AESOP 3000 SYSTEM AND ACCESSORIES

K972699 · Computer Motion, Inc. · GCJ · Dec 19, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972699
• Device Name: AESOP 3000 SYSTEM AND ACCESSORIES
• Applicant: Computer Motion, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Dec 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The AESOP 3000 System is intended to be used as a robotic, computer-driven system whose function is to hold and position a rigid laparoscope/endoscope .

Device Story

Robotic computer-driven system; holds and positions rigid laparoscope/endoscope under direct surgeon control. Used in OR settings by various surgical specialists (general, cardiac, thoracic, etc.). Surgeon controls scope positioning via system interface; replaces manual holding of scope by assistant. Benefits include stable visualization and potential reduction in human assistant fatigue/error during endoscopic procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Device safety and effectiveness supported by functional testing against established standards including IEC 601-1, IEC 601-2-18, and EMC Directive 89/336/EEC.

Technological Characteristics

Robotic computer-driven system for endoscopic positioning. Electrical safety: IEC 601-1, IEC 601-1 Amendment 1, IEC 601-2-18, UL 2601-1. EMC compliance: 89/336/EEC. Reprocessing: AAMI TIR 12. Form factor: robotic arm/controller for rigid endoscopes.

Indications for Use

Indicated for general thoracoscopy, cardiothoracic surgery, laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy requiring rigid laparoscope/endoscope. Used by general, gynecological, cardiac, thoracic, plastic, orthopedic, ENT, and urological surgeons for procedures including cholecystectomy, hernia repair, appendectomy, lymph node dissection, hysterectomy, spinal fusion, lung/pleural biopsy, and coronary artery bypass.

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 (K931783)
• AESOP (K960655)
• AESOP (K963126)

Submission Summary (Full Text)

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

# AESOP 3000 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: July 17, 1997

DEC 1 9 1997 K972699

2) Name of Device

Proprietary Name: AESOP 3000 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, K960655 and K963126.

4) The AESOP 3000 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 3000 System is a robotic computer driven system whose function is to hold and position a rigid laparoscope/endoscope . The AESOP 3000 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 cholecystectorny, 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 3000 System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

5) The AESOP 3000 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 .
- . UL 2601-1
- 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 3000 System Functional Test Requirements

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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure with three faces in profile, representing the department's focus on people. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 19 1997

Mr. Douglas P. Bueschel Director, Regulatory Affairs & Quality Assurance Computer Motion, Incorporated 130-B Cremona Drive Goleta, California 93117

K972699 Re:

> Trade Name: "AESOP 3000 System and Accessories" Regulatory Class: II Product Code: GCJ Dated: October 21, 1997 Received: October 22, 1997

Dear Mr. Bueschel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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

Page 2 - Mr. Bueschel

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Sincerely vours.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# AESOP 3000 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: July 17, 1997

DEC 1 9 1997 K972699

2) Name of Device

Proprietary Name: AESOP 3000 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, K960655 and K963126.

4) The AESOP 3000 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 3000 System is a robotic computer driven system whose function is to hold and position a rigid laparoscope/endoscope . The AESOP 3000 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 cholecystectorny, 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 3000 System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

5) The AESOP 3000 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 .
- . UL 2601-1
- 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 3000 System Functional Test Requirements

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

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure with three faces in profile, representing the department's focus on people. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 19 1997

Mr. Douglas P. Bueschel Director, Regulatory Affairs & Quality Assurance Computer Motion, Incorporated 130-B Cremona Drive Goleta, California 93117

K972699 Re:

> Trade Name: "AESOP 3000 System and Accessories" Regulatory Class: II Product Code: GCJ Dated: October 21, 1997 Received: October 22, 1997

Dear Mr. Bueschel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

{5}------------------------------------------------

Page 2 - Mr. Bueschel

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Sincerely vours.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

### 3. Intended Use and Indications for Use

### 3.1. Intended Use

The AESOP 3000 System is intended to be used as a robotic, computer-driven system whose function is to hold and position a rigid laparoscope/endoscope .

### 3.2. Indications For Use

The AESOP 3000 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 hysterectorny, laparoscopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectorny, 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 3000 System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K972699