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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, Non 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) STERIZONE® VP4 Sterilizer (Cycle 1)

The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.

The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 has an indicator ink bar printed on a white plastic strip. The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide. 3M™ Comply™ Hydrogen Peroxide Indicator 1248 is a Type 1 (Category e1) Process Indicator as categorized by ISO 11140-1:2014.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the 3MTM Comply™ Hydrogen Peroxide Chemical Indicator 1248. This device is a chemical indicator, not an AI/ML powered medical device, therefore, many of the requested bullet points regarding AI/ML studies are not applicable.

Here's the information extracted from the document:

1. Table of acceptance criteria and the reported device performance

The document presents a summary of non-clinical testing, which includes acceptance criteria and results.

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

The document specifies non-clinical testing was conducted to support the product performance. However, it does not explicitly state the specific sample size (e.g., number of indicators tested) for each test. The provenance of the data is implied to be from laboratory testing conducted by 3M, as indicated by "3M conducted nonclinical testing". The data would be prospective, directly generated from these tests. No country of origin for the data is specified beyond being conducted by 3M.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is a chemical indicator, not an AI/ML-powered diagnostic device. Therefore, no human experts were used to establish "ground truth" in the way one would for diagnostic image interpretation. The ground truth for chemical indicators is established by objective physical and chemical changes in response to specific sterilization parameters and assessed against a predefined color reference.

4. Adjudication method for the test set

Not applicable. As this is a chemical indicator, there is no human adjudication process involved in interpreting results as there would be for an AI/ML diagnostic system. The results are based on objective chemical reactions and color changes.

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 a chemical indicator, not an AI-assisted diagnostic device. No MRMC study was performed.

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

Not applicable. This is a chemical indicator. Its performance is inherent in its chemical reaction, not an algorithm.

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

The ground truth for this device is based on objective physical/chemical changes in the indicator ink (color change from blue toward pink) in response to specific controlled exposure conditions of vaporized hydrogen peroxide, as defined by sterilization standards (e.g., ISO 11140-1:2014) and verified by manufacturer testing. It's a binary outcome (reacted/not reacted, or sufficient/insufficient change) compared to a known reference.

8. The sample size for the training set

Not applicable. This is a chemical indicator, not an AI/ML device that requires a training set.

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

Not applicable. This is a chemical indicator, not an AI/ML device that requires a training set.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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® 100, 100S, NX® (Standard and Advanced cycles), 100NX® (Standard, Flex, Express and Duo cycles), 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 chemical indicator bar turns from blue to 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 is a 510(k) premarket notification for a chemical indicator used in sterilization processes. It concerns the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248. The primary purpose of this 510(k) is to expand the indications for use of an already cleared device to include additional sterilizers (AMSCO® V-PRO™ 1, AMSCO® V-PRO™ 1 Plus, and AMSCO® V-PRO™ maX).

Here's an analysis based on the provided text:

Nature of the Device and Study:
This device is a chemical indicator, not an AI/ML powered medical device for diagnostic imaging or similar applications. It physically changes color (blue to pink) upon exposure to vaporized hydrogen peroxide during sterilization cycles to indicate successful processing. Therefore, many of the typical acceptance criteria and study methodologies asked for in AI/ML performance evaluations (like MRMC studies, standalone AI performance, large expert panels for ground truth of complex data, etc.) are not applicable to this type of device.

The "study" here refers to non-clinical testing to demonstrate the physical performance of the chemical indicator under specified sterilization conditions.

Acceptance Criteria and Device Performance Table:

Given the nature of the device, the acceptance criteria are based on the indicator's physical color change within specific sterilization cycle parameters. The document primarily focuses on demonstrating that the indicator performs identically to its predicate and successfully changes color within the new sterilizer cycles.

• STERRAD® 100: Color change within 10-15 minutes (per K013228).
• STERRAD® 100S: Color change within 4-8 minutes (per K013228).
• STERRAD® NX (Standard/Advanced): Standard cycle: 5.25-7 minutes; Advanced cycle: 11.25-15 minutes (per K150622).
• STERRAD® 100NX (Standard/Flex/Express/Duo): Flex: 12.75-17 minutes; Express: 4.5-6 minutes; Duo: 10 seconds-8 minutes (per K150622).
  Finding: Testing had previously verified this performance with the predicate device, which is identical in design. |
  | Color Change after Exposure to VHP (New Sterilizers):
  Indicator turns from blue to pink when exposed to complete cycles in AMSCO® V-PRO™ 1 (Lumen), AMSCO® V-PRO™ 1 Plus (Lumen & Non Lumen), and AMSCO® V-PRO™ maX (Lumen, Non Lumen, & Flexible). | Demonstrated for New Sterilizers:
  Testing verified that the indicator turned from blue to pink, indicating a "pass" in relation to the color match, under complete cycles in the AMSCO® V-PRO™ maX Low Temperature Sterilization System:
• Lumen cycle: Between 7 seconds and 8 minutes.
• Non Lumen cycle: Between 6 minutes and 9 minutes.
• Flexible cycle: Between 9 minutes and 12 minutes.
  Note: While V-PRO 1/1 Plus cycles are mentioned in the IFU, the detailed performance data specifically for AMSCO® V-PRO™ maX is provided in the comparison table regarding "Cycle Conditions for Color Change." The statement "Samples from six different lots were verified to meet the requirements for detectable color change in the AMSCO® V-PRO™ maX Low Temperature Sterilization System" implies successful color change for these specific cycles. |
  | Minimum Exposure Parameters to Affect Change:
  Determine the minimum time required for the color change within the new sterilizer cycles. | Samples from six different lots were evaluated. The minimum times are reported above for the AMSCO® V-PRO™ maX cycles. |
  | Endpoint Color Stability:
  The "pass" color (pink) remains stable for a specified period after exposure. | The color was verified to be stable to storage under typical office lighting conditions for at least one month (4 weeks) post-exposure in a Hydrogen Peroxide Health Care Facility Cycle. (Identical to predicate). |
  | Shelf Life: | Two (2) years. (Identical to predicate). |

Since this is a simple chemical indicator and not an AI/ML software, many of the requested detailed points are not applicable or the information is not provided because it's not relevant to this type of device submission.

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: For the new sterilizer (AMSCO® V-PRO™ maX), "Samples from six different lots" were used for both "Color Change" and "Minimum Exposure Parameters" testing. Specific numbers of indicators per lot or per test run are not detailed in this summary.
   • Data Provenance: The data is from manufacturer testing ("Nonclinical Testing"). The country of origin is not explicitly stated, but the company (3M) is based in the USA, and the submission is to the FDA. This is considered prospective testing, specifically designed to demonstrate the device's performance under controlled conditions.

2. 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 is not applicable. The "ground truth" for a chemical indicator is its observable color change, verified against a printed color match. This is a physical, objective observation, not a subjective interpretation requiring expert consensus in the typical sense of medical image analysis. No human "experts" in the clinical sense were used to "establish ground truth" for the indicator's performance. The "ground truth" for whether the sterilizer cycle was appropriate comes from established sterilization parameters and validated equipment (which the indicator is designed to verify exposure to).

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

   • Not applicable. This is not a study requiring reader adjudication. The color change is a direct physical property.

4. 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.

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

   • Not applicable. This is not an AI/ML device. It is a passive chemical indicator.

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

   • The "ground truth" is the physical state of the chemical indicator (color change from blue to pink, validated against a color match on the product) and its performance under controlled and validated sterilization cycle conditions. It's an objective physical/chemical reaction.

7. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or a "training set."

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

   • Not applicable.

Ask a specific question about this device

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® 100, 100S, NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes. The chemical indicator bar turns from blue to pink after exposure to vaporized hydrogen peroxide.

The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 consists of a non-cellulosic 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 a breakdown of the acceptance criteria and study information for the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a premarket notification [510(k)] submission for an expanded indication for use of an existing device, the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248. Crucially, the document states: "No clinical data was included in this premarket application submission." The focus of this specific submission is on nonclinical testing to demonstrate substantial equivalence for the expanded indications.

Therefore, the following details relate to the nonclinical studies conducted to support the expanded indications.

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

• Color Change in Health Care Facility Cycle: "Samples from six different lots" were verified.
• Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle: "Samples from six different lots" were evaluated.
• End Point Color Stability: "Samples from four different lots" were verified.
• Data Provenance: The studies were conducted by 3M Health Care. Origin of data (e.g., country) is not specified but implied to be internal testing. The studies are prospective in nature, as they involve testing new lots of the device under controlled conditions to verify performance against pre-defined criteria.

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 chemical indicators, the ground truth is typically visual observation against a color match standard. The document mentions "color match" and "color specification," implying a pre-defined standard (the comparison color match printed on the product). The determination of "pass" or "fail" is based on whether the indicator sufficiently changes color to match this standard. It doesn't typically involve human expert interpretation in the same way as, for example, a medical imaging diagnosis.

4. Adjudication method for the test set:

• This information is not explicitly stated. Given the nature of a chemical indicator changing color to a pre-defined standard, adjudication in a multi-rater sense is less common. The "pass" or "fail" is usually determined by direct comparison to the color target on the indicator. The mention of "all indicators" in relation to color change implies a quantitative or objective assessment rather than subjective expert consensus.

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. This is a chemical indicator, not an AI-powered diagnostic device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not applicable and was not performed.

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

• Yes, effectively. The device itself is a standalone chemical indicator designed to change color based on exposure. Its performance (color change, stability) is evaluated independently, without requiring human interpretation in a diagnostic loop that would alter or confirm its output in a clinical decision-making process. The "reading" of the indicator (e.g., "blue to pink") is an inherent property of the device itself.

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

• For the performance testing, the ground truth is established by physical measurement and visual comparison against a pre-defined color standard/specification. The actual exposure parameters within the sterilizer cycles (time, presence of vaporized hydrogen peroxide) serve as the objective truth for whether the indicator should change color. The "pass" or "fail" is determined by whether the observed color reaches the specified end-point color.

8. The sample size for the training set:

• This device does not involve a "training set" in the context of an AI or machine learning algorithm. It is a chemical indicator that reacts based on chemical principles, not learned patterns.

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

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

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