INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS

K040237 · Intuitive Surgical, Inc. · NAY · Jul 7, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040237
• Device Name: INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Jul 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intuitive Surgical® Endoscopic Instrument Control System (hereinafter referred to as the "da Vinci™ System") 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, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing during general 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. 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 Instructions for Use.

Device Story

da Vinci Surgical System assists physicians in performing minimally invasive surgery. System provides accurate control of endoscopic instruments (dissectors, scissors, scalpels, forceps, needle holders, retractors, stabilizers, electrocautery). Used in operating rooms by trained physicians for laparoscopic and thoracoscopic procedures, including cardiac revascularization. System enables precise tissue manipulation, grasping, cutting, dissection, approximation, ligation, and suturing. Benefits include enhanced control during complex endoscopic procedures.

Clinical Evidence

Bench testing only. Design analysis and in vitro testing confirm functional characteristics are substantially equivalent to predicate devices.

Technological Characteristics

System consists of endoscopic instrument control system and accessories. Instruments are modified standard surgical tools for robotic-assisted use. Function, size, and shape are equivalent to standard endoscopic medical devices.

Indications for Use

Indicated for trained physicians performing general laparoscopic, general noncardiovascular thoracoscopic, and thoracoscopically-assisted cardiotomy procedures, including coronary anastomosis during cardiac revascularization, using endoscopic instruments for tissue manipulation, dissection, and suturing.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• K022574
• K021036
• K011002
• K002489
• K990144
• K965001

Submission Summary (Full Text)

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JUL - 7 2004

# 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: K040237

#### Applicant Information:

| Date Prepared: | January 28, 2004 |
|-------------------|-----------------------------------------------|
| Name: | Intuitive Surgical, Inc. |
| Address: | 950 Kifer Road<br>Sunnyvale, California 94086 |
| Contact Person: | Usha Kreaden, M.Sc |
| Phone Number: | [phone] |
| Facsimile Number: | [phone] |
| E-mail: | [e-mail] |

#### Device Information:

| Classification/Name: | Class II<br>Endoscope and Accessories (21 CFR §876.1500)<br>Gynecologic Laparoscope and Accessories (21 CFR §884.1720 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Intuitive Surgical® da Vinci™ Endoscopic Instrument<br>Control System and Endoscopic Instruments or da Vinci™ Surgical System |
| Common Name: | Endoscopic Instruments, Control System and Accessories |

#### Predicate Devices:

Substantial equivalence data for the Intuitive Surgical® da Vinci™ Surgical System and Endoscopic Instruments were provided in the original pre-market notifications (K022574, K021036, K011002, K002489, K990144, K965001).

#### Device Description:

The working ends and elements of the Intuitive Surgical® da Vinci™ Surgical System, Endoscopic Instruments and Accessories are essentially identical in function, size and shape to the predicate devices referenced. They represent standard embodiments of

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standard surgical tools, which have been modified for use with the Intuitive Surgical® da Vinci™ Surgical System.

## Indications for Use:

The Intuitive Surgical® Endoscopic Instrument Control System (hereinafter referred to as the "da Vinci™ System") 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, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing during general 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. 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 Instructions for Use.

## Comparison to Predicate Device(s):

The Intuitive Surgical® Instruments are essentially identical in terms of shape, size, function and tissue effect to the standard Class I and II endoscopic medical devices previously cited.

## In Vitro Test Data:

Design analysis and comparison as well as in vitro testing confirm that basic functional characteristics are substantially equivalent to the predicate devices cited.

### Summary:

Based upon the product technical information provided, intended use, and performance information provided in this pre-market notification, the Intuitive Surgical® Endoscopic Instrument Control System has been shown to be substantially equivalent to currently marketed predicate devices.

Intuitive® and Intuitive Surgical® is a registered trademark of Intuitive Surgical, Inc.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Usha S. Kreaden Director Clinical and Regulatory Affairs Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, California 94086

JUL - 7 2004

Re: K040237

Trade/Device Name: Intuitive Surgical Endoscopic Instrument Control System and Endoscopic Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscopes and accessories Regulatory Class: II Product Code: NAY Dated: June 9, 2004 Received: June 15, 2004

Dear Ms. Kreaden:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce pror of they 2017 - 11:14 provisions of the Federal Food, Drug, de nees may na ve been resuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelevy, mans of the Act include requirements for annual registration, listing of general voltarely pro revering 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 rryour device is classified (600 as 2010). Existing major regulations affecting your device can may be subject to back as a same as a ritle 21, Parts 800 to 898. In addition, FDA may be found in the Coursements 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 that + Dr has Intatutes and regulations administered by other Federal agencies. You must or any I cateral state and strequirements, 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 – Ms. Usha S. Kreaden

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will anow your your e 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 11 you aton't the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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): K040237

Device Name: Intuitive Surgical® Endoscopic Instrument Control System and Endoscopic Instruments

Indications For Use:

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adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It adjunctive meanability will be mained 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)

Miriam C. Provost

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

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