(85 days)
No
The summary mentions "Software revisions / changes" and an "active stability system" but does not explicitly mention AI or ML, nor does it describe any features or performance metrics typically associated with AI/ML applications in medical devices.
No.
The device is a powered wheelchair for mobility, not designed for treating a disease or condition.
No
Explanation: The device is described as a multi-mode powered wheelchair intended for mobility, not for diagnosis of any medical condition.
No
The device description explicitly states it includes hardware components such as "stair climbing drive wheels, frame, sealed electronics, sensors, battery packs, motors, active stability system and battery charger." While software revisions are mentioned as an update, the core device is a physical powered wheelchair.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to persons restricted to a sitting position, including the ability to climb stairs. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The device is described as a multi-mode powered wheelchair with features like active stabilization, stair climbing, and power positioning. These are all related to physical mobility and support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Performance Studies: The performance studies focus on compliance with standards related to wheelchairs, batteries, and biocompatibility, not on diagnostic accuracy or analytical performance.
In summary, the iBOT® Personal Mobility Device is a medical device, specifically a powered wheelchair, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor and outdoor mobility to persons restricted to a sitting position. The device allows for the option to climb stairs. The operator(s), either the wheelchair occupant or an assistant, must meet the requirements of the training certification program. The wheelchair occupant must meet the requirements of the user assessment.
Product codes (comma separated list FDA assigned to the subject device)
IMK, ITI
Device Description
The proposed device is an update to the previously cleared iBOT® PMD (K210920). The device retains all the following from the original device including:
The device is a multi-mode powered wheelchair that enables users to manewer in confined spaces, climb curbs, stairs, and other obstacles. The device is intended to provide indoor mobility, including stair climbing, to persons limited to a seated position who are capable of operating a powered wheelchair.
The device still includes active stabilization in multiple driving modes and allows for traversing aggressive and difficult terrain and operation at an elevated seat height offers benefits in activities of daily living (e.g., accessing higher shelves) and interaction with other people at "eye level" while either stationary or moving.
The device still utilizes the primary components of a stair climbing drive wheels, frame, sealed electronics, sensors, battery packs, motors, active stability system and battery charger. It can also be produced without the stair climbing function.
The device still allows occupied transportation while an individual is seated in through both a 4-point tie down system and a docking system.
In addition, the device incorporates the following updates to the iBOT® PMD design:
- · Modified the device to add the Motion Concepts Modular Power Positioning Seating System (K150574) as an option / accessory which includes greater degrees of posterior tilt, power recline with shear reduction, and power elevating legrests
- · Adds anterior tilt to the power positioning options available on the product
- · Adds the existing power seat elevation to the Standard Mode of the device
- · Updates that operator of the chair can be the occupant or an attendant to increase clarity
- · Updates contraindications to increase clarity
- · Adds optional seat interface brackets that include seat height and static tilt angle adjustments
- · Minor redesign of front casters and changes of materials / processes in support of design for manufacturing efforts
- · Software revisions / changes
- · Removes the contraindication for a mechanical ventilator mount can be added to the device, when the device is modified to remove stair and balance modes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: The following performance testing was conducted to demonstrate that the proposed device complies with 21 CFR 890.3890. 21 CFR 890.3860. special controls and recognized standards. This testing demonstrates substantial equivalence to the predicate device through:
- Evaluation to current versions of the standards used in testing of the predicate ● device; with modification for updates in battery technology,
- Software testing per the current version of FDA guidance on software testing ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3890 Stair-climbing wheelchair.
(a)
Identification. A stair-climbing wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use.
(2) Performance testing must demonstrate adequate mechanical performance under simulated use conditions and environments. Performance testing must include the following:
(i) Fatigue testing;
(ii) Resistance to dynamic loads (impact testing);
(iii) Effective use of the braking mechanism and how the device stops in case of an electrical brake failure;
(iv) Demonstration of adequate stability of the device on inclined planes (forward, backward, and lateral);
(v) Demonstration of the ability of the device to safely ascend and descend obstacles (i.e., stairs, curb); and
(vi) Demonstration of ability to effectively use the device during adverse temperatures and following storage in adverse temperatures and humidity conditions.
(3) The skin-contacting components of the device must be demonstrated to be biocompatible.
(4) Software design, verification, and validation must demonstrate that the device controls, alarms, and user interfaces function as intended.
(5) Appropriate analysis and performance testing must be conducted to verify electrical safety and electromagnetic compatibility of the device.
(6) Performance testing must demonstrate battery safety and evaluate longevity.
(7) Performance testing must evaluate the flammability of device components.
(8) Patient labeling must bear all information required for the safe and effective use of the device, specifically including the following:
(i) A clear description of the technological features of the device and the principles of how the device works;
(ii) A clear description of the appropriate use environments/conditions, including prohibited environments;
(iii) Preventive maintenance recommendations;
(iv) Operating specifications for proper use of the device such as patient weight limitations, device width, and clearance for maneuverability; and
(v) A detailed summary of the device-related adverse events and how to report any complications.
(9) Clinician labeling must include all the information in the Patient labeling noted in paragraph (b)(8) of this section but must also include the following:
(i) Identification of patients who can effectively operate the device; and
(ii) Instructions on how to fit, modify, or calibrate the device.
(10) Usability studies of the device must demonstrate that the device can be used by the patient in the intended use environment with the instructions for use and user training.
0
January 30, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Mobius Mobility Joseph Sullivan Director of Quality Assurance & Regulatory Affairs 540 Commercial St. Suite 310 Manchester, New Hampshire 03101
Re: K243442
Trade/Device Name: iBOT® PMD Regulation Number: 21 CFR 890.3890 Regulation Name: Stair-Climbing Wheelchair Regulatory Class: Class II Product Code: IMK, ITI Dated: November 1, 2024 Received: November 6, 2024
Dear Joseph Sullivan:
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.
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).
1
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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
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
3
Indications for Use
510(k) Number (if known) K243442
Device Name iBOT® PMD
Indications for Use (Describe)
The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor and outdoor mobility to persons restricted to a sitting position. The device allows for the option to climb stairs. The operator(s), either the wheelchair occupant or an assistant, must meet the requirements of the training certification program. The wheelchair occupant must meet the requirements of the user assessment.
| 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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4
510(K) SUMMARY
This 510(k) summary for K243442 is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR 807.92.
Date Prepared: November 1, 2024
Submitter's Information
| 510(k) Sponsor: | Mobius Mobility
540 North Commercial Street Suite 310
Manchester, NH 03101 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph Sullivan
QA / RA Manager
Mobius Mobility
Phone: (833) 346-4268
Fax: (603) 621-0789
jsullivan@mobiusmobility.com |
| Device Information | |
| Common/Usual Name: | Stair-climbing wheelchair |
| Trade/Proprietary Name: | iBOT® PMD |
| Classification Name: | Stair-climbing wheelchair |
| Device Classification: | 890.3890 |
Device Classification: 890.3890 2nd Device Classification: 890.3860 Primary Product Code (stair feature): IMK Secondary Product Code: ITI Device Panel: Physical Medicine
Predicate Device(s)
The iBOT® PMD is substantially equivalent to the iBOT® Personal Mobility Device ("iBOT PMD"), which was previously cleared under K210920.
K243442 - 510(k) Summary
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Device Description
The proposed device is an update to the previously cleared iBOT® PMD (K210920). The device retains all the following from the original device including:
The device is a multi-mode powered wheelchair that enables users to manewer in confined spaces, climb curbs, stairs, and other obstacles. The device is intended to provide indoor mobility, including stair climbing, to persons limited to a seated position who are capable of operating a powered wheelchair.
The device still includes active stabilization in multiple driving modes and allows for traversing aggressive and difficult terrain and operation at an elevated seat height offers benefits in activities of daily living (e.g., accessing higher shelves) and interaction with other people at "eye level" while either stationary or moving.
The device still utilizes the primary components of a stair climbing drive wheels, frame, sealed electronics, sensors, battery packs, motors, active stability system and battery charger. It can also be produced without the stair climbing function.
The device still allows occupied transportation while an individual is seated in through both a 4-point tie down system and a docking system.
In addition, the device incorporates the following updates to the iBOT® PMD design:
- · Modified the device to add the Motion Concepts Modular Power Positioning Seating System (K150574) as an option / accessory which includes greater degrees of posterior tilt, power recline with shear reduction, and power elevating legrests
- · Adds anterior tilt to the power positioning options available on the product
- · Adds the existing power seat elevation to the Standard Mode of the device
- · Updates that operator of the chair can be the occupant or an attendant to increase clarity
- · Updates contraindications to increase clarity
- · Adds optional seat interface brackets that include seat height and static tilt angle adjustments
- · Minor redesign of front casters and changes of materials / processes in support of design for manufacturing efforts
- · Software revisions / changes
- · Removes the contraindication for a mechanical ventilator mount can be added to the device, when the device is modified to remove stair and balance modes.
Indications for Use
The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor mobility, including the option to climb K243442 - 510(k) Summary
6
stars, to persons restricted to a sitting position. The option to climb stairs. The operator(s), either the wheelchair occupant or an assistant, must meet the requirements of the training certification program. The wheelchair occupant must meet the requirements of the user assessment.
Comparison to Predicate Device
The proposed device has similar technological characteristics and mobility functions as compared to the design modifications were done to add an option of a seating system that allows for full powered tilt, recline, and/or elevating leg rests (K150574).
Where appropriate, component design has been maintained from the previous iBOT® PMD. The overall system architecture and fundamental technology from the iBOT® PMD has been maintained.
The first table below shows the similarities and differences between the proposed devices. We believe the proposed modifications from the predicate device do not raise new questions regarding safety or effectiveness of the device.
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Table of Comparisons from Predicate Device to Proposed Device
| Characteristic | Predicate Device
(iBOT® PMD K210920) | Proposed
(iBOT® PMD) | Assessment of difference
(if applicable) |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Characteristics | | | |
| Indications for Use | The iBOT® Personal Mobility Device
("iBOT® PMD") is intended to provide
indoor and outdoor mobility to persons
restricted to a sitting position who meet the
requirements of the user assessment and
training certification program. The device
allows for the option to climb stairs.
Companions who are required to provide
assistance during Assisted Stair Climbing
Mode must meet the requirements of the
training certification program.
The iBOT® Personal Mobility Device
("iBOT® PMD") Occupied Transport
option is indicated for providing persons,
unable to transfer from their wheelchair
into a standard factory motor vehicle seat,
the option for transportation while seated
in their iBOT® PMD wheelchair. | The iBOT® Personal Mobility Device
("iBOT® PMD") is intended to provide indoor
and outdoor mobility to persons restricted to a
sitting position. The device allows for the
option to climb stairs. The operator(s), either
the wheelchair occupant or an assistant, must
meet the requirements of the training
certification program. The wheelchair
occupant must meet the requirements of the
user assessment. | The modifications to the
indications for use were made
to clarify that the trained
operator in control of the
device could be either the
wheelchair occupant or an
assistant. This does not
constitute a new intended use
and does not introduce issues
of safety and effectiveness.
An additional modification to
the indications for use was to
remove the occupied transport
because it's an option. |
| General Characteristics | | | |
| Manufacturer | Mobius Mobility, LLC | Mobius Mobility, LLC | No change |
| Product Code | IMK, ITI | IMK, ITI | No change |
| Characteristic | Predicate Device
(iBOT® PMD K210920) | Proposed
(iBOT® PMD) | Assessment of difference
(if applicable) |
| Contraindications | • Weigh less than 50 lbs. (22.5 kg) or
more than 300 lbs. (136kg)
• Are at risk for seizure or loss
of consciousness.
• Are at risk of fracture while
driving over rough terrain or
while experiencing jarring
forces related to rapid iBOT
PMD transitions.
• Have not successfully
completed the user training
program
• Need a mechanical ventilator | • Weigh less than 50 lb (22.5 kg)
• Weigh more than 300 lb (136 kg).
• Weigh more than 275 lb (125
kg) if the device has any
combination of the 55 degree
tilt, recline, or elevating legrest.
• Have uncontrolled seizures or
loss of consciousness.
• Have a known serious risk for
fractures due to jarring forces.
• Have not successfully completed
the user training program. | Weight capacity updated to
reflect original seat and new
additional power positioning
options.
Mechanical ventilator mount
added to system.
Wording for contraindications
updated for clarity.
No new issues of safety or
effectiveness. |
| Physical Characteristics | | | |
| Drive wheel type | Pneumatic, 5 bolt pattern, split rim design –
2-inch width. | Pneumatic, 5 bolt pattern, split rim design –
2-inch or 4-inch width. | Added 4-inch width option. No
new issues of safety or
effectiveness. |
| Caster assembly | Standard caster wheel with suspension
assembly | Standard caster wheel with suspension
assembly | Casters redesigned since
predicate. No functional change.
No new issues of safety or
effectiveness. |
| Batteries | Four or Six Li-ion batteries, each rated
57.6 VDC, 5.1 Ah | Four or Six Li-ion batteries, each rated 57.6
VDC, 5.1 Ah | No change |
| Characteristic | Predicate Device
(iBOT® PMD K210920) | Proposed
(iBOT® PMD) | Assessment of difference
(if applicable) |
| Physical Characteristics | | | |
| Communication with
external applications
/devices | Bluetooth 4.2 Low Energy | Bluetooth 4.2 Low Energy | No change |
| Drive system | Rear wheel drive, 4-wheel drive, 2-wheel
balancing | Rear wheel drive, 4-wheel drive, 2-wheel
balancing | No change |
| Operating modes | Standard, 4-Wheel, Balance, Stair-climbing,
Remote, Docking | Standard, 4-Wheel, Balance, Stair-climbing,
Remote, Docking | No change |
| Inertial Measurement | MEMS based sensors | MEMS based sensors | No change |
| Wheel gear train | Helical Gear | Helical Gear | No change |
| Position monitoring | Internal absolute position sensor | Internal absolute position sensor | No change |
| System Communication | CAN bus | CAN bus and UART | No change for iBOT. UART is
used for communication to the
Modular Power Positioning
System. No new issues of safety
or effectiveness. |
| Weight (including batteries) | 242.5 lb. | 242.5 lb. (without Modular Power
Positioning System)
295.0 lb. (with Modular Power Positioning
System) | Weight of the system with optional
Modular Power Positioning
System added. No new issues of
safety or effectiveness. |
| Device Performance | | | |
| Driving Range | 15.5 miles | 14.3 miles | Updated testing done with seat
changes. No new issues of safety
or effectiveness. |
| Characteristic | Predicate Device
(iBOT® PMD K210920) | Proposed
(iBOT®PMD) | Assessment of difference
(if applicable) |
| Device Performance | | | |
| Dynamic stability | 10 degrees (standard)
12 degrees (4 wheel)
8 degrees (balance) | 10 degrees (standard)
12 degrees (4 wheel)
8 degrees (balance) | No change |
| Max Speed Settings by Mode | Standard: 6.7 mph
4-Wheel: 5.1 mph
Balance: 3.5 mph
Docking: 0.6 mph | Standard: 6.8 mph
4-Wheel: 5.1 mph
Balance: 3.5 mph
Docking: 0.6 mph | No change in electronics that
impact speed. No new issues of
safety or effectiveness. |
| Maximum user weight
capacity | 300 lb. with Maxx Rehab Seat | 300 lb. without Modular Maxx Rehab Seat
275 lb. with Modular Ultra Low Maxx Seat
with power positioning options. | Maximum weight capacity
reduced for devices with seating
systems that include any
combination of 55-degree tilt,
recline, or elevating leg rests. |
| Obstacle Climbing | 5 in. (in 4-wheel mode) | 6 in. (in 4-wheel mode) | Increased obstacle height. No new
issues of safety or effectiveness. |
| Turning Radius | 24.5 in. - 33.8 in.
(dependent on mode) | 24.5 in. - 37 in.
(dependent on mode) | Due to length of the seating
system. |
| User Interface Features | | | |
| Seating | Maxx Rehab Seat | Maxx Rehab Seat
Ultra Low Maxx Rehab Seat with power
positioning options. | Added seating options that allow
for full tilt, recline, and/or
elevating leg rests. |
| | | | Risks specific to the power
positioning options were
identified via FMEA. All risk
mitigations were successfully
verified / validated with no
impact to safety or effectiveness
of the device. |
| Power Seat Elevation | Available in 4-Wheel, Balance and Stair
modes. Seat elevation height maximum of
17" | Available in 4-Wheel, Balance, Stair and
Standard modes. Seat elevation height
maximum of 17" | Added existing functionality in
the powerbase to Standard mode |
| | | | Risks specific to adding elevate
to Standard mode were identified
via FMEA. All risk mitigations
were successfully verified /
validated with no impact to safety
or effectiveness of the device. |
| Characteristic | Predicate Device
(iBOT® PMD K210920) | Proposed
(iBOT®PMD) | Assessment of difference
(if applicable) |
| User Interface Features | | | |
| User controller, joystick,
screen buttons, etc. | User controller with integrated joystick,
display, buttons, speed setting reduction
wheel, and optional toggle switches. The user
controller incorporates user assist
confirmation. Power off request button
located on the powerbase. | Color Joystick (also named user controller)
with integrated joystick, display, buttons,
speed setting reduction wheel, and optional
toggle switches. The color joystick
incorporates user assist confirmation. Power
off request button located on the powerbase. | Updated terminology. No change
to design or function. |
| Transportation | Unoccupied Transport Option
Occupied Transport Options | Unoccupied Transport Option
Occupied Transport Options | No change |
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Performance Data
The following performance testing was conducted to demonstrate that the proposed device complies with 21 CFR 890.3890. 21 CFR 890.3860. special controls and recognized standards. This testing demonstrates substantial equivalence to the predicate device through:
- Evaluation to current versions of the standards used in testing of the predicate ● device; with modification for updates in battery technology,
- Software testing per the current version of FDA guidance on software testing ●
A summary of the testing performed is provided below.
Performance Testing
The proposed device has been demonstrated to comply with the following standards:
-
- IEC 62133-2:2021 Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
-
- ISO 7176-1:2014 Wheelchairs Part 1: Determination of Static Stability
-
- ISO 7176-2:2017 Wheelchairs – Part 2: Determination of Dynamic Stability of Electrically Powered Wheelchairs
-
- ISO 7176-3:2012 Wheelchairs Part 3: Determination of Effectiveness of Brakes
-
- ISO 7176-4:2008 Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
-
- ISO 7176-5:2008 Wheelchairs Part 5: Determination of dimensions, mass and maneuvering space
-
- ISO 7176-6:2018 Wheelchairs Part 6: Determination of Maximum Speed, Acceleration & Retardation for Electric Wheelchairs
-
- ANSI RESNA WC-1:2019, Section 7 Wheelchairs Method of measurement of seating and wheel dimensions
-
- ISO 7176-8:2014 Wheelchairs Part 8: Requirements & Test Methods for Static, Impact & Fatigue Strengths
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-
- ISO 7176-9:2009 Wheelchairs Part 9: Climatic tests for electric wheelchairs
-
- ISO 7176-10:2008 Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
-
- ISO 7176-11: 2012 Wheelchairs Part 11: Test dummies
-
- ISO 7176-13: 1989 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces
-
- ISO 7176-14: 2008 Wheelchairs Part 14: Power & Control Systems for Electric Wheelchairs-Requirements & Test Methods
-
- ISO 7176-15:1996 Wheelchairs Part 15: Requirements For Information Disclosure, Documentation And Labeling
-
- ANSI RESNA WC-1:2019 Section 16 Resistance to Ignition of Postural Support Devices
-
- ISO 7176-19: 2022 Wheelchairs- Part 19: Wheeled Mobility Devices for Use as Seats in Motor Vehicles
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- ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
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- ISO 7176-22:2014 Wheelchairs-Part 22: Set Up Procedures
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- ISO 7176-25:2013 Wheelchairs Part 25: Batteries and Chargers for Powered Wheelchairs
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- ISO 7176-28:2012 Wheelchairs Part 28: Requirements and Test Methods For Stair-Climbing Devices
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- ISO 7176-30:2018 Wheelchairs for changing occupant posture
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- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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- ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
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- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in Vitro Cytotoxicity
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- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization
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- UL 2054:2021 Household and Commercial Batteries
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- UN 38.3 United Nations, New York & Geneva, Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, Subsection 38.3
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- EN 1021-1:2014 Furniture: Assessment of ignitability of upholstered furniture. Ignition source smouldering cigarette.
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- EN 1021-2:2014 Furniture: Ignition source match flame equivalent.
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- California Technical Bulletin 117-2013 Requirements. Test Procedure and Apparatus for Testing the Smolder Resistance of Materials Used in Upholstered Furniture.
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- AIM 7351731 Rev. 3.00 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers
Software Testing
Software development and validation was conducted according to IEC 62304 and the FDA guidance document General Principles of Software Validation – Final Guidance for Industry and FDA Staff.
Software documentation to the Enhanced Documentation Level is included and conducted according to the FDA's Guidance for the Content of Premarket Submissions for Device Software Functions.
Cybersecurity risks were assessed, and documentation is included based on the FDA 's Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions and Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.
Usability Testing
The fundamental functions and movements of the proposed device are equivalent to those on the predicate device and the Modular Power Positioning System (K150574). The user interaction with these functions (based on joystick, toggle, and button interactions) is also equivalent to the predicate and K150574. The usability testing information was submitted within K210920 and K150574.
Biocompatibilitv
Bio-Compatibility was evaluated for all surface materials where prolonged skin contact may occur and demonstrated to be Biocompatible. Cytotoxicity testing per ISO 10993 Part 5, Sensitization testing per ISO 10993 Part 10 and Irritation testing per ISO 10993 Part 10 and 23 were performed on all skin contacting surface materials. Skin contacting materials were cleared in K210920 and K150574.
K243442 - 510(k) Summary
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Conclusion
The performance data included in this premarket notification demonstrate that the proposed device is as safe and effective as the iBOT® PMD predicate device. Mobius Mobility finds the iBOT® PMD to be substantially equivalent to the predicate device.