Transcription
APR 0 9 2003NomadTMND1OOOM Augmented Vision System 51O(k) SubmissionMICROVISIONphone:19910 North Creek ParkwayP.O.BO OO Bothell. Washington 98011website:6 ) 51O(k) SummaryDate:Company Name and AddressMicrovision Incorporated19910 North Creek ParkwayBothell, WA 98011Contact PersonKarl BylundRegulatory and Compliance EngineerTelephone: 425-415-6634Device Trade NameNomadTMND1000M Augmented Vision SystemCommon NameVideo MonitorClassification NameEndoscope and AccessoriesPredicate DevicesDevice name:Manufacturer:Head Mounted DisplayVista Medical Technologies5451 Avenida Encinas, Suite ACarlsbad, CA 92008,Class IIClassification :510K Number :K961800Regulation Number : 876.1500Product code :GCJii-View Personal Video DisplayMediVision Endoscopy Incorporated1440 S . State College Boulevard, #1DAnaheim, CA 92806Class I IClassification :51OK Number :KO00669Regulation Number : 876.1500GCJProduct code :Device name:Manufacturer:425-41 5-6847facsimile: 425-41 56600Microvision, Inc.www.mvis.com
NomadTMND1OOOM Augmented Vision System 51O(k) SubmissionDescription of the DeviceThe NomadN NDIOOOM Augmented Vision System is a monochromatic head-wornmonocular display. The intended use of the NomadTMND1000M system is to displayvideo data or images while worn on the user's head. It can be connected to anySVGA video source. The display combines the ambient environment with thedisplayed image (the image is superimposed over the normal field of vision). Thedisplay may be adjusted over either eye. Optionally, the display may be used in anon see-through fashion (occluded) with addition of the provided ocular cover.The system consists of a display module, attached to headgear, that is connected viaa non-detachable interconnecting cable to a video control electronics module. Thevideo input is connected to the video control electronics module. The device acceptspower from a battery or an optional medical grade AC to DC power supply, bothsupplied with the device. A belt to hold the video control module and battery isprovided. A rechargeable Li-Ion battery is also supplied along with a battery charger.Intended UseThe Nomadm NDI OOOM Augmented Vision System is designed to display videodata or images while worn on the user's head.Technological Characteristics Comparison with Predicate DevicesThe NomadTMNDlOOOM system is similar to the Vista HMD (Head Mounted Display)which received FDA clearance on September 11, 1996 (K961800), and theMedivision i-View Personal Video Display which received FDA clearance on May 26,2000 (K000669). An exception is that the Nomadm NDIOOOM system ismonochromatic while the other systems are full color. All of these devices acceptvideo signals and display video data or images while worn on the user's head.I
DEPARTMENT OF HEALTH & HUMAN SERVICESPublic Health ServicezFood and Drug Administration9200 Corporate BoulevardRockville M D 20850Microvision Incorporatedc/o Mr. Charles MackEngineering Team LeaderUnderwriters Laboratories, Inc.2600 NW Lake RoadCamas, Washington 98607-8642Re: KO30940Trade/Device Name: NomadTMND 1OOOM Augmented Vision SystemRegulation Number: 2 1 CFR 876.1500Regulation Name: Laparoscope and accessoriesRegulatory Class: I1Product Code: GCJDated: March 2 1,2003Received: March 25,2003Dear Mr. Mack:We have reviewed your Section 5 1O(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices 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. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration.If your device is classified (see above) into either class I1 (Special Controls) or class I11 (PMA), itmay be subject to such additional controls. Existing major regulations affecting your device canbe found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.Please be advised that FDA’s issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act’s requirements, including, but not limited to: registration and listing (2 1CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (2 1 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 53 1-542 of the Act); 2 1 CFR 1000-1050.
Page 2 - Mr. Charles MackThis letter will allow you to begin marketing your device as described in your Section 5 1O(k)premarket notification. The FDA finding of substantial equivalence of your device to a legallymarketed predicate device results in a classification for your device and thus, permits your deviceto proceed to the market.If you desire specific advice for your device on our labeling regulation (2 1 CFR Part 80 l), pleasecontact the Office of Compliance at (301) 594-4659. Additionally, for questions on thepromotion and advertising of your device, please contact the Office of Compliance at (301) 5944639. Also, please note the regulation entitled, "Misbranding by reference to premarketnotification" (21CFR Part 807.97) you may obtain. Other general information on yourresponsibilities under the Act may be obtained from the Division of Small Manufacturers,International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597htmlor at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.Sincerely yours,v k e l i a M. Witten, Ph.D., M.D.DirectorDivision of General, Restorativeand Neurological DevicesOffice of Device EvaluationCenter for Devices andRadiological HealthEnclosure
Attachment 1bPage - of -5 1O(k) Number (if known):Device Name:Indications For Use: 030'ICiOVideo MonitorThe intended use of the NomadTMND1 OOOM system is to displayvideo data or images while worn on the user's head.(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)flW&w91,'%?l* -(Division Sign-off)Division of General, Restorativeand Neurological Devices5 lO(k) Numberpc 0,3034(5;(Optional Format 1-2-96)
MICROVISION Microvision, Inc. phone: 425-41 5-6847 19910 North Creek Parkway facsimile: 425-41 56600 Bothell. Washington 9801 1 website: www.mvis.com P.O.BO OO 6) 51O(k) Summary Date: Company Name and Address Microvision Incorporated 1991 0 North Creek Parkway Bothell, WA 9801 1 Contact Person Karl Bylund Regulatory and Compliance Engineer
