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510(k) Data Aggregation
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(177 days)
The Flowflex® Plus Strep A Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of Group A Streptococcus antigen from throat swab specimens from symptomatic patients. The test is used to aid in the diagnosis of Group A Streptococcal infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.
The Flowflex® Plus Strep A Rapid Test Strip is a rapid chromatographic immunoassay for the qualitative detection of Group A Streptococcus antigen from throat swab specimens from symptomatic patients. The test is used to aid in the diagnosis of Group A Streptococcal infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.
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(180 days)
Fenom Flo™ FeNO Monitoring System is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammatory processes, such as asthma, and decreases in response to anti-inflammatory treatment. Fenom Flo measures fractional exhaled nitric oxide (FeNO) according to guidelines established by the American Thoracic Society.
Measurement of FeNO by Fenom Flo is a non-invasive quantitative method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of therapeutic effect in patients with elevated FeNO levels. FeNo measurements are to be used as an adjunct to established clinical assessments. Fenom Flo is suitable for adults and children ages seven years and older.
Fenom Flo should be used in a point-of-care healthcare setting under professional supervision. Fenom Flo should not be used in critical care, emergency care, or anesthesiology.
Fenom Flo™ FeNO Monitoring System quantitatively measures fractional exhaled nitric oxide (NO), an important marker for airway inflammation in exhaled human breath.
The system consists of:
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A handheld FeNO monitoring device (hereafter referred to as "Fenom Flo Device" or "Device") that houses a rechargeable lithium-ion battery, a nitric oxide sensor, and integrated pneumatics and electronics for breath analysis. The device supports secure wireless communication through dedicated hardware and firmware.
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A Point-Of-Care Application (hereafter referred to as a "POC App") operating on a Windows platform serves as the primary interface for displaying FeNO scores in parts per billion (ppb). The POC App offers key features, including test initiation, viewing of current and historical results, quality control, adjustable settings, a patient tutorial, and activity and error tracking. The POC App operates on any healthcare provider's (HCP's) device running Windows 10 or 11. It is the HCP's responsibility to ensure that the device on which the POC App is installed meets all necessary performance, security, and compatibility requirements.
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A single-patient use, non-sterile disposable mouthpiece with an antibacterial/antiviral filter to prepare the exhaled breath for the measurement. The manufacturer is Polytechnic Resources, and the FDA clearance reference is K042758.
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The power supply recharges the battery or enables the device to operate.
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(267 days)
FEops HEARTguide™ Simulation Application is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.
The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.
FEops HEARTguide™ Simulation Application is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment.
FEops HEARTguide™ Simulation Application is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.
FEops HEARTguide™ Simulation Application is prescription use only.
FEops HEARTguide™ Simulation Application predicts implant frame deformation after percutaneous LAAO device implantation through computer simulation. The predicted deformation provides additional information during LAAO procedural planning.
The information provided by FEops HEARTguide™ Simulation Application is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment.
The customer (clinician) does not interact with the simulation software directly. The simulations are performed by trained FEops case analysts through an established workflow. Based on a patient-specific 3D model of the anatomy, a computational model of the anatomy is generated and combined with a predefined computational model of the device.
The simulation results are delivered to the customer through the medical device FEops HEARTguide™ ALPACA (FEops - K223855) in the form of 3D model visualizations and a PDF report. All results are accessible through a standard web browser. The customer cannot modify the simulation results nor run additional simulations.
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