(86 days)
The SPSmedical H2O2 Chemical Indicators are indicated for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro 1, V-Pro 1 Plus and V-Pro maX sterilizers. They 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 items. Indicators change to a signal color of Blue after exposure to vapor hydrogen peroxide.
SPSmedical Vaporized Hydrogen Peroxide (HzOn) Chemical Indicators are process indicators which are cleared for use in verifying exposure to vapor hydrogen peroxide in the STERRAD® 100S, 200, 100NX, NX, STERIS® V-Pro lumen and non lumen sterilization processes. Testing has been performed which validates the SPSmedical Vaporized Hydrogen Peroxide (H2O2) Chemical Indicators for use in the STERIS® V-Pro flexible sterilization cycle and the STERIS® V-Pro maX sterilizer.
Indicators will identify if an item has seen H2O2 during the STERIS® V-Pro flexible sterilization process by changing to a Blue signal color. They provide a visual indication to help distinguish between processed and unprocessed items.
The provided text describes a 510(k) summary for the SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators. The information focuses on the device's similarity to a predicate device and its intended use, rather than a detailed study with specific acceptance criteria and performance metrics typically seen in AI/software device submissions. Therefore, a direct response to some of the requested points is not possible given the nature of the document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as would be expected for a sophisticated AI/software device. Instead, it states that:
- "All lots of SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators gave acceptable results for all test performed."
This implies that the indicators successfully changed color as expected when exposed to vaporized hydrogen peroxide and did not change color when not exposed, or when exposed to conditions that should not trigger a change. The acceptance is qualitative (color change) rather than quantitative (e.g., sensitivity, specificity, AUC).
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- "Multiple lots of indicators with various levels of shelf life were included in testing."
However, it does not specify an exact sample size for the test set or the number of indicators from each lot.
The data provenance is not explicitly mentioned as "country of origin," but the testing was performed to AAMI/ANSVISO 11140:2005 requirements and in simulated use in the STERIS® V-Pro maX sterilizer. It can be inferred that the testing occurred in a controlled lab environment associated with the device manufacturer, SPSmedical Supply Corp. in Rush, NY, U.S.A. The study is prospective in the sense that controlled experiments were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts
This information is not applicable to this type of device. The "ground truth" for a chemical indicator is a visible color change, which is a direct physical reaction, not an interpretation requiring expert human judgment (like a radiologist reading an image).
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. There is no ambiguous result that would require adjudication by multiple experts. The color change is a clear binary outcome.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable. This is a physical chemical indicator, not an AI or software device that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this product.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable. The device is a physical chemical indicator, not an algorithm. Its performance is inherently "standalone" in that it physically reacts to the presence of vaporized hydrogen peroxide; human observation is required to interpret the color change, but there is no "algorithm" or "computer" involved in its core function.
7. The Type of Ground Truth Used
The ground truth used is the direct physical exposure to vaporized hydrogen peroxide under controlled conditions and the expected visual color change of the indicator. For example, indicators exposed to a validated sterilization cycle should change color to "Blue," while unexposed indicators or those exposed to inadequate cycles should not.
8. The Sample Size for the Training Set
This information is not applicable. As a physical chemical indicator, there is no "training set" in the context of machine learning or AI. The indicators are manufactured to a specific chemical formulation, and their performance is verified through testing, not trained through data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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).