NAVIGATOR I

{0}------------------------------------------------ ## NOV 1 3 2003 510(k) Summary - Navigator I Powered Scooter 1.4. ## Adaptive Healthcare Technologies, Inc. - P.O. Box 614, Marstons Mills, MA 02648-0614 Submitter: | Phone: 508 420-5035 | Contact Person: Joan Johnson | Date Prepared: June 6, 2003 | |---------------------|------------------------------|-----------------------------| |---------------------|------------------------------|-----------------------------| Navigator I Classification Name: Motorized Three-wheeled Vehicle Proprietary Name: ## Identification of predicate devices - Primary Predicate Device - A-BEC Mobility, Inc. Sterling Scooter (K880425), Product Code INI | SPECIFIC FEATURE | Secondary Predicate Devices RELATED TO SPECIFIC FEATURE | |--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Steering Arm (Tiller) | Electric Mobility Corp, Rascal Convertible (K924515), Product Code INI | | Parking Brakes | Amigo Sales Inc., Scooter, Motorized (K830345), Product Code INI | | Anti-tip Wheels Vary Width | Amigo Sales Inc., Scooter, Motorized (K830345), Product Code INI | | Rear Motor Drive System | Hoveround Corp. Hoveround MPV (K935410), Product Code ITI | | Torsional Elements - | Everest & Jennings Inc., Modular Power Base (K854051), Product Code ITI | | Rotational Feature and Front<br>and Rear Springs | Pride Health Care Inc., JAZZY (K945936), Product Code ITI<br>Golden Technologies Inc., Golden Eagle GT2000 (K971043). Product Code INI | | Rear Caster Wheel Damper | TEFTEC Corp, OMEGATRAC (K955240), Product Code ITI | | Curb Climbing | Pride Health Care Inc., JAZZY (K945936). Product Code ITI | Intended use - To provide improved mobility, both indoors and outdoors, for persons who have adequate upper body strength suitable for manual steering, and who have a medical condition that impairs their ability to stand for periods of time or to walk. Description of the device - Navigator I was designed to assist individuals with limited mobility to maintain an active lifestyle. Its manual steering, high-torque four brush motor with rear wheel drive, large diameter (16") front wheels, high ground clearance (5.4"), full circle turning radius (27.5"), side to side anti-tip resistance, and curb climbing (5.5") ability make it a versatile vehicle equally adept in the shopping mall, on firm surface wilderness trails, or in the close quarters of a restaurant or home kitchen. Navigator I is a blended hybrid drawine elements from both scooters and wheelchairs, to meet desired features requested by long term scooter users. It does this while still maintaining the three-wheel scooter configuration with manual steering and anti-tip wheels adjacent to the single steering wheel. Navigator I is an clectronically controlled motorized 3-wheeled vehicle employing a rear single wheel remotely steerable motor drive system (11.5" tire). It employs a 24 Volt DC permanent magnet motor powered by two 12 Volt scaled lead acid deep cycle batteries. The rigid Front Frame Assembly holds the two batteries, mounts the two front 16" diameter wheels, the two front hand controlled parking brakes, the swing up front foot rests, the electronic motor controller, and the steering arm with handle incorporating the 6-position variable speed-control. The Rear Frame Assembly is made up of the rear motor drive, the swing out Anti-tip wheels, the rear bearing block assembly and pivot wheel assembly. The Front and Rear Frame Assemblies are connected together by two semi-rigid Torsional Elements™ (relatively rigid to a vertical load, but allowing limited rotation), which also support the scat block mounting assembly. The Torsional Elements™ allow limited twist (similar to the Articulation Beam in the Pride Jazzy, K945936) to occur between the Front and Rear Frame Assemblics up to 5° of rotation, at which point one Anti-tip wheel with the ground. This greatly enhances side to side stability when driving Navigator I over rough terrain, since Navigator I is smothly transformed from three wheels to four wheels with ground contact on all four wheels. Substantial equivalence - The Navigator I design is shown to be substantially cauvalent to the motorized threewheeled scoolers that were classified in class II under 21 CFR Section 890,3800. The basic three-wheeled scooter design is augmented with a patented frame design with anti-tip wheels that improve stability. Navigator I is a blended hybrid drawing features primarily from scooters, with some mechanical wheelchair features to improve safety and effectiveness, as outlined in the list of specific features from the predicate devices listed above and detailed in this 510(k). Safety and effectiveness - The Navigator I Powered Scooter is substantially equivalent to the technology cmployed in the predicate devices listed in this 510(k). Navigator I docs not raise any new issues of salety and clectiveness. The occupant initiated swing-out anti-tip wheels allow the occupant to readily improve resistance to side-tip and the Torsional Elements™ provide both a smooth ground engagement of the anti-tip wheels and a side-tip warning mechanism via front wheel pickup, which we have shown by testing to significantly improve occupant safety. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. 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 NOV 1 3 2003 Ms. Joan Johnson Adaptive Healthcare Technologies, Inc. P.O. Box 614 Marstons Mills, Massachusetts 02648-0614 Re: K032879 Trade/Device Name: Navigator I Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized tree-wheeled vehicle Regulatory Class: II Product Code: INI Dated: October 22, 2003 Received: October 24, 2003 Dear Ms. Johnson: 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. {2}------------------------------------------------ Page 2 - Ms. Joan Johnson 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, R. Mark N. Wilkerson Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page 1 of 1 510(k) Number (if known): K032879 Device Name: Navigator I Indications for Use: To provide improved mobility, both indoors and outdoors, for persons who have adequate upper body strength suitable for manual steering, and who have a medical condition that impairs their ability to stand for periods of time or to walk. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98) fo Mark N. Mulkerson Divis of General. Restorative and is arological D 510(, Number: K032874