ENDOSCOPIC LIGHT SOURCE XL202/L3

K020889 · World of Medicine Lemke GmbH · GCT · Jun 5, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020889
• Device Name: ENDOSCOPIC LIGHT SOURCE XL202/L3
• Applicant: World of Medicine Lemke GmbH
• Product Code: GCT · Gastroenterology, Urology
• Decision Date: Jun 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Endoscopic Light Source XL202/L3 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures. The device is classified as Cardiac Floating (CF) which allows the use in endoscopic cardiac procedures when used in conjunction with the proper instrumentation.

Device Story

Endoscopic light source providing illumination for fiber optic endoscopes; utilizes 180 W xenon lamp for primary illumination and 150 W halogen lamp for diagnostic applications and backup. Device connects to fiber optic cables; used in clinical settings for endoscopic surgery and diagnostics. Classified as Cardiac Floating (CF) for cardiac procedures. Healthcare providers operate the device to visualize internal anatomy, facilitating surgical or diagnostic decision-making. Benefits include reliable illumination and procedure continuity via backup lamp.

Clinical Evidence

Bench testing only. Device complies with IEC 601-1, IEC 601-1-2, and UL2601-1 standards.

Technological Characteristics

180 W xenon lamp (6000 K, 500-hour life) and 150 W halogen lamp (3400 K, 50-hour life). Cardiac Floating (CF) classification. Fiber optic cable connectivity. Complies with IEC 601-1, IEC 601-1-2, and UL2601-1.

Indications for Use

Indicated for illumination of body cavities, hollow organs, and canals during endoscopic procedures, including endoscopic cardiac procedures, in patients requiring such interventions.

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 Xenon Light Source Model 201320-20 (K934559)
• Xenon Light Source Auto Lip 5123, Model 2123.011 (K983628)
• Battery Powered Endoscopic Light Source (K960081)
• LH-150 (Pentax Precision Instrument Corp.)
• CLH-SC Halogen Light Source (Olympus America, Inc.)

Submission Summary (Full Text)

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

K020889

Poglogy

## 510(K) SUMMARY Endoscopic Light Source XL202/L3

#### L Submitter:

WORLD OF MEDICINE Lemke GmbH Danziger Strasse 21 82194 Gröbenzell Germany

#### II. Device Names:

- Classification Name: 1.
- Common or Usual Name: 2.
- Proprietary Name: 3.

Accessory to an Endoscope Endoscopic Light Source Endoscopic Light Source XL202/L3

#### III. Classification:

Class II. This device is described in 21 C.F.R. § 876.1500. The product code for the device is GCT.

#### IV. Predicate Devices:

- Karl Storz Xenon Light Source Model 201320-20 (K934559) manufactured t by Karl Storz Imaging, Inc.
- Xenon Light Source Auto Lip 5123. Model 2123.011 (K983628) . manufactured by Richard Wolf Medical Instruments Corp.
- Battery Powered Endoscopic Light Source (K960081)manufactured by 0 Mitsubishi Cable America, Inc.
- LH-150 manufactured by Pentax Precision Instrument Corp. .
- LH SC Halogen Light Source manufactured by Olymous America, Inc. t

#### V. Intended Use:

The Endoscopic Light Source XL202/L3 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.

The device is classified as Cardiac Floating (CF) which allows the use in endoscopic cardiac procedures when used in conjunction with the proper instrumentation.

#### VI. Device Description:

The Endoscopic Light Source XL202/L3 uses a 180 W xenon lamp to provide illumination during endoscopic surgery through a fiber optic cable, which is

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

connected to the device. Furthermore, the light source can be equipped with an additional 150 W halogen lamp for diagnostic applications in endoscopy. The 150 W halogen lamp also function as a backup up lamp to avoid interrupting a procedure in case of a malfunction of the xenon lamp. The color temperature of the xenon lamp and halogen lamp is approximately 6000 % and 3400 % respectively, the lamp life approximately 500 hours and 50 h respectively.

#### VII. Substantial Equivalence:

The Endoscopic Light Source XL202/L3 described in this notification is similar in design and technological characteristics to the Karl Storz Xenon Light Source Model 201320-20 (K934559) manufactured by Karl Storz Imaging, Inc. and the Xenon Light Source Auto Lip 5123, Model 2123.011 (K983628) manufactured by Richard Wolf Medical Instruments Corp., the Battery Powered Endoscopic Light Source (K960081)manufactured by Mitsubishi Cable America, Inc., the LH -150 manufactured by Pentax Precision Instrument Corp.and the CLH-SC Halogen Light Source manufactured by Olympus America, Inc.

Both the Endoscopic Light Source XL202/L3 and the predicate devices are intended to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.

The differences between the Endoscopic Light Source XL202/L3 and predicate device are minor and raise no new questions of safety and effectiveness.

Accordingly. WORLD OF MEDICINE Lemke GmbH believes that the Endoscopic Light Source XL202/L3 is substantially equivalent to the predicate devices currently on the market.

# VIII. Performance Data:

The Endoscopic Light Source XL202/L3 complies with the International Standard IEC 601-1, IEC 601-1-2 and conforms to the Medical Device Directive 93/42/EEC. In addition, the Endoscopic Light Source XL202/L3 meets the requirements of the Underwriters Laboratories standard UL2601-1.

Signed:

S. Raab

Susanne Raab Official Correspondent

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

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 0 5 2002

WORLD OF MEDICINE Lemke GmbH % Ms. Susanne Raab 91 Trowbridge Street CAMBRIDGE MA 02138

Re: K020889 Trade/Device Name: Endoscopic Light Source XL202/L3 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 GCT Dated: March 15, 2002 Received: March 19, 2002

Dear Ms. Raab:

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 vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

Page 2

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). 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/odrh/dsma/dsmamain.html.

Sincerely yours,

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/3/Figure/9 description: The image contains a scattering of small, dark, irregular shapes against a bright white background. The shapes are distributed sparsely across the frame, with some clustering towards the bottom left. The contrast between the dark shapes and the white background is high, making the shapes stand out distinctly.

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

# STATEMENT OF INDICATIONS FOR USE

0208889

APPLICANT:

WORLD OF MEDICINE Lemke GmbH

510(K) NUMBER (if known):

DEVICE NAME:

Endoscopic Light Source XL202/L3

INDICATIONS FOR USE:

The Endoscopic Light Source XL202/L3 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.

The device is classified as Cardiac Floating (CF) which allows the use in endoscopic cardiac procedures when used in conjunction with the proper instrumentation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 C.F.R. § 801.109)

(Optional Format 1-2-96)

Prescription Use
(Per 21 CFR 801.109)

Nancy C Brogdon

vision Signivision of Reproducti and Radiological Device 510(k) Number