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.

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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for software modifications to the da Vinci Xi Surgical System and da Vinci X Surgical System. The modifications allow for cloud-based features such as Surgeon Cloud Accounts, Procedure List, and Central Configuration.

However, the document does not contain any information regarding clinical performance studies, acceptance criteria, sample sizes for test or training sets, expert review processes for ground truth establishment, or multi-reader multi-case (MRMC) studies.

The "Performance Data" section explicitly states:

"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 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."

This indicates that the performance data for this 510(k) submission primarily consists of design verification and validation testing, hazard analysis, and cybersecurity assessment, rather than a clinical study measuring diagnostic or treatment outcome performance against specific acceptance criteria. The claim of "substantial equivalence" is based on these engineering and software system evaluations, and the fact that the modifications do not alter the intended use of the device.

Therefore, I cannot populate the requested table or answer most of the questions regarding acceptance criteria, study design, and ground truth, as this information is not present in the provided text.

However, I can extract the following relevant non-clinical information:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Based on the text, the acceptance criteria are implicitly tied to the successful completion of design verification and validation testing, hazard analysis per ISO 14971, and cybersecurity control verification per FDA guidance. The overall goal is to demonstrate that the software modifications perform as intended and do not raise new questions of safety and effectiveness, thus maintaining substantial equivalence to the predicate device.
Reported Device Performance:
- Software modifications performed as intended.
- Modifications did not raise new questions of safety and effectiveness.
- Cybersecurity controls performed as expected.
- Design output meets design input requirements.
- No impact on the intended use or indications for use.

2. Sample sized used for the test set and the data provenance:

Not applicable/Not provided. The "test set" here refers to engineering and software validation, not a clinical data set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. Ground truth in a clinical sense (e.g., diagnosis, pathology) was not established for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was done. This submission is for software modifications that add cloud-based functionality, not for AI assistance in diagnosis or treatment.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not provided. The device is a surgical system requiring human operation. The software modifications are infrastructure and user preference-related, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" for this submission would be defined by engineering specifications and functional requirements, against which the software was verified and validated.

8. The sample size for the training set:

Not applicable/Not provided. No machine learning training set is mentioned in the context of this 510(k) for software modifications.

9. How the ground truth for the training set was established:

Not applicable/Not provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☑ 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.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
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:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

Image /page/2/Picture/13 description: The image shows the word "INTUITIVE" in blue font. There is a small blue circle above the "U" in the word. The font is sans-serif and the word is centered in the image. The letters are evenly spaced and the word is easy to read.

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	DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020
	Indications for Use	See PRA Statement below.
510(k) Number (if known)K191529
Device Nameda Vinci X Surgical System (Model IS4200)

Indications for Use (Describe)endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery andligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes andsystem can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiacoperating room environment in accordance with the representative, specific procedures set forth in the ProfessionalInstructions for Use.		The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System. Model IS4200) is intended toassist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharpaccessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation,accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopicsurgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. Therevascularization. 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:Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff(@fda.hhs.gov	The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand 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 ofinformation 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.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Brandon HansenManager, Regulatory SubmissionsPhone Number: 408-523-7485Fax Number: 408-523-8907Email: brandon.hansen@intusurg.com
Date Summary Prepared:	February 04, 2020
Trade Name:	da Vinci® Xi™ Surgical Systemda Vinci® X™ Surgical System
Common Name:	Endoscopic instrument control system
Classification:	Class II21 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®Instruments, and Accessories with Remote SoftwareUpdate (K161271)da Vinci® Xi™ Surgical System, Model IS4200 (K171294)

Device Description

. 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)

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).

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.