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510(k) Data Aggregation
(118 days)
INFUSET FLOW CONTROL EXTENSION SET
The Infuset™ Flow Control Extension Set is intended for use with the RMS Freedom 60 Syringe Infusion Pump System to provide flow rate control to administer fluids from a contained to a patient's vascular system.
EMED Infuset™ Flow Control Extension Sets are disposable devices allowing users to obtain a controlled and precise rate of fluid flow when used with the RMS Freedom 60 Syringe Infusion Pump System. Each Infuset™ Flow Control Extension Sets consist of a given length of medium-density PVC tubing and rigid PVC standard luer lock connectors. Robust componentry and bonding techniques allow the Infuset™ Flow Control Extension Sets to withstand fluid pressures up to 25 psi. These sets can be physically connected to fluid sources compatible with the Freedom60 Syringe Infusion System and patient administrations sets using the standard luer lock connectors. The Infuset™ Flow Control Extension Sets are provided sterile for single use. The Infuset™ Flow Control Extension Sets rely upon the properties inherent to the static fluid path dimensions dictated by the Infuset™ Flow Control Extension Set length and tubing inner diameter to provide a precise, controlled flow rate. This follows the Poiseuille equation in that pressure, length of fluid path, diameter of fluid path, and viscosity of a fluid in a system directly influence resultant flow rates of that fluid. Available configurations with differing lengths and tubing diameters offer users several target flow rates to choose from.
The provided text describes the acceptance criteria and performance of the Infuset™ Flow Control Extension Set, primarily through comparison with a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Internal Product Specifications/Requirements) | Reported Device Performance (Infuset™ Flow Control Extension Sets) | Predicate Device Performance (RMS Precision Flow Rate Tubing Sets (K933652)) |
|---|---|---|---|
| Flow Rate Control | Not explicitly stated as acceptance criteria, but tested for equivalence and conformance to internal specifications. Implicitly, less than 5% RSD for precision, and +/- 10% accuracy. | Range: 202-2244 ml/hr | |
| Precision: Less than 5% RSD | |||
| Accuracy: +/- 10% | Range: 47 - 1743 ml/hr | ||
| Precision: Less than 5% RSD | |||
| Accuracy: -27% to +38% | |||
| Pressure | Not less than 25 psi | Not less than 25 psi | Not less than 15 psi |
| Biocompatibility | Pass all tests based on ISO 10993-1:2009 | Pass (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Pyrogenicity, Hemocompatibility, LAL Endotoxin Test) | (Not provided for predicate in this context) |
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶ | 10⁻⁶ SAL | (Not provided for predicate in this context) |
| Shelf-life | 5 years | 5 years | (Not provided for predicate in this context) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for performance testing (Flow Rate Control, Pressure, Biocompatibility). The data provenance is not explicitly stated in terms of country of origin, but the testing was performed to establish conformance to "internal product specifications and requirements, as well as equivalence to the predicate device." It is implied to be prospective testing conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The performance testing involves objective measurements of physical properties (flow rate, pressure) and biological responses (biocompatibility tests), rather than subjective evaluations by experts.
4. Adjudication Method for the Test Set:
Not applicable, as the data is based on objective measurements and laboratory tests.
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 a passive medical device (flow control extension set) and does not involve human readers, AI, or diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. As mentioned, this is a passive medical device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests consists of:
- Flow Rate Control: Direct measurement of fluid flow over time using the RMS Freedom 60 Syringe Infusion Pump System with 0.9% saline at controlled temperatures.
- Pressure: Direct measurement of pressure the device can withstand.
- Biocompatibility: In vitro and in vivo laboratory tests according to specified ISO and ASTM standards.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This device does not involve machine learning or a "training set."
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