da Vinci Xi Surgical System

K161271 · Intuitive Surgical, Inc. · NAY · Jul 11, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K161271
• Device Name: da Vinci Xi Surgical System
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Jul 11, 2016
• 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 (da Vinci Xi Surgical System, Model IS4000) 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, 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, 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. 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

The da Vinci Xi Surgical System (Model IS4000) is a computer-controlled endoscopic instrument control system used by trained physicians in operating rooms. It facilitates tissue manipulation—including grasping, cutting, dissection, suturing, and ablation—via robotic-assisted control of endoscopic instruments. This submission introduces a 'Remote Software Update' feature, enabling software downloads and installations over a network without requiring an on-site service engineer. The system utilizes 'OnSite' functions to manage updates, which are downloaded via secure protocols and cryptographically verified using digital signatures. Metadata within the update package guides the user through the installation process. This feature maintains the system's operational readiness while ensuring software integrity through secure verification, ultimately supporting the clinical utility of the robotic platform.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including software verification and user interface testing.

Technological Characteristics

Endoscopic instrument control system; networked connectivity for remote software updates; software-based update management using secure communication protocols and cryptographic digital signature verification; system architecture remains consistent with the predicate da Vinci Xi Surgical System (K131861).

Indications for Use

Indicated for adult and pediatric patients undergoing urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, and thoracoscopically assisted cardiotomy procedures, including coronary anastomosis via adjunctive mediastinotomy.

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 Xi Surgical System (K131861)

Submission Summary (Full Text)

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

July 11, 2016

Intuitive Surgical, Inc. Mr. Brandon Hansen Project Manager, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086

Re: K161271

Trade/Device Name: Da Vinci Xi Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: June 20, 2016 Received: June 21, 2016

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 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 of medical devicerelated 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

**Indications for Use**

| Form Approved: OMB No. 0910-0120 |
|-----------------------------------|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |

| 510(k) Number (if known) | K161271 |
|--------------------------|-----------------------------|
| Device Name | da Vinci Xi Surgical System |

**Indications for Use (Describe)**

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4000) 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, 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, 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. 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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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FORM FDA 3881 (8/14)

| Page 1 of 1 | PSC Publishing Services [phone] | EF |
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Image /page/2/Picture/3 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in a sans-serif font, with a small yellow dot above the "I". Below the word "INTUITIVE" is the word "SURGICAL" in a smaller font, with the registered trademark symbol next to it. The logo is simple and modern, and the use of the color yellow adds a touch of warmth.

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#### 510(k) Summary

| 510(k) Owner: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brandon Hansen<br>Regulatory Affairs<br>Phone Number: 408-523-7485<br>Fax Number: 408-523-8907<br>Email: [e-mail] |
| Date Summary Prepared: | May 4, 2016 |
| Trade Name: | da Vinci® Xi™ Surgical System |
| Common Name: | Endoscopic instrument control system |
| Classification: | Class II<br>21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | NAY (System, Surgical, Computer Controlled Instrument) |
| Classification Advisory<br>Committee: | General and Plastic Surgery |
| Predicate Device: | da Vinci® Xi™ Surgical System device, K131861 |

## Device Description

Remote Software Update is a software enabled feature that performs software update downloads and installations without the need of a service engineer to be physically at the user's site. Remote Software Update utilizes the OnSite functions of the da Vincio Xi™ Surgical System to facilitate and manage software updates.

The software update is downloaded over a network connection using secure communication protocols. Once the software update package is downloaded and cryptographically verified with a digital signature, metadata inside the package determines the type of installation required and if necessary guides the user through all of the steps required to complete the software update.

## Intended Use/Indications for Use:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection,

Image /page/3/Picture/8 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in large, light gray, sans-serif font. Above the "I" is a small yellow circle. Below "INTUITIVE" is the word "SURGICAL" in a smaller, light gray, sans-serif font with a registered trademark symbol.

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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, 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. 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.

## Technological Characteristics:

In terms of intended use, indications for use, and technological characteristics, the da Vinci Xi Surgical System with Remote Software Update is substantially equivalent to the currently marketed da Vinci Xi Surgical System device, cleared under K131861.

# Performance Data:

Performance test data demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. Software testing was conducted to support this modification.

The software testing included user interface, algorithm, and software verification testing.

#### Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the da Vinci Xi Surgical System with Remote Software Update is substantially equivalent to the currently marketed da Vinci Xi Surgical System device, cleared under K131861.

Image /page/4/Picture/9 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in a sans-serif font, with a small yellow circle above the "I". Below the word "INTUITIVE" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent the company's brand.