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510(k) Data Aggregation
K Number
K062338Device Name
TELEVISIT
Manufacturer
Date Cleared
2006-10-25
(76 days)
Product Code
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
PHD MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TELEVISIT software allows healthcare professionals to conduct remote medical check-ups through interactive sessions with patients who have limited mobility or live in remote locations. The TELEVISIT software is intended for the purposes of collecting physiological data such as: Non-Invasive Blood Pressure; Pulse Oximetry, Temperature and Breath Sounds (Auscultation). The software provides physicians with a tool to schedule appointments with remote patients; to initiate and manage a medical check-up session, to provide data acquisition of medical device data, and to view session reports.
The intended use of the TELEVISIT software is in hospital/clinical environments with established specialized care providing access to each patient in their home and/or local community health center. TELEVISIT software is a non-invasive medical device, which does not flag any abnormal results from the medical device inputs. The TELEVISIT software does not monitor, assess or diagnose a disease, a disorder, or an abnormal physical state. The intended use for the software is data acquisition and collection only, with no treatment function or danger to the end user. The data obtained from TELEVISIT software can be used only as an aid in the diagnosis and treatment of the patient.
Device Description
TELEVISIT is consist of the following 3 main components: Televisit Terminal (Patient/Physician), TELEVISIT Medical Device Gateway Box and the TELEVISIT Management Software. FDA Cleared accessories are provided to record physiological data such as: Breath Sounds (Auscultation); Non-Invasive Blood Pressure; Temperature / Thermometry; Pulse Oximetry.
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K Number
K060616Device Name
NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100
Manufacturer
Date Cleared
2006-06-29
(113 days)
Product Code
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
PHD MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of NPOSES (Nocturnal Pulse Oximetry Study Expert System) software is to collect, analyze, report and archive oximetry trend data to provide information to a Medical Doctor specializing in sleep medicine, as a supplemental tool to assist in the timely diagnosis of pediatric obstructive sleep apnea (OSA).
NPOSES is intended for use by an MD/Respiratory Specialist through the following process steps (1) recording and transferring data from a pulse oximeter to a computer in order to maintain unique records per patient of pulse oximetry data, (2) analyzing. reviewing and validating patient data and summary statistics according to customized. user-selected parameters, and (3) generating and archiving reports.
NPOSES in itself is not a diagnosis tool. It is a decision management tool which allows medical personnel to upload and view data related to a sleep study and provide output reports as feedback which may be used by an MD to form a diagnosis.
Device Description
The PHD Medical NPOSES (Nocturnal Pulse Oximetry Study Expert System) application scores data in the patient history, physician comments and test results to automatically produce an analysis report as input to the identification of pediatric obstructive sleep apnea which is presented to Respiratory Specialists and Medical Doctors. The suggested diagnosis is used to assist the Medical Director in the diagnosis of the severity of obstructive sleep apnea. The application enables the efficient processing of patient sleep evaluation studies while allowing the medical staff to concentrate on critical cases.
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