XENON LIGHT SOURCE PES 1

K992540 · Laser Optik Systeme GmbH & Co. KG · GCT · Sep 14, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992540
• Device Name: XENON LIGHT SOURCE PES 1
• Applicant: Laser Optik Systeme GmbH & Co. KG
• Product Code: GCT · Gastroenterology, Urology
• Decision Date: Sep 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The indication for use of the Xenon Light Source PES 1 is to provide illumination for fiberoptic endoscopy to gastrointestinal, urological, gynecological and ENT cavities, hollow organs and canals. The PES 1 replaces current equipment in this branch. Operation is only allowed in medically used rooms in which the electrical installation meets the safety requirements of national standards (e.g. VDE 0107). The device is not intended for direct application at the heart or central nerve system.

Device Story

Xenon Light Source PES-1 provides illumination for fiberoptic endoscopy; used in gastrointestinal, urological, gynecological, and ENT procedures. Device replaces existing illumination equipment in clinical settings. Operates in medically designated rooms meeting national electrical safety standards (e.g., VDE 0107). Physician or trained clinician operates device to provide light through fiberoptic cables to visualize internal cavities. Output is high-intensity light; facilitates visualization for diagnostic or surgical procedures. Benefits include improved visibility during endoscopic examinations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Xenon light source; fiberoptic illumination; electrical operation compliant with national safety standards (e.g., VDE 0107).

Indications for Use

Indicated for providing illumination for fiberoptic endoscopy in gastrointestinal, urological, gynecological, and ENT cavities, hollow organs, and canals. Contraindicated for direct application at the heart or central nervous system.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1993

Mr. Rainer Happersbergen Chairman Chairman
LASER OPTIK SYSTEME GmbH & Co. KG AM Sägewerk 11, 55124 Mainz GERMANY

Re: K992540 Xenon Light Source PES-1 Dated: July 16, 1999 Received: July 29, 1999 Regulatory Class: Il Regulatory 01:1500/Procode: 78 GCT

Dear Mr. Happersberger:

Dear Mr. Happersberger:
We have reviewed your Sedion 510(k) notification of intent to market the device referenced above and we have been the We have reviewed your Section of intent to make the setective terms. In the encosy of the encosy of o legally
delemined the levice is substantialy equivalent for the indicati vie have is subsentialy equivalent (for the indications of the enatons) in the endrophy in of the endred the of the endred the of the endred the of the deciminos of the marked in interstate commerce pror only 20, 1970, me enemals on the
Medical Device Amentments, or to devices that have been redassified in ageneral con maketed predices on to devices that have been reclassine in accordine will in brondone on the general of only in the general on the general on Medical Dod, Drug, Indicated (Ad). You may, therefor, market the devels starter and registration, listing of
Federal Food, Drug, The general controls provisions of the Acti . Germ Post of the Act. The general controls provisions of the Acclinents of annually of the arrants of the arrants of addleration.
devices, good manufacturing practice, la

de nool go a since (see above) into either class II (Special Controls) or class III (Premarket Approval), it may lf your device is classified (see above) into cliber class in (1 chass in (1 chines) (1) in the mail only in the mail only in the of t
e subject to such and it as Tile 31 . il your do was not and control. Existing major regulation developments of romanniliance with
Federal Regulation control contribution in enestering in defermination assembli Bould Regulation of Title 21, Pats 800 to 85. A substantially equility System Regulation (QS) for
the Current Good Mannels requirenents, as set forth in the Quality System R Posted on the Good Manufacturing as set than his chrom the Color of the Pood and (no Galleries: Seneral regulation Failure to complexible Compountine (no result in
Medical Devices: (FDA) will veify such assumptions Failure to complements on the Ee Drug Administration (FDA) will enify such assumptions. Faller to common your device in the Federal
regulatory action. In addition, FDA may publish uither announcement conce Programmedian ( ------------------------------------------------------------------------------------------------------------------------------------------------------------rogencer) and this response to your premarket notification submition books for and the more of the control.
Register. Please note: the Act for devices under the Electronic might have under occareer of laws or regulations.

province will all would begin marketing your device as described in your 510(k) premarket notification. The FDA
Classified of the same classes of your device to a legally m This letter will allow you to begin marketing your device as described in a classified with a classification in a classification for
finding of substance and suise to associe finding of substantial equivalence or your device to more to mage your device and the market.

lf you desire specific advice for your labeling regulation (21 CFR Pat 801 and additionally 80.10 for in
ly for gesting in the becament the Office of Compliance at (301) 59 If you desire specific advice or your labeling regulation (21 c. F. F. F. F. F. F. F. (2006)
vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4 r your diagnostic devices), please contact the Office of Corposation All (1974).
vite diagnostic devices, please contact he Office of Complanea at [phone]. Also, 197 the promotion and advorising of your device, please contract incluincation it (c) CFF 8 07.97). Other
please note the regulation entitled "Mishranding by reference to prem please note the regulation entitled, thistranding of the Act moments of the Division of Small Manufacturers
general information on your responsibilities under the Act inchisi general information on your responsibilities under the Act may of online world be and the may and the suress
Assistance at its toll-free number [phone] or (301) 443-65 "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of

510(k) Number (if known):*_*
Device Name: Xenon Light Source PES 1

Indications For Use:

The indication for use of the X e n o n L i g h t S o u r c e PES 1 is to provide The indication for use of the X e n o ff Erg in o transmioning in cavities, urological,
illumination for fiberoptic endoscopy to gastroenters The PES 1 replaces illumination for fiberopic encoscopy to same of canals. The PES 1 replaces
gynecological and ENT cavities, hollow organs and canals. The PES 1 replaces gynecological and ENT cavitles, monow organis only allowed in medically used rooms
current equipment in this branch. Operation is only securisments of national standards current equipment in this branch. Operation is a minutements of national standards.
in which the electrical installation meets the safety requirements of the heard of in which the electrical installation mects the callery of
(e.g. VDE 0107). The device is not intended for direct application at the heard or central nerve system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number