MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER

K991734 · Computer Motion, Inc. · GCJ · Jun 9, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991734
• Device Name: MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER
• Applicant: Computer Motion, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 9, 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 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.

Indications for Use

Indicated for use with specific Stryker/WOM endoscopic equipment in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy. Patient population includes those undergoing endoscopic procedures such as cholecystectomy, hernia repair, appendectomy, hysterectomy, spinal fusion, lung/pleural biopsy, and cardiac procedures. Users include 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

• SE 5 Shaver (K974771)
• HERMES (K990691)

Submission Summary (Full Text)

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## ×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: [phone] Ext. 214 FAX [phone] 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,

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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.

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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.

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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) 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 [phone].
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 [phone] 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

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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