da Vinci Xi Surgical System, da Vinci X Surgical System

K191529 · Intuitive Surgical · NAY · Feb 6, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K191529
• Device Name: da Vinci Xi Surgical System, da Vinci X Surgical System
• Applicant: Intuitive Surgical
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Feb 6, 2020
• Decision: SESE
• Submission Type: Traditional
• 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 (IS4000) and X (IS4200) are endoscopic instrument control systems. This submission introduces cloud-based software features: Surgeon Cloud Accounts, Procedure List, and Central Configuration. Surgeon Cloud Accounts allow surgeons to log into multiple systems to access personalized settings (vision, ergonomics, motion scaling, energy) stored on a central Intuitive server. Procedure List enables selection of surgical procedures via the surgeon console touchscreen. Central Configuration allows authorized Intuitive employees to remotely configure system features. These modifications facilitate workflow management and system setup in the operating room. The device remains an endoscopic instrument control system; the software updates do not alter the fundamental surgical function or intended use.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing performed per ISO 62304 and ISO 14971 risk management processes confirmed that software modifications and server infrastructure changes perform as intended and meet design requirements.

Technological Characteristics

Endoscopic instrument control system. Software modifications introduce cloud-based connectivity for user preference storage, procedure selection, and remote configuration. Operates via networked server infrastructure. Software developed per ISO 62304; risk management per ISO 14971. Cybersecurity controls implemented per FDA guidance.

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. Used by trained physicians in operating rooms for tissue manipulation, dissection, and ablation.

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, Model IS4000, EndoWrist Instruments, and Accessories with Remote Software Update (K161271)
• da Vinci Xi Surgical System, Model IS4200 (K171294)

Submission Summary (Full Text)

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February 6, 2020

Intuitive Surgical Brandon Hansen Manager, Regulatory Submission 1266 Kifer Road Sunnyvale, California 94086

Re: K191529

Trade/Device Name: da Vinci Xi Surgical System, da Vinci X Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: January 8, 2020 Received: January 9, 2020

Dear Brandon 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jitendra Virani Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality 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) K191529

Device Name

da Vinci Xi Surgical System - Model IS4000

#### 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="text-align:left;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="text-align:left;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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| | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for Use | See PRA Statement below. |
| 510(k) Number (if known)<br>K191529 | | |
| Device Name<br>da Vinci X Surgical System (Model IS4200) | | |
| | | |
| Indications for Use (Describe)<br>endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and<br>ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and<br>system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac<br>operating room environment in accordance with the representative, specific procedures set forth in the Professional<br>Instructions for Use. | | The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System. Model IS4200) is intended to<br>assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp<br>accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation,<br>accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic<br>surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The<br>revascularization. The system is indicated for adult and pediative use. It is intended to be used by trained physicians in an |
| | | |
| | | |
| > Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) |
| | CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| | This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| | *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| | of this information collection, including suggestions for reducing this burden, to:<br>Department of Health and Human Services<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff<br>PRAStaff(@fda.hhs.gov | The burden time for this collection of information is estimated to average 79 hours per response, including the<br>time to review instructions, search existing data sources, gather and maintain the data needed and complete<br>and review the collection of information. Send comments regarding this burden estimate or any other aspect |
| Type of Use (Select one or both, as applicable) | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of<br>information unless it displays a currently valid OMB number." | |

Image /page/3/Picture/3 description: The image shows the word "INTUITIVE" in blue font. There is a small circle above the letter "I". The font is sans-serif and the word is all capitalized. There is a trademark symbol after the letter "E".

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#### റ് 510(k) Summary

| 510(k) Owner: | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brandon Hansen<br>Manager, Regulatory Submissions<br>Phone Number: 408-523-7485<br>Fax Number: 408-523-8907<br>Email: [e-mail] |
| Date Summary Prepared: | February 04, 2020 |
| Trade Name: | da Vinci® Xi™ Surgical System<br>da Vinci® X™ Surgical System |
| Common Name: | Endoscopic instrument control system |
| Classification: | Class II<br>21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | NAY |
| Classification Advisory Committee: | General and Plastic Surgery |
| Predicate Device: | da Vinci® Xi Surgical System, Model IS4000, EndoWrist®<br>Instruments, and Accessories with Remote Software<br>Update (K161271)<br>da Vinci® Xi™ Surgical System, Model IS4200 (K171294) |

# Device Description

The subject of this 510(k) submission are software modifications to the da Vinci Xi Surgical System (Model IS4000) and da Vinci X Surgical System (Model IS4200). These modifications allow Intuitive Surgical to offer cloud-based features to the IS4000 and IS4200 systems such as Surgeon Cloud Accounts, Procedure List, and Central Configuration.

- . Surgeon Cloud Accounts – Enable surgeons to log in to multiple IS4000 systems and access their personal IS4000 system settings (vision, ergonomic, motion scaling, and energy) by storing user preferences in a cloud-based central Intuitive data server.
- . Procedure List – Enable surgeons/OR staff to select a surgical procedure they intend to perform from the surgeon console touchscreen before the start of surgery.
- . Central Configuration – Enable authorized Intuitive Surgical employees to remotely configure features of one or more IS4000 systems simultaneously.

# INTUÍTIVE

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## Intended Use/Indications for Use:

### Indications for Use statement – da Vinci Xi Surgical System, Model IS4000

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, 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.

### Indications for Use statement - (da Vinci X Surgical System, Model IS4200)

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System, Model IS4200) 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, 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 fundamental scientific technology, the software modifications to the subject do Vinci Xi Surgical System is substantially equivalent to the currently marketed da Vinci Xi Surgical System device with Remote Software Update, cleared under K161271. The software modifications introduce new network-based features such as Surgeon Cloud Accounts, Procedure List, and Central Configuration. However, these changes do not alter the intended use of the subject device.

#### Performance Data:

Using an ISO 14971 compliant risk management process, a comprehensive hazard analysis of the software was performed, and impacted risks assessed, mitigations were evaluated and tested to be acceptable through verification and validation testing. The software development process based on ISO 62304 ensured that the software changes were appropriately documented, risk assessed and tested. Design verification tests were performed to verify the proposed software modifications performed as intended. The testing also verified the modifications to the da Vinci system software and server infrastructure did not raise new questions of safety and effectiveness. In addition, the pre and

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postmarket FDA guidance documents regarding cybersecurity were followed to document, risk assess and verify that the cybersecurity controls performed as expected in the event of an exploitation of a cybersecurity vulnerability. 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. None of the software modifications impact the intended use or indications for use of the da Vinci X/Xi Systems.

## Summary:

The intended use/indications for use remain identical to the predicate devices. Based on the intended use, indications for use, technological characteristics, and performance data, the modified devices (subjects), da Vinci X/Xi Surgical Systems with Surgeon Cloud Accounts, Procedure List and Central Configuration are substantially equivalent to the current devices in the market (predicates).