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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 following sterilizers:

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 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 tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.

The 3MTM ComplyTM Hydrogen Peroxide Indicator Tape 1228 consists of a noncellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.

This document describes the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228, a chemical indicator for sterilization processes. The acceptance criteria and the study proving the device meets these criteria are detailed, primarily for its use with the V-PRO® s2 Low Temperature Sterilization System.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the specific sample sizes used for each test (Color Change, Minimum Exposure Parameters, End Point Color Stability) within the test set. It mentions "nonclinical testing was performed," but quantitative details on the number of tapes tested or the number of cycles run are not provided.

The data provenance is from non-clinical testing conducted specifically for this submission, focusing on the newly claimed sterilizer and cycles (V-PRO® s2 Low Temperature Sterilization System). The document does not specify the country of origin, but given it's an FDA submission for a US-based company (3M Company, St. Paul, Minnesota), the testing was likely conducted in the US. The testing appears to be prospective as it was done to demonstrate performance for new claims.

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 a chemical indicator like this, the "ground truth" is typically the physical-chemical reaction (color change) itself under specified conditions, rather than expert interpretation of complex clinical imagery. The "Pass" results suggest that the required color change was observed consistently.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document does not mention any adjudication method. For the type of device (chemical indicator with a clear visual color change), a formal adjudication process involving multiple human observers is typically not necessary if the color change is unambiguous and measurable by standardized methods. The "Pass" results imply a straightforward assessment against the defined visual criteria.

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 device is a chemical indicator, not an AI-assisted diagnostic tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant to its functionality.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is a physical chemical indicator, not a software algorithm. Its performance is directly observed through a color change, which is a "human-in-the-loop" observation in that a human visually checks the tape. There is no automated algorithmic assessment.

7. The type of ground truth used:

The ground truth for this device is the physical-chemical reaction of the indicator within the specified sterilization environments. Specifically, it's the expected color change from blue toward pink upon exposure to vaporized hydrogen peroxide under effective sterilization conditions, and the stability of that color change over time.

8. The sample size for the training set:

Not applicable. This device is a pre-manufactured chemical indicator, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As explained above, there is no training set for this device.

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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, 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), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles), and AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen and Flexible, and Fast Non Lumen cycles) sterilizers. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.

The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 consists of a noncellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.

The device is the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228, a chemical indicator used to determine if items have been processed in specific hydrogen peroxide sterilization systems.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes for each test in Table 6.1. It describes the "Purpose" as demonstrating performance in specific sterilizers and cycles. The provenance of the data is not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a chemical indicator, not an AI/medical imaging device. Therefore, the concept of "experts" establishing ground truth in the context of human interpretation of data (like radiologists for imaging) is not directly applicable. The "ground truth" for chemical indicators is determined by their physical and chemical response to specific sterilization conditions. The testing would be performed by qualified laboratory personnel following established protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a chemical indicator. Adjudication methods are typically relevant for subjective interpretations, often in medical image analysis. The performance of a chemical indicator is based on observable color changes under controlled conditions.

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-assisted device or an imaging product that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical chemical indicator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for chemical indicators is the physical/chemical response of the indicator to controlled sterilization parameters (e.g., exposure to a specified concentration of hydrogen peroxide for a given time and temperature, resulting in a color change). The sterilization process itself, as defined by the sterilizer's validated cycles, serves as the "gold standard" or ground truth for whether sterilization conditions were met. The indicator is designed to react to these conditions.

8. The sample size for the training set

Not applicable. This product is a physical chemical indicator and does not involve AI or machine learning models that require a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set is used for this type of device.

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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.

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.

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