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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

*3-D printed items should not be double pouched.

to be sterilized in the:

· Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast and Specialty Cycles of the V-PRO® Low Temperature Sterilization Systems

• · Default Cycle of the STERRAD** 100S Sterilizer
• · Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear** Technology Sterilizers

· Express, Standard, Flex Scope and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers

**STERRAD and ALLClear are trademarks of Advanced Sterilization Products

NOTE: Trays must be legally marketed for use in the V PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed.

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.

V-PRO 60 & s2 Lumen Cycle

· Non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

· Non-lumened devices including non-lumened rigid and semi-rigid endoscopes

· Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations:

o single or dual lumen devices

0.77 mm internal diameter (ID) and 30% RH using 100% ETO (750-790 mg/L)

• · 4.5 hour exposure at 100(±5) °F, * >30% RH using 100% ETO (750-790 mg/L)
• *±5 °F is used during sterilization phase following an equilibrium period of 10% of exposure time.

The ethylene oxide process indicator is intended to be used by health care providers with the Vis- U-All Low Temperature Sterilization Pouches to distinguish between processed and unprocessed units.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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 or STERRAD 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. Available sizes and configurations are shown in Table 5-1.

The provided text describes the acceptance criteria and study for the STERIS Vis-U-All Low Temperature Sterilization Pouches/Tubing (K231500).

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific "sample size used for the test set" in terms of the number of individual pouches or sterilization cycles. However, it mentions "worst-case test articles" were used in the testing.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective as it's a validation study for an existing product to extend its claims (qualify for use in the V-PRO maX 2 Specialty Cycle).

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

This information is not provided in the document. The study's ground truth for sterilization effectiveness is based on the ability of the worst-case test articles to be reproducibly sterilized under specific cycle conditions, which implies a direct measurement of sterility rather than expert consensus on an image or clinical assessment.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth is based on physical sterilization validation, not expert review or consensus.

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 typically performed for diagnostic or AI-assisted interpretation devices to assess human performance with and without AI assistance. The described device is a sterilization pouch, and its performance is evaluated through physical tests of sterilization effectiveness.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The study assessed the device's ability to achieve sterilization in the specified V-PRO cycles without human intervention in the sterilization process itself, beyond loading and operating the sterilizer. The performance criteria directly relate to the pouch's material and design allowing sterilant penetration.

7. The Type of Ground Truth Used

The ground truth used is based on physical sterilization effectiveness, specifically demonstrating that "Worst case test articles shall be reproducibly sterilized under worst case ½ cycle conditions." This implies microbiological testing to confirm the absence of viable microorganisms after sterilization.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a physical product (a sterilization pouch), not an AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As mentioned above, the device is a physical product and does not involve an AI algorithm with a training set.

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