(142 days)
The CHOICE powered wheelchair is intended to provide mobility for a person who, due to medical reasons, the debilitating nature of some illnesses, because of accident, injury and/or subsequent paralysis, is either missing or unable to use the lower extremities. Some, but not all of the specific indications for use of a power wheelchair are: paraplegia, quadriplegia. ALS, muscular dystrophy, muscular sclerosis, lower limb amputation and any one or more of numerous neurological or muscular diseases which render the limbs too weak or unstable for normal use.
The CHOICE powered wheelchair is manufactured using fabricated steel for the power base and seat assemblies. All components determined to be a permanent part of the structural frame or seating are welded. Any parts which are required to be removable for service or adjustment to perform it's function are attached with locking fasteners.
The CHOICE is supplied with two, 12 volt gel cell batteries, either Group 22, Group 24 or Group 27 with a #891 style post, wired in series to provide 24 volts DC [Vortex Batteries, Doraville, GA]. The controller of the device is completely manufactured, tested and certified by Penny & Giles, Dorset, UK, which also contains the software programming and power output to operate the chair's drive motors, as well as interface to various optional features. A joystick, 'sip-n-puff', or alternative control mechanism is used to direct the function of the controller. Two drive motors are located on the power base and attached to a gearbox which provides the appropriate speed control and torque for the chair through a direct drive to the drive wheels.
Electrically controlled actuators are used to provide the various movement features of the seating system, including: reduced-shear recline, power elevating leg rests, 'tilt-in-space' and seat elevation. The chair is recharged overnight using a dual-mode, fully automatic battery charger [Lester Electrical, Lincoln, NE Model Number 24EL8, 120V/60Hz] certified for safety and fire resistance in compliance with current ANSI/RESNA standards.
The provided 510(k) summary for the CHOICE Powered Wheelchair details acceptance criteria and the results of non-clinical studies. No clinical trials were submitted.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the ANSI/RESNA Standard, Wheelchairs -Testing of Power and Control Systems for Electric Wheelchair. WC/14, December 1991, parts 00, 01, 02, 03, 05 and 10, as well as Electromagnetic Compatibility (EMC) requirements.
| Acceptance Criteria (ANSI/RESNA Standard) | Reported Device Performance |
|---|---|
| WC 01: Static Stability (e.g., maximum angle without tip/slide) | Seat fully down: - Downhill (Wheel locks locked): No slide, Tip at 17.5° (with 1.6" block)- Uphill (Wheel locks locked): No slide, Tip at 18° (with 0" block)- Uphill (Wheel locks unlocked): Tip at 43° (with 1.6" block)- Sideways (Wheel locks locked): Tip at 49° (with 3.9" block), No slide, Tip at 22° (with 0" block), Tip at 35° (with 1.6" block)Seat fully up: - Downhill (Wheel locks locked): No slide, Tip at 12° (with 1.6" block)- Uphill (Wheel locks locked): No slide, Tip at 18° (with 0" block)- Uphill (Wheel locks unlocked): Tip at 43° (with 1.6" block)- Sideways (Wheel locks locked): Tip at 49° (with 3.9" block), No slide, Tip at 19° (with 0" block), Tip at 26° (with 1.6" block) |
| WC 02: Dynamic Stability (e.g., stability during ramps, braking, turning) | Seat fully down: - Up ramp with max acceleration: 22° to lift (front-wheel-drive unit)- Braking down 5 deg.: Stable (equipped with anti-tip devices)- Turning: Stable (equipped with anti-tip devices)Seat fully up: - Up ramp with max acceleration: 19° to lift (front-wheel-drive unit)- Braking down 5 deg.: Stable (equipped with anti-tip devices)- Turning: Stable (equipped with anti-tip devices) |
| WC 03: Stopping Distances from Maximum Speed | Max Speed (mph): Forward 5.2, Reverse 1.3- Forward, Horizontal Plane: Max 3.3 ft, Auto 3.8 ft- Backward, Horizontal Plane: Max 2.3 ft, Auto 2.8 ft- Forward, down 5° Incline: Max 3.3 ft, Auto 3.8 ft |
| WC 05: Overall Dimensions (turning space) | Turning radius: 24 inches (610 mm)Turnaround width between limiting walls: 44 inches (1118 mm) |
| WC 10: Obstacle Climbing | - Forward no run-up: 2.25 inches (57.15 mm)- Backward no run-up: 2.25 inches (57 mm)- Forward 20 inch run-up: 3 inches (76 mm)- Backward 20 inch run-up: 2.25 inches (57 mm) |
| Electromagnetic Compatibility (EMC) | Fully compliant with EMC specification requirements with a test level of 40 V/m. Meets or exceeds all requirements of the test specification. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical testing performed on "The CHOICE" wheelchair itself. This implies that the 'sample size' for the test set is one device (the CHOICE powered wheelchair).
The data provenance is from non-clinical laboratory testing performed in accordance with established standards (ANSI/RESNA Standard WC/14 and EMC proposals). The testing was conducted for the purpose of a premarket notification, suggesting a prospective assessment of the device against these standards. The location of the testing is not explicitly stated beyond referencing American Medical Technologies, Inc. (Canton, Georgia) and the controller's manufacturer (Penny & Giles, Dorset, UK), but the standards are international (ANSI/RESNA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This study involved non-clinical physical and electrical testing of a medical device against pre-defined engineering standards. There was no 'ground truth' established by human experts in the context of diagnostic or interpretive tasks. The "ground truth" here is the pass/fail criteria of the engineering standards themselves.
4. Adjudication Method for the Test Set
Not applicable. As the study involved physical testing against engineering standards, an adjudication method for human interpretation or consensus was not required. The results were numerical measurements or observations of stability (e.g., tip angle, stopping distance, obstacle height) directly compared to the standard's requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. A MRMC comparative effectiveness study was not performed. This type of study is relevant for assessing the impact of AI on human reader performance, typically in diagnostic imaging or similar fields. This submission is for a physical medical device (powered wheelchair) and focuses on its engineering performance against safety and functionality standards.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in essence. The entire submission can be considered a "standalone" performance assessment, but not in the context of an "algorithm only" as typically applied to AI. The tests evaluated the intrinsic performance of the CHOICE powered wheelchair itself (the "device only") against objective engineering standards, without a human operator's performance being assessed or augmented. There is no AI algorithm being evaluated; rather, the performance of the physical wheelchair is being characterized.
7. The Type of Ground Truth Used
The ground truth used is the defined pass/fail criteria and measurement thresholds specified within the ANSI/RESNA Standard, Wheelchairs -Testing of Power and Control Systems for Electric Wheelchair. WC/14, December 1991 (parts 00, 01, 02, 03, 05 and 10), and the "Proposal, Addition to ANSI/RESNA WC/14 - Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters', Ver. 1.5; 1/11/94". These standards establish the acceptable performance limits for various safety and functional aspects of powered wheelchairs.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in this context. The CHOICE powered wheelchair is a physical device being tested against pre-existing engineering standards. It does not involve machine learning or AI models that require data for training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for a training set.
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AMERICAN MEDICAL TECHNOLOGIES, INC.
COMPASSION ● DEDICATION ● INNOVATION
510(k) Summary K962808
- (a) (1) Submitter's name, address American Medical Technologies, Inc. 160 Lee Street Canton, Georgia 30114
Contact Person J.R. McLaughlin Vice President. Operations (770) 479-1695
FEB 1 3 1997
Date of preparation of this summary: 14 September 1996
- Device trade or proprietary name: (2)
CHOICE Powered Wheelchair
Device common or usual name or classification name
| Product Nomenclature | Classification Number | Class | Panel |
|---|---|---|---|
| WHEELCHAIR, POWERED | 89 ITI | II PHYSICAL MEDICINE |
Substantial Equivalence (3)
The CHOICE powered wheelchair is substantially equivalent in safety, efficacy, technology and intended use to its predicate model EXCELSIOR SR powered wheelchair currently marketed by American Medical Technologies as well as numerous other devices such as the Permobil, Inc. 'Chairman' power wheelchair, the Sunrise Medical 'Quickie P300' power wheelchair [K900330] and the Invacare 'Action Storm' power wheelchair [K940051].
Description of the new device (4)
The CHOICE powered wheelchair is manufactured using fabricated steel for the power base and seat assemblies. All components determined to be a permanent part of the structural frame or seating are welded. Any parts which are required to be removable for service or adjustment to perform it's function are attached with locking fasteners.
The CHOICE is supplied with two, 12 volt gel cell batteries, either Group 22, Group 24 or Group 27 with a #891 style post, wired in series to provide 24 volts DC [Vortex Batteries, Doraville, GA]. The controller of the device is completely manufactured, tested and certified by Penny & Giles, Dorset, UK, which also contains the software programming and power output to operate the chair's drive motors, as well as interface to various optional features. A joystick, 'sip-n-puff', or alternative control mechanism is used to direct the function of the controller. Two drive motors are located on the power base and attached to a gearbox which provides the appropriate speed control and torque for the chair through a direct drive to the drive wheels.
Electrically controlled actuators are used to provide the various movement features of the seating system, including: reduced-shear recline, power elevating leg rests, 'tilt-in-space' and seat elevation. The chair is recharged overnight using a dual-mode, fully automatic battery charger [Lester Electrical, Lincoln, NE Model Number 24EL8, 120V/60Hz] certified for safety and fire resistance in compliance with current ANSI/RESNA standards.
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Intended use of the device. (ર)
The CHOICE powered wheelchair is intended to provide mobility for a person who, due to medical reasons, the debilitating nature of some illnesses, because of accident, injury and/or subsequent paralysis, is either missing or unable to use the lower extremities. Some, but not all of the specific indications for use of a power wheelchair are: paraplegia, quadriplegia. ALS, muscular dystrophy, muscular sclerosis, lower limb amputation and any one or more of numerous neurological or muscular diseases which render the limbs too weak or unstable for normal use.
Technological characteristics of the device. (6)
Sizes, configurations and functions of each device component
The CHOICE is available with either a 16- or 18-inch wide base in combination with seats widths from 14- to 20-inches and seat depths from 14- to 24-inches to accommodate most users.
The CHOICE is available as a basic, powered wheelchair with a fixed seat, or with any or all of the following seating and positioning options:
- . seat elevator providing 8 to 10 inches of vertical lift
- . reduced-shear recliner, with or without power elevating leg rests
- . 'Tilt-in-Space', 0 to 55 degrees
Both tilt and recline are used to provide pressure relief and, can be used either in combination or independently as necessary.
The elevator feature provides many vocational and functional benefits associated with position. While not providing any physically therapeutic benefit, the practical value tends to make this feature very desirable for those persons with enough use of arms and hands.
Specifications
Weight: 199 lb. w/o batteries, 270 to 300 lb. with batteries Length: 34 inches, plus footrest Height: 19.5 inches, floor to seat Overall Width: customized, from 26 to 28 inches Seat Width: customized, from 14 to 22 inches Front Wheels: 14" OD x 3" wide Rear Wheels: 8" OD x 2" wide
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(b) (1) Summary of nonclinical tests submitted with the premarket notification for the device.
The CHOICE was tested in accordance with the ANSI/RESNA Standard, Wheelchairs -Testing of Power and Control Systems for Electric Wheelchair. WC/14, December 1991, parts 00, 01, 02, 03, 05 and 10:
WC 01: Static Stability Test Results
| Test Number | 7.1 | 7.1 | 7.2 | 7.3 | ||||
|---|---|---|---|---|---|---|---|---|
| Chair position | Downhill | Uphill | Uphill | Sideways | ||||
| Wheel locks | locked | locked | unlocked | locked | ||||
| Action | Slide | Tip | Slide | Tip | Tip | Slide | Tip | |
| Block Size | 0" | 1.6" | 0" | 0" | 1.6" | 3.9" | 0" | 1.6" |
| seat postionfully down | no slide | 17.5° | 18° | 43° | 49° | 22° | 35° | |
| seat positionfully up | no slide | 12° | 18° | 43° | 49° | 19° | 26° |
WC 02: Dynamic Stability Test Results
| Test Number | 7.1 | 7.2 | 7.3 |
|---|---|---|---|
| description | Up ramp withmax.accelleration | Braking down 5 deg.[lift, tip, slide, stable] | Turning[lift, tip or stable] |
| seat positionfully down | 22° to liftunit is front-wheel-drive | stable. unit is equippedwith anti-tip devices | stable. unit is equippedwith anti-tip devices |
| seat positionfully up | 19° to liftunit is front-wheel-drive | stable. unit is equippedwith anti-tip devices | stable. unit is equippedwith anti-tip devices |
WC 03: Stopping Distances from Maximum Speed Maximum Effort (Max) and Automatic (Auto) Braking
| Test Number | 7.2.1a | 7.2.1b | 7.2.1c | ||||
|---|---|---|---|---|---|---|---|
| Maximum Speed(mph) | Forward, HorizontalPlane (feet) | Backward, Horiz.Plane (feet) | Forward, down 5Incline (feet) | ||||
| Forward | Reverse | Max | Auto | Max | Auto | Max | Auto |
| 5.2 | 1.3 | 3.3 | 3.8 | 2.3 | 2.8 | 3.3 | 3.8 |
WC 05: Overall Dimensions
| 5.1.1 | 5.1.2 | 5.1.3 | 5.1.4 | ||||
|---|---|---|---|---|---|---|---|
| Overall length withleg supportand footrest | Overall length withoutleg supportand footrest | Overall width | Overall height withbackrest in uprightposition | ||||
| inches | mm | inches | mm | inches | mm | inches | mm |
| 45 | 1143 | 31.5 | 800 | 26 | 660 | 41 | 1041 |
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| 7.1 | 7.2 | ||
|---|---|---|---|
| Turning radius | Turnaround widthbetween limitingwalls | ||
| inches | mm | inches | mm |
| 24 | 610 | 44 | 1118 |
WC 05; Overall Dimensions (turning space)
WC 10: Obstacle Climbing Test Results
| 7.1Forwardno run-up | 7.2Backwardno run-up | 7.3Forward20 inch run-up | 7.4Backward20 inch run-up | ||||
|---|---|---|---|---|---|---|---|
| inches | mm | inches | mm | inches | mm | inches | mm |
| 2.25 | 57.15 | 2.25 | 57 | 3 | 76 | 2.25 | 57 |
Additionally, the CHOICE was tested in accordance with the ANSI/RESNA "Proposal, Addition to ANSI/RESNA WC/14 - Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters', Ver. 1.5; 1/11/94 to conclude that the CHOICE is fully compliant with the EMC specification requirements with a test level of 40 V/m.
The CHOICE was also tested for compliance to the specification, Electromagnetic Compatibility for Industrial Process Measurement and Control Equipment, also related to the above ANSI/RESNA Proposal to determine that the CHOICE meets or exceeds all requirements of the test specification.
(b) (2) Summary of clinical tests submitted with the premarket notification for the device.
No clinical tests were submitted with the pre-market notification for the CHOICE Powered Wheelchair.
(b) (3) Conclusions drawn from the clinical and nonclinical trials.
Analysis of the comparison of design, function and features of the CHOICE Powered Wheelchair to other devices currently legally marketed for the same intended use, together with the results of testing conducted to assess the CHOICE's compliance with existing ANSI/RESNA standards for powered wheelchairs demonstrates the CHOICE to be substantially equivalent to these predicate devices in terms of safety, efficacy, intended use and technology.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).