(485 days)
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.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.