Endo Assist positions a Laparescope, and is indicated for use laparoxopic, thoracoscopic and pelvic procedures. Laparoscopic: cholecystectory hernia repair Fundaplication Splenectomy appendectiony henicolectory synpathe ctony by oph node dissection hysterectory nysterectomy

Device Description

EndoAssist is a microprocessor-driven robotic arm which holds a rigid laparoscope for the surgeon during laparoscopic surgical procedures. It stands separately from the operating table, and reaches up and over into the surgical field through a series of motorized mechanical linkages. These motors allow the microprocessor to change the configuration of the linkage.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria.

It is a 510(k) summary for the EndoAssist device, which is a robotic arm for manipulating a laparoscope during surgery. The document focuses on:

Device identification: Proprietary name (EndoAssist), common name, classification name.
Substantial equivalence claim: Comparison to predicate devices (AESOP and Endex Endoscopy Positioning System).
Device description: How it works, its components, and its unique technological characteristics compared to predicates.
Intended use: Mechanical laparoscope holder and manipulator for laparoscopic and thoracoscopic surgery.
Safety issues: Design features to ensure operational, electrical, and mechanical safety.
FDA correspondence: The FDA's letter confirming substantial equivalence and allowing the device to be marketed.
Indications for Use: A list of specific laparoscopic, thoracoscopic, and pelvic procedures for which the device is indicated.

While safety features are mentioned, there is no mention of specific acceptance criteria (e.g., performance metrics, thresholds) or a study that evaluates and reports on these criteria. The determination of substantial equivalence is explicitly stated as "not based on an assessment of clinical performance data."

Summary

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

Image /page/0/Picture/0 description: The image shows a logo for Armstrong Healthcare Limited. The word "ARMSTRONG" is written in large, bold, white letters inside a black rectangular box with rounded corners. Below the box, the words "HEALTHCARE LIMITED" are written in smaller, less bold letters.

NOV 26 1997

Riverlock House Spring Gardens Road Hiah Wvcombe HP13 7AG United Kingdom

telephone +44 1494 441 446 fax +44 1494 441242 Email pfinlay@armstrong.co.uk

510(k) SUMMARY

K973249

This document comprises a Summary of Safety and Effectiveness Information for EndoAssist

August 26th 1997 Date Prepared:

Submitter:

Armstrong Healthcare Ltd. Riverlock House, Spring Gardens Road High Wycombe HP13 7AG United Kingdom

Contact:

Patrick Finlay PhD Managing Director

Email: pfinlay@armstrong.co.uk

Device Name B.

EndoAssist Proprietary name: Common or Usual Name: Endoscopic Camera manipulator Rigid Endoscope Accessory Classification Name:

C. Devices to which Substantial Equivalence is being claimed

Automated Endoscopic System for Optimal Positioning (AESOP), manufactured and distributed by Computer Motion Inc. (California, USA). 510(k) reference K931783
Endex Endoscopy Positioning System, manufactured and distributed by Andronics Devices Ltd. (Canada). 510(k) reference K922626

Device Description D.

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

surgical field through a series of motorized mechanical linkages. These motors allow the microprocessor to change the configuration of the linkage.

Intended Use ui

EndoAssist is intended to be used as a mechanical laparoscope holder and manipulator for all forms of laparoscopic and thoracoscopic surgery.

Technological Characteristics ட்

With the exceptions described below, the technological characteristics of EndoAssist are similar to those of predicate devices.

EndoAssist positions the laparoscope in response to direct commands from the surgeon by means of a headset worn by the surgeon. An indicator box positioned close to the video monitor provides feedback to the surgeon before the command is actioned. AESOP positions the laparoscope in response to foot pedal instructions, and does not provide visual feedback to the surgeon before the command is actioned.

EndoAssist is free-standing whereas AESOP is attached to the operating table side-rail; EndoAssist uses stepper motors to produce movement, AESOP uses DC servo motors.

EndoAssist uses the physical positioning of the device to ensure registration of the axis focal spot, and has the minimum number of motorized axes for the movements required. The geometry of the mechanism ensures that the laparoscope always passes through the focal spot. AESOP uses a software algorithm to achieve registration. The geometry of AESOP does not automatically ensure that motion passes through a focal point. Instead AESOP uses additional motorized axes and a software algorithm to ensure this.

Method of Determination of Substantial Equivalence G.

The determination of substantial equivalence is not based on an assessment of clinical performance data.

EndoAssist has the same intended use, and is as safe and effective, as the Computer Motion device "AESOP" and other mechanical laparoscope holders. EndoAssist does not raise different questions of safety and effectiveness because it is an incremental improvement of predicate devices which achieves equivalent diagnostic results through modifications based on existing technology.

H. Safety Issues

ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ

EndoAssist was designed to address safety concerns at a number of levels:

The area of operational safety was addressed by designing a simple and intuitive user interface. All commands are given in reference to the image seen on the video monitor. For example, to cause the video image to pan to the left. the surqeon looks to the left of the video image, sees a left-pointing arrow on the indicator box, and presses a footswitch to action the movement.

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

At the electrical level, EndoAssist uses stepper motors to produce movement, thereby ensuring that in the event of an error condition, movement of the laparoscope stops.

At the mechanical level, safety is achieved by incorporating force limitations and a quick release mechanism such that the device cannot exert significant force on the patient.

Additionally, EndoAssist monitors itself electronically and by extensive and continuous error-checking in the firmware. Finally, there is electronic redundancy in the hardware of all important safety-related components, so that EndoAssist is fail-safe.

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

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Patrick A. Finlay, Ph.D. Managing Director Armstrong Healthcare Limited Riverlock House Spring Gardens Road High Wycombe, HP13 7AG United Kingdom

NOV 26 1997

K973249 Re:

Trade Name: Endoassist Regulatory Class: II Product Code: GCJ Dated: August 26, 1997 Received: August 29, 1997

Dear Dr. Finlay:

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 (QS) 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

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

Page 2 - Dr. Finlay

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

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

pranacter notification K973249 510(k) N umber (if known): ___________________________________________________________________________________________________________________________________________________

ENDC ASSIST Ucuce Name _

ludioances For Use.

Endo Assist positions a Laparescope , and is indicated for use laparoxopic , thoracoscopic and pelvic procedures

Laparoscopic: cholecystectory hernia repair Fundaplication Splenectomy appendectiony henicolectory synpathe ctony by oph node dissection hysterectory nysteroscorr

(PLE ASE LX) NOT WRITE BELOW THIS LINE - CONTENUE ON ANOTHER PAGB IF NEBOLD)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 973249

Prescription Use
(Pc. 21 CFR 801.109)

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

301 480 4224

P.B

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.