(112 days)
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:
- medical devices in a single or double pouch configuration ●
- trays* containing medical devices in a single or double pouch configuration
- . small items requiring surface sterilization in a single pouch configuration within a tray*
to be sterilized in the Lumen. Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. The pouches maintain the sterility of the enclosed devices until used.
When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.
The proposed Vis-U-All Low Temperature Sterilization Pouch/Tubing is identical to the predicate and is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in V-PRO Low Temperature Sterilization Systems. As is the predicate, the proposed device is available as a self seal pouch, a heat seal pouch, or heat seal tubing.
The purpose of this submission is to add claims for: use in the V-PRO maX Flexible cycle; pouching of sterilization trays and for sterilization of pouched items within a sterilization tray.
While the document provided details about the device's intended use and the tests performed, it does not contain the kind of detailed information about acceptance criteria and study design typically associated with a medical AI/ML device as outlined in the prompt. The device, "Vis-U-All Low Temperature Sterilization Pouch/Tubing," is a physical sterilization containment pouch, not an AI/ML device.
Therefore, the following information cannot be extracted from the provided text as it pertains to AI/ML device evaluation, which is not applicable here:
- Sample size used for the test set and data provenance
- Number of experts used and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm only) performance
- Type of ground truth used (expert consensus, pathology, outcomes data)
- Sample size for the training set
- How the ground truth for the training set was established
However, I can provide the available information regarding the device's acceptance criteria and reported performance from the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Effective Sterilant Penetration | Worst case test article shall be reproducibly sterilized under worst case ½ cycle conditions. | PASS |
| Package Integrity: Event Related Package Integrity Pouching a Qualified Tray | No visual damage to pouch material (no holes or tears). Seals remain intact. | PASS |
2-9. Information not applicable to this device type.
The provided document describes a 510(k) submission for a sterilization pouch, which is a physical medical device. The evaluation criteria are therefore focused on physical performance, sterility maintenance, and material integrity, rather than AI/ML performance metrics like sensitivity, specificity, reader studies, or training/test set provenance common in the context of AI/ML medical devices.
§ 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).