The Intuitive Surgical® Endoscopic Instrument Control 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/pickups, 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 general 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. 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 special 510(k) is being submitted for a modification to the endoscopic instruments to incorporate monopolar electrosurgical capability on an endoscopic curved scissor instrument. This modification affects the instrument only and there are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci® Surgical System.
The endoscopic instruments are used with the da Vinci® Surgical System which 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 a modification to the Intuitive Surgical® da Vinci® Surgical System, specifically incorporating monopolar electrosurgical capability on a curved scissor instrument. This submission is for a medical device and, as such, the "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to predicate devices rather than the performance of an AI algorithm against specific metrics.

Therefore, many of the requested fields are not directly applicable to this type of regulatory submission. However, I can extract information related to the device's performance demonstration for its substantial equivalence.

Here's a breakdown of the available information:

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

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Basic functional characteristics operate as intended and are similar to predicate devices.	"Bench testing has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate devices cited."
Design output meets design input requirements.	"Results of the design control process confirm that the design output meets the design input requirements."
No changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the core da Vinci® Surgical System.	"There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci® Surgical System."
The modification (monopolar electrosurgical capability on curved scissors) does not introduce new questions of safety or effectiveness.	The submission concludes "Substantially Equivalent" without raising new safety/effectiveness concerns, implying successful demonstration.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated. The "bench testing" would involve a number of units of the modified instrument, but a specific quantity is not reported.
Data Provenance: Not specified, but generally, bench testing for medical devices is conducted in a controlled lab environment. This is a prospective assessment of the device's capabilities.

3. 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 in this context. Substantial equivalence for this type of device modification typically relies on engineering and functional testing, not expert interpretation of outputs like with AI or imaging diagnostics.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of data where there might be disagreement, often in clinical or AI performance studies. This submission focuses on engineering and bench testing.

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 conducted. This device is a surgical instrument system, not an AI diagnostic or assistance tool in the conventional sense that would involve "human readers" and "AI assistance" for diagnostic improvement.

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

Not applicable. This device is a surgical system that is operated by a human, not a standalone algorithm. The "bench testing" could be considered a form of standalone performance measurement for the instrument's functional characteristics, but not in the context of an AI algorithm.

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

Ground Truth: For this type of submission, the "ground truth" for the device's performance is adherence to established engineering specifications, functional requirements, and safety standards, as demonstrated through design analysis and bench testing. It's not a clinical or diagnostic "ground truth" derived from patient data or expert consensus.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no training set in the conventional sense.

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

Not applicable. As there is no training set, there is no ground truth established for it.

Summary

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K05 0005 1/3 007

JAN 2 5 2005 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.

510(k) Number:

Date	December 30, 2004
Submitter	Intuitive Surgical, Inc.950 Kifer RoadSunnyvale, CA 94086
ER Number	2955842
Contact	Mike YramateguiDirector, Regulatory AffairsTelephone: (408) 523 - 2145Fax: (408) 523 - 1390e-mail: mike.yramategui@intusurg.com
SubjectDevice	Name: Intuitive Surgical® da Vinci® Surgical System and EndoscopicInstrumentsClassification Name: System, Surgical, Computer Controlled Instrument(21 CFR 876.1500)Common Name: Endoscopic Instrument, Monopolar Curved Scissors
PredicateDevices	Intuitive Surgical® da Vinci® Surgical System and EndoscopicInstruments (legally marketed under K990144 / K002489 / K011002 /K013416 / K021036 / K022574 / K040237 / K043153)
DeviceDescription	This special 510(k) is being submitted for a modification to theendoscopic instruments to incorporate monopolar electrosurgicalcapability on an endoscopic curved scissor instrument. This modificationaffects the instrument only and there are no changes in the design,technology, materials, manufacturing, performance, specifications, andmethod of use for the da Vinci® Surgical System.The endoscopic instruments are used with the da Vinci® Surgical Systemwhich consists of two integrated sub-systems as follows:

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K050005 2/3 008

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 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.

The Intuitive Surgical Endoscopic Instrument Control System is Intended Use 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/pickups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, dissection, approximation, ligation. and sharp cutting, blunt electrocautery, suturing and delivery and placement of microwave ablation probes and accessories during general laparoscopic surgical non-cardiovascular thoracoscopic surgical procedures. general procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. 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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Kosovoos 3/3 009

Comparison toPredicateDevice	The design, technology, materials, manufacturing methods, performance,specifications and methods of use are essentially the same for theMonopolar Curved Scissors as for other Intuitive Surgical® EndoscopicInstruments with the primary difference being that monopolarelectrosurgical capability is incorporated into a curved scissor instrument.There are no changes in the design, technology, materials,manufacturing, performance, specifications, and method of use for the daVinci® Surgical System
TechnologicalCharacteristics	The technological characteristics of the subject devices are essentially thesame as for the predicate devices.
PerformanceData	Design analysis and comparison, as well as bench testing, has beenconducted to confirm that basic functional characteristics aresubstantially equivalent to the predicate devices cited, and that designoutput meets the design input requirements.
Conclusion	Based upon the technical information, intended use, and performanceinformation provided in this pre-market notification, the da Vinci®Surgical System and Monopolar Curved Scissors described herein hasbeen shown to be substantially equivalent to current legally marketedpredicate devices, and the results of the design control process confirmthat the design output meets the design input requirements.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.

Public Health Service

JAN 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050005

Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessoreis Regulatory Class: II Product Code: NAY Dated: December 30, 2004 Received: January 3, 2005

Dear Mr. Yramategui :

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalent of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for asso stated in the encreations of the enactment date of the Medical Device Amendments, or to conniner of the to rias if its accordance with the provisions of the Federal Food, Drug, de nees that have been route approval of a premarket approval application (PMA). and Cosmetic Free (110) that the device, subject to the general controls provisions of the Act. The r ou may, areres, include requirements for annual reguirements 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 Of It Fart 877, its 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.

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Page 2 -- Mr. Michael Yramategui

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. 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):

Intuitive Surgical® Endoscopic Instrument Control System Device Name:

Indications 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)

Miriam C. Provost

(Division Sign-Off) Division of General. Restorative. and Neurological Devices

510(k) Number_4650005

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.