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Found 7 results
510(k) Data Aggregation
K Number
K061676Device Name
RIGIDOMETER, MODEL DIR-4U
Manufacturer
UROAN 21
Date Cleared
2006-12-27
(196 days)
Product Code
LIL
Regulation Number
N/AWhy did this record match?
Product Code :
LIL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Uroan DIR-4U Rigidometer measures penile axial rigidity.
Device Description
The DIR-4U Rigidometer consists of an instrument and attached sensor that measures penile axial rigidity. It has been designed, so that men can use this instrument in the privacy of their homes to measure their penile axial rigidity.
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K Number
K062042Device Name
PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)
Manufacturer
PLETHORA SOLUTIONS
Date Cleared
2006-09-06
(49 days)
Product Code
LIL
Regulation Number
N/AWhy did this record match?
Product Code :
LIL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Plethora Solutions Sexual Assessment Monitor (SAM) is intended for use as a diagnostic tool for use in the quantifiable assessment and monitoring of penile tumescence and ejaculatory latency.
Device Description
The Plethora Solutions Sexual Assessment Monitor (SAM) is intended for use as a diagnostic tool for use in the quantifiable assessment and monitoring of penile tumescence and ejaculatory latency. The Sexual Assessment Monitor (SAM) includes the following components: SAM application software, device control box, vibrator with integral 3m lead, serial port communications cable, 0.5m sensor lead adapter, device charger.
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K Number
K052929Device Name
PREFTEST PROFESSIONAL SUITE
Manufacturer
LIMESTONE TECHNOLOGIES INC.
Date Cleared
2006-04-26
(189 days)
Product Code
LIL
Regulation Number
N/AWhy did this record match?
Product Code :
LIL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PrefTest Professional Suite™ is used to measure penile tumescence in response to visual and auditory stimuli. Penile Tumescence data can later be combined with other standardized psychological testing procedures to assist clinicians with their assessment and treatment of sexual offenders.
Device Description
Limestone Technologies Penile Plethysmograph is based on a circumference measurement using a strain gauge transducer which measure penile tumescence in millimeters. PrefTest Professional Suite™ computer software is used to store, tabulate, display and print out the acquired data from a personal computer or lap top.
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K Number
K033126Device Name
MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM
Manufacturer
BEHAVIORAL TECHNOLOGY, INC.
Date Cleared
2003-10-29
(29 days)
Product Code
LIL
Regulation Number
N/AWhy did this record match?
Product Code :
LIL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MONARCH 21 system's intended use is to measure sexual response to visual and auditory stimuli in male sexual offenders as an important part of evaluating individual treatment need and determining risk for recidivism.
Device Description
MONARCH 21 Penile Plethysmograph consists of attached sensors, which measure penile tumescence. A laptop computer is used to store, tabulate, display and print out the acquired data.
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K Number
K000194Device Name
DIGITAL INFLECTION RIGIDOMETER (DIR)
Manufacturer
UROAN XXI ELECTROMEDICINA
Date Cleared
2000-04-10
(80 days)
Product Code
LIL
Regulation Number
N/AWhy did this record match?
Product Code :
LIL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991479Device Name
VISER PENILE TUMESCENCE MONITOR
Manufacturer
LABORIE MEDICAL TECH CORP.
Date Cleared
1999-07-07
(70 days)
Product Code
LIL
Regulation Number
N/AWhy did this record match?
Product Code :
LIL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VISER™ penile tumescence monitor is a noninvasive monitoring device used to measure intracavernosal pressure (ICP) and blood flow in the penis. This monitoring assists the physician in the diagnosis of erectile dysfunction. VISERTM is a prescriptive device to be used under the direction of a physician or other authorized health care professional.
Device Description
Not Found
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K Number
K980627Device Name
NEVA SYSTEM
Manufacturer
UROMETRICS, INC.
Date Cleared
1998-04-07
(48 days)
Product Code
LIL
Regulation Number
N/AWhy did this record match?
Product Code :
LIL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NEVA™ System is an device to measure and record penile erectile events nocturnally.
Device Description
The UroMetrics NEVA system consists of three disposable electrodes sets, a portable battery powered recorder, a host interface, cables and a computer program. Two of the three electrode sets are placed on the penis so that one electrode set is on the glans terminating just proximal to the glans, one set is at the base of the penis terminating a fixed distance from the base of the penis. The third electrode is attached to the patient's hip. The wires from the electrodes terminate in a phone connector which plugs into the portable NEVA recorder.
The electrodes and the recorder are used by the patient to monitor nocturnal tumescence for up to three nights. The host interface and the computer program are used to prepare (initialize) the recorder for use and to download the data from the recorder for display and analysis on a physician's computer.
The NEVA system indicates penile tumescence by monitoring changes in volume, length and area. Due to a variety of factors (patient position, etc.) the size of the penis can change its shape. An increase in length, by itself, may not indicate tumescence. Tumescence is generally indicated by an increase in volume, length and area. This is the primary reason the NEVA system displays volume, length and area throughout the test.
Impedance values which are used to determine penile volume, length and area are continuously recorded at one second intervals. The one second time base and the change in volume data allow a physician to determine the fill rate once periods of tumescence are identified.
The NEVA system determines changes in volume by measuring the impedance within the penis. A low powered alternating current is sent from the electrode on the glans to the ground electrode on the hip. The remaining electrodes are used to measure the impedance. The electrode set at the base of the penis includes electrodes which are separated by a fixed distance. As the cross-sectional area of the blood volume in the penis increases, there is a decrease in measured impedance in the base electrode set. These impedance changes are then converted to a volume reading by the host computer. With an increase in distance between the base electrode and the electrode posterior to the glans (penis length) there is an increase in the impedance between these electrodes. This change in impedance is converted to a length reading.
To begin a test, the NEVA recorder is plugged into a computer through the host interface to a host computer running the NEVA software. The computer and software will recognize the recorder and will display a menu which allows the physician to download previously recorded data or initialize the recorder for a new test. To begin a new test, the physician enters the patient's name and other information and initializes the recorder. All previous data are cleared and the patient information is saved to the recorder.
The NEVA software allows the physician the option of real time measurements while connected to the computer. This capability is useful to demonstrate the proper placement of the electrodes and to check for proper operation. Once the NEVA recorder is initialized and the patient is instructed in its use, the recorder and electrodes are sent home with the patient. The electrodes are designed for single use so a separate set of electrodes is needed for each night (sleep period) of the test.
The NEVA recorder is normally in standby mode until the electrodes are placed on the patient and the connector is plugged into the recorder. When the connector is removed the recorder returns to the standby mode. Patients should be instructed to plug in the electrodes at the beginning of the test and unplug the electrodes at the end of the test. The recorder can store data for a maximum of 36 hours, typically three sleep periods.
At the end of the test period, the NEVA recorder is plugged into a computer through the host interface to a host computer running the NEVA software. The computer and software will recognize the recorder and will display a menu which allows the physician to download the data.
The data are then downloaded to the computer and stored on the computer's hard drive. The impedance data are converted to volume, length and crosssectional area plots which are displayed graphically on the computer screen.
The software incorporates a number of features which facilitate the analysis and interpretation of the data by the physician.
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