3-CCD DIGITAL CAMERA SYSTEM

K031098 · Linvatec Corp. · GCJ · Jun 4, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031098
• Device Name: 3-CCD DIGITAL CAMERA SYSTEM
• Applicant: Linvatec Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Linvatec 3-CCD Digital Camera System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery.

Device Story

The Linvatec 3-CCD Digital Camera System consists of a camera control unit and a camera head; used with an endoscope for visualization during minimally invasive surgical procedures. The system captures optical images via the endoscope, processes the signal, and displays the video for the surgeon. It is used in operating rooms by surgeons and clinical staff. The system is capable of interfacing with the ConMed I.S. Operating Room Control System. The device provides real-time visualization to assist the surgeon in performing procedures, potentially improving surgical outcomes by providing clear, magnified views of the surgical site.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises a camera control unit and camera head. Camera head and cable are compatible with steam sterilization. Interfaces with ConMed I.S. Operating Room Control System.

Indications for Use

Indicated for patients undergoing endoscopic surgical procedures, including orthopedic, laparoscopic, urologic, sinuscopic, plastic, and microscopic surgeries.

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

• Linvatec Corporation Digital 3-Chip Camera System (K970605)
• Stryker Endoscopy Model 888 Video Camera (K983566)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is a square with three chevrons inside. The word "Linvatec" is in a bold, sans-serif font.

Largo, FL 33773-4908 727-392-6464 11311 Concept Boulevard

April 1, 2003

# SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 3-CCD Digital Camera System 510(k) Number _________________________________________________________________________________________________________________________________________________________

#### Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

#### Company Contact B.

Laura D. Seneff, RAC Manager, Regulatory Affairs [phone] Telephone [phone] FAX

#### C. Device Name

| Trade Name: | 3-CCD Digital Camera System |
|----------------------|---------------------------------------------------------------------|
| Common Name: | 3-CCD Digital Camera System |
| Classification Name: | Laparoscope, General & Plastic Surgery<br>Endoscope and Accessories |
| Proposed Class: | Class II |
| Device Product Code: | GCJ |

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KO3109X

Summary of Safety and Effectiveness 3-CCD Digital Camera System 510(k) # April 1, 2003 Page 2 of 2

### Predicate/Legally Marketed Devices D.

Linvatec Corporation Digital 3-Chip Camera System 510(k) K970605

Stryker Endoscopy Model 888 Video Camera 510(k) K983566

## E. Device Description

The Linvatec 3-CCD Digital Camera System consists of a camera control unit and a camera head that is used in conjunction with an endoscope to allow for visualization during minimally invasive surgical procedures. Sterilization of the camera head and cable is required before use. The camera heads may be sterilized using steam sterilization.

The Linvatec 3-CCD Digital Camera System will be capable of interfacing with the ConMed I.S. Operating Room Control System with no impact on normal camera system operation.

# F. Intended Use

The Linvatec 3-CCD Digital Camera System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery.

# G. Substantial Equivalence

The 3-CCC Digital Camera System is substantially equivalent in materials, design and intended use to the predicate devices. There are no significant differences to the new device that raise issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.

Public Health Service

JUN - 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura Seneff, RAC Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K031098

Trade/Device Name: 3-CCD Digital Camera System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 1, 2003 Received: April 7, 2003

Dear Ms. Seneff:

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 - Ms. Laura Seneff, RAC

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]. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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. Milkerson

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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April 1, 2003

510(k) Number (if known): KO31099

Device Name: 3-CCD Digital Camera System

Indications for Use:

The Linvatec 3-CCD Digital Camera System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR
(Per 21 CFR 801.109)
Over-the-Counter Use_

(Optional Format 1-2-96)

Mark A. Milliken

(Division Sign-Off)

Division of General, Restorative and Neurological Devices 03 1098

510(k) Number_

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