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 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.

AI/ML Overview

The provided text is a 510(k) summary for the da Vinci Xi Surgical System with a Remote Software Update feature. It states that the device is substantially equivalent to a previously cleared predicate device (K131861). The document does not describe specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) or a study that quantitatively measures the device's performance against such criteria. Instead, it focuses on demonstrating substantial equivalence based on technological characteristics and performance data related to software functionality.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, ground truth details) are not directly applicable or available in this document, as the submission is for a software update feature rather than a diagnostic or AI-driven decision-making tool.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The document describes the "Performance Data" in a general sense, stating that it demonstrates substantial equivalence and that the design output meets design input requirements. The explicit acceptance criteria and corresponding reported performance are not presented in a quantitative table for metrics commonly associated with AI/diagnostic devices.

Acceptance Criteria (Implied)	Reported Device Performance
Software Functionality:	Software Testing:
- Ability to perform software update downloads securely	- Software update downloaded over a network connection using secure communication protocols.
- Ability to cryptographically verify downloaded software package	- Software update package is cryptographically verified with a digital signature.
- Ability to determine installation type and guide user	- Metadata inside the package determines the type of installation required and guides the user through steps.
- No adverse impact on the existing device's intended use or indications for use.	- Performance test data demonstrate substantial equivalence.
- Design output meets design input requirements	- Design output meets design input requirements.
Equivalence to Predicate Device:	Substantial Equivalence Demonstrated:
- Equivalent in intended use, indications for use, and technological characteristics.	- "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."

Additional Information based on the document:

Sample size used for the test set and the data provenance:
- The document mentions "Software testing was conducted to support this modification," including user interface, algorithm, and software verification testing. However, it does not specify the sample size of the test set (e.g., number of software updates tested, number of simulated scenarios).
- Data Provenance: Not specified, but given it's software testing for a medical device feature, it's typically internal testing by the manufacturer (Intuitive Surgical, Inc.). The document does not indicate country of origin for test data or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the testing described is primarily software verification and validation, not clinical performance against a medical ground truth involving expert review of patient data.
Adjudication method for the test set:
- Not applicable for software verification testing as described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not conducted according to this document. The submission is for a software update feature, not for a diagnostic or AI-assisted interpretation tool that would benefit from MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Remote Software Update" is an algorithmic feature designed to function primarily without direct human intervention in the download and verification steps. The description points to "algorithm, and software verification testing," which implies standalone testing of this automated process. However, explicit details of a "standalone performance study" in terms of clinical metrics for the surgical system itself are not provided as this submission is for the software update mechanism.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For software testing, the "ground truth" would be the expected behavior and outcomes defined by the software requirements and specifications (e.g., successful download, correct verification, appropriate installation guidance). It's not a clinical "ground truth" in the sense of pathology or outcomes.
The sample size for the training set:
- Not applicable. This document describes a software update feature for an existing device, not a machine learning or AI model that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for machine learning.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting health and well-being.

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.

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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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

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)
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/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.

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

510(k) Summary

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Brandon HansenRegulatory AffairsPhone Number: 408-523-7485Fax Number: 408-523-8907Email: brandon.hansen@intusurg.com
Date Summary Prepared:	May 4, 2016
Trade Name:	da Vinci® Xi™ Surgical System
Common Name:	Endoscopic instrument control system
Classification:	Class II21 CFR 876.1500, Endoscope and Accessories
Product Codes:	NAY (System, Surgical, Computer Controlled Instrument)
Classification AdvisoryCommittee:	General and Plastic Surgery
Predicate Device:	da Vinci® Xi™ Surgical System device, K131861

Device Description

Intended Use/Indications for Use:

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.

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

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.

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.