INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000

K021036 · Intuitive Surgical, Inc. · NAY · Jun 26, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021036
• Device Name: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Jun 26, 2002
• 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 (hereinafter referred to as the "da Vinci™ System") is intended to assist in the accurate control of Intuitive Surgical® endoscopic instruments including: rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories during laparoscopic surgical procedures such as cholecystectomy, Nissen fundoplication, radical prostatectomy, and general non-cardiac thoracoscopic surgical procedures such as internal mammary artery mobilization. It is intended to be used by trained physicians in an operating room environment. Intuitive Surgical® Endoscopic Instruments including scissors, scalpels, forceps/pick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.

Device Story

The da Vinci™ Surgical System (Model IS1200) is a robotic-assisted endoscopic instrument control system. It consists of a Surgeon Console, a Patient Side Cart (PSC), and the Insite™ Vision System. The surgeon sits at the console, using Master Tool Manipulators (MTM) to control endoscopic instruments and the endoscope. Movements are relayed via cable array to Patient Side Manipulators (PSM) and the Endoscope Camera Manipulator (ECM) on the PSC, which is positioned adjacent to the patient. The Insite™ Vision System provides 3-D or 2-D stereo visualization of the surgical field. Proprietary EndoWrist™ instruments provide multi-degree-of-freedom movement (yaw, pitch, rotation, insertion/withdrawal) mimicking human wrist motion. The system assists physicians in performing precise tissue manipulation, dissection, and suturing during minimally invasive surgeries. A second provider assists at the PSC for instrument and camera changes. The system aims to provide enhanced control and visualization for the surgeon, potentially improving surgical precision.

Clinical Evidence

Bench testing only. Design analysis and safety testing were performed to confirm functional equivalence to the predicate devices.

Technological Characteristics

System comprises Surgeon Console, Patient Side Cart (PSC), and Insite™ Vision System. Features proprietary EndoWrist™ instruments with yaw, pitch, rotation, and insertion/withdrawal capabilities. Uses stereo endoscope, endoscopic camera, light source, and light guides for 3-D/2-D visualization. Connectivity via cable array between console and PSC. Electrocautery and ultrasonic shear capabilities included.

Indications for Use

Indicated for use by trained physicians in an operating room for laparoscopic and general non-cardiac thoracoscopic surgical procedures, including cholecystectomy, Nissen fundoplication, radical prostatectomy, and internal mammary artery mobilization. Instruments are indicated for tissue manipulation, including grasping, cutting, dissection, approximation, ligation, electrocautery, and suturing.

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

• da Vinci™ Surgical System (K965001)
• da Vinci™ Surgical System (K990144)
• da Vinci™ Surgical System (K002489)
• da Vinci™ Surgical System (K011002)

Submission Summary (Full Text)

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# JUN 2 6 2002

## Section II

# 510(k) SUMMARY

Ko21036

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:

| Date | March 29, 2002 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Intuitive Surgical<br>950 Kifer Road<br>Sunnyvale, CA 94086 |
| ER Number | 2955842 |
| Contact | David Casal, Ph.D.<br>Vice-President, Clinical, Regulatory and Quality Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Subject Device | Classification<br>Class I/II - Gynecologic Laparoscope and Accessories,<br>Electrocautery, Endoscope and Accessories<br><br>Trade Name<br>Intuitive Surgical® da Vinci™ Surgical System<br><br>Common Name<br>Endoscopic Instrument Control System, Endoscopic Instruments<br>and Accessories<br><br>Classification Name<br>Endoscope and Accessories (21 CFR 876.1500)<br>Gynecologic Laparoscope and Accessories (21 CFR 884.1720) |
| Predicate<br>Devices | da Vinci™ Surgical System<br>(legally marketed under K965001/K990144/K002489/K011002) |
| Device<br>Description | The Intuitive Surgical® Endoscopic Instrument Control System<br>(Model IS1200), also known as the da Vinci™ Surgical System,<br>consists of three major integrated sub-systems . A brief description<br>of each of these sub-systems is provided below while a more |

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#### Device Description (continued)

comprehensive description of their characteristics is provided in subsequent sections of this document. The major sub-systems are as follows:

Intuitive Surgical® Endoscopic Instrument Control System: This subsystem of the da Vinci™ Surgical System is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls virtually all 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), also located on the PSC. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via a cable array. 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, known as Intuitive Surgical® Insite™ Vision System, consists of a stereo endoscope, endoscopic 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) of the surgical field.

Intuitive Surgical® Endoscopic Instruments: The da Vinci™ Surgical System is designed to use unique endoscopic instruments utilizing a proprietary architecture conveying movements similar to those of the human wrist. These movements - yaw, pitch, rotation, and insertion/withdrawal - are controlled by the surgeon seated at the Surgeon Console. These endoscopic instruments, many of which are referred to as EndoWrist™ endoscopic instruments, include scissors. scalpels, graspers/forceps/pick-ups, needle holders, ultrasonic shears, and electrocautery instruments.

The Intuitive Surgical® Endoscopic Instrument Control System Intended Use (hereinafter referred to as the "da Vinci™ System") is intended to assist in the accurate control of Intuitive Surgical® endoscopic

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| | instruments including: rigid endoscopes, blunt and sharp endoscopic<br>dissectors, scissors, scalpels, forceps/pick-ups, needle holders,<br>endoscopic retractors, stabilizers, electrocautery and accessories<br>during laparoscopic surgical procedures such as cholecystectomy,<br>Nissen fundoplication, radical prostatectomy, and general non-cardiac<br>thoracoscopic surgical procedures such as internal mammary artery<br>mobilization. It is intended to be used by trained physicians in an<br>operating room environment. |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intuitive Surgical® Endoscopic Instruments including scissors,<br>scalpels, forceps/pick-ups, needle drivers and electrocautery are<br>intended for endoscopic manipulation of tissue, including: grasping,<br>cutting, blunt and sharp dissection, approximation, ligation,<br>electrocautery and suturing. |
| Comparison to<br>Predicate<br>Device | The Intuitive Surgical® da Vinci™ Surgical System and Endoscopic<br>Instruments described herein are essentially identical in terms of<br>shape, size, function, activation, and intended use to the predicate<br>Class II endoscopic instrument cited. |
| Technological<br>Characteristics | The technological characteristics of the subject devices are virtually<br>identical to the predicate devices. |
| Performance<br>Data | Design analysis and comparison as well as appropriate safety testing<br>confirm that basic functional characteristics are substantially<br>equivalent to the predicate device cited. |
| Conclusion | Based upon the product technical information provided, intended use,<br>and performance information provided in this pre-market notification,<br>the Intuitive Surgical® da Vinci™ Surgical System described herein is<br>substantially equivalent to the current legally marketed predicate<br>devices. |

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JUN 2 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Intuitive Surgical, Inc David Casal, Ph.D. Vice President, Clinical, Regulatory and Quality Affairs 950 Kifer Road Sunnyvale, California 94086

Re: K021036

Trade Name: Intuitive Surgical® DaVinci Surgical System, Model IS1200 Regulation Number: 876.1500 Regulation Name: Endoscopic instrument control system and Endoscopic instruments Regulatory Class: II Product Code: NAY Dated: March 29, 2002 Received: April 1, 2002

Dear Dr. Casal:

We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dr. David Casal

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 and additionally 21 CFR Part 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section III

### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Intuitive Surgical® Endoscopic Instrument Control System and Device name: Endoscopic Instruments.

Indications for Use:

The Intuitive Surgical® Endoscopic Instrument Control System (hereinafter referred to as the "da Vinci™ System") is intended to assist in the accurate control of Intuitive Surgical® endoscopic instruments including: rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories during laparoscopic surgical procedures such as cholecystectomy, Nissen fundoplication, radical prostatectomy, and general non-cardiac thoracoscopic surgical procedures such as internal mammary artery mobilization. It is intended to be used by trained physicians in an operating room environment.

Intuitive Surgical Endoscopic Instruments including scissors, scalpels, forceps/pick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.

#### PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | L | Over-the Counter Use | |
|----------------------|-----------------------------------------------------------|----------------------------------|--|
| (per 21 CFR §801.109 | | (Optional Format 1-2-96) | |
| | <div> <div>(Division Sign-Off)</div> </div> | | |
| Intuitive Surgical® | Division of General, Restorative and Neurological Devices | da Vinci™ Surgical System 510(k) | |
| 510(k) Number | K021036 | | |