INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS

K050404 · Intuitive Surgical, Inc. · HET · Apr 21, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K050404
• Device Name: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
• Applicant: Intuitive Surgical, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Apr 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during gynecologic laparoscopic surgical procedures. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Device Story

The da Vinci Surgical System is a computer-controlled endoscopic instrument system used in operating rooms by trained physicians. It consists of a Surgeon Console and a Patient Side Cart. The surgeon operates Master Tool Manipulators at the console to control endoscopic instruments and an endoscope held by Patient Side Manipulators and an Endoscope Camera Manipulator on the cart. The Intuitive Surgical Insite Vision System provides 3-D or 2-D visual feedback of the surgical field to the surgeon. The system translates surgeon hand movements into precise instrument movements, facilitating minimally invasive gynecologic laparoscopic surgery. It serves as a robotic-assisted interface between the surgeon and the patient, aiming to improve surgical precision compared to manual laparoscopic instruments.

Clinical Evidence

Bench testing only. Design analysis and validation confirmed that the system's functional characteristics are substantially equivalent to the predicate devices for performing surgical tasks in gynecologic laparoscopic procedures.

Technological Characteristics

Computer-controlled robotic surgical system. Components: Surgeon Console (Master Tool Manipulators), Patient Side Cart (Patient Side Manipulators, Endoscope Camera Manipulator), and Insite Vision System (stereo endoscope, camera, light source). Provides 3-D/2-D visualization. Connectivity: Wired communication between console and cart. Class II device.

Indications for Use

Indicated for use by trained physicians in an operating room environment to assist in the accurate control of endoscopic instruments during gynecologic laparoscopic surgical procedures.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Predicate Devices

• Intuitive Surgical da Vinci Surgical System and Endoscopic Instruments (K990144, K002489, K011002, K011281, K012833, K013416, K021036, K022574, K040237, K040948, K043153, K042855, K050005)

Submission Summary (Full Text)

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## Section II

## 510(k) SUMMARY

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: K050404

| Date | April 19, 2005 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Intuitive Surgical, Inc.<br>950 Kifer Road<br>Sunnyvale, CA 94086 |
| ER Number | 2955842 |
| Contact | Mike Yramategui<br>Director, Regulatory Affairs<br>Telephone: (408) 523 - 2145<br>Fax: (408) 523 - 1390<br>e-mail: [e-mail] |
| Subject<br>Device | Name: Intuitive Surgical ^® da Vinci ^® Surgical System and Endoscopic<br>Instruments<br>Classification Name: System, Surgical, Computer Controlled Instrument<br>(21 CFR 876.1500)<br>Common Name: Endoscopic Instrument Control System, Endoscopic<br>Instruments and Accessories |
| Predicate<br>Devices | Intuitive Surgical da Vinci Surgical System and Endoscopic Instruments<br>(legally marketed under K990144 / K002489 / K011002 / K011281 /<br>K012833 / K013416 / K021036 / K022574 / K040237 / K040948 /<br>K043153 / K042855 / K050005). |
| Device<br>Description | This 510(k) is being submitted for an expansion of the Indications for<br>Use to include gynecologic laparoscopic surgical procedures. There are<br>no changes in the design, technology, materials, manufacturing,<br>performance, specifications, and method of use for the da Vinci Surgical<br>System associated with this pre-market notification. |

510(k) Section 11, Page 1 of 3

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The da Vinci Surgical System consists of two integrated sub-systems as lollows:

Intuitive Surgical Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. While scated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via cables, Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.

Intuitive Surgical Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci Surgical System, also known as Intuitive Surgical Insite® Vision System, consists of a stereo endoscope, ondoscopic camera, and various accessories, including a light source and light guides. The Insite Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.

### Intended Use

Device

Description

(continued)

The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during gynecologic laparoscopic surgical procedures. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procodures set forth in the Professional Instructions for Use.

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| Comparison to<br>Predicate<br>Device | There are no changes in the design, technology, materials, manufacturing,<br>performance, specifications, and method of use for the da Vinci Surgical<br>System. The expansion of the labeling to include gynecologic<br>laparoscopic surgical procedures is based on the da Vinci Surgical System<br>and endoscopic instruments being currently cleared for performing a full<br>array of surgical tasks across multidisciplinary surgical specialties, and a<br>comparison of surgical tasks performed in cleared procedures to those<br>performed in gynecologic laparoscopic surgical procedures with the<br>system. Additionally, a comparison of endoscopic instruments available<br>on the da Vinci® Surgical System with predicate instruments cleared for<br>gynecologic laparoscopic surgical procedures demonstrates substantial<br>equivalence to existing laparoscopic instruments cleared for gynecologic<br>indications. | | | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Technological<br>Characteristics | The technological characteristics of the subject device are the same as for<br>the predicate device (da Vinci Surgical System) cleared to perform<br>similar surgical tasks in other specialties. The primary difference<br>between the subject device and the predicate devices cleared for use in<br>gynecologic laparoscopic surgical procedures is that the subject device<br>provides computerized robotic assistance to precisely manipulate and<br>move the instruments and the predicate devices are hand operated<br>laparoscopic instruments. | | | |
| Performance<br>Data | Design analysis and comparison, has been conducted to confirm that<br>basic functional characteristics are substantially equivalent to the<br>predicate devices cited, and design validation confirm that there are no<br>new issues of safety or effectiveness for performing surgical tasks in<br>gynecologic laparoscopic surgical procedures. | | | |
| Conclusion | Based upon the information provided in this pre-market notification, the<br>da Vinci Surgical System described herein has been shown to be<br>substantially equivalent to current legally marketed predicate devices,<br>and the results of the risk analysis and design validation confirm that the<br>there are no new issues of safety or effectiveness. | | | |

.... ...

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael H. Yramategui Director, Regulatory Affairs Intuitive Surgical, Inc. 950 Kifer Road SUNNYVALE CA 94086

Re: K050404 K050404
Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control System Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories ﻠﺴﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ Regulatory Class: II Product Code: HET Dated: February 16, 2005

Received: February 17, 2005

Dear Mr. Yramategui:

Deal Mr. Tranatogal.
We have reviewed your Section be startielly equivalent (for the indications for use stated in We have reviewed your Section 5 U(K) premantially equivalent (for the indications for use stated in
above and have determined the device is substantially interstate commerce above and have determined the devices marketed in interstate commerce price to
the enclosure) to legally marketed predicate devices marketed in interstate commerce price that the enclosure) to legally marketed predical Devices inianced an memors, or to devices that have been
May 28, 1976, the enactment date of the Medical Food Drus, and Cosmetic May 28, 1976, the enactment date of the Federal Food, Drug, and Cosmetic Act (Act) that
reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmence reclassified in accordance with the provisions of the Posts of the may, therefore, market the do not require approval of a premarket approvation (The Act. The general controls provisions of the Act
device, subject to the general controls provisions of the Actives pr device, subject to the general controls provisions of the Act. The general contraction, labeling,
include requirements for annual registration, lisenties Include requirements for and adulteration.

APR 2 1 2005

If your device is classified (see above) into either class II (Special Controls) or class III (Prematket If your device is classified (see above) into eliment on the transmiss regulations affecting your regulations affecting your Approval), it may be subject to such adonoist controls. Date 8 105.
device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA device can be found in the Code of Federal Regulations Provide in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA's issuation isqurvalies with other menuments of the Act or any
FDA has made a determination the your device complies. You must comply with all FDA has made a determination that your device compless. You must comply with all the
Federal statutes and regulations administered by other Federal and listing (1 CFF Part Federal statutes and regulations administed by other recordisting (21 CFR Part 807); Labeling
Act's requirements, including, but not limited to registration and listing (21 C Act's requirements, including, but not implex to registration the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set forth in the quality (21 CFR Part 801); good manutacturing practice tequirements as sol secure of the provisions
regulation (21 CFR Part 820); and if applicable, the electronic product radiation regulation (21 CFR Pull 020); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:___________ Intuitive Surgical® Endoscopic Instrument Control System

Indications For Use:

The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the The Intuitive Surgical Endoscopic Instruments during gynecologic laparoscopic
accurate control of Intuitive Surgical Endoscopic Instruments during room accurate control of millilive Surgical Endoscopic metranicis and 1997 in the surgical procedures. This intended for use by trainou pryolance in and proposedures set forth in the Professional Instructions for Use.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Nancy C. Broadon

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number