VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)

{0}------------------------------------------------ K08 H66 7 ### SECTION 5: 510(k) Summary # VİSİONSENSE ### Submitter Visionsense Ltd. (Previously known as Envision Advanced Medical Systems) 20 Hamagshimim Street P.O. Box 7149 Petach Tikva 49348 Israel Owner/Operator Number: 9042467 Establishment Registration Number: 9616637 ### Contact Person(s) Gerard J. Prud'homme Partner Hogan & Hartson LLP 555 13th Street, NW Washington, DC 20004-1108 Tel: (202) 637-5735 Fax: (202) 637-5910 E-mail: GJPrudhomme@hhlaw.com ### Date Prepared September 12, 2008 ### Device Information Trade name: VSn Common name: Visionsense Stereoscopic Vision System Classification Name: Nasopharyngoscope Review Panel: Ear, Nose and Throat Product Code: EOB Device Class: Class II ### Predicate Devices | 510(k) number | Trade or propriety name | Manufacturer | |------------------|--------------------------------------------------|-------------------------------| | K081102, K073279 | VSII - Visionsense Stereoscopic<br>Vision System | Visionsense Ltd. | | K032822 | asap ENT Endoscope | asap Endoscopic Products GmbH | ## OCT 3 0 2008 {1}------------------------------------------------ ### Intended Use/Indications for Use The VSn is intended to visualize the nasal cavity and nasal pharynx during diagnostic and therapeutic procedures, as well as for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures. ### Technological Characteristics/Principles of Operation Visionsense Stereoscopic Vision System (VSn) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal endoscope. An array of miniature lenses --- the Lenticular Array (LA) - built onto the CCD surface during the wafer fabrication process, captures the image from slightly different angles, thus mimicking the natural human "stereo vision" obtained when the eyes simultaneously pick up two different images of the same object (right and left). The captured image is subsequently transmitted to a PC workstation, processed and presented on a stereoscopic display panel. Images are recorded and may be later downloaded for further analysis. ### Substantial Equivalence Visionsense's VSn was previously cleared by FDA for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures (K081102, K073279). The subject device is technologically similar to the device for which FDA has granted marketing clearance, except -Visionsense is now seeking to expand the indication to include visualization of the nasal cavity and nasal pharynx during diagnostic and therapeutic procedures. Visionsense's VS11 System is also substantially equivalent to other previously cleared nasopharyngoscopes/ endoscopes, namely the asap ENT Endoscope (K032822). Performance data, to support this claim, is included in the body of the submission file. Thus, the VSn System is substantially equivalent to the identified predicate devices. #### Performance No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") for nasopharyngoscopes. However, the VSu System and its components comply with international standards for electrical safety, electromagnetic compatibility, and biocompatibility. {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Visionsense, Ltd. c/o Gerald J. Prud'homme Hogan & Hartson, LLP 555 13th Street, NW Washington, DC 20004-1108 OCT 3 0 2008 Rc: K082667 Trade/Device Name: VSn Visionsense Stereoscopic Vision System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: EOB Dated: September 12, 2008 Received: September 12, 2008 Dear Mr. Prud'homme: 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, Or ug 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}------------------------------------------------ Page 2 -- Gerald J. Prud'homme 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 yours, Malvina B. Egerter, und 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}------------------------------------------------ ### Indications for Use 510(k) Number: Device Name: VSn - Visionsense Stereoscopic Vision System Indications for Use: The VSn is intended to visualize the nasal cavity and nasal pharynx during diagnostic and therapeutic procedures, as well as for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures. V Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 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 Koren Baker vision Sian-Off vision of Ophthalmic Ear, Nose and Throat Devises 510(k) Number K082667