(131 days)
Ahlstrom Reliance® Tandem and Solo Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following:
- Pre-vacuum Steam 270°F/132°C for 4 minutes
- Gravity Steam 250°F/121°C for 30 minutes
- 100% Ethylene Oxide (EO) with a concentration of 725-735 mg/L @ 131°F/55°C and 40% 80% relative humidity for 60 minutes
- Advanced Sterilization Products (ASP) STERRAD® 100S
- Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles)
- STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles)
The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used.
The Reliance® Solo and Reliance® Tandem Sterilization Wraps are square or rectangular nonwoven sheets produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The Reliance® SMS Sterilization Wraps are separated into two distinct product offerings:
Reliance® Tandem: Consists of single sheets of SMS wrap, where two sheets are used together for the sequential wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.
Reliance® Solo: Consists of two sheets of SMS wrap, ultrasonically bonded together along two edges for convenient simultaneous wrapping of one or a collection of medical devices that will be sterilized following standard healthcare practices.
The Reliance® Solo and Reliance® Tandem Sterilization Wraps are composed of polypropylene with the addition of blue or green pigment and an anti-static treatment. Reliance® Tandem and Reliance® Solo wraps allow a sterilized package of medical devices to be opened aseptically.
This document is a 510(k) premarket notification for the Reliance® Solo Sterilization Wrap and Reliance® Tandem Sterilization Wrap, indicating substantial equivalence to a predicate device. It is not an AI/ML device, and therefore the standard questions about acceptance criteria for AI/ML devices, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training sets are not directly applicable.
However, I can extract the closest analogous information regarding the performance criteria and studies done to demonstrate the substantial equivalence of this medical device (sterilization wrap) to its predicate.
1. A table of acceptance criteria and the reported device performance:
Since this is not an AI/ML device, the performance is not about accuracy, sensitivity, or specificity. Instead, it revolves around functional and safety characteristics meeting established standards.
| Acceptance Criterion (Category) | Reported Device Performance |
|---|---|
| Biocompatibility (Cytotoxicity) | Pass per ISO 10993 |
| Sterilant Penetration | Pass per ANSI/AAMI ST79:2010 & A1:2010 and ANSI/AAMI/ISO 14937:2009 |
| Dry Time (Pre-Vacuum Steam) | Models T100/S100, T200/S200, T300/S300: 20 minutes (validated) |
| Models T400/S400, T500/S500, T600/S600: 30 minutes (validated) | |
| Dry Time (Gravity Steam) | Models T100/S100, T200/S200, T300/S300: 20 minutes (validated) |
| Models T400/S400: 30 minutes (validated) | |
| Models T500/S500 and T600/S600: Not validated for gravity steam sterilization. | |
| Aeration Time (Ethylene Oxide) | 8 hours at 55°C (validated) |
| Physical Integrity | Pass (implicitly through comparison to predicate and adherence to standards) |
| Microbial Barrier Properties (Packaging Integrity) | Pass (through comparison to predicate) |
| Material Compatibility | Pass (through comparison to predicate) |
| Toxicological Properties (Biocompatibility) | Pass (through comparison to predicate) |
| Maintenance of Sterility (Shelf-Life) | 90 days |
| Various Sterilization Cycles (ASP STERRAD, STERIS V-PRO) | All models validated for specific cycles and load configurations as detailed in the "Indications for Use" section (e.g., specific lumen diameters, lengths, maximum weights). |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of wraps tested for dry time). It refers to "testing," implying a sufficient number of units were tested to meet the requirements of the cited standards.
- Sample Size: Not explicitly stated as numerical values for each test, but implied to be sufficient to demonstrate compliance with the referenced industry standards for sterilization wraps.
- Data Provenance: The studies were conducted by Ahlstrom Nonwovens LLC to support their 510(k) submission. The exact country of origin of the data/testing labs is not specified, but the submission is to the U.S. FDA, suggesting U.S. or internationally recognized standards-compliant testing. These would be prospective studies specific to the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not relevant for the evaluation of a sterilization wrap. "Ground truth" in this context would be derived from physical measurements during testing against established scientific and engineering standards (e.g., bacterial filtration tests, air permeability tests, strength tests, sterility tests). The "experts" would be the scientists and engineers performing and interpreting these standardized tests.
4. Adjudication method for the test set:
Not applicable. Adjudication methods are typically for subjective assessments, which are not relevant for the objective physical and biological performance tests of a sterilization wrap.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
The "ground truth" for this device's performance relies on:
- Physical and Chemical Standards: Adherence to established ASTM, AAMI, ANSI, and ISO standards for properties like air permeability, tensile strength, tear resistance, material compatibility, sterilant penetration, and residual chemicals.
- Biological Standards: Performance in microbiological tests to demonstrate bacterial filtration efficiency and maintenance of sterility.
- Validated Sterilization Cycle Parameters: The ability of the wrap to perform as intended within defined and validated parameters of various sterilization cycles (e.g., steam, EO, low-temperature plasma).
8. The sample size for the training set:
Not applicable. This is not an AI/ML device, so there is no training set in the AI/ML sense. The "training" in manufacturing would refer to process validation and quality control, which are continuously monitored rather than a one-time dataset.
9. How the ground truth for the training set was established:
Not applicable. As noted above, there is no AI/ML training set. The "ground truth" for ensuring consistent product quality in manufacturing is established through adherence to Good Manufacturing Practices (GMP) and ongoing quality assurance processes, with specifications derived from the performance testing mentioned in point 7.
§ 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).