The da Vinci Connect is an accessory to the da Vinci S Surgical System and is intended for use by trained Surgical proctors to communicate and to provide surgical advice to the operating surgeon when using the da Vinci S Surgical System, Model IS2000. In addition, the Remote Proctor Interface can be used to view surgical procedures related to the use of the da Vinci S Surgical System, Model IS2000.

Indications For Use - da Vinci OnSite:

The da Vinci OnSite is an accessory to the da Vinci S Surgical System and is intended for use by trained Intuitive Surgical Customer Service personnel to obtain da Vinci S Surgical System information for the purpose of diagnosing faults with the da Vinci S Surgical System, Model IS2000.

Device Description

The da Vinci S Surgical System, Model IS2000 with da Vinci Connect and da Vinci OnSite, is a minor modification to the existing computer assisted device designed to facilitate complex surgery using minimally invasive approach. An overview of the IS2000 consists of the following three main integrated sub-systems: The Surgeon Console, Model SS2000: The control center of the surgical system, and allows the surgeon to control critical aspects of the surgical procedure (including movement of the endoscopic instruments and endoscope). Instrument and camera movements are controlled by the Master Tool Manipulators (MTM), two hand operated controllers, and foot pedals at the Surgeon Console's base. These allow the surgeon to be as dexterous as in "open" surgery. while operating in a minimally invasive environment. The surgeon has the option to change the surgical view from full screen mode to a multi-image mode, which displays an optional 3- dimensional High Definition (3-D HD), 3-D, or 2-D standard definition image of the operative field.

The Patient Side Cart (PSC, Model PS2000): The operative component of the surgical system within the sterile field. Its primary function is to support the endoscopic instrument arms and camera arm, during surgical procedures. Endoscopic instruments are held in a fixed position (with respect to the patient) by unique Patient Side Manipulators (PSM), and the endoscope is held by the Endoscope Camera Manipulator (ECM). The PSM's and ECM are attached to surgical arms on the PSC known as Set-up Joint (SUJ) arms. Commands from the Surgeon Console are relayed to the PSC, via a cable.

InSite ® Vision System (Model VS2000): Houses the system's image processing equipment and is operated by a person outside the sterile field during surgery. The cart provides space for an optional touch screen monitor, as well as ancillary surgical equipment. The VS2000 consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The InSite Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D image (or alternatively a 2-D) of the surgical field for the surgeon's reference.

AI/ML Overview

The provided text describes a 510(k) submission for the Intuitive Surgical da Vinci S Surgical System, Model IS2000, with da Vinci Connect™ and da Vinci OnSite™. This submission is a request for clearance for minor modifications to an existing device, not a new device requiring extensive clinical trials to establish de novo safety and effectiveness.

Therefore, the information typically associated with acceptance criteria and studies proving the device meets those criteria (such as detailed performance metrics, sample sizes for training/test sets, ground truth establishment, or specific study designs like MRMC or standalone performance) is not present in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device, as opposed to establishing new safety and effectiveness for a novel device.

The study presented is a comparison to predicate device and a performance design analysis to demonstrate substantial equivalence, rather than a clinical study with detailed performance metrics against acceptance criteria.

Here's an analysis based on the information provided, highlighting what is available and what is explicitly not available or applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Aspect	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Summary from Submission)
Safety and Effectiveness	The modified device (with da Vinci Connect and da Vinci OnSite) should introduce no new safety or effectiveness issues compared to the predicate device.	"The Intuitive Surgical da Vinci S Surgical System with da Vinci Connect and da Vinci OnSite does not raise any new safety or effectiveness issues and is substantially equivalent to, and have been determined to be substantially equivalent to devices in commercial distribution..."
Technological Characteristics	Should be essentially the same as the predicate device.	"The technological characteristics of the subject device are essentially the same as for the predicate device."
Device Operation, Functionality, Methods of Use	Must be identical to the predicate device.	"Device operation, functionality, and methods of use for the subject device are identical to the predicate device."
Materials, Manufacturing Methods	Must be essentially the same as the predicate device.	"The technology, materials, manufacturing methods, and performance are essentially the same for the predicate device as the subject device."
Indications for Use	Must remain unchanged from the predicate device (for the core surgical system). The new accessories "da Vinci Connect" and "da Vinci OnSite" have their own stated intended uses.	"The indications for use, remains unchanged from the predicate device." (referring to the core da Vinci S Surgical System). Separate indications for use are provided for da Vinci Connect (communication and surgical advice for proctors, viewing procedures) and da Vinci OnSite (diagnosing faults by customer service).

Note on Acceptance Criteria and Performance: For this 510(k) submission, the "acceptance criteria" are predominantly framed around demonstrating substantial equivalence to an already legally marketed predicate device. This means the primary "performance" reported is the demonstration that the modified device performs as intended and is as safe and effective as the predicate, without introducing new risks. Specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific tolerances) for the new functionalities (Connect and OnSite) are not detailed in this summary, as the modifications are described as "minor" and primarily involve communication and diagnostics.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable/Not provided. This submission is for a modification to an existing surgical system, not a diagnostic device requiring a "test set" of patient data for performance evaluation in the typical sense. The "studies" conducted were design analysis, bench testing, and risk analysis.
Data Provenance: Not applicable/Not provided. No patient or clinical data sets are mentioned or used in this summary. The evaluation is based on design, engineering analysis, and bench testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable/Not provided. No "ground truth" for patient data was established, as this was not a clinical or diagnostic performance study on patient cases. The evaluation concerned the engineering and functional equivalence of hardware and software modifications.

4. Adjudication Method for the Test Set

Not applicable/Not provided. As there was no test set of patient data, no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No. An MRMC study was not done. These studies are typically for evaluating the impact of a new diagnostic technology on human reader performance, which is not the scope of this submission. The "da Vinci Connect" allows a proctor to provide advice, but this submission does not contain a study quantitatively measuring the effect size of this assistance on surgical outcomes or human reader performance.

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

Not applicable/Not provided. This is not an AI or algorithm-only device. The "da Vinci Connect" is an accessory for human proctors to communicate and advise, and "da Vinci OnSite" is for customer service personnel to diagnose system faults. Neither is a standalone algorithm whose performance would be independently assessed in this manner.

7. The Type of Ground Truth Used

Not applicable. The concept of "ground truth" (e.g., pathology, outcomes data) doesn't apply to this submission, as it's not a diagnostic or treatment outcome-measuring device in the context of this modification. The "ground truth" for the engineering performance and safety would be the established specifications and safety profiles of the predicate device, against which the modifications were compared through design analysis and bench testing.

8. The Sample Size for the Training Set

Not applicable/Not provided. There is no "training set" in the context of machine learning for this device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided. As there was no training set for machine learning, this information is not relevant to the submission.

Summary Conclusion for this Submission:

This 510(k) submission for the da Vinci S Surgical System with da Vinci Connect and da Vinci OnSite is a request for clearance based on substantial equivalence to existing predicate devices. The modifications are described as "minor hardware modifications" to support new communication and diagnostic features.

The "study" or evidence presented for FDA clearance relies on:

Design analysis and comparison: Demonstrating that the modified components function as intended and do not alter the core safety or effectiveness of the surgical system.
Bench testing: Verifying the performance of the new components and their integration.
Risk analysis activities: Ensuring that the modifications do not introduce new, unacceptable risks.

The document explicitly states that the device "does not raise any new safety or effectiveness issues" and that its "indications for use remains unchanged from the predicate device" (for the core system). The new functionalities (Connect and OnSite) have their own stated intended uses, but their acceptance is based on demonstrating that they function correctly and safely within the existing system, rather than through complex clinical performance studies with patient data.

Summary

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

081207

510(k) SUMMARY

DEC 1 9 2008

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

5 December 2008 Date Submitter Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 ER Number 2955842 9028901 Owner/Operator James Farnworth Contact Director, Regulatory Affairs Direct: 408-523-8687 Fax: 408-523-1390 james.farnworth@intusurg.com Name: Intuitive Surgical® da Vinci® S" Surgical System, Model IS2000, Subject with da Vinci Connect™, da Vinci OnSite™ Device Classification Name: System, Surgical, Computer Controlled Instrument (2 CFR 876.1500) Common Name: Endoscopic Instrument Control System, Endoscopic Instruments, and accessories Predicate Devices Intuitive Surgical da Vinci S Surgical System (Model IS2000) with Endoscopic and EndoWrist Instruments (legally marketed under K050369 and K063220). The da Vinci S Surgical System, Model IS2000 with da Vinci Connect and Device Description da Vinci OnSite, is a minor modification to the existing computer assisted device designed to facilitate complex surgery using minimally invasive approach. An overview of the IS2000 consists of the following three main integrated sub-systems: The Surgeon Console, Model SS2000: The control center of the surgical system, and allows the surgeon to control critical aspects of the surgical procedure (including movement of the endoscopic instruments and endoscope). Instrument and camera movements are controlled by the Master Tool Manipulators (MTM), two hand operated controllers, and foot pedals at the Surgeon Console's base. These allow the surgeon to be as dexterous as in "open" surgery. while operating in a minimally invasive

510(k) Number:

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

DeviceDescription(continued)	environment. The surgeon has the option to change the surgical view fromfull screen mode to a multi-image mode, which displays an optional 3-dimensional High Definition (3-D HD), 3-D, or 2-D standard definitionimage of the operative field.
	The Patient Side Cart (PSC, Model PS2000): The operative component ofthe surgical system within the sterile field. Its primary function is tosupport the endoscopic instrument arms and camera arm, during surgicalprocedures. Endoscopic instruments are held in a fixed position (withrespect to the patient) by unique Patient Side Manipulators (PSM), and theendoscope is held by the Endoscope Camera Manipulator (ECM). ThePSM's and ECM are attached to surgical arms on the PSC known as Set-upJoint (SUJ) arms. Commands from the Surgeon Console are relayed to thePSC, via a cable.
	InSite ® Vision System (Model VS2000): Houses the system's imageprocessing equipment and is operated by a person outside the sterile fieldduring surgery. The cart provides space for an optional touch screenmonitor, as well as ancillary surgical equipment. The VS2000 consists of astereo endoscope, endoscopic camera, and various accessories, including alight source and light guides. The InSite Vision System provides twoindependent images that are relayed to the viewer located in the SurgeonConsole, where they are fused to form a 3-D image (or alternatively a 2-D)of the surgical field for the surgeon's reference.
Indications forUse	da Vinci Connect:
	The da Vinci Connect is an accessory to the da Vinci S Surgical Systemand is intended for use by trained Surgical proctors to communicate and toprovide surgical advice to the operating surgeon when using the da VinciS Surgical System, Model IS2000. In addition, the Remote ProctorInterface can be used to view surgical procedures related to the use of theda Vinci S Surgical System, Model IS2000.
	da Vinci OnSite:
	The da Vinci OnSite is an accessory to the da Vinci S Surgical Systemand is intended for use by trained Intuitive Surgical Customer Servicepersonnel to obtain da Vinci S Surgical System information for thepurpose of diagnosing faults with the da Vinci S Surgical System, ModelIS2000.
Comparison toPredicate Device	This 510(k) notification is being submitted for minor designmodifications to the Surgeon Console and Vision System Cart of theEndoscopic Instrument Control System, Model IS2000.
	• da Vinci Connect allows a skilled remote proctoring surgeon to

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

provide advice to the console surgeon via audio, video or using instructional telestration, during a surgical procedure.

da Vinci OnSite allows trained Intuitive Surgical, Inc. Customer . Support personnel to obtain system information for the purpose of debugging and diagnosing problems with the system.
Minor hardware modifications to the Surgeon Console (SS2000) to support da Vinci Connect and da Vinci OnSite consists of:

Comparison to Predicate Device (continued)

. Router,
Workgroup Bridge, .
. Antenna,
Rear Service Panel Modification to allow connection to hospital ethernet .

Minor hardware modifications to the Vision System Cart (VS2000) to support da Vinci Connect and da Vinci OnSite consists of:

. a da Vinci Connect PC (also known as "Proctor PC") mounted on the Vision System Cart, with customized software.
a Uninterruptable Power Supply (UPS) with a battery backup, connected . to an existing Medical Grade Isolation Transformer, for the Proctor PC only.
. Rear Panel modification, two (2) additional User Video Input connections, and an Ethernet connector.

Device operation, functionality, and methods of use for the subject device are identical to the predicate device. The technology, materials, manufacturing methods, and performance are essentially the same for the predicate device as the subject device.

Technological The technological characteristics of the subject device are essentially the Characteristics same as for the predicate device.

Performance Design analysis and comparison, as well as bench testing and risk Data analysis activities, have been conducted to confirm that the characteristics of the modified device are substantially equivalent to the predicate devices cited.
Conclusion The da Vinci S Surgical System (Model IS2000) is a sophisticated computer assisted device designed to facilitate complex surgery using a minimally invasive approach. The indications for use, remains unchanged from the predicate device. The Intuitive Surgical da Vinci S Surgical System with da Vinci Connect and da Vinci OnSite does not raise any new safety or effectiveness issues and is substantially equivalent to, and have been determined to be substantially equivalent to devices in commercial distribution, prior to May 28, 1976.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2008

Director, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086

Intuitive Surgical, Inc.

% Mr. James Farnworth

Re: K081207

Trade/Device Name: Intuitive Surgical® da Vinciço Sm Surgical System, Model IS200, with da Vinci Connect™, da Vinci Onsite™

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NAY Dated: December 5, 2008 Received: December 8, 2008

Dear Mr. Farnworth:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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

Page 2 - Mr. James Famworth

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K081207

Device Name: Intuitive Surgical da Vinci S Surgical System, Model IS2000 with da Vinci OnSite and da Vinci Connect

Indications For Use:

Indications For Use - da Vinci Connect:

Indications For Use - da Vinci OnSite:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Neill R. Oglin Cor mem

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page 1 of 1
-------------

510(k) Number	K081207
---------------	---------

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.