(49 days)
The Extreme X8 Power Wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.
The Extreme X8 Power Wheelchair is designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject device is intended to provide mobility to persons who are restricted or limited to a sitting position. The Extreme X8 Power Wheelchair is a battery powered, electric motor driven device that can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips).The Extreme X8 Power Wheelchair offers two basic seating options: MPS and Rehab. The MPS option is more static and does not allow for additional aftermarket cushions. The Rehab option is more adjustable to adhere to recommendations from the user's physician or physical therapist.
The provided text is a 510(k) summary for a powered wheelchair, not an AI/ML medical device. Therefore, the information requested in the prompt, which is specific to AI/ML device studies (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set sample size), is not applicable and cannot be extracted from this document.
The document discusses the substantial equivalence of the "Extreme X8 Power Wheelchair" to a predicate device, focusing on non-clinical testing for performance, EMC and electrical safety, biocompatibility, and software in the context of general medical device safety and effectiveness.
Here's a breakdown of the relevant information provided, tailored to the context of a non-AI/ML medical device for which the prompt's questions are not appropriate:
1. Acceptance Criteria and Reported Device Performance:
The acceptance criteria are implicitly defined by compliance with various ISO standards for wheelchairs. The reported device performance is that the "Extreme X8 Power Wheelchair has undergone testing to ensure that any differences in technological characteristics (i.e., battery, castor wheels, and no anti-pitch mechanism) do not affect safety and effectiveness when compared to the predicate device."
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 7176-1 (Static stability) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-2 (Dynamic stability) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-3 (Effectiveness of brakes) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-4 (Energy consumption) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-5 (Dimensions, mass, maneuvering) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-6 (Max speed, accel, decel) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-7 (Seat & wheel dimensions) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-8 (Static, impact, fatigue) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-9 (Climatic test) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-10 (Obstacle climbing) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-11 (Test dummies) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-14 (Power & control systems) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-15 (Documentation & labeling) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-16 (Resistance to ignition) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-19 (Dynamic Test) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-26 (Vocabulary) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-21 (EMC testing) | Met, indicated by substantial equivalence to predicate device |
| ISO 7176-25 (Batteries and chargers) | Met, indicated by substantial equivalence to predicate device |
| ISO 10993-1 (Biocompatibility eval.) | Met, based on previous use and cytotoxicity testing conducted |
| ISO 10993-5 (In vitro cytotoxicity) | Met, based on previous use and cytotoxicity testing conducted |
| IEC 62304 (Software life cycle process) | Met, indicated by substantial equivalence to predicate device |
The study proving the device meets these criteria is the non-clinical testing summarized in the "Summary of Non-Clinical Testing" section. This testing demonstrated that the Extreme X8 Power Wheelchair does not raise new issues of safety or effectiveness compared to the predicate device, leading to a conclusion of substantial equivalence.
The following numbered points from the prompt cannot be answered as they pertain to AI/ML device studies, and this document is for a physical medical device (powered wheelchair):
- Sample sizes used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
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July 9, 2021
Magic Mobility % Michelle Rubin-Onur Senior Regulatory Specialist AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave Suite B-257 San Diego, California 92110
Re: K211574
Trade/Device Name: Extreme X8 Power Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: May 20, 2021 Received: May 21, 2021
Dear Michelle Rubin-Onur:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211574
Device Name Extreme X8 Power Wheelchair
Indications for Use (Describe)
The Extreme X8 Power Wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
DATE PREPARED
July 9, 2021
MANUFACTURER AND 510(k) OWNER
Magic Mobility 3 International Court, Scoresby, VIC, 3179 Australia Telephone: Official Contact: Alex Suen, Quality Assurance and Regulatory Affairs Manager
REPRESENTATIVE/CONSULTANT
Michelle Rubin-Onur, Ph.D. Matthieu Kirkland, M.S. AcKnowledge Regulatory Strategies, LLC Telephone: Email: mrubin@acknowledge-rs.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Extreme X8 Power Wheelchair |
|---|---|
| Common Name: | Wheelchair, Powered |
| Regulation Number: | 21 CFR 890.3860 |
| Class: | Class II |
| Product Code: | ITI |
| Premarket Review: | Neuromodulation and Physical Medicine Devices (DHT5B) |
| Review Panel: | Physical Medicine |
PREDICATE DEVICE IDENTIFICATION
The Extreme X8 Power Wheelchair is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Predicate Relationship |
|---|---|---|
| K090350 | Extreme 4x4-X8 / Innovation In Motion | Predicate Device |
| K172384 | Quickie® Q700-UP M / Sunrise Medical (US) LLC | Reference Device |
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DEVICE DESCRIPTION
The Extreme X8 Power Wheelchair is designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject device is intended to provide mobility to persons who are restricted or limited to a sitting position.
The Extreme X8 Power Wheelchair is a battery powered, electric motor driven device that can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips).The Extreme X8 Power Wheelchair offers two basic seating options: MPS and Rehab. The MPS option is more static and does not allow for additional aftermarket cushions. The Rehab option is more adjustable to adhere to recommendations from the user's physician or physical therapist.
The Extreme X8 Power Wheelchair includes the following accessories:
- Extra spreader bar
- Slide in table ●
- Lights
- Luggage rack
- Accessory charger ●
- Posture belt
- Roho cushion
- Jay cushion
- MPS push rail
- MPS peg push handle
- Scooter stopper ●
- Retractable docking pin
- Fold forward kit
- Steering lock
INTENDED USE
Magic Mobility power chairs are designed for the exclusive use of people (adults and children) who are unable to walk or have limited mobility and have the cognitive, physical and visual ability to control the vehicle safety. The Magic Mobility Extreme X8 is intended to be selfpropelled on a range of surfaces. The All-Terrain tires can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips).
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INDICATIONS FOR USE
The Extreme X8 Power Wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Magic Mobility believes that the Extreme X8 Power Wheelchair is substantially equivalent to the predicate device based on the information summarized here:
The subject device has a similar design and dimensions and uses similar or identical materials as the device cleared in K090350. The subject device has the same intended use and similar technological characteristics (i.e., base technology and OEM joystick control) to the devices cleared in K093050 and K172384. The subject device has the same intended use environment, including off road capabilities, as the device cleared in K090350. The subject device uses the same software as the device cleared in K172384. The Extreme X8 Power Wheelchair has undergone testing to ensure that any differences in technological characteristics (i.e., battery, castor wheels, and no anti-pitch mechanism) do not affect safety and effectiveness when compared to the predicate device.
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| Subject Device | Predicate Device | Reference Device | ||
|---|---|---|---|---|
| Magic Mobility | Innovation In Motion | Sunrise Medical (US) LLC | Statement of Equivalence | |
| Extreme X8 Power Wheelchair | Extreme 4x4-X8 | Quickie® Q700-UP M | ||
| K090350 | K172384 | |||
| Indications for Use | The Extreme X8 Power Wheelchair is abattery-operated device with wheelsthat is intended for medical purposesto provide mobility to personsrestricted to a sitting position who havethe capability of operating a powerwheelchair. | The intended use of the X8 powerwheelchair is to provide mobility topersons limited to a sitting position, whohave the capability of operating a powerwheelchair. | The Sunrise Medical Quickie®Q700-UP M power wheelchairsare battery operated devices,that are indicated for medicalpurposes to provide mobilityand repositioning of the user,including a stand-up feature. | Identical to predicate device. Noimpact on safety oreffectiveness. |
| Product Codes /Regulation Number | ITI / 21 CFR 890.3860 | ITI / 21 CFR 890.3860 | IPL / 21 CFR 890.3900 | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Regulation Description | Powered Wheelchair | Powered Wheelchair | Standup Wheelchair | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Technical Specifications | ||||
| General | ||||
| Maximum User Weight(lbs.) | 400 | 400 | 265 | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Storage Temperature(°C) | -40 to 70°C | -40 to 70°C | -40 to 70 | Identical to predicate andreference devices. No impact onsafety and effectiveness. |
| Location for Use | Indoors and outdoors including carefacilities, residences, and soft/roughterrain. | Indoors and outdoors including carefacilities, and residences | Indoors and outdoors includingcare facilities, and residences | Identical to predicate andreference devices. No impact onsafety and effectiveness. |
| Frame Material | Steel | Steel | Steel and aluminum | Identical to predicate andreference devices. No impact onsafety and effectiveness. |
| Biocompatibility | Uses materials common to manywheelchairs | Uses materials common to manywheelchairs | Uses materials common tomany wheelchairs | Identical to predicate andreference devices. No impact onsafety and effectiveness. |
| Ground Clearance | 4" | 4" | Unknown | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Base | ||||
| Overall Dimensions(length by width;inches) | 45.25"x37" | 45.25"x37" | 25"x36" | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Subject Device | Predicate Device | Reference Device | ||
| Magic Mobility | Innovation In Motion | Sunrise Medical (US) LLC | Statement of Equivalence | |
| Extreme X8 Power Wheelchair | Extreme 4x4-X8 | Quickie® Q700-UP M | ||
| K090350 | K172384 | |||
| Rolling Base Weight(lbs.) | 145 | 145 | 152 | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Power Source | Batteries | Batteries | Batteries | Identical to predicate andreference devices. No impact onsafety and effectiveness. |
| Battery Details | 2- 73 AMP/hour AGM Group 24 12-voltWeight 55 lbs | 2- 73 AMP/hour AGM Group 24 12 voltWeight 55 lbs | 24V (2x12V) / 73 Ah/20h | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Battery Charger InputVoltage (volts) | 110 | 110 | Unknown | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Motors | 4-24V, 4 pole direct drive gear in linemotors/gearbox. Freewheelinglever/motor lock releases & engagesrear motor brakes | 4-24V, 4 pole direct drive gear in linemotors/gearbox. Freewheelinglever/motor lock releases & engages rearmotor brakes | Unknown | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Wheel Size (inches) | 4"x14" | 4"x14" | Unknown | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Turing Radius (inches) | 52" | 52" | Unknown | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Range (miles) | 15.5 | 15.5 | Unknown | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Maximum Speed (mph) | 6.2 | 6.2 | 6 (with an option of 8) | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Anti-pitch Mechanismfor Climbing | None | None | Additional anti-pitch lock out | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Lift Range (inches) | 0-12 | 0-12 | 0-12 | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Tilt Range (degrees) | 0-50 | 0-50 | 0-50 | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Recline Range (degrees) | 0-170 | 0-170 | 0-172 | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Subject Device | Predicate Device | Reference Device | ||
| Magic Mobility | Innovation In Motion | Sunrise Medical (US) LLC | Statement of Equivalence | |
| Extreme X8 Power Wheelchair | Extreme 4x4-X8 | Quickie® Q700-UP M | ||
| K090350 | K172384 | |||
| impact on safety andeffectiveness. | ||||
| Suspension | None | None | Unknown | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Braking System | Electromagnetic, regenerative brakeswith a free-wheeling mode | Electromagnetic, regenerative brakeswith a free-wheeling mode | Unknown | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Minimum BrakingDistance at MaximumSpeed (meters) | 1.7 | 1.7 | Unknown | Identical to predicate device. Noimpact on safety andeffectiveness. |
| User Controller | Joystick and hand control buttons | Joystick and hand control buttons | Joystick and hand controlbuttons | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Joystick Mount | Fixed mount, height adjustable, swing-away | Fixed mount, height adjustable, swing-away | Fixed mount, height adjustable,swing-away | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Software | ||||
| Software | R-Net from PGDT | Dynamic DX2-PMA70L electronic controland joystick | R-Net from PGDT | Identical to reference device.No impact on safety andeffectiveness. |
| Seat/Armrest/Footrest | ||||
| Seat Height (minimum,inches) | 19" | 19" | 16.2" | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Seat Width (inches) | 16"-24" | 16"-24" | 16"-22" | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Armrest | Height adjustable, removable, flip upoption | Height adjustable, removable, flip upoption | Unknown | Identical to predicate device. Noimpact on safety andeffectiveness. |
| Footrest | 1 or 2 pieces, fixed or flip up, angle andheight adjustable rigid footplates, andothers | 1 or 2 pieces, fixed or flip up, angle andheight adjustable rigid footplates, andothers | Unknown | Identical to predicate device. Noimpact on safety andeffectiveness. |
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SUMMARY OF NON-CLINICAL TESTING
The following tests were performed to demonstrate substantial equivalence based on current industry and FDA recognized standards. The results of these tests indicate that the Extreme X8 Power Wheelchair is substantially equivalent to the predicate device.
PERFORMANCE
- Static stability (per ISO 7176-1) ●
- Dynamic stability (per ISO 7176-2) ●
- Effectiveness of brakes (per ISO 7176-3)
- Energy consumption (per ISO 7176-4) ●
- . Dimensions, mass, and maneuvering space (per ISO 7176-5)
- Maximum speed, acceleration, and deceleration (per ISO 7176-6)
- Measurement of seat and wheel dimensions (per ISO 7176-7)
- Static, impact, and fatigue (per ISO 7176-8)
- Climatic test (per ISO 7176-9)
- Obstacle climbing (per ISO 7176-10)
- Test dummies (per ISO 7176-11)
- Power and control systems for power wheelchairs (per ISO 7176-14)
- Documentation and labeling (per ISO 7176-15)
- Resistance to ignition (per ISO 7176-16)
- Dynamic Test (per ISO 71716-19)
- Vocabulary (per ISO 7176-26)
EMC AND ELECTRICAL SAFETY
- EMC testing (per ISO 7176-21) ●
- Batteries and chargers per (per ISO 7176-25)
BIOCOMPATIBILITY
- Evaluation and testing within a risk management process (per ISO 10993-1) ●
- In vitro cytotoxicity (per ISO 10993-5)
The materials used in the subject device are identical composition, formulation processing, sterilization, and geometry as the materials found in the Extreme 4x4-X8 Power Wheelchair by Magic Mobility LLC (K090350) and the Quickie Q700-UP M by Sunrise Medical (US) LLC (K172384) device. Furthermore, the Extreme X8 Power Wheelchair has the same nature of tissue contact and contact duration as the predicate and reference devices. Therefore, based on previous use and the cytotoxicity testing conducted, the subject device is considered to have met the requirements of ISO 10993-1 and FDA's Guidance for Industry and Food and Drug Administration Staff – Use of International ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
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SOFTWARE
- Software life cycle process (per IEC 62304)
CONCLUSION
Based on the testing performed (including wheelchair dynamic testing and flammability) it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed Extreme X8 Power Wheelchair are assessed to be substantially equivalent to the predicate device.
§ 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).