(70 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) for a maximum of 180 days or 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 text describes the acceptance criteria and the comprehensive non-clinical testing performed for the PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 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 TIR12 ANSI, AAMI ST79 | Maintain sterility for 180 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 (Ethylene Oxide) | 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, 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 Data Provenance
The document does not explicitly state the numerical sample size for each test set. However, it indicates that the testing was non-clinical. This implies that the data provenance is from laboratory testing and not from human patient data. The origin of the data is implicit in the "non-clinical" nature and the use of ISO/ASTM standards for testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of device and study. The "ground truth" for sterilization wraps and their performance is established through adherence to recognized international standards (ISO, AAMI, ASTM, EN) and empirical laboratory testing, not through expert consensus from human observation (e.g., radiologists).
4. Adjudication Method for the Test Set
This information is not applicable as the evaluations are based on objective laboratory measurements against predefined technical specifications and standards, not on subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable as the device is a sterilization wrap, not an AI-powered diagnostic or assistive tool for human readers.
6. Standalone Performance Study
Yes, the studies described are standalone performance studies (algorithm only without human-in-the-loop performance), as they focus on the intrinsic properties and performance of the sterilization wrap itself against established technical and biological criteria. The "algorithm" in this context refers to the defined device specifications and its physical/chemical interactions, not a software algorithm.
7. Type of Ground Truth Used
The ground truth used is primarily based on established industry standards and regulatory requirements for medical device sterilization and packaging, including:
- Biological indicators (for sterilant penetration and sterility maintenance) which have a known, predictable response.
- Physical and chemical property specifications (e.g., burst strength, air permeability, pH, leachable content) that are objectively measurable and defined by standards.
- Biocompatibility standards that define acceptable levels of cytotoxicity, irritation, and sensitization.
- Package integrity criteria for maintaining a sterile barrier for a specified duration.
8. Sample Size for the Training Set
This information is not applicable. The device is a sterilization wrap, not an AI/ML-based algorithm that requires a "training set" of data. The development and validation process for this device involves material science, engineering, and microbiology, not machine learning.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in point 8.
§ 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).