(16 days)
Not Found
No
The summary describes a mechanical flow rate controller and its performance characteristics, with no mention of AI or ML.
Yes
The device is intended for the precise intravascular infusion of fluids, which is a therapeutic intervention.
No.
The device is described as a flow rate controller for intravenous fluid infusion, indicating it is an active treatment device rather than a diagnostic one that identifies medical conditions. Its function is to deliver fluids, not to diagnose.
No
The device description explicitly states it is a "disposable device" and mentions "standard luer lock connectors," indicating a physical hardware component for fluid delivery.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "intravascular infusion of fluids to be delivered to the patient". This describes a device used on the patient to deliver substances into their body.
- Device Description: The description reinforces this by mentioning connection to "administration sets and fluid sources utilizing standard luer lock connectors," which are used for delivering fluids intravenously.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The VersaRate™ Flow Rate Controller is a device used for controlling the flow of fluids into a patient, not for analyzing samples from a patient.
N/A
Intended Use / Indications for Use
The VersaRate™ Flow Rate Controller is intended for use in the intravascular infusion of fluids to be delivered to the patient in a precise manner for no longer than 72 hours.
Product codes
FPA
Device Description
The EMED VersaRate™ Flow Rate Controller is a disposable device allowing users to adjust the flow rate of fluids. The EMED VersaRate™ Flow Rate Controller can be connected to commercially available administration sets and fluid sources utilizing standard luer lock connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Table 5-2 summarizes testing results performed to establish conformance of the VersaRate™ Flow Rate Controller to internal product specifications and requirements, as well as equivalence to the predicate device.
- Flow Rate Control Range: 5 – 230 mL/hr at 80 cm head height
- Residual Volume of Set:
§ 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.
0
Section 5. 510(k) Summary
K123729 K Number
Submission Date:
11/6/12
Class II
General Information
Classification
Trade Name
VersaRate™ Flow Rate Controller
Common Name:
I.V. Flow Controller
Classification Name and Reference:
Intravascular Administration Set
21 CFR §880.5440
Submitter
Peter Kollings EMED Technologies Corporation 1264 Hawks Flight Ct., Ste. 200 El Dorado Hills, Ca 95762 916.932.0071 x114 Tel: 916.932.0074 Fax:
Intended Use
The VersaRate™ Flow Rate Controller is intended for use in the intravascular infusion of fluids to be delivered to the patient in a precise manner for no longer than 72 hours.
Predicate Device(s)
Baxter Extension Set w/Flow Regulator (K890489)
Device Description
The EMED VersaRate™ Flow Rate Controller is a disposable device allowing users to adjust the flow rate of fluids. The EMED VersaRate™ Flow Rate Controller can be connected to commercially available administration sets and fluid sources utilizing standard luer lock connectors.
Materials and Characteristics
The EMED VersaRate™ Flow Rate Controller is equivalent in performance, physical properties, using similar materials, and having the same indications for use as the
DEC 2 1 2012
1
predicate device. Therefore no new issues of safety or effectiveness are introduced by the minimal differences in design.
Table 5-1 below provides a comparison of technological and other characteristics of the EMED VersaRate™ Flow Rate Controller and the predicate.
| | EMED VersaRate™
Flow Rate Controller | Baxter Extension Set
w/Flow Regulator |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The VersaRate™ Flow
Rate Controller is
intended for use in the
intravascular infusion of
fluids to be delivered to
the patient in a precise
manner for no longer than
72 hours. | The Extension set with
Flow Regulator is
intended for use in the
administration of
intravenous fluids to be
delivered to the patient in
a precise manner over a
specified period of time. |
| Flow Control
Material/Components | Biocompatible, non-toxic
materials widely used in
medical products, such as:
Luer: PVC
Tubing: PVC
Regulator: Polycarbonate
and styrene-ethylene-
butylene | Biocompatible, non-toxic
materials widely used in
medical products. |
| Method of
Sterilization | Ethylene Oxide | Radiation |
| Principle of Flow Rate
Control | The fluid path of the
VersaRate™ Flow Rate
Controller is regulated by
rotating the flow dial to
alter dimensions of the
internal fluid path, thereby
altering the flow rate. | Fluid flow is regulated by
rotating the diaphragm
holder to create a
restrictive path of varying
depth thereby altering the
rate of fluid
administration. |
| Length | 16 cm | 46 cm |
Table 5-1
2
Performance
Table 5-2 below summarizes testing results performed to establish conformance of the VersaRate™ Flow Rate Controller to internal product specifications and requirements, as well as equivalence to the predicate device.
Table 5-2
| | VersaRate™ Flow Rate
Controller | Baxter Extension Set
w/Flow Regulator |
|----------------------------|----------------------------------------------------------|----------------------------------------------------------|
| Flow Rate Control
Range | 5 – 230 mL/hr at 80 cm
head height | 5 – 250 mL/hr |
| Residual Volume of
Set |