(13 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The COMFORT SCOOTER, LY-E'V415 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device c in be disassembled for transport and is provided with an onboard battery charger.
The provided text describes a 510(k) submission for the COMFORT SCOOTER, LY-EW415, and focuses on demonstrating substantial equivalence to a predicate device, the COMFORT WINDJOY SCOOTER LY-EW302 (K022369). The "acceptance criteria" here refer to the performance and design characteristics that the new device must meet to be considered substantially equivalent to the predicate device. The study proving the device meets these criteria is the comparison summary provided by the manufacturer.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the specifications of the predicate device. The study demonstrates that the new device (subject device) either meets these specifications directly or has differences that do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Predicate Device K022369) | Reported Device Performance (Subject Device K063032) | Justification/Comment |
|---|---|---|
| Intended Use: The device is intended for medical purposes to provide mobility to persons restricted to a seated position. | SAME | Substantially equivalent. |
| Overall Length: 48" | 59.8" / 152 cm | New device is larger; applicant states this is "NOT related to the safe aspect" and that "larger dimensions can hold more mass and possess more balance," leading to "more safety." |
| Overall Width: 24.4" | 28.3" / 72 cm | New device is larger; applicant states this is "NOT related to the safe aspect" and that "larger dimensions can hold more mass and possess more balance," leading to "more safety." |
| Max Loading: 265 lbs | 180 kgs / 400 lbs | New device has higher maximum loading capacity. Implies improved safety for heavier users. |
| Electronics: Dynamic Rhino series | SAME | Substantially equivalent. |
| Batteries Type: Sealed lead acid, 40Ah 12VDC | Sealed lead acid, 75Ah 12VDC | Same type, but new device has higher capacity (75Ah vs 40Ah). Applicant states batteries are from the "same supplier and they are certificated by UL." |
| Range per Charge: 28 miles | 75 km / 46.8 miles | New device has a significantly longer range per charge due to higher battery capacity. |
| Front Tires: 85 x 260 mm | 4.00-5 (pneumatic) | Different specified dimensions/types of pneumatic tires. No safety concern raised. |
| Rear Tires: 4.10 / 3.50-5" | 3.00-10 (pneumatic) | Different specified dimensions/types of pneumatic tires. No safety concern raised. |
| Maximum Speed: 5.5 mph | 8 km / 5.0 mph | New device has a slightly lower maximum speed (0.5 mph difference). Applicant states this difference does "not mean any performance differences" and that "the new device has lower maximum speed, thus leading to more safety and less hazard." |
| Turning Radius: 43.3" | 180 cm / 70.8" | New device has a larger turning radius. Related to overall dimension increase. No safety concern raised. |
| Back Upholstery: Fabric | SAME | Same material; applicant states it "passed the resistance ignition test by SGS." |
| Scooter Weight: 165 lbs (w/o battery) | 140 kgs / 308 lbs (with battery) | New device is heavier (with battery compared to predicate's weight without battery). Implies robust construction. |
| Recharger: DC 24V 5A Remote | DC 24V 8A Remote | Same resource, both UL certified; difference in output current (8A vs 5A) leads to "charging period differences or arise from the different battery capacity, not related with safety aspect." |
| Safe Climbing Angle: 12° | SAME | Substantially equivalent. |
| Warranty (Main Frame): 3 years | SAME | Substantially equivalent. |
| Warranty (Controller / Gear Motor): 1 year | (Implicitly same, as the controller/motor are the same or similar) | Substantially equivalent for main components. |
2. Sample size used for the test set and the data provenance
This is a design and performance comparison study against a predicate device, not a clinical study involving a test set of patients or data samples in the traditional sense of AI/diagnostic device evaluation. Therefore:
- Sample size for test set: Not applicable. The "test set" consists of the specifications and performance characteristics of the subject device being compared.
- Data provenance: Not applicable in the context of clinical data. The data originates from the manufacturer's engineering specifications, testing (e.g., EMC report, SGS ignition test), and component certifications (UL for batteries and chargers). The devices are manufactured in Taiwan, R.O.C.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in this context, refers to the established safety and performance of the predicate device, which has already been legally marketed. The assessment relies on engineering comparisons and regulatory standards, not expert clinical interpretation of test cases.
4. Adjudication method for the test set
Not applicable. There is no "test set" of cases requiring adjudication by experts. The comparison is based on objective specifications and performance testing.
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/diagnostic device. It's a mobility scooter.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/diagnostic device. Performance testing involved direct engineering measurements and compliance with standards like ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers -- requirements and test methods).
7. The type of ground truth used
The "ground truth" used for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate device (COMFORT WINDJOY SCOOTER LY-EW302, K022369), as well as compliance with recognized performance standards for electric wheelchairs.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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).