(199 days)
The V-PROTM Sterilization Tray is used to contain reusable medical devices for sterilization in the Amsco® V-PRO™ 1 Low Temperature Sterilizer and to maintain sterility of properly processed medical devices during normal handling and storage until they are removed for use. The trays must be wrapped with a legally marketed, FDA cleared sterilization wrap for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer prior to placing in the Sterilizer.
The V-PRO "M Sterilization Tray can be used with V-PRO "10 Instrument Organizers to allow stabilization of various cylindrical medical devices during processing. The medical device organizers attach to the V-PROTM Sterilization Tray bottom and stabilize cylindrical medical instruments.
The V-PRO™ Sterilization Tray is available in various sizes, 10''x 10" x 21" to accommodate the loads to be processed. The tray contains two handles that remain internalized during wrapping/processing and a lid with two clamping mechanisms for securing to the tray. There are numerous 0.01" diameter holes in the lid and tray for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally marketed, FDA cleared sterilization wrap for use in the Amsco® V-PROTM 1 Low Temperature Sterilizer to maintain sterility of the devices.
The tray can contain medical device organizers to allow stabilization of various cylindrical medical devices during processing. Each organizer consists of a device holding element and lock base that attach to the V-PRO™ Sterilization Tray. The sizes for the device holding element range from a 5 mm diameter and 6 mm stem height to a 19 mm diameter and 25 mm stem height. For attachment to the tray, each device holding element is positioned over one of the numerous holes at the inner tray surface and pushed into a lock base located at the respective tray hole on the outer tray surface. A minimum of two, aligned organizers should be used for each device requiring stabilization. Once the device is placed into the organizers, it is secured by each organizer's twist lock.
This document is a 510(k) summary for the V-PRO™ Sterilization Tray and Instrument Organizers, which is a medical device intended to hold, transport, and store sterilized medical devices. It is a premarket notification to the FDA, and it focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a detailed study with acceptance criteria and device performance in the way one might expect for a novel therapeutic or diagnostic device.
Therefore, the requested information, specifically regarding acceptance criteria and a study proving the device meets those criteria in detail, including sample sizes, expert qualifications, and specific adjudication methods, is not explicitly provided in this 510(k) summary.
However, I can extract the information that is implicitly or explicitly stated about the device's performance and the general nature of its qualification.
Summary of Device Qualification (based on the provided text):
The V-PRO™ Sterilization Tray (and instrument organizers) underwent qualification testing to support its suitability for use in the Amsco® V-PRO™ 1 Low Temperature Sterilization System. The goal was to demonstrate that it is safe and effective and has the same intended use and characteristics as its predicate devices.
The performance specifications mentioned are:
- Demonstrate sterilization of devices when wrapped.
- Material compatibility with various healthcare processing chemistries and Vaprox HC Sterilant.
- Cleaning efficacy.
- Inability to emit harmful substances after processing.
Missing Information:
- Specific numerical acceptance criteria for "sterilization of devices," "cleaning efficacy," or "inability to emit harmful substances."
- Detailed study protocols, blinding, sample sizes for specific tests, data provenance for these tests, or expert involvement in establishing ground truth.
- No Multi-Reader Multi-Case (MRMC) or standalone algorithm performance studies are applicable as this is a physical medical device, not an AI/software device.
Here's the best I can construct based on the provided text, acknowledging the significant gaps in the requested details for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Performance Specifications / Requirements) | Reported Device Performance |
|---|---|
| Sterilization Efficacy: Demonstrate sterilization of devices when wrapped | Device qualified by STERIS Corporation for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer has been shown to be safe and effective. |
| Material Compatibility: Compatibility with various healthcare processing chemistries and Vaprox HC Sterilant. | Device qualified by STERIS Corporation for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer has been shown to be safe and effective. |
| Cleaning Efficacy: Efficacy in cleaning. | Device qualified by STERIS Corporation for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer has been shown to be safe and effective. |
| Substance Emission: Inability to emit harmful substances after processing. | Device qualified by STERIS Corporation for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer has been shown to be safe and effective. |
| Substantial Equivalence: Same intended use and characteristics as predicate devices. | The FDA completed its review and determined the device is substantially equivalent to legally marketed predicate devices. |
Study Information (Based on interpretation of a 510(k) submission for a physical device, which typically relies on internal testing and comparison to predicates):
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "qualification testing data," but does not detail the number of units or cycles tested.
- Data Provenance: The testing was "performed by STERIS Corporation." This indicates proprietary in-house testing. Country of origin of the data is implicitly USA, where STERIS Corporation is located. The nature of testing would be prospective, as it's qualification testing for a new product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified in this type of submission. Ground truth for sterilization efficacy, material compatibility, and cleaning efficacy would typically be established through validated internal laboratory protocols, rather than expert human review of a "test set" in the diagnostic sense.
4. Adjudication method for the test set
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 typically refer to expert review for diagnostic AI studies. For physical device qualification, results are determined by objective measurements against established 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
- Not applicable. This is a physical sterilization tray and instrument organizer, not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
- The "ground truth" for the performance specifications would be based on objective laboratory measurements and validated test methods according to relevant industry standards (e.g., for sterilization, material compatibility, cleaning). For example, demonstrating "sterilization of devices" would involve sterility testing (e.g., absence of microbial growth) after sterilization cycles.
8. The sample size for the training set
- Not applicable. This is a physical device, not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set. The "ground truth" for demonstrating the device works as intended would be through established scientific and engineering principles applied in controlled laboratory settings for device performance testing.
§ 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).