HERMES OPERATING ROOM CONTROL CENTER

K990691 · Computer Motion, Inc. · GCJ · Mar 23, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990691
• Device Name: HERMES OPERATING ROOM CONTROL CENTER
• Applicant: Computer Motion, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 23, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator and W.O.M. 2.0L Arthroscopy Pump. 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 laparoscopic appendectomy, laparoscopic pelvic symph node dissection. repair. 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 cardiac 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 designed to centralize control of surgical equipment in the operating room. It interfaces with specific endoscopic devices (Stryker 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump). The system utilizes voice control to allow surgeons to adjust device parameter settings directly, eliminating the need for manual interface manipulation or verbal communication with OR staff. The device is operated by surgeons during endoscopic procedures. By streamlining equipment adjustments, the system aims to simplify surgical workflows and improve efficiency in the operating room.

Clinical Evidence

No clinical data provided; bench testing only. The device was tested for compliance with international standards including IEC 601-1, IEC 601-2-18, UL 2601-1, and various EN/EMC immunity standards.

Technological Characteristics

Computer-driven control system; voice-controlled interface for surgical equipment. Complies with IEC 601-1 (1990), IEC 601-2-18 (1990), UL 2601-1, and EN55022/EN61000 series for electromagnetic compatibility and safety.

Indications for Use

Indicated for use with specific Stryker and W.O.M. endoscopic equipment in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy. Patient population includes those undergoing endoscopic procedures such as cholecystectomy, hernia repair, appendectomy, lymph node dissection, hysterectomy, spinal fusion, lung/pleural biopsy, and cardiac valve replacement. Intended for use by general, gynecological, cardiac, thoracic, plastic, orthopedic, ENT, and urological surgeons.

Regulatory Classification

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.

Predicate Devices

• HERMES Operating Room Control Center and Accessories (K990787)

Submission Summary (Full Text)

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3/23/99

## 10. Premarket Notification 510(k) Safety and Effectiveness Summary

K990691

## HERMES OR Control Center System 510(k) Summary

In accordance with 21 CFR section 807.92 Computer Motion is submitting the following safety and effectiveness summary.

- 1) Submitter Information
Computer Motion. Inc. 130-B Cremona Drive Goleta, CA 93117

Contact: David Thomas Prepared: March 1, 1999

- 2) Name of Device:
Proprietary Name: HERMES™ Operating Room Control Center and Accessories Common Name is HERMES Operating Room Control Center Classification Name: Laparoscope for Use in General and Plastic Surgery, Regulation Number 876.1500, Class II.

- 3) Substantially equivalent to HERMES Operating Room Control Center and Accessories K990787
- 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, W.O.M. 20L Insufflator and W.O.M. 2.0L Arthroscopy Pump 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, W.O.M. 20L Insufflator and W.O.M. 2.0L Arthroscopy Pump. 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 laparoscopic appendectomy, laparoscopic pelvic symph node dissection. repair. 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

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cardiac 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

- 5) The HERMES OR Control Center is designed and tested to the following Computer Motion and voluntary standards.
IEC 601-1 Second Edition 1990 International Standard for Medical Electrical Equipment IEC 601-1 Amendment 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. 601.1-M90 & NO. 601.2.18-92

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird, composed of three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1999

Mr. David U. Thomas Regulatory Affairs Specialist Computer Motion, Inc. 130 Cremona Drive, Suite B Goleta, California 93117

Re: K990691

> Trade Name: Hermes™ Operating Room Control Center Regulatory Class: II Product Code: GCJ Dated: March 1, 1999 Received: March 3, 1999

Dear Mr. Thomas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note; this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David U. Thomas

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 9906691

Device Name:

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 and W.O.M. 2.0L Arthroscopy Pump. 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 hemia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic 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 is indicated and examination of the evacuated cardiac 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General Restorative Devices

| 510(k) Number | K99069/ |
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Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use

(Optional Format 1-2-96)