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Applicable to Product Code 2N3383: For the administration of blood components or solutions from a container into the patient's vascular system through a vascular access device.

Applicable to Product Code 2N3385: For the administration of blood components or solutions from a container into the patient's vascular system through a vasular access device. Only for use with Neonates and Pediatios. Not for use in Trauma situations.

Baxter's IV Administration Sets (Blood Administration Sets) are single use, nonpyrogenic, sterile disposable devices intended for the administration of fluids from a container into the patient's vascular system. They can be used to administer solutions, blood, and blood products to patients.

The proposed blood set configuration (Product Code 2N3385) consists of non-DEHP PVC (

The provided text describes a medical device, "Blood Administration Sets," and its substantial equivalence to a predicate device, but it does not contain information relevant to AI/ML device acceptance criteria or studies. The document is a 510(k) premarket notification for a traditional medical device (intravascular administration set), not an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/ML device from this document.

The document focuses on:

• Device Description: Physical components, materials, and intended use as a blood administration set.
• Technological Characteristics Comparison: A detailed table comparing the proposed device (2N3385) with a predicate device (2N3383), highlighting differences like length, priming volume, and specific components (e.g., spike, blood chamber, dual anti-siphon valve, Clearlink LAV).
• Nonclinical Tests: Bench tests (e.g., Luer tests, tensile strength, leak tests, blood filter tests, spike tests, LAV tests, particulate matter, DEHP claim, blood compatibility, microbial ingress, shelf-life, shipping simulation) to evaluate functional performance and safety.
• Biocompatibility: Assessments per ISO 10993-1.
• Sterility: Validation of gamma radiation sterilization according to ISO 11137-2.
• Shelf-Life: 3-year claim supported by aging testing.
• Microbial Ingress Testing: Evaluations of potential entry points.

All these tests are standard for conventional medical devices and do not involve AI/ML performance evaluation.

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For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.

The proposed device is an IV Administration Set (Blood Administration Set). It is a single use, non-pyrogenic, sterile disposable device intended for the administration of fluids from a container into the patient's vascular system. It can be used to administer solutions, blood, blood products to patients of all ages ranges - neonatal, pediatric, and adult.

The proposed set consists of non-DEHP PVC (

The provided text describes the regulatory filing for a medical device called a "Blood Administration Set" (K210335) by Baxter Healthcare Corporation. It details the device's indications for use, technological characteristics, and substantial equivalence to a predicate device, as well as a list of nonclinical tests performed to support its safety and effectiveness.

Here's an analysis of the provided information regarding acceptance criteria and study details:

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

Biocompatibility Tests:

Sterility Tests:

Shelf-Life:

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

The document does not explicitly state the sample sizes for each of the nonclinical tests. It refers to "risk analyses and design verification tests" and "bench tests" conducted by Baxter Healthcare Corporation. The data provenance is internal to Baxter Healthcare Corporation, indicated by "Baxter Healthcare Corporation conducts risk analyses and design verification tests". There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective, as these are nonclinical bench tests on the device itself.

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

This section is not applicable as the studies described are nonclinical (bench) tests on the device's physical and functional properties, not clinical studies involving human patients or expert interpretation of medical data. Therefore, no "ground truth" was established by experts in a healthcare context.

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

This section is not applicable for the same reasons as point 3. Adjudication methods are relevant for clinical studies where human interpretation or expert consensus is required for complex outcomes.

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 section is not applicable as the device is a "Blood Administration Set," a physical medical device, not an AI software/algorithm requiring human reader evaluation. There is no mention of AI or human reading in the context of this device.

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

This section is not applicable as the device is a physical medical device, not an AI algorithm.

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

For the nonclinical tests, the "ground truth" or reference standards are the specified international and national standards (e.g., ISO 80369-7, ISO 1135-4, USP , USP , USP , ISO 10993 series, ANSI/AAMI/ISO 11137 series) that the device must comply with. These standards define the acceptable performance parameters.

8. The sample size for the training set

This section is not applicable. The context is the regulatory filing for a physical medical device, not a machine learning model. There is no concept of a "training set" for the type of nonclinical tests performed for this device.

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

This section is not applicable for the same reason as point 8.

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The 200 Micron Blood Component Filter and Syringe Adapter is designed to filter clots and other particles from blood and blood components for delivery.

Tubing assembly with a 200 micron filter connected by tubing with clamp and luer on one end and a purchased piston syringe on the other end.

The provided text describes a 510(k) summary for the "200 Micron Blood Component Filter and Syringe Adapter" and regulatory correspondence from the FDA. This device is a blood filter, not an AI/ML-driven diagnostic or image analysis tool, therefore many of the requested categories (e.g., efficacy studies, MRMC studies, ground truth establishment, sample sizes for training/test sets, expert qualifications, adjudication methods) are not applicable.

Here's an analysis based on the information provided, focusing on what is relevant to a non-AI medical device submission:

Acceptance Criteria and Device Performance

A direct table of acceptance criteria with reported device performance is not explicitly presented as a consolidated table in the document. However, the performance testing section states that the device is suitable for its intended use and performs equivalently to predicate devices. The acceptance criteria would be implicitly derived from the referenced standards and the comparison to the predicate devices.

Study Details (where applicable for a non-AI device):

1. Sample size used for the test set and the data provenance: Not applicable in the context of clinical data for an AI/ML system. Performance testing for this medical device would involve laboratory testing on a defined number of device units, potentially using simulated blood products or actual blood/blood components. The sample size for such engineering or biocompatibility tests is not specified in the summary but would be determined by the relevant ISO standards (e.g., for cytotoxicity, irritation, etc.) and good manufacturing practices. There is no "data provenance" in the sense of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI systems (e.g., expert-labeled images) is not relevant here. The "ground truth" for this device would be its physical and chemical properties meeting the specified standards and performing its filtration function as intended.

3. Adjudication method for the test set: Not applicable. This is not an observational or diagnostic study requiring adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical blood filter, not an AI system that interacts with human readers or clinical cases in that manner.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.

6. The type of ground truth used: For this type of device, the "ground truth" is defined by adherence to recognized voluntary standards (e.g., ISO 10993 series for biocompatibility, ANSI/AAMI BF7 for filtration performance) and direct comparison of performance and characteristics to a legally marketed predicate device. This typically involves:

   • Laboratory Testing Results: Demonstrating the device's physical properties, filtration efficiency, flow rates, and material compatibility.
   • Predicate Device Comparison: Establishing substantial equivalence by showing that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate.

7. The sample size for the training set: Not applicable. No AI model is being trained.

8. How the ground truth for the training set was established: Not applicable. No AI model is being trained.

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Blood Transfusion Set is used to administer blood from a container (plastic bag or glass bottle) to a patient's vascular system through a needle or catheter inserted into a vein.

The proposed device is plastic, disposable and sterile blood transfusion set, which is intended to be used to administer the blood from the container to a patient's vascular system through a needle or catheter inserted into a vein via gravity method.

The blood transfusion set consists of protective cap of the closure-piercing device, closure piercing device, tubing, drip, flow regulator, transfusion needle and needle sheath. In addition, there are two kinds of the transfusion set, one has a drug-adding feature and the other hasn't.

There are two specifications of transfusion needle, which are 0.9# transfusion needle and 1.2# transfusion needle.

The proposed device is provided sterilized.

The provided text describes a 510(k) submission for a Blood Transfusion Set, and thus there is no information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a premarket notification for a medical device seeking substantial equivalence to a predicate device.

Specifically:

• No acceptance criteria or device performance table is provided. The document states that "Laboratory testing was conducted to validate and verify that Blood Transfusion Set met all design specifications and was substantially equivalent to the predicate device," but it does not specify what those design specifications or acceptance criteria were, nor does it report specific performance metrics.
• No information on sample size for test sets or data provenance is available. No clinical or performance study details are included in this summary.
• No information on experts for ground truth or adjudication methods is available. There is no mention of a ground truth in the context of this device's submission, as it relates to a physical device rather than an AI or diagnostic algorithm.
• No MRMC comparative effectiveness study or standalone algorithm performance study was mentioned. These types of studies are typically relevant for AI/ML-based diagnostic devices, which is not the case here.
• The type of ground truth used is not applicable/not mentioned. For a physical device like a blood transfusion set, "ground truth" would not be established in the same way as for a diagnostic algorithm. The validation would likely involve engineering and biocompatibility testing against predefined standards.
• No information on training set sample size or how ground truth was established for a training set is available. This is not relevant for the type of device described.

In summary, the provided document is a 510(k) summary for a Blood Transfusion Set, focusing on its description, intended use, and substantial equivalence to a predicate device, rather than detailed performance studies or AI-specific validation criteria.

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Administration of blood and blood by-products.

Fenwal markets a broad range of intravascular administration sets for administration of I.V. solutions or blood involving hundreds of different sets marketed. While the design of these sets differs for each particular application, they are all based on a common basic design involving polyvinyl chloride extruded tubings, with attendant extruded or injection molded connecting parts of other thermoplastics (such as acrylic, ABS, nylon, and similar polymers) plus latex and synthetic rubber injection sites.

This document is a 510(k) summary for Fenwal's Blood Component Recipient and Infusion Sets. It does not contain a study evaluating the performance of the device against specific acceptance criteria.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices (K881321 and K811078).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, because such a study is not part of this 510(k) submission. The submission states: "Since this 510(k) notification is only being submitted to obtain a number under Fenwal, the safety and effectiveness for these products have not changed." This implies that the design and performance characteristics are identical to the predicate devices, and a separate study for this 510(k) was not deemed necessary for safety and effectiveness, as long as it is proven to be substantially equivalent.

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To Administer Blood to the patient's vascular system.
To administer Blood and Blood Derivatives into a patient's vascular system

The PENTATRASFU™ Blood Transfusion Sets are Single Use, Non-toxic, Sterile, Non-Pyrogenic devices used to administer Blood to a patient's vascular system through a Needle or Catheter inserted into a vein.

The provided document describes the PENTATRASFU™ Blood Transfusion Sets and their substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML device. Therefore, the information required for this request (AI/ML acceptance criteria, study details, expert involvement, etc.) is not present in the provided text.

However, I can extract the information related to the performance testing and compliance with standards as described for this medical device.

Here's the information as best as can be extracted from the provided text, focusing on the performance criteria and testing mentioned for the PENTATRASFU™ Blood Transfusion Sets:

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

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

This information is not provided in the document. The document refers to "Performance Testing" but does not specify sample sizes or data provenance.

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

This information is not provided in the document. The testing mentioned refers to compliance with a standard (ISO 1135-4) and biocompatibility, which typically involve laboratory testing, not expert-adjudicated ground truth as would be relevant for an AI/ML device.

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

This information is not applicable/not provided. The assessment of this medical device is based on compliance with recognized standards and laboratory testing, not a human reader adjudication process.

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/not provided. This device is a blood transfusion set, not an AI/ML-driven diagnostic or assistive device that would involve human readers or AI assistance.

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

This information is not applicable/not provided. This device is a physical medical instrument, not an algorithm.

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

The "ground truth" for this device's performance is established through compliance with recognized international standards (ISO 1135-4 for performance, ISO 10993 for biocompatibility) and direct physical/material testing, rather than clinical outcomes or expert consensus on diagnostic interpretations.

8. The sample size for the training set

This information is not applicable/not provided. This device is a physical product and does not have a "training set" in the context of AI/ML.

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

This information is not applicable/not provided. This device is a physical product and does not have a "training set" or "ground truth" in the context of AI/ML.

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Blood Product Specialties Pedi-Syringe Filter™ is intended to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma and cryoprecipitate for pediatric and/or neonatal transfusion.

Tubing assembly with a 150 micron filter connected by tubing to a spike at one end and connected by tubing to a piston syringe at the other end. Between the filter and the spike there is a clamp.

The provided text is a 510(k) premarket notification for a medical device called the "Pedi-Syringe Filter™". The document discusses the device's intended use and FDA's substantial equivalence determination, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) summary (page 1, section "Device Description") describes the device as a "Tubing assembly with a 150 micron filter connected by tubing to a spike at one end and connected by tubing to a piston syringe at the other end. Between the filter and the spike there is a clamp."

The "Intended Use" (page 1) states: "Intended to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets plasma and cryoprecipitate for pediatric and/or neonatal transfusion."

The FDA's letter (pages 2-4) confirms that the device is "substantially equivalent" to a legally marketed predicate device (Charter Medical Neonatal Syringe Set K000685). This substantial equivalence determination means that the FDA believes the new device is as safe and effective as the predicate device already on the market. However, a 510(k) submission primarily focuses on demonstrating substantial equivalence, and it does not typically require or present detailed performance acceptance criteria and a study report demonstrating the device meets those criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, I cannot provide the requested information from the given text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set or data provenance.
3. Number of experts used or their qualifications for ground truth.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes of human readers with/without AI.
6. Information about a standalone algorithm performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth was established for a training set.

This document is a regulatory approval notice based on substantial equivalence, not a detailed performance study report.

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A single use, disposable, blood administration set with pressure pump and blood filter used to deliver blood/blood products rapidly through use of the pressure pump and/or gravity flow.

The Blood Hand Pump Administration Set is a single use, disposable, gravity blood set with a blood filter and hand pressure pump. The addition of the hand pressure pump provides the capability for delivering blood/blood products more rapidly by compressing the pump by hand.

The provided document is a 510(k) summary for a medical device (Blood Hand Pump Set) and is not a study. Therefore, it does not contain detailed information about acceptance criteria, specific performance metrics, sample sizes, or ground truth establishment typically found in a scientific study.

The document indicates that the device's substantial equivalence was determined based on its "technological characteristics" and "performance data" indicating it "meets specified requirements." However, it does not specify what those requirements are or how the performance data was generated beyond a general statement.

Here's an analysis based on the information available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The flow rate for hand pump compression administration "may be as much as twice that of gravity flow." (This is a characteristic, not a performance metric against a specific criterion). |

Missing Information:

• Specific quantitative acceptance criteria (e.g., minimum flow rate, pressure limits, material biocompatibility, sterility) are not provided.
• Actual measured performance values against these criteria are not given.

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

Missing Information:

• Sample Size: Not reported. The document does not describe any specific "test set" of data or how it was generated.
• Data Provenance: Not reported. It's unclear if any testing involved human subjects or was entirely bench testing, and if so, where it took place (country of origin). The document refers to "performance data" generally.
• Retrospective/Prospective: Not specified.

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

Missing Information:

• Not applicable. This type of device (blood administration set) does not typically involve "ground truth" derived from expert image interpretation or clinical diagnosis in the way an AI diagnostic device would. Its performance is assessed through engineering and biocompatibility testing. The "ground truth" for a device like this would be engineering specifications and safety standards.

4. Adjudication Method for the Test Set

Missing Information:

• Not applicable for this type of device and submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Missing Information:

• Not applicable. This is a medical device for fluid administration, not an AI-assisted diagnostic tool for human readers. No human interpretation is involved.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Missing Information:

• Not applicable. This is not an AI algorithm. Its performance is inherent to its mechanical design and materials.

7. Type of Ground Truth Used

Missing Information:

• The document implies that the ground truth/basis for evaluation was adherence to engineering specifications, safety standards, and equivalence to predicate devices. It does not mention pathology, outcomes data, or expert consensus in a clinical sense for performance evaluation.

8. Sample Size for the Training Set

Missing Information:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Missing Information:

• Not applicable. This device is not an AI/ML algorithm that requires a training set and associated ground truth.

In summary: The provided 510(k) summary is a regulatory document demonstrating substantial equivalence, not a detailed scientific study. It focuses on comparing the new device's technological characteristics and overall performance to already cleared predicate devices rather than presenting detailed raw data, specific acceptance criteria values, sample sizes, or methodologies of internal validation tests. For medical devices like this, performance data typically refers to results from bench testing (e.g., flow rate tests, pressure resistance, sterility testing, material compatibility) and not clinical trial data involving "ground truth" from experts for diagnostic purposes.

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Administration of Intravenous fluids and drugs.

The Tuta Healthcare Pty. Limited Blood Administration Set is a device used to administer fluids, blood and blood products from a container to a patient's vascular system Through a catheter or venous access system inserted into a vein.

Use of Needle-Free Access site may aide in the prevention of needlestick injury.

The Tuta Healthcare Blood/Solution Administration Set is designed administer fluids from a container to a patient's vascular system through a needle catheter inserted into a vein. The pump helps to control the rate of flow of fluids from the container to the patient.

The provided text describes a 510(k) summary for the Tuta Healthcare Blood/Solution Administration Set, comparing it to the legally marketed Baxter Healthcare's Solution Administration Set (K924721). The submission aims to demonstrate substantial equivalence, focusing on design, materials, intended use, and performance.

However, the document does not contain the kind of detailed information typically found in studies for AI/ML-enabled medical devices or diagnostic devices, especially regarding acceptance criteria, specific performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or adjudication methods for ground truth, as these are not relevant to this type of device (an administration set) or the type of substantial equivalence submission presented.

The study referenced is a laboratory bench testing to assess the new device against the predicate device.

Here's a breakdown of the information that is available in the provided text in relation to your questions:

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

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

• Sample Size for Test Set: Not specified. The document states "Laboratory beach testing has been performed," but does not provide details on the number of units or test repetitions.
• Data Provenance: The testing was "Laboratory beach testing," implying it was conducted in a controlled environment. The manufacturer is based in Australia, but the testing location is not explicitly stated. It is a prospective study as tests were performed specifically for this submission.

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

Not applicable. This device is an administration set, not a diagnostic device requiring expert interpretation of results or establishing ground truth based on clinical expert consensus. The "ground truth" here is the performance of the predicate device and established safety standards.

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

Not applicable. This device is an administration set. Adjudication methods are typically relevant for diagnostic studies where there's variability in interpretation or a need for consensus on clinical findings.

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 not an AI-enabled diagnostic tool, and no human reader studies were conducted.

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

Not applicable. This device does not have an algorithm or AI component.

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

The "ground truth" in this context is the performance of the legally marketed predicate device (Baxter Healthcare's Solution Administration Set K924721) and adherence to recognized safety and performance standards (e.g., biocompatibility testing per General Program Memorandum #G95).

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device and not an AI/ML model.

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

Not applicable, as there is no training set. The "ground truth" for comparison is the predicate device's established performance and regulatory compliance.

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