(84 days)
The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. 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 sterilization.
The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® 100S Sterilizer.
The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:
- Self-sealing sterilization pouches
- Sterilization pouches, Flat
- Sterilization pouches, Gusseted
- Sterilization rolls, Flat
- Sterilization rolls, Gusseted
Sterilization Pouch/Roll Made with Tyvek® is intended to contain medical devices to be terminally sterilized in the STERRAD® 100S Sterilization System. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the STERRAD® 100S Sterilization System (The recommended cycle parameter is 6 minutes (Injection volume: 2880µL) at 50°C.). After completion of the sterilization process, the Pouch/Roll maintains 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 sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® 100S Sterilization System.
The pouches are constructed from Tyvek®/plastic films, with H2O2 Chemical Indicator printed onto the Tyvek® film. 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 STERRAD® Sterilization Systems.
The H2O2 Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. H2O2 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to blue (or lighter) when exposed to hydrogen peroxide.
The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:
- Self-sealing sterilization pouches
- Sterilization pouches, Flat
- Sterilization pouches, Gusseted
- Sterilization rolls, Flat
- Sterilization rolls, Gusseted
The provided text describes the regulatory submission for a medical device (Sterilization Pouch/Roll Made with Tyvek®) seeking 510(k) clearance from the FDA. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the safety and effectiveness of a novel AI/software-as-a-medical-device (SaMD).
Therefore, the information typically requested regarding acceptance criteria and study design for AI/SaMD devices (like sample size for test/training sets, data provenance, expert
qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) is not applicable to this submission. This device is a physical product, and its performance is evaluated through material science, sterility, and packaging tests.
However, I can extract the acceptance criteria and reported performance for the physical device based on the non-clinical testing summaries.
1. A table of acceptance criteria and the reported device performance:
| Test Category | Test Method / Standard (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Sterilant Penetration | AAMI / ANSI / ISO 14937:2009, "Sterilization of Health Care Products - General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices" (Acceptance: Able to penetrate and sustain direct contact with the medical instrument inside) | Confirmed that the sterilant is able to penetrate the device and sustain direct contact with the medical instrument inside. |
| Sterilant Penetration | Half-Cycle Efficacy (Acceptance: 6 log reduction of Geobacillus stearothermophilus) | Showed a 6 log reduction of Geobacillus stearothermophilus. |
| Biocompatibility | ISO 10993-10:2010(E), "Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization" (Acceptance: Meets requirements, non-irritating) | Showed "negative reaction" (non-irritating) and met requirements. |
| Package Integrity | ASTM F2251-03, "Standard Test Method for Thickness Measurement of Flexible Packaging Material" (Acceptance: Passed) | Passed |
| Package Integrity | ASTM D882, "Standard Test Method for Tensile Properties of Thin Plastic Sheeting" (Acceptance: Passed) | Passed |
| Package Integrity | ASTM D 5035, "Standard Test Method for Breaking Force and Elongation of Textile Fabrics (Strip Method)" (Acceptance: Passed) | Passed |
| Package Integrity | ASTM D1922, "Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method" (Acceptance: Passed) | Passed |
| Package Integrity | ASTM F1140-07, "Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages" (Acceptance: Passed) | Passed |
| Package Integrity | ASTM F88/F88M; ISO 11607-1, "Standard Test Method for Seal Strength of Flexible Barrier Materials" (Acceptance: Passed) | Passed |
| Package Integrity | ASTM F1929-98 (04); ISO 11607-1, "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration" (Acceptance: Passed) | Passed |
| Material Compatibility | AAMI / ANSI / ISO 11607-1:2006//A1:2014, "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems" (Acceptance: Met criteria) | Met material compatibility acceptance criteria. |
| Sterility Maintenance | DIN 58953-6:2010-05, "Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized" (Acceptance: Passed) | Passed |
| Sterility Maintenance | AAMI / ANSI / ISO 11607-1:2006//A1:2014 (Acceptance: Met criteria for sterility maintenance after aging) | Met sterility maintenance acceptance criteria. |
| Sterility Maintenance | Durability: Accelerated Aging Test (ASTM F 1980-2007; ISO 11607-1) (Acceptance: Passed for 3 years accelerated aging, maintaining seal strength) | Passed (3 years accelerated aging, seal strength maintained). |
| Chemical Indicator Efficacy | AAMI / ANSI / ISO 11140-1:2014, "Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements" (Acceptance: Sterilant penetrated through pouch, CI color changed to endpoint color, color stability for 3 years, completeness/uniformity of color change) | The sterilant penetrated through the pouch, the CI color changed to the endpoint, indicator dye remained stable for 3 years real-time aging, and the color change was effective. |
For the following points, as explained, they are not applicable because this is a 510(k) submission for a physical medical device (sterilization pouches) based on substantial equivalence, not an AI/SaMD (Software as a Medical Device). The evaluation focuses on material properties and performance under sterilization conditions rather than algorithmic performance on complex data (like images or medical records).
2. Sample sizes used for the test set and the data provenance: Not applicable. The tests performed are engineering and material-science based, using samples of the device and specific test setups, not patient-derived data. The document does not specify a "test set" in the context of an AI algorithm, nor "data provenance" (e.g., country of origin) relevant to patient data. The non-clinical tests were likely conducted in a controlled laboratory environment.
3. 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 as typically defined for AI/SaMD (e.g., disease diagnosis from medical images) is not relevant here. The "ground truth" for these tests are objective measurements against established engineering and biological standards (e.g., quantitative measures of tensile strength, observable microbial growth, or chemical indicator color change).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve disagreements among human annotators/experts for ground truth establishment in AI/SaMD; this is not relevant for materials testing.
5. 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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance evaluations are based on established industry standards and scientific principles for material properties (e.g., ASTM standards for mechanical properties), biological efficacy (e.g., 6-log reduction for sterilization), and chemical reactivity (e.g., color change of indicators). No human expert consensus or outcomes data in a clinical context is used as "ground truth" for this device's acceptance.
8. The sample size for the training set: Not applicable. There is no AI training set involved.
9. How the ground truth for the training set was established: Not applicable. There is no AI training set involved.
§ 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).