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, blunt and sharp dissection, approximation, ligation. cutting. electrocautery and suturing 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.

Intuitive Surgical® Harmonic Curved Shears Instruments are designed to be used in conjunction with the da Vinci® Surgical System and with the Ethicon Endo-Surgery UltraCision® Harmonic Scalpel® Hand Piece (HP054) and UltraCision® Harmonic Scalpel® Generator Model 300 (GEN04), and is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. This instrument is not intended for use on cartilage, bone or hard objects, or for contraceptive tubal occlusion.

Device Description

This special 510(k) is being submitted for a modification of Intuitive Surgical® Ultrasonic Shears. The subject device is similar to the Ultrasonic Shears instrument cleared by FDA in 2001 (K011281) and UltraCision® Harmonic Scalpel® LCS & CS Curved Shears instrument cleared by FDA in 2001 for Ethicon Endo-Surgery, Inc. (K993054). The Harmonic Curved Shears Instruments are to be used with the Intuitive Surgical® Endoscopic Instrument Control System, known as the da Vinci® Surgical System.

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

This submission is an abbreviated 510(k) for a modified device. The review of this document indicates that the acceptance criteria are not explicitly defined in terms of specific performance metrics or thresholds. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through design analysis, comparison, and bench testing, confirming that the basic functional characteristics are the same and that the design output meets the design input requirements.

Here's a breakdown of the requested information based on the provided text:

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

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device in terms of shape, function, activation, and use.	The device is essentially identical in terms of shape, function, activation, and use to the predicate Class II endoscopic instrument. The primary difference is the use with the da Vinci Surgical System.
Basic functional characteristics are met and substantially equivalent to predicate devices.	Bench testing confirms that basic functional characteristics are substantially equivalent to the predicate devices.
Design output meets design input requirements.	Design analysis and comparison, as well as bench testing confirm that design output meets the design input requirements.

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

The document does not specify a "test set" in the context of clinical data or patient data. The performance evaluation is based on "design analysis and comparison" and "bench testing." Therefore, information on sample size and data provenance for a clinical test set is not applicable or provided.

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):

This information is not applicable as the performance evaluation is based on engineering design and bench testing, not on expert-adjudicated clinical ground truth from a test set.

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

This information is not applicable, as there is no mention of a human-adjudicated test set.

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:

This is not an AI/CAD device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

This is not an AI/CAD device. Therefore, standalone algorithm performance is not applicable.

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

The "ground truth" for this engineering-focused submission is established through comparison with predicate devices and verification against design input requirements via bench testing and design analysis, rather than clinical outcomes or expert consensus on clinical data.

8. The sample size for the training set:

This information is not applicable as this is not an AI/CAD device that relies on a training set of data.

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

This information is not applicable as this is not an AI/CAD device that relies on a training set of data with established ground truth.

Summary

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K042855 1/2

NOV 1 2 2004

Section II

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance I ms summary of 91 ST (1) santy said 21 CFR 807.92.

510(k) Number:

Date	October 12, 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
New Device	Name: Harmonic Curved Shears InstrumentClassification Name: System, Surgical, Computer Controlled InstrumentCommon Name: Endoscopic Instrument, Harmonic Curved Shears
PredicateDevices	Intuitive Surgical® Endoscopic Instrument Control System and IntuitiveSurgical® Endoscopic Instruments and accessories (legally marketedunder K990144 / K002489 / K011002 / K021036 / K022574 / K040237),Intuitive Surgical® Ultrasonic Shears (K011281) and Ethicon Endo-Surgery, Inc., UltraCision® Harmonic Scalpel® LCS & CS Curved Shears(K993054).
DeviceDescription	This special 510(k) is being submitted for a modification of IntuitiveSurgical® Ultrasonic Shears. The subject device is similar to theUltrasonic Shears instrument cleared by FDA in 2001 (K011281) andUltraCision® Harmonic Scalpel® LCS & CS Curved Shears instrumentcleared by FDA in 2001 for Ethicon Endo-Surgery, Inc. (K993054). TheHarmonic Curved Shears Instruments are to be used with the IntuitiveSurgical® Endoscopic Instrument Control System, known as the daVinci® Surgical System.

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2042855 2/2

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

Device Description (continued)

The Intuitive Surgical® Endoscopic Instrument Control System Intended Use 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, blunt and sharp dissection, approximation, ligation. cutting. electrocautery and suturing 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.

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Intended Use(continued)	Intuitive Surgical® Harmonic Curved Shears Instruments are designed tobe used in conjunction with the da Vinci® Surgical System and with theEthicon Endo-Surgery UltraCision® Harmonic Scalpel® Hand Piece(HP054) and UltraCision® Harmonic Scalpel® Generator Model 300(GEN04), and is intended for soft tissue incisions when bleeding controland minimal thermal injury are desired. This instrument is not intendedfor use on cartilage, bone or hard objects, or for contraceptive tubalocclusion.
Comparison toPredicateDevice	The Intuitive Surgical® Harmonic Curved Shears Instruments describedherein is essentially identical in terms of shape, function, activation, anduse to the predicate Class II endoscopic instrument cited. The primarydifference is that the Ethicon Endo-Surgery predicate device is a hand-held instrument, and the subject device is to be used in conjunction withthe Intuitive Surgical® da Vinci Surgical System.
TechnologicalCharacteristics	The technological characteristics of the subject devices are the same asfor the predicate devices.
PerformanceData	Design analysis and comparison, as well as bench testing confirm thatbasic functional characteristics are substantially equivalent to thepredicate devices cited, and that design output meets the design inputrequirements.
Conclusion	Based upon the product technical information, intended use, andperformance information provided in this pre-market notification, theIntuitive Surgical® Harmonic Curved Shears Instruments describedherein has been shown to be substantially equivalent to current legallymarketed predicate devices, and the results of the design control processconfirm that the design output meets the design input requirements.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with its wings spread. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2004

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

Re: K042855

Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control System Regulation Number: 21 CFR 876. 1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NA Y Dated: October 13, 2004 Received: October 15, 2004

Dear Mr. Yramategui:

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.

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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) 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provoost

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:

The Intuitive Surgical® Endoscopic Instrument Control System is intended to assist in the The Minine Surgical "Endoscopic Instruments including rigid endoscopes, accurate control of nonomic dissectors, scalpels, ultrasonic shears, forceps/pickups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for ups, neoule norders, choos tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing during general laparoscopic surgical approximation, neation, on-cardiovascular thoracoscopic surgical procedures, and procedures, general cardiotomy procedures. The system can also be employed, with mediastinotomy to perform coronary anastomosis during cardiac adjunctive adjunctive mediabline 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 __ X (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 K042855

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Intuitive Surgical® Harmonic Curved Shears Instruments

SPECIAL 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.