(308 days)
The Bioshield® Express™ Sterilization Wrap is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. This wrap is intended for use in prevacuum steam sterilization processes.
The Allegiance BioShield® Express™ Sterilization Wrap is composed of a wet formed non-woven cellulose fiber with acrylic binders. The Allegiance BioShield® Express™ Sterilization Wrap is a single-use, non-sterile device.
The provided document is a 510(k) Pre-Market Notification for the Allegiance BioShield® Express™ Sterilization Wrap. This type of document is for a medical device that does not use AI/machine learning and therefore, the requested information about acceptance criteria for AI performance, sample sizes for test and training sets, expert qualifications, and MRMC studies is not applicable.
The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, material composition, and performance attributes.
However, based on the Summary of Safety and Effectiveness and the Summary of Testing sections, I can extract and infer some information regarding the device's performance evaluation against established standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of quantitative acceptance criteria with reported numerical performance values in the way one would for an AI model's metrics (e.g., sensitivity, specificity). Instead, it states compliance with established standards and successful completion of tests.
| Performance Attribute / Test Category | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO Standard 10993 Part 1 | Material was evaluated and tested as required in ISO 10993 Part 1. |
| Skin Sensitization | Acceptable non-sensitization response | Subjected to skin sensitization testing. |
| Intracutaneous Reactivity | Acceptable non-reactive response | Subjected to intracutaneous reactivity testing. |
| Cytotoxicity | Acceptable non-cytotoxic response | Subjected to cytotoxicity testing. |
| Physical and Performance | Compliance with established standards for sterilization wrap (e.g., tensile strength, porosity, fluid repellency, microbial barrier properties, etc.) | Physical and performance testing was completed. |
| Sterilization Performance | Ability to allow sterilization and maintain sterility for its intended use in prevacuum steam sterilization processes. | Sterilization performance testing was completed. |
| Overall Compliance | Deemed acceptable for intended use and compliance with applicable established standards. | Product is in compliance with established standards, where applicable, and is deemed acceptable for its intended use. |
Note: The specific numerical acceptance criteria (e.g., "tensile strength X N/mm^2") are not detailed in this summary document but would be part of the detailed test reports submitted to the FDA.
2. Sample Sizes and Data Provenance for Test Set:
Not applicable. This is a physical product and the "test set" refers to samples of the sterilization wrap material subjected to laboratory and performance tests, not a dataset for an algorithm. The source of material is the manufacturer, Allegiance Healthcare Corporation.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. Ground truth for a physical medical device like sterilization wrap is established through recognized laboratory testing standards validated by scientific and engineering principles, not through expert consensus on diagnostic interpretations.
4. Adjudication Method for Test Set:
Not applicable. As described above, performance is evaluated through standardized physical, chemical, and biological tests, not through human adjudication of diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is relevant for diagnostic imaging devices or software where human readers interpret medical images. The BioShield® Express™ Sterilization Wrap is a commodity medical device.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device does not involve an algorithm.
7. Type of Ground Truth Used:
The ground truth for this device's safety and effectiveness relies on:
- Established ISO Standards (e.g., ISO 10993 Part 1 for biocompatibility): These standards define acceptable methodologies and limits for biological evaluation of medical devices.
- Industry-recognized test methods: For physical and performance attributes (e.g., material strength, air permeability, fluid resistance, microbial barrier properties relevant to sterilization wrap).
- Sterilization efficacy studies: Demonstrating the ability of the wrap to allow steam penetration for sterilization and maintain sterility.
8. Sample Size for Training Set & 9. How Ground Truth for Training Set Was Established:
Not applicable. There is no concept of "training set" for a physical medical device. The device's formulation and design are based on established engineering principles for materials science and sterilization technology, not machine learning training.
§ 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).