SOCRATES ROBOTIC TELEMONITORING SYSTEM

K013804 · Computer Motion, Inc. · NEQ · Dec 10, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K013804
• Device Name: SOCRATES ROBOTIC TELEMONITORING SYSTEM
• Applicant: Computer Motion, Inc.
• Product Code: NEQ · Gastroenterology, Urology
• Decision Date: Dec 10, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The SOCRATES System is indicated for use in general cardiothoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples include 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 grafting, and examination of the evacuated cardiac chamber during performance of valve replacement. Use of the SOCRATES System enables a remote surgeon to telecommunicate with any local surgeon with field-of-view positioning.

Device Story

SOCRATES Robotic Telemonitoring System facilitates remote surgical telecollaboration; enables remote surgeon to communicate with local surgeon and control field-of-view positioning during endoscopic procedures. System acts as a telemonitoring/telecollaboration interface for endoscopic visualization; allows remote expert to assist local surgeon via communication link and camera control. Used in OR settings by surgeons (general, cardiac, thoracic, gynecological, orthopedic, ENT, urological). Output consists of visual field-of-view positioning and telecommunication; assists local surgeon in surgical decision-making and visualization during complex procedures; potentially benefits patient by providing remote expert guidance during surgery.

Clinical Evidence

No clinical data provided. Device safety and effectiveness supported by bench testing to international standards including IEC 601-1, UL 2601-1, and electromagnetic compatibility standards (EN55022, EN61000 series).

Technological Characteristics

Robotic telemonitoring system for endoscopic visualization. Complies with IEC 601-1 (1990/1998), IEC 601-1 Amendment 1, UL 2601-1, and CAN/CSA-C22.2 No. 601.1-M90/601.2.18-92. Connectivity includes communication link for remote telecollaboration and camera control. Electrical safety and EMC testing performed per EN55022 and EN61000 series.

Indications for Use

Indicated for use in general cardiothoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where endoscopic visualization is required. Patient population includes those undergoing procedures such as cholecystectomy, hernia repair, appendectomy, pelvic lymph node dissection, hysterectomy, spinal fusion, lung biopsy, and cardiac valve replacement. Users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.

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

• Socrates Robotic Telemonitoring System (K003661)

Submission Summary (Full Text)

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013804

## DEC 1 0 2001

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

SOCRATES Robotic Telemonitoring 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: November 7, 2001

2) Name of Device:

Proprietary Name: SOCRATES™ Robotic Telemonitoring System Proprietary Name. SOCRATES Robotic Telecollaboration System Common Name is SOCRATES Koolic Teleconaboration System
Classification Name: Laparoscope for Use in General and Plastic Surgery, Regulation Number 876.1500, Class II.

3) Substantially equivalent to the Computer Motion, Inc. Socrates Robotic Telemonitoring System (K003661)

4) The SOCRATES System is indicated for use in general thoracoscopy, general cardiothoracic 4) The SOCKATES System Is muched for as massage, and sinuscopy and sinuscopy where a rigid surgery, general laparoscopy, hasopharyigosopy, car of the more common endoscopic laparoscope is indicator cholecystectorny, aparoscopic hemia repair, alaparoscopic appendectomy, laparoscopic pelvic lymph node dissection, vodeo resection, wodge resection, lunc appendectoric & thorascopic anterior spinal fusion, decompression fixation, wedge resection, lung laparoscopic & thorascopic aliterior Spital Lusion, accessis, internal mammary artery dissection is biopsy, pleural biopsy, dorsal sylipatiicsconly, prourodening where endoscopic visualization is coronary artery bypass, coronaly artery oypass gramber during performance of valve Use of the SOCRATES System remote controller enables a remote surgeon to replacement. replacement. Use of the SOCKATES System remore communication link allows the telecommunicate "Win" any e 1sed surgeon with field-of-view positioning.

- 5) The SOCRATES Robotic Telemonitoring System 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 Second Battlon 1998 International Standard for Medical Electrical Equipment IEC 601-1 Amendment 1 1770 0 International Standard for Medical Electrical Equipment UL 2601-1

Conducted & Radiated Emission EN55022/A1: 1995

Conducted & Radiated Entission EN950227117778
Immunity Tests EN61000-4-2: 1995; EN61000-4-3: 1995; EN50140:1994; EN61000-4-4:1995;
Immunity Tests EN61000-4-2; 1995; EN61000-4 EN61000-4-5:1995; EN61000-4-6:1995.

CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92

Socrates™ Robotic Telemonitoring System 510(k) with Insufflator Status

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes.

#### Public Health Service

Food and Drug Administration i 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 0 2001

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

Re: K013804

K013804
Trade Name: Socrates™ Robotic Telemonitoring System Regulation Number: 876.1500 Regulation Name: Robotic Telemedicine Device Regulatory Class: III Product Code: NEQ Dated: November 14, 2001 Received: November 15, 2001

Dear Mr. Thomas:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(i) pictualism in substantially equivalent (for the referenced above and we have determined the devices marketed in interstate commerce prior to
indications for use stated in the enclosures in the Devices that have indications for use stated in the enclosure) in to acvice Amendments, or to devices that have
May 28, 1976, the enactment date of the Medical Device American Drug, and Cosmet May 28, 1976, the enactment date of the Mccircan Drondon Cood, Drug, and Cosmetic Act
been reclassified in accordance with the provisions of the Federal Food, Drug may been reclassified in accordance with a provise approval application (PMA). You may,
(Act) that do not require approval of a premarket apprisions of the Act . The gen (Act) that do not require approval of a promations of the Act. The general therefore, market the device, subject to the general segistration, listing of devices,
controls provisions of the Act include requirements for amongst misbranding and adulter controls provisions of the Act include requirements for animals regions misbranding and adulteration.
The surfacturing practice, labeling, and prohibitions against misbrandin

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mio existing major regulations affecting your device can
may be subject to such additional controls. Title may be subject to such additional controlis. Laisting may sogato 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Federal Regenations, your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA \$ issualice of a subscribes with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decemmanon that your secred by other Federal agencies. You must or any Federal statules and regulations administered of ont limited to: registration and listing (21)
comply with all the Act's requirements, including, but not him maysomen comply with all the Act s requirements, mercess cannotacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 800); gold manage (200); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); 21 CFR 1000, form in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. David U. Thomas

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your device of your device to a legally
premarket notification. The FDA in a lassification for your device to a legally premarket notification. The FDA finding of substantial equivalice or 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 If you desire specific advice for your device directions of the essee contact the Office of
additionally 21 CFR Part 809.10 for in vited diagnostic devices on the organism a additionally 21 CFR Part 809. ID for in Vitto drives on the promotion and advertising of
Compliance at [phone]. Additionally, for questions on the promotions of the Compliance at [phone]. Additionally, to questions of Class. Also, please note the your device, please contact the Office of Compination was are and fication" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket may be obtained f regulation entitled, «Misbranding of relective to premaxtee Act may be obtained from the obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its Division of Sinan Manazacter or at its Internet address [phone] of (cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker

Image /page/2/Picture/5 description: The image contains a simple, abstract symbol. It appears to be a stylized, handwritten character or a logo. The symbol consists of a curved line that resembles a 'C' shape, with a small, angular stroke extending from the bottom right of the curve.

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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16138041

Page of

# 510(k) Number (if known):

# Device Name: SOCRATES™ Robotic Telemonitoring System

## Indication For Use:

The SOCRATES System is indicated for use in general cardiothoracoscopy, general cardiothoracic surged laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy, and sinuscopy where a
laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy, and general laparoscope/endoscope is indicated tot use. A rew example appendectony, laparosopic pelvic
laparoscopic cholecystectorny, laparosopic hernir repair, aparoscopic atterior spin laparoscopic cholecystectory, laparosopic nema topan oppic & thorascopic & thorascopic anterior spinal
lymph node dissection, laparoscopically assisted, hyserectonic & thoras lymph node dissection, laparoscopcaly assuser inforemonty, pleural biopsy, dorsal sympathectomy,
fusion, decompression fixation, wedjie resection, ling biopsy, pleural biopsy fusion, decompression fixation, wedge tesection, in coronary artery bypass gratiing
pleurodesis, internal mammary attery dissection for coronary artery bypass gratiac chamber pleurodesis, internal mammary atsection for coronation of the evacuated cadiac chamber during
where endoscopic visualization is indicated and examination of the evacuates a r where endoscopic visualization is not exhibition of the SOCRATES System enables a remote surgeon to
performance of valve replacement. I Use of the SOCRATES Spistem enables fo performance of valve replacement. Use of he telecomminicale with any AEBOT THE vocal surgeon with field-of-view positioning.
the remote surgeon to assist the local surgeon with field-of-view positioning.

The users of the SOCRATES System are general surgeons, gynecologists, ardiac surgeons, thoracic The users of the SOCRATES System are general surgeons and urologists.
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) | |
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| Prescription Use (Per 21 CFR 801.109) | <div style="display:inline-block; vertical-align:top;">OR Over-The-Counter Use (Optional Format)</div> |

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| | (Division Sign-Off) |
| | Division of General, Restorative and Neurological Devices |
| 510(k) Number | K013804 |