(966 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The device "i3" is an indoor/outdoor use mobility scooter that is intended to be used by a person who is able to walk but still with "minor mobility problems." The mobility scooter "i3" is composed of metal alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a speed control throttle lever for high/low speed adjustment, a upper control console with a battery indicator, a horn, a key, and a speed control dial, a Li-ion battery with an off-board charger, a motor/electromagnetic brake assembly, an electric motor controller, and a seat/backrest set. The overall dimension of the scooter is L1014W468H981 mm. The total weight of the scooter is 25 kg without battery inside. It can easily be folded and unfolded for transportation in a car boot. The maximum weight capacity of "i3" is 300 lbs. (Approx.136 kg), and its maximum speed is allowed 4 mph (Approx. 6 km/h).
This document describes a 510(k) submission for the "i3 Foldable Mobility Scooter." It's important to understand that a 510(k) submission primarily demonstrates substantial equivalence to a previously cleared predicate device, rather than proving novel safety and efficacy through clinical studies per se. The "acceptance criteria" here are typically compliance with recognized consensus standards and a comparison to the predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally fulfillment of relevant safety and performance standards for mobility scooters. The reported performance is demonstrated by passing these tests.
| Acceptance Criteria (Standard) | Reported Device Performance (Summary from text) |
|---|---|
| ISO 7176-13: Determination of coefficient of friction of test surfaces | The device "i3" is designed to fulfill the requirements of this standard. Report stated as found in "004 Appendix B". |
| ISO 7176-15: Requirements for information disclosure, documentation and labeling | The device "i3" is designed to fulfill the requirements of this standard. |
| ISO 7176-4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | The device "i3" is designed to fulfill the requirements of this standard. Max distance of travel on charged battery approx. 9.13 km. |
| ISO 7176-5: Determination of overall dimensions, mass and maneuvering space | The device "i3" is designed to fulfill the requirements of this standard. Overall dimension: L1014W468H981 mm; Total weight (without battery): 25 kg; Max weight capacity: 300 lbs (136 kg). |
| ISO 7176-10: Determination of obstacle-climbing ability of electrically powered wheelchairs | The device "i3" is designed to fulfill the requirements of this standard. |
| ISO 7176-14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods | The device "i3" is designed to fulfill the requirements of this standard. Braking system is electromagnetic; automatic engagement on lever release. PG S45 controller detects faults and stops the scooter. |
| ISO 7176-21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers | The device "i3" is designed to fulfill the requirements of this standard. Also mentioned: ANSI/RESNA WC 2, Section 21 for EMC test. |
| ISO 7176-9: Climatic tests for electric wheelchairs | The device "i3" is designed to fulfill the requirements of this standard. |
| ISO 7176-11: Test dummies | The device "i3" is designed to fulfill the requirements of this standard. |
| ISO 7176-16: Resistance to ignition of postural support devices | The device "i3" is designed to fulfill the requirements of this standard. |
| ISO 7176-3: Determination of effectiveness of brakes | The device "i3" is designed to fulfill the requirements of this standard. Information on time to brake for noted stopping distance on page 3 of test report. |
| ISO 7176-1: Determination of static stability | The device "i3" is designed to fulfill the requirements of this standard. |
| ISO 7176-7: Measurement of seating and wheel dimensions | The device "i3" is designed to fulfill the requirements of this standard. |
| ISO 7176-8: Requirements and test methods for static, impact and fatigue strengths | The device "i3" is designed to fulfill the requirements of this standard. |
| ISO 7176-2: Determination of dynamic stability of electrically powered wheelchairs | The device "i3" is designed to fulfill the requirements of this standard. Max safe speed to prevent tip over: 3 km/hr. Min turning radius to prevent tip over: 1500 mm. |
| ISO 7176-6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs | The device "i3" is designed to fulfill the requirements of this standard. Max speed allowed: 4 mph (6 km/h). |
| ISO 7176-30: Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements | The device "i3" is designed to fulfill the requirements of this standard. |
| ANSI/RESNA WC-1:2019 (multiple sections) & WC-2:2019 (multiple sections) | The device "i3" is designed to fulfill the requirements of these standards. |
| IEC 60335-2-29: Safety of household and similar electrical appliance | The device "i3" is designed to fulfill the requirements of this standard. |
| IEC 62133: Secondary Cells and Batteries – Safety Requirements | The device "i3" is designed to fulfill the requirements of this standard. |
| IEC 60601–1–6 and IEC 62366: Medical Electrical Equipment Usability Report | The device "i3" is designed to fulfill the requirements of these standards (implicitly, as part of safety/effectiveness). |
| ISO 10993 (various parts) for Biocompatibility | The device "i3" is designed to fulfill the requirements of these standards. (Specifically listed 10993-1, -5, -10). |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify "sample sizes" in the typical sense for clinical trials. The testing described is bench testing and performance testing of the physical device according to industry standards (ISO, ANSI/RESNA, IEC). Therefore:
- Sample Size for Test Set: Implicitly, one or more units of the "i3 Foldable Mobility Scooter" were tested as per the requirements of each standard. Specific numbers are not provided, but for design verification, often a small number of units are tested to confirm compliance.
- Data Provenance: The device is manufactured by PUC Perfect Union Co., LTD. in Taiwan. The testing was conducted to international and national standards recognized globally. The data is from prospective bench and performance testing of their own device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This concept is not directly applicable to this type of submission. "Ground truth" established by experts is typically for diagnostic devices where human interpretation is involved. For a mobility scooter, compliance with engineering and safety standards is determined by measurement and observation against predefined criteria, not expert consensus on an interpretation. The "experts" would be the certified test engineers and organizations performing the standardized tests.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used in studies where multiple human readers assess data, and disagreements need resolution (e.g., in radiology image interpretation). The tests for a mobility scooter are objective measurements and performance checks against established thresholds in standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of an AI system on human reader performance, typically for diagnostic or screening devices. The i3 Foldable Mobility Scooter is a physical mobility aid, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device does not feature an AI algorithm that would operate in a "standalone" fashion.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is defined by the specific requirements and test methods outlined in the cited international and national consensus standards (e.g., ISO 7176 series, ANSI/RESNA WC series, IEC standards). Compliance means the device's measured performance characteristics (e.g., speed, braking distance, stability, battery range) fall within the acceptable parameters defined by these standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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).