INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1

K990188 · Intuitive Surgical, Inc. · GCJ · Apr 1, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990188
• Device Name: INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1
• Applicant: Intuitive Surgical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 1, 1999
• 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 surgical sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed to be used with the Intuitive Surgical™ Endoscopic Instrument Control System during thoracoscopic and laparoscopic surgical procedures.

Device Story

System consists of stereo endoscope, camera, and light source; designed for attachment to Intuitive Surgical™ Endoscopic Instrument Control System. Provides 3D visualization of internal surgical sites during minimally invasive procedures (thoracoscopic/laparoscopic). Used in OR by surgeons to view anatomy; facilitates minimally invasive surgical intervention. Substantially equivalent to existing 3D endoscopic systems.

Clinical Evidence

Bench testing only. Design analysis and comparison to predicate devices confirm functional equivalence.

Technological Characteristics

Rigid endoscope system; 3D stereo visualization; includes camera and light source. Materials, size, and shape are essentially identical to standard endoscopes. Connectivity via attachment to Intuitive Surgical™ Endoscopic Instrument Control System.

Indications for Use

Indicated for endoscopic viewing of internal surgical sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. Designed for use with the Intuitive Surgical™ Endoscopic Instrument Control System during thoracoscopic and laparoscopic surgical procedures.

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

• Olympus 3D Surgical Endoscopy System (K943305)
• Origin/Medsystems 5mm Endoscope (K960637)

Submission Summary (Full Text)

{0}------------------------------------------------

4/1/99

## 510(k) SUMMARY

# K990188

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: TBD

### Applicant Information:

| Date Prepared: | January 1, 1999 |
|-------------------|-----------------------------------------------------------------------------|
| Name: | Intuitive Surgical, Inc. |
| Address: | 1340 W. Middlefield Road<br>Mountain View, California 94043<br>650-237-7000 |
| Contact Person: | John N. Zorich, Jr. |
| Phone Number: | [phone] |
| Facsimile Number: | [phone] |

#### Device Information:

| Classification: | Class II | Gynecologic Laparoscope and Accessories<br>Rigid Endoscope<br>Endoscope and Accessories | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--|
| Trade Name: | Intuitive Surgical™ Instruments / Accessories: Endoscopic<br>Instruments including: Stereo Endoscope and accessories for use<br>with: The Intuitive Surgical™, Endoscopic Instrument Control<br>System | | |
| Common Name: | 3D Endoscope and Accessories | | |
| Classification Name: | Endoscope and Accessories<br>Rigid Endoscope<br>Gynecologic laparoscope and Accessories, | 21 CFR 876.1500<br>21 CFR 876.1500<br>21 CFR 884.1720 | |

### Predicate Devices:

The Intuitive Surgical™ Endoscope is substantially equivalent in intended use and/or method of operation to the following predicate devices:

Olympus 3D Surgical Endoscopy System ( Premarket Notification # K943305) Origin/Medsystems 5mm Endoscope (Premarket Notification # K960637)

{1}------------------------------------------------

#### Device Description:

The Intuitive Surgical™ Stereo View System consists of an Intuitive Surgical endoscope, an Intuitive Surgical camera, and a commercially available light source. The endoscope is essentially identical in size and shape to the predicate devices referenced above, with minor modifications so that it can be attached to the Intuitive Surgical™ Endoscopic Instrument Control System. The camera and illumination sources attach to the endoscope and are essentially identical in function to those incorporated with the predicate Olympus System.

#### Intended Use:

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

#### Comparison to Predicate Devices:

The Intuitive Surgical™ Stereo View Endoscopic System endoscopes are essentially identical in terms of shape, size, materials, and function to the standard endoscopes cited. The stereo view feature of the camera is essentially identical to the 3D feature of the predicate Olympus System. The illumination source is identical to the one in the predicate Olympus system.

#### Test Data:

Design analysis and comparison 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 Stereo View Endoscopic 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three overlapping human profiles facing to the right, with flowing lines beneath them that resemble water or fabric.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1999 APR

Mr. John N. Zorich, Jr. Manager, Quality Systems and Regulatory Compliance Intuitive Surgical, Inc. 1340 West Middlefield Road Mountain View, California 94043

Re: K990188 Trade Name: Intuitive Surgical™ Stereo View Endoscopic System Regulatory Class: II Product Code: GCJ Dated: January 19, 1999 Received: January 20, 1999

Dear Mr. Zorich:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2 - Mr. John N. Zorich, Jr.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten. Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

#### K 990188 510(k) Number (if known): TBD

Intuitive Surgical™ Stereo View Endoscopic System Device Name:

Indications For Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

colees

Restorative Devices

Image /page/4/Picture/12 description: The image shows the words "Prescription Use" on the top line. The second line says "(Pcr 21 CFR 801.109)". There is a line above the second line that extends to the right, and there is an X drawn over the right side of the line.

OR

Over-The-Counter Use

page 9

(Optional Format 1-2-96)