AESOP SYSTEM AND ACCESSORIES

K960655 · Computer Motion, Inc. · GCJ · May 3, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960655
• Device Name: AESOP SYSTEM AND ACCESSORIES
• Applicant: Computer Motion, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The intended use of the AESOP System is a robotic computer driven system whose function is to hold and position a laparoscope. It is indicated for use in all forms of laparoscopic surgery. A few examples are cholecystectomy, laparoscopic hernia repair, and laparoscopic appendectomy.

Device Story

Robotic computer-driven system; holds and positions laparoscope during laparoscopic surgery. Operated by surgeon via hand, foot, or voice control. Voice control utilizes self-contained, speaker-dependent speech recognition system to translate verbal commands into positioning movements. System replaces manual holding of laparoscope; provides stable, surgeon-controlled visualization. Used in operating room environment.

Clinical Evidence

Bench testing only. System tested against IEC 601-1, IEC 601-1 Amendment 1, IEC 601-2-18, UL544, AAMI TIR 12, EMC Directive 89/336/EEC, CAN/CSA-C22.2 standards, and internal functional test requirements.

Technological Characteristics

Robotic arm system; electromechanical actuation. Voice control interface: speaker-dependent speech recognition. Standards: IEC 601-1, IEC 601-1 Amendment 1, IEC 601-2-18, UL544, AAMI TIR 12, EMC Directive 89/336/EEC, CAN/CSA-C22.2. Reusable medical device.

Indications for Use

Indicated for use in all forms of laparoscopic surgery, including cholecystectomy, laparoscopic hernia repair, and laparoscopic appendectomy.

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

• AESOP System (K931783)

Submission Summary (Full Text)

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K960655

# AESOP 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
805-685-3729
Contact: Douglas Bueschel
Prepared February 14, 1996

2) Name of Device
Proprietary Name: AESOP System and Accessories
Common Name: Automated Endoscopic System for Optimal Positioning
Classification Name: Operating Room Table and Accessories

3) Substantially equivalent to AESOP 510(k) K931783

4) The AESOP System is a robotic computer-driven system whose basic function is to hold and position a laparoscope under the direct control of a surgeon.

5) The intended use of the AESOP System is a robotic computer driven system whose function is to hold and position a laparoscope. It is indicated for use in all forms of laparoscopic surgery. A few examples are cholecystectomy, laparoscopic hernia repair, and laparoscopic appendectomy.

6) The AESOP System is comparable to original AESOP System in that it uses the same control methods to position the laparoscope and introduces a new control method of voice control. The control method of voice control is a self-contained speaker dependent speech recognition system. The Voice Control Interface recognizes verbal commands and passes them to the AESOP System to hold and position a laparoscope the same as the Hand or Foot Control of the AESOP System.

The AESOP System is designed and tested to the following Computer Motion and voluntary standards.

- IEC 601-1 Second Edition 1988 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
- UL544 Third Edition
- AMMI TIR 12 Design, Testing, and Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities
- EMC Directive European Union 89/336/EEC
- CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92
- AESOP System Functional Test Requirements

Computer Motion Inc. 510(K)
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