Search Results

I.V. Administration Set for the infusion of parenteral fluids and medications from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.

The Volumat Polyethylene I.V. Administration Sets (PE Sets) are available for dedicated use with the Agilia Infusion Pump and the Agilia VP MC Pump, or they can administer parenteral fluids and medications by gravity flow. Both the Agilia Infusion Pump and the Volumat I.V. Administration Sets were cleared under K121613. The Agilia VP MC Pump was cleared under K210073. The PE Sets include a spike, drip chamber, roller clamp, upstream/downstream clamp, backcheck valve, pump segment, needle-free port, rotating male luer lock, and tubing.

The provided text describes the regulatory clearance of a medical device, the "Volumat Polyethylene I.V. Administration Set," by the FDA. It does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the format requested.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Baxter Administration Set K203609) rather than establishing novel performance metrics or conducting a clinical study with acceptance criteria.

Therefore, the specific information requested cannot be fully extracted from the provided text. However, I can provide the available information relevant to performance and testing:

Response based on available information:

The document outlines performance testing conducted to support the substantial equivalence determination by showing the device performs as intended and that differences from the predicate device do not raise new questions of safety or effectiveness. It does not explicitly state "acceptance criteria" in a quantitative table with "reported device performance" against those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with corresponding reported device performance values. Instead, it lists various standards and tests that were applied, and it states that these tests "demonstrate equivalence" or confirmed that differences "do not impact safety or effectiveness."

For example, regarding the listed technological characteristic differences:

• Operating Mechanism (presence of pumping cassette): "Difference has been verified through performance testing including flow rate accuracy under various environmental conditions (temperature, pressure, humidity) which demonstrate equivalence." (No specific flow rate accuracy acceptance criteria or results are given).
• Length: "Difference tested according to ISO 8536-4 and flow rate accuracy to demonstrate the subject device performance." (No specific length or flow rate acceptance criteria or results are given).
• Priming Volume: "Bench testing confirmed that the differences in priming volume do not impact safety or effectiveness." (No specific priming volume acceptance criteria or results are given).
• Internal/External Tube Diameter: "Difference tested to ISO 8536-8 has demonstrated equivalence." (No specific diameter acceptance criteria or results are given).
• Components (e.g., pump segment): "The differences have been verified in various aspects to demonstrate the subject device's safety and performance including: Biocompatibility testing according to ISO 10993 collateral standards, Microbial Ingress Testing, and Particulate Testing; Performance Testing according to ISO 8536-4, ISO 80369-20, ISO 8536-8 and ISO 8436-14." (No specific acceptance criteria or results for these tests are provided).

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

The document does not detail the sample sizes used for the "performance bench testing" or the specific data provenance (e.g., country of origin, retrospective/prospective). It only lists the types of tests conducted.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This information is typically relevant for studies involving human interpretation or subjective assessments, such as imaging AI algorithms. The described testing is primarily bench testing of a hardware device.

4. Adjudication Method for the Test Set

Not applicable for the type of bench testing described.

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

No MRMC study was done, as this is a physical medical device (I.V. administration set) and not an interpretive diagnostic tool or AI algorithm requiring human reader comparison. The document explicitly states: "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device."

6. Standalone Performance Study (Algorithm Only)

Not applicable, as this is a physical medical device, not an algorithm. The testing described is for the physical device's performance.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" would be the specifications and requirements defined by the referenced ISO standards (e.g., ISO 8536-4, ISO 80369-20, ISO 8536-8, ISO 8436-14, ISO 11607-1 & 2, USP). The device's performance was compared against the pass/fail criteria within these standards to "demonstrate equivalence" and that it "performs as intended."

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms.

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

Not applicable, as this is a physical medical device.

Ask a specific question about this device

IV Administration Set for the infusion of parenteral fluids and medications from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.

Transfusion Set for the infusion of blood derivatives from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.

The Volumat 100 Line is available for dedicated use with the Volumat MC Agilia Infusion Pump and the Agilia VP MC Pump, or they can administer parenteral fluids and medications by gravity flow. Both the Volumat MC Agilia Infusion Pump and the Volumat I.V. Administration Sets were cleared under K121613, and the Agilia VP MC Pump was cleared under K210073. The Volumat TM Line components include a spike, drip chamber, roller clamp, upstream/downstream clamp, backcheck valve, pump segment, upstream filter, needle free port, rotating male luer lock, luer lock connector, Yconnector, tubing, and burette.

The provided text is a 510(k) summary for the Fresenius Kabi Volumat™ Line, an Intravascular Administration Set. This document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility testing, rather than a clinical study involving human readers or AI algorithms.

Therefore, many of the requested details, such as MRMC studies, human reader improvement with AI, ground truth establishment for training and test sets, number of experts, and adjudication methods, are not applicable to this device submission as it is a physical medical device (IV administration set) and not an AI/ML-driven diagnostic or therapeutic device.

However, I can extract the relevant information regarding acceptance criteria and the studies performed to demonstrate the device meets these criteria.

Device: Volumat™ Line (Intravascular Administration Set)
Submission Type: 510(k) Premarket Notification (K220301)
Predicate Device: Baxter Administration Set (K203609)

The acceptance criteria for this type of device are primarily based on established performance standards for IV administration sets, ensuring safety and effectiveness through physical, chemical, and biological compatibility. The "study" proving the device meets these criteria is a series of bench tests and biocompatibility evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct table of "acceptance criteria" with specific pass/fail values for each test. Instead, it lists the types of tests and applicable ISO standards used to demonstrate that the Volumat™ Line performs as intended and is as safe and effective as the predicate device. The implicit acceptance criterion for each test is successful compliance with the respective standard.

General Acceptance Principles (Implied from the document):

• Functional Equivalence: The device must perform its intended function (infusion of fluids/medications/blood products) safely and accurately.
• Physical Integrity: The device components must withstand operational stresses without leakage, cracking, or separation.
• Biocompatibility: The materials used must be safe for patient contact.
• Sterility: The device must be sterile and maintain sterility until use.
• Compatibility: The device must be compatible with its intended use environment (e.g., infusion pumps, gravity flow).

Reported Device Performance:
The document states that all performance testing and design control activities were "conducted and has confirmed that the different technological characteristics of the proposed devices do not raise different questions of safety and effectiveness." It explicitly states that the device was found to be "at least as safe and effective as the legally marketed predicate device" and "substantially equivalent."

While specific numerical performance results are not provided in this public summary, the successful completion of the listed tests implies that the device met the established acceptance criteria for each standard.

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

The document does not specify the exact sample sizes for each bench test. For physical device testing, sample sizes are typically determined by relevant industry standards (e.g., ISO, ASTM) and statistical methods to ensure representativeness and confidence in results.

• Data Provenance: This is bench testing of a physical medical device. The tests were performed to support a 510(k) submission to the FDA. The country of origin for the testing is not specified, but the applicant (Fresenius Kabi) has locations in Germany (address listed) and the USA. The testing would be prospective in the sense that it was conducted specifically to support this regulatory submission for the new device.

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

Not Applicable. This is a physical medical device. The "ground truth" for evaluating its performance is established by validated test methods and international standards (ISO, ASTM, USP), not by human expert opinion (e.g., radiologists interpreting images). The "experts" involved would be engineers, material scientists, and quality assurance professionals performing and reviewing the test results against the specified standards.

4. Adjudication Method for the Test Set

Not Applicable. There is no "adjudication" in the sense of multiple human evaluators reviewing outputs. The objective performance is measured against predefined pass/fail criteria from the standards.

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

No. MRMC studies are typically performed for diagnostic devices (e.g., AI algorithms for image interpretation) to evaluate the impact of the device on human reader performance. This is a physical IV administration set.

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

Not Applicable. This is not an algorithm-based device. "Standalone performance" in this context refers to the device's ability to meet its functional specifications independently, which was assessed through the various bench tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is derived from established international standards and validated test methods.

• Functional Performance Standards: ISO 8536-8, ISO 80369-20, ISO 8536-4, ISO 8536-14, USP.
• Biocompatibility Standards: ISO 10993 series.
• Sterilization Standards: ISO 11135.
• Packaging Standards: ISO 11607-1, ASTM D4169.

These standards define the expected performance thresholds (e.g., maximum leakage, acceptable tensile strength, no cytotoxicity) against which the device's measured performance is compared.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a "training set" in the computational sense. The device's design and manufacturing processes are developed based on engineering principles and regulatory requirements.

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

Not Applicable. As there is no "training set" for an AI/ML model, there is no corresponding ground truth establishment process for a training set. The "ground truth" for the device's design and manufacturing are the established engineering principles, material science knowledge, and regulatory standards for medical device safety and efficacy.

Ask a specific question about this device