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The Liebel-Flarsheim™ IBP Transfer Set is indicated for the transfer of Optiray® (loversol) Imaging Bulk Package contrast media to empty, single-use only, sterile syringes on syringe based contrast injection systems indicated for the controlled, automatic intra-vascular administration of radiopaque contrast agents for their indicated procedures. The IBP Transfer Set is to be discarded after the contrast media container has been emptied or after 12 hours have elapsed since the container has been penetrated, whichever occurs first.

Contra-indications for the use of this device are determined by the prescribing physician at the time of use based upon the contrast media package inserts.

The Liebel-Flarsheim™ IBP Transfer Set is a sterile tubing set connection between Optiray® (Ioversol) contrast media imaging bulk packages (hereinafter Optiray IBPs) and empty sterile singleuse syringes on syringe-based automatic contrast injection systems. The Liebel- Flarsheim™ IBP Transfer Set consists of a small bore (1/8" ID) clear polyvinyl chloride (PVC) tube with standard medical component end terminations. Bonded to the proximal end of the PVC tube is a vented IV spike that is used to pierce a rubber stopper belonging to an imaging bulk contrast media container. Distally, a self-sealing Luer type connector (Smiths Medical Nu- Site®) is bonded to the opposite end of the PVC tube. The Liebel-Flarsheim™ IBP Transfer Set, shown in the image below, has an overall length of 19-inches, a protective cap on the IV Spike, and both untethered and tethered protective caps on the Luer end to protect the Nu-Site® Luer Activated fitting between syringe fills. The transfer sets are individually packaged in blister packs with a perimeter heat sealed Tyvek lid. Sealed blister packs are packaged in an outer box containing 50 units (50 units/box) which are terminally sterilized with ethylene oxide.

The Liebel-Flarsheim™ IBP Transfer Set is intended for the transfer of fluids from bulk containers to empty sterile syringes on syringe-based contrast injection systems.

Here's a breakdown of the acceptance criteria and study information for the Liebel-Flarsheim™ IBP Transfer Set, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (a transfer set) and does not describe an AI/ML-based device. Therefore, many of the requested fields related to AI/ML studies (like test set size for AI, number of experts for ground truth, MRMC studies, training set size for AI, etc.) are not applicable to this device. The study described is a traditional medical device verification and validation (V&V) study, comparing a new device to a predicate device.

Acceptance Criteria and Device Performance (Verification and Validation)

The document describes various tests performed to demonstrate substantial equivalence to a predicate device, focusing on safety and effectiveness. The acceptance criteria are generally "compliance with the standards" or "performs as intended."

Study Details (Traditional Medical Device V&V)

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

   • The document does not specify a "test set" in the context of an AI/ML model where data provenance like country of origin or retrospective/prospective is relevant.
   • Instead, for traditional device testing, sample sizes would be determined by statistical methods for each specific test (e.g., sterilization validation, biocompatibility, functional performance). These specific sample sizes are not explicitly stated in this summary for each test, but standard good manufacturing practices and regulatory requirements would apply.
   • The data provenance is implicitly from manufacturing and laboratory testing conducted by Liebel-Flarsheim Company LLC (part of Guerbet LLC).

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

   • N/A. This is not an AI/ML device, so there is no "ground truth" in the sense of expert annotation for an algorithm. The "ground truth" for this type of device is established through adherence to recognized international standards (ISO, USP) and verified performance against predefined specifications, often evaluated by qualified laboratory personnel and engineers.

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

   • N/A. Adjudication methods are specific to expert consensus in AI/ML model evaluation. For this device, compliance is assessed against objective technical specifications and performance limits defined by the relevant standards and internal company requirements.

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:

   • N/A. This is not an AI/ML device. MRMC studies are for evaluating clinical performance of diagnostic algorithms with human readers.

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

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

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

   • N/A (in the AI/ML context). For this device, "ground truth" is based on:
     • Objective physical measurements and chemical analyses: e.g., sterility levels, EtO residuals, particulate matter, leachable compounds.
     • Functional performance tests: verifying fluid transfer, connection integrity (Luer taper), and absence of microbial ingress.
     • Biocompatibility evaluations: ensuring the materials are safe for patient contact according to established biological testing standards.
     • Adherence to recognized industry standards: ISO, USP.

7. The sample size for the training set:

   • N/A. This is not an AI/ML device. There is no "training set."

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

   • N/A. This is not an AI/ML device. There is no "training set" or "ground truth" for AI training. The safety and effectiveness of this device are established through direct physical, chemical, and biological testing, manufacturing controls, and adherence to design specifications and regulatory standards.

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The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is indicated for the transfer of Gadavist® (gadobutrol) injection contrast media as supplied in an approved Imaging Bulk package presentation (30 mL or 65mL) to empty, sterile hand syringes and/or empty, sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for MR procedures.

The Transfer Spike is to be discarded after one of the following conditions has occurred first: the contrast media container has been depleted, the Transfer Spike has been disconnected from the contrast vial, or after 24 hours has elapsed since the container was penetrated.

The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is a pre-administration filling device that is designed to transfer fluid from an imaging bulk package into multiple sterile syringes via a powered injector system prior to an MR procedure. There is no direct patient contact with the use of this device. It is intended to spike one bulk package of Gadavist® (gadobutrol) injection contrast media only. Each imaging bulk transfer set consists of a spike and a swabbable valve. The transfer spike is provided sterile, individually packaged, and is not intended to be resterilized.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MEDRAD® Imaging Bulk Package Transfer Spike:

The document is a 510(k) Premarket Notification from the FDA for the MEDRAD® Imaging Bulk Package Transfer Spike. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials. Therefore, the "studies" are primarily bench and verification tests to show compliance with standards and functional specifications.

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

The document doesn't explicitly present a dedicated "acceptance criteria" table with specific quantitative thresholds. Instead, it lists various performance tests and states that "All testing passed" or "Verification results indicate that the Transfer Spike complies with the standards" or "Verification results indicate that the Transfer Spike complies with its predetermined specifications."

Here's a table summarizing the tests performed and the reported outcomes, essentially inferring the acceptance criteria as "compliance with the standard" or "meeting predetermined specifications":

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

The document does not specify general "sample sizes" for the test sets in a clinical study sense, as the testing described is primarily bench validation. For validation tests like sterilization, shelf-life, packaging, and biocompatibility, sample sizes would be determined by the relevant ISO standards and internal validation protocols, but these specifics are not provided in the summary.

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for compliance with the cited ISO standards and internal protocols.
• Data Provenance: The studies are prospective bench and laboratory testing conducted by or for Bayer Medical Care Inc. The location of the test facilities is not explicitly stated beyond Bayer's address in Indianola, Pennsylvania, USA.

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 applicable to this submission. The device is a medical accessory (transfer spike) and the studies are technical engineering verifications (sterilization, shelf-life, biocompatibility, etc.), not diagnostic or treatment efficacy studies that would require expert consensus for ground truth. The "ground truth" is established by adherence to recognized national and international standards.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert readers interpret medical images or data to establish a consensus ground truth. The tests performed for this device are objective measurements and validations against predefined technical standards, not subjective interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is not an AI algorithm or an imaging 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

No, a standalone algorithm performance study was not done. This device is a mechanical accessory, not an algorithm.

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

The "ground truth" for the various tests performed is the compliance with established national and international standards and predetermined specifications for medical devices and their components. Examples include:

• ISO 11137-1, 11137-2, 11137-3 for sterilization.
• ISO 11607-1 and ISO 11607-2 for packaging.
• ISO 10993-1:2018 for biocompatibility.
• ISO 80369-7 and ISO 8536-4:2010 for bench performance.
• **USP ** for injectable particulate matter.
• Approved release specifications for chemical compatibility with Gadavist.

These standards and specifications are the "ground truth" against which the device's technical performance is measured.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this device is not an AI algorithm.

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

This information is not applicable as there is no training set for this device.

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The MEDRAD® Imaging Bulk Package Transfer Set (IBP Transfer Set) is indicated for the transfer of ULTRAVIST® (Iopromide), ISOVUE® (Iopamidol), and OMNIPAQUE™ (Iohexal) contrast media as supplied in an approved Imaging Bulk Package (IBP) presentation to empty sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for CT procedures. The Transfer Set is to be discarded after one of the following conditions has occurred first; the contrast media container has been depleted, the contrast media use time has expired, or 10 hours has elapsed since the container was penetrated.

The MEDRAD ® Imaging Bulk Package Transfer Set is a pre-administration filling device that is designed to transfer fluid from an imaging bulk package into multiple sterile syringes via a powered injector system prior to a CT procedure. There is no direct patient contact with the use of this device. It is intended to spike one bulk package of iodinated contrast media only. Each imaging bulk transfer set consists of a spike, flexible tubing, and a swabbable valve. The transfer set is provided sterile, individually packaged, and is not intended to be resterilized.

The MEDRAD® Imaging Bulk Package Transfer Set is not an AI device, therefore, the requested information regarding AI device performance, sample sizes for training and test sets, expert involvement, and ground truth establishment is not applicable.

This device is an intravascular administration set designed for transferring contrast media. The provided document focuses on its substantial equivalence to a predicate device, as required for a 510(k) submission to the FDA.

Here's the relevant information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI related):

• ISO 594-2:1998 (Conical fittings with 6% Luer taper)
• ISO 8536-4:2007 (Infusion sets for single use, gravity feed) | Complies with the standards |
  | Additional Performance Testing:
• Microbial ingress testing (Swabbable Valve, Bottle Septum, Spike, Syringe) at T=0, 4, 10, 14 hrs, and bottle depletion
• Chemical compatibility and injectable particulate (Evaluation of conformance to approved release specifications of ULTRAVIST® and USP monographs for ISOVUE® and OMNIPAQUE™)
• Material compatibility (Evaluation under worst-case conditions and simulated use with ULTRAVIST® 370 as solvent for leachable compounds) | Complies with its predetermined specifications |

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

• This device is not an AI/software device, so there isn't a "test set" in the traditional sense of a dataset for algorithm evaluation.
• The performance "testing" refers to bench testing, sterilization validations, and biocompatibility assessments of the physical device components and its interaction with contrast media. The document does not specify the sample sizes for these physical and chemical tests, which is common for this type of submission.
• Data provenance is from internal testing and validation by Bayer U.S. LLC, an American company. The tests are prospective in nature, as they are conducted to validate the new device.

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, as this is not an AI device relying on expert review of clinical data for ground truth. The "ground truth" for this medical device comes from established industry standards (e.g., ISO standards) and specified performance criteria for physical and chemical properties.

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

• Not applicable, as this is not an AI device.

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, as this is not an AI device.

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

• Not applicable, as this is not an AI device.

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

• For physical product testing, the "ground truth" is defined by established international standards (e.g., ISO, USP monographs), internal design specifications, and validated test methods. Compliance implies that the device meets these pre-defined, objectively measurable criteria (e.g., sterility level, material compatibility, functional performance).

8. The sample size for the training set:

• Not applicable, as this is not an AI device.

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

• Not applicable, as this is not an AI device.

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The ulrich Transfer Set is indicated for the transfer of OmnipaqueTM (Iohexol) contrast media as supplied in an Imaging Bulk Package to non pre-filled single-use only sterile syringes on syringe-based contrast injection systems indicated for the controlled, automatic administration on the venous side of contrast media for CT procedures. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated. whichever occurs first.

The ulrich Transfer Set (Transfer Set) is a sterile tubing set connection between an imaging bulk package and empty sterile syringes on single-use-only, syringe based contrast injection systems. The Transfer Set consists of a spike with protective cap and integrated air filter on one side, 20" (50.8 cm) tubing segment and one female swabable (also referenced as swabbable) valve (Swabsite Swabbable Valve - K002689) with a protective cap on the other side. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated, whichever occurs first.

The provided text describes the ulrich Transfer Set and its successful 510(k) submission for substantial equivalence to a predicate device. This is a medical device, and the acceptance criteria and supporting studies are focused on its safety and performance standards rather than AI/algorithm performance.

Here's a breakdown of the requested information based on the document:

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 specify exact sample sizes for each test mentioned (e.g., number of transfer sets tested for sterility, biocompatibility, or performance). The studies are "verification results" indicating compliance with standards, implying a sufficient sample size was used as per the standard's requirements.

• Data Provenance: The studies are laboratory-based bench tests and materials testing, conducted by ulrich GmbH & Co. KG or their contracted testing facilities. The country of origin of the data would likely be Germany (where ulrich GmbH & Co. KG is located) or the location of the testing laboratories. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission to demonstrate compliance.

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

This section is not applicable to this device submission. The ulrich Transfer Set is a physical medical device (an intravascular administration set), not an AI/software device that requires expert-established ground truth for diagnostic or interpretative tasks. The "ground truth" here is defined by meeting established engineering, chemical, and biological standards (e.g., a device is sterile if it meets SAL 10⁻⁶; materials are biocompatible if they pass ISO 10993 tests).

4. Adjudication method for the test set

This is not applicable as it pertains to expert consensus on diagnostic or interpretative AI performance. The tests described are objective, quantitative measurements against predefined 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)

This is not applicable. The device is an intravascular administration set, not an AI or imaging diagnostic tool. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

This is not applicable. The device is a physical medical device, not an algorithm or AI.

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

As explained in point 3, the concept of "ground truth" in the AI/diagnostic sense is not directly applicable. The "ground truth" for the ulrich Transfer Set's performance is established by:

• International Standards: Compliance with ISO 11135-1, ISO 11607-1/2, ISO 10993 series, ISO 8536-4, ISO 22413, ISO 594-2.
• National Standards: Compliance with ASTM F756-13, ASTM F619-14, USP 38.
• Predetermined Specifications: The device's own internal design and performance specifications confirmed by testing.

8. The sample size for the training set

This is not applicable. The device 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

This is not applicable. See point 8.

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The Bracco Injeneering Transfer Set is a component of a contrast management system and is indicated for the transfer of Isovue (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package to empty sterile syringe-based contrast injection systems included automatic administration on the venous side, of contrast agents for CT procedures. The Transfer Set is to be discarded after the contrast media container has been deplected or 10 hours has elapsed since the container was penetrated, whichever occurs first.

The Bracco Injeneering (BINJ) Transfer Set is a sterile tubing set for connection between an imaging bulk package and empty sterile syringes on single-use-only, syringe based contrast delivery systems (injectors). The BINJ Transfer Set is approximately 20 inches long, and its components are made with medical grade materials. The BINJ Transfer Set is supplied ethylene oxide (EtO) sterilized to a Sterility Assurance Level (SAL) of 10-6, and is individually packaged. At the time of this submission, accelerated aging tests confirm a one (1) year shelf life. The BINJ Transfer Set is disposable, and is to be discarded after the contrast media container has been depleted, or 10 hours has elapsed since the container was spiked.

This document is a 510(k) Summary for the Bracco Injeneering Transfer Set, indicating substantial equivalence to a predicate device. It primarily details the device's intended use, technological characteristics, and performance testing related to safety and manufacturing standards, rather than providing a study comparing device performance against specific clinical acceptance criteria in terms of diagnostic accuracy or reader improvement.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily related to safety, sterility, shelf-life, and material compatibility, demonstrating that the device meets established medical device standards. No specific performance metrics like sensitivity, specificity, or accuracy (as one might find for an AI diagnostic device) are provided, as this is a medical device for fluid transfer, not a diagnostic tool.

• ISO 594-2: 1998, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings
• ISO 8536-4: 2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed.
• Microbial ingress testing
• Chemical compatibility, leachable compounds, and particulates testing. | Test and verification results indicate that the BINJ Transfer Set complies with its predetermined specifications and the standards. |
  | Substantial Equivalence (Overall) | Demonstrated equivalence to predicate device (E-Z-EM, Inc. Empower Transfer Set, K041178) in intended use, indications for use, and technological characteristics. | The BINJ Transfer Set is considered substantially equivalent to the predicate device, being safe and effective when used in accordance with its intended use and labeling. |

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

The document does not specify a "test set" in the context of diagnostic accuracy, as this is a device for fluid transfer. The testing described (sterilization, shelf-life, biocompatibility, and bench performance) involves specific samples of the device and its components, but the sample sizes for these engineering tests are not explicitly stated. The data provenance is internal testing conducted by Bracco Injeneering S.A.

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. The device is a transfer set, and the "ground truth" for its performance is assessed through compliance with engineering and safety standards, not through expert consensus on diagnostic interpretations.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was conducted or is relevant for this type of medical device (a fluid transfer set). This is not an AI diagnostic or assistive device.

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 medical component, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is adherence to established international and national standards for medical devices, including:

• Sterility: Sterility Assurance Level (SAL) of 10-6 per ISO 11135-1.
• Packet integrity and Shelf-life: Compliance with ISO 11607-1 and ISO 11607-2, and confirmed 1-year shelf life via accelerated aging.
• Biocompatibility: Compliance with ISO 10993-1.
• Functional Performance: Compliance with IEC 62366, ISO 594-2, ISO 8536-4, and specific testing for microbial ingress, chemical compatibility, leachable compounds, and particulates.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of device development for a fluid transfer set.

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

This information is not applicable for the reasons stated above.

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