INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM

K013952 · Intuitive Surgical, Inc. · GCJ · Feb 28, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K013952
• Device Name: INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM
• Applicant: Intuitive Surgical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Intuitive Surgical® Stereo View Endoscopic System is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with the Intuitive Surgical® Endoscopic Instrument Control system during laparoscopic and thoracoscopic surgical procedures.

Device Story

Endoscopic system comprising endoscope, camera, and light source; used for visualization during minimally invasive surgery. Input: optical signals from internal surgical sites. Transformation: 3-channel optical path allows surgeon to toggle between 3D stereo view and 2D wide-angle view via video switch on vision system cart. Output: visual feed displayed to surgeon. Used in OR by surgeons during laparoscopic/thoracoscopic procedures. Facilitates navigation and instrument control within peritoneal/thoracic cavities; enhances surgical precision via depth perception provided by stereo imaging.

Clinical Evidence

Bench testing only. Design analysis and comparison confirm functional equivalence. Biocompatibility verified per ISO 10993. Electrical safety and electromagnetic compatibility verified per UL 2601-1, CSA C22.2 No 601.1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and EN 55011.

Technological Characteristics

Rigid endoscope with 3-channel optical system. Materials: biocompatible materials consistent with ISO 10993. Connectivity: connects to vision system cart (illumination sources, camera controllers, video processing). Standards: UL 2601-1, CSA C22.2 No 601.1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, EN 55011.

Indications for Use

Indicated for endoscopic visualization of internal surgical sites during minimally invasive laparoscopic and thoracoscopic procedures within the peritoneal and thoracic cavities.

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® Stereo View Endoscopic System (K990188)
• Intuitive Surgical® Stereo View Endoscopic System (K001666)

Submission Summary (Full Text)

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## Section II

## FEB 2 8 2002

## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance This summary of STO(It) callory and 21 CFR 807.92.

510(k) Number: K O 13 952

| Date | November 28, 2001 | |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Submitter | Intuitive Surgical<br>1340 West Middlefield Road<br>Mountain View, CA 94043 | |
| ER Number | 2955842 | |
| Contact | Michael Yramategui<br>Director, Quality and Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | |
| New Device | Name: Intuitive Surgical® Stereo View Endoscopic System | |
| | Classification Name: | |
| | Endoscope and Accessories | 21 CFR §876.1500 |
| | Rigid Endoscope | 21 CFR §876.1500 |
| | Gynecologic Laparoscope/Accessories | 21 CFR §884.1720 |
| | Common Name: 3-D Endoscope and Accessories | |
| Predicate Devices | Intuitive Surgical® Stereo View Endoscopic System<br>(legally marketed under K990188 and K001666) | |

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#### Device Description

The Intuitive Surgical® Stereo View System consists of an endoscope, camera, and light source. The endoscope is essentially identical in size and shape to the predicate devices referenced above, but built by a different manufacturer. This endoscope has 3 channels allowing the surgeon to alternate between a stereo threedimensional view and a wide angle two-dimensional view using a simple video switch that can be used to toggle between the two images. This switch is located between the camera and the Intuitive Surgical® Endoscopic Instrument Control System, on a vision system cart that includes the illumination sources, camera controllers and other video processing equipment. The camera controllers and illumination sources that attach to the endoscope and camera are identical in function to those described for the predicate devices. The intended use for the subject device is identical to the previously cleared intended use for the Intuitive Surgical® Stereo View Endoscopic System through the premarket notification process (K990188 and K001666).

The Intuitive Surgical® Stereo View Endoscopic System is intended Intended Use for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with the Intuitive Surgical® Endoscopic Instrument Control system during laparoscopic and thoracoscopic surgical procedures.

The basic design and function of the Intuitive Surgical® Stereo View Comparison to Endoscopic System is essentially identical in terms of shape, size, Predicate materials, and function to the predicate device, except that it is built Device by a different manufacturer and includes an additional optical and video channel. The illuminator (light source) and light guide are similar in function to those described in the predicate system.

#### Technological Characteristics

The technological characteristics of the subject devices are similar to those of the predicate devices.

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#### Performance Data

Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the predicate device cited. Components of the Intuitive Surgical® Stereo View Endoscopic System are manufactured using materials that are identical to materials used in the predicate device that have a long history of human contact bio-compatibility. Where applicable, electrical components of the Intuitive Surgical® Stereo View Endoscopic System have been tested to ensure compliance with safety characteristics described in standards from UL 2601-1, CSA C22.2 No 601.1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and EN 55011, as well as relevant provisions of the European Medical Device Directive 93/42/EEC. The biocompatibility of materials used in the subject device is consistent with standards described in ISO 10993.

#### Conclusion

Based upon the product technical information provided, intended use, and performance information provided in this pre-market notification, the Intuitive Surgical® Stereo View Endoscopic System described herein is substantially equivalent to the current legally marketed predicate devices (K990188 and K001666).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles a caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2002

Mr. Michael Yramategui Director, Quality and Regulatory Affairs Intuitive Surgical 1340 West Middlefield Road Mountain View, California 94043

Re: K013952

Trade/Device Name: Intuitive Surgical® Stereo View Endoscopic System Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: November 28, 2001 Received: November 30, 2001

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 Yramategui

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will anow you to obgin mailing of substantial equivalence of your device to a legally premaired predicated 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 and If you desire specific ad 1.0 for in vitro diagnostic devices), please contact the Office of additionally 21 OF R Far 807. Additionally, for questions on the promotion and advertising of Compliance at (301) by the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation ciritied, "Miooranang of esponsibilities under the Act may be obtained from the Oiler general information of your versational 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 Millman

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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### Section III

# INDICATIONS FOR USE STATEMENT

k013952 510(k) Number (if known):

Device name: Intuitive Surgical® Stereo View Endoscopic System

Indications for Use:

The Intuitive Surgical® Stereo View Endoscopic System is intended for endoscopic I he internal surgery sites during minimally invasive surgery in the peritoneal viewing of internal surgery sites daming hammary new with the Intuitive Surgical®
cavity, thoracic cavity, and peritoneum. It is designed for use with researche surgical Carly, undracte cavity, and periodical and the proscopic and thoracoscopic surgical procedures.

### PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-align:center;">X</div> | Over-the Counter Use | |
|------------------|-----------------------------------------|----------------------|--|
|------------------|-----------------------------------------|----------------------|--|

(per 21 CFR
§801.109

[Signature]

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

| 510(k) Number | K013952 |
|---------------|---------|
|---------------|---------|

(Optional Format 1-2-96)