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510(k) Data Aggregation
(76 days)
The MPS Gravity Flow Control Set is intended only for a gravity infusion of I.V. fluids and drugs. The MPS Gravity Flow Control Set maintains a pre-selected flow rate for I.V. fluids and drugs to a patient.
The MPS Gravity Flow Control Set is a family of specialized IV sets designed to deliver a fluid flow at a specified rate. The MPS Gravity Flow Control Sets will be available in both primar I.V. sets and extension sets. It incorporates a standard bag spike, flexible drip chamber, PVC tubing, Clamp and ending with a standard male luer lock. Various flow rates are established by rotating the barrel to vary the position of the accurate slot in the barrel relative to the oppositely disbursed inlet and outlet. Each MPS Gravity Flow Control Set is sterilized in sealed individual pouches or trays. Full labeling information is provided with each MPS Gravity Flow Control Set. Multi-unit shelf packs of individual pouches or trays are provided for convenience.
Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies.
Based on the provided text, it appears this is a 510(k) summary for a medical device that does not involve AI or machine learning. The device, "MPS Gravity Flow Control Set," is essentially an IV set accessory designed to control fluid flow rates via a mechanical rotary device. Therefore, many of the typical questions for AI/ML device studies, such as ground truth establishment with experts, MRMC studies, and standalone algorithm performance, are not applicable.
The core of this submission is demonstrating substantial equivalence to a legally marketed predicate device, primarily through technological comparison and material biocompatibility testing.
Here's a breakdown of the requested information, adjusted to reflect the nature of the device:
1. A table of acceptance criteria and the reported device performance
Since this is a non-AI/ML device submission focusing on substantial equivalence, the "acceptance criteria" are not framed in terms of AI performance metrics (like sensitivity, specificity, AUC). Instead, they revolve around demonstrating that the device is safe and performs comparably to the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Biocompatibility and Safety | Plastic component materials and bonding agents have been tested per ISO 10993 Biological Testing of Medical and Dental Materials. Testing indicates that materials are safe and biocompatible. |
| Functional Equivalence to Predicate Device (Flow Control) | "The MPS Gravity Flow Control Set is a family of specialized IV sets designed to deliver a fluid flow at a specified rate." |
| "There are no technological differences between the Master Medical STAT-2 set and the MPS Gravity Flow Control Set. Both devices control gravity flow rates by rotating the barrel to vary the position of the accurate slot in the barrel relative to the oppositely disbursed inlet and outlet." | |
| "The MPS Gravity Flow Control Set maintains a pre-selected flow rate for I.V. fluids and drugs to a patient." | |
| Intended Use Equivalence to Predicate Device | Intended Use for gravity infusion of I.V. fluids and drugs, setting and maintaining pre-selected flow rates, single-use. This matches, or is substantially equivalent to, the implied intended use of the predicate. Prohibited uses (pressure infusion, blood, enteral solution) are also stated. |
| Sterility | "Each MPS Gravity Flow Control Set is sterilized in sealed individual pouches or trays." (Implied to meet sterility standards, though no specific test results are detailed in this summary). |
| Substantial Equivalence (Overall) | "The MPS Gravity Flow Control Set is substantially equivalent to the legally marketed predicate device." |
Study that proves the device meets the acceptance criteria:
The primary "study" is a combination of:
- Nonclinical Test Summary: This specifically addresses the biocompatibility and safety of materials.
- Technological Comparison Analysis: This is an argumentative comparison establishing that the device's design and mechanism for flow control are identical to the predicate device, K871753 and K852254, marketed by ConMed Corporation (originally Master Medical Corporation).
Additional Information (where applicable for this non-AI/ML device):
- 2. Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" in the sense of clinical data or images. The "testing" involved material testing per ISO 10993, for which sample sizes are not specified in this summary.
- 3. 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/ML is not relevant here. The "ground truth" for material safety relies on established ISO standards.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI-assisted device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For biocompatibility, the ground truth is established by the standards outlined in ISO 10993. For functional performance, the "ground truth" is the established function of the predicate device.
- 8. The sample size for the training set: Not applicable. There is no training set for this type of device.
- 9. How the ground truth for the training set was established: Not applicable.
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