(17 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 following sterilizers and cycles: STERRAD 100® Sterilization System, STERRAD 100S® Sterilization System, STERRAD NX® Sterilization System (Standard and Advanced cycles), STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles), STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles), STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles), V-PRO® 1 Low Temperature Sterilization System (Lumen cycle), V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles), V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles), V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles). The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.
The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 consists of a noncellulosic 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.
This document describes the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248, a Class II medical device, and its acceptance criteria for showing substantial equivalence to a predicate device (K192937). The device is a chemical indicator that changes color (blue to pink) upon exposure to vaporized hydrogen peroxide, verifying exposure to sterilization conditions.
The context of this document is a 510(k) premarket notification for a medical device that is not an AI/ML powered device. The questions provided in the prompt are designed for AI/ML powered devices. Therefore, a direct answer to each question as it pertains to an AI/ML study is not possible. However, the document does contain information about how the device's performance was evaluated and accepted.
Here's an interpretation based on the provided document and the nature of the device:
Device Acceptance Criteria and Performance:
The device's acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (K192937). Since no changes were made to the device's fundamental design, materials, or performance specifications, the primary acceptance criteria revolve around its functionality as a chemical indicator in newly claimed sterilizers and cycles.
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria for a chemical indicator like this are typically based on its ability to accurately change color under specified sterilization conditions (Pass) and not change under non-sterilization conditions (Fail), as well as maintaining the changed color for a defined period.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248) |
|---|---|---|
| Functionality in Healthcare Facility Cycles | Color change from blue to pink when exposed to vaporized hydrogen peroxide in specified sterilizers and cycles. | Pass (for all newly claimed V-PRO® s2 cycles) |
| Minimum Exposure Parameters | Indicator must show color change at or above the minimum effective exposure parameters. | Pass (for all newly claimed V-PRO® s2 cycles) |
| End Point Color Stability | The changed color (pink) must remain stable for a specified duration (e.g., at least one month). | Pass (Identical to predicate, which has 1 month stability) |
| Shelf Life | Device maintains its performance for its stated shelf life. | Two (2) years (Identical to predicate) |
| Biocompatibility | Exposure to healthcare professionals is minimal and below toxic thresholds. | Identical (to predicate, which deemed acceptable) |
2. Sample size used for the test set and the data provenance:
The document states that "nonclinical testing was performed in accordance with the FDA Guidance for Industry and Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003." This guidance would specify the number of indicators to be tested for each condition. While the exact sample size isn't explicitly stated in this summary, the "Pass" results imply that the required sample sizes per the FDA guidance were met.
- Sample Size: Not explicitly stated, but implied to be sufficient as per FDA guidance for chemical indicators.
- Data Provenance: The testing was "nonclinical testing," meaning it was conducted in a laboratory setting, likely at 3M's facilities. The location (country) is not specified, but 3M is a US-based company, so it's most likely in the US. This would be considered prospective testing, as it was specifically conducted to validate the device for the new indications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
For a chemical indicator, the "ground truth" is a direct, observable, and objective chemical reaction (color change) based on exposure to a known concentration of hydrogen peroxide for a defined time/temperature. It does not typically involve human expert interpretation in the same way an AI diagnostic image analysis would. The ground truth is established by the controlled sterilization cycles themselves. The "experts" would be the laboratory personnel or engineers who set up and monitor the sterilization cycles and visually inspect the chemical indicators according to defined pass/fail criteria. Their qualifications would be in laboratory practices, quality control, and understanding of sterilization processes.
4. Adjudication method for the test set:
Not applicable in the context of a chemical indicator. The determination of "pass" or "fail" is based on the visible color change according to a reference, not on human interpretation or consensus of complex data.
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:
Not applicable. This is not an AI/ML device involving human readers or interpretation of complex data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML algorithm. The device's "performance" is its physical color change, which is then visually interpreted by a human user (e.g., healthcare professional) to verify sterilization.
7. The type of ground truth used:
The ground truth used for this device is based on controlled exposure to specific sterilization parameters. In a laboratory setting, the chemical indicators are subjected to precisely defined concentrations of vaporized hydrogen peroxide under specific temperature and time conditions that are known to achieve sterilization, and also to conditions that are known not to achieve sterilization (e.g., minimum exposure parameters). The "pass" or "fail" is determined by whether the indicator exhibits the expected color change given the known exposure conditions.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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).