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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 Fast 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 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 acceptance criteria and study proving device performance are described below:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes a submission (K183297) to add claims for the Vis-U-All Low Temperature Sterilization Pouches/Tubing, including use with specific lumen configurations and diffusion-restricted spaces in various V-PRO sterilizer cycles (V-PRO 60, V-PRO s2, V-PRO 1, 1 Plus, maX & maX 2). The study is non-clinical performance testing.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the numerical sample sizes used for each specific test (e.g., number of pouches, lumens, or test articles). It refers to "worst case" scenarios for sterilant penetration tests and "samples" for physical property tests.

The data provenance is not explicitly mentioned as retrospective or prospective, nor the country of origin. However, given the context of a 510(k) submission to the U.S. FDA, it is highly likely that the testing was conducted in a controlled laboratory environment to support regulatory approval in the U.S.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This is a performance study for sterilization efficacy and package integrity. The "ground truth" for the test set is established through scientific and engineering principles of sterilization and package testing, rather than human expert interpretation of images or physiological data. Therefore, the concept of "experts" to establish ground truth in the same way as, for example, radiologists for image analysis, does not apply. The tests described (e.g., microbial retention, tensile strength) rely on objective measurements and established standards.

4. Adjudication Method for the Test Set:

Not applicable in the context of this type of performance study. Adjudication methods (like 2+1 or 3+1) are typically used for subjective clinical assessments where multiple human readers interpret data to reach a consensus ground truth. Here, the outcomes are objective measurements of sterilization and physical properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is not a study involving human readers or AI assistance. It is a performance study of a medical device (sterilization pouches).

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study:

Not applicable. This device is a physical product (sterilization pouches), not an AI algorithm.

7. Type of Ground Truth Used:

The ground truth used for these tests is based on objective, quantifiable measures related to sterilization efficacy and physical properties, typically defined by:

• Microbial Sterilization: Defined by the absence of microbial growth after processing, often using sterility assurance levels (SAL) based on biological indicator (BI) challenge testing. The "worst case 1x10^-2 cycle conditions" refers to a reduced cycle used for BI testing to demonstrate appropriate sterilant penetration and microbial kill.
• Physical and Barrier Properties: Defined by adherence to established engineering standards for tensile strength, burst strength, seal strength, and microbial retention, often with statistical comparisons between processed and unprocessed samples.
• Chemical Residuals: Defined by laboratory analysis to ensure residual levels of hydrogen peroxide are below acceptable safety thresholds.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model 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 device.

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