INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000

K050369 · Intuitive Surgical, Inc. · NAY · Apr 29, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050369
• Device Name: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Apr 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intuitive Surgical da Vinci Surgical System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. 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, a Patient Side Cart (PSC), and the Insite Vision System. The surgeon operates from the console using Master Tool Manipulators (MTM) to control endoscopic instruments and an endoscope held by Patient Side Manipulators (PSM) and an Endoscope Camera Manipulator (ECM) on the PSC. The vision system provides 3-D or 2-D images of the surgical field to the surgeon. Commands are relayed from the console to the PSC via cable. The system facilitates precise tissue manipulation, including grasping, cutting, dissection, suturing, and ablation. By providing enhanced visualization and ergonomic control, the system assists surgeons in performing complex minimally invasive procedures, potentially improving surgical accuracy and patient outcomes.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is supported by design analysis, comparison to predicate devices, and risk analysis activities.

Technological Characteristics

Computer-controlled endoscopic instrument system. Components: Surgeon Console (Model IS2000-SSC), Patient Side Cart (Model IS2000-PSC), and Insite Vision System (Model VS1000). Features stereo endoscope, camera, light source, and manipulators (PSM, ECM). Connectivity via cable between console and cart. System utilizes electromechanical components for instrument control. Software-driven interface for surgeon control of robotic arms.

Indications for Use

Indicated for trained physicians performing urologic, general laparoscopic, gynecologic laparoscopic, general noncardiovascular thoracoscopic, and thoracoscopically assisted cardiotomy procedures, including coronary anastomosis via adjunctive mediastinotomy, using endoscopic instruments and accessories for tissue manipulation.

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

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

Submission Summary (Full Text)

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### Section II

# APR 2 9 2005

## 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: K050369

| Date | April 26, 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 Endowrist™<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 / K013416 /<br>K021036 / K022574 / K040237 / K043153 / K050005) |
| Device<br>Description | The da Vinci Surgical System, consists of three integrated sub-systems as<br>follows: |
| | Endoscopic Instrument Control System: The Endoscopic Instrument<br>Control System is comprised of two sub-systems - the Surgeon Console,<br>Model IS2000-SSC, and Patient Side Cart. Model IS2000-PSC. While<br>seated at the Surgeon Console, the surgeon controls critical aspects of the<br>procedure, including movement of the endoscopic instruments and<br>endoscope, within the operative field. Endoscopic instrument and camera<br>movements are controlled by the surgeon through |

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#### Device Description (continued)

use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a lixed position (with respect to the patient) by cither two (or optionally three) unique manipulators 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 manipulator, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC). The PSM and ECM are attached to surgical arms on the PSC known as Set-up Joint (SUJ) arms. Commands from the Surgeon Console arc relayed to the PSC, which is located immediately adjaccnt to the patient, via a cable. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.

Stereo View Endoscopic Vision System: The endoscopic vision system used with the da Vinci Surgical System, also known as Intuitive Surgical Insite Vision System. Model VS1000, 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) image of the surgical field.

#### Intended Use

The Intuitive Surgical da Vinci Surgical System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, clectrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing and delivery and placement of microwave ablation probos and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. 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.

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| Comparison to<br>Predicate<br>Device | This 510(k) notification is submitted for design modifications to the<br>Endoscopic Instrument Control System. These modifications affect<br>primarily the PSM, ECM, and the Patient Side Cart in order to enhance<br>case of use. There are also associated minor changes to the Surgeon<br>Console and endoscopic instruments. The user interface design is<br>essentially identical to the predicate device except for minor<br>modifications to accommodate the aforementioned changes. |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device operation, functionality, and methods of use for the subject device<br>are identical to the predicate device. The technology, materials,<br>manufacturing methods, and performance are essentially the same for the<br>predicate device as the subject device. The primary differences are 1)<br>changes to the PSM and ECM form factor and associated<br>electromechanical components; 2) changes to the Patient Side Cart<br>mechanics and circuitry to accommodate the modified PSM and ECM;<br>and 3) changes to the Surgeon Console and software to accommodate the<br>modified Patient Side Cart. Minor mechanical modifications to the<br>endoscopic instruments to interface with the modified PSM are also<br>described. |
| Technological<br>Characteristics | The technological characteristics of the subject devices are essentially the<br>same as for the predicate devices. |
| Performance<br>Data | Design analysis and comparison, as well as bench testing and risk<br>analysis activities, have been conducted to confirm that the<br>characteristics of the modified device are substantially equivalent to the<br>predicate devices cited. |
| Conclusion | Based upon the device's general specifications, intended use, and results<br>of risk analysis and performance testing provided in this pre-market<br>notification, the da Vinci Surgical System described herein has been<br>shown to be substantially equivalent to current legally marketed predicate<br>device. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 9 2005

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

Re: K050369

K050507
Trade/Device Name: Intuitive Surgical da Vinci Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NA Y Dated: February 10, 2005 Received: February 14, 2005

Dear Mr. Yramategui:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premainter is substantially equivalent (for the indications referenced above and nave determined the arrest are devices marketed in interstate for use stated in the enclosure) to tegally manced profithe Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 20, 1970, the enactition with the provisions of the Federal Food, Drug, devices that have been recrassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require apperal controls provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general consucted pos You may, inerefore, market the device, belyer to meet general controls provisions of the Fet merade requirements of the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mis chairs are regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may may be subject to such additional controlis. Entroling and on 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Peacharies.
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 Please be advised that FDA s issualice of a substitive only other requirements of the Act
that FDA has made a determination that your device acteral agencies. You must that FDA has made a determination that your arrest by other Federal agencies. You must and or any Federal statutes and regulations and united to: registration and listing (21)
comply with all the Act's requirements, including, but not one provine moutrements as set comply with all the Act s requirements, mendanturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR 1 at 601); god manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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Page 2 – Mr. Michael H. Yramategui

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your article equivalence of your device to a legally
premarket notification. The FDA finding of sybstantial end this permits yo premarket notification. The FDA multing of substantial equive 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
rs of the may of the more of 0115. All any desse not the requiries entitled If you desire specific advice for your ac not on on success note the regulation entitled, the regulation entitled, contact the Office of Complaned at (210) 276 - 1 - 1 - (21)FR Part 807.97). You may obtain "Misbranding by reference to premarket nothleadon (en oet from the Division of Small
other general information on your responsibilities under the Act from number (800) 638-20 other general information on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-findex html Manufacturers, international and Consulter Abolokation and Consultances of the new onlines.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known): K050369

Intuitive Surgical® da Vinci® Surgical System and Endowrist 60 Device Name: Instrumicats

Indications For Use:

The Intuitive Surgical" da Vinci" Surgical System is intended to assist in the accurate control of Intuitive Surgical® Endoscopic Instruments including rigid endoscopes, blunt and sharp cadoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, clectrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and shapp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probos and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to norform coronary anastomosis during cardiac revascularization. It is intended for use by trained physicians in an operating toom environment in accordance with the representative specific procedures 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 NEEDCO)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

tive

Ko 50369

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Intuitive Surgical" da Vinci Surgical System

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