(56 days)
The Frontier Series Power Wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.
The Frontier Series Power Wheelchairs have four configurations: V4 RWD, V4 FWD, V6, and C73. The Frontier Series Power Wheelchairs are designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject devices are intended to provide mobility to persons who are restricted or limited to a sitting position. The Frontier Series Power Wheelchairs are battery powered, electric motor driven devices that can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips).
This is a 510(k) premarket notification for the "Frontier Series Power Wheelchairs". This document is a submission to the FDA to demonstrate that the new device is "substantially equivalent" to already legally marketed predicate devices. Therefore, the "acceptance criteria" here refers to the performance of the device relative to established standards and the predicate devices, rather than strict statistical thresholds for an AI algorithm.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are established by adherence to recognized international standards and comparison to predicate devices, showing that any differences do not affect safety or effectiveness. The reported device performance is demonstrated by meeting these standards and having similar or identical characteristics to the predicate devices.
| Acceptance Criteria / Performance Metric | Reported Device Performance / Evaluation |
|---|---|
| Indications for Use (Substantial Equivalence) | The Frontier Series Power Wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair. This is described as "Substantially equivalent to predicate devices." |
| Product Codes / Regulation Number (Substantial Equivalence) | ITI / 21 CFR 890.3860. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Regulation Description (Substantial Equivalence) | Powered Wheelchair. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Maximum User Weight (Substantial Equivalence) | Frontier V4 FWD: 400 lbs, Frontier V4 RWD: 400 lbs, Frontier V6: 400 lbs, Frontier V6 C73: 400 lbs. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Primary predicate K030783 also 400 lbs). |
| Storage Temperature (Substantial Equivalence) | -40 to 70 °C. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Primary predicate K030783 also -40 to 70 °C). |
| Location for Use (Substantial Equivalence) | Indoors and outdoors including care facilities, and residences. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Frame Material (Substantial Equivalence) | Steel. Described as "Identical to the primary predicate." (Primary predicate K030783 also Steel). |
| Base Overall Dimensions (Substantial Equivalence) | Varied across models (e.g., Frontier V4 FWD AT tires: 39.2 x 28 inches). Described as "Substantially equivalent to the predicate and reference devices. No impact on safety and effectiveness." |
| Rolling Base Weight (Substantial Equivalence) | 260 lbs (with batteries). Described as "Substantially equivalent to the predicate device. No impact on safety and effectiveness." (Primary predicate K030783: 130 lbs; K142457: 152 lbs) - Note: While a difference exists, the claim is "No impact on safety and effectiveness.". |
| Power Source (Substantial Equivalence) | Batteries. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Battery Details (Substantial Equivalence) | Two (2) 73 Ahr. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Reference device K172384: 24V (2x12V)/73 Ah/20h). |
| Castor Wheel Size (Substantial Equivalence) | 8.25 x 2.5 inches. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Predicate K030783 and K142457 listed as 'Unknown'). |
| Range (Substantial Equivalence) | 15-20 miles. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Predicate K030783 and K142457 listed as 'Unknown'). |
| Anti-pitch Mechanism for Climbing (Substantial Equivalence) | None. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Predicates K030783 and K142457: "Additional anti-pitch lock out"). Note: This is a stated difference with the predicate, but claimed "No impact on safety and effectiveness.". |
| Lift Range (Substantial Equivalence) | 0-12 inches. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Tilt Range (Substantial Equivalence) | 0-50 degrees. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Recline Range (Substantial Equivalence) | 0-170 degrees. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Reference device K172384: 0-172 degrees - Note: claimed identical despite slight difference). |
| Suspension (Substantial Equivalence) | Independent drive wheel suspension with shock absorber on pivoting swing arm and articulated castors to ensure all wheels maintain adhesion at all surface angles. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Maximum Speed (Substantial Equivalence) | 6 mph. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Reference device K172384: 6 mph (with an option of 8)). |
| Minimum Braking Distance at Maximum Speed (Substantial Equivalence) | 1.8 meters. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Predicate K030783 and K142457 listed as 'Unknown'). |
| User Controller (Substantial Equivalence) | Joystick and hand control buttons. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Joystick Mount (Substantial Equivalence) | Joystick and hand control buttons (implies variable, but then states Fixed mount, height adjustable, swing-away). Described as "Identical to the predicate and reference devices. No impact on safety and effectiveness." |
| Software (Substantial Equivalence) | R-Net from PGDT. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Primary predicate K030783 uses VR2 from PGDT; Reference device K172384 uses R-Net from PGDT). Note: This is a stated difference with the primary predicate, but claimed "No impact on safety and effectiveness" due to similarity to the reference device. |
| Seat Height (minimum, inches) (Substantial Equivalence) | 17.1 inches. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Primary predicate K030783: 16.2 inches). Note: claimed identical despite slight difference. |
| Seat Width (inches) (Substantial Equivalence) | 16-24 inches. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Primary predicate K030783: 12-24 inches). |
| Armrest (Substantial Equivalence) | Height adjustable, removable, flip up option. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Predicate K030783 and K142457 listed as 'Unknown'). |
| Footrest (Substantial Equivalence) | Rigid footplate, flip up nylon. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Predicate K030783 and K142457 listed as 'Unknown'). |
| Static stability (per ISO 7176-1) | Performed. Results indicated substantial equivalence. |
| Dynamic stability (per ISO 7176-2) | Performed. Results indicated substantial equivalence. |
| Effectiveness of brakes (per ISO 7176-3) | Performed. Results indicated substantial equivalence. |
| Energy consumption (per ISO 7176-4) | Performed. Results indicated substantial equivalence. |
| Dimensions, mass, and maneuvering space (per ISO 7176-5) | Performed. Results indicated substantial equivalence. |
| Maximum speed, acceleration, and deceleration (per ISO 7176-6) | Performed. Results indicated substantial equivalence. |
| Measurement of seat and wheel dimensions (per ISO 7176-7) | Performed. Results indicated substantial equivalence. |
| Static, impact, and fatigue (per ISO 7176-8) | Performed. Results indicated substantial equivalence. |
| Climatic test (per ISO 7176-9) | Performed. Results indicated substantial equivalence. |
| Obstacle climbing (per ISO 7176-10) | Performed. Results indicated substantial equivalence. |
| Test dummies (per ISO 7176-11) | Performed. Results indicated substantial equivalence. |
| Power and control systems for power wheelchairs (per ISO 7176-14) | Performed. Results indicated substantial equivalence. |
| Documentation and labeling (per ISO 7176-15) | Performed. Results indicated substantial equivalence. |
| Resistance to ignition (per ISO 7176-16) | Performed. Results indicated substantial equivalence. |
| Dynamic Test (per ISO 71716-19) | Performed. Results indicated substantial equivalence. |
| Vocabulary (per ISO 7176-26) | Performed. Results indicated substantial equivalence. |
| EMC testing (per ISO 7176-21) | Performed. Results indicated substantial equivalence. |
| Batteries and chargers per (per ISO 7176-25) | Performed. Results indicated substantial equivalence. |
| Biocompatibility (per ISO 10993-1 and ISO 10993-5) | Uses materials identical in composition, formulation processing, sterilization, and geometry to predicate devices. Same nature of tissue contact and duration. Also, "in vitro cytotoxicity (per ISO 10993-5)" was performed. Considered to have met requirements. |
| Software life cycle process (per IEC 62304) | Performed. Results indicated substantial equivalence. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission describes non-clinical performance and engineering testing on the device prototypes, not a clinical study on human subjects with a test set of data in the traditional sense of an AI/imaging device. The "test set" would be the physical Frontier Series Power Wheelchairs themselves, subjected to various standardized tests. No specific numerical sample size (e.g., how many wheelchairs were tested for each test) is provided in the document, other than implying the testing of "the subject devices." The provenance is manufacturing in Australia. The testing is presumably prospective for the purpose of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device submission. Ground truth, in the context of this 510(k), refers to the established standards (e.g., ISO 7176 series, ISO 10993 series, IEC 62304) and the performance characteristics of the predicate devices. The "experts" are the creators of these standards, and the engineers/testers who conduct measurements and compare the device's performance against these benchmarks and the predicate devices' specifications. No specific number or qualifications of such 'experts' are provided in this document beyond the general statement of "testing performed."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The evaluation is based on objective measurements against engineering standards and comparison of technical specifications to predicate devices, not subjective assessments requiring adjudication by multiple readers.
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
This is not applicable as the device is a power wheelchair, not an AI-assisted diagnostic or therapeutic tool that involves human readers or interpretation of medical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device (power wheelchair), not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this submission is established by:
- International Standards: Complying with numerous ISO and IEC standards for wheelchairs (e.g., ISO 7176-1 for static stability, ISO 10993-1 for biocompatibility, IEC 62304 for software life cycle).
- Predicate Device Performance: Demonstrating that the subject device's technological characteristics and performance are similar or identical to legally marketed predicate devices, or that any differences do not raise new questions of safety or effectiveness.
8. The sample size for the training set
This is not applicable as the device is a physical power wheelchair, not an AI algorithm trained on a dataset. The design and manufacturing process would involve engineering iterations and testing, but not a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. As described above, this is about adherence to engineering standards and comparison to predicate devices, not machine learning ground truth.
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November 19, 2021
Magic Mobility % Matthieu Kirkland Regulatory Specialist Acknowledge Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, California 92110
Re: K213090
Trade/Device Name: Frontier Series Power Wheelchairs Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 20, 2021 Received: September 24, 2021
Dear Matthieu Kirkland:
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/cdrh/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 L. Dean -S
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) K213090
Device Name Frontier Series Power Wheelchairs
Indications for Use (Describe)
The Frontier Series Power Wheelchairs are battery-operated devices with wheels that are 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
DATE PREPARED
September 20, 2021
MANUFACTURER AND 510(k) OWNER
Magic Mobility 3 International Court, Scoresby, VIC, 3179 Australia Telephone: Official Contact: Jill McKechnie, General Manager
REPRESENTATIVE/CONSULTANT
Matthieu Kirkland, M.S. Allison Komiyama, Ph.D., RAC AcKnowledge Regulatory Strategies, LLC Telephone: Email: mkirkland@acknowledge-rs.com Website: https://www.acknowledge-rs.com/
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Frontier Series Power Wheelchairs |
|---|---|
| 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 Frontier Series Power Wheelchairs are substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Predicate Relationship |
|---|---|---|
| K030783 | Frontier Power Wheelchair/ Innovation In Motion | Primary PredicateDevice |
| K142457 | Quickie® and Zippie® Powered Wheelchairs /Sunrise Medical (US) LLC | Secondary PredicateDevice |
| K172384 | Quickie® Q700-UP M / Sunrise Medical (US) LLC | Reference Device |
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DEVICE DESCRIPTION
The Frontier Series Power Wheelchairs have four configurations: V4 RWD, V4 FWD, V6, and C73. The Frontier Series Power Wheelchairs are designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject devices are intended to provide mobility to persons who are restricted or limited to a sitting position.
The Frontier Series Power Wheelchairs are battery powered, electric motor driven devices 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 Frontier Series Power Wheelchairs include 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 ●
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 Frontier series 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 Frontier Series Power Wheelchairs are battery-operated devices with wheels that are 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 Frontier Series Power Wheelchairs are substantially equivalent to the predicate devices based on the information summarized here:
The subject devices have a similar design and dimensions and uses similar or identical materials as the devices cleared in K030783 and K142457. The subject devices have intended use and similar technological characteristics (i.e., base technology and OEM joystick control) to the devices cleared in K030783, K142457, and K172384. The subject devices have the same intended use environment, including off road capabilities, as the device cleared in K030783. The subject devices use the same software as the device cleared in K172384. The Frontier Series Power Wheelchairs have 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 and reference devices.
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| Subject Devices | Predicate Device | Predicate Device | Reference Device | Statement of Equivalence | |
|---|---|---|---|---|---|
| Magic Mobility | Innovation in Motion | Sunrise Medical (US) LLC | Sunrise Medical (US) LLC | ||
| Indications for Use | Frontier Series PowerWheelchairs | Frontier Power Wheelchair | Quickie® and Zippie® PoweredWheelchairs | Quickie® Q700-UP M | Substantially equivalent topredicate devices. |
| The Frontier Series PowerWheelchairs are battery-operated devices withwheels that are intendedfor medical purposes toprovide mobility topersons restricted to asitting position who havethe capability ofoperating a powerwheelchair. | K030783The intended use of theFrontier Power wheelchairis to provide mobility topersons limited to a sittingposition, who have thecapability of operating apower wheelchair. | K142457Quickie® and Zippie® powerwheelchairs are battery-operateddevices with wheels that areintended for medical purposes toprovide mobility to personsrestricted to a sitting position. TheZippie® power wheelchairs arespecifically for people who areslightly smaller in stature—including children. | K172384The Sunrise MedicalQuickie® Q700-UP Mpower wheelchairsare battery operateddevices, that areindicated for medicalpurposes to providemobility andrepositioning of theuser, including astand-up feature. | ||
| Product Codes /RegulationNumber | ITI/21 CFR 890.3860 | ITI/21 CFR 890.3860 | ITI/21 CFR 890.3860 | IPL/21 CFR890.3900 | Identical to the primary predicate.No impact on safety andeffectiveness. |
| RegulationDescription | Powered Wheelchair | Powered Wheelchair | Powered Wheelchair | Standup Wheelchair | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Technical Specifications | |||||
| GeneralMaximum UserWeight (lbs) | Frontier V4 FWD: 400Frontier V4 RWD: 400Frontier V6: 400Frontier V6 C73:400 | 400 | 300 | 265 | Identical to the primary predicate.No impact on safety andeffectiveness. |
| StorageTemperature(°C) | -40 to 70 | -40 to 70 | -40 to 70 | -40 to 70 | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Location forUse | Indoors and outdoorsincluding care facilities,and residences | Indoors and outdoorsincluding care facilities, andresidences | Indoors and outdoors includingcare facilities, and residences | Indoors andoutdoors includingcare facilities, andresidences | Identical to the primary predicate.No impact on safety and effectiveness. |
| Frame Material | Steel | Steel | Steel and aluminum | Steel and aluminum | Identical to the primary predicate. |
| Subject Devices | Predicate Device | Predicate Device | Reference Device | Statement of Equivalence | |
| Magic MobilityFrontier Series PowerWheelchairs | Innovation in MotionFrontier Power Wheelchair | Sunrise Medical (US) LLCQuickie® and Zippie® PoweredWheelchairs | Sunrise Medical (US)LLCQuickie® Q700-UP M | ||
| K030783 | K142457 | K172384 | |||
| Biocompatibility | Uses materials common tomany wheelchairs | Uses materials common to manywheelchairs | Uses materialscommon to manywheelchairs | No impact on safety andeffectiveness.Identical to the primary predicate.No impact on safety andeffectiveness. | |
| BaseOverallDimensions(length bywidth; inches) | 43.34 x 28 | 24"x34" | 25"x36" | Substantially equivalent to thepredicate and reference devices.No impact on safety andeffectiveness. | |
| Frontier V4 FWD AT tires:39.2 x28Frontier V4 FWD Hybridtires: 39.2 x 26.3Frontier V4 RWD AT tires:36.6 x 28Frontier V4 RWD Hybridtires: 36.6 x 26.3Frontier V6 AT tires:42 x 28Frontier V6 Hybrid tires:42 x 27.5Frontier V6 C73:39.5 x 25.5 | |||||
| Rolling BaseWeight (lbs) | 260 (with batteries) | 130 | 152 | Substantially equivalent to thepredicate device. No impact onsafety and effectiveness. | |
| Power Source | Batteries | Batteries | Batteries | Identical to the primary predicate.No impact on safety andeffectiveness. |
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| Subject DevicesMagic Mobility | Predicate DeviceInnovation in MotionFrontier Series PowerWheelchairs | Predicate DeviceSunrise Medical (US) LLCQuickie® and Zippie® PoweredWheelchairs | Reference DeviceSunrise Medical (US) LLC | Statement of Equivalence |
|---|---|---|---|---|
| Frontier Power Wheelchair | Quickie® Q700-UP M | |||
| Battery Details | Two (2) 73 Ahr | K14245722 NF, sealed lead acid or gel cell | K17238424V (2x12V)/73Ah/20h | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Castor WheelSize (inches) | 8.25 x 2.5 | Unknown | Unknown | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Range (miles) | 15-20 | Unknown | Unknown | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Anti-pitchMechanism forClimbing | None | Additional anti-pitch lock out | Additional anti-pitchlock out | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Lift Range(inches) | 0-12 | 0-12 | 0-12 | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Tilt Range(degrees) | 0-50 | 0-50 | 0-50 | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Recline Range(degrees) | 0-170 | 0-170 | 0-172 | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Suspension | Independent drive wheelsuspension with shockabsorber on pivotingswing arm andarticulated castors toensure all wheelsmaintain adhesion at allsurface angles | Independent drive wheelsuspension with shockabsorber on pivoting swingarm and articulated castorsto ensure all wheelsmaintain adhesion at allsurface angles | Unknown | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Maximumspeed (mm) | 6 | 6 | 6 (with an option of8) | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Subject Devices | Predicate DeviceInnovation in Motion | Predicate DeviceSunrise Medical (US) LLC | Reference DeviceSunrise Medical (US)LLC | Statement of Equivalence |
| Magic MobilityFrontier Series PowerWheelchairs | Frontier Power Wheelchair | Quickie® and Zippie® PoweredWheelchairs | Quickie® Q700-UP M | Identical to the primary predicate.No impact on safety andeffectiveness. |
| K030783 | K142457 | K172384 | ||
| MinimumBrakingDistance atMaximumSpeed (meters) | 1.8 | Unknown | Unknown | Identical to the primary predicate.No impact on safety andeffectiveness. |
| User Controller | Joystick and hand controlbuttons | Joystick and hand control buttons | Joystick and handcontrol buttons | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Joystick Mount | Joystick and hand controlbuttons | Fixed mount, height adjustable,swing-away | Fixed mount, heightadjustable, swing-away | Identical to the predicate andreference devices. No impact onsafety and effectiveness. |
| Software | R-Net from PGDT | VR2 from PGDT | R-Net from PGDT | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Seat/Armrest/Footrest | ||||
| Seat Height(minimum,inches) | 17.1 | 16.2 | 16.2" | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Seat Width(inches) | 16-24 | 12-24 | 16-22 | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Armrest | Height adjustable,Removable, flip up option | Unknown | Unknown | Identical to the primary predicate.No impact on safety andeffectiveness. |
| Footrest | Rigid footplate, flip upnylon | Unknown | Unknown | Identical to the primary predicate.No impact 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 Frontier Series Power Wheelchairs are substantially equivalent to the predicate devices.
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 devices are identical composition, formulation processing, sterilization, and geometry as the materials found in the devices cleared in K030783, K142457, and K172384 . Furthermore, the Frontier Series Power Wheelchairs have 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 devices are 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 devices do not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Frontier Series Power Wheelchairs are assessed to be substantially equivalent to the predicate devices.
§ 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).