ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105

{0}------------------------------------------------ #### 510(k) SUMMARY OPTIM's ENTity NasoView LED Nasopharyngoscope APR - 2 2008 ## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared #### OPTIM Incorporated 64 Technology Park Road Sturbridge, MA 01566-1253 Phone: (508) 347-5100 Facsimile: (508) 347-2380 Contact Person: Robert Krupa Date Prepared: March 5, 2008 # Name of Device and Name/Address of Sponsor ENTity NasoView LED Nasopharyngoscope OPTIM, Incorporated 64 Technology Park Road Sturbridge, MA 01566-1253 ### Common or Usual Name Nasopharyngoscope # Classification Name and Product Code Nasopharyngoscope; EOB #### Predicate Devices OL-1 Airway Fiberscope, K864821 Vision-Sciences EF100 nasopharyngoscope, K942265 Vision-Sciences ENT-3000 nasopharyngoscope, K050972 Vision-Sciences ENT-5000 nasopharyngoscope, K072073 ## Purpose of the Special 510(k) Notice The ENTity NasoView is a modification of the OL-1 Airway Fiberscope. ## VI. - 1 {1}------------------------------------------------ #### Intended Use / Indications for Use For oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords. ## Technological Characteristics The ENTity NasoView is a modification of the OL-1 Airway Fiberscope. The device has been modified to include a battery-operated LED light source internal to the device control body. An accessory charger is provided for charging the battery outside the scope. ### Performance Data In support of this Special 510(k), OPTIM has certified compliance with 21 CFR § 820.30, Design Control Requirements, including a risk analysis assessment. Verification and validation activities have been completed for the device modifications. ### Substantial Equivalence ENTity NasoView has the same intended use and indications for use, and similar technological characteristics and principles of operation, as the predicates. The modifications incorporated in the ENTity NasoView do not raise any new questions of safety or effectiveness. Validation and verification testing demonstrates that the ENTity NasoView is as safe and effective as the predicate devices. Thus, the ENTity NasoView is substantially equivalent to legally marketed devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of several curved lines and shapes, and it is oriented towards the right side of the seal. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 2 2008 OPTIM Incorporated c/o Robert Krupa 64 Technology Park Road Sturbridge, MA 01566-1253 Re: K080622 Trade/Device Name: ENTity NasoView LED Nasopharyngoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: March 5, 2008 Received: March 5, 2008 Dear Dr. Krupa: 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. {3}------------------------------------------------ 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Marlina B. Egleston, Md Malvina B. Eydelman. M.D Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Ko 80622 #### Indications for Use Statement 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: OPTIM's ENTity NasoView LED Nasopharyngoscope Indications for Use: For oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords. Prescription Use X (Per 21 C.F.R. 801.109) AND/OR Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Kurent Boker Division Sign-Off Division of Ophthalmic Ea Nose and Throat Devis 510(k) Number V. - 1