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510(k) Data Aggregation
(264 days)
Medline Reusable Sterilization Wrappers
Medline Reusable Sterilization Wrappers are intended to be used to enclose another medical device or component that is to be sterilized by health care professionals. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Medline Reusable Sterilization Wrap is a non-sterile, reusable device, with a wash/dry/autoclave life cycle as indicated on the Wrap.
Medline Reusable Sterilization Wrappers are available in 3 different fabrics that are either single or double ply bonded sheets of cotton and polyester blends. Model Angelstat is reusable up to 50 times; Models Resistat and Ripstop are reusable up to 75 times . The Medline Reusable Sterilization Wrappers are available in Misty Green, Jade Green or Ceil Blue with configurations 12"x12" through 72"x72" and 60"x90". The Medline Reusable Sterilization Wrappers are intended to be laundered then sterilized prior to use, and examined prior to use for defects and debris.
A prevacuum steam sterilization cycle at 270 F for 4 minutes has been validated for use on textile packs, with a minimum weight of 25 pounds and 30 minute dry time.
Medline recommends following the below standards for pack configuration and assembly in sterilization facilities. · AAMI ANSI ST79 • AAMI ANSI ST65
The Medline Reusable Sterilization Wrappers are offered in bulk, non-sterile packaging. The Medline Reusable Sterilization Wrappers are available in 3 different fabrics that are either single or double ply bonded sheets of cotton and polyester blends. The Medline Reusable Sterilization Wrappers are available in Misty Green, Jade Green or Ceil Blue with configurations 12"x12" through 72"x72" and 60"x90". The Medline Reusable Sterilization Wrappers are intended to be sterilized and laundered per the instructions.
The provided text describes the acceptance criteria and the results of non-clinical testing for the Medline Reusable Sterilization Wrappers.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Resistance to Water Penetration | AATCC 127-2018 | Test and Report - Average hydrostatic pressure | Pass |
| Tensile Strength and Elongation | ASTM D5034-21 | Test and Report - Average load at break and elongation at break for machine and cross direction | Pass |
| Particle Generation (Linting) | ISO 9073-10:2004 | Test and Report - Average lint counts of particles and coefficient of linting | Pass |
| Cytotoxicity | ISO 10993-5 | Non-Cytotoxicity - device did not show cytotoxicity potential | Pass |
| Sensitization | ISO 10993-10 | Non-sensitizing - device showed no significant evidence of causing delayed dermal contact sensitization | Pass |
| Irritation | ISO 10993-10 | Non-irritating - the irritation response category of the device was classified as Negligible | Pass |
| Acute Systemic Toxicity | ISO 10993-11 | Non-systemic toxicity – device did not show systemic toxicity potential | Pass |
| Sterilization Validation | ST79:2017 | All biological indicators shall be negative, positive controls shall be positive, chemical integrators shall demonstrate adequate steam penetration, negative and environmental controls shall be negative | Pass |
| Dry Time Validation | ST79:2017 | Average pre and post sterilization wrought difference of less than 0.2% within 5 minutes of cycle completion, no visible moisture following 30 minute cooling period and all integrators shall demonstrate steam penetration | Pass |
| Cleaning Validation | AAMI TIR30:2011 | Each test sample shall show a TOC level of less than 12µg/cm2 and no visible soil after cleaning | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes for each test listed. It mentions "Each test sample" for Cleaning Validation, implying multiple samples were tested. For other tests like Resistance to Water Penetration, Tensile Strength, and Particle Generation, it refers to "Test and Report" without specifying quantity.
The data provenance is not specified. It can be inferred that these tests were conducted by the manufacturer, Medline Industries, LP, to support their 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The listed tests are non-clinical bench tests and sterilization validations, which typically rely on standardized methods and laboratory analysis rather than expert human interpretation for "ground truth" establishment in the same way, for example, medical image analysis would.
4. Adjudication method for the test set
Not applicable. The tests are objective, laboratory-based physical, chemical, and biological evaluations, not requiring human adjudication of results in the traditional sense.
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 device is a medical accessory (sterilization wrapper) and does not involve AI or human "readers" for interpretation. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this device does not involve an algorithm or AI component.
7. The type of ground truth used
The ground truth for these tests is established by:
- Standardized Test Methods and Criteria: For physical and material properties (e.g., AATCC 127-2018 for water penetration, ASTM D5034-21 for tensile strength, ISO 9073-10:2004 for particle generation).
- Biological Test Outcomes: For biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity), the "ground truth" is determined by the biological response observed according to the protocols of ISO 10993 series.
- Sterilization Efficacy Indicators: For Sterilization Validation and Dry Time Validation, the "ground truth" is determined by the results of biological indicators, chemical integrators, and physical observations (e.g., moisture, weight difference) as per ST79:2017.
- Chemical Analysis: For Cleaning Validation, the "ground truth" is based on measurable chemical residuals (TOC level) and visual inspection for soil, guided by AAMI TIR30:2011.
8. The sample size for the training set
Not applicable. This device does not use an AI/ML component, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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