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510(k) Data Aggregation
K Number
K091648Device Name
NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8
Manufacturer
Date Cleared
2009-08-05
(57 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
CONMED INTEGRATED SYSTEMS (CMIS)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nurse's Assistant® O.R. Control System, 1.8 is a programmable electrical medical system that is intended to provide trained staff with a centralized user interface from which to route audio and video signals, and to perform auxiliary control functions for activating, adjusting and monitoring certain settings of compatible medical and non-medical equipment.
The Nurse's Assistant® O.R. Control System, 1.8 is Indicated for use in an operating room for video assisted surgery during minimally invasive and traditional open procedures in all surgical specialities. The System is also used as an adjunct display of interventional techniques and provides teleconferencing capability through an optional interface.
Device Description
The Nurse's Assistant® O.R. Control System, 1.8, is a modification of an existing device that is composed of off-the-shelf audio/video hardware components, proprietary software that runs on a non-Windows based operating system and a touch panel interface with an intuitive graphical user interface. The Nurse's Assistant® System 1.8 communicates with interconnected devices through standard data communication protocols which allows the adjustment of equipment settings and routing of audio/video signals from one location in the operating room.
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K Number
K060717Device Name
NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEM
Manufacturer
Date Cleared
2006-04-25
(39 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
CONMED INTEGRATED SYSTEMS (CMIS)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route audio and video from multiple sources to multiple destinations.
The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in an operating room for video assisted surgery. This includes minimally invasive procedures in all surgical specialties, as an adjunct display of interventional techniques and traditional open procedures.
The Nurse's Assistant® 1.7 O.R. Control System indicated for use with ConMed Linvatec IM3300 Endoscopic Camera, ConMed Linvatec LS7500 Xenon Light Source, ConMed Linvatec GS1002 40L Insufflator, ConMed Electrosurgery System 5000 Electrosurgery Unit (ESU), ConMed Linvatec VP-1500 Digital Capture Device, Getinge ALM Surgical Lamp Energix WPS, Getinge ALM PrismaVision PRV3 Surgical Light Camera, Berchtold Chromophare D-Series Surgical Lamps, Berchtold ChromoVision HR24 Surgical Light Camera, National Display Systems 15" & 18" Vector III and 19" & 32" Radiance flat panel displays, Sony LMD-2140MD 21" flat panel display, Sony UP-51MD or Sony UP-51MDU video printers, Sony SVO-9500MD VCR, ProVation™ procedure documentation device, Skytron Stellar Series Surgical Lights, optional Surgeon's Assistant™ accessory touch panel and an audio/video conferencing interface.
The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thoracoscopy, general cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, nasopharynqoscopy, ear endoscopy and sinusoscopy.
Device Description
The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route audio and video from multiple sources to multiple destinations.
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K Number
K052740Device Name
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
Manufacturer
Date Cleared
2005-10-17
(17 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
CONMED INTEGRATED SYSTEMS (CMIS)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route video from multiple sources to multiple destinations.
The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in an operating room for video assisted surgery. This includes minimally invasive procedures in all surgical specialties, as an adjunct display of interventional techniques and traditional open procedures.
The Nurse's Assistant 1.7 O.R. Control System indicated for use with ConMed Linvatec IM3300 Endoscopic Camera, ConMed Linvatec LS7500 Xenon Light Source, ConMed Linvatec GS1002 40L Insufflator, ConMed Electrosurgery System 5000 Electrosurgery Unit (ESU), ConMed Linvatec VP-1500 Digital Capture Device, Getinge ALM Surgical Lamp Energix WPS, Getinge ALM PrismaVision PRV3 Surgical Light Camera, Berchtold Chromophare D-Series Surgical Lamps, Berchtold ChromoVision HR24 Surgical Light Camera, National Display Systems 15" & 18" Vector III and 19" Radiance flat panel displays, Sony LMD-2140MD 21" flat panel display, Sony UP-51MD or Sony UP-51MDU video printers, Sony SVO-9500MD VCR, and ProVation™ procedure documentation device.
The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thoracoscopy, general cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, nasopharyngoscopy, ear endoscopy and sinusoscopy.
Device Description
The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route video from multiple sources to multiple destinations.
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K Number
K050829Device Name
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
Manufacturer
Date Cleared
2005-05-06
(35 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
CONMED INTEGRATED SYSTEMS (CMIS)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nurse's Assistant® 1.7 is intended to be used to route video from multiple sources to multiple destinations, to be used to turn on and off power to specific 110 volt receptacles within the OR, and to be used to adjust specific operating parameters of video displays, analog or digital recording, communication and playback equipment, endoscopic cameras, endoscopic light sources, surgical lamps, observation cameras, surgical cameras and operating room lights.
The Nurse's Assistant® 1.7 is indicated for use in an operating room for video assisted surgery. This includes minimally invasive procedures in all surgical specialties, as an adjunct display of interventional techniques and traditional open procedures.
The Nurse's Assistant® 1.7 is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thoracoscopy, general cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, nasopharyngoscopy, ear endoscopy and sinusoscopy.
Device Description
The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that provides operating room (OR) staff with a simple touch panel interface from which to activate, adjust and monitor certain settings of equipment located in the OR.
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K Number
K031979Device Name
CONMED INTEGRATED SYSTEMS NURSES ASSISTANT
Manufacturer
Date Cleared
2003-07-25
(29 days)
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
CONMED INTEGRATED SYSTEMS (CMIS)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nurse's Assistant® is a programmable controller operated through a touch screen GUI that offers professional O.R. staff a simplified remote user interface and a real time display of settings for the devices attached to the system thereby eliminating the necessity for using the various control panels on diverse surgical equipment.
The Nurse's Assistant® is intended to be used to turn on and off, and adjust certain settings of, endoscopic and surgical cameras, electrosurgical generators such as the ConMed System 5000 ESU, laparoscopic insufflators such as the Linvatec GS1002 Insufflator, surgical lamps, operating room ("O.R.") lights, and operate digital documentation products, VCR's, video monitors, video printers, radios and CD players.
The Nurse's Assistant® is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thorascoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy. A few examples of the more common surgical procedures where this system could be used are laparoscopic cholecystectorny, laparoscopic hernia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic and thorascopic anteriorspinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated, examination of the evacuated cardiac chamber during performance of valve replacement, arthroscopic meniscus repair, anterior cruciate ligament repair and associated procedures.
Device Description
The Nurse's Assistant is a programmable controller operated through a touch screen GUI that offers professional O.R. staff a simplified remote user interface and a real time display of settings for the devices attached to the system thereby eliminating the necessity for using the various control panels on diverse surgical equipment.
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