(31 days)
- The MPS Fixed Flow Rate Set is intended for single use in continuous or intermittent infusion therapy.
- For use for infusion of I.V. fluids, and drugs.
The MPS Fixed Flow Rate Set is a family of specialized IV sets designed to deliver a fluid flow at a specified rate. The MPS Fixed Flow Rate Set incorporates a standard bag spike, flexible drip chamber, microbore infusion tubing, and ending with a standard male luer connector with luer-lock. Flow rate control is established by the flow dynamics of the microbore infusion tubing. Each set is provided with a spike protector, luer cap, and tubing clamp. Various configurations may also include 0.2 micron IV filter.
Each MPS Fixed Flow Rate Set is sterilized in sealed individual pouches or trays. Full labeling information is provided with each MPS Fixed Flow Rate Set. Multi-unit shelf packs of individual pouches or trays are provided for convenience.
The provided text is related to a 510(k) premarket notification for a medical device called the "MPS Fixed Flow Rate Set." This documentation focuses on establishing substantial equivalence to a predicate device, as opposed to proving performance against specific acceptance criteria through a clinical study with detailed statistical analysis.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided document.
The document primarily focuses on:
- Device Description and Intended Use: The MPS Fixed Flow Rate Set is a family of specialized IV sets designed to deliver fluid at a specified rate, incorporating standard components and controlling flow via microbore tubing. It's intended for single use in continuous or intermittent infusion therapy for I.V. fluids and drugs.
- Technological Comparison to Predicate Device: The core of the submission is to demonstrate substantial equivalence to the I-Flow® Fixed Flow Rate Gravity Set. The submission explicitly states, "There are no technological differences between the I-Flow Fixed Rate Gravity Set and the MPS Fixed Flow Rate Set. Both devices control gravity flow rates by varying the length of fixed internal diameter microbore tubing."
- Nonclinical Test Summary: Mentions that plastic components and bonding agents were tested per ISO 10993 for biocompatibility and safety.
Given these points, here is a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., flow rate accuracy within X%, duration of flow within Y%). The acceptance criterion for this 510(k) submission is "substantial equivalence" to the predicate device.
- Reported Device Performance: No specific quantitative performance data is provided for the MPS Fixed Flow Rate Set beyond the statement that "Flow rate control is established by the flow dynamics of the microbore infusion tubing." The document relies on the equivalence to the predicate device, which presumably has its own established performance characteristics.
2. Sample sized 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 applicable/not provided. This was a substantial equivalence submission, not a performance study with a 'test set' in the traditional sense of evaluating an algorithm. Nonclinical tests (biocompatibility) are mentioned, but sample sizes for those are not given.
- Data Provenance: Not applicable/not provided. The nonclinical tests are internal to the manufacturer (Medical Product Specialists, Inc., Brea, CA).
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. There was no 'ground truth' established by experts for a test set in the context of this 510(k) for this device type.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No such adjudication was performed for device performance.
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 an intravenous fluid delivery set, not an AI-assisted diagnostic or therapeutic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth in this sense was used. The basis for approval is substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set
- Not applicable. There is no 'training set' as this device does not involve machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Device Acceptance/Proof:
The "acceptance criteria" for the MPS Fixed Flow Rate Set, in the context of this 510(k) submission, was demonstrating substantial equivalence to the predicate device, the I-Flow® Fixed Flow Rate Gravity Set.
The "study that proves the device meets the acceptance criteria" in this case is the 510(k) submission itself, which presents:
- A clear description of the device and its intended use.
- A direct comparison of technological characteristics to the predicate device, explicitly stating "There are no technological differences." Both devices utilize the same principle of controlling gravity flow rates by varying the length of fixed internal diameter microbore tubing.
- A summary of nonclinical biocompatibility testing (per ISO 10993).
The FDA's review of this submission led to the determination that the device is substantially equivalent to the legally marketed predicate device, thus allowing it to be marketed. This regulatory process acknowledges that if a new device is sufficiently similar to an already approved one, it does not need to undergo the same rigorous, full-scale clinical trials required for novel devices.
§ 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.