(232 days)
Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) are intended to protect the ReNew Reusable Tips (Scissors, Graspers and Dissectors) and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap, sterility of the enclosed sterilization trays (Catalog #3708 and #3709) is maintained until used.
The Microline Surgical ReNew Sterilization Trays (Catalog #3709) are used to secure the ReNew Reusable Tips (Scissors, Graspers and Dissectors). Catalog #3708 measures at 7.8" length , 4.31" width, and 1.22" height , in dimensional measurements, as intended load during the transport, sterilization and storage between their intended use. Similarly, Catalog #3709 measures at 6.32" length, 3.32" width, and 1.21" height, in dimensional measurements as intended load during the transport, sterilization and storage between their intended use.
The ReNew Sterilization Tray (Catalog #3708 & 3709) have been validated with the ReNew Reusable Tips (Scissors,Graspers and Dissectors) wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing a calculated total weight of 280.52 grams, for Catalog number 3708, and 148.195 grams for Catalog #3709. The validation included Cleaning Validation (Automated and Manual) Testing and Steam Sterilization Cycles. The validated prevacuum cycle parameters are as follows: time: 4 minutes at temperature 132 °C, with a dry time of 30 minutes. The validated gravity cycle parameters are as follows: Time: 30 minutes at 121 °C with a dry time of 20 minutes, as well as time: 15 minutes at temperature 132 °C with a dry time of 20 minutes.
Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) intended purpose is to secure the ReNew Tips (Graspers, Dissectors, and Scissors) devices during its transportation, and storage purposes.
Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) consist of a base, a lid and device holding brackets. The lid can be fastened to the base by means of a locking tab, which is designed as a part of the lid. The brackets are constructed from biomedical grade silicone material. These brackets are used to secure the intended devices during their transport, sterilization and storage purpose. The ReNew Sterilization Trays (Catalog #3708 and #3709) are intended to be used for ReNew Tips sterilization purpose which are non-porous devices including graspers, dissectors, and scissors.
The Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) are medical devices intended to protect reusable tips and facilitate the sterilization process.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) | 10⁻⁶ (Met using biological indicator (BI) overkill method) |
| Cleaning Validation | Successful (Automated and Manual Testing) |
| Steam Sterilization Cycles | Validated: |
- Prevacuum cycle: 4 minutes at 132°C, 30 minutes dry time
- Gravity cycle: 30 minutes at 121°C, 20 minutes dry time
- Gravity cycle: 15 minutes at 132°C, 20 minutes dry time |
| Limits of Reuse | Validation completed (Specific limit not detailed in abstract) |
| Design Tolerance Analysis | Completed (Specific findings not detailed) |
| Shelf-Life Validation | Completed (Specific findings not detailed) |
| Biocompatibility | Not deemed necessary (Implies materials are known to be biocompatible for this use or testing was not required for substantial equivalence) |
| Bench Testing | Not deemed necessary (Implies similar performance to predicate or testing was not required for substantial equivalence) |
| New Validation (Design for Manufacturing/Assembly/Packaging) | Not deemed necessary (Implies processes are sufficiently similar to predicate) |
| Protection of ReNew Reusable Tips | Designed to secure and protect tips during transport, sterilization, and storage |
| Facilitation of Sterilization (Steam Penetration & Air Removal) | Lids and bases designed with evenly distributed hole patterns |
| Maintenance of Sterility (with wrap) | Maintained until used, when used with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a "sample size" for a test set in the traditional sense of a clinical trial or a large-scale data analysis. Instead, it refers to validation studies for sterilization and cleaning.
- Test Sample Description:
- ReNew Sterilization Tray (Catalog #3708) with a calculated total weight of 280.52 grams (when loaded with ReNew Reusable Tips, wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap).
- ReNew Sterilization Tray (Catalog #3709) with a calculated total weight of 148.195 grams (when loaded with ReNew Reusable Tips, wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap).
- Data Provenance: The studies were conducted by Microline Surgical, Inc., or their contract manufacturer (Symmetry Medical, Inc.) in the USA. The data appears to be prospective as it involves validation testing specifically for these devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document mentions "sterilization validation testing" and "cleaning validation testing" but does not specify the number of experts or their qualifications involved in establishing a "ground truth" for these tests. For sterility validation, common practice involves microbiologists and sterilization experts, but this information is not detailed in the provided text. The Acceptance Criteria are based on established standards (AAMI TIR12:2010 and EN ISO 17664:2004), implying that the "ground truth" is adherence to these recognized industry and regulatory benchmarks.
4. Adjudication Method for the Test Set:
Not applicable. The document describes engineering and performance validation tests against pre-defined acceptance criteria based on standards, rather than expert review or adjudication of complex cases.
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 sterilization tray, not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device for sterilization, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for this device's validation is based on established industry standards and scientific principles for sterilization and cleaning efficacy. Specifically:
- Sterility Validation: Achieved a Sterility Assurance Level (SAL) of 10⁻⁶ using the biological indicator (BI) overkill method, which is a universally accepted method for demonstrating sterility. This is a scientific and technical ground truth.
- Cleaning Validation: Conducted via Automated and Manual Testing against defined criteria (not explicitly detailed but implied by "Cleaning Validation Testing"). This is a technical ground truth.
- Compliance with Standards: Adherence to AAMI TIR12:2010 and EN ISO 17664:2004, which are recognized standards for reprocessing reusable medical devices.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set." The development would involve design, prototyping, and testing cycles, but not in the context of data-driven machine learning.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" for this type of device. The design and performance validation are based on engineering principles, material science, and established sterilization protocols.
§ 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).