CONNECT FOR DA VINCI SURGICAL SYSTEM(S)

K123840 · Intuitive Surgical, Inc. · NAY · Feb 14, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K123840
• Device Name: CONNECT FOR DA VINCI SURGICAL SYSTEM(S)
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Feb 14, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Connect™ for da Vinci® Surgical System(s) is an accessory intended for use by trained surgical proctors to (1) communicate and provide surgical advice to the operating surgeon when using da Vinci Surgical System(s) and (2) view surgical procedures related to the use of da Vinci Surgical System(s) using the Remote Proctor Interface. The wireless connectivity option provides a suitable alternative for the wired Ethernet connection between the da Vinci Surgical System(s) and the hospital's Internet Protocol (IP) infrastructure.

Device Story

Connect is a software accessory for the da Vinci Surgical System enabling remote proctoring. It facilitates communication between a remote proctor and an operating surgeon via a Remote Proctor Interface (RPI). Inputs include audio and video signals from the OR; the system transmits these over wired or wireless Ethernet connections to the hospital's IP infrastructure. Features include bi-directional audio, video streaming, remote telestration, and a remote pointer. The proctor uses the RPI to view procedures and provide real-time advice. The system allows the operating surgeon to enable or disable the connection via the da Vinci touchscreen. The device aims to support surgical training and consultation by allowing expert proctors to assist surgeons remotely, potentially improving surgical outcomes through enhanced guidance.

Clinical Evidence

No clinical data. Performance was established through software verification and validation testing to confirm the modified accessory performed as intended and did not adversely impact the da Vinci Surgical System functionality.

Technological Characteristics

Software accessory for da Vinci Surgical System. Utilizes wired or wireless Ethernet connectivity to hospital IP infrastructure. Encodes audio and video for internet transport. Integrates with embedded da Vinci system software. Features include bi-directional audio, video streaming, remote telestration, and remote pointer functionality.

Indications for Use

Indicated for use by trained surgical proctors to communicate, provide surgical advice, and view surgical procedures performed by operating surgeons using the da Vinci Surgical System.

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 OnSite and da Vinci Connect (K081207)
• Intuitive Surgical da Vinci S Surgical System, Model IS2000 with Connect OnSite and Wireless Connectivity Option (K101581)

Submission Summary (Full Text)

{0}------------------------------------------------

K123840'

Intuitive Surgical, Inc.

Special 510(k) Connect for da Vincio Surgical System(s)

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

### 510(k) Number:

| Date | February 12, 2013 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Intuitive Surgical, Inc. |
| | 1266 Kifer Road |
| | Sunnyvale, CA 94086 |
| Contact | Cherece L. Jones |
| | Sr. Regulatory Affairs Specialist |
| | Telephone: (408) 523 - 6925 |
| | Fax: (408) 523 - 8907 |
| | e-mail: [e-mail] |
| Subject<br>Device | Trade Name: ConnectTM for da Vinci® Surgical System(s) |
| | Common Name: System, surgical, computer controlled<br>instrument |
| | Classification Name: Endoscope and Accessories, 21 CFR<br>876.1500 |
| Predicate Devices | Intuitive Surgical® da Vinci® STM Surgical System, Model IS2000<br>with da Vinci OnSiteTM and da Vinci ConnectTM (legally marketed<br>under K081207). |
| | Intuitive Surgical® da Vinci® STM Surgical System, Model IS2000<br>with ConnectTM OnSiteTM and Wireless Connectivity Option (legally<br>marketed under K101581). |
| Device<br>Description | Connect is a software accessory, with a Remote Proctor Interface,<br>intended for use by trained surgical proctors to communicate and<br>provide surgical advice to operating surgeons when using the da<br>Vinci Surgical System. By using the Remote Proctor Interface,<br>proctors can also view da Vinci Surgical Procedures.<br>Communication can be established through either a wired or |
| | wireless Ethernet connection between the da Vinci Surgical |
| | System(s) and the hospital's Internet Protocol (IP) infrastructure. |
| | The modified Connect software developed by ISI has the<br>following capabilities: |
| | • Bi-directional audio |
| | • Video from the OR to the RPI |
| | • Enable/Disable connection on the da Vinci<br>Touchscreen |
| | • Image selection from RPI |
| | • Remote Telestration |
| | • Remote Pointer |
| Indications for<br>Use | Connect™ for da Vinci® Surgical System(s) is an accessory<br>intended for use by trained surgical proctors to (1) communicate<br>and provide surgical advice to the operating surgeon when using<br>da Vinci Surgical System(s) and (2) view surgical procedures<br>related to the use of da Vinci Surgical System(s) using the Remote<br>Proctor Interface. The wireless connectivity option provides a<br>suitable alternative for the wired Ethernet connection between the<br>da Vinci Surgical System(s) and the hospital's Internet Protocol<br>(IP) infrastructure. |
| Technological<br>Characteristics | The fundamental technological characteristics of the subject<br>device are identical to the predicate device(s). Both the subject<br>and predicate device(s):<br>• encode audio and video for transport over the internet, and<br>• utilize the embedded da Vinci system software to facilitate<br>Connect's interaction with the system. |
| Performance<br>Data | Software Verification Testing and Validation Testing was<br>performed to confirm that the modified Connect accessory<br>performed as intended and that changes made to the software had<br>no adverse impact on the functionality of the system. All test<br>cases met requirements demonstrating that the subject device<br>performed as expected. |
| Conclusion | The modified Connect accessory has the same Intended Use and<br>technological characteristics and similar Indications for Use and<br>functional characteristics as the predicate devices (K081207 and |

Page | 1

{1}------------------------------------------------

. .

.

·

'

{2}------------------------------------------------

K101581).

The Risk analysis did not identify any new issues related to the safety and effectiveness of the device. In addition, verification and validation results demonstrate that the modified software performs as expected and in accordance to the functional specification, thereby also supporting that the Connect accessory is substantially equivalent to the predicate devices.

{3}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Intuitive Surgical, Incorporated % Ms. Cherece L. Jones Senior Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086

February 14, 2013

Re: K123840

Trade/Device Name: Connect ™ for da Vinci@ Surgical System(s) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: January 31, 2013 Received: February 01, 2013

Dear Ms. Jones:

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

{4}------------------------------------------------

Page 2 -- Ms. Cherece L. Jones

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/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/ReportalProblem/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.

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

{5}------------------------------------------------

Intuitive Surgical, Inc.

# INDICATIONS FOR USE

510(k) Number if known: K123840

Device Name: Connect" for da Vincio Surgical System(s)

Connect™ for da Vincio Surgical System(s) is an accessory intended for use by trained surgical proctors to (1) communicate and provide surgical advice to the operating surgeon when using da Vinci Surgical System(s) and (2) view surgical procedures related to the use of da Vinci Surgical System(s) using the Remote Proctor Interface. The wireless connectivity option provides a suitable alternative for the wired Ethernet connection between the da Vinci Surgical System(s) and the hospital's Internet Protocol (IP) infrastructure.

Prescription Use X (Per 21 CFR 801 Subpart D) Subpart C)

AND/OR ...

Over-the-Counter Use (Per 21 CFR 807

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/5/Picture/11 description: The image shows the name "Long Chen" in large, bold font on the left side. To the right of the name is a graphic design element that includes the letter "S". The right side of the image contains a digital signature block with text such as "Digitally signed by Long H. Chen -5" and a date: "2013.02.20 08:25:27-05'00'".

(Division Sign-Off)

Division of Surgical Devices

510(k) Number