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510(k) Data Aggregation
(158 days)
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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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(89 days)
F Care RF System is intended to conduct radio frequency (RF) current for coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures. The devices are prescription use (Rx) devices.
F Care RF System is designed for thermocoagulation (RF) of tissue by administration of high frequency energy by means of electrosurgical electrodes of soft tissue in a broad range of surgical procedures. The system consists of:
- MedRF4000, electrosurgical generator (00MEDRF4000US)
- Rafaelo probe, electrosurgical electrode (05RAFAELORPROBE)
- Sphera probe, electrosurgical electrode (05SPHERAPROBE)
- Output cable (06OUTPUTKAB)
- Foot pedal (06PedalST1)
The F Care RF System includes the MedRF4000 generator and two sterile, single-use monopolar electrodes. the Rafaelo and Sphera probes designed to deliver high-frequency radiofrequency (RF) energy to soft tissue for coagulation and hemostasis. The system is for prescription use only and intended for trained healthcare professionals.
The MedRF4000 generator, previously cleared under 510(k) K210077, has been modified to remove the USB interface; no other changes have been made to its performance or design. The Rafaelo probe connects directly to the generator, while the Sphera probe connects via a reusable handle. Only one probe is used per procedure. The Rafaelo probe consists of a handle, output cable, and a stainless-steel tube with a sharp, insulated tip. The Sphera probe includes a handle and a rounded, ball-shaped insulated tip. Both feature anti-adhesive coated tips and are intended for external communication with limited (<24-hour) contact duration.
Radiofrequency energy from the generator is delivered through the probe tip and converted into heat in the tissue, causing coagulation. Visual and audible signals from the MedRF4000, including beeps every 2 seconds and energy alerts at 500 J and 1500 J, help track treatment. If these indicators fail, treatment must be stopped to avoid thermal injury.
The Rafaelo and Sphera probes are substantially equivalent to the predicate device HPR45i in design, function, materials, and intended use. Both subject and predicate devices use similar biocompatible materials, are activated via foot pedal, and are EO-sterilized under the same sterilization cycle. They do not have power regulation or diagnostic features.Functionally, the Rafaelo probe is used internally with a sharp tip, while the Sphera probe is used externally with a rounded tip. The Rafaelo probe is packaged in a double sterile pouch, and the Sphera probe in a single sterile pouch. Overall, the F Care RF System, including the updated MedRF4000 and both probes, is safe, effective, and substantially equivalent to the predicate device for soft tissue coagulation in surgical procedures.
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(256 days)
Treatment of dental hypersensitivity and reduction of post-operative sensitivity.
The FluoroDose Varnish is a fluoride varnish available in mint flavor. FluoroDose varnish is sold in single-use Lollitrays, containing a 0.3ml dose and a Benda Brush applicator brush. The device is not sold as sterile and does not require sterilization prior to use. The product is offered in a 2.1% sodium fluoride variation and a 5% sodium fluoride variation. The device is used as a dentin desensitizer to be used by healthcare professionals including dentists and dental hygienists.
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