The Intuitive Surgical® da Vinci® Surgical System is intended to assist in the accurate control of Intuitive Surgical® Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, 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 ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general non-cardiovascular 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 for use 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

This 510(k) is being submitted for an expansion of the Indications for Use to include pediatric use. There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System associated with this premarket notification.

The da Vinci Surgical System consists of two integrated sub-systems as follows:

Intuitive Surgical Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via cables. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.

Intuitive Surgical Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci Surgical System, also known as Intuitive Surgical Insite® Vision System, 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 (or alternatively a 2-D image) image of the surgical field.

AI/ML Overview

The provided text is a 510(k) summary for the Intuitive Surgical da Vinci Surgical System, seeking to expand its Indications for Use to include pediatric use. It asserts that there are no changes to the device itself, only to its intended use population.

Here's a breakdown of the acceptance criteria and study information, based on the provided document:

Acceptance Criteria and Device Performance

There are no explicit, quantifiable acceptance criteria or reported device performance metrics in the provided document. The submission is based on the premise that the device (da Vinci Surgical System) is already cleared for a wide array of surgical tasks in adults and that its use in pediatrics would not introduce new safety or effectiveness concerns.

The core argument for the expanded indication is based on:

Substantial Equivalence: The device is technologically identical to the predicate device cleared for adult use.
Risk Analysis and Assessment: This was conducted to confirm that basic functional characteristics are substantially equivalent to the predicate device without introducing new safety or effectiveness issues.
Review of Field Experience and Published Literature: This was performed to validate that there are no new issues of safety or effectiveness for performing surgical tasks in representative pediatric surgical procedures.

Therefore, the "acceptance criteria" appear to be:

Acceptance Criteria	Reported Device Performance (as stated in the document)
No changes in design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System compared to the predicate device.	"There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System associated with this premarket notification." "The technological characteristics of the subject device are the same as for the predicate device (da Vinci Surgical System)."
Substantial equivalence to the predicate device without introducing any new issues of safety or effectiveness for pediatric use.	"Risk analysis and assessment has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate device without introducing any new issues of safety or effectiveness..."
Validation that there are no new issues of safety or effectiveness for performing surgical tasks in representative pediatric surgical procedures.	"...a review of the field experience and published literature provides validation that there are no new issues of safety or effectiveness for performing surgical tasks in representative pediatric surgical procedures."

Study Details

The provided document does not describe a traditional clinical study with a test set, ground truth, or statistical analysis of performance metrics. Instead, it relies on a comparison to existing clearances, risk analysis, and a review of external data.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. No specific "test set" of patients or cases is mentioned.
- Data Provenance: Not applicable in the context of a prospective or retrospective study specific to this submission. The "review of field experience and published literature" would encompass data from various sources and potentially countries, but this is not detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No "ground truth" was established for a specific test set within the scope of this 510(k) submission. The assessment relies on the existing safety and effectiveness profile of the device in adults and the broader medical literature/field experience concerning pediatric surgical procedures using similar technology.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no specific test set requiring adjudication.
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:
- Not applicable. This device is a surgical system, not an AI-assisted diagnostic tool for "human readers." No MRMC study was mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a human-controlled surgical system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the expanded pediatric indication appears to be based on a combination of:
  - Historical performance/safety data of the da Vinci system in adults (as cleared under previous 510(k)s).
  - Risk analysis and assessment of potential differences in pediatric use.
  - Published medical literature and field experience regarding robotic surgery in pediatric populations.
  - Expert opinion from the submitter that the existing device can be safely and effectively used in pediatrics.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that involves a training set in the conventional sense. The "training" for safe and effective use refers to physician training, as stated in the Indications for Use: "It is intended for use by trained physicians..."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an algorithm.

Summary

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Section II 510(k) SUMMARY

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

June 23, 2005 Date Intuitive Surgical, Inc. 950 Kifer Road Submitter Sunnyvale, CA 94086 ER Number 2955842 Mike Yramategui Contact Director, Regulatory Affairs Telephone: (408) 523 - 2145 Fax: (408) 523 - 1390 e-mail: mike.yramategui(@intusurg.com Name: Intuitive Surgical® da Vinci® Surgical System and Endoscopic Subject Device Instruments Classification Name: System, Surgical, Computer Controlled Instrument (21 CFR 876.1500) Common Name: Endoscopic Instrument Control System, Endoscopic Instruments and Accessories Predicate Intuitive Surgical da Vinci Surgical System and Endoscopic Instruments Devices (legally marketed under K990144 / K002489 / K011002 / K012833 / K013416 / K021036 / K022574 / K040237 / K040948 / K043153 / K043288 / K050005 / K050369 / K050404). --------------------------------------------------------------------------------------------------------------------------------------Device This 510(k) is being submitted for an expansion of the Indications for Use to include pediatric use. There are no changes in the design, Description technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System associated with this premarket notification.

... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..

510(k) Number: K050802

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The da Vinci Surgical System consists of two integrated sub-systems as follows:

Device Description (continued) Intuitive Surgical Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and cndoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camcra Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via cables. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.

The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Intended Use Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, 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 ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general non-cardiovascular 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 for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

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Comparison toPredicateDevice	There are no changes in the design, technology, materials, manufacturing,performance, specifications, and method of use for the da Vinci SurgicalSystem. The expansion of the labeling to include pediatric use is based onthe da Vinci Surgical System and endoscopic instruments being currentlycleared for performing a full array of surgical tasks acrossmultidisciplinary surgical specialtics in adults, and comparison of use inrepresentative pediatric procedures. This comparison along with a riskassessment and review of field experience and the published literature onpediatric use of da Vinci surgical system establish equivalency andconfirm that there are no new issues of safety or effectiveness.
TechnologicalCharacteristics	The technological characteristics of the subject device are the same as forthe predicate device (da Vinci Surgical System).
PerformanceData	Risk analysis and assessment has been conducted to confirm that basicfunctional characteristics are substantially equivalent to the predicatedevice without introducing any new issues of safety or effectiveness, anda review of the field experience and published literature providesvalidation that there are no new issues of safety or effectiveness forperforming surgical tasks in representative pediatric surgical procedures.
Conclusion	Based upon the information provided in this pre-market notification, theda Vinci Surgical System described herein has been shown to besubstantially equivalent to current legally marketed predicate devices,and the results of the risk analysis and design validation confirm that thethere are no new issues of safety or effectiveness.

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

JUN 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael H. Yramategui Director, Regulatory Affairs Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, California 94086

Re: K050802

K050602
Trade/Device Name: Intuitive Surgical da Vinci Surgical System and Endoscopic Instruments Regulation Number: 21 CFR 876.1500

Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NAY Dated: May 26, 2005 Received: May 31, 2005

Dear Mr. Yramategui:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10) use stated in the entribute) 75 the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, in easondance with the provisions of the Federal Food, Drug, de necs that have been resuire approval of a premarket approval application (PMA). and Cosmetic Fee (110) market the device, subject to the general controls provisions of the Act. The r ou may, mererore, mans of the Act include requirements for annual registration, listing of general controll provision 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 If your device is classified (600 as 910) als. Existing major regulations affecting your device can may oc subject to success as success, Title 21, Parts 800 to 898. In addition, FDA may be found in the Cour acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I teast of advised that I DT b ibeautes over device complies with other requirements of the Act that I DIT has made a coulations administered by other Federal agencies. You must or any I edelares and equirements, 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 forth in the quarty by router (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Michael H. Yramategui

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manieting of substantial equivalence of your device to a legally premarket notheation: The PDA mixing of easification 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 If you desire specific acrice 101 Jour as 10 1) 276-0115. Also, please note the regulation entitled, Colliact the Office of Computation in (21CFR Part 807.97). You may obtain Misolanuning by reference to premailities under the Act from the Division of Small other general miorination on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K050802

Intuitive Surgical® da Vinci® Surgical System and Device Name: Endoscopic Instruments

Indications For Use:

The Intuitive Surgical® da Vinci® Surgical System is intended to assist in the accurate The Intuitive Surgical® Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, 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 ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general noncardiovascular 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 for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.

× 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

-Vision Sign-Off) Sivision of General, Restorative_ and Neurological Device

Kc50802

Page 1 of 1

510(k) Section III, Page 1 of 1

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.