INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000

K101581 · Intuitive Surgical, Inc. · NAY · Apr 8, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K101581
• Device Name: INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Apr 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The da Vinci Wireless Connectivity Option is intended to provide a suitable alternative for the wired Ethernet connection between the da Vinci Surgical System and the hospital's Internet Protocol (IP) infrastructure. The Intuitive Surgical Endoscopic Instrument Control System (IS2000 da Vinci S Surgical System with da Vinci Connect™, da Vinci OnSite) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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, gynecological laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, general cardiovascular and noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system is indicated for adult and pediatric use. 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 Wireless Connectivity Option is a modification to the da Vinci S Surgical System (IS2000) providing IEEE 802.11 wireless connectivity as an alternative to wired Ethernet for communication with hospital IP infrastructure. The system assists trained physicians in an operating room environment by enabling accurate control of endoscopic instruments for tissue manipulation, dissection, and suturing. The wireless option facilitates data transmission within the hospital network; it does not alter the core surgical functionality of the da Vinci system. The device benefits patients by maintaining the established surgical capabilities of the da Vinci platform while offering increased flexibility in operating room connectivity.

Clinical Evidence

Bench testing only. Performance tests were conducted to demonstrate conformance to design controls and ensure the design output meets design input requirements. No clinical data was required or provided.

Technological Characteristics

The device utilizes IEEE 802.11 wireless connectivity for communication between the surgical system and hospital IP infrastructure. It maintains the same materials, sensing/actuation principles, and energy sources as the predicate da Vinci S Surgical System (IS2000).

Indications for Use

Indicated for adult and pediatric patients undergoing urologic, general laparoscopic, gynecological laparoscopic, transoral otolaryngology (T1/T2 benign/malignant tumors), general cardiovascular/noncardiovascular thoracoscopic, and thoracoscopically assisted cardiotomy procedures. Used for tissue manipulation, dissection, suturing, and ablation. Contraindications not specified.

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 S™ Surgical System, Model IS2000, with da Vinci Connect™ and da Vinci OnSite™ (K081207)

Submission Summary (Full Text)

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Special 510(k): Device Modification

da Vinci Wireless Connectivity Op

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APR - 8 2011

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## 510(k) Summary

(As Required by 21 CFR 807.92(c))

| Date: | 6/4/2010 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
| Official Contact: | Karen Uyesugi<br>Vice President, Clinical and Regulatory Affairs<br>Ph: [phone]<br>Fax: [phone]<br>[e-mail] |
| Trade Name: | da Vinci Wireless Connectivity Option |
| Common Name: | Endoscopic Instrument Control System,<br>Endoscopic Instruments, and accessories |
| Classification: | System, Surgical, Computer Controlled Instrument<br>21 CFR 876.1500) |
| Predicate Device: | K081207: Intuitive Surgical® da Vinci S™<br>Surgical System, Model IS2000, with da Vinci<br>Connect™ and da Vinci OnSite™ |
| Device Description: | The da Vinci Wireless Connectivity Option for<br>the da Vinci S Surgical System Model IS2000 with<br>da Vinci Connect™ and da Vinci OnSite, is a<br>minor modification that will provide<br>an<br>alternative to the wired Ethernet connection in<br>the existing device. Specifically, the Wireless<br>Connectivity Option will provide IEEE 802.11<br>wireless connectivity between the da Vinci S<br>Surgical System and the hospital's Internet<br>Protocol (IP) infrastructure. |

Confidential

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Intended Use: The da Vinci Wireless Connectivity Option is intended to provide a suitable alternative for the wired Ethernet connection between the da Vinci Surgical System and the hospital's Internet Protocol (IP) infrastructure.

The Intuitive Surgical Endoscopic Instrument Control System (IS2000 da Vinci S Surgical System with da Vinci Connect™, da Vinci OnSite) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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, gynecological laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, general cardiovascular and noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system is indicated for adult and pediatric use. 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.

## Technological Characteristics: The subject device is identical in intended use, design and technology as compared to the predicate device.

Performance Data:

Summary:

Performance tests (bench tests) were conducted to demonstrate conformance to Design Controls, and that the design output meets the design input requirements. The results of the testing do not raise any new issues of safety or efficacy.

Based on the technical characteristics, intended use and performance test data, the Intuitive Surgical® da Vincio S™ Surgical System, Model IS2000, with da Vinci Connect™, da Vinci OnSite™ and Wireless Connectivity Option has been determined to be equivalent in safety, efficacy, and performance to the predicate device.

Intuitive Surgical. Inc.

Confidential

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Intuitive surgical. Inc. % Mr. Brandon Hansen Sr. Manager, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086

APR - 8 2011

Re: K101581

Trade/Device Name: Intuitive Surgical® da Vinci® S™ Surgical System, Model IS2000 with Connect"" OnSite and Wireless Connectivity Option Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NA Y Dated: February 10, 2011 Received: February 11, 2011

Dear Mr. Hansen:

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

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Page 2 - Mr. Brandon Hansen

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.

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/ucm111.co01/jp11/f01 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" (21 CFF) Pact 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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Aty B. D.h
for

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

Enclosure

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## Indications for Use

K101281 510(k) Number if known:

Device Name: Intuitive Surgical� da Vinci® S™ Surgical System, Model IS2000 with Connect™ OnSite and Wireless Connectivity Option

## INDICATION FOR USE:

The da Vinci Wireless Connectivity Option is intended to provide a suitable alternative for the wired Ethernet connection between the da Vinci Surgical System and the hospital's Internet Protocol (IP) infrastructure.

The Intuitive Surgical Endoscopic Instrument Control System (IS2000 da Vinci S Surgical System with da Vinci Connect™, da Vinci OnSite) 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, includina 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, gynecological laparoscopic suraical procedures, fransoral otolarynaology suraical procedures restricted to benlan and malignant tumors classified as T1 and T2, general cardiovascular and noncardlovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardlotomy procedures. The system is indicated for adult and pediatric use. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardlac 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.

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)

Ati B. Dester

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(Division Sign-Off) Division of Surgical, Orthopedic, and ResContractivity alces

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Intuitive Surgical, Inc.

510(k) Number____KI 01581