(79 days)
No
The summary describes a powered wheelchair with various mobility features and updates to the mechanical and software components. There is no mention of AI or ML in the intended use, device description, or performance studies. The software revisions are described in the context of standard software validation and cybersecurity, not AI/ML capabilities.
No
Explanation: The device is a multi-mode powered wheelchair intended to provide mobility to persons restricted to a sitting position. It is not designed to treat, cure, or prevent any disease or condition. While it aids in mobility, it's categorized as a mobility device rather than a therapeutic one.
No
The device is a powered wheelchair designed for mobility, not for diagnosing medical conditions. Its intended use describes providing indoor mobility, stair climbing, and occupied transport for individuals restricted to a sitting position.
No
The device description explicitly states that the device includes numerous hardware components such as wheels, frame, electronics, sensors, battery packs, motors, and a seating stability system. While software revisions are mentioned as an update, the device is fundamentally a physical powered wheelchair with integrated software, not a software-only device.
Based on the provided text, the iBOT® Personal Mobility Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for providing indoor mobility to persons restricted to a sitting position, including features like stair climbing and occupied transport. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The description details a powered wheelchair with various mechanical and electronic components for mobility. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays
The iBOT® PMD is a medical device, specifically a powered wheelchair, but its function is related to physical mobility and transportation, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor mobility to persons restricted to a sitting position who meet the requirements of the use[r] 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 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.
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 device Next Generation iBOT® (K172601). The device retains all the following from the original device including:
The device is a multi-mode powered wheelchair that enables users to maneuver 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 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 proposed device still utilizes the primary components of a stair climbing power wheels, frame, sealed electronics, sensors, battery packs, motors, seative stability system and battery charger. It can also be produced without the stair climbing function.
In addition, the device will incorporate the following updates to the Next Generation iBOT® design:
- Allows for occupied transportation in a motor vehicle
- Incorporates the use of an alternate seating system, mounting and peripherals
- Wheel gear train changed from spur to helical
- Redesigned brake release lever mechanism
- Changes of materials / processes in support of Design for Manufacturing efforts
- Software revisions / changes
- Incorporates change of the Trade name to iBOT® PMD
- Updates contraindications to increase clarity
The device is a multi-mode powered wheelchair that enables users to maneuver 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 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 proposed device still utilizes the primary components of a stair climbing power wheels, frame, sealed electronics, sensors, battery packs, motors, seative stability system and battery charger. It can also be produced without the stair climbing function.
In addition, the device will incorporate the following updates to the Next Generation iBOT® design:
- Allows for occupied transportation in a motor vehicle
- Incorporates the use of an alternate seating system, mounting and peripherals
- Wheel gear train changed from spur to helical
- Redesigned brake release lever mechanism
- Changes of materials / processes in support of Design for Manufacturing efforts
- Software revisions / changes
- Incorporates change of the Trade name to iBOT® PMD
- Updates contraindications to increase clarity
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
The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor mobility to persons restricted to a sitting position who meet the requirements of the user assessment and training certification program.
Companions who are required to provide assistance during Assisted Stair Climbing Mode must meet the requirements of the training certification program.
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)
The following performance testing was conducted to demonstrate that the proposed device complies with the 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, and
- usability testing focused on changes in the user interface when compared with the predicate device.
Bench Testing: The proposed device has been demonstrated to comply with the following standards: IEC 62133, ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-6, RESNA WC-1, ISO 7176-8, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 7176-16, ISO 7176-19, ISO 7176-21, ISO 7176-22, ISO 7176-25, ISO 7176-28, ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-10, UL 2054, UN 38.3, AIM 7351731.
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 is included according to the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for Major level of concern for the software embedded in the Next Generation iBOT® stair-climbing wheelchair. Cybersecurity risks were assessed and documentation is included based on the FDA's Guidance of Premarket Submissions for Management of Cybersecurity in Medical Device.
Usability Testing: A usability evaluation was conducted on the elements of the device (selection of docking mode and use of pin and loop interfaces for occupied transportation) which have changed from the predicate device (Next Generation iBOT® #K172601). There have been no changes to the intended use environment, other modes of operation or drive architecture.
Conclusion: The performance data included in this premarket notification demonstrate that the proposed device is as safe and effective as the Next Generation iBOT® predicate device. Mobius Mobility finds the iBOT® PMD to be substantially equivalent to the predicate device.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
June 16, 2021
Mobius Mobility Joseph Sullivan QA / RA Manager 540 Commercial St. Suite 310 Manchester, New Hampshire 03101
Re: K210920
Trade/Device Name: iBOT® Personal Mobility Device ("iBOT® PMD") Regulation Number: 21 CFR 890.3890 Regulation Name: Stair-Climbing Wheelchair Regulatory Class: Class II Product Code: IMK, ITI Dated: March 25, 2021 Received: March 29, 2021
Dear Mr. 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 (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.
1
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.
For 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210920
Device Name
iBOT® Personal Mobility Device (iBOT® PMD)
Indications for Use (Describe)
The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor 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.
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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3
510(K) SUMMARY
This 510(k) summary 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: March 22, 2021
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® Personal Mobility Device ("iBOT® PMD") |
| Classification Name: | Stair-climbing wheelchair |
| 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 Next Generation iBOT®, which was previously cleared under 510(k) #K172601.
4
Reference Device
Permobil F5 Corpus VS (K191874).
Device Description
The proposed device is an update to the previously cleared device Next Generation iBOT® (K172601). 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 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 proposed device still utilizes the primary components of a stair climbing power wheels, frame, sealed electronics, sensors, battery packs, motors, seative stability system and battery charger. It can also be produced without the stair climbing function.
In addition, the device will incorporate the following updates to the Next Generation iBOT® design:
- Allows for occupied transportation in a motor vehicle ●
- Incorporates the use of an alternate seating system, mounting and peripherals ●
- . Wheel gear train changed from spur to helical
- Redesigned brake release lever mechanism
- Changes of materials / processes in support of Design for Manufacturing efforts .
- Software revisions / changes ●
- Incorporates change of the Trade name to iBOT® PMD ●
- Updates contraindications to increase clarity ●
5
Indications for Use
The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor mobility to persons restricted to a sitting position who meet the requirements of the uses ment 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 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.
Comparison to Predicate Device and Reference Device
The proposed device has similar technological characteristics and mobility functions as compared to the design modifications were done to do the following:
- Add indication for use as a seat in a motor vehicle .
- Take advantage of improvements in technology since the Next Generation iBOT® was originally cleared .
Where appropriate, component design has been maintained from the Next Generation iBOT®. The overall system and fundamental technology from the Next Generation iBOT® has been maintained.
The reference device was chosen to demonstrate substantial equivalence for the following components and features on the device:
- · Occupied Transportation Options
- · Power Wheelchair Seating System cleared for use in a motor vehicle
The first table below shows the similaries and differences between the proposed devices. The second table below shows the similarities and differences between the reference and proposed modifications from the predicate device or reference devices do not raise new questions regarding safety or effectiveness of the device.
6
Table of Comparisons from Predicate Device to Proposed Device
| Characteristic | Predicate Device
(Next Generation iBOT®)
(K172601) | Proposed
(iBOT® PMD) | Assessment of difference
(if applicable) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | General Characteristics | | |
| Indications for Use | The Next Generation iBOT® 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 is intended 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") 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 modifications to the
Indications for Use to make the
stair-climbing functions
optional and to add the
(optional) Occupied Transport
capability do not constitute a
new intended use and do not
introduce new issues of safety
and effectiveness. |
| Manufacturer | DEKA Research & Development | Mobius Mobility, LLC | Product continues to be
designed by DEKA and is now
distributed by Mobius Mobility. |
| Product Code | IMK | IMK, ITI | No product difference, applying
for additional code for non-stair
climbing version |
7
| Characteristic | Predicate Device
(Next Generation iBOT®)
(K172601) | Proposed
(iBOT® PMD) | Assessment of difference
(if applicable) |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Characteristics | | | |
| Contraindications | • Weigh less than 50 lbs. (22.5 kg) or more
than 300 lbs. (136kg)
• Have lost consciousness or had a seizure
in the past 90 days (there are some
exceptions, ask your clinician for details)
• Have a condition where jarring forces
could cause fractures
• Have not successfully completed the user
training program
• Need a mechanical ventilator | • 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 | Wording updated for clarity.
No new risks identified. |
| Physical Characteristics | | | |
| Drive wheel type | Pneumatic or foam-filled. 5 bolt pattern,
split rim design. | Pneumatic or foam-filled. 5 bolt pattern,
split rim design. | No change |
| Caster assembly | Standard caster wheel with suspension
assembly | Standard caster wheel with suspension
assembly | No change |
| 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
(Next Generation iBOT®)
(K172601) | 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 | Standard, 4-Wheel, Balance, Stair-climbing,
Remote, Docking | One additional mode option
(docking) available. Design
follows structure for other
modes available in the
controller and does not involve
additional safety risk.
Confirmation done through
human factors testing to ensure
no new risks emerged in use. |
| Inertial Measurement | MEMS based sensors | MEMS based sensors | No change |
| Wheel gear train | Spur Gear | Helical Gear | Gear changed to reduce drive
noise. No new risks identified. |
| Position monitoring | Internal absolute position sensor | Internal absolute position sensor | No change |
| System Communication | CAN bus | CAN bus | No change |
| Weight (including batteries) | 242.5 lb. | 242.5 lb. | No change |
| Device Performance | | | |
| Driving Range | 15.5 miles | 15.5 miles | No change |
| Characteristic | Predicate Device
(Next Generation iBOT®)
(K172601) | 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: 5.2 mph
Balance: 3.3 mph | Standard: 6.7 mph
4-Wheel: 5.1 mph
Balance: 3.5 mph
Docking: 0.6 mph | Docking mode added. |
| Maximum user weight
capacity | 300 lb. | 300 lb. | No change |
| Obstacle Climbing | 5 in. (in 4 wheel mode) | 5 in. (in 4 wheel mode) | No change |
| Turning Radius | 24.5 in. – 33.8 in.
(dependent on mode) | 24.5 in. – 33.8 in.
(dependent on mode) | No change |
| User Interface Features | | | |
| Seating | Gen 3 Seat | Maxx Rehab Seat | Equivalent in:
● Safety features
● General design
● Standards met
● Seat angles
● Movement, including
angles and heights
They differ in:
● Modularity
● Seat Interface
● Peripherals
● Stair Assist Handle
● Available seat sizes |
| Characteristic | Predicate Device
(Next Generation iBOT®)
(K172601) | 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. | 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. | No change |
| Transportation | Unoccupied Transport Option | Unoccupied Transport Option
Occupied Transport Options | Equivalent in:
Both have 4 tie down loops to
secure device in vehicle Differences: Testing done to allow tie
down loops to be used while
device is occupied in vehicle Interface to docking system
added to allow alternate
method of securing occupied
device in vehicle Occupied Transport version
complies with ISO 7176-19. Risks specific to the occupied transport
option were identified via FMEA. All
risk mitigations were successfully
verified/validated with no impact to
safety or effectiveness of the device. |
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9
10
Table of Comparisons from Predicate Device to Proposed Device
11
Table of Comparisons from Reference Device to Proposed Device
| Characteristic | Reference
(Permobil F5 Corpus VS)
(K191874) | Proposed
(iBOT® PMD) | | |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| General Characteristics | | | | |
| Indications for Use | The F5 Corpus VS powered wheelchair is to provide indoor
and outdoor mobility, including stand-up feature, to persons
limited to a seating position that are capable of operating a
powered wheelchair. | 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 intended to provide 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. | | |
| Product Code | IPL, ITI | IMK, ITI | | |
| Physical Characteristics | | | | |
| Drive wheel type | Pneumatic or foam-filled. | Pneumatic or foam-filled. | | |
| Caster assembly | Standard caster wheel with suspension assembly | Standard caster wheel with suspension assembly | | |
| Batteries | 2 x 12V 73 Ah gel Group M24 | Four or Six Li-ion batteries, each rated 57.6 VDC, 5.1 Ah | | |
| Communication with
external applications/devices | Bluetooth | Bluetooth | | |
| Drive system | Front wheel drive, standing | Rear wheel drive, 4-wheel drive, 2-wheel balancing | | |
| Characteristic | Reference
(Permobil F5 Corpus VS)
(K191874) | Proposed
(iBOT® PMD) | | |
| Operating modes | Standard, Stand-Up | Standard, 4-Wheel, Balance, Stair-climbing, Remote, Docking | | |
| Position monitoring | Internal position sensors | Internal absolute position sensor | | |
| System Communication | CAN bus | CAN bus | | |
| Weight (including batteries) | 421 lb. | 242.5 lb. | | |
| Device Performance | | | | |
| Driving Range | Up to 16 miles | 15.5 miles | | |
| Max Speed Settings | Up to 7.5 mph | Up to 6.7 mph | | |
| Maximum user weight
capacity | 300 lb. | 300 lb. | | |
| Obstacle Climbing | 3 in. | 5 in. (in 4-wheel mode) | | |
| Turning Radius | 30" | 24.5 in. - 33.8 in.
(dependent on mode) | | |
| User Interface Features | | | | |
| Seating | Corpus | Maxx Rehab Seat | | |
| User controller, joystick,
screen, buttons, etc. | User controller with integrated joystick, display, buttons,
speed setting reduction wheel, and optional toggle switches. | User controller with integrated joystick, display, buttons,
speed setting reduction wheel, and optional toggle switches. | | |
| Transportation | Unoccupied Transport Option
Occupied Transport Options
• 4 Point Tie-Down
Docking | Unoccupied Transport Option
Occupied Transport Options
• 4 Point Tie-Down
Docking | | |
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Performance Data
The following performance testing was conducted to demonstrate that the proposed device complies with the 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, and ●
- usability testing focused on changes in the user interface when compared ● with the predicate device.
A summary of the testing performed is provided below.
Bench Testing
The proposed device has been demonstrated to comply with the following standards:
-
- IEC 62133:2012 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 3. 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 6. maneuvering space
-
- ISO 7176-6:2018 Wheelchairs Part 6: Determination of Maximum Speed, Acceleration & Retardation for Electric Wheelchairs
-
- 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
-
- ISO 7176-16:2012 Wheelchairs Part 16: Resistance to Ignition of Postural Support Devices
-
- ISO 7176-19: 2008 Wheelchairs- Part 19: Wheeled Mobility Devices for Use as Seats in Motor Vehicles
-
- ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
-
- ISO 7176-22:2014 Wheelchairs-Part 22: Set Up Procedures
-
- ISO 7176-25:2013 Wheelchairs Part 25: Batteries and Chargers for Powered Wheelchairs
-
- ISO 7176-28:2012 Wheelchairs Part 28: Requirements And Test Methods For Stair-Climbing Devices
-
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
- ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
-
- ISO 10993-5:2014 Biological evaluation of medical devices Part 5: Tests for in Vitro Cytotoxicity
-
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization
-
- UL 2054:2004 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
-
- AIM 7351731 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 is included according to the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for Major level of concern for the software embedded in the Next Generation iBOT® stair-climbing wheelchair.
Cybersecurity risks were assessed and documentation is included based on the FDA's Guidance of Premarket Submissions for Management of Cybersecurity in Medical Device.
Usability Testing
A usability evaluation was conducted on the elements of the device (selection of docking mode and use of pin and loop interfaces for occupied transportation) which have changed from the predicate device (Next Generation iBOT® #K172601). There have been no changes to the intended use environment, other modes of operation or drive architecture.
Conclusion
The performance data included in this premarket notification demonstrate that the proposed device is as safe and effective as the Next Generation iBOT® predicate device. Mobius Mobility finds the iBOT® PMD to be substantially equivalent to the predicate device.