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510(k) Data Aggregation
K Number
K081984Device Name
LABORPRO SYSTEM
Manufacturer
TRIG MEDICAL LTD
Date Cleared
2009-03-04
(236 days)
Product Code
NPB, SYS
Regulation Number
884.2800Why did this record match?
Product Code :
NPB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LaborPro System is intended for monitoring the active phase of labor in women with term gestations and a singleton fetus in vertex presentation. The device intermittently assesses fetal head station, position and cervical dilation. Cervical dilation using LaborPro is assessed using position sensors during vaginal examination. The Labor Pro also may be used to measure cervical length, pubic arch angle and interspinous diameter using position sensors during vaginal examination. The LaborPro combines a magnetic tracking system including a transmitter and position sensor with an ultrasound imaging system (not included with the LaborPro). Measurements are displayed numerically and graphically as a function of time to show the progress of labor.
Device Description
The LaborPro System is comprised of the following components:
1. A magnetic based tracking system
2. A system console which integrates the tracker unit electronics and the system computer,
3. A touch screen monitor, used for display and operation.
4. LaborPro software application
5. Sensor Sleeve and reference sticker (an "off the shelf" tape and bandage adhesive).
6. An 'off the shelf' ultrasound device; not supplied with the system
7. An 'off the shelf CardioTocoGram (CTG) monitor (optional); not supplied with the system
LaborPro System, a minimally invasive device, assesses labor The parameters intermittently by accompanying the physician during his/her routine examinations.
The LaborPro magnetic position tracking system is designed for tracking the spatial location of the sensor tip. Spatial localization of landmarks may be simply obtained by either touching external landmarks of interest with the sensor tip and/or by marking structures of interest on a ultrasound image extracted from an "off the shelf" calibrated ultrasound probe aligned with a position sensor. The spatial localization of each sensor then may allow for the assessment of certain measurements such as cervical dilatation simply by touching points within the system's working area and yielding the relative distance/angles between the touched points in a caliper-like fashion. In addition, localization of key anatomical points either by touching external landmarks with a sensor tip or marking structures of interest on an ultrasound image enable mapping of the spatial position and orientation of the pelvis and specifically the level of the pelvic inlet plane; which is used as the relative plane for the fetal head station measurement.
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K Number
K082704Device Name
BIRTHTRACK (A.K.A. CLM)
Manufacturer
BARNEV, LTD.
Date Cleared
2009-01-09
(115 days)
Product Code
NPB
Regulation Number
884.2800Why did this record match?
Product Code :
NPB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BirthTrack System is an ultrasound device intended to be used for monitoring the active phase of labor in women with term pregnancies, vertex presentation, and ruptured membranes. It is intended to be placed when cervical dilation is between 3 cm and 7 cm. The device continuously measures cervical dilation and fetal head station with ultrasound transducers attached to the maternal abdomen and cervix and to the fetal scalp. These measurements are displayed numerically and graphically as a function of time to show the progress of labor.
Device Description
Barnev's BirthTrack system uses ultrasound technology to provide measurements of cervix dilatation and fetal head station. The BirthTrack Workflow and measurements cycle have not changed with this version and signals from disposable sensors located on the maternal cervix and fetal head provide objective and continuous cervical dilatation and fetal head station data, reducing the need for frequent vaginal examinations. However signal analysis was enhanced with a new algorithm- a "side inclination" correction algorithm. The system's GUI was also enhanced introducing a graphic illustration of CD and HS as measured by the BirthTrack system
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K Number
K080672Device Name
BIRTHTRACK
Manufacturer
BARNEV, LTD.
Date Cleared
2008-07-08
(120 days)
Product Code
NPB
Regulation Number
884.2800Why did this record match?
Product Code :
NPB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BirthTrack System is an ultrasound device intended to be used for monitoring the active phase of labor in women with term pregnancies, vertex presentation, and ruptured membranes. It is intended to be placed when cervical dilation is between 3 cm and 7 cm. The device continuously measures cervical dilation and fetal head station with ultrasound transducers attached to the maternal abdomen and cervix and to the fetal scalp. These measurements are displayed numerically and graphically as a function of time to show the progress of labor.
Device Description
Barnev's BirthTrack system uses ultrasound technology to provide measurements of cervix dilatation and fetal head station. Signals from disposable sensors located on the maternal cervix and fetal head provide objective and continuous cervical dilatation and fetal head station data, reducing the need for frequent vaginal examinations.
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K Number
DEN060006Device Name
COMPUTERIZED LABOR MONITORING SYSTEM
Manufacturer
BARNEV, LTD.
Date Cleared
2007-01-30
(104 days)
Product Code
NPB
Regulation Number
884.2800Why did this record match?
Product Code :
NPB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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