LINVATEC 300W XENON LIGHT SOURCE

K031994 · Linvatec Corp. · GCT · Aug 21, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031994
• Device Name: LINVATEC 300W XENON LIGHT SOURCE
• Applicant: Linvatec Corp.
• Product Code: GCT · Gastroenterology, Urology
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.

Device Story

The Linvatec 300W Xenon Light Source is a light-generating device used in minimally invasive surgical procedures. It connects to an endoscope to provide illumination of the surgical site. The device features an interface capability with the ConMed I.S. Operating Room Control System, allowing for remote user control. It is intended for use in an operating room environment by trained medical professionals. By providing consistent illumination, it enables visualization of internal anatomy during endoscopic surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

300W Xenon light source; provides illumination for endoscopes; includes interface for ConMed I.S. Operating Room Control System.

Indications for Use

Indicated for use with an endoscope to provide illumination during endoscopic procedures in patients undergoing minimally invasive surgery.

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

• Karl Storz Endoscopy Xenon 300W Light Source (K962595)
• World of Medicine Lemke GMBH Endoscopic Light Source XL300/L5 (K021717)

Submission Summary (Full Text)

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June 26, 2003

# eg lof 2 KO31994

## 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 300W Xenon Light Source, 510(k) Number ________________________________________________________________________________________________________________________________________________________

#### Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

#### Company Contact B.

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

#### C. Device Name

| Trade Name: | Linvatec 300W Xenon Light Source |
|------------------------|----------------------------------|
| Common Name: | Light Source |
| Classification Name: | Endoscope and accessories |
| Classification Number: | 876.1500 |
| Proposed Class: | Class II |
| Product Code: | GCT |

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K03 1994 pg 2 of 2

Summary of Safety and Effectiveness Device Name 510(k) # June 26, 2003 Page 2 of 2

#### Predicate/Legally Marketed Devices D.

Karl Storz Endoscopy Xenon 300W Light Source 510(k) #K962595

World of Medicine Lemke GMBH Endoscopic Light Source XL300/L5 510(k) #K021717

#### ட். Device Description

The Linvatec 300W Xenon Light Source is a light generating device that when used in conjunction with an endoscope will illuminate the surgical site during minimally invasive surgical procedures.

The Linvatec 300W Xenon Light Source is capable of interfacing with the ConMed I.S. Operating Room Control System to allow an alternate means for user control.

#### F. Intended Use

The Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.

#### Substantial Equivalence G.

The Linvatec 300W Xenon Light Source described in this notification is similar in design, technology and intended use to the Karl Storz 300 Xenon Light Source (K962595) and the World of Medicine Lemke GMBH Model XL300/L5 Light Source (K021717).

The differences between the Linvatec 300W Xenon Light Source and the predicate devices are minor and raise no new questions of safety and effectiveness. Accordingly, Linvatec Corp. believes that the Linvatec 300W Xenon Light Source is equivalent to the predicate devices currently on the market.

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.

AUG 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031994

Trade/Device Name: Linvatec 300W Xenon Light Source Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCT Dated: June 26, 2003 Received: June 27, 2003

Dear Ms. Krejci:

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 Krejci

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 Mellema

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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June 26, 2003

Page 1 of 1

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Linvatec 300W Xenon Light Source

Indications for Use:

The Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.

(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 Millhuser

(Division Sign-Of Restorative Division of Gene and Neurological

510(k) Number: K03