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510(k) Data Aggregation

    K Number
    K031956
    Device Name
    MODIFICATION TO HERMES O.R. CONTROL CENTER
    Manufacturer
    COMPUTER MOTION, INC.
    Date Cleared
    2003-07-17

    (22 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUTER MOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HERMES® O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, Steris Amsco Table Model SP3085, AESOP®HR (HERMES-Ready™), Valleylab Force FX™ Electro-surgical Unit, Smith & Nephew Dyonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, Skytron Stellar Series O.R. Lights, S&N Dyonics® Power Shaver (K030240) and the Smith & Nephew 400 Insufflator. It can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thoracoscopic anterior spinal 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 in indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
    Device Description
    The HERMES O.R. Control Center is a computer-driven system whose basic function is to offer the surgeon the additional option of voice control for ancillary devices. The intent of the HERMES O.R. Control Center is to allow for simplified and more direct control of medical device settings by the physician, thereby eliminating the necessity of using the various interfaces existing on ancillary devices, or relying on verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.
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    K Number
    K031720
    Device Name
    MODIFICATION TO HERMES O.R. CONTROL CENTER
    Manufacturer
    COMPUTER MOTION, INC.
    Date Cleared
    2003-07-11

    (38 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUTER MOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HERMES® O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator System, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, Steris Amsco Table Model SP3085, AESOP®R (HERMES-Ready™), Valleylab Force FX™ Electrosurgical Unit, Smith & Nephew Dyonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, Skytron Stellar Series O.R. Lights, S&N Dyonics® Power Shaver (K030240) and the Smith & Nephew InteliJET Arthroscopic Fluid Management System. It can be used in general laparoscopy. nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, appendectorny, laparoscopic pelvic lymph node laparoscopic dissection. laparoscopically assisted hysterectomy, laparoscopic & thoracoscopic anterior spinal 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 in indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
    Device Description
    The HERMES O.R. Control Center is a computer-driven system whose basic function is to offer the surgeon the additional option of voice control for ancillary devices. The intent of the HERMES O.R. Control Center is to allow for simplified and more direct control of medical device settings by the physician, thereby eliminating the necessity of using the various interfaces existing on ancillary devices, or relying on verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.
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    K Number
    K031382
    Device Name
    MODIFICATION TO HERMES O.R. CONTROL CENTER
    Manufacturer
    COMPUTER MOTION, INC.
    Date Cleared
    2003-06-30

    (60 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUTER MOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HERMES® O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, Steris Amsco Table Model SP3085, AESOP®HR (HERMES-Ready™), Valleylab Force FX™ Electro-surgical Unit. Smith & Nephew Dvonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, Skytron Stellar Series O.R. Lights, Smith & Nephew Dyonics® Power Shaver, and the Smith & Nephew Dyonics® 325Z DV Camera. It can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectorny, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection. laparoscopically assisted hvsterectomy. laparoscopic & thoracoscopic anterior spinal 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 in indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
    Device Description
    The HERMES O.R. Control Center is a computer-driven system whose basic function is to offer the surgeon the additional option of voice control for ancillary devices. The intent of the HERMES O.R. Control Center is to allow for simplified and more direct control of medical device settings by the physician, thereby eliminating the necessity of using the various interfaces existing on ancillary devices, or relying on verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.
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    K Number
    K030578
    Device Name
    BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM
    Manufacturer
    COMPUTER MOTION, INC.
    Date Cleared
    2003-06-24

    (120 days)

    Product Code
    NAY
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUTER MOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bipolar Grasper and Bipolar Scissors are instruments used with the ZEUS® MicroWrist™ Surgical System. The Bipolar Grasper is intended to grasp, dissect, and coagulate tissue. The Bipolar Scissors provide mechanical cutting and bipolar coagulation. These bipolar instruments augment the means of performing electrosurgical procedures with the ZEUS® MicroWrist™ Surgical System.
    Device Description
    This premarket notification adds a bipolar grasper and bipolar scissors to the ZEUS® MicroWrist™ Surgical System. These surgical instruments are used in conjunction with an electrosurgical generator unit (ESU), and they augment the means of performing electrosurgical procedures with the ZEUS® MicroWrist™ Surgical System. These devices are additions to the MicroAssist 100 line of ZEUS surgical instruments. MicroAssist instruments consist of commercially available hand-held devices that have been modified in order to be attached to the ZEUS arm. As with all MicroAssist instruments, the distal end that is used to perform surgical tasks remains unchanged from the hand-held version. The ZEUS® MicroWrist™ Surgical System, consisting of a surgeon console and three table-mounted arms, serves as a platform for holding, positioning, and manipulating endoscopic instruments in order to perform selected surgical tasks. One arm of the ZEUS System incorporates the AESOP® endoscope positioner which provides the surgeon with a steady view of the internal operating field. The HERMES® O.R. Control Center, which uses voice-recognition technology to control devices outside the sterile field, is a standard component of the ZEUS System.
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    K Number
    K030718
    Device Name
    SCB COMPUTER MOTION INTERFACE CONTROLLER
    Manufacturer
    COMPUTER MOTION, INC.
    Date Cleared
    2003-06-05

    (90 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUTER MOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SCB Computer Motion Interface Controller is indicated for use with the Storz Communication Bus (SCB) manufactured by Karl Storz to connect HERMES-Ready™ devices to the SCB.
    Device Description
    The SCB Computer Motion Interface Controller (SCIC) connects devices that are controlled by Computer Motion's voice-control system to the Storz Communication Bus (SCB) manufactured by Karl Storz.
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    K Number
    K030240
    Device Name
    MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
    Manufacturer
    COMPUTER MOTION, INC.
    Date Cleared
    2003-02-21

    (29 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUTER MOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HERMES® O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, Steris Amsco Table Model SP3085, AESOP®HR (HERMES-Ready™), Valleylab Force FXTM Electrosurgical Unit, Smith & Nephew Dyonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, Skytron Stellar Series O.R. Lights, and Smith & Nephew Dyonics® Power Shaver. It can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thoracoscopic anterior spinal 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 in indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the HERMES O.R. Control Center are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
    Device Description
    The HERMES O.R. Control Center is a computer-driven system whose basic function is to offer the surgeon the additional option of voice control for ancillary devices. The intent of the HERMES O.R. Control Center is to allow for simplified and more direct control of medical device settings by the physician, thereby eliminating the necessity of using the various interfaces existing on ancillary devices, or relying on verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.
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    K Number
    K024294
    Device Name
    MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
    Manufacturer
    COMPUTER MOTION, INC.
    Date Cleared
    2003-01-08

    (15 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUTER MOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HERMES® O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, Steris Amsco Table Model SP3085, AESOP®HR (HERMES-Ready™), Valleylab Force FX™ Electrosurgical Unit, Smith & Nephew Dyonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, and Skytron Stellar Series O.R. Lights. It can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic & thoracoscopic anterior spinal 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 in indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
    Device Description
    The HERMES O.R. Control Center is a computer-driven system whose basic function is to offer the surgeon the additional option of voice control for ancillary devices. The intent of the HERMES O.R. Control Center is to allow for simplified and more direct control of medical device settings by the physician, thereby eliminating the necessity of using the various interfaces existing on ancillary devices, or relying on verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.
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    K Number
    K023095
    Device Name
    HERMES OPERATING ROOM CONTROL CENTER
    Manufacturer
    COMPUTER MOTION, INC.
    Date Cleared
    2002-11-15

    (58 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUTER MOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HERMES ™ O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, AESOP®HERMES-Ready™, Valleylab Force FX™ Electro-surgical Unit, and Smith & Nephew Dyonics® Vision 635 Digital Image Management System. It can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thoracoscopic anterior spinal 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 in indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the HERMES O.R. Control Center are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
    Device Description
    The HERMES O.R. Control Center is a computer-driven system whose basic function is offer voice control of ancillary devices.
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    K Number
    K022897
    Device Name
    MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
    Manufacturer
    COMPUTER MOTION, INC.
    Date Cleared
    2002-10-11

    (38 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUTER MOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HERMES™ O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, AESOP®HERMES-Ready™, Valleylab Force FX™ Electro-surgical Unit, and Dyonics® Access 15 Arthroscopic Fluid Irrigation System. It can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thoracoscopic anterior spinal 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 in indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
    Device Description
    The HERMES O.R. Control Center is a computer-driven system whose basic function is offer voice control of ancillary devices.
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    K Number
    K021152
    Device Name
    ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES
    Manufacturer
    COMPUTER MOTION, INC.
    Date Cleared
    2002-09-24

    (167 days)

    Product Code
    NAY
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUTER MOTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZEUS® MicroWrist "Surgical System (ZEUS System) and Accessories are intended to be used to assist a surgeon during procedures such as Laparoscopic Cholecystectomy and Nissen Fundoplication, to hold and position an endoscope, and to control laparoscopic instruments in performance of the surgical tasks of grasping, sharp cutting, blunt dissection, electro-cautery and suturing with knot placement. The ZEUS System is intended to be used by surgeons who are trained in minimally invasive surgery, have successfully completed a ZEUS System training program, and are certified in accordance with their respective hospital's customary practice for ZEUS System use. The ZEUS® MicroWrist™ Surgical System is intended to be used in an operating room environment in which the ZEUS System, the operating surgeon and patient are in the same room.
    Device Description
    The ZEUS® MicroWrist™ Surgical System (ZEUS System) and Accessories, consisting of a surgeon console and three table-mounted arms, serves as a platform for holding, positioning, and manipulating endoscopic instruments in order to perform selected surgical tasks. One arm of the ZEUS System incorporates the AESOP® endoscope positioner, which provides the surgeon with a steady view of the internal operating field. The HERMESTM Control Center, which uses voice-recognition technology to control devices outside the sterile field, is a standard component of the ZEUS® MicroWrist™ Surgical System and Accessories, and has been cleared to operate with many ancillary devices.
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