(202 days)
Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the STERRAD® 100, 100S, NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes. The chemical indicator bar turns from blue to pink after exposure to vaporized hydrogen peroxide.
The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 consists of a non-cellulosic plastic material onto which a chemical indicator bar is printed. A comparison color match is also printed on the product to aid in color interpretation.
Here's a breakdown of the acceptance criteria and study information for the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria / Feature | Reported Device Performance |
|---|---|
| Color Change (STERRAD® 100) | Turned from blue to pink. Minimum time for all indicators to indicate a "pass" in relation to the color match was found to be between 10 and 15 minutes. (Demonstrated per original submission K013228). |
| Color Change (STERRAD® 100S) | Turned from blue to pink. Minimum time for all indicators to indicate a "pass" in relation to the color match was found to be between 4 and 8 minutes. (Demonstrated per original submission K013228). |
| Color Change (STERRAD® NX® - Standard & Advanced) | Turned from blue to pink. Minimum time required for all indicators to indicate a "pass" in relation to the color specification was found when exposed to these cycles. |
| Color Change (STERRAD® 100NX® - Standard, Flex, Express, Duo) | Turned from blue to pink. Minimum time required for all indicators to indicate a "pass" in relation to the color specification was found when exposed to these cycles. |
| Stability of the endpoint reaction | At least one month (4 weeks). Samples from four different lots were verified to be stable to storage under typical office lighting conditions for at least one month post-exposure in a Hydrogen Peroxide Health Care Facility Cycle. |
| Shelf life | Two (2) years. |
| Safety (Biocompatibility/Toxicity) | Components of the indicator ink were all of low general toxicity. Exposure to health care professional is minimal and below identified toxic thresholds. Indirect patient exposure is minimal and below identified toxic thresholds. |
Study Details
The provided document describes a premarket notification [510(k)] submission for an expanded indication for use of an existing device, the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248. Crucially, the document states: "No clinical data was included in this premarket application submission." The focus of this specific submission is on nonclinical testing to demonstrate substantial equivalence for the expanded indications.
Therefore, the following details relate to the nonclinical studies conducted to support the expanded indications.
2. Sample size used for the test set and the data provenance:
- Color Change in Health Care Facility Cycle: "Samples from six different lots" were verified.
- Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle: "Samples from six different lots" were evaluated.
- End Point Color Stability: "Samples from four different lots" were verified.
- Data Provenance: The studies were conducted by 3M Health Care. Origin of data (e.g., country) is not specified but implied to be internal testing. The studies are prospective in nature, as they involve testing new lots of the device under controlled conditions to verify performance against pre-defined criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For chemical indicators, the ground truth is typically visual observation against a color match standard. The document mentions "color match" and "color specification," implying a pre-defined standard (the comparison color match printed on the product). The determination of "pass" or "fail" is based on whether the indicator sufficiently changes color to match this standard. It doesn't typically involve human expert interpretation in the same way as, for example, a medical imaging diagnosis.
4. Adjudication method for the test set:
- This information is not explicitly stated. Given the nature of a chemical indicator changing color to a pre-defined standard, adjudication in a multi-rater sense is less common. The "pass" or "fail" is usually determined by direct comparison to the color target on the indicator. The mention of "all indicators" in relation to color change implies a quantitative or objective assessment rather than subjective expert consensus.
5. 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:
- No. This is a chemical indicator, not an AI-powered diagnostic device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The device itself is a standalone chemical indicator designed to change color based on exposure. Its performance (color change, stability) is evaluated independently, without requiring human interpretation in a diagnostic loop that would alter or confirm its output in a clinical decision-making process. The "reading" of the indicator (e.g., "blue to pink") is an inherent property of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance testing, the ground truth is established by physical measurement and visual comparison against a pre-defined color standard/specification. The actual exposure parameters within the sterilizer cycles (time, presence of vaporized hydrogen peroxide) serve as the objective truth for whether the indicator should change color. The "pass" or "fail" is determined by whether the observed color reaches the specified end-point color.
8. The sample size for the training set:
- This device does not involve a "training set" in the context of an AI or machine learning algorithm. It is a chemical indicator that reacts based on chemical principles, not learned patterns.
9. 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).