AESOP SYSTEM AND ACCESSORIES

K963126 · Computer Motion, Inc. · GCJ · Apr 7, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963126
• Device Name: AESOP SYSTEM AND ACCESSORIES
• Applicant: Computer Motion, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 7, 1997
• 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 rigid laparoscope/endoscope. The AESOP System is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a rigid 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 AESOP System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

Device Story

Robotic computer-driven system; holds and positions rigid laparoscope/endoscope. Operated by surgeon via direct control; replaces manual assistant for scope positioning. Used in OR for various endoscopic procedures (e.g., cholecystectomy, hernia repair, CABG, spinal fusion). Provides stable, surgeon-controlled visualization; reduces fatigue and potential for camera movement errors; improves surgical efficiency.

Clinical Evidence

Bench testing only; compliance with IEC 601-1, IEC 601-2-18, UL544, and AAMI TIR 12 standards. No clinical data provided.

Technological Characteristics

Robotic computer-driven positioning system. Standards: IEC 601-1, IEC 601-2-18, UL544, AAMI TIR 12, EMC Directive 89/336/EEC, CAN/CSA-C22.2. Electrical energy source. Designed for reusable medical device reprocessing.

Indications for Use

Indicated for use in general thoracoscopy, cardiothoracic surgery, laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy requiring rigid laparoscope/endoscope positioning. Applicable to general surgeons, gynecologists, cardiac, thoracic, plastic, orthopedic, 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

• AESOP 510(k) (K931783)
• AESOP 510(k) (K960655)

Submission Summary (Full Text)

{0}

AESOP System 510(k) Summary

K963126

In accordance with 21 CFR section 807.92 Computer Motion is submitting the following safety and effectiveness summary.

APR - 7 1997

1) Submitter Information

Computer Motion. Inc.

130-B Cremona Drive

Goleta, CA 93117

805-685-3729

Contact: Douglas Bueschel

Prepared: August 9, 1996

2) Name of Device

Proprietary Name: AESOP System and Accessories

Common Name: Automated Endoscopic System for Optimal Positioning

Classification Name: Laparoscope, General & Plastic Surgery

3) Substantially equivalent to AESOP 510(k)'s K931783 and K960655.

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

The intended use of the AESOP System is a robotic computer driven system whose function is to hold and position a rigid laparoscope/endoscope. The AESOP System is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a rigid 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 AESOP System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

5) 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)