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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

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.

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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

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.

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