MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER

K024294 · Computer Motion, Inc. · GCJ · Jan 8, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K024294
• Device Name: MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
• Applicant: Computer Motion, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 8, 2003
• 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, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, Steris Amsco Table Model SP3085, AESOP®HR (HERMES-Ready™), Valleylab Force FX™ Electrosurgical Unit, Smith & Nephew Dyonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, and Skytron Stellar Series O.R. Lights. 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 hysterectorny, 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 for ancillary surgical devices; eliminates need for manual interface adjustment or verbal communication between surgeon and OR staff. System integrates with various cameras, light sources, shavers, insufflators, pumps, surgical tables, and electrosurgical units. Used in OR by surgeons; provides centralized control of equipment settings. Benefits include simplified, direct control of surgical environment, potentially increasing efficiency and reducing reliance on OR personnel for equipment adjustments.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety (IEC 601-1, IEC 601-2-18, UL 2601-1, CAN/CSA-C22.2 No. 601.1), electromagnetic compatibility (EN55022, EN61000 series), and system functional/software verification and validation testing.

Technological Characteristics

Computer-driven control system; provides voice-activated interface for ancillary surgical equipment. Connectivity via port expander to various surgical devices. Complies with IEC 601-1, IEC 601-2-18, UL 2601-1, and EN 60601-1-2 standards. Software-based control logic.

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, pelvic lymph node dissection, hysterectomy, spinal fusion, lung/pleural biopsy, and coronary artery bypass. Users are 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 O.R. Control Center (K973700)
• HERMES control of the Dyonics® Vision 635 Digital Image Management System (K023095)

Submission Summary (Full Text)

{0}------------------------------------------------

024294

000024

## HERMES® O.R. Control Center 510(k) Summary

In accordance with 21 CFR section 807.92 Computer Motion, Inc. (CMI) is submitting the following 510(k) Summary:

1) Submitter Information

Computer Motion, Inc. 130-B Cremona Drive Goleta, CA 93117

Contact: Cathy Stupak, Ph.D. Prepared: 12/23/02

2) Name of Device:

| Proprietary Name: | Modification to HERMES® O.R. Control Center |
|----------------------|----------------------------------------------------|
| Common Name: | HERMES |
| Product Code: | GCJ |
| Classification Name: | Laparoscope for Use in General and Plastic Surgery |
| Regulation Number: | 876.1500 |
| Regulation Class: | Class II. |

- 3)This device is substantially equivalent to the HERMES O.R. Control Center, K.973700, and the more recent 510(k) for HERMES control of the Dyonics® Vision 635 Digital Image Management System, K023095.
- 4) The HERMES O.R. Control Center is a computer-driven system whose basic function is to offer the surgeon the additional option of voice control for ancillary devices.

The intent of the HERMES O.R. 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 ancillary devices, or relying on verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.

- 5) 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, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, AESOP®HR (HERMES-Ready™), Valleylab Force FX™ Electro-surgical Unit, Smith & Nephew Dyonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, and Skytron Stellar Series O.R. Lights. It can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few

{1}------------------------------------------------

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.

| Test | Title |
|-------------------------|---------------------------------------------------------------------------------------------------------|
| IEC 601-1 | International Standard for Medical<br>Electrical Equipment |
| IEC 601-1 Amendment 1 | International Standard for Medical<br>Electrical Equipment |
| IEC 601-2-18 | International Standard for Medical<br>Electrical Equipment |
| UL 2601-1 | Underwriters Laboratory |
| CAN/CSA-C22.2 No. 601.1 | Medical Electrical Equipment Part 1,<br>General Requirements for Safety,<br>General Instructions 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<br>Electrical Equipment |
| EN60601-1-1 | General Requirements for Safety –<br>Collateral Standard |
| EN 60601-1-2 | Emissions and Immunity Test<br>Measurements |
| VA-23763 | CMI System Functional Testing |
| CP-15345 | CMI Software Verification and<br>Validation |
| VA 19795 | CMI Environmental Testing |

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

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 0 8 2003

Computer Motion, Inc. Cathy Stupak, Ph.D. Regulatory Specialist 130-B Cremona Drive Santa Barbara, California 93117

Re: K024294

Trade/Device Name: Modification to Hermes® Operating Room Control Center Regulation Number: 876.1500 Regulation Name: Laparoscope, General and Plastic Surgery Regulatory Class: Class II Product Code: GCJ Dated: December 23, 2002 Received: December 24, 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

{3}------------------------------------------------

Page 2 - Dr. Cathy Stupak

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.

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), 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" (21CFR 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

fol 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

{4}------------------------------------------------

## INDICATION FOR USE STATEMENT

510(k) Number (if known): k024254

Device Name:

Modification to HERMES® O.R. Control Center

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, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, Steris Amsco Table Model SP3085, AESOP®HR (HERMES-Ready™), Valleylab Force FX™ Electrosurgical Unit, Smith & Nephew Dyonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, and Skytron Stellar Series O.R. Lights. 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 hysterectorny, 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.

## (PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CRDH, Office of Device Evaluation (ODE)

Miriam C. Provost

sion Sign-Off) Divion of General, Restorative and Neurological Devices

Number K024294

OR Over-the-Counter

Prescription Use (per 21 CFR 801.109)

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