(182 days)
The PRIMED Sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider via the following:
- Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes. The wrap has been validated for dry time of 20 minutes for P100 and P200 and dry time of 30 minutes for P300, P400, P500 and P600.
- 100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% 80% relative humidity for 60 minutes. Validated for aeration times of 8 hours at 55°C or 12 hours at 43.3°C.
- Lumen. Non-Lumen. and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems.
- Advanced Sterilization Products STERRAD 100S system
- Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle]
- Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle]
PRIMED Sterilization wraps are available in 6 models and different sizes ranging from 12" X 12" to 54" X 90" and are intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used. PRIMED Sterilization wraps are validated for use with above listed sterilization systems with the intended loads as described below.
The PRIMED Sterilization wraps are made of SMS (Spunbond) Polypropylene with addition of a master batch pigment for coloration and are available in three separate product offerings:
1-The Fused one colour double layer bonded wrap is comprised of two sheets ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
2- The Fused two colours double layer bonded wrap is comprised of two sheets of purple and blue fabrics ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple or blue pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
3- The Single layer one colour wrap is comprised of a single nonwoven sheet. The standard purple wrap is composed of polypropylene with the addition of a purple pigment. Two sheets are used to sequentially wrap medical devices to be sterilized in accordance with standard healthcare practices.
PRIMED Sterilization wraps are available in various dimensions ranging from 12″ x 12″ x 90″ and six different weights as detailed in table 1.
The provided document is a 510(k) Summary for the PRIMED Sterilization Wrap. It outlines the device's technical characteristics, intended use, and a comparison to a predicate device, along with a summary of non-clinical testing.
However, the document does not describe an AI/ML-enabled medical device. It pertains to a physical sterilization wrap. Therefore, the questions related to AI/ML model performance, such as:
- Sample sizes for test and training sets
- Data provenance
- Number and qualifications of experts for ground truth
- Adjudication methods
- MRMC studies and effect sizes
- Standalone AI performance
- Type of ground truth
cannot be answered from the provided text. The document focuses on demonstrating substantial equivalence of a physical product to a predicate device through non-clinical testing of its physical, chemical, and functional properties related to sterilization and sterility maintenance.
Here's an analysis of the acceptance criteria and study as presented for this physical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Test Method | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|---|
| Sterilant Penetration | ANSI/AAMI ST79, ANSI/AAMI/ISO 11138-7 | All BI test samples should be negative for growth following the minimum incubation period | Pass |
| Maintenance of Package Integrity | ANSI/AAMI/ISO 11607-1, AAMI TIR12ANSI, AAMI ST79 | Maintain sterility for 30 days | Pass |
| Maintenance of package sterility | AAMI TIR12 -ANSI/AAMI ST77 | No growth in any of the culture vessels containing test coupons after the minimum incubation period | Pass |
| Residual | ISO 10993-7 | Less than maximum theoretical residual limits or the tolerable contact limit following a 100% ethylene oxide sterilization process | Pass |
| Biocompatibility | Cytotoxicity, Irritation and Sensitization ISO 10993-5 and ISO 10993-10 | non-cytotoxic, non-irritating and non-sensitizing | Pass |
| Physical and Chemical Properties and Material compatibility with the intended sterilization method, PH value, chloride content, sulphate content, colour fastness, Basis weight, Air permeability, Material burst strength, Grab Tensile strength, Trapezoidal Tear strength, Hydrostatic Pressure, Linting. | ISO 11607-1 and EN 868-2, ASTM D3776, ASTM D737-04, ASTM D3786, ASTM D5034-09, ASTM D5587-15, AATC127-2014, NWSP 160.1 | Meets physical and chemical properties, non-sterile and post sterilization | Pass |
2. Sample size used for the test set and the data provenance:
- The document refers to "non-clinical testing" and does not specify a "test set" in the context of data for an AI/ML model. Instead, it refers to tests performed on the physical sterilization wraps.
- The sample sizes for each specific physical test (e.g., number of wrap samples for sterilant penetration, integrity, etc.) are not provided in this summary.
- Data provenance is not applicable in the AI/ML sense; the data is generated from laboratory testing of the physical device. The country of origin for the data (where the tests were conducted) is not specified, but the manufacturer is based in Canada.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this device. Ground truth, in this context, refers to established scientific and engineering standards and methods for assessing the performance of sterilization wraps, not expert interpretation of images or clinical data.
4. Adjudication method for the test set:
- Not applicable to this device. Testing is based on established laboratory protocols and quantitative or qualitative measurements leading to pass/fail criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Not applicable. This device is a physical sterilization wrap, not an AI/ML-assisted diagnostic or treatment aid for humans.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used:
- For this device, the "ground truth" is established by adherence to recognized international and national standards for medical device sterilization and packaging. These include:
- ANSI/AAMI ST79 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities)
- ANSI/AAMI/ISO 11138-7 (Sterilization of health care products - Biological indicators - Part 7: Biological indicators for ethylene oxide sterilization processes)
- ANSI/AAMI/ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems)
- AAMI TIR12 (Guidance for establishing product family groupings for sterilization)
- ANSI/AAMI ST77 (Sterilization of health care products - Sterile device packaging - Requirements)
- ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
- ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- EN 868-2 (Packaging for terminally sterilized medical devices - Part 2: Sterilization wraps - Requirements and test methods)
- Various ASTM (American Society for Testing and Materials) standards for fabric properties (D3776, D737-04, D3786, D5034-09, D5587-15)
- AATCC127-2014 (Water Resistance: Hydrostatic Pressure Test)
- NWSP 160.1 (Nonwoven Standard Procedure for linting)
- These standards define the methodologies and acceptable performance limits.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML model.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).