(315 days)
Batec is not intended for specific clinical use, but as a support to the mobility of active manual wheelchairs' users. It is designed to add auxiliary power to the manual wheelchair, increasing the mobility for the wheelchair's user. Therefore, bearing in mind the operating precautions described in this document, there is no need for professional, technical or aptitude requirements to operate or use a Batec device.
Batec devices are intended as add-on devices for wheelchairs, thus the intended user is a person with motor disability who needs of the wheelchair support for movement.
The Handbike Batec Electric is a handcycle mechanism that adapts to a manual wheelchair, forming a three-wheeled chair, allowing the user to move with the help of an electric motor located in the front wheel, optimizing the user's capabilities and increasing their autonomy.
Handbike Batec Electric aims to convert a manual wheelchair into an electrically propelled tricycle that allows the disabled collective to make larger and more complex movements and routes that can be made only with the manual wheelchair, increasing their independence and autonomy in daily life by performing recreational and sporting activities.
The operation of the Handbike Batec Electric is the same in all models, changing only the wheel size, maximum speed, and equipment. First the handbike must be coupled to the wheelchair. Once the two parts are attached, we will have a set consisting of three wheelchair seat, the transmission and traction on the front wheel. To operate the handbike, the transmission of the handbike must be operated by pedaling with the controls or by pressing the accelerator. In this way we will drive the front wheel with the manufactured product.
The device has two independent mechanical brakes (right and a parking brake. In addition. there is an automatic speed-limiting motor brake managed by software, which prevents exceeding 120% of the speed limit setting in each mode.
This document is a 510(k) Premarket Notification for the "Handbike Batec Electric." It seeks to establish substantial equivalence to a legally marketed predicate device, "Klick (Product Code ITI)."
The provided document describes a physical medical device (a powered add-on for manual wheelchairs), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested criteria related to AI/SaMD performance studies (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable to this submission.
The acceptance criteria and proof of meeting those criteria for this non-SaMD device primarily rely on compliance with established performance standards and comparison to a predicate device.
Here's an analysis of the provided information based on the typical requirements for a physical medical device 510(k) submission:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal "acceptance criteria" table in the way one might see for an SaMD with performance metrics like sensitivity, specificity, or AUC. Instead, it demonstrates compliance through non-clinical testing against recognized standards and a detailed comparison table with the predicate device. The "reported device performance" is implied by its adherence to these standards and the equivalence shown in the comparative table.
Here's a summary derived from the "SUMMARY OF COMPARISON WITH PREDICATE DEVICE" table and "SUMMARY DISCUSSION OF NON-CLINICAL DATA":
| Criterion/Feature (Implicit Acceptance Criteria: Equivalence to Predicate, Compliance with Standards) | Handbike Batec Electric (Subject Device) Performance/Specification | Klick (Predicate Device) Performance/Specification | Equivalence Discussion (Meets Acceptance) |
|---|---|---|---|
| Regulatory Information | |||
| 510(k) Number | K241159 | K222502 | - |
| Product Code | ITI | ITI | Same |
| Class | Class II | Class II | Same |
| Regulation Number | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Intended Use/Indications | |||
| Device Name | Handbike Batec electric | Handbike klaxon Klick | Equivalent |
| Indication for Use | Support mobility of active manual wheelchair users; adds auxiliary power. Not for specific clinical use; no professional/technical requirements needed to operate. Intended for persons with motor disability needing wheelchair support. | Same wording. | Same |
| Intended Use | Medical device for active, disabled wheelchair users (max 110 kg), adds auxiliary power. Intended user: person with motor disability needing wheelchair support. Raises front castors; single front wheel for steering. Improves mobility, allows for larger routes. First setup by Batec's trained specialist. | Similar wording, max 120 kg weight. First setup by Klaxon's trained specialist. | Same (slight difference in max user weight, but deemed equivalent). |
| Use condition | Indoor and outdoor. | Indoor and outdoor. | Same |
| Technical Specifications | |||
| Number of wheels | 1 | 1 | Same |
| Function of wheels | Front wheel: driven, suitable for rotation, acceleration, brake. | Front wheel: driven, suitable for rotation, acceleration, brake. | Same |
| Movement control method | Electronic and mechanic system | Electronic and mechanic system | Same |
| Driving System | Direct drive, steering bar, handlebar and twist throttle | Direct drive, steering bar, handlebar and twist throttle | Same |
| Display | LCD display | LCD display | Same |
| Brake system | Two mechanical brake levers, two callipers, one disc brake (Ø140mm/Ø200mm). Automatic electronic brake limits max speed to ≤ 120% of set limit. | Electronic brake, left and right mechanical brake. | Similar, no safety or effectiveness concerns. |
| Braking distance |
§ 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).