VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

{0}------------------------------------------------ K652452 ## SEP 2 1 2005 ## 510(k) SUMMARY # VISERA Rhino-Laryngovideoscope Olympus ENF type VT August 26, 2005 #### General Information 1 | ■ Applicant | Olympus Medical Systems Corp.<br>2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507<br>Establishment Registration No.: 8010047 | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ■ Official Correspondent | Laura Storms-Tyler<br>Executive Director,<br>Regulatory Affairs & Quality Assurance<br>Olympus America Inc.<br>Two Corporate Center Drive,<br>Melville, NY 11747-9058, USA<br>Phone: 631-844-5688<br>FAX: 631-844-5554<br>Email: Laura.storms-tyler@olympus.com<br>Establishment Registration No.: 2429304 | | ■ Manufacturer | Aizu Olympus Co., Ltd.<br>500 Aza Muranishi, Oaza-Iidera, Monden-cho, | 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No.: 9610595 #### Device Identification 2 | Device Name | VISERA Rhino-Laryngovideoscope Olympus ENF type VT | |------------------------|-------------------------------------------------------| | Common Name | Nasopharyngoscope | | Regulation No: | 21 CFR 874.4760 | | Regulation Name: | Nasopharyngoscope (flexible or rigid) and accessories | | Regulatory Class: | II | | Product Code: | EOB | | Prescription Status: | Prescription device | | Performance Standards: | None established under Section 514 of FDCA. | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains a sequence of characters that appear to be handwritten. The characters are 'Kos 2452'. The writing style is cursive, and the characters are connected. The image is in black and white. #### Predicate Device Information 3 | Device Name | Rhino-Laryngofiberscope Olympus XENF-TP | |----------------|-----------------------------------------| | 510(k) No: | K013591 | | Decision Date: | 12/26/2001 | #### Device Description ব The VISERA Rhino-Laryngovideoscope Olympus ENF type VT, hereafter referred to as ENF-VT, is and The VISERA Knino-Laryngovicessope Olympos EN. Type V., Hersament within the nasal and nasopharyngeal lumens. The modifications that were made are: - Field of view is wider. l - Instrument channel inner diameter is smaller. - - Instrument changed to a CCD based system, allowing endoscopic image display on a video monitor. - Improved resolution - - Improved resolution The subject device is not compatible with a miniature light source, whereas the predicate device -ાંડ - ، ### 5 Intended Use This instrument has been designed to be used with an Olympus video system center, light souncent This institutient has been designed to be acou therapy accessories, and other and documentation equipment, alsployment within the nasal and nasopharyngeal lumens. This intended use is identical to the predicate device, the Rhino-Laryngofiberscope Olympus XENF-TP. #### Conclusion 6 The VISERA Rhino-Laryngovideoscope Olympus ENF type VT has the following similarities to the predicate device: - The same intended use. । - The same operating principle except for the optical system. - - The same reprocessing method. - - The same basic endoscope design except for the optical system. - - The same patient contacting materials as for the Olympus predicate devices. - In summary, the ENF-VT described in this submission is, in our opinion, substantially equivalent to the predicate device. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection. SEP 2 1 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Olympus Medical Systems Corporation c/o Laura Storms-Tyler Executive Director Olympus America, Inc. Regulatory Affairs and quality Assurance Two Corporate Center Drive PO Box 9058 Melville, NY 11747-9058 Re: K052452 KU52432 Trade/Device Name: VISERA Rhino-Laryngovideoscope Olympus ENF type VT Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: September 1, 2005 Received: September 7, 2005 Dear Ms. Storms-Tyler: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained in the may arranger started in interests a referenced above and nave determined the arrest as a recess marketed in interstate for use stated in the enclosure) to legally manative provide in one of the Enderal Food. Device commerce prior to May 26, 1976, the encordance with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while toproval applicians of the Act . The and Cosmetic Act (Act) that do not require approvial controls) provisions of the Act. The You may, therefore, market the device, seeject to since general registration, listing of general controls provisions of the Act include requirements for annual registration, general controls provisions of the Fist list increases of the adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) this child be sites). may be subject to such additional controls. Existing major regalation FDA may may be subject to such additional connolor Entrological of 898 In addition, FDA may be found in the Code of Federal Regulations, Title 21, Parts 800 to Securer be found in the Code of Poderal Regarning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a but can and other requirements of the Act that FDA has made a determination that your device complies with on must that FDA has made a decemination administered by other Federal agencies. You must or any Federal Statutes and regulations administers of a fimited to: registration and listing (21 l comply with all the Act Stequirements, morams manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 800); god a frapplicable, the electronic forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 app 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) The start of the same of the same of the same of your device to a legal This letter will allow you to begin marketing your artice of your device of your device to a legally premarket notification. The FDA finding of substantial equivales on the premarket notification. The FDA inding of substantial equivalians 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 rs the latest of the most of an 11 companses and the regulation entitled If you desire specific advice for your ac 1100 cm ... Also, please note the regulation entitled, and the regulation entitled, would contact the Office of Complance at (301) 627 07 (21CFR Patt 807.97). You may obtain " Misbranding by relerence to premarket notified.com < < t from the Division of Small other general information on your responsibilities under the Act from the (800) 638-200 other general information on your responsionnes and its toll-fire number (800) 638-2041 or Manufacturers, International and Consumer Assistance of thindex html Manufacturers, International and Consumer Assistance at 10 % + (301) 443-6597 or at its Internet address http://www.fda.gov/cdrhindustry/support/index.html. Sincerely yours, David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Device Name: VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT Indications For Use: This instrument has been designed to be used with an Olympus video system center, light This instrument has been designed to be acost man and otherapy accessories, and other source, documentation equipment, display monitor, within the nasal and nasopharyngeal lumens. Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of _1 Kama Baha 510(k) Numb