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The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

IV Administration Sets are gravity, single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, stopcock, manifold, tubing, luer connections (connector, adaptor), filter, and hand pump. IV Administration sets are configured to ensure the intended use of the device is met.

The provided text is a 510(k) summary for an IV Administration Set (K213778). It describes the device, its intended use, comparison to a predicate device, and nonclinical testing performed to demonstrate substantial equivalence.

However, the request primarily asks about acceptance criteria and a study proving a device meets acceptance criteria, specifically in the context of an AI/Software as a Medical Device (SaMD). The document furnished details on a physical medical device (IV Administration Set) and its substantial equivalence to a predicate through bench testing and adherence to ISO standards.

Therefore, the information required to answer the prompt regarding AI/SaMD acceptance criteria and proof of performance (e.g., sample size, expert ground truth, MRMC study, standalone performance) is not present in the provided text. The document clearly states: "No clinical testing was performed as these devices does not require clinical studies to demonstrate substantial equivalence with the predicate device."

To reiterate, the provided document does not contain the information requested in your prompt regarding AI/SaMD performance studies and acceptance criteria. This device is a physical IV administration set, not an AI/SaMD.

If you can provide a document related to an AI/SaMD, I would be happy to help answer your questions.

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IV Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

IV Administration Sets are gravity, single use, disposable, IV sets and extension sets. IV Administration Sets are used to deliver fluids from a container into a patient's vascular system. Extension sets are connected to primary IV administration sets to add length and provide clamping capabilities or added to an intravascular catheter hub as a conduit for flow to and from the catheter and are used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, check valve, tubing, luer connections (connector/adaptor), y-connector, and flow regulator.

This is a 510(k) summary for IV Administration Sets by B. Braun Medical Inc. The document discusses the substantial equivalence of their proposed device (K202618) to two predicate devices (K170595 and K153293). It details the non-clinical performance testing conducted.

Here's an analysis of the provided text in response to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside specific quantitative performance metrics as typically seen in device efficacy studies (e.g., Sensitivity, Specificity, Accuracy for diagnostic devices). Instead, it lists various non-clinical tests performed to demonstrate substantial equivalence to predicate devices and conformity to established standards. The "performance" is reported as a conclusion that the tests were "successfully completed" or that "verification results confirm that the differences in the set components do not raise new or different questions of safety and effectiveness."

Here's a compilation of the tests and the implicit performance:

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

The document does not specify the sample sizes used for the non-clinical tests. Non-clinical studies for devices like IV administration sets typically involve testing a statistically significant number of units to ensure reliability, but the exact numbers are not disclosed in this summary.

The data provenance is from non-clinical performance testing conducted by B. Braun Medical Inc. The studies are by nature prospective as they are specifically conducted to support the 510(k) submission. There is no information regarding the country of origin of the data beyond the manufacturer being B. Braun Medical Inc. (located in Allentown, Pennsylvania, USA).

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

This information is not applicable in the context of this 510(k) summary. The ground truth for the non-clinical performance tests is based on objective measurements against established engineering standards (e.g., ISO, USP) and internal B. Braun procedures, not on expert consensus or interpretation.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. The tests described here are physical and mechanical performance tests with objective pass/fail criteria based on standards.

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

There was no MRMC comparative effectiveness study done. This device is an IV administration set, a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with or without AI assistance is irrelevant here.

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

There was no standalone (algorithm only) performance study done. As mentioned, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests is derived from established industry standards (ISO, USP) and internal B. Braun procedures, which outline specific test methodologies, parameters, and pass/fail criteria. For instance, for flow rate, the ground truth would be the expected flow rate range defined by the standard under specific conditions. For tensile strength, it would be the minimum force the material must withstand.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, and the evaluation involves non-clinical performance testing, not machine learning or AI that requires a "training set" of data.

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

This is not applicable for the same reasons as point 8.

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The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

IV Administration Sets are gravity, single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, needleless luer access device, injection site, check valve, tubing, clamp, and luer connection (connector, adaptor). IV Administration sets are configured to ensure the intended use of the device is met.

The provided document is a 510(k) summary for an IV Administration Set, not an AI-powered medical device. Therefore, the information required to answer your query (acceptance criteria and study details for an AI/algorithm-based device) is not present in the given text.

The document focuses on demonstrating substantial equivalence of a conventional medical device (IV administration set) to a predicate device, based on:

• Similar indications for use and intended use.
• Similar principle of operation and fundamental scientific technology.
• Similar component types and materials (with specific testing for material differences).
• Compliance with recognized performance standards (e.g., ISO 8536-4, ISO 10993-1).
• Successful completion of non-clinical performance and biocompatibility testing.

The concept of "acceptance criteria" in this context refers to meeting the performance specifications outlined in the relevant ISO standards and the functional and performance tests listed. There is no mention of an algorithm, AI, or comparative effectiveness studies involving human readers and AI assistance.

To summarize why I cannot provide the requested information:

1. Nature of the Device: The device is a physical medical administration set, not a software or AI-based diagnostic/assistive tool.
2. Type of Submission: This is a 510(k) premarket notification for substantial equivalence, not a de novo or PMA submission that would typically involve extensive clinical performance data for novel AI devices.
3. No AI/Algorithm Mentioned: The document does not describe any AI component, algorithm, or software functionality.
4. No Human-in-the-Loop Study: Since there's no AI, there's no MRMC study, no human reader improvement data, and no standalone algorithm performance.
5. No Ground Truth Establishment: The concept of "ground truth" for diagnostic accuracy is not applicable to a physical IV administration set.

Therefore, I cannot populate the table or answer the specific questions related to AI device evaluation based on the provided text.

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The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

IV Administration Sets are single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, check valve, stopcock, manifold, tubing, luer connections (connector, adaptor), and filter. IV Administration sets are configured to ensure the intended use of the device is met. The proposed device, IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system.

The provided text describes a 510(k) premarket notification for "IV Administration Sets" by B. Braun Medical Inc. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving that the device meets specific acceptance criteria in the manner of an AI/algorithm-based device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of regulatory submission, as it's for a physical medical device (IV administration sets), not an AI/ML algorithm.

However, I can extract information related to acceptance criteria (performance standards) and the "study" (non-clinical performance testing) used to demonstrate adherence to these criteria.

Here's the information formatted as requested, with "N/A" for inapplicable fields:

Acceptance Criteria and Device Performance for IV Administration Sets (K170595)

1. Table of Acceptance Criteria and Reported Device Performance

Details of the "Study" (Non-Clinical Performance Testing)

2. Sample size used for the test set and the data provenance: Not explicitly stated how many individual IV sets were tested for each performance test. The data provenance is from "nonclinical performance testing" performed by B. Braun Medical Inc. (manufacturer), as part of a 510(k) submission to the FDA. This is considered prospective testing for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth for physical device testing is typically based on objective measurements against established technical standards, not expert consensus in the diagnostic sense.

4. Adjudication method for the test set: N/A. Testing is based on objective measurement against defined pass/fail criteria from international standards.

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: N/A. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is not an AI/ML device.

7. The type of ground truth used: The "ground truth" for this device's performance is adherence to the specified international performance standards (e.g., ISO 594-1, ISO 8536-4) and biocompatibility standards (ISO 10993-1). This involves objective measurement of physical and material properties.

8. The sample size for the training set: N/A. This is not an AI/ML device.

9. How the ground truth for the training set was established: N/A. This is not an AI/ML device.

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The IV Administration Sets with 200um Blood Filter are used to deliver blood, blood components, and IV fluids from a container to a patient's vascular system. When the hand pump component is activated, the device is intended to deliver blood, blood products and crystalloid and colloid resuscitative fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and the duration of therapy.

The IV Administration Sets with 200um Blood Filter are single use, disposable, intravenous administration sets used to deliver blood, blood components, and IV fluids from a container to a patient's vascular system, rapidly through the use of a hand pump, or through gravity flow. The sets include tubing, a 60 cm filter with a 200 micron pore size, bag spike, luer connector, roller clamp and slide clamp. The sets may be equipped with a manually activated hand pump, stopcocks, manifolds, and/or luer access devices.

I am sorry, but the provided text does not contain the specific information required to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification for an IV Administration Set with a blood filter, primarily focused on establishing substantial equivalence to a predicate device.

Here's what is missing that would be needed to fulfill your request:

• Specific acceptance criteria values: While the document mentions utilizing acceptance criteria from ISO 1135-4 for "Blood Filter Surface Area" and "Blood Filter Composition," it does not explicitly state what those acceptance criteria values are.
• Reported device performance values: Similarly, it lists types of performance tests conducted (e.g., "Flow rate under gravity," "Blood Filter Mesh Efficiency Test"), but it does not provide the actual numerical results or performance metrics achieved by the device for these tests.
• Details about the study and its results: The document broadly states that "functional performance testing was completed" and "performance data were provided in support of the substantial equivalence determination," but it does not detail the methodology, sample sizes, data provenance, ground truth establishment, or multi-reader studies for these performance tests.

Without these specific details about the acceptance criteria and the quantitative results of the performance testing, I cannot create the requested table or describe the study in the manner you specified. This document focuses more on what tests were done and why they were done (to prove substantial equivalence) rather than the precise results of those tests.

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Hospira Burette sets are indicated for the delivery of fluids including but not limited to blood products from a container to a patient's vascular system.

The Hospira Burette Sets with Secure Lock are intended for use as gravity sets. Hospira Burette sets are comprised of various components including the following: male luer adapter with cap, tubing, flow control device, piercing pin assembly, burette assembly and injection site assembly. Burette sets are configured to ensure the intended use of the device is met. Hospira Burette sets are intended for the delivery of fluids from a container to a patient's vascular system. The sets are disposable devices for single patient use.

The provided document is a 510(k) summary for the Hospira Burette Sets, which is a medical device. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study of AI performance.

Therefore, many of the requested elements for describing the acceptance criteria and study proving device meets those criteria, particularly those related to AI effectiveness, human readers, sample sizes for training sets, and expert adjudication, are not applicable to this document. This document describes a medical device, Burette Sets, not an AI or imaging diagnostic device.

However, I can extract and infer some information based on the document's content regarding the device's performance and the testing conducted.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific numerical targets and corresponding reported device performance values in the way you might expect for an AI diagnostic study. Instead, it refers to compliance with international standards and internal testing.

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

• Sample Size: The document does not specify the exact sample size used for performance or material testing. It states that "new performance data has been generated" and "all testing is acceptable."
• Data Provenance: Not explicitly stated, but assumed to be from internal lab testing conducted by Hospira, Incorporated as part of their 510(k) submission. This would be prospective testing 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 is a physical medical device (intravascular administration set), not a diagnostic device requiring expert interpretation or ground truth establishment in the context of medical imaging or AI. Testing would involve engineering and laboratory personnel following established protocols and standards.

4. Adjudication method for the test set

• Not Applicable. As above, this type of testing for a physical device does not typically involve adjudication methods like those used for expert consensus in diagnostic studies. Compliance with standards (e.g., ISO) is the primary method of evaluation.

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 study is not an MRMC comparative effectiveness study, nor does it involve AI assistance for human readers. It's for a physical medical device.

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

• Not Applicable. This is not an AI algorithm. It's a medical device. Performance testing for the device would be analogous to "standalone" performance testing for a physical product, demonstrating it meets its specifications independently.

7. The type of ground truth used

The "ground truth" for this device is based on compliance with established international standards for medical devices (ISO 10993 for biocompatibility, ISO 594-1, ISO 594-2, ISO 8536-4 for various performance aspects of injection and infusion equipment) and achieving a specific sterility assurance level (10-6). The performance claims are also against the intended use of the device for fluid delivery.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not Applicable. As above, this is not an AI model.

In summary, the provided document is a regulatory submission for a physical medical device, not a study evaluating an AI diagnostic tool. Therefore, many of the questions related to AI performance, human readers, and ground truth establishment for AI models are not relevant to this context. The "study" proving the device meets the criteria refers to the non-clinical performance testing and material testing conducted to ensure compliance with relevant ISO standards and the stated Sterility Assurance Level.

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The IV Administration Sets with Hand Pump are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. When the hand pump component is activated to deliver only crystalloid and colloid resuscitative fluids. These devices may patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

The IV Administration Sets with Hand Pump are single use, disposable, intravenous administration sets with a pressure pump and air guard filter used to deliver fluids from a container into a patient's vascular system rapidly through the use of the pressure pump and/or gravity flow. These sets may be comprised of various generic components which are broadly used throughout the industry such as a bag spike, drip chamber, slide clamp, roller clamp, luer access device, stopcocks, manifolds, tubing, and luer connections. Each of these needleless components have already been cleared through the 510(k) process either individually or as part of a B. Braun IV pump 510(k) which included sets. The unique components to these sets include the manual hand pump and a 15um filter integrated within the drip chamber to reduce the potential for bubble formation within the set during use. The addition of the hand pressure pump provides the capability for delivering IV fluids more rapidly by compressing the pump by hand.

This document describes a 510(k) premarket notification for the B. Braun IV Administration Set with Hand Pump and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices. However, the document does not present specific acceptance criteria or reported device performance in a quantitative manner that can be organized into a table. The performance testing section broadly states that functional performance testing was completed to demonstrate that the sets perform as intended and that results of testing demonstrate that the proposed device performs similarly to the predicate device and can be used safely and effectively according to its intended use. This is a qualitative conclusion rather than a presentation of specific metrics against predefined thresholds.

Based on the provided text, here is an attempt to address your request, acknowledging the limitations of the input:

1. Table of Acceptance Criteria and Reported Device Performance

As the document does not specify quantitative acceptance criteria or precise performance metrics, the table below reflects the qualitative statements provided.

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

The document does not explicitly state the sample size used for the performance or biocompatibility testing. It only mentions that "Functional performance testing was completed" and "The materials of construction...were tested."

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective.

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 document. The testing described is primarily engineering/laboratory-based functional and biocompatibility testing, not clinical studies involving expert interpretation of results to establish a "ground truth" in the way one might for diagnostic devices.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the testing (functional and biocompatibility), an adjudication method in the context of expert consensus on clinical findings is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through functional performance and biocompatibility testing against predicate devices and relevant industry standards, not on human reader performance with or without AI assistance.

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

This question is not applicable as the device is an IV administration set with a hand pump, not an AI or algorithm-driven device.

7. The Type of Ground Truth Used

For the functional performance testing, the "ground truth" would be the expected physical and mechanical performance of an IV administration set as defined by engineering specifications and industry standards (e.g., flow rates, luer connection integrity, pressure resistance). For biocompatibility, the "ground truth" is that the materials do not elicit adverse biological responses, as determined by ISO 10993-1 standard tests.

8. The Sample Size for the Training Set

This question is not applicable as the device is not an AI/machine learning device that requires a training set.

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

This question is not applicable.

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The US Safety Syringes IV Administration set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The device may include the tubing, a flow regulator, filter, drip chamber, Y port, needless injection port, backflow valve, fluid delivery tubing, connectors between parts of the set and a hollow spike to connect the tubing to an IV bag or medication bag.

The provided text is a 510(k) summary for a medical device (US Safety Syringes IV Administration Set with Flow Regulator & Filter). It concerns regulatory approval from the FDA.

Based on the provided text, there is no information about acceptance criteria, device performance studies, or any of the detailed aspects requested (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set information).

This document describes the regulatory approval process (510(k)) and states that the device is substantially equivalent to legally marketed predicate devices. It does not contain the technical study details you are asking for.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and device performance studies because that information is not present in the provided text.

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The IV Administration Sets with Ultrablock UV-Resistant Tubing are intended for the pump or gravity administration of IV fluids involving light sensitive solutions.

The IV Administration Sets with Ultrablock UV-Resistant Tubing are a single-use, sterile, non-pyrogenic tubing set intended for the administration of light sensitive solutions from a container to a patient's vascular system. The device is composed of UV-Resistant IV tubing and may include one or more of the following: universal chamber assembly, injection site, male luer lock, slide clamp, 0.2 micron air eliminating filter, flow clip assembly, and pump cassette.

This 510(k) pertains to "IV Administration Sets with Ultrablock UV-Resistant Tubing." The provided document is a 510(k) summary and the FDA's clearance letter, which means it describes the device and its intended use, and states that the device is substantially equivalent to predicate devices.

However, the provided text does NOT contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

This type of information is typically found in detailed testing reports, design validation documentation, or perhaps summarized within a more extensive 510(k) submission, but it is not present in the excerpt provided.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets the acceptance criteria from the given text. The document primarily focuses on regulatory clearance based on substantial equivalence to existing devices.

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The CODAN IV Administration Set B400 Sp is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container, into the patient.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the CODAN IV Administration Set B400 Sp does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a clearance letter, confirming that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices. It discusses:

• The device name and regulation details.
• The FDA's determination of substantial equivalence.
• General controls provisions and additional controls that may apply.
• Contact information for specific advice.
• Indications for Use: "The CODAN IV Administration Set B400 Sp is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container, into the patient."

Therefore, I cannot fulfill your request for:

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

This information would typically be found in the 510(k) summary or other supporting documentation submitted to the FDA, but it is not present in the clearance letter provided.

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