CONMED INTEGRATED SYSTEMS NURSES ASSISTANT

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird in flight, with its wings and tail feathers represented by thick, curved lines. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ConMed Intergrated Systems Mr. C. Jeff Lipps Director of Regulatory Affairs 1815 NW 169th Place, Suite 4020 Beaverton, OR 97006 JUL 2 7 2015 Re: K031979 > Trade/Device Name: ConMed Integrated Systems' Nurse's Assistant® O.R. Control System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ, FET, FSY, HET, HIF, GEI and LMC Dated (Date on orig SE ltr): June 25, 2003 Received (Date on orig SE ltr): June 26, 2003 Dear Mr. Lipps, This letter corrects our substantially equivalent letter of July 25, 2003. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be {1}------------------------------------------------ Page 2 - found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Benjamin R. Fisher -S Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # XIV. INDICATIONS FOR USE STATEMENT 510(k) Number: K031979 Device Name: #### Modification to ConMed Integrated Systems' Nurse's Assistant® O.R. Control System Indications for 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. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) oncurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use_ (Per 21 C.F.R. 801.109) (Optional Formal 1-2-96) ConMed Integrated Systems Nurse's Assistant Special 510/k) Notification {3}------------------------------------------------ 03/979 Confidential #### JUL 25 2003 XIII. 510(K) SUMMARY # Modified Nurse's Assistant® O.R. Control System In accordance with 21 CFR section 807.92, ConMed Integrated Systems is submitting the following 510(k) summary: # 1) Date Submitted June 25, 2003 ## 2) Submitter Information ConMed Integrated Systems 1815 NW 169th Place, Suite 4020 Beaverton, OR 97006 Contact: C. Jeff Lipps, BS/MBA, Dir. of RA (503) 614-1106 ext. 1206 Phone Fax (503) 614-1109 ### 3) Name of Device | Proprietary Name: | Nurse's Assistant® O.R. Control System | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Surgical Control Center | | Classification Names: | Surgical Lamp, 878.4580<br>Endoscope and accessories, 876.1500<br>Gynecologic laparoscope and accessories, 884.1720<br>Laparoscopic insufflator, 884.1730<br>Electrosurgical cutting and coagulation device<br>and accessories, 878.4400<br>Medical image hardcopy device, 892.2040 | | Product Codes: | FSY, GCJ, FET, KOG, HET, HIF, GEI, LMC | | Classification Panel: | General & Plastic Surgery | | Device Class: | Class II | 1 of 3 ConMed Integrated Systems Nurse's Assistant Special 510(k) Notification {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the text "Ko3/1979 Confidential". The text is written in black ink on a white background. The word "Confidential" is written in a smaller font size than the other text. 510(k) Summary - Modified Nurse's Assistant® O.R. Control System Page 2 #### 4) Predicate Devices This device is substantially equivalent to the ConMed Integrated Systems' Nurse's Assistant®O.R. Control System (K010754), Modification to Olympus' Integrated Endosurgery System EndoALPHA (K022270), and Modification to Computer Motion's HERMES Operatir g Room Control Center (K030240). ### 5) 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. #### 6) Intended Use 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.H.") lights, and operate digital documentation products, VCR's, video monitors, video printers, radics and CD players. #### 7) Indications for Use: 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 hysterectomy, laparoscopic and thorascopic anteriorspinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectorny, pleurodesis, internal mammary artery dissection for coronary antery 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. ConMed Integrated Systems Nurse's Assistant Special 510{k} Notification 27 2 of 3 {5}------------------------------------------------ Ko31979 Confidential 510(k) Summary – Modified Nurse's Assistant® O.R. Control System Page 3 # 8) Applied Safety Standards: The Nurse's Assistant®O.R. Control System has been tested to the following standards: | Test | Title | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | IEC 601-1 | International Standard for Medical Electrical<br>Equipment | | IEC 601-1 Amendment 1 | International Standard for Medical Electrical<br>Equipment | | IEC 601-2-18 | International Standard for Medical Electrical<br>Equipment | | EN 60601-1 | International Standard for Medical Electrical<br>Equipment | | EN 60601-1-1 | General Requirements for Safety - Collateral<br>Standard | | EN 60601-1-2 (2001) | International Standard for Medical Electrical<br>Equipment, Electro Magnetic Compatibility<br>(EMC) | | CAN/CSA C22.2 601.1-M90 | Medical Electrical Equipment - Part 1: General<br>Requirements for Safety, General Instruction<br>No. 1; Supplement 1; 1994 R(1997) | | UL 2601-1, 2nd Ed. | UL Standard for Safety Medical Electrical<br>Equipment, Part 1: General Requirements for<br>Safety, 2nd Ed. | | EN 55011 | Conducted Emissions | | EN 55011 | Radiated Emissions | | IEC 61000-4-2 | Electrostatic Discharge | | IEC 61000-4-3 | Radio Frequency Electromagnetic Fields | | IEC 61000-4-4 | Fast Transients Common Mode | | IEC 61000-4-5 | High Energy Surge | | IEC 61000-4-6 | Conducted Immunity | 28