INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182

K060391 · Intuitive Surgical, Inc. · NAY · Apr 10, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060391
• Device Name: INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182
• Applicant: Intuitive Surgical, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Apr 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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/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 Story

EndoWrist Stabilizer is a robotic surgical instrument modification for the da Vinci Surgical System; incorporates vacuum-based tissue stabilization and irrigation functionality. Input: pressurized irrigation fluid and vacuum source. Operation: surgeon at console controls instrument via Master Tool Manipulators (MTM); stabilizer pods provide suction to grip tissue; irrigation clears blood from surgical site. Output: stabilized, irrigated tissue for improved visualization and access during cardiac revascularization or other procedures. Used in operating rooms by trained physicians. Benefits: enhanced tissue stability and site clarity during complex robotic procedures.

Clinical Evidence

Bench testing only. Design analysis and functional testing confirmed that the EndoWrist Stabilizer meets design input requirements and performs equivalently to the predicate devices.

Technological Characteristics

Multiple-use robotic instrument with collapsible suction pods. Includes disposable tubing assemblies (ClearField for irrigation, CardioVac/Vacuum Source for suction). Robotic operation via da Vinci Surgical System (IS2000). Materials and architecture identical to existing EndoWrist instruments; stabilizer end-effector and irrigation features identical to Medtronic Octopus TE.

Indications for Use

Indicated for adult and pediatric patients undergoing urologic, general laparoscopic, gynecologic laparoscopic, general non-cardiovascular thoracoscopic, and thoracoscopically assisted cardiotomy procedures, including coronary anastomosis via adjunctive mediastinotomy. Used by trained physicians in operating rooms.

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 Surgical System and Endoscopic Instruments (K990144, K050369, K050802)
• Medtronic Octopus TE Tissue Stabilizer (K041338)

Submission Summary (Full Text)

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APR 1 0 2006

## 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 | 13 February 2006 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Intuitive Surgical, Inc.<br>950 Kifer Road<br>Sunnyvale, CA 94086 |
| ER Number | 2955842 |
| Contact | Mike Yramategui<br>Director, Regulatory and Quality Affairs<br>Telephone: (408) 523 - 2145<br>Fax: (408) 523 - 1390<br>e-mail: [e-mail] |
| Subject<br>Device | Trade Name: Intuitive Surgical EndoWrist® Stabilizer<br>Classification Name: System, Surgical, Computer Controlled Instrument<br>(21 CFR 876.1500)<br>Common Name: Cardiovascular Surgical Instrument / Heart Stabilizer |
| Predicate<br>Devices | Intuitive Surgical da Vinci® Surgical System and Endoscopic Instruments<br>is the predicate device (legally marketed under K990144, modified under<br>K050369, and labeling modified under K050802). The Medtronic<br>Octopus TE Tissue Stabilizer, K041338, is listed as a secondary predicate<br>device, due to this submission being a design modification of the<br>Intuitive Surgical instruments to incorporate the features of the<br>Medtronic Octopus TE Tissue Stabilizer as described in this submission. |

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### Device Description

This SPECIAL 510(k) is being submitted for a design modification to the Intuitive Surgical EndoWrist Instruments to incorporate the functionality (vacuum stabilization, irrigation) of the Medtronic Octopus TE Tissue Stabilizer (class I, cardiovascular surgical instrument, Product Codes DWS and MWS, under CFR Section 870.4500) on an EndoWrist Instrument known as the EndoWrist Stabilizer. This modification affects the instrument only, and there are no changes to the da Vinci Surgical System associated with this pre-market notification.

The Intuitive Surgical EndoWrist Stabilizer is a multiple use instrument similar to existing EndoWrist instruments and has the following key features:

- The EndoWrist Stabilizer incorporates collapsible "pods" as grips that ্ত provide suction based tissue stabilization. The collapsible feature allows the instrument to be used through a 12mm thoracic port.
- o A disposable, pre-packaged sterilized tubing assembly known as "ClearField" tubing is used to connect the instrument to pressurized irrigation fluid to irrigate the surgical site reducing the amount of blood on the stabilized tissue.
- A disposable, pre-packaged sterilized tubing assembly known as o "CardioVac" tubing provides vacuum suction to the stabilizer pods from the Vacuum Source tubing described below.
- O A disposable, pre-packaged sterilized tubing assembly known as "Vacuum Source" tubing that connects the CardioVac tubing to a canister with a four-meter vacuum hose, and also includes a two-meter vacuum hose (with filter) to connect to a regulated vacuum source.

The Intuitive Surgical Endowrist Stabilizer is used with the da Vinci Surgical System Model IS2000, which is also known as the da Vincis S™ Surgical System. The surgeon sits at a Surgeon Console and controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The EndoWrist Stabilizer is operated in the same way as other Intuitive Surgical EndoWrist Instruments, and the surgeon "locks" the stabilizer in position by switching MTM control away from the arm holding the tabilizer instrument by tapping a foot pedal on the Surgeon Console.

#### The Intuitive Surgical Endoscopic Instrument Control System is intended Intended Use 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

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| | for endoscopic manipulation of tissue, including grasping, cutting, blunt<br>and sharp dissection, approximation, ligation, electrocautery, suturing, and<br>delivery and placement of microwave ablation probes and accessories<br>during urologic surgical procedures, general laparoscopic surgical<br>procedures, gynecologic laparoscopic surgical procedures, general non-<br>cardiovascular thoracoscopic surgical procedures, and thoracoscopically<br>assisted cardiotomy procedures,. The system can also be employed with<br>adjunctive mediastinotomy to perform coronary anastomosis during cardiac<br>revascularization. The system is indicated for adult and pediatric use. It is<br>intended for use by trained physicians in an operating room environment in<br>accordance with the representative, specific procedures set forth in the<br>Professional Instructions for Use. |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>Predicate<br>Device | The Intuitive Surgical EndoWrist Stabilizer is identical to existing Intuitive<br>Surgical endoscopic instruments as cleared by FDA under K050369 with<br>the additional functionality of vacuum stabilization and irrigation as<br>incorporated on a Class I tissue stabilizer. The vacuum stabilization and<br>irrigation features are identical to the Medtronic Octopus TE Tissue<br>Stabilizer and accessories cleared by FDA under K041338. There are no<br>changes in the design, technology, materials, manufacturing, performance,<br>specifications, and method of use for the da Vinci Surgical System. |
| Technological<br>Characteristics | The technological characteristics of the subject device are the same as for<br>the predicate device(s). The robotic operation and architecture are the<br>same as existing Intuitive Surgical EndoWrist Instruments; the stabilizer<br>end effector and irrigation is the same as the Octopus TE Stabilizer<br>(Medtronic). |
| Performance<br>Data | Design Analysis and comparison, as well as bench testing, has been<br>conducted to confirm that basic functional characteristics are substantially<br>equivalent to the predicate devices cited, and that the design output meets<br>the design input requirements. |
| Conclusion | Based upon the technical information, intended use, and performance data<br>provided in this pre-market notification, the Intuitive Surgical EndoWrist<br>Stabilizer as used with the da Vinci S Surgical System described herein, has<br>been shown to be substantially equivalent to current legally marketed<br>predicate devices, and the results of the design control process confirm that<br>the design input meets the design output requirements, and that the there<br>are no new issues of safety or effectiveness. |

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APR 1 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Intuitive Surgical, Inc. c/o Mr. Michael H. Yramategui Senior Director, Regulatory & Quality Affairs 950 Kifer Road Sunnyvale, California 94086

Re: K060391

Trade/Device Name: Intuitive Surgical Endowrist® Stabilizer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NAY Dated: March 16, 2006 Received: March 21, 2006

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.set

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## Page 2 - Mr. Michael H. Yramategui

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. 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 [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,

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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# Indications for Use

510(k) Number (if known):

Device Name: Intuitive Surgical Endowrist® Stabilizer For use with Intuitive Surgical Endoscopic Instrument Control System

#### Indications For Use:

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 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)

l.gll.

Division of General. Restorative. and Neurological Devices

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