HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY).

K991444 · Computer Motion, Inc. · GCJ · Jun 25, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991444
• Device Name: HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY).
• Applicant: Computer Motion, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The HERMES™ Control Center is indicated for use with Stryker Endoscopy 882 Camera. Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump and AESOP®3000HR (HERMES-Ready). 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 & 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.

Device Story

HERMES Control Center is computer-driven system for centralized voice control of surgical equipment; integrates with Stryker 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump, and AESOP 3000HR. Used in operating room by surgeons; eliminates need for manual interface adjustment or verbal communication with staff. System transforms voice commands into parameter settings for connected devices. Benefits include simplified, direct control of surgical equipment, potentially improving workflow efficiency and reducing reliance on OR personnel for equipment adjustments.

Clinical Evidence

Bench testing only. Device safety and effectiveness verified through adherence to international standards including IEC 601-1 (Medical Electrical Equipment), IEC 601-2-18, UL 2601-1, and electromagnetic compatibility standards (EN55022, EN61000 series). No clinical study data provided.

Technological Characteristics

Computer-driven control system; voice-activated interface. Connectivity via integration with specific surgical peripheral devices (camera, light source, shaver, insufflator, pump, robotic arm). Designed to IEC 601-1, IEC 601-2-18, and UL 2601-1 standards. Electromagnetic compatibility per EN55022 and EN61000 series. Form factor: Operating Room Control Center.

Indications for Use

Indicated for use 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. 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

• HERMES Operating Room Control Center and Accessories (K990691)
• AESOP 3000 (K972699)

Submission Summary (Full Text)

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## ×991444

## 10.0 Premarket Notification 510(k) Safety and Effectiveness Summary

## HERMES™ OR Control Center System with AESOP® 3000HR 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: April 22, 1999

2) Name of Device:

Proprietary Name: HERMES™ Operating Room Control Center and Accessories with AESOP®3000HR (HERMESTM Ready) Common Name is HERMES Control Center with control of AESOP 3000HR 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 (K990691) and AESOP®3000 (K972699).
- 4) The HERMES™ Control Center is a computer-driven system whose basic function is to offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control.

The intent of the HERMES™ 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, W.O.M. 2.0L Arthroscopy Pump and AESOP®3000HR 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.

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The HERMESTM Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump and AESOP®3000HR. 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 & 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 in indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the HERMES Control Center are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists

- 5) The HERMES™ Control Center and AESOP 3000HR are 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human profiles or a caduceus-like design, rendered in black.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1999

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

Re: K991444 Trade Name: HERMES™ Operating Room Control Center with AESOP® 3000HR Regulatory Class: II Product Code: GCJ Dated: April 22, 1999 Received: April 26, 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 Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 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 your 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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Page 1 of 1

510(k) Number (if known):

Device Name: AESOP ® 3000 HR W/HER.

Indications For Use:

The HERMES™ Control Center is indicated for use with Stryker Endoscopy 882 Camera. Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump and AESOP®3000HR (HERMES-Ready). It can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where ଥ 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 hysterectorny, 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Usë

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices K991444
510(k) Number.