INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER

K072627 · Intuitive Surgical, Inc. · NAY · Feb 7, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K072627
• Device Name: INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Feb 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intuitive Surgical EndoWrist Introducer, 5Fr is intended to be used as a conduit through which compatible surgical laser fibers may be held and directed in conjunction with da Vinci and da Vinci S surgical systems. At this time, only the following surgical laser systems are compatible for use with the da Vinci and da Vinci S systems: Lisa Laser Revolix Jr. and Laserscope Aura-XP systems. It may also be used to perform blunt dissection when the laser fiber is retracted or not within the instrument.

Device Story

EndoWrist Introducer, 5Fr is a modified endoscopic instrument for da Vinci and da Vinci S surgical systems. Device acts as a conduit to hold and position compatible surgical laser fibers (Laserscope Aura XP or Lisa Laser RevoLix Jr.) during laser-assisted surgery. Instrument features a modified distal tip lumen to accommodate laser fibers and sheaths; cautery functionality from predicate removed. Used by surgeons in clinical settings to direct laser energy or perform blunt tissue dissection when fiber is retracted. Device does not conduct laser energy directly; it serves as a mechanical positioning tool. Benefits include integration of laser therapy into robotic-assisted surgical workflows.

Clinical Evidence

Bench testing only. Design analysis and comparison confirmed functional characteristics are substantially equivalent to predicate devices and meet design input requirements.

Technological Characteristics

Endoscopic instrument for robotic surgical systems. Materials, manufacturing, and sterilization processes are identical to predicate da Vinci instruments. Features a distal tip lumen for laser fiber passage. Mechanical device; no electrical energy conduction. Compatible with da Vinci and da Vinci S systems (IS1200/IS2000).

Indications for Use

Indicated for use as a conduit to hold and direct compatible surgical laser fibers during surgical procedures performed with da Vinci and da Vinci S surgical systems; also indicated for blunt tissue dissection.

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

• Intuitive Surgical da Vinci and da Vinci S Surgical System and Endoscopic Instruments (K990144, K002489, K011002, K013416, K021036, K022574, K040237, K43153, K043288, K050404, K050369, K050802, K063220)
• Intuitive Surgical EndoWrist Monopolar Cautery Instrument (K990144, K013416, K021036, K050369)
• Laserscope Aura XP Series Surgical Laser System & Accessories (K024206)
• Lisa Laser RevoLix Family of Laser Systems (K051167)

Submission Summary (Full Text)

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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.

#### 510(k) Number: K072627

| Date | January 30, 2008 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Intuitive Surgical, Inc.<br>950 Kifer Road<br>Sunnyvale, CA 94086 |
| ER Number | 2955842 |
| Contact | Michael Yramategui<br>Sr. Director, Regulatory Affairs<br>Telephone: (408) 523 - 2145<br>Fax: (408) 523 - 1390<br>E-mail: [e-mail] |
| Subject<br>Device | Trade Name(s):<br>Intuitive Surgical® EndoWrist® Introducer, 5Fr Instrument<br>Classification Name:<br>System, Surgical, Computer Controlled Instrument (21 CFR 876.1500)<br>Common Name:<br>Endoscopic Instrument Control System, Endoscopic Instruments and Accessories<br>Device Class:<br>Intuitive Surgical® da Vinci® Surgical System and Endoscopic Instruments: Class II, NAY, System, Surgical, Computer Controlled Instrument |

11:

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| Predicate<br>Devices | Intuitive Surgical da Vinci® and da Vinci® S™ Surgical System and<br>Endoscopic Instruments<br>(legally marketed under K990144, K002489, K011002,<br>K013416, K021036, K022574, K040237, K43153, K043288,<br>K050404, K050369, K050802 and K063220) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intuitive Surgical EndoWrist® Monopolar Cautery Instrument<br>(legally marketed under K990144, K013416, K021036, and<br>K050369) |
| | Laserscope Aura XP™ Series Surgical Laser System & Accessories<br>(legally marketed under K024206) |
| | Lisa Laser RevoLix™ Family of Laser Systems including the<br>RevoLix and RevoLix Jr.<br>(legally marketed under K051167) |
| Device<br>Description | This 510(k) is being submitted for a modified EndoWrist®<br>instrument, the EndoWrist Introducer, 5Fr, to be utilized with<br>surgical lasers delivering energy through flexible laser fibers. This |

submission also includes the product labeling for the new instrument. There are no changes in the design, technology, materials, manufacturing, performance, specifications or method of use for the da Vinci Surgical System or the other predicate devices listed.

## EndoWrist® Introducer, 5Fr

The Introducer, 5Fr is used with the da Vinci Surgical Systems to hold and position compatible laser fibers used in conjunction with surgical laser systems such as the Laserscope Aura XP or Lisa Laser RevoLix Jr. Laser Systems during indicated surgical procedures. The instrument will also facilitate blunt tissue dissection when the fiber is not present or is retracted into the instrument. The "Introducer, 5Fr" instrument may herein be referred to as the "Introducer" or the "Introducer Instrument".

Similar to currently used minimally invasive endoscopic or laparoscopic surgical instruments, the Introducer Instrument will only hold and position surgical laser fibers and will not directly conduct laser energy.

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Device This Intuitive Surgical instrument is compatible with the Description previously cleared da Vinci and da Vinci S Endoscopic (continued) Instrument Control Systems Models IS1200 and IS2000. To address use of the Introducer Instrument with surgical laser systems, a supplemental Instructions for Use sheet is included with each Introducer instrument. EndoWrist® Introducer, 5Fr Intended Use The Intuitive Surgical EndoWrist Introducer, 5Fr is intended to be used as a conduit through which compatible surgical laser fibers may be held and directed in conjunction with da Vinci and da Vinci S surgical systems. At this time, only the following surgical laser systems are compatible for use with the da Vinci and da Vinci S systems: Lisa Laser Revolix Jr. and Laserscope Aura-XP systems. It may also be used to perform blunt dissection when the laser fiber is retracted or not within the instrument. EndoWrist® Introducer, 5Fr Comparison to Predicate The predicate device, the 5mm Monopolar Cautery Instrument, Device was modified to meet the requirements of the Introducer Instrument. The cautery function has been removed, as the Introducer Instrument is intended to only hold and position compatible laser fibers. Consequently, all electrical contacts, wiring and other components related to the cautery function have been removed. The distal tip lumen was modified to accept a laser fiber and a laser fiber sheath, and the distal tip will no longer accept the cautery accessories, but is now shaped to facilitate blunt dissection of tissue when the laser is not activated. There is no change in the instrument technology, materials, manufacturing or sterilization processes, common instrument requirements or compatibility with the da Vinci Surgical Systems.

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| Comparison to<br>Predicate<br>Device<br>(continued) | Labeling modification for the Introducer Instrument consists of<br>updated box labeling and the addition of a supplement to the<br>Instrument Instructions For Use which describes the use of the<br>instrument with surgical laser systems. |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | da Vinci® Surgical Systems, Laserscope Aura XP™ Series<br>Surgical Laser System, Lisa Laser RevoLix Jr. Surgical Laser<br>System |
| | There are no changes in the design, technology, materials,<br>manufacturing, performance, specifications, or method of use<br>for the Intuitive da Vinci Surgical Systems and there are no<br>changes intended for surgical laser systems which utilize fibers<br>compatible with the Introducer Instrument, or the fibers<br>themselves. |
| | There will be no modifications to labeling for the surgical laser<br>systems or the compatible fibers. |
| Technological<br>Characteristics | The technological characteristics of the subject devices are identical<br>to the predicate devices. |
| Performance<br>Data | Design analysis and comparison, as well as bench testing, have<br>been conducted to confirm that basic functional characteristics of<br>the subject devices are substantially equivalent to the predicate<br>devices cited, and that design output meets the design input<br>requirements. |
| Conclusion | Based upon the technical information, intended use and<br>performance information provided in this pre-market notification,<br>the EndoWrist® Introducer, 5Fr has been shown to be substantially<br>equivalent to the current legally marketed predicate device. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

FEB -- 7 ZUUS

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K072627

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: January 10, 2008 Received: January 14, 2008

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 Protmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours.

Mark N. Wilkinson

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

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### Section III

#### Indications for Use

510(k) Number (if known): K072627

Intuitive Surgical® EndoWrist Introducer, 5Fr Device Name: Indications For Use:

The Intuitive Surgical EndoWrist Introducer, 5Fr is intended to be used as a conduit through which compatible surgical laser fibers may be held and directed in conjunction with da Vinci and da Vinci S surgical systems. At this time, only the following surgical laser systems are compatible for use with the da Vinci S systems: Lisa Laser Revolix Jr. and Laserscope Aura -XP systems. It may also be used to perform blunt dissection when the laser fiber is retracted or not within the instrument.

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)

Deo Of
2/6/08

Division of Ge and Neurologica

**510(k) Number**

C6

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Intuitive Surgical® da Vinci® Surgical System Introducer, 5Fr Instrument

CONFIDENTIAL

510(k) Section III, Page 1 of 1