(150 days)
Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the STERRAD® 100, 100S, NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes and AMSCO® V-PRO™ 1 (Lumen cycle), AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles), and AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) sterilizers. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue to pink after exposure to vaporized hydrogen peroxide.
The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 consists of a non-cellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side.
The provided document is a 510(k) Premarket Notification for the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228. This document details the device's equivalence to a predicate device and provides information on non-clinical testing performed.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device, a chemical indicator tape, are primarily focused on its ability to change color reliably under specific sterilization conditions and the stability of that color change. The reported performance confirms that the device meets these criteria.
| Acceptance Criteria & Performance Metric | Reported Device Performance |
|---|---|
| Color Change in Health Care Facility Cycle | |
| - Detectable color change from blue to pink when exposed to sterilization cycles | Verified in: |
| - STERRAD® 100 | - Samples from 3M Comply Hydrogen Peroxide Indicator Tape 1228 turned from blue to pink. Minimum time for "pass" color match found. (Demonstrated per K020589) |
| - STERRAD® 100S | - Samples from 3M Comply Hydrogen Peroxide Indicator Tape 1228 turned from blue to pink. Minimum time for "pass" color match found. (Demonstrated per K020589) |
| - STERRAD® NX (Standard and Advanced cycles) | - Samples from 3M Comply Hydrogen Peroxide Indicator Tape 1228 turned from blue to pink. Minimum time for "pass" color specification found. (Demonstrated per K150694) |
| - STERRAD® 100NX (Standard, Flex, Express and Duo cycles) | - Samples from 3M Comply Hydrogen Peroxide Indicator Tape 1228 turned from blue to pink. Minimum time for "pass" color specification found. (Demonstrated per K150694) |
| - AMSCO® V-PRO™ 1 (Lumen cycle) | - Samples from 3M Comply Hydrogen Peroxide Indicator Tape 1228 turned from blue to pink. Minimum time for "pass" color specification found. |
| - AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles) | - Samples from 3M Comply Hydrogen Peroxide Indicator Tape 1228 turned from blue to pink. Minimum time for "pass" color specification found. |
| - AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) | - Samples from 3M Comply Hydrogen Peroxide Indicator Tape 1228 turned from blue to pink. Minimum time for "pass" color specification found. Samples from six different lots were verified to meet requirements in these cycles. |
| Minimum Exposure Parameters to Affect the Change of the Indicator | |
| - Minimum time required for the color change to "pass" | - Minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match/specification was found for all listed sterilizer cycles. Samples from six different lots were evaluated for AMSCO® V-PRO™ maX Low Temperature Sterilization System cycles. |
| End Point Color Stability | |
| - Stability of the final color post-exposure | - Twelve (12) months (for STERRAD cycles, and for new V-PRO cycles). Samples from six different lots were verified to be stable to storage under typical office lighting conditions for at least twelve months post-exposure in a Hydrogen Peroxide Health Care Facility Cycle (for new V-PRO cycles). |
| Shelf life | - Eighteen (18) months |
2. Sample Size Used for the Test Set and Data Provenance
For the new AMSCO® V-PRO™ maX Low Temperature Sterilization System cycles (Lumen, Non Lumen, and Flexible cycles), the testing involved samples from six different lots of the device. The data provenance is not explicitly stated as retrospective or prospective, but it describes laboratory testing of new product lots, which implies prospective non-clinical testing. The country of origin of the data is not specified but is presumably where 3M conducts its research and development or contract testing.
For the previously cleared STERRAD cycles, the document references previous submissions (K020589 and K150694), implying the data for those cycles originated from prior non-clinical testing associated with those submissions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention human experts used to establish ground truth for color change. This is a chemical indicator, and its performance is determined by a quantifiable color change observed under specific conditions. The "ground truth" here is the chemical reaction itself and comparison to a predefined color specification for a "pass."
4. Adjudication Method for the Test Set
No adjudication method involving multiple human observers is mentioned, as the "ground truth" for the color change is based on a pre-defined color specification that the indicator must meet after exposure. The document states "in relation to the color match/specification," implying an objective chemical standard rather than subjective human interpretation needing adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or mentioned. This is a non-clinical device (chemical indicator) and its effectiveness is not assessed through human reader performance or diagnostic accuracy.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a chemical indicator, not an algorithm. Its performance is inherent in its chemical reaction.
7. Type of Ground Truth Used
The ground truth used for this chemical indicator is an objective color specification or standard that the tape's chemical indicator stripes must meet after exposure to a specific sterilization cycle. For instance, the tape needs to turn from blue to pink, and the pink must fall within a defined color range to indicate a "pass." The document mentions "color match" and "color specification."
8. Sample Size for the Training Set
This concept is not applicable here as this is a non-clinical chemical indicator device, not an AI/ML algorithm. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
§ 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).