← Product Code [GCJ](/productcode/GCJ) · K991734 # MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER (K991734) _Computer Motion, Inc. · GCJ · Jun 9, 1999 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K991734 ## Device Facts - **Applicant:** Computer Motion, Inc. - **Product Code:** [GCJ](/productcode/GCJ.md) - **Decision Date:** Jun 9, 1999 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SES Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump. and the Stryker Total Performance System (endoscopy port only). 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 symph node dissection, laparoscopically assisted hysterectomy, laparoscopic 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 chamber during performance of valve replacement. The users of the HERMES ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists. ## Device Story HERMES OR Control Center is a computer-driven system providing voice-controlled selection of surgical device parameter settings. It integrates with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump, and Stryker Total Performance System. Device eliminates need for manual interface adjustment or verbal communication between surgeon and OR staff. Operated by surgeons in OR setting. System transforms voice commands into control signals for connected equipment. Benefits include simplified, direct control of surgical equipment settings, potentially improving OR efficiency and reducing reliance on auxiliary personnel for equipment adjustments. ## Clinical Evidence No clinical data. Bench testing only, including electrical safety (IEC 601-1, IEC 601-2-18, UL 2601-1) and electromagnetic compatibility (EN55022, EN61000-4-2 through EN61000-4-6, EN50140). ## Technological Characteristics Computer-driven control system; voice-controlled interface; connects to endoscopic surgical equipment (camera, light source, shaver, insufflator, pump). Designed to IEC 601-1, IEC 601-2-18, UL 2601-1 standards. Electromagnetic compatibility per EN55022 and EN61000 series. Connectivity via dedicated ports to specified Stryker/WOM devices. ## Regulatory Identification An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Special Controls *Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9. In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period. ## Predicate Devices - SE 5 Shaver ([K974771](/device/K974771.md)) - HERMES ([K990691](/device/K990691.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## ×991734 Premarket Notification 510(k) Safety and Effectiveness Su 10. ## HERMES™ Operating Room Control Center 510(k) Summary Computer Motion, Inc. is submitting the following safety and effectiveness summary. - 1) Submitter Information: Computer Motion 130-B Cremona Drive Goleta, CA 93117 Contact: David U. Thomas, Regulatory Affairs Specialist Phone: (805) 968-9600 Ext. 214 FAX (805) 685-9277 Prepared: May 20, 1999 - 2) Name of Device: Proprietary Name: HERMESTM Operating Room Control Center Common Name is HERMESTM Classification Name: Laparoscope for Use in General and Plastic Surgery, Regulation Number 876.1500, Class II. - 3) Substantially equivalent to SE 5 Shaver and HERMES™ (510(k)'s K974771 and K990691, respectively) - 4) The HERMES Operating Room Control Center is a computer-driven system whose basic function is offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control. The intent of the HERMES OR 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 the Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump and the Stryker Total Performance System (endoscopy port only) in the Operating setting, or relying upon verbal communications between the surgeon and other personnel in the operation room in order to adjust surgical equipment. The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump and the Stryker Total Performance System (endoscopy port only). 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 appendectorny, laparoscopic pelvic symph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic anterior spinal fusion, decompression fixation, {1}------------------------------------------------ wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal weage resources, iang over for coronary artery bypass, coronary artery bypass grafting where maninal y artery diosenian indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the HERMES ORCC are general surgeons, performation of varies repeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists. The HERMES ORCC was designed and tested to the following standards: IEC 601-1 Second Edition 1990 International Standard for Medical Electrical Equipment IEC 601-1 Second Domn 1 1991 International Standard for Medical Electrical Equipment IEC 601-2-18 First Edition 1990 International Standard for Medical Electrical Equipment UL 2601-1 Conducted & Radiated Emission EN55022/A1: 1995 Immunity Tests EN61000-4-2: 1995; EN61000-4-3: 1995; EN50140:1994; EN61000-4-4:1995; EN61000-4-5:1995; EN61000-4-6:1995. CAN/CSA-C22.2 NO. 601. {2}------------------------------------------------ Public Health Service ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 0 1999 JUN Mr. David U. Thomas Regulatory Affairs Specialist Computer Motion, Inc. 130 Cremona Drive, Suite B Goleta, California 93117 K991734 Trade Name: HERMES™ Operating Room Control Center Trade Name: HERMESTM Operating Room Control Center Re: Regulatory Class: II Product Code: GCJ Dated: May 20, 1999 Received: May 21, 1999 Dear Mr. Thomas: Deal WIT Tribution of the Stock) notification of intent to market the device referenced. The have reviews in the device is substantially equivalent (for the indications for We have reviewed your Section 510(k) notification of themsel and contracted to the indications for above and we have determined the devices marketed in interstate commerce pr above and we have determined the devices marketed in interstate commerce prior to use stated in the enclosure) to devices marketed in merisiale comments, or to devices that May 28, 1976, the enactment date with the novisions of the Federal Food, Drug, and May 28, 1976, the enactment date of the Meeting of the Federal Food, Drug, and have been reclassified in accordance with the provisions of the general controls Cosmetic Act (Act). You may, therefore, market the device, subject to the equirements for Cosmetic Act (Act). You may, therefore, market the aevice, shoped to enquirements for Cosmetic Act (Act). You may, the no, good manufacturing provisions for provisions of the Act. The general controls provisions of the research of the office of annual registration, listing direction, and gdulteration, annual registration, fisting of 2014-02-2 prohibitions against misbranding and adulteration. . If your device is a more to subscribed into either class II (Special Controls) or class III n and controller and control and intribut to such additional controls. Existing If your device is classified (see above) into ender class in (oposto). Existing major (Premarket Approval), it may be subject to such additional controls, Existing major (Premarket Approval), it may be subject to such adultions Regulations, Title 21, regulations affecting your device can be found in the Code of Federal Regulance with the regulations affecting your device can be found in the Counces compliance with the Parts 800 to 895. A substantially equivalent as set forth in the Quality System Parts 800 to 895. A substantally equivalent determination in the Quality System current Good Manufacturing Practice requirement, as set forth in the Quality System current Good Manufacturing Practice requirencin, as soon (21 CFR Part 820) and that, Regulation (QS) for Medical Devices: General regulation (FDA) will verif Regulation (QS) for Mcdical Devices: Geheral Ingualibin (FDA) will verify through periodic (QS) inspections, the Food and Drug Administration (FDA) werify through periodic (QS) inspections, the roomply with the GMP regulation may result in regulatory such assumptions. Failure to comply with the GMP regulation may result in the such assumptions. Failure to comply with the United Concerning your device in the action. In addition, FDA may publish further announcements concerning your commission does action. In addition, FDA may publish turner announcements ontification submission does Federal Register. Please note: this response to your premarks notification on for Federal Register. Please note: this response or your promants of the Act for not affect any obligation you might have under seculous 531 urough on 100 million was or regulations. {3}------------------------------------------------ Page 2 -- Mr. David U. Thomas This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow you to begin maiketing your device of your device and thus, ne premarket notification. The FDA midnig of subtainter equal device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFFP Part 801 If you desire specific advice for your donostic devices), please contact the Office of and additionally 809.10 for in vitro diagnostic devices the promotion and and additionally 809.10 for in Vitto ditignally, for questions on the promotion and Compliance at (301) 394-4.997. Aduntonatify 16th-office of Compliance at (301) 594-4639. advertising of your device, please contact the Office of Compliance to premarket Also, please note the regulation entitled, "Misbranding by reference to premarket Also, please note the regulation entities, "Information on your responsibilities under the notification" (21 CFR 807.97). This general Manufactures Assistance at its toll-free Act may be obtain-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K99173< Page 1 of 1 510(k) Number (if known): `991734` Device Name: HERMES™ with Stryker Total Performance System (endoscopy port only) Indications For Use: The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SES Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump. and the Stryker Total Performance System (endoscopy port only). 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 symph node dissection, laparoscopically assisted hysterectomy, laparoscopic 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 chamber during performance of valve replacement. The users of the HERMES ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists. > (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER P. NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General Restorative Devices 510(k) Number K991734 Prescription Use X (Per 21 CFR 801.109) OR Over-The-Counter Us (Optional Form --- **Source:** [https://fda-staging.innolitics.com/device/K991734](https://fda-staging.innolitics.com/device/K991734) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com