(59 days)
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.
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.
The provided text is a 510(k) summary for the "Navigator I Powered Scooter." It describes the device, its intended use, and argues for its substantial equivalence to predicate devices, particularly focusing on safety and effectiveness.
However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as one would expect for a diagnostic or AI-driven medical device. This is a mobility device, and the evaluation relies on a comparison of features to legally marketed predicate devices, rather than statistical performance metrics from a study with a test set, ground truth, or expert review.
Therefore, many of the requested sections (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of submission.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
No explicit quantitative acceptance criteria or corresponding reported performance values (e.g., sensitivity, specificity, accuracy) are presented in this document. The "acceptance" is based on demonstrating substantial equivalence to predicate devices in terms of functionality and safety, rather than meeting specific performance thresholds derived from a clinical trial in the way an AI diagnostic would.
The document highlights the following features as improvements for safety and effectiveness, effectively acting as "performance claims" without quantitative metrics:
| Feature/Claim | Description/Performance |
|---|---|
| Improved mobility (indoors and outdoors) | For persons with adequate upper body strength and medical conditions impairing standing/walking. (Claim, but no specific performance metric) |
| Manual steering (requires adequate upper body strength) | (Design feature) |
| High-torque four brush motor with rear wheel drive | (Design feature for performance) |
| Large diameter (16") front wheels | (Design feature for varied terrain) |
| High ground clearance (5.4") | (Design feature for varied terrain) |
| Full circle turning radius (27.5") | (Design feature for maneuverability) |
| Side to side anti-tip resistance | Enhanced by occupant-initiated swing-out anti-tip wheels and Torsional Elements™. Testing claimed to "significantly improve occupant safety." (Claim, but no specific quantitative metric like tilt angle before tipping or frequency of tipping events.) |
| Curb climbing (5.5") ability | (Performance claim, no specific test data provided but implied by design) |
| Torsional Elements™ allowing 5° rotation | Design feature that allows limited twist between frame assemblies, smoothly transforming from three wheels to four wheels with ground contact, enhancing stability over rough terrain. Also provides a side-tip warning mechanism via front wheel pickup. Testing claimed to "significantly improve occupant safety." (Claim, but no specific quantitative metric.) |
| Occupant initiated swing-out anti-tip wheels | Allows occupant to "readily improve resistance to side-tip." (Claim, but no specific quantitative metric.) |
| Rear Caster Wheel Damper | (Design feature, implicitly for stability/safety based on predicate comparison) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document refers to "testing" regarding improved occupant safety due to anti-tip features and Torsional Elements™, but provides no details on the study design, sample size, or data provenance. This is not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no concept of a "test set" or "ground truth" derived from expert consensus in this 510(k) submission for a mobility device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a motorized scooter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. "Ground truth" in the context of this device would relate to its physical performance characteristics (e.g., turning radius, curb climbing ability, stability angle) which are inherent design attributes or measured engineering specifications. The document states "testing to significantly improve occupant safety" but does not detail the nature of this testing or how a "ground truth" was established.
8. The sample size for the training set
Not applicable. There is no machine learning or AI algorithm development described.
9. How the ground truth for the training set was established
Not applicable.
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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 Frontand Rear Springs | Pride Health Care Inc., JAZZY (K945936), Product Code ITIGolden 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.
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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.
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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
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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
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).