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510(k) Data Aggregation
(97 days)
Zhe jiang Cleisman Industry and Trade Co.,LTD
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The wheelchair uses lithium batteries as its power source. The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions. The frame's material of model ZH-W001 and ZH-W002 is aluminium alloy,the model ZH-W003 is carbon steel. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. The wheels are PU tires. When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement. The DC motor and brake system are fixed on the rear wheels. The max loading of the device is 120KG. Only for one person sit.
The provided FDA 510(k) clearance letter and summary discuss the substantial equivalence of an Electric Wheelchair to a predicate device. This document is for a physical medical device, not an AI/ML-driven device. As such, many of the requested criteria related to AI/ML model performance evaluation (e.g., sample size for AI test sets, expert adjudication, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission.
The acceptance criteria provided focus on fundamental safety and performance attributes typical of medical devices that are not AI-driven, and the "study" referred to is a series of non-clinical laboratory tests adhering to established ISO standards.
Here's the information that can be extracted and a clear statement about the inapplicable sections:
Acceptance Criteria and Device Performance for Electric Wheelchair (K250158)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by compliance with a comprehensive set of ISO 7176 series standards and FDA guidance for Power Wheelchairs. The "reported device performance" refers to the results of non-clinical laboratory tests showing compliance with these standards.
| Acceptance Criteria (Evaluated Standard/Parameter) | Proposed Device Performance | Predicate Device Performance (K113463) | Outcome/Remark |
|---|---|---|---|
| Safety: | |||
| Braking Distance | ZH-W001: ≤1.2m; ZH-W002: ≤1.0m; ZH-W003: ≤1.0m | 1.5m | Shorter braking distance in proposed device is considered safer. |
| Maximum Safe Operational Incline Degree | 10° | 9° | Minor difference, not impacting performance significantly. |
| Max Speed Backward | 0.5m/s (1.8 km/h) | 2.4 mph (3.84 km/h) | Lower backward speed in proposed device is considered safer. |
| Biocompatibility (user-contacting materials) | Compliance with ISO10993-5, ISO10993-10, ISO10993-23 | Compliance with ISO10993-5, ISO10993-10 | Substantially Equivalent (SE); proposed device meets more recent extensive standards. |
| EMC | Compliance with IEC 60601-1-2 & ISO7176-21 | Compliance with IEC 60601-1-2 & ISO7176-21 | SE |
| Performance | Compliance with ISO7176 series (listed below) | Compliance with ISO7176 series (listed below) | SE |
| Label and Labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | SE |
| Performance (ISO 7176 Series Compliance - specific values often not detailed in summary, rather confirmation of compliance): | |||
| ISO 7176-1 (Static ability) | Compliant | Compliant | SE |
| ISO 7176-2 (Dynamic stability) | Compliant | Compliant | SE |
| ISO 7176-3 (Brake performance) | Compliant | Compliant | SE |
| ISO 7176-4 (Theoretical distance range) | ZH-W001: 14.3 km; ZH-W002: 13.8 km; ZH-W003: 13.8km | 20 km | Difference due to battery size/wheel size; no new safety concerns. |
| ISO 7176-5 (Dimensions and weight) | Compliant (dimensions vary slightly but shown not to impact safety/performance) | Compliant | SE |
| ISO 7176-6 (Maximum speed) | ZH-W001: 1.8m/s; ZH-W002: 1.6m/s; ZH-W003: 1.6m/s | Up to 6 km/h (1.6 m/s) | Minor speed differences, no new safety concerns. |
| ISO 7176-7 (Measurements of seat and wheel dimensions) | Compliant | Compliant | SE |
| ISO 7176-8 (Static, impact and fatigue strengths) | Compliant | Compliant | SE |
| ISO 7176-9 (Climatic tests) | Compliant | Compliant | SE |
| ISO 7176-10 (Obstacle-climbing ability) | 20mm | 30 mm | Minor difference, no new safety concerns identified. |
| ISO 7176-11 (Test dummies) | Compliant | Compliant | SE |
| ISO 7176-13 (Friction of test surfaces) | Compliant | Compliant | SE |
| ISO 7176-14 (Power and control systems) | Compliant | Compliant | SE |
| ISO 7176-15 (Documentation and labeling) | Compliant | Compliant | SE |
| ISO 7176-21 (Resistance to ignition) | Compliant | Compliant | SE |
| ISO 7176-25 (Batteries and chargers) | Compliant | Compliant | SE |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Compliant | Compliant | SE |
| Electrical Safety | Compliant | Compliant | SE |
| Maximum Loading Weight | 120kg (265lbs) | 114kg (251lbs) | Proposed device handles higher load; validated with max rated dummy. |
| Turning Radius | ZH-W001: 938mm; ZH-W002: 875mm; ZH-W003: 875mm | 800 mm | Minor difference, no new safety concerns. |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a series of non-clinical laboratory tests conducted on the proposed device models (ZH-W001, ZH-W002, ZH-W003) in accordance with the specified international standards (ISO 7176 series, IEC 60601-1-2, and ISO 10993 series for biocompatibility). The 510(k) summary explicitly states: "The non-clinical laboratory data support the safety and performance of the subject device and demonstrate that the subject device should perform as intended in the specified use conditions."
AI/ML Specific Questions (Not Applicable to this Device):
The following questions are not applicable to this 510(k) submission as the device is an Electric Wheelchair, a physical medical device, and not an AI/ML software or system. Therefore, there is no AI/ML model being evaluated.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, no AI test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no AI ground truth established by experts.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no AI test set requiring adjudication.
- 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, no AI component or human reader study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, ground truth related to AI/ML is not relevant here. The "ground truth" for this device's performance is objective measurements against engineering and safety standards.
- The sample size for the training set: Not applicable, no AI training set.
- How the ground truth for the training set was established: Not applicable, no AI training set.
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