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510(k) Data Aggregation
K Number
K152930Device Name
PeriFlux6000
Manufacturer
PERIMED AB
Date Cleared
2016-05-05
(213 days)
Product Code
DPW
Regulation Number
870.2100Why did this record match?
Applicant Name (Manufacturer) :
PERIMED AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PeriFlux 6000 equipped with PF 6010 is intended for measuring micro-vascular perfusion in skin and muscle in humans. It is also intended for measuring micro-vascular perfusion in all tissues in animals for research purposes. The PF 6010 is also intended for evaluating tissue response in skin to local heating and providing temperature stabilization of skin at blood perfusion measurement.
PeriFlux 6000 equipped with PF 6050 is intended for measuring the pressure cuffs, to simplify simultaneous measurements of perfusion and pressure when used in conjunction with a laser Doppler perfusion monitor. PeriFlux 6000 equipped with PF 6050 is also intended for Pulse Volume Recording (PVR) on human limbs and digits for diagnosis and evaluation of vascular disease in adults. It is not intended for use on neonates and pregnant women.
PeriFlux 6000 equipped with PF 6040 is intended for continuous non-invasive transcutaneous monitoring of the partial pressures of oxygen and/or carbon dioxide. It is intended for use on neonates, pediatrics, and adults not under gas anesthesia.
Device Description
The PeriFlux 6000 is a modular multichannel system that offers several tests for diagnosis and evaluation of vascular disease in one instrument. It consists of a Main Unit (PF 6001), which accommodates up to eight different function units of the same type or of different types enabling simultaneous measurements of several parameters. Currently, one type of unit –PF 6040 tcpO2/pCO2 Unit– is available for the US market. Two more units have been developed:
- PF 6010 LDPM/Temp Unit
- PF 6050 Pressure Unit
The PeriFlux 6000 equipped with PF 6010 function units measures microcirculatory blood flow using Laser Doppler technology. In combination with the PF 6050 function unit to inflate blood pressure cuffs and to register the cuff pressure, it enables a range of different tests, including ankle pressure, toe pressure, skin perfusion pressure (SPP), pulse volume recording (PVR), segmental pressures, heat provocations and post-occlusive reactive hyperemia (PORH).
In Laser Doppler Perfusion Monitoring, an optical fibre leads light generated by a laser to the LDPM probe tip, which rests against the tissue. The beam of light will enter the tissue and become scattered. Blood cells moving within the volume illuminated by the beam will cause the light to change frequency. This change in frequency is called a Doppler shift and it is used to calculate the blood flow in the illuminated tissue.
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K Number
K131253Device Name
PERIFLUX 6000
Manufacturer
PERIMED AB
Date Cleared
2013-10-22
(173 days)
Product Code
LKD, KLK, LPP
Regulation Number
868.2480Why did this record match?
Applicant Name (Manufacturer) :
PERIMED AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PeriFlux 6000 equipped with PF 6040 is intended for continuous non-invasive transcutaneous monitoring of the partial pressures of oxygen and/or carbon dioxide. It is intended for use on neonates, pediatrics, and adults not under gas anesthesia.
Device Description
PeriFlux 6000 is a transcutaneous oxygen/carbon dioxide (tcpO2/CO2) monitor, and consists of a main unit, PF 6001, that can be equipped with 1 to 8 PF 6040 function units. An electrode E5250 or E5280 is connected to each function unit and is applied to a patient's skin. Electrode E5250 consists of a Clark sensor and is used for O2 measurement. Electrode E5280 is a combined Clark sensor and Stow-Severinghaus-type sensor, and is used for both O2 and CO2 measurement. Upon measurement, the electrode is heated to make the skin permeable to gas diffusion, which allows O2 and CO2 to diffuse through the skin into the sensor. The instrument is operated from its touch screen interface and allows the users to record, analyze and report top(22 and tcpCO2 values.
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K Number
K120884Device Name
PERICAM PSI
Manufacturer
PERIMED AB
Date Cleared
2012-07-03
(102 days)
Product Code
DPT
Regulation Number
870.2120Why did this record match?
Applicant Name (Manufacturer) :
PERIMED AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PeriCam PSI is intended for non-invasive two-dimensional imaging of peripheral tissue blood perfusion. This can be used in a wide range of applications and disciplines including dermatology, wound healing, burns assessment etc.
Device Description
The PeriCam PSI is a device to perform non-contact imaging of tissue blood perfusion in the microcirculation, for example skin, using Laser Speckle contrast analysis. The full measurement area surface is illuminated with a laser beam resulting in a laser speckle pattern. The pattern is imaged by a CCD camera and image processing of the speckle contrast is used to generate high resolution color code images showing the blood perfusion in the tissue.
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K Number
K011899Device Name
PF 5050 PRESSURE UNIT, MODEL PF 5050
Manufacturer
PERIMED AB
Date Cleared
2001-11-06
(141 days)
Product Code
DPW
Regulation Number
870.2100Why did this record match?
Applicant Name (Manufacturer) :
PERIMED AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use of the PF 5050 Pressure Unit is indicated for non-invasive Pulse Volume waveform Recordings (PVR) on extremities of patients with vascular diseases.
It is also intended to measure and control the pressure in a blood pressure cuff to simplify simultaneous measurements of perfusion and pressure when used in conjunction with a laser Doppler perfusion monitor.
Device Description
The PF 5050 Pressure Unit is a modular unit that can be installed in the PeriFlux System 5000. The device provides Pulse Volume waveform Recordings (PVR) on various limb and digit extremities made possible through air plethysmography. The PF 5050 Pressure Unit includes a small display where the mean cuff pressure is displayed.
The PVR tracing is accomplished by attaching a standard blood pressure cuff on various areas of the extremities. To provide skin contact, atmospheric air is inflated to approximately 50 - 65 mmHg using the balloon pump supplied with a standard blood pressure gauge. A pressure transducer records the pressure change in the cuff (Pulse Volume waveforms) secondary to change in v the extremity segment under the cuff during repeated cardiac cycles.
The PeriFlux System 5000 is a multi-channel, multi-functional system capable of hosting one, two, three or four function units including for example a PF 5010 LDPM Unit for blood perfusion measurements. The PeriFlux 5001 Main Unit accommodates up to four different function units of the same type or of different types enabling simultaneous measurements of several parameters. There are three different function unit types available at the moment.
PF 5010 LDPM Unit for blood perfusion measurements.
PF 5020 Temp Unit for temperature measurements.
PF 5040 tcpO2 / pCO2 for measurements of transcutaneous O2 and CO2.
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