(546 days)
A chemical indicator for monitoring all cycles within the STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Duo, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO® 1 Plus (Lumen & Non-lumen), V-PRO® maX (Flexible, Lumen & Non-lumen) and Sterilucent™ PSD-85 (Lumen & Non-lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.
The Crosstex VH2O2 Chemical Indicators are intended for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX (Standard, Duo, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX, and Sterilucent™ PSD-85 sterilization processes. The Crosstex VH2O2Chemical Indicators are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Chemical indicators change to a color of blue after exposure to vaporized hydrogen peroxide. Colors other than blue such as yellow/green should be treated as a process failure.
This document describes the Crosstex VH2O2 Chemical Indicators, a device designed to monitor vaporized hydrogen peroxide sterilization cycles. The information provided outlines the device's acceptance criteria and the studies conducted to prove its performance.
Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ANSI/AAMI/ISO 11140-1:2014 testing for Type 1 Process Indicator | To demonstrate compliance to requirements specified in ISO 11140-1:2014 | Device functions and transitions to blue when processed in a STERRAD® 100NX™ DUO sterilization cycle. | Pass |
| Testing Color Change | To demonstrate the color change of the device when used in the STERRAD® 100NX™ DUO sterilization cycle. | Color change to blue without ink bleeding | Pass |
| End Point Color Stability | To demonstrate the post sterilization color stability of the device after use in the STERRAD® 100NX™ DUO sterilization cycle | No significant color change after exposure to fluorescent light for a minimum of six (6) months. | Pass |
| Biocompatibility and ink transfer test. | To demonstrate device and materials of construction are biocompatible with end-users and Healthcare Professionals. | Tested per ISO 11140-2:2014. Materials of construction is the same as currently cleared device. Device does not release any toxic substance in sufficient quantities to cause a health hazard. No ink migration or transfer observed with unprocessed and processed devices. | Pass. |
Detailed Study Information:
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Sample size used for the test set and the data provenance:
The document does not specify a distinct "test set" sample size in terms of number of indicators. The testing involves subjecting the indicators to specific sterilization cycles (e.g., STERRAD® 100NX™ DUO) and then evaluating their performance, color change, and stability. The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted by Crosstex International, Inc., a U.S. company. The studies appear to be prospective, laboratory-based tests designed to evaluate the physical and chemical properties of the indicators under controlled conditions. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This type of device (chemical indicator) does not typically involve human expert interpretation for "ground truth" establishment in the way an AI diagnostic algorithm would. The "ground truth" for these tests is based on objective, measurable changes in the indicator's color and stability following exposure to defined sterilization conditions, and compliance with established international standards (ISO 11140-1:2014). The assessment would likely be performed by trained laboratory personnel or quality control specialists rather than medical experts. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. The assessment criteria are objective (e.g., "Color change to blue," "No significant color change"). There is no mention of a subjective evaluation process requiring adjudication. -
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 device is a chemical indicator, not an AI-assisted diagnostic tool for human readers. Its function is to provide a direct visual indication of sterilization processing, not to interpret complex medical images or data. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This device is not an algorithm. Its performance is observed directly by human users (healthcare providers) who visually assess the color change of the indicator. The "standalone" performance here refers to the intrinsic chemical and physical response of the indicator itself, which is what the non-clinical tests evaluate. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth is based on the objective physical and chemical reaction of the indicator when exposed to vaporized hydrogen peroxide under specific, controlled sterilization conditions, as defined by international standards (ANSI/AAMI/ISO 11140-1:2014) and verified by direct observation in laboratory settings. -
The sample size for the training set:
Not applicable. This device is a physical chemical indicator, not a machine learning or AI algorithm that requires a training set. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).