Search Results

Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with a 3M TM Attest ™ Super Rapid Readout Biological Indicator 1492V along with or without SteriScan Integrators.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Dana Reusable Test Pack." It primarily discusses regulatory compliance and does not contain scientific study details, acceptance criteria, or performance data beyond the statement of substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance from the provided document. The document confirms that the device is cleared for marketing based on substantial equivalence, but it does not include the specifics of performance metrics, study designs, sample sizes, or ground truth establishment that would typically be found in a study report.

Ask a specific question about this device

Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with SGM Biotech's Self-Contained Biological Indicator Smart-Read EZTest - Steam along with or without SteriScan Integrators.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Dana Reusable Test Pack." While it states the intended use and regulation information, it does not contain the detailed acceptance criteria or a study that proves the device meets those criteria.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts, their qualifications, or adjudication methods for ground truth establishment.
4. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
5. Information about standalone algorithm performance.
6. The type of ground truth used.
7. Training set sample size or how its ground truth was established.

The letter is a regulatory document confirming that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for market clearance, but it does not provide the underlying performance study details that would typically include acceptance criteria and specific performance metrics.

Ask a specific question about this device

The Dana Reusable Bowie Dick Type Test Pack, when used with a Dana Bowie Dick indicator, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°-0°C) temperature difference between the center of the ANSVAAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for validating this device were 134℃ for 3.5 minutes with a 2 minute dry time.

Dana Reusable Bowie Dick Type Pack and Dana Bowie Dick Indicators

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Dana Reusable Bowie Dick Type Pack and Dana Bowie Dick Indicators". This document typically outlines the FDA's decision on substantial equivalence based on data submitted by the manufacturer. However, it does not contain a detailed study report with specific acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case study results.

The document states:

• Device Name: Dana Reusable Bowie Dick Type Pack and Dana Bowie Dick Indicators
• Intended Use: For testing the air removal efficiency of pre-vacuum steam sterilizers.
• Performance Claim: The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°-0°C) temperature difference between the center of the ANSVAAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window).
• Test Parameters for Validation: 134℃ for 3.5 minutes with a 2-minute dry time.

Based on the information provided in the given document, I cannot provide a complete answer to your request. The document is a regulatory approval letter, not a detailed scientific study report. It states that the device is "substantially equivalent" to predicate devices, implying that testing was conducted, but it does not include the specifics of that testing.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (Not available in the provided document):

• 2. Sample size used for the test set and the data provenance: Not specified.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. The ground truth here is a physical condition (temperature difference, vacuum presence/absence) measured by instruments, not expert interpretation of an image or signal.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable (ground truth is instrumental/physical).
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is a chemical indicator, not an AI or imaging device requiring human interpretation for its primary function.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone indicator. Its "performance" is whether the dye changes correctly. There's no AI algorithm or human-in-the-loop for its direct function.
• 7. The type of ground truth used: Based on the description, the ground truth is physical measurement of sterilization conditions, specifically the temperature difference in a standard test pack and the presence/absence of proper vacuum, conforming to ANSVAAMI/ISO 11140-5:2007 Standard. This is not expert consensus, pathology, or outcomes data in the traditional sense.
• 8. The sample size for the training set: Not applicable for this type of device. There is no "training set" in the context of an AI/machine learning model. The device's performance is based on its chemical and physical properties.
• 9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

Dana Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum 4 minute steam sterilization cycles with the Dana Emulating Indicator cleared by FDA under K100891.

Reusable Integrator Test Pack for Dana Emulating Indicator.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Reusable Integrator Test Pack for Dana Emulating Indicator." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance. It is a regulatory clearance, not a scientific study report.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

To obtain this information, you would typically need to refer to the original 510(k) submission (K110253) made by Dana Products, Inc. to the FDA. Such submissions contain the technical data, study protocols, and results that demonstrate the device meets its intended performance and regulatory requirements. These documents are usually not publicly available in full detail through a simple clearance letter.

Ask a specific question about this device

The disposable polypropylene sleeve assembly with 3M's 1292 Bl used with the Dana Reusable Test Pack can be used for routine monitoring of 10 Minute 270° F pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with Dana Reusable Test Pack cleared under K 092944.

Reusable Biological Indicator Test Pack for Steam Sterilization.

The provided document (K103321) is a 510(k) clearance letter from the FDA for a Reusable Biological Indicator Test Pack for Steam Sterilization. It indicates substantial equivalence to a predicate device. However, this document does not contain the detailed study information, acceptance criteria, or performance data typically found in a summary or report of a scientific study.

Therefore, I cannot provide the requested information from the given text. A 510(k) summary or a more detailed technical report would be needed to answer these questions.

Ask a specific question about this device

Dana Emulating Indicator is for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met. Critical Parameters in a standard hospital pre-vacuum steam sterilizer Temperature : 270°F (132°C) Time: 4 Minutes

Not Found

The provided text is a decision letter from the FDA regarding a 510(k) premarket notification for a medical device called "Dana Emulating Indicator." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, specifically:

• A table of acceptance criteria and the reported device performance: This information is not present in the FDA letter. The letter only refers to "indications for use" as stated in the enclosure, but the details of performance criteria and actual test results are absent.
• Sample size and data provenance: Not mentioned.
• Number of experts and qualifications: Not mentioned.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone performance: Not mentioned.
• Type of ground truth: Not mentioned.
• Sample size for training set: Not applicable for this type of device (it's a physical indicator, not an AI/software device).
• Ground truth for training set: Not applicable.

The "Indications for Use" section (page 2) describes what the device is intended to do and the specific parameters it's designed to monitor in a sterilization process:

Device Name: Dana Emulating Indicator

Indications For Use: "Dana Emulating Indicator is for use in 4 minute 270°F (132°C) pre-vacuum steam sterilization process. When exposed to steam sterilization temperature and time the dark bar will travel along the window and enter the accept area giving an indication that steam sterilization conditions were met."

Critical Parameters:

• Temperature: 270°F (132°C)
• Time: 4 Minutes

While these are the conditions the device is designed to indicate, the document does not provide the specific performance acceptance criteria (e.g., how accurate is the "dark bar travel" or what tolerance it has) nor does it provide a study report demonstrating its performance against such criteria. This kind of detail would typically be found in the actual 510(k) submission document or a separate test report, not in the FDA's decision letter.

Ask a specific question about this device

Dana reusable challenge test pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with SteriScan Integrators.

Reusable SteriScan Integrator Test Pack for Steam

This document is a 510(k) clearance letter from the FDA for a medical device (Reusable SteriScan Integrator Test Pack for Steam Sterilization). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the device was cleared based on its substantial equivalence to a predicate device, not on a new study demonstrating its performance against specific acceptance criteria. The FDA determined that the new device is as safe and effective as a legally marketed predicate device, therefore a detailed performance study as you've requested is typically not included or required for a 510(k) clearance.

Therefore, I cannot provide the requested information from the given input.

Ask a specific question about this device

Dana reusable test pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4 minute 270°F pre-vacuum steam sterilization cycles with 3M's 1292 Rapid Readout Biological Indicators along with or without SteriScan Integrators.

Reusable Biological Indicator and Integrator Test Pack for Steam Sterilization.

Unfortunately, the provided document is a letter from the FDA regarding a 510(k) clearance for a Reusable Biological Indicator and Integrator Test Pack for Steam Sterilization. It confirms substantial equivalence to a predicate device and provides information on regulatory compliance.

However, the document does not contain any information about the acceptance criteria and the study that proves the device meets those criteria. Specifically, the request asks for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance study details
7. Type of ground truth used
8. Sample size for the training set
9. How training set ground truth was established

None of this information is present in the provided text. To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or similar technical documentation that details the testing performed for the device.

Ask a specific question about this device

Dana Steam Sterilization Integrators are intended to monitor critical parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (when steam is present). The end point is determined by the migration of the steam sensitive dye to an area marked safe on the indicator. The integrators are intended to be used in 30 minute gravity cycles at 250 degrees F and 3 minute gravity and pre- vacuum cycles at 270 degrees F.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Dana Steam Sterilization Integrator." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain specific information about:

• Acceptance criteria and reported device performance in a table.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for a study.
• Training set sample size or how its ground truth was established.

The document primarily focuses on the regulatory approval process and the indications for use of the device, which are described as:

• Indications for Use: Dana Steam Sterilization Integrators are intended to monitor critical parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (when steam is present). The endpoint is determined by the migration of the steam-sensitive dye to an area marked safe on the indicator. The integrators are intended to be used in 30-minute gravity cycles at 250 degrees F and 3-minute gravity and pre-vacuum cycles at 270 degrees F.

Therefore, I cannot provide the requested table or study details based on the given information. The document is a regulatory approval letter, not a study report.

Ask a specific question about this device