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510(k) Data Aggregation
K Number
K232922Device Name
Pure-Vu EVS System
Manufacturer
Motus GI Medical Technologies Ltd.
Date Cleared
2023-10-20
(31 days)
Product Code
FDF, FDS
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Motus GI Medical Technologies Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pure-Vu EVS System is intended to connect to standard or slim colonoscopes to help facilitate intra-procedural cleansing of the GI tract by irrigating or cleaning irrigation fluid (water), feces, and other bodily fluids and matter, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctors' offices.
Device Description
The Pure-Vu EVS System enables cleaning of the GI tract during endoscopy using a standard or slim colonoscope with a length of 1630mm - 1710mm and an outer diameter range of 11.7mm - 13.2mm or gastroscope with a length of 950 – 1030mm and an outer diameter of 9.2 - 10mm The EVS Flex Channel , which fits alongside the endoscope and is connected to an external Workstation, generates fluid and gas to break up debris The debris & fluids are removed through the suction channel of the EVS Flex Channel into an external waste container/bag.
The Pure-Vu EVS System consists of the following main components:
Disposable device which includes a Flex Channel section and an Umbilical Section (US) - The EVS Flex Channel fits alongside the endoscope to allow a physician to cleanse the GI tract and is connected to the external Workstation via a disposable US. Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water or saline and gas, and evacuates debris and fluids. The Workstation includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the GI tract, and suction of fluid and matter from the GI tract. Irrigation Bag/Bottle (saline or water) which is connected to the irrigation line. Waste Containers for collecting the GI content & fluids that are suctioned from the GI tract through the suction lines. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fluid and matter from the GI tract. A foot pedal activates the cleansing, suction and purging functions, and enables switching between cleansing modes used by the physician.
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K Number
K220007Device Name
Pure-Vu EVS System
Manufacturer
Motus GI Medical Technologies Ltd.
Date Cleared
2022-02-10
(37 days)
Product Code
FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Motus GI Medical Technologies Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pure-Vu EVS System is intended to connect to standard and slim colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the irrigation the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctor offices.
Device Description
The Pure-Vu EVS System enables colon cleaning during colonoscopy using a standard or slim colonoscope with a length of 1630mm – 1710mm and an outer diameter range of 11.7mm – 13.7mm. The Oversleeve, which fits over the colonoscope and is connected to an external Workstation, generates fluid and gas to break up feces. The fecal matter & fluids are removed through the suction channel of the Oversleeve into an external waste container.
The Pure-Vu EVS System consists of the following main components:
Oversleeve (OS) and Umbilical Section (US) - The disposable Oversleeve is mounted on Standard or Slim commercially available colonoscopes to allow a physician to cleanse the GI tract and is connected to the external Workstation via a disposable US.
Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water or saline and gas, and evacuates fecal material and fluids. The Workstation includes the following components:
A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the GI tract, and suction of fluids and feces from the colon.
Irrigation Bag/Bottle (saline or water) which is connected to the irrigation line.
Waste Containers for collecting the GI content & fluids that are suctioned from the GI tract through the suction lines.
Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device.
Outlet Module that includes pumps to evacuate fluid and matter from the GI tract.
A foot pedal activates the cleansing, suction and purging functions, and enables switching between cleansing modes used by the physician.
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K Number
K210981Device Name
Pure Vu System
Manufacturer
Motus GI Medical Technologies Ltd.
Date Cleared
2021-04-29
(28 days)
Product Code
FDF, FDS
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Motus GI Medical Technologies Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pure-Vu System is intended to connect to standard or slim colonoscopes and gastroscopes to facilitate intra-procedural cleansing of the GI tract by irrigating and evacuating the irrigation fluids (water), bodily fluids and other debris, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctors' offices.
Device Description
The Pure-Vu System enables cleansing of the digestive tract during endoscopy using a standard or slim colonoscope with a length of 1630mm - 1710mm and an outer diameter range of 11.7mm - 13.3mm (slim) and 12.8mm - 13.7mm (standard), or gastroscope with length of 950-1030mm and an outer diameter of 10mm - 10.9mm. The Oversleeve, which fits over the endoscope and is connected to an external Workstation, generates fluid and gas to break up debris. The debris & fluids are removed through the suction channels of the Oversleeve into an external waste container.
The Pure-Vu System consists of the following main components:
• Oversleeve (OS) and Umbilical Section (US) - The disposable Oversleeve is mounted on Standard or Slim commercially available colonoscopes or gastroscopes to allow a physician to cleanse the GI tract and is connected to the external Workstation via a disposable US.
• Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water/saline and gas, and evacuates bodily fluid and matter. The Workstation [WS] includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the colon, and suction of bodily fluid and matter from the GI tract. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fluid and matter from the Gl tract. A foot pedal activates the cleansing, suction and purging function, and switch between cleansing modes used by the physician.
• Loading fixture - The loading fixture is reusable and aids in assembling the Oversleeve onto the endoscope. Unloading aids - A disposable luer lock syringe/ duckbill check valve assembly used in unloading the Oversleeve from the endoscope.
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K Number
K191220Device Name
Pure Vu System
Manufacturer
Motus GI Medical Technologies Ltd.
Date Cleared
2019-06-06
(30 days)
Product Code
FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Motus GI Medical Technologies Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodly fluids and matter, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctor offices.
Device Description
The Pure-Vu System enables colon cleansing during colonoscopy using a standard or slim colonoscope with a length of 1630mm – 1710mm and a slim colonoscope outer diameter range of 11.7mm – 13.3mm and a standard colonoscope outer diameter range of 12.8mm – 13.7mm. The Oversleeve, which fits over the colonoscope and is connected to an external Workstation, generates fluid to break up feces. The fecal matter & fluids are removed through the suction channels of the Oversleeve into an external waste receptacle.
The Pure-Vu System consists of the following main components:
Oversleeve (OS) and Umbilical Section (US) - The disposable Oversleeve is mounted on Standard or Slim commercially available colonoscopes to allow a physician to cleanse the colon and is connected to the external Workstation via a disposable US. Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water/saline and gas, and evacuates fecal material & fluids. The Workstation [WS] includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the colon, and suction of fluids and feces from the colon. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fecal matter and fluids from the colon. A foot pedal activates the cleansing, suction and purging function, and switch between cleansing modes used by the physician. Loading fixture- The loading fixture is reusable and aids in assembling the Oversleeve onto the colonoscope. Unloading aids - A disposable 60cc lure lock syringe and 3-way stopcock used in unloading the Oversleeve from the colonoscope are provided in the disposable packaging.
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K Number
K181437Device Name
Pure Vu System
Manufacturer
Motus GI Medical Technologies Ltd.
Date Cleared
2018-06-21
(20 days)
Product Code
FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Motus GI Medical Technologies Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctor offices.
Device Description
The Pure Vu system comprises the following components:
Oversleeve - The Oversleeve is mounted on Standard or Slim commercially available colonoscopes to allow a physician to cleanse the colon.
Workstation (WS) - The Workstation operates by using simultaneous irrigation and evacuation of colon content. Irrigation is based on a mixture of liquid (water or saline) and gas (air). The workstation includes:
Monitoring & Control Unit that continuously monitors and controls irrigation and evacuation. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fecal matter and fluids from the colon. External foot pedals that control the cleansing process to be operated by a physician.
WS Connector (WSC) connects the Oversleeve to the WS and saline or water bag.
Loading fixture to aid the nurse in mounting the Oversleeve onto a colonoscope.
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K Number
K173392Device Name
Pure-Vu System
Manufacturer
Motus GI Medical Technologies Ltd.
Date Cleared
2017-12-12
(43 days)
Product Code
FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Motus GI Medical Technologies Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctor offices.
Device Description
The Pure-Vu system comprises the following components:
Oversleeve - The Oversleeve is mounted on standard commercially available colonoscopes allowing the physician to clean the colon.
Workstation (WS) - The Workstation operates by using cyclic irrigation and evacuation of colon content. Irrigation is based on mixture of liquid and air. The workstation includes:
Monitoring & Control Unit that continuously monitors and controls irrigation and evacuation. Inlet Module that includes pumps and regulators enabling water & airflow into the cleansing device. Outlet Module that includes pumps to evacuate fecal matter and fluids from the colon. External on\off foot pedals that operate the cleansing process to be used by the physician.
WS Connector (WSC) connects the Oversleeve to the WS and saline or water bag.
Loading fixture to aid the nurse in mounting the Oversleeve on to a colonoscope.
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K Number
K160015Device Name
Pure Vu
Manufacturer
Motus GI Medical Technologies Ltd.
Date Cleared
2016-09-22
(262 days)
Product Code
FDF
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Motus GI Medical Technologies Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pure Vu System is intended to connect to standard colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctor offices.
Device Description
The Pure Vu system comprises the following components:
Add-on - The Add-on is mounted on standard commercially available colonoscopes allowing the physician to clean the colon.
Workstation (WS) - The Workstation operates by using cyclic irrigation and evacuation of colon content. Irrigation is based on mixture of liquid and air. The workstation includes: Monitoring & Control Unit that continuously monitors and controls irrigation and evacuation. Inlet Module that includes pumps and regulators enabling water & airflow into the cleansing device. Outlet Module that includes pumps to evacuate fecal matter and fluids from the colon. External on\off foot pedals that operate the cleansing process to be used by the physician.
WS Cartridge (WSC) connects the Add on to the WS and saline or water bag.
Loading fixture to aid the nurse in mounting the Add-on to a colonoscope.
Unloading fixture to aid the nurse in removing the Add-on from a colonoscope.
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