(99 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® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles), AMSCO® V PRO® 1 (Lumen cycle), AMSCO® V PRO® 1 Plus (Lumen and Non Lumen cycles), AMSCO® V PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles) and AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles) sterilizers. 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.
Here's an analysis of the provided text in the context of acceptance criteria and a study proving device performance, focusing on the information given.
It's important to note that the provided document is an FDA 510(k) clearance letter and a 510(k) Summary for a medical device (a chemical indicator for sterilization). This type of document is for pre-market notification and demonstrates substantial equivalence to a predicate device, not necessarily a comprehensive clinical study report for an AI/ML device. Therefore, many of the requested categories for AI/ML device studies will not be directly applicable or detailed in this document.
The document describes the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248, a chemical indicator that turns from blue to pink when exposed to vaporized hydrogen peroxide during sterilization cycles.
Acceptance Criteria and Device Performance Study Analysis
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table as one might see for an AI/ML diagnostic device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated by the chemical indicator's ability to "Pass" the relevant non-clinical tests.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Color Change in Health Care Facility Cycle: The indicator must visibly change from blue toward pink after exposure to required sterilization conditions in the specified cycles. | Pass |
| Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle: The indicator must react appropriately to a defined minimum exposure of vaporized hydrogen peroxide. | Pass |
| End Point Color Stability: The final color (pink) must remain stable for at least one month (4 weeks) after exposure. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of chemical indicators tested in the non-clinical studies. It refers to "nonclinical testing" without providing specific counts of units or repetitions.
- Data Provenance: The tests were "nonclinical testing," meaning controlled laboratory experiments. The document doesn't specify the country of origin for the data collection, but given it's a 3M product undergoing FDA clearance, it's likely conducted in the US or under US-equivalent standards. It is retrospective in the sense that the device was fully developed prior to these tests, but the tests themselves would be prospective controlled experiments.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This category is not applicable for this type of device. The "ground truth" for a chemical indicator is its physical reaction to chemical exposure, not a subjective interpretation by human experts. The "ground truth" is defined by the physical or chemical parameters of the sterilization cycle itself (e.g., concentration of hydrogen peroxide, temperature, time).
4. Adjudication Method for the Test Set
Not applicable. There's no human interpretation or "adjudication" necessary for the chemical indicator's performance in these non-clinical tests. The color change is a physical phenomenon observed and assessed against a pre-defined standard (blue to pink).
5. MRMC Comparative Effectiveness Study
Not applicable. This is not an AI/ML diagnostic device where human readers interact with AI. This is a physical chemical indicator.
6. Standalone Performance (Algorithm Only)
The device itself is a "standalone" chemical indicator; there is no embedded algorithm. Its performance is evaluated directly through the physical and chemical tests mentioned.
7. Type of Ground Truth Used
The ground truth for this device's performance is based on physical and chemical parameters of the sterilization cycles (e.g., validated STERRAD® and AMSCO® V-PRO® sterilizer cycles' hydrogen peroxide exposure, temperature, and time). The expectation is that the indicator will change color when exposed to these validated sterilization conditions and not change color inappropriately under non-sterilizing conditions.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The device is a physical chemical indicator with inherent chemical properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there's no training set for this type of device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study described is non-clinical testing focusing on the chemical indicator's performance in various vaporized hydrogen peroxide sterilization cycles. The core of the study is a series of controlled laboratory tests to ensure the indicator performs as expected:
- Objective: To demonstrate that the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 functions correctly (changes color from blue to pink) when exposed to specific, validated sterilization cycles in various sterilizers (STERRAD® and AMSCO® V-PRO® models, including newer variants).
- Methodology: The tests were conducted according to the FDA Guidance for Industry and Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003. This guidance outlines the required testing for chemical indicators. The document lists three specific non-clinical tests performed:
- Color Change in Health Care Facility Cycle: Verified that the indicator changes color as intended under actual or simulated sterilization conditions.
- Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle: Confirmed that the indicator visibly reacts when exposed to the minimum effective parameters of the sterilization process.
- End Point Color Stability: Assessed that the final color change remains stable for at least one month.
- Results: All tests were reported as "Pass."
- Rationale for Equivalence: The submission emphasizes that the device is identical in materials, performance specifications, and fundamental technology to a previously cleared device (K170321). The non-clinical testing specifically addressed performance in newly claimed sterilizers and cycles (e.g., STERRAD® NX with ALLClear™ Technology, STERRAD® 100NX with ALLClear™ Technology, AMSCO® V-PRO® 60).
- Conclusion: Based on these non-clinical performance data, the manufacturer concluded that the device is "as safe, as effective, and performs as well as or better than the legally marketed device."
This "study" is typical for demonstrating substantial equivalence for a Class II medical device like a chemical indicator, where the primary concern is its physical/chemical performance under specified conditions, rather than a diagnostic or therapeutic effect that requires clinical trials or complex AI/ML evaluation.
§ 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).