INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR

K965001 · Intuitive Surgical, Inc. · GCJ · Jul 31, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K965001
• Device Name: INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR
• Applicant: Intuitive Surgical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intuitive Surgical Endoscopic Instrument Control System is intended for precise and accurate control of selected tracoscopic and laparoscopic instruments including, rigid laparoscopes, blunt endoscopic dissectors, and endoscopic retractors, during thoracoscopic and laparoscopic surgical procedures. It is intended to be used by trained professionals in operating room environments.

Device Story

Electro-mechanical system for minimally invasive surgery; consists of surgical console with master manipulators, articulated slave manipulators (instrument control arms), and limited-reuse end effectors (retractors, blunt dissectors). Physician operates master manipulators at console to control slave manipulators; system translates inputs into precise movement of endoscopic instruments. Used in operating room environments for thoracoscopic and laparoscopic procedures. Enhances surgical precision and control of instruments compared to manual methods. System includes specific manual instrument tips: retractor, blunt dissector, kitner, and stabilizer.

Clinical Evidence

Bench testing only. Evaluation included reproducibility, hysteresis, and functional adequacy. All data met internal specifications and predicate performance expectations.

Technological Characteristics

Electro-mechanical system; master-slave manipulator architecture. Includes surgical console, articulated control arms, and limited-reuse instruments. Materials include unspecified surgical-grade components. System provides precise motion control for endoscopic tools. Sterilization and specific material standards not detailed.

Indications for Use

Indicated for use by trained professionals in operating room environments for the precise control of rigid endoscopes, blunt endoscopic dissectors, and endoscopic retractors during thoracoscopic and laparoscopic surgical procedures.

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

• Computer Motion AESOP Laparoscope Positioning and Control System
• Adronic Devices Endex (Adept) Instrument Positioning Accessory (IPA)
• US Surgical Auto Suture Endoscopic Fan Retractor (K914190)
• Inman Medical Corp. Endoscopic Blunt Dissector (K933169)
• Medical Perspectives Corp. Kittner Dissector (K953059)

Submission Summary (Full Text)

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4155262066 T-164 P.02/03 Job-265
510(k) SUMMARY
JUL 31 1997
K965001

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## 510(k) Number: K965001

### Applicant Information:

Date Prepared: June 20, 1997

Name: Intuitive Surgical, Inc.
Address: 1340 W. Middlefield Road
Mountain View, California 94043 415-237-7036
Contact Person: Michael A. Daniel
Phone Number: [phone]
Facsimile Number: [phone]

### Device Information:

Classification: Class I / II Surgical Table and Accessories
Endoscope and Accessories
Gynecologic Laparoscope and Accessories

Trade Name: Intuitive Surgical, Endoscopic Instrument Control System
Accessories: “Resposable” (limited reuse) Instruments consisting of Retractors and Blunt Dissectors

Common Name: Endoscopic Instrument Control System
Endoscope and Accessories for Minimally Invasive Surgery

Classification Name: Surgical Table and Accessories, 21 CFR 878.4960
Endoscope and Accessories, 21 CFR 876.1500
Gynecologic laparoscope and acces. 21 CFR 884.1720

### Predicate Devices:

The Intuitive Surgical Endoscopic Instrument Control System and Tools are substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices:

1. Computer Motion AESOP Laparoscope Positioning and Control System
2. Adronic Devices Endex (originally “Adept”) Instrument Positioning Accessory (IPA)
3. And various atraumatic Class I Exempt surgical instruments including the US Surgical Auto Suture* Endoscopic Fan Retractor (K914190), Inman Medical Corp. Endoscopic Blunt Dissector (K933169) and Medical Perspectives Corp. Kittner Dissector (K953059)

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# 510(k) SUMMARY

(Continued)

## Device Description:

The Intuitive Surgical Endoscopic Instrument Control System is an electro-mechanical device consisting of a Surgical Console including "Master Manipulators", articulated Instrument Control Arms or "Slave Manipulators" and Limited Reuse Tools or end effectors.

## Intended Use:

The Intuitive Surgical Endoscopic Instrument Control System is intended for precise and accurate control of selected tracoscopic and laparoscopic instruments including, rigid laparoscopes, blunt endoscopic dissectors, and endoscopic retractors, during thoracoscopic and laparoscopic surgical procedures. It is intended to be used by trained professionals in operating room environments.

## Comparison to Predicate Device(s):

The Intuitive Surgical Endoscopic Instrument Control System and Responsible Tools are substantially equivalent to a combination of the Computer Motion AESOP Laparoscope Positioning and Control System, the Adept/Andronic Laparoscopic Positioning and Manipulation System and various other Class I Exempt endoscopic instruments in terms of intended use and basic functionality. The Intuitive System is substantially equivalent to both the Computer Motion and Andronic devices in terms of the capability of precisely moving and controlling endoscopic tools. The Intuitive system is substantially equivalent to the cited predicates in terms of the tissue effects.

## In Vitro Test Data:

Design analysis and in vitro data confirm that basic functional characteristics are substantially equivalent to the predicate devices sited. Testing included evaluation of reproducibility, hysteresis, and functional adequacy. All data fell well within both internal specification requirements as well as external standard requirements and predicate performance expectations.

## Summary:

Based upon the product technical information provided, intended use, and performance information provided in this pre-market notification, the Intuitive Surgical Endoscopic Instrument Control System has been shown to be substantially equivalent to currently marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Michael A. Daniel
Vice President, Regulatory/Clinical Affairs & Quality Assurance
Intuitive Surgical, Inc.
1340 W. Middlefield Road
Mountain View, California 94304

JUL 31 1997

Re: K965001
Trade Name: Intuitive Surgical Endoscopic Instrument Control System
Regulatory Class: II
Product Code: GCJ
Dated: June 30, 1997
Received: July 1, 1997

Dear Mr. Daniel:

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. The substantial equivalence determination for the Intuitive Surgical Endoscopic Instrument Control System includes use with rigid endoscopes and the following manual surgical instruments only: (1) the Intuitive™ Retractor, (2) the Intuitive™ Blunt Dissector, (3) the Intuitive™ Kitner, and (4) the Intuitive™ Stablizer manual instrument tips.

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

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Page 2 - Mr. Michael A. Daniel

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 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 yours,


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

Enclosure

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07 24 97 THU 17 08 FAX [phone]
INTUITIVE SURGICAL
002

510(k) Number (if known): K965001

Device Name: Intuitive Surgical Endoscopic Instrument Control System

Indications For Use:

The Intuitive Surgical Endoscopic Instrument Control System is intended for accurate control of selected endoscopic instruments including, rigid endoscopes, blunt endoscopic dissectors and endoscopic retractors during thoracoscopic and laparoscopic surgical procedures. It is intended to be used by professionals in operating room environments.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑
(Per 21 CFR 801 109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)

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