(99 days)
The Varian Sterilization boxes are intended to securely store the applicator parts during steam sterilization process and subsequent storage.
The Varian Sterilization boxes consist of an aluminium box with hinged lid and fasteners. There are arrays of holes in the top and bottom surfaces to allow evacuation during pre-vacuum processes. In the Universal Sterilization Box there is a perforated plastic inlay to allow placement of the components or devices to be sterilized. In the device-specific boxes there are supports to hold the components.
This is a 510(k) premarket notification for the Varian Sterilization Boxes (K160021). The device is intended to securely store applicator parts during steam sterilization and subsequent storage.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Aspect | Reported Device Performance (Varian Sterilization Boxes) |
|---|---|
| Material Durability (Steam Sterilization Cycles) | Device can withstand up to 500 steam sterilization cycles. |
| Component Storage & Protection | Device enables components of applicators to be stored for easy access and does not damage them. |
| Sterilization Effectiveness | Sterilization validation performed on equivalent devices demonstrates that specified applicator components and accessories can be sterilized in the box. |
| Usability | Reviewed in comparison to similar devices to the requirements of IEC 62366:2007. Conforms to applicable requirements and specifications. |
| Biocompatibility/Toxicological Properties | N/A; non-invasive product, not intended for patient contact (per ISO 10993-1 / FDA G-95-1). |
| Microbial Barrier Properties (Packaging Integrity) | Device does not provide a sterile barrier. Sterilization wrap must be used. Hospital is responsible for wrapping materials, method, and shelf life validation. |
| Shelf Life | No sterile wrap supplied with the sterilization box. |
| Drying Time | 25 minutes (validated for specific pre-vacuum autoclave cycles). |
| Aeration Time | N/A |
| Physical Properties | Dimensionally stable, no water absorption. |
| Chemical Properties | N/A, no polymeric composites used as packing materials. |
2. Sample Size Used for the Test Set and Data Provenance:
The document primarily describes bench testing and sterilization validation. Specific sample sizes for each test are not explicitly stated in the provided text.
- Data Provenance: The studies are "bench testing" and "sterilization validation". Given the nature of these tests for a sterilization container, they are most likely prospective data generated specifically for this submission. The country of origin of the data is not specified, but the submission is from Varian Medical Systems, Inc. in Palo Alto, CA, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable for this device. The evaluation is based on objective bench testing and sterilization validation, not on expert interpretation of medical images or outcomes where human "ground truth" would be established.
4. Adjudication Method for the Test Set:
- None specified or inferred. This type of device evaluation (bench testing) typically involves objective measurements and adherence to engineering specifications and international standards, rather than adjudicated expert reviews.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted clinical decision support tools. This device is a physical sterilization container, not a diagnostic or therapeutic medical AI large language model.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:
- Not applicable. This device is not an algorithm and does not involve AI or human-in-the-loop performance. Its function is mechanical and relates to physical containment and steam sterilization.
7. The Type of Ground Truth Used:
- For the bench testing related to durability, component storage, and physical properties, the "ground truth" is based on engineering specifications, material science principles, and observed functional performance against predefined criteria (e.g., "withstanding 500 cycles," "no damage to components").
- For sterilization validation, the ground truth is established by microbiological testing (e.g., using biological indicators or test organisms) to confirm the complete inactivation of microbes under the specified sterilization parameters. This is a highly standardized and objective process.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical product, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable as there is no training set for this type of device.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.