(150 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, Flexible and Fast Non Lumen Cycles of the V-PRO Low Temperature Sterilization Systems. The pouches are intended to 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 Pouches/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 device, the proposed device is available as a self seal pouch, a heat seal pouch, or heat seal tubing.
The purpose of K172749 is to add claims for:
- use in the V-PRO maX 2 Fast Non Lumen Cycle
- the sterilization of titanium mated surfaces (diffusion-restricted spaces) in ● the V-PRO 1 Plus, maX, and maX 2 Sterilizers Non Lumen Cycle
- addition of the V-PRO maX 2 Sterilizer to the indications for use in the Lumen, Non Lumen and Flexible Cycles of the V-PRO 1, 1 Plus and maX Sterilizers (the V-PRO maX 2 Sterilizer Lumen, Non Lumen, and Flexible Cycles are identical, with the exception of the condition phase of the Lumen Cycle, to the previously cleared cycles listed in Table 2-1).
The provided document describes the acceptance criteria and study results for STERIS Vis-U-All Low Temperature Sterilization Pouches/Tubing (K172749).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Effective Sterilant Penetration into Pouches: | ||
| - V-PRO maX 2 Sterilizer Fast Non Lumen Cycle | Worst case test article shall be reproducibly sterilized under worst case abbreviated ½ cycle conditions for Fast Non Lumen Cycle. | PASS |
| - V-PRO 1 Plus, maX, and maX 2 Sterilizer Non Lumen Cycle, diffusion restricted titanium claims (first entry) | Diffusion-restricted spaces (composed of stainless steel and titanium, as well as contact points between medical devices and tray accessories) shall be reproducibly sterilized under worst case abbreviated ½ cycle conditions for Fast Non Lumen Cycle. | PASS |
| - V-PRO 1 Plus, maX, and maX 2 Sterilizer Non Lumen Cycle, diffusion restricted titanium claims (second entry) | Diffusion-restricted spaces (titanium) shall be reproducibly sterilized under worst case ½ cycle conditions for the Non Lumen Cycle. | PASS |
| Pouch Integrity: Physical and Microbial Barrier Properties: | ||
| - Tensile Strength | Pouch material tensile strength will show no statistical difference between processed and unprocessed samples. | PASS |
| - Whole Package Integrity (Burst) | Pouch burst strength will show no statistical difference between processed and unprocessed pouches. | PASS |
| - Seal Strength | Pouch seal strength will show no statistical difference between processed and unprocessed pouches. | PASS |
| - Microbial Retention | Tyvek microbial retention will show no statistical difference between processed and unprocessed pouches. | PASS |
| Maintenance of Package Integrity | Packaged instruments shall remain sterile through event related and real time studies. | PASS |
| Aeration: Hydrogen Peroxide Residuals | Hydrogen peroxide residuals on the pouch will be reduced to acceptable levels for dermal contact in Fast Non Lumen Cycle with 3 minute aeration. | PASS |
| Cytotoxicity | Pouch materials shall be non-cytotoxic following worst case exposure in a V-PRO Sterilizer for Fast Non Lumen Cycle with 3 minute aeration. | PASS |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes used for each test. It refers to "worst case test article" and "processed and unprocessed samples/pouches" without providing numerical details for the test sets.
The data provenance is not specified in terms of country of origin or whether it's retrospective or prospective. Given the nature of a 510(k) submission, these are likely laboratory-based studies conducted by the manufacturer to demonstrate product performance for regulatory approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided in the document. The tests performed are objective physical, chemical, and microbiological evaluations of the sterilization pouches, not interpretations of medical images or patient data that would require medical experts to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of data by multiple human readers, not for objective laboratory testing of device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on the performance of the sterilization pouches themselves through laboratory tests, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not applicable. The device is a physical sterilization pouch, not an algorithm or AI system. The tests are focused on its physical and functional capabilities.
7. The Type of Ground Truth Used
The "ground truth" for these tests is based on established scientific principles and regulatory standards for sterilization and material performance. For example:
- Sterilant Penetration: Ground truth is complete sterilization, typically demonstrated by the absence of microbial growth in biological indicators after exposure to the sterilization process. The ½ cycle conditions are a recognized method to challenge sterilization efficacy.
- Pouch Integrity (Tensile, Burst, Seal Strength): Ground truth is maintaining pre-determined physical properties within acceptable ranges after processing, ensuring the pouch remains intact.
- Microbial Retention: Ground truth is the ability of the material to prevent microbial ingress.
- Hydrogen Peroxide Residuals: Ground truth is residuals falling below acceptable safety limits.
- Cytotoxicity: Ground truth is the material being non-toxic to cells.
These are objective, empirical measures determined by laboratory testing, not by expert consensus, pathology, or outcomes data in a medical context.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product and does not involve AI or machine learning, which would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this device.
§ 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).