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The BD PhaSeal™ Optima system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The BD PhaSeal™ Optima system also prevents microbial ingress for up to 168 hours.

BD PhaSeal™ Optima Closed System Drug Transfer Devices (CSTD) are sterile, single use closed system drug transfer devices intended for the reconstitution and transfer of antineoplastic or other hazardous drugs in the healthcare setting. The BD PhaSeal™ Optima system is comprised of four devices—Protector, Injector, Connector, and Infusion Adapter.

The closed transfer of liquid drugs takes place through a double membrane utilizing self-sealing elastomeric membranes that are tightly fitted together through the collet-style fitting on each of the BD PhaSeal™ Optima system devices. During use, the single lumen cannula of the Injector perforates the double membranes for the transfer of liquids. When the cannula is retracted the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, leaks and spills. The BD PhaSeal™ Optima system prevents microbial ingress for up to 168 hours. Performance of the self-sealing membrane has been substantiated up to 10 penetrations.

Device labeling includes the following statement: "The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying, extending, or superseding a manufacturer's labeling recommendations for the storage and expiration dating of the drug vial. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information."

The provided text describes the regulatory clearance for the BD PhaSeal™ Optima Closed System Drug Transfer Device-Injector (N40-O). It does not describe an AI/ML powered medical device. Therefore, many of the requested fields are not applicable.

Here's the information that can be extracted from the provided text:

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

The text states: "all predetermined acceptance criteria were met."

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

The sample sizes for the performance tests are not specified in the provided document.
The data provenance is not specified beyond the tests being conducted by the manufacturer, Becton, Dickinson and Company.

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

This is not applicable as the device is a mechanical Closed System Drug Transfer Device, not an AI/ML system requiring expert ground truth for interpretation.

4. Adjudication method for the test set

This is not applicable as the device is a mechanical Closed System Drug Transfer Device, not an AI/ML system or a diagnostic device requiring adjudication of interpretations. The performance tests appear to be quantitative measurements against defined 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

This is not applicable. The device is a mechanical Closed System Drug Transfer Device and not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a mechanical Closed System Drug Transfer Device and does not have an algorithm component.

7. The type of ground truth used

For the performance tests (Attachment/detachment force, Fragmentation, System flow rate), the ground truth would be established by objective physical measurements against predefined engineering or regulatory specifications.

8. The sample size for the training set

This is not applicable as there is no training set for a mechanical device.

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

This is not applicable as there is no training set for a mechanical device.

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The BD PhaSeal™ Optima system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The BD PhaSeal™ Optima system also prevents microbial ingress for up to 168 hours.

The BD PhaSeal™ Optima Closed System Transfer Device (CSTD) is a sterile single-use closed system drug transfer device intended for the reconstitution and transfer of antineoplastic or other hazardous drugs in the healthcare setting. The system is comprised of four devices-Protector, Injector, Connector, and Infusion Adapter. The closed transfer of liquid drugs takes place through a double membrane utilizing self-sealing elastomeric membranes that are tightly fitted together through the collet-style fitting on each of the BD PhaSeal™ Optima system devices. During use, the single lumen cannula of the Injector perforates the double membranes for the transfer of liquids. When the cannula is retracted the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, leaks and spills. The BD PhaSeal™ Optima system prevents microbial ingress for up to 168 hours. Performance of the self-sealing membrane has been substantiated up to 10 penetrations.

The BD PhaSeal™ Optima Closed System Transfer Device is an airtight and leakproof closed system drug transfer device (CSTD) designed to prevent environmental contaminants from entering the system and to prevent drug vapor concentrations from escaping, thus minimizing exposure to drug vapor, aerosols, and spills. It also prevents microbial ingress for up to 168 hours.

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 performance test. It only indicates that "Performance testing was conducted" and that the "Results of these tests demonstrate that the subject device is substantially equivalent to the predicate device." The data provenance is not specified beyond being generated by the device manufacturer, Becton, Dickinson and Company. The studies appear to be retrospective in nature, performed by the manufacturer to demonstrate product performance for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable. This device is a medical device (Closed System Transfer Device), not an AI-powered diagnostic or assistive tool that would require expert-established ground truth for its performance assessment. The tests conducted are laboratory-based and measure physical, chemical, and biological properties according to established standards.

4. Adjudication Method for the Test Set:

Not applicable. See point 3.

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-powered device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an AI-powered device. The "standalone" performance here refers to the device's inherent mechanical and material performance.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established by the pre-defined acceptance criteria set by recognized international (ISO, ASTM) and national (FDA, USP) standards and guidance documents. For example, for microbial ingress, the ground truth is the absence of microbial contamination as defined by the FDA guidance. For airtight connections, the "ground truth" is the non-detection of vapor using the TiCl4 test. For biocompatibility, the ground truth is that the materials do not elicit adverse biological responses as defined by ISO 10993 standards.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

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The PhaSeal system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.

The PhaSeal® System is a sterile single-use closed system drug transfer device. The closed transfer of liquid takes place through a double membrane utilizing self-sealing elastomeric membranes, tightly fitted together through a bayonet fitting on all PhaSeal components. A single lumen cannula perforates the double membranes for the transfer of liguid. When the cannula is retracted the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols and spills and also minimizing the risk of microbial contamination.

The PhaSeal Injector is one component of the PhaSeal system. It is a luer device adaptor that may be fitted to a syringe or IV tubing. It is used to gain dry and leak-proof access to a drug container or administration device which has been sealed with a PhaSeal Protector or Connector. Liquid transfer takes place through tightly fitting elastomeric double membranes to minimize exposure to potentially hazardous drug aerosols and spills occurring during reconstitution, administration and disposal processes.

This document describes the performance and acceptance criteria for the BD PhaSeal Closed System Transfer Device - Injector, as summarized from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines design verification tests to demonstrate substantial equivalence to the predicate device. The acceptance criteria are implicit in the "Equivalent to Predicate" or "Per ISO 10993" results for each characteristic.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for the "Dye Leak Test" or "Fragmentation Test." It mentions "Design Verification tests were performed based on the risk analysis performed," suggesting a controlled testing environment, but no specific sample numbers are given. The data provenance is internal to BD Medical - Medical Surgical Systems, likely conducted in a laboratory setting for device validation. It is a prospective study in the sense that the tests were performed specifically to verify the modified device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the given text. The tests appear to be objective performance tests (dye leak, fragmentation) rather than expert-dependent assessments requiring ground truth establishment by human experts. Biocompatibility (ISO 10993) is likely assessed by trained laboratory personnel in accordance with the standard, not necessarily clinical "experts" in the sense of radiologists or similar.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests performed (Biocompatibility, Membrane Leakage, Membrane Fragmentation) are objective measurements or adherence to standards, not subjective assessments requiring adjudication by multiple readers.

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:

This information is not applicable. The device is a Closed System Transfer Device (CSTD), a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with human readers and AI assistance is irrelevant to its purpose and performance evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. The device is a physical product and does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

For the performance tests:

• Biocompatibility: The "ground truth" would be adherence to the established scientific and regulatory standards outlined in ISO 10993 for biological evaluation of medical devices.
• Membrane Leakage & Fragmentation: The "ground truth" or reference for performance is the predicate device (BD PhaSeal® Connector, Injector, Protector - K123213). The goal was to prove "equivalence," meaning the modified device should perform as well as the predicate device in these specific functional tests.

8. The Sample Size for the Training Set:

This information is not applicable. The described study is a design verification for a physical medical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as above (no training set).

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The PhaSeal system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor contractions outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.

The PhaSeal® System is a sterile single-used closed system drug transfer device. The closed transfer of liguid takes place through a double membrane utilizing self-sealing elastomeric membranes, tightly fitted together through a bayonet fitting on all PhaSeal components. A single lumen cannula perforates the double membranes for the transfer of liquid. When the cannula is retracted the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols and spills and also minimizing the risk of microbial contamination.

The PhaSeal Protector is one component of the PhaSeal system. It is a drug vial adapter that is fitted to the drug vial and is used as a docking station between the drug vial and the BD PhaSeal Injector. In addition the Protector equilibrates the pressure difference which occurs when fluid or air is added or removed from the drug vial. Liquid transfer takes place through tightly fitting elastomeric double membranes to minimize exposure to potentially hazardous drug aerosols and spills occurring during reconstitution, administration and disposal processes.

The provided 510(k) summary (K130197) does not contain information related to acceptance criteria, device performance, or any studies involving human readers or AI algorithms.

This document describes a medical device called the "BD PhaSeal Closed System Transfer Device - P55," which is a sterile, single-use closed system drug transfer device. The 510(k) summary focuses on the device's description, intended use, and substantial equivalence to a predicate device (BD PhaSeal® Connector, Injector, Protector - K123213).

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document describes the function of the device (airtight, leakproof, prevents transfer of contaminants, etc.) but does not quantify performance against specific criteria.
2. Sample size used for the test set and the data provenance: Not applicable as no such study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is described.
4. Adjudication method for the test set: Not applicable as no such study is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable as this is a physical medical device, not an AI or imaging diagnostic tool.
6. If a standalone performance study was done: While there would undoubtedly be internal testing by the manufacturer for a device of this type (e.g., leak tests, microbial ingress tests), the provided 510(k) summary does not detail these studies' acceptance criteria, methodologies, or results. The summary focuses on the regulatory submission process.
7. The type of ground truth used: Not applicable as no ground truth for diagnostic or interpretative accuracy is relevant or discussed for this device.
8. The sample size for the training set: Not applicable as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable as this is not a machine learning device.

In summary, the provided text details a regulatory submission for a physical medical device and does not include the type of performance study data or acceptance criteria typically associated with AI/ML devices or diagnostic tools.

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The PhaSeal system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.

The PhaSeal® System is a sterile single-used closed system drug transfer device. The closed transfer of liquid takes place through a double membrane utilizing self-sealing elastomeric membranes, tightly fitted together through a bayonet fitting on all PhaSeal components. A single lumen cannula perforates the double membranes fro the transfer of liquid. When the cannula is retracted the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols and spills and also minimizing the risk of microbial contamination.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

Description of the Study Proving Acceptance Criteria

The study described is a series of non-clinical tests designed to demonstrate that the BD PhaSeal® Closed System Drug Transfer Device meets the specified performance criteria for leakproofness, airtightness, and microbial ingress. The summary states, "As there is no change to the subject device in comparison to the predicate devices, the performance data provided represent the performance of both the predicate and subject device of this 510(k)." The tests were conducted to substantiate its use as a Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System (ONB product code).

Details on the Tests:

• Leakproof Connections: Tested using a Fluorescein Test.
• Airtight Connections: Tested using a TiCl4 Test (which detects vapor/smoke).
• Microbial Ingress: Tested to ensure no ingress at the Protector or Connector.

Additional Information Not Present in the Document:

The provided 510(k) summary focuses on demonstrating substantial equivalence through technological characteristics and a summary of performance tests. It does not contain the following information typically found in detailed study reports:

2. Sample size used for the test set and the data provenance: Not specified. The document only mentions "additional tests referenced in the table" without detailing sample sizes or the origin (country, retrospective/prospective) of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for these types of physical performance tests (leak, airtight, microbial ingress). Ground truth is established by the test method itself, not expert consensus.
4. Adjudication method for the test set: Not applicable for these performance tests. The outcome is typically a pass/fail based on direct observation (e.g., presence/absence of leaks, smoke, or microbial growth).
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 medical device for drug transfer, not an imaging or diagnostic AI product, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/algorithm-driven device.
7. The type of ground truth used: The ground truth for these tests is defined by the objective results of the specified testing methodologies (Fluorescein Test, TiCl4 Test, and microbial ingress testing). For example, "no leaks" is the ground truth from the fluorescein test.
8. The sample size for the training set: Not applicable. This device does not use machine learning or require a training set.
9. How the ground truth for the training set was established: Not applicable. This device does not use machine learning or require a training set.

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The indication for use is reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, administration and disposal process.

The single lumen docking station of the Protector is fitted to the drug vial for the parenteral drug. The Injector is connected to the Protector and liquid transfer takes place through tightly fitting elastomeric double membranes to minimize leakage during reconstitution, administration and disposal processes. The Protector equilibrates the pressure difference which occurs when fluid or air is added to, or removed from the drug vial.

The provided text describes a 510(k) summary for a medical device called "PhaSeal® - A Closed System Drug Transfer Device for Preparation and Administration of Parenteral Drugs" and its components (Protector P14, P21, P28, and P50). However, the document does not contain acceptance criteria, a specific study proving the device meets those criteria, or the detailed information requested in your prompt (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details).

Instead, the document details a substantial equivalence comparison to predicate devices for regulatory clearance. The core of the submission is to demonstrate that the new devices (Modified P14, P21, P28, P50) are functionally equivalent to previously cleared devices (Predicate P14, P21, P50 from K001368).

The relevant sections are "5. Technological characteristics, comparison to predicate device" and "6. Discussion of performance testing."

Here's a breakdown of what can be extracted and what information is missing based on your prompt:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or a direct measurement of "device performance" in terms of specific metrics like leakage rates or contamination levels. Instead, it relies on demonstrating equivalence to predicate devices, which are presumed to meet established safety and effectiveness standards.

The closest we can get to "performance" is the comparison table which shows direct equivalence in intended use, material, spike type (with one exception for P28), drug vial size, expansion chamber, and sterilization method.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document states "The Protectors have been tested and found in compliance with applicable requirements and standards specifications," but does not detail what tests, how many samples, or where the data originated from.

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

• This type of information is entirely absent. The submission is based on demonstrating substantial equivalence through material and design comparisons and general performance testing (details not provided), not an expert-driven ground truth assessment.

4. Adjudication method for the test set

• Not applicable/Not specified. There's no mention of a formal adjudication process for test results in this 510(k) summary.

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

• This is not an AI/software device. No MRMC comparative effectiveness study was conducted or is relevant to this submission.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable in the context of expert-derived ground truth. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices. The new devices are deemed "substantially equivalent" if they meet the same functional and material characteristics and do not raise new safety or effectiveness concerns.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a "training set."

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

• Not applicable. (See answer for #8).

Study that proves the device meets the acceptance criteria:

The document refers to a general "Discussion of performance testing" stating: "The Protectors have been tested and found in compliance with applicable requirements and standards specifications."

This is a high-level statement indicating that the device has undergone testing, but the 510(k) summary does not provide details of a specific study or its results to quantitatively demonstrate compliance with acceptance criteria. The core approval mechanism here is demonstration of substantial equivalence to predicate devices, not a novel performance study against specific acceptance metrics. The FDA's letter confirms this, stating, "The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

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The Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible to administer drugs into the patient using the sealed double membrane technique.

PhaSeal is a closed system for handling of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the drug, the administration of the drug to the patient, and waste handling.

All drug transferring utilizes a double membrane technique. Each component device is sealed off with an elastomeric membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage.

The Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible administer drugs into the IV line of the patient using the PhaSeal Injector. Liquid transfer takes place through tightly fitting elastomeric membranes to minimize exposure to potentially hazardous drug aerosols and spills that occur during the administration and disposal processes.

This document is a 510(k) summary for the PhaSeal Y-site Line, an intravascular administration set. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K980381) rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report as one might find for a novel device undergoing extensive clinical trials.

Therefore, the requested information elements related to specific acceptance criteria, detailed study design, expert ground truth, and AI-specific metrics (like MRMC studies) are not fully present in the provided text because this type of submission is for a device deemed substantially equivalent to an already approved one.

However, I can extract the available information and point out where the requested details are absent.

Description of Device and Comparison to Predicate

The PhaSeal Y-site Line is a component of the PhaSeal closed system for handling parenteral drugs, particularly cytotoxic drugs. It serves as a port for IV administration when a Luer Lock fitting is not available in the patient's IV line. It uses a built-in connector that works with the PhaSeal Injector, utilizing a double membrane technique designed to prevent leakage of hazardous drug aerosols and spills.

The device is considered substantially equivalent to previously cleared PhaSeal devices included in 510(k) Number K980381. This claim of substantial equivalence replaces the need for extensive de novo performance studies in this specific 510(k) submission. Therefore, detailed acceptance criteria and a specific performance study in the manner requested are not explicitly outlined for this particular submission entry (K060866) beyond the general safety and efficacy implied by substantial equivalence to its predicate.

Requested Information Based on Provided Document:

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

Note: The document states, "The device is substantially equivalent to previously cleared PhaSeal devices included in 510(k) Number K980381." This means the foundational acceptance criteria and performance data would have been established and met by the predicate device. This specific 510(k) (K060866) relies on demonstrating that the Y-site Line performs equivalently.

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

• Not explicitly stated in this 510(k) summary. Since this is a substantial equivalence submission, a new, independent performance study with a specific "test set" and sample size as described for a de novo device is not presented. The "data" refers to the established performance of the predicate device (K980381).
• Data Provenance: The predicate device (PhaSeal system) was developed by Carmel Pharma AB (Molndal, Goteborg, Sweden). The provided text does not specify the country of origin of testing data for the predicate, nor whether it was retrospective or prospective.

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

• Not applicable/not explicitly stated in this 510(k) summary. This type of information is typically for diagnostic devices, particularly those involving image interpretation where expert consensus is needed to establish "ground truth." This device is an administration set. The "ground truth" for its safety and effectiveness would be established through engineering validation, material testing, and potentially clinical use data of the predicate, as opposed to expert interpretation of data.

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

• Not applicable/not explicitly stated in this 510(k) summary. This concept is generally applied to diagnostic studies where multiple readers interpret data and discrepancies are adjudicated.

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 an intravascular administration set, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.

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

• Not applicable. This device is a physical medical device, not an algorithm, so "standalone" performance in this context is irrelevant.

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

• For this type of device (intravascular administration set), the "ground truth" for its performance, safety, and effectiveness would be established through a combination of:
  • Engineering specifications and tests: Demonstrating the physical integrity of the component, the sealing mechanism (double membrane), burst pressure, leak tests, and flow rates.
  • Biocompatibility testing: Compliance with ISO 10993 standards.
  • Sterilization validation: Ensuring the device is sterile.
  • Clinical performance data (for the predicate): Evidence from the predicate device (K980381) demonstrating its effectiveness in preventing drug exposure during preparation, administration, and waste handling in actual use, likely supported by observational studies or post-market surveillance.
• None of these specific details are provided in this 510(k) summary. The summary relies on the overarching claim of substantial equivalence to K980381.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a "training set."

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

• Not applicable. As above, no training set is involved.

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The Infusion Adapter serves as a the connecting part between the IV bag and an external IV line (e.g. IV regulators). The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal double membrane technique.

PhaSeal is a closed system for handling of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the drug, the administration of the patient, and waste handling. All drug transferring utilizes a patented double membrane technique. Each component device is sealed off with an elastomeric membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) premarket notification summary for a medical device (PhaSeal Infusion Adapter). It describes the device, its intended use, and states its substantial equivalence to previously accepted PhaSeal devices. The letter from the FDA confirms the substantial equivalence determination and permits the device to proceed to market, subject to general controls and regulations.

The text does not include:

• A table of acceptance criteria or reported device performance.
• Details about a sample size, test set, data provenance, or ground truth establishment.
• Information regarding expert involvement, adjudication methods, or MRMC studies.
• Any standalone algorithm performance data.
• Details about a training set or its ground truth.

Therefore, I cannot fulfill your request for this specific information using the provided document.

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PhaSeal® closed system for the preparation and administration of parenteral drugs

PhaSeal Infusion Adapter - Intravascular Administration Set: The Infusion Adapter serves as the connecting part between the IV bag and an external IV line. (Example IV regulators.) The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed double membrane technique.

PhaSeal Protection Cap - Special accessories: The Protection Cap is intended to be used as a mechanical cover for the membrane in the bayonet fitting of PhaSeal devices The Protection Cap mates with the other PhaSeal components equipped with the bayonet fitting. One end of the Protection Cap has a male bayonet fitting and in the other a female bayonet fitting.

PhaSeal Secondary Set - Intravascular Administration Set: The Secondary Set is a non-vented infusion set used when drug is handled as an admixture and is administered via Intravenous infusion. The Secondary Set has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal technique.

PhaSeal Extension Set - Intravascular Administration Set: The Extension Set serves as the port for bolus injection with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Extension Set has a built in Connector which makes it possible inject drugs into the IV line of the patient using the sealed double membrane technique.

PhaSeal is a closed system for preparation and administration of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the administration of the drug to the patient, and waste handling. All drug transferring utilizes a patented double membrane technique. Each component devices is sealed off with an elastomeric membrane cover. The membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage.

The provided text is a 510(k) summary for the PhaSeal® closed system for the preparation and administration of parenteral drugs. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth cannot be extracted directly from this type of regulatory submission.

Here's an analysis based on the provided text, highlighting what is and isn't available:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria or quantitative performance metrics typically associated with a clinical study. The submission focuses on demonstrating substantial equivalence in function and components to already marketed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical "test set" in the context of a performance study. No sample sizes for testing or data provenance (country, retrospective/prospective) are mentioned, as the basis of the submission is a comparison to predicate devices, not a de novo performance evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable or available. Ground truth establishment for a test set implies a performance study (e.g., diagnostic accuracy), which is not detailed in this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not applicable or available, as no performance study with a test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement

This information is not applicable or available. The submission does not detail any comparative effectiveness study, especially one involving human readers with and without AI assistance. The PhaSeal system is a physical medical device, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable or available. The PhaSeal system is a physical device, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable or available. The submission doesn't describe establishing ground truth for a performance study. Instead, it relies on the known safety and efficacy of the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable or available. There is no mention of a "training set" as this is not an algorithm-based device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or available, as there is no training set described.

Summary of what the document DOES provide, relevant to its purpose:

The document explains the function of the PhaSeal system components (Infusion Adapter, Protection Cap, Secondary Set, Extension Set) and argues for their substantial equivalence to existing predicate devices based on:

• Similar components: "all use similar components"
• Similar function: "provide a pathway to administer fluids from a container to a patient's vascular system" or "a protection and mechanical cover for a connections to IV systems."

This 510(k) submission is a regulatory filing aimed at demonstrating that the new device is as safe and effective as a legally marketed predecessor, not a detailed report of a clinical performance study with specific acceptance criteria.

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