MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER

K022897 · Computer Motion, Inc. · GCJ · Oct 11, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022897
• Device Name: MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
• Applicant: Computer Motion, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The HERMES™ O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, AESOP®HERMES-Ready™, Valleylab Force FX™ Electro-surgical Unit, and Dyonics® Access 15 Arthroscopic Fluid Irrigation System. 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 & thoracoscopic 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 O.R. Control Center are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

Device Story

HERMES O.R. Control Center is a computer-driven system providing voice control of ancillary surgical devices in the operating room. It acts as a central interface for surgeons to manage equipment such as cameras, light sources, insufflators, and electrosurgical units via voice commands. The system integrates with various third-party surgical peripherals to streamline OR workflows. By enabling hands-free control of OR equipment, the device aims to improve surgical efficiency and reduce reliance on manual adjustments by OR staff. It is intended for use by various surgical specialists during endoscopic procedures.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including system functional testing, software verification and validation, and environmental testing. Compliance with international safety standards (IEC 601-1, IEC 601-2-18, UL 2601-1, CAN/CSA-C22.2 No. 601.1) and electromagnetic compatibility standards (EN55022, EN61000 series) was demonstrated.

Technological Characteristics

Computer-driven system for voice-controlled integration of surgical ancillary devices. Operates as a central control hub. Tested to IEC 601-1, IEC 601-2-18, UL 2601-1, and EN 60601-1-2 standards for electrical safety and electromagnetic compatibility. Connectivity involves interfacing with specific surgical peripherals (cameras, pumps, lights, electrosurgical units).

Indications for Use

Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy by general, gynecological, cardiac, thoracic, plastic, orthopedic, ENT, and urological surgeons. Used with specific ancillary surgical equipment (cameras, light sources, shavers, insufflators, pumps, surgical tables, and electrosurgical units).

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 O.R. Control Center (K973700)
• HERMES O.R. Control Center (K003222)

Submission Summary (Full Text)

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K022897

## HERMES™ O.R. Control Center 510(k) Summary of Safety and Effectiveness

OCT 11 2002

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: Cathy Stupak, Ph.D.

2) Name of Device:

| Proprietary Name: | HERMES™ O.R. Control Center |
|----------------------|----------------------------------------------------|
| Common Name: | HERMES |
| Classification Name: | Laparoscope for Use in General and Plastic Surgery |
| Regulation Number: | 876.1500 |
| Class: | Class II. |

- 3) Substantially equivalent to HERMES O.R. Control Center, K973700, and the more recent 510(k), K003222, for HERMES control of the Valleylab Force FXTM Electrosurgical Unit.
- 4) The HERMES O.R. Control Center is a computer-driven system whose basic function is offer voice control of ancillary devices.

The HERMESTM O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, AESOP® HERMES-Ready™, Valleylab Force FX™ Electro-surgical Unit, and Dyonics® Access 15 Arthroscopic Fluid Irrigation System. 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 & thoracoscopic 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 O.R. Control Center are general surgeons,

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gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

| Test | Comments |
|-------------------------|---------------------------------------------------------------------------------------------------------|
| 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 |
| UL 2601-1 | Underwriters Laboratory |
| CAN/CSA-C22.2 No. 601.1 | Medical Electrical Equipment Part 1, General<br>Requirements for Safety, General Instructions<br>Part 1 |
| EN55022/A1 | Conducted Emission |
| EN55022/A1 | Radiated Emission |
| EN61000-4-2 | Electrostatic Discharge |
| EN61000-4-3 and EN50140 | RF Immunity |
| EN61000-4-4 | EFT/Bursts Immunity |
| EN61000-4-5 | Surge Immunity |
| EN61000-4-6 | Conducted Immunity |
| EN60601-1 | International Standard for Medical Electrical<br>Equipment |
| EN60601-1-1 | General Requirements for Safety -Collateral<br>Standard |
| EN 60601-1-2 | Emissions and Immunity Test<br>Measurements |
| N/A | System Functional Testing |
| N/A | Software Verification and Validation |
| N/A | Environmental Testing |

- 5) The HERMES O.R. Control Center has been tested to the following standards:

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# 11 2002

Computer Motion, Inc. Cathy Stupak, Ph.D. Regulatory Specialist 130 Cremona Drive, Suite B Goleta, California 93117

Re: K022897

Trade/Device Name: Modification to Hermes Operating Room Control Center Regulation Number: 876.1500 Regulation Name: Laparoscope for use in general and plastic surgery Regulatory Class: Class II Product Code: GCJ Dated: October 1, 2002 Received: October 2, 2002

Dear Dr. Stupak:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.

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Page 2 – Dr. Cathy Stupak

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ra Celia M. Witten, Ph.D., M.D.

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

Enclosure

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CONFIDENTIAL

## INDICATION FOR USE STATEMENT

510(k) Number (if known):

HERMES O.R. Control Center Device Name:

The HERMES™ O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, AESOP®HERMES-Ready™, Valleylab Force FX™ Electro-surgical Unit, and Dyonics® Access 15 Arthroscopic Fluid Irrigation System. 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 & thoracoscopic 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 O.R. Control Center are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

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Concurrence of CRDH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-align: left;">✓</div> |
|----------------------|----------------------------------------|
| (per 21 CFR 801.109) | |

OR

| Over-the-Counter Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |

(Division Sign-Off)
Division of General, Restorative and Neurological Devices

| 510(k) Number | K022897 |
|---------------|---------|
|---------------|---------|

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