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510(k) Data Aggregation
K Number
K110064Device Name
SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
Manufacturer
Date Cleared
2011-03-18
(67 days)
Product Code
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
SNAP DIAGNOSTICS, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SNAP Model 8 device is indicated for use in the diagnostic evaluation of patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring.
The SNAP Model 8 system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages or EEG activity are required.
The target population consists of patients who are suspected of apnea and/or complain about snoring. The majority of the test procedures will take place at the patient's home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested.
Device Description
The SNAP Model 8 system consists of several components. The Model 8 data recorder and associated sensors and accessories, the SNAP application software which run on a PC in the physician's office, and the SNAP data analysis software located on computers at the SNAP Diagnostics central location.
The SNAP Model 8 Data Recorder is a small DC powered device designed to be simple and easy to use by a patient. It is self-contained, with integrated microcontroller and LCD display and all necessary interface electronics to perform all system recording functions. It does not require connection to a host computer in order to perform the recording functions. The data recorder consists of the physical hardware and firmware that interfaces to the patient to collect the physiological data. The recorder has sensors to collect sound, pulse oximetry, respiration effort (belt), and body position. The information is digitized and stored on a removable solid state memory card (SD card). The data on the removable data card is accessed through a USB port on the device, connecting to a PC running the SNAP application software. The recorder is made from flame retardant ABS plastic and has the following specifications.
Respiratory Channels: 4
Sample Rate: 14 Hz (flow, effort), 2240 Hz (audio)
Measurements: Air Flow, Effort(2), Audio
Oximeter Channels: 2
Measurements: SaO2, Pulse (both sampled at 14 Hz)
Body Position Channel (optional): 1 (sampled at 14 Hz)
Height: 1.375 inches (34.925 mm)
Width: 5.5 inches (139.7 mm)
Depth: 4 inches (101.6 mm)
Weight (with power adapter): 15.9 ounces (0.45 kg)
Power: AC 100-240v 50-60Hz, Battery backup 3.6v Lithium Ion
The SNAP application software consists of a DLL (dynamic link library) and GUI (graphical user interface) and provides the interface for all communication between the recorder and the computer in the doctor's office. The GUI calls DLL functions to interact with the data recorder. The GUI also interacts through the Internet with the central website to transfer the patient data, and provides various data entry functions. The GUI calls DLL functions to program the recorder, check status, clear memory, check USB connectivity, retrieve serial number, retrieve patient data, get time, etc.. The GUI interacts with the website to identify the patient for the programming step and to transfer the collected patient data to the web server.
The data analysis follows a pre-existing procedure that is already in place for earlier models. The patient data from the website is securely downloaded to analysis workstations at SNAP Diagnostics for analysis and processing. The SNAP data analysis software, which runs on PC computers at the SNAP Diagnostics central location, consists of a GUI and algorithms that allow SNAP to display the recorded data and mark the recorded events that are characteristic of sleep and respiratory disorders such as apnea. The software summarizes the events and provides the data necessary to generate a report. The resulting report is then securely uploaded back to the website so it can be made available to the referring physician by a transfer mechanism of their choice.
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