(197 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. 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 text describes a 510(k) premarket notification for a medical device: the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228. This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device, especially for expanded indications for use with specific sterilizer models.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
Purpose of the Device: To secure packs and act as an external process indicator to differentiate unprocessed items from items processed in certain STERRAD® hydrogen peroxide sterilization processes (specifically STERRAD® 100, 100S, NX® - Standard and Advanced cycles, and 100NX® - Standard, Flex, Express and Duo cycles). The indicator stripes turn from blue to pink when exposed to vaporized hydrogen peroxide.
Overall Goal of the Submission: To expand the indications for use of an existing device (the 3M™ Comply™ 1228 Gas Plasma Indicator Tape, K020589) to include new STERRAD® sterilizer models (STERRAD® NX® and STERRAD® 100NX®). The core technology (indicator agent, design) is largely identical to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed in a "criteria" column with specific numerical targets but are inferred from the tests performed and the statements of successful verification. The reported device performance is described in the "Effectiveness" section and the "Comparison to Predicate Device" table.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Detectable color change from blue to pink when exposed to STERRAD® NX® (Standard & Advanced cycles) | Samples from six different lots were verified to meet the requirements for detectable color change in the STERRAD® NX® (Standard and Advanced cycles) sterilizers. Minimum time required for all indicator tape samples to indicate a "pass" in relation to the color specification was found. |
| Detectable color change from blue to pink when exposed to STERRAD® 100NX® (Standard, Flex, Express & Duo cycles) | Samples from six different lots were verified to meet the requirements for detectable color change in the STERRAD® 100NX® (Standard, Flex, Express and Duo cycles) sterilizers. Minimum time required for all indicator tape samples to indicate a "pass" in relation to the color specification was found. |
| Post-sterilization adhesion in STERRAD® NX® (Standard & Advanced cycles) | Samples from six different lots were verified to meet the requirements for post-sterilization adhesion in the STERRAD® NX® (Standard and Advanced cycles) sterilizers. |
| Post-sterilization adhesion in STERRAD® 100NX® (Standard, Flex, Express & Duo cycles) | Samples from six different lots were verified to meet the requirements for post-sterilization adhesion in the STERRAD® 100NX® (Standard, Flex, Express and Duo cycles) sterilizers. |
| Stability of the endpoint color reaction to storage under typical office lighting conditions for at least twelve months post-exposure | Samples from four 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. |
| Performance in STERRAD® 100 and 100S cycles (consistent with predicate, K020589) | Testing verified that the device turned from blue to pink when exposed to STERRAD® 100 and 100S cycles, and the minimum time for "pass" was consistent with original submission K020589. |
| Shelf life | Eighteen (18) months (Identical to predicate) |
| Biocompatibility (components of ink) | Components of the indicator ink are all of low general toxicity. Exposure to health care professionals is minimal and well below identified toxic thresholds. No anticipated exposure to medical instruments or patients. |
2. Sample Size used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For performance (color change and adhesion) in STERRAD® NX® and 100NX® cycles: "Samples from six different lots" were used.
- For End Point Color Stability: "Samples from four different lots" were used.
- The exact number of individual tapes per lot or per test condition is not specified in the provided text.
- Data Provenance: The studies were conducted as "Nonclinical Comparison" and "Effectiveness" testing by 3M Health Care. The text indicates "Health Care Facility Cycle" but does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a premarket submission for a new indication, it would inherently be prospective testing.
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 text. The device is a chemical indicator that changes color. The "ground truth" for whether it passed or failed (i.e., turned pink) would likely be based on a visual assessment against a pass/fail reference color, which doesn't directly require radiologists or similar medical experts to establish a "ground truth" in the same way an AI diagnostic imaging system would. The document mentions "color match" and "color specification," implying objective criteria.
4. Adjudication method for the test set
- This information is not provided. Given the nature of a chemical indicator, which changes from blue to pink (a binary outcome), formal adjudication methods like 2+1 or 3+1 typically used for subjective human interpretation of complex medical images are not generally applicable or necessary. The "color specification" implies an objective assessment.
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. An MRMC study is not mentioned as this device is a standalone chemical indicator, not an AI-assisted diagnostic tool that aids human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device itself is a standalone chemical indicator. Its performance (color change and adhesion) is evaluated directly, and its function is to provide a visible indication. There is no human-in-the-loop aspect for its performance; humans simply read the indicator's result. The tests described ("Performance in a Health Care Facility Cycle," "Minimum Exposure Parameters," "End Point Color Stability") are standalone evaluations of the device's physical and chemical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the device's performance appears to be established by controlled laboratory and "health care facility cycle" testing where the known exposure to the sterilant (hydrogen peroxide) under validated conditions (specific STERRAD® sterilizers and cycles) serves as the "truth." The "pass" or "fail" is determined by whether the indicator changes color according to a pre-defined "color specification" or "color match" and if adhesion is maintained. This falls under physical and chemical property verification against defined specifications.
8. The sample size for the training set
- This information is not applicable. This is a physical chemical indicator, not a machine learning/AI algorithm that requires a "training set." The device's color-changing chemistry is inherent to its design, not "trained."
9. How the ground truth for the training set was established
- This information is not applicable as there is no training set for this 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).