(351 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Mobility Scooter. S15 is an indoor / outdoor powered scooter that is battery operated. It has a base with four-wheeled with a seat, and armrests. The movement of the powered scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an external battery recharger.
The provided documents describe a 510(k) premarket notification for the HEARTWAY Power Mobility Scooter, S15. This is a submission for substantial equivalence to a predicate device, not a study performing a clinical trial to establish acceptance criteria for a new medical device technology. As such, the information typically requested in your prompt (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, types of ground truth for a clinical study) are not present in these documents.
Instead, the documents demonstrate substantial equivalence by comparing the proposed device (S15) to a legally marketed predicate device (HEARTWAY Power Mobility Scooter, S12, K092650) based on performance testing to recognized standards and direct comparison of specifications.
Here's a breakdown of the relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present explicit "acceptance criteria" in the sense of predefined thresholds for a study. Instead, it relies on demonstrating compliance with recognized performance standards and direct specification comparison to a predicate device. The performance is "reported" through the completion of tests against these standards and the assertion of "same" or minor, justifiable differences in specifications.
| Performance Characteristic/Standard | Predicate Device (S12) Performance | Subject Device (S15) Performance | Equivalence Rationale/Comment |
|---|---|---|---|
| Intended Use | For medical purposes to provide mobility to persons restricted to a sitting position. | For medical purposes to provide mobility to persons restricted to a seated position. | Same |
| Frame | Folded | Folded | Same |
| Frame Material | Carbon Steel Pipe | Carbon Steel Pipe | Same |
| Overall Length | 1400 mm / 55.1" | 1400 mm / 55.1" | Same (Implied, as no difference noted in the comparison table) |
| Overall Width | 700 mm / 27.5" | 700 mm / 27.5" | Same (Implied, as no difference noted in the comparison table) |
| Overall Height | 1360 mm / 53.5" | 1360 mm / 53.5" | Same (Implied, as no difference noted in the comparison table) |
| Seat Width | 620 mm / 24.5" | Same | Same |
| Seat Height | 820 mm / 32.25" | Same | Same |
| Weight Limit | 160 kgs / 352 lbs | Same | Same |
| Maximum Speed | 9.6 km/h (6.0 mile/h) | Same | Same |
| Batteries (Quantity, Type, Range) | Two, 50 Ah 12VDC, 40km / 25 miles | Same | Same |
| Motor | 24V DC, 700 W | Same | Same |
| Rear Wheels | 13" x 3.5" solid x 2 | Same | Same |
| Casters | 13" x 5.0" solid x 2 | Same | Same |
| Footplates | ABS | Same | Same |
| Suspension | Cross brace | Same | Same |
| Incline | 10 degrees | Same | Same |
| Turning Radius | 1,280 mm / 50.4" | Same | Same |
| Ground Clearance | 75 mm / 2.9" | Same | Same |
| Kerb Climbing Ability | 80 mm / 3.1" | Same | Same |
| Back Upholstery | Fabric | Same | Same (passed resistance ignition test ISO 7176-16) |
| Armrest Types | Flip-backward | Same | Same |
| Wheel Lock | Push-to-Lock | Same | Same |
| Warranty | 3 years: Main frame; 1 year: Controller / gear motor / batteries (w/o exhaustive and wear parts) | Same | Same |
| Patient Contacting Materials | Seat PVC, Hand grip PVC, Seat belt PVC | Same | Same |
| Biocompatibility | ISO 10993-1, ISO 10993-5 | Same | Same |
| Wheelchair Weight (with batteries) | 132 kgs (291 lbs) | 136 kgs (299 lbs) | Difference of 4 kgs (approx. 3.03%). Deemed not to significantly change the center of weight, thus maintaining safety and effectiveness. |
| Electronics Controller | RHINO DS112K Drive | RHINO DS120 Drive | Both controllers are TUV certified. |
| Recharger Model | 24VDC 4C24080A (UL E201162 certified) | 24VDC 4F24050 (UL E241359 certified) | Both rechargers are UL certified. |
| EMC Report | ANSI / RESNA WC/Vol.2: 2009, CISPR 11: 2004+A2:2006, EN61000-4-2: 2008, IEC61000-4-3: 2006, IEC61000-4-8: 2001 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods) | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with [...] ANSI / RESNA WC 2, Section 21 for the EMC test") | Both devices demonstrate compliance with relevant EMC standards. |
| Static Stability | ISO 7176-1: 1999 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant stability standards. |
| Dynamic Stability | ISO 7176-2: 2001 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant stability standards. |
| Brakes Effectiveness | ISO 7176-3: 2012 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant braking effectiveness standards. |
| Energy Consumption | ISO 7176-4: 2008 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant energy consumption standards. |
| Overall Dimensions, Mass, Manoeuvring Space | ISO 7176-5: 2008 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant dimensional standards. |
| Max Speed, Acceleration, Deceleration | ISO 7176-6: 2001 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant speed and acceleration standards. |
| Seating Dimensions | ISO 7176-7: 1998 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant seating dimension standards. |
| Static, Impact, Fatigue Strength | ISO 7176-8: 1998 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant strength standards. |
| Climatic Tests | ISO 7176-9: 2009 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant climatic test standards. |
| Obstacle-climbing Ability | ISO 7176-10: 2008 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant obstacle-climbing standards. |
| Test Dummies | ISO 7176-11: 2012 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant test dummy standards. |
| Coefficient of Friction | ISO 7176-13: 1989 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant friction standards. |
| Power and Control System | ISO 7176-14: 2008 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant power and control system standards. |
| Information Disclosure, Documentation, Labeling | ISO 7176-15: 1996 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant information standards. |
| Resistance to Ignition of Upholstered Parts | ISO 7176-16: 2012 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant ignition resistance standards. |
| Electromagnetic Compatibility | ISO 7176-21: 2009 | (Not explicitly listed for S15, but stated that "Two devices also completed the performance tests in accordance with ISO 7176 series standards") | Both devices demonstrate compliance with relevant EMC standards. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This is a device comparison based on compliance with standards and specifications, not a clinical trial with a "test set" of patients or data. The testing mentioned refers to performance testing on the physical device itself.
- Data Provenance: The documents do not specify the provenance (e.g., country of origin, retrospective/prospective) of any clinical data because none appears to have been collected for this 510(k) submission. The performance testing was conducted according to international standards (ISO, ANSI/RESNA, CISPR, EN, IEC).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts/Qualifications: Not applicable. Ground truth for clinical data is not a concept applied in this 510(k) submission for a power mobility scooter. The "ground truth" here is compliance with engineering and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This refers to consensus among human readers in a clinical study, which is not relevant to this submission.
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:
- MRMC Study/Effect Size: No. This type of study is relevant to AI-powered diagnostics or image analysis, not a power mobility scooter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is not an AI/algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" is established by adherence to international and national standards for medical devices and wheelchairs, such as the ISO 7176 series ("Wheelchairs") and ANSI/RESNA WC/Vol.2: 2009 (Electrically powered wheelchairs, scooters), as well as certifications for components (TUV, UL). These standards define performance requirements and test methods.
8. The sample size for the training set:
- Sample Size for 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:
- Ground Truth for Training Set: Not applicable.
§ 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).