(507 days)
Used to enclose another medical device that is to be sterilized. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the device until used. ArjoRad Sterilization Wraps will maintain sterility for a maximum period of thirty (30) days. Intended for use with STERRAD 100S, NX, and 100NX Systems.
ArjoRad Sterilization Wrap is a sterilization packaging system consisting of one SMS sheet to be double wrapped during use. ArjoRad Sterilization Wrap will be sold in a non-sterile condition in packaged form of various sizes depending on the needs of the end user.
The ArjoRad Sterilization Wrap is a sterilization packaging system. The performance testing detailed in the provided 510(k) summary demonstrates its substantial equivalence to the predicate device (K092167 - Kimguard one step sterilization wrap - Kimberly - Clark Corporation) and its ability to meet acceptance criteria for maintaining sterility and allowing sterilant penetration.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Device Performance (ArjoRad Sterilization Wrap) | Predicate Device (K092167) | Test Standard/Method | Outcome/Proof |
|---|---|---|---|---|
| Physical Protection/Strength Properties | EN 868-2:2009, ASTM D737 | |||
| Substance Weight | Meets minimum requirements; specific values not provided. | Not detailed | Not detailed | ArjoRad meets criteria for non-woven sterilization wrap. |
| Strip Tensile Strength | Higher than predicate sterilization wrap. | Lower than ArjoRad | Not detailed | ArjoRad performs better or equally. |
| Mullen Burst | Higher than predicate sterilization wrap. | Lower than ArjoRad | Not detailed | ArjoRad performs better or equally. |
| Elmendorf Tear | Higher than predicate sterilization wrap. | Lower than ArjoRad | Not detailed | ArjoRad performs better or equally. |
| Air Permeability | Meets acceptance criteria after sterilization. | Not detailed | ASTM D737 | ArjoRad meets minimum requirement level. |
| Sterile Barrier Integrity | ||||
| Germ Resistance (after H2O2 sterilization) | Demonstrated germ resistance. | Demonstrated germ resistance | Microbial Aerosol Challenge Test | ArjoRad shows similar germ resistance to predicate. |
| Maintenance of Sterility | Maintains sterility for 30 days. | Maintains sterility for 30 days | Shelf Life Study | ArjoRad is a sterile barrier system capable of 30-day sterility (if barrier not compromised). |
| Sterilant Penetration/Efficacy | ||||
| Sterilization Efficacy (STERRAD cycles) | Assures a Sterility Assurance Level (SAL) of 10^-6 after each half cycle tested. | Performed similarly | Sterilization Efficacy Studies | Demonstrated successful penetration and sterilization across various STERRAD systems. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" in terms of number of wraps tested for each physical property or sterility test. However, it implicitly refers to "performance testing" and "studies" being carried out.
- Data Provenance: The studies were conducted by Arjo Wiggins Medical to demonstrate substantial equivalence to a legally marketed predicate device (Kimguard one step sterilization wrap). The testing would typically be performed in a controlled laboratory setting. No country of origin for data is specified, but it originates from the manufacturer for submission to the US FDA. The studies are prospective in nature, designed specifically to evaluate the performance of the ArjoRad Sterilization Wrap against established standards and a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the summary. For a physical device like sterilization wrap, "ground truth" is typically established through adherence to recognized international standards (e.g., EN, ASTM) and validated test methodologies rather than expert consensus on a test set in the way a diagnostic algorithm might require. The "experts" would be the scientists and engineers conducting the tests in accordance with these standards.
4. Adjudication Method for the Test Set
This concept is not applicable in the context of testing a physical device like sterilization wrap. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers when establishing ground truth for diagnostic studies, particularly in medical imaging. For device performance testing, results are determined by objective measurements against predefined acceptance criteria from standards.
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
This is not applicable as the device is a sterilization wrap, not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical sterilization wrap, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance of the ArjoRad Sterilization Wrap is based on:
- Objective Measurements against Industry Standards: Physical properties (tensile strength, burst, tear, air permeability) are measured against criteria defined in standards like EN 868-2:2009 and ASTM D737.
- Validated Test Methodologies: Microbial aerosol challenge tests and sterilization efficacy studies follow validated protocols to demonstrate germ resistance and sterility assurance levels (SAL).
- Comparability to Predicate Device: The performance data is explicitly compared to a legally marketed predicate device (K092167) to establish substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical product and does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as above (not an AI/ML device). The "ground truth" for the development and validation of the sterilization wrap would involve materials science, engineering principles, and adherence to regulatory and industry standards for medical device manufacturing and sterilization.
§ 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).