(88 days)
The XT2 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 XT4 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 XT Series Power Wheelchair has two configurations: XT2 and XT4. They are 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 XT 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 XT Series 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 document is an FDA 510(k) clearance letter and summary for a Magic Mobility XT Series Power Wheelchair. It details the device's technical specifications, indications for use, and a comparison to predicate devices, along with the non-clinical testing performed to establish substantial equivalence.
However, the document does not contain any information about an AI/ML-based medical device, nor does it include details about a study conducted to demonstrate its performance against specific acceptance criteria for such a device. The device described, a powered wheelchair, is a physical medical device, not a software or AI-driven diagnostic or therapeutic tool that would typically have acceptance criteria related to accuracy, sensitivity, specificity, or human-in-the-loop performance improvement.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, a sample size, expert qualifications, ground truth establishment, or MRMC studies, as these concepts are not applicable to the content of the provided document.
The document focuses on non-clinical bench testing to demonstrate the safety and effectiveness of the physical wheelchair in comparison to existing predicate devices, primarily through adherence to ISO standards for wheelchairs.
To directly answer your prompt, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- This document does not present acceptance criteria or reported performance for an AI/ML device. It lists various ISO standards that the physical wheelchair was tested against. The "reported device performance" is essentially that it met these standards, thus demonstrating substantial equivalence to predicate devices. For example, for "Static stability," the acceptance criterion is compliance with ISO 7176-1, and the reported performance is implicit compliance as it contributed to the substantial equivalence determination.
| Acceptance Criterion (Implicitly Compliance with Standard) | Reported Device Performance (Implicitly Met) |
|---|---|
| ISO 7176-1: Static stability | Met standard |
| ISO 7176-2: Dynamic stability | Met standard |
| ISO 7176-3: Effectiveness of brakes | Met standard |
| ISO 7176-4: Energy consumption | Met standard |
| ISO 7176-5: Dimensions, mass, and maneuvering space | Met standard |
| ISO 7176-6: Maximum speed, acceleration, and deceleration | Met standard |
| ISO 7176-7: Measurement of seat and wheel dimensions | Met standard |
| ISO 7176-8: Static, impact, and fatigue | Met standard |
| ISO 7176-9: Climatic test | Met standard |
| ISO 7176-10: Obstacle climbing | Met standard |
| ISO 7176-11: Test dummies | Met standard |
| ISO 7176-14: Power and control systems | Met standard |
| ISO 7176-15: Documentation and labeling | Met standard |
| ISO 7176-16: Resistance to ignition | Met standard |
| ISO 7176-19: Dynamic Test | Met standard |
| ISO 7176-26: Vocabulary | Met standard |
| ISO 7176-30: Wheelchairs for changing posture | Met standard |
| ISO 7176-21: EMC testing | Met standard |
| ISO 7176-25: Batteries and chargers | Met standard |
| ISO 10993-1: Biocompatibility | Met standard (via material commonality) |
| IEC 62304: Software life cycle process | Met standard |
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided for an AI/ML device. The "test set" here refers to the physical wheelchairs undergoing bench testing. The sample size for such physical product testing is not specified, but typically involves a small number of units. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of medical device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of an AI/ML device's performance (e.g., disease detection) is not established for a physical powered wheelchair. The "truth" for this device is its adherence to engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a concept for reconciling disagreements among human readers in a diagnostic AI/ML study, not for physical product testing.
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:
- No, an MRMC study was not done as this is a physical wheelchair, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no AI algorithm being submitted for standalone performance evaluation in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of AI/ML. The "ground truth" for this device's performance is adherence to established international engineering and safety standards (e.g., ISO, IEC).
8. The sample size for the training set:
- Not applicable. This document does not describe an AI/ML device, so there is no training set for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 4, 2024
Magic Mobility % Pierre Bounaud Principal Consultant Ram+ 2251 San Diego Ave, Suite B-257 San Diego, California 92110
Re: K233877
Trade/Device Name: XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: November 26, 2023 Received: December 7, 2023
Dear Pierre Bounaud:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
Tushar Bansal -S
for Heather Dean, PhD
Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation 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) K233877
Device Name
XT Series Power Wheelchair (XT2); XT Series Power Wheelchair (XT4)
Indications for Use (Describe)
The XT2 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 XT4 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) | X |
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510(k) Summary K233877
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Image /page/5/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is written in a stylized font, with the first half of the word in red and the second half in black. Below the word "magic" is the word "Mobility" written in a cursive font. The logo is simple and modern, and it conveys a sense of movement and innovation.
K233877 510(k) SUMMARY
DATE PREPARED
November 26, 2023
MANUFACTURER AND 510(k) OWNER
Magic Mobility 3 International Court, Scoresby, VIC, 3179 Australia Telephone: Official Contact: Terence Walsh, Quality and Regulatory Affairs Manager
REPRESENTATIVE/CONSULTANT
Pierre Bounaud, Ph.D. Allison C. Komiyama, Ph.D., RAC RQM+ Telephone: +1 (412) 816-8139 Email: pbounaud@rqmplus.com; akomiyama@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | XT Series Power Wheelchair (XT2 and XT4 models) |
|---|---|
| Common Name: | Powered wheelchair |
| Regulation Number: | 21 CFR 890.3860 |
| Class: | II |
| Product Code: | ITI |
| Premarket Review: | OHT5/Neuromodulation and Physical Medicine Devices(DHT5B) |
| Review Panel: | Physical Medicine |
PREDICATE DEVICE IDENTIFICATION
The XT Series Power Wheelchair is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | PrimaryPredicate | ReferenceDevice |
|---|---|---|---|
| K211574 | Extreme X8 / Magic Mobility | ✓ | |
| K172384 | Quickie® Q700-UP M / Sunrise Medical (US) LLC | ✓ |
The predicate devices have not been subject to a design related recall.
DEVICE DESCRIPTION
The XT Series Power Wheelchair has two configurations: XT2 and XT4. They are 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 XT Series Power Wheelchairs are battery powered, electric motor driven devices that can be
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Image /page/6/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is written in a stylized font, with the top half of the letters in red and the bottom half in black. Below the word "magic" is the word "Mobility" written in a cursive font. The letters in "Mobility" are black.
used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips). The XT Series 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 XT 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
- 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 safely. The XT Series Power Wheelchairs are intended to be selfpropelled on a range of surfaces and can be used on both indoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips).
INDICATIONS FOR USE
The XT2 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 XT4 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 XT Series 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 devices cleared in K211574. The subject device has the same intended use and similar technological characteristics (i.e.. base technology and OEM jovstick control) to the devices cleared in K211574 and K172384. The subject device has the same intended use environment. including off road capabilities, as the device cleared in K211574. The subject device uses the same software as the device cleared in K211574 and K172384. The Magic XT Series Power Wheelchairs have undergone testing to ensure that any differences in technological characteristics (i.e., battery size, frame design) do not affect safety and effectiveness when compared to the predicate devices.
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Image /page/7/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is written in a stylized font, with the "ma" in red and the "gic" in black. Below the word "magic" is the word "Mobility" in a cursive font. The logo is simple and modern.
| Subject Device | Predicate Device | Reference Device | Statement of Equivalence | |
|---|---|---|---|---|
| Magic MobilityXT Series Power WheelchairK233877 | Magic MobilityExtreme X8 Power WheelchairK211574 | Sunrise Medical (US) LLCQuickie® Q700-UP MK172384 | ||
| Indications forUse | The XT2 power wheelchair is a battery-operated device with wheels that isintended for medical purposes to providemobility to persons restricted to a sittingposition who have the capability ofoperating a power wheelchair.The XT4 power wheelchair is a battery-operated device with wheels that isintended for medical purposes to providemobility to persons restricted to a sittingposition who have the capability ofoperating a power wheelchair. | The Extreme X8 Power Wheelchair is abattery-operated device with wheels thatis intended for medical purposes toprovide mobility to persons restricted toa sitting position who have the capabilityof operating a power wheelchair. | The Sunrise Medical Quickie® Q700-UP M power wheelchairs are batteryoperated devices, that are indicated formedical purposes to provide mobilityand repositioning of the user,including a stand-up feature. | Identical to predicate device. Noimpact on safety or effectiveness. |
| Product Code /RegulationNumber | ITI / 21 CFR 890.3860 | ITI / 21 CFR 890.3860 | IPL / 21 CFR 890.3900 | Identical to predicate device. Noimpact on safety and effectiveness. |
| RegulationDescription | Powered Wheelchair | Powered Wheelchair | Standup Wheelchair | Identical to predicate device. Noimpact on safety and effectiveness. |
| Maximum UserWeight (lbs) | XT2: 300XT4: 400 | 400 | 265 | Similar to predicate device. Noimpact on safety and effectiveness. |
| StorageTemperature(°C) | -40 to 70°C | -40 to 70°C | -40 to 70°C | Identical to predicate and referencedevices. No impact on safety andeffectiveness. |
| Location for Use | Indoors and outdoors including carefacilities, residences, and soft/roughterrain | Indoors and outdoors including carefacilities, residences, and soft/roughterrain | Indoors and outdoors including carefacilities, and residences | Identical to predicate and referencedevices. No impact on safety andeffectiveness. |
| Frame Material | Steel | Steel | Steel and aluminum | Identical to predicate and referencedevices. No impact on safety andeffectiveness. |
| Biocompatibility | Uses materials common to manywheelchairs | Uses materials common to manywheelchairs | Uses materials common to manywheelchairs | Identical to predicate and referencedevices. No impact on safety andeffectiveness. |
| GroundClearance | 5" | 4" | Unknown | Similar to predicate device. Noimpact on safety and effectiveness. |
| Subject Device | Predicate Device | Reference Device | ||
| Magic MobilityXT Series Power WheelchairK233877 | Magic MobilityExtreme X8 Power WheelchairK211574 | Sunrise Medical (US) LLCQuickie® Q700-UP MK172384 | Statement of Equivalence | |
| Overall Dimensions(length by width; inches) | XT2: 43.5" x 27"XT4: 39.5"x 27.5" | 45.25" x 27" | 25" x 26" | Similar to predicate device. No impact on safety and effectiveness. |
| Rolling Base Weight (lbs) | XT2: 167XT4: 183 | 145 | 152 | Similar to predicate device. No impact on safety and effectiveness. |
| Power Source | Batteries | Batteries | Batteries | Identical to predicate and reference devices. No impact on safety and effectiveness. |
| Battery Details | 2- Group 31 12-volt AGM or Gel20h capacity in 95-115 AMP/hour range. | 2- 73 AMP/hour AGM Group 24 12-voltWeight 55 lbs | 24V (2x12V) / 73 Ah/20h | Similar to predicate device. No impact on safety and effectiveness. |
| Battery Charger Input Voltage(volts) | 110 | 110 | Unknown | Identical to predicate device. No impact on safety and effectiveness. |
| Motors | XT2: 2 motorsXT4: 4 motors24V, 4 pole direct drive gear in line motors/gearbox. Freewheeling lever/motor lock releases & engages motor brakes | 4-24V, 4 pole direct drive gear in line motors/gearbox. Freewheeling lever/motor lock releases & engages rear motor brakes | Unknown | Similar to predicate device. No impact on safety and effectiveness. |
| Wheel Size(inches) | 4" x 14" | 4" x 14" | Unknown | Identical to predicate device. No impact on safety and effectiveness. |
| Turning Radius(inches) | XT2: 69"XT4: 55.5" | 52" | Unknown | Similar to predicate device. No impact on safety and effectiveness. |
| Range (miles) | XT2: 33XT4: 24 | 15.5 | Unknown | Similar to predicate device. No impact on safety and effectiveness. |
| Maximum Speed (mph) | 6.2 | 6.2 | 6 (with an option of 8) | Identical to predicate device. No impact on safety and effectiveness. |
| Anti-pitch Mechanism for Climbing | None | None | Additional anti-pitch lock out | Identical to predicate device. No impact on safety and effectiveness. |
| Lift Range(inches) | 0-12" | 0-12" | 0-12" | Identical to predicate device. No impact on safety and effectiveness. |
| Tilt Range(degrees) | 0-50 | 0-50 | 0-50 | Identical to predicate device. No impact on safety and effectiveness. |
| Subject Device | Predicate Device | Reference Device | ||
| Magic MobilityXT Series Power WheelchairK233877 | Magic MobilityExtreme X8 Power WheelchairK211574 | Sunrise Medical (US) LLCQuickie® Q700-UP MK172384 | Statement of Equivalence | |
| Recline Range(degrees) | 0-170 | 0-170 | 0-172 | Identical to predicate device. Noimpact on safety and effectiveness. |
| Suspension | Front and Rear | None | Unknown | Similar to predicate device. Noimpact on safety and effectiveness. |
| Braking System | Electromagnetic, regenerative brakes witha free-wheeling mode | Electromagnetic, regenerative brakeswith a free-wheeling mode | Unknown | Identical to predicate device. Noimpact on safety and effectiveness. |
| MinimumBrakingDistance atMaximumSpeed (meters) | 1.7 | 1.7 | Unknown | Identical to predicate device. Noimpact on safety and effectiveness. |
| User Controller | Joystick and hand control buttons | Joystick and hand control buttons | Joystick and hand control buttons | Identical to predicate device. Noimpact on safety and effectiveness. |
| 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 and effectiveness. |
| Software | R-Net from PGDT | R-Net from PGDT | R-Net from PGDT | Identical to predicate device. Noimpact on safety and effectiveness. |
| Seat Height(minimum,inches) | 19" | 19" | 16.2" | Identical to predicate device. Noimpact on safety and effectiveness. |
| Seat Width(inches) | 12"-24" | 16"-24" | 16"-22" | Similar to predicate device. Noimpact on safety and effectiveness. |
| Armrest | Height adjustable, removable, flip upoption | Height adjustable, removable, flip upoption | Unknown | Identical to predicate device. Noimpact on safety and effectiveness. |
| 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 and effectiveness. |
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Image /page/8/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is written in a stylized font, with the first two letters in red and the last three letters in black. The word "Mobility" is written in a cursive font below the word "magic". The logo is simple and modern, and it is likely used to represent a company that sells mobility products or services.
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Image /page/9/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is written in a stylized font, with the "ma" in red and the "gic" in black. Below the word "magic" is the word "Mobility" in a cursive font. The logo is simple and modern.
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Image /page/10/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is written in a stylized font, with the first half in red and the second half in black. Below the word "magic" is the word "Mobility" written in a cursive font, also in black. The TM symbol is in the bottom right corner of the word "Mobility".
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 XT Series Power Wheelchair is substantially equivalent to the predicate device.
| BENCH TESTING | |
|---|---|
| ISO 7176-1 | Static stability |
| ISO 7176-2 | Dynamic stability |
| ISO 7176-3 | Effectiveness of brakes |
| ISO 7176-4 | Energy consumption |
| ISO 7176-5 | Dimensions, mass, and maneuvering space |
| ISO 7176-6 | Maximum speed, acceleration, and deceleration |
| ISO 7176-7 | Measurement of seat and wheel dimensions |
| ISO 7176-8 | Static, impact, and fatigue |
| ISO 7176-9 | Climatic test |
| ISO 7176-10 | Obstacle climbing |
| ISO 7176-11 | Test dummies |
| ISO 7176-14 | Power and control systems for power wheelchairs |
| ISO 7176-15 | Documentation and labeling |
| ISO 7176-16 | Resistance to ignition |
| ISO 7176-19 | Dynamic Test |
| ISO 7176-26 | Vocabulary |
| ISO 7176-30 | Wheelchairs for changing occupant posture |
| EMC AND ELECTRICAL SAFETY | |
| ISO 7176-21 | EMC testing |
| ISO 7176-25 | Batteries and chargers |
| BIOCOMPATIBILITY | |
|---|---|
| ISO 10993-1 | Evaluation and testing within a risk management process |
The materials used in the subject device are identical composition, formulation processing, and geometry as the materials found in the Extreme X8 Power Wheelchair by Magic Mobility LLC (K211574) and the Quickie Q700-UP M by Sunrise Medical (US) LLC (K172384) device. Furthermore, the T Series Power Wheelchair has the same type and duration of patient contact as the predicate and reference devices. Therefore, based on previous use, 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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Image /page/11/Picture/0 description: The image shows the logo for Magic Mobility. The word "magic" is written in a stylized font, with the top half of the letters in red and the bottom half in black. The word "Mobility" is written in a cursive font below the word "magic". The logo is simple and modern, and it is likely used to represent a company that provides mobility solutions.
| SOFTWARE | |
|---|---|
| IEC 62304 | Software life cycle process |
The results of these tests indicate that the XT Series Power Wheelchair is substantially equivalent to the predicate devices.
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 devices. The similar indications for use, technological characteristics and performance characteristics for the proposed XT Series 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).