INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS

K123463 · Intuitive Surgical, Inc. · NAY · Dec 3, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K123463
• Device Name: INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Dec 3, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Intuitive Surgical Endoscopic Instrument Control 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 and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used 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

Computer-assisted surgical system; facilitates minimally invasive surgery. Components: Surgeon Console, Patient Cart, Vision Cart. Surgeon manipulates endoscopic instruments via Master Tool Manipulators (MTMs) and foot pedals. Modification: transition from Functional Footpedal Mapping (pedals assigned by instrument function) to Left/Right Associative Footpedal Mapping (pedals associated with specific MTM hand controller). Instruments assigned to left MTM controlled by left pedal bank; right MTM by right pedal bank. Used in OR by trained physicians. Enhances user interface intuitiveness; maintains safety/effectiveness profile of predicate.

Clinical Evidence

No clinical data. Evidence consists of human factors testing to evaluate error rates and risk profile of the modified footpedal mapping, and software verification testing.

Technological Characteristics

Computer-assisted endoscopic instrument control system. Components: Surgeon Console, Patient Cart, Vision Cart. Modification involves software-based remapping of footpedal control logic to associate pedal banks with specific hand controllers (MTMs).

Indications for Use

Indicated for adult and pediatric patients (excluding transoral otolaryngology for pediatrics) undergoing urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, thoracoscopically assisted cardiotomy, and transoral otolaryngology (T1/T2 benign/malignant tumors) procedures. Used by trained physicians in operating rooms.

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 Si Surgical System (K081137)
• da Vinci Si Surgical System (K090993)

Submission Summary (Full Text)

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### . Left /Right Associative Footpedal Mapping Special 510(k): Device Modification

#### 6. 510(K) SUMMARY

| 510(K) SUMMARY |
|---------------------|
| (per 21 CFR 807.92) |

DEC 0 3 2012

| Submitter: | Intuitive Surgical, Inc. |
|------------|-----------------------------------|
| | 1266 Kifer Road |
| | Sunnyvale, CA 94086 |
| | Ph: [phone] |
| | Fax: [phone] |
| Contact: | Crystal Ong |
| | Sr. Regulatory Affairs Specialist |

Date Summary Prepared: November 7, 2012

#### Device Name:

| Trade Name: | Intuitive Surgical TM da Vinci ® SiTM Surgical System<br>SmartPedalsTM |
|----------------------|--------------------------------------------------------------------------|
| Common Name: | Endoscopic instrument control system |
| Classification Name: | Endoscope and Accessories (21 CFR 876.1500,<br>Product Code NAY) |

#### Predicate Device:

Device Description:

(with Functional Footpedal Mapping) was originally cleared under K081137, with additional indications under K090993 (TORS).

The Intuitive Surgical" da Vincio Si™ Surgical System

The Intuitive Surgical da Vinci Si Surgical System is a computer-assisted device designed to facilitate complex surgery using a minimally invasive approach. The system consists of three main components: the Surgeon Console, the Patient Cart, and the Vision Cart. The Surgeon Console houses the hand (Master Tool Manipulators or MTMs) and foot controls for the system. These controls allow the surgeon to manipulate the endoscopic instruments and camera located on the Patient Cart. The Vision Cart houses the system's image processing unit as well as the Instrument Control Box and any electrosurgical generators used in conjunction with the endoscopic instruments.

The proposed modification to the Intuitive Surgical da Vinci Si Surgical System user interface will result in a change from Functional Footpedal Mapping to Left/Right Associative Footpedal Mapping. Currently, under Functional Footpedal Mapping, instruments are assigned to

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| | Intuitive Surgical Inc. | Left/Right Associative Footpedal Mapping<br>Special 510(k): Device Modification |
|--------------|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| STOS E O 330 | | footpedal banks according to their function (monopolar,<br>bipolar, etc). The proposed change to Left/Right<br>Associative Footpedal Mapping will provide a more<br>intuitive user interface by associating each pedal bank with a<br>hand controller or "master tool manipulator" (MTM).<br>Therefore, instruments assigned to the left MTM will be<br>controlled by the left pedal bank and the instruments<br>assigned to the right MTM will be controlled by the right<br>pedal bank. |
| | Indications For Use: | The Intuitive Surgical Endoscopic Instrument Control<br>System is intended to assist in the accurate control of<br>Intuitive Surgical Endoscopic Instruments including rigid<br>endoscopes, blunt and sharp endoscopic dissectors, scissors,<br>scalpels, ultrasonic shears, forceps/pick-ups, needle holders,<br>endoscopic retractors, stabilizers, electrocautery and<br>accessories for endoscopic manipulation of tissue, including<br>grasping, cutting, blunt and sharp dissection, approximation,<br>ligation, electrocautery, suturing, and delivery and<br>placement of microwave and cryogenic ablation probes and<br>accessories, during urologic surgical procedures, general<br>laparoscopic surgical procedures, gynecologic laparoscopic<br>surgical procedures, transoral otolaryngology surgical<br>procedures restricted to benign and malignant tumors<br>classified as T1and T2, general thoracoscopic surgical<br>procedures, and thoracoscopically assisted cardiotomy<br>procedures. The system can also be employed with<br>adjunctive mediastinotomy to perform coronary anastomosis<br>during cardiac revascularization. The system is indicated<br>for adult and pediatric use (except for transoral<br>otolaryngology surgical procedures). It is intended to be<br>used by trained physicians in an operating room<br>environment in accordance with the representative, specific<br>procedures set forth in the Professional Instructions for Use. |
| | Technological Characteristics: | The subject device (da Vinci Si System, with Left/Right<br>Associative Footpedal Mapping) is substantially equivalent<br>in technological characteristics in terms of the intended use,<br>indications for use and technological characteristics as<br>compared to the da Vinci Si System, with Functional<br>Footpedal Mapping (the predicate device). |
| | Performance Data: | Human Factors testing was conducted to demonstrate that<br>the subject device is substantially equivalent to the predicate<br>device in terms of error rate and risk profile. Software<br>verification testing was performed to confirm that the design<br>specifications meet the design requirements. The results of<br>the testing did not raise any new types of safety or<br>effectiveness questions. |
| | Summary: | Based on the intended use, indications for use, technological<br>characteristics, and performance data, the modified Intuitive<br>Surgical da Vinci Si Surgical System, with Left/Right |

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Intuitive Surgical Inc.

.

Associative Footpedal Mapping, is substantially equivalent to the Intuitive Surgical da Vinci Si Surgical System, with Functional Footpedal Mapping (the predicate device).

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ge 6-3

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Intuitive Surgical, Incorporated % Ms. Crystal Ong Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086

December 3, 2012

Re: K123463

RT25 103
Trade/Device Name: Intuitive Surgical® da Vinciø Si™ Surgical System SmartPedals™ Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: November 7, 2012 Received: November 9, 2012

Dear Ms. Ong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class.II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Ms. Crystal Ong

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Intuitive Surgical Inc.

510(k) Number if known:

Device Name: Intuitive Surgical" da Vincio Si™ Surgical System SmartPedals™

### INDICATIONS FOR USE:

The Intuitive Surgical Endoscopic Instrument Control 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 and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic ublation procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Prescription Use __X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Per 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Dwight Yen 2012.11.30 12:41:51 -05'00'

(Division Sign-off) Division of Surgical Devices 510(k) Number__K123463