM F 2251-03, ASTM D 1004, ASTM E 1140-07, ASTM E 1929-98 (04), ASTM E 88-2007, ASTM F 1980-2007, ASTM F 1608-00 | Testing performed as described. Results confirm effective performance (specific quantitative result not detailed, but implied by meeting standard). |
| Chemical Indicator Efficacy | AAMI / ANSI / ISO 11140-1:2005 | Demonstrates effective stability of ink before use, lasting quality (color stability), completeness and uniformity of color change, and all-or-none change (unless color standard provided). Meets requirements of ISO 11140-1:2005. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample sizes used for each specific test within the validation studies. The studies reference adherence to international standards (AAMI, ISO, ASTM), which typically define appropriate sample sizes for such tests.
The data provenance can be inferred as originating from testing laboratories in connection with Sigma Medical Supplies Corp., which is based in Taiwan. The studies appear to be prospective, as they were conducted specifically for the validation of the SIGMA Sterilization Pouch and Roll.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The studies rely on established international standards and laboratory testing rather than expert-based ground truth for the performance criteria of sterilization pouches and chemical indicators.
4. Adjudication Method for the Test Set:
This information is not provided in the document. The validation methods described are primarily objective physical and chemical tests, rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images or clinical data. The SIGMA Sterilization Pouch and Roll is a Class II device for sterilization wraps and indicators, and its performance is evaluated through laboratory testing against established physical and chemical standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are standalone performance evaluations of the device itself (the pouches and their integrated chemical indicators). This is inherent to the nature of testing sterilization packaging and chemical indicators, which are designed to function independently based on physical and chemical principles, without human interpretation of "algorithm-only" performance in the context of AI.
7. The Type of Ground Truth Used:
The ground truth used for these studies is based on established scientific and engineering principles codified in international consensus standards (AAMI, ISO, ASTM). These standards define the acceptable performance parameters for sterilant penetration, drying time, aeration, biocompatibility, package integrity, material compatibility, sterility maintenance, and chemical indicator efficacy. The "ground truth" is therefore the successful compliance with these predefined objective criteria.
8. The Sample Size for the Training Set:
This is not applicable. The device is a physical product (sterilization pouch and roll) and does not involve AI or machine learning algorithms that require a training set. The validation studies focused on testing the manufactured product's compliance with performance standards.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable, as there is no training set for this device.
§ 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).