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.

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.

AI/ML Overview

This document is an FDA 510(k) summary for a medical device called the "iBOT® PMD," a stair-climbing wheelchair. It describes an updated version of a previously cleared device. The purpose of this 510(k) is to demonstrate that the updated device is substantially equivalent to the predicate device, meaning it is as safe and effective.

Based on the provided text, the device in question is a Stair-Climbing Wheelchair (iBOT® PMD). The context of "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to the regulatory requirement that the updated device must demonstrate substantial equivalence to its predicate device through performance testing and compliance with recognized standards.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly list "acceptance criteria" in a quantitative sense as might be seen for a diagnostic AI device (e.g., target specificity/sensitivity). Instead, the acceptance criteria are implicitly satisfied by demonstrating compliance with a long list of recognized performance standards for wheelchairs and related components. The "reported device performance" is essentially a comparison of the updated iBOT® PMD's specifications against those of its predicate device, as well as the results of compliance testing to the listed standards.

Characteristic	Predicate Device (iBOT® PMD K210920)	Proposed (iBOT® PMD)	Assessment of Difference (if applicable)
Indications for Use	Provides indoor and outdoor mobility for persons restricted to a sitting position, option to climb stairs. User assessment & training cert. Occupied transport option.	Provides indoor and outdoor mobility for persons restricted to a sitting position, option to climb stairs. Operator (occupant or assistant) and occupant must meet training/assessment.	Clarified that operator can be occupant or assistant, removed occupied transport as it's an option. No new safety/effectiveness issues.
Manufacturer	Mobius Mobility, LLC	Mobius Mobility, LLC	No change.
Product Code	IMK, ITI	IMK, ITI	No change.
Contraindications	Weight <50 lbs or >300 lbs. Risk of seizure/loss of consciousness. Risk of fracture from jarring forces. Unsuccessful user training. Need mechanical ventilator.	Weight <50 lb, >300 lb, or >275 lb (with 55-degree tilt/recline/legrest). Uncontrolled seizures/loss of consciousness. Known serious risk of fractures. Unsuccessful user training.	Weight capacity updated for new seating options. Mechanical ventilator mount added (when stair/balance modes removed). Wording updated for clarity. No new issues of safety or effectiveness.
Drive Wheel Type	Pneumatic, 5 bolt, 2-inch width.	Pneumatic, 5 bolt, 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.	Standard caster wheel with suspension.	Casters redesigned but no functional change. No new issues of safety or effectiveness.
Batteries	Four or Six Li-ion, 57.6 VDC, 5.1 Ah.	Four or Six Li-ion, 57.6 VDC, 5.1 Ah.	No change.
Communication with External Apps/Devices	Bluetooth 4.2 Low Energy	Bluetooth 4.2 Low Energy	No change.
Drive System	Rear wheel, 4-wheel, 2-wheel balancing.	Rear wheel, 4-wheel, 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	Added UART for communication to Modular Power Positioning System. No new issues of safety or effectiveness.
Weight (incl. batteries)	242.5 lb.	242.5 lb. (without Modular Power Positioning System); 295.0 lb. (with Modular Power Positioning System).	Weight with optional Modular Power Positioning System added. No new issues of safety or effectiveness.
Driving Range	15.5 miles	14.3 miles	Updated testing done with seat changes. No new issues of safety or effectiveness.
Dynamic Stability	10 (standard), 12 (4-wheel), 8 (balance) degrees.	10 (standard), 12 (4-wheel), 8 (balance) degrees.	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 affecting 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).	Reduced for devices with seating systems including 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.
Seating	Maxx Rehab Seat	Maxx Rehab Seat; Ultra Low Maxx Rehab Seat with power positioning options.	Added seating options allowing full tilt, recline, and/or elevating leg rests. Risks identified via FMEA, mitigations verified. No impact to safety/effectiveness.
Power Seat Elevation	Available in 4-Wheel, Balance and Stair modes. Max 17".	Available in 4-Wheel, Balance, Stair, and Standard modes. Max 17".	Added existing functionality to Standard mode. Risks identified via FMEA, mitigations verified. No impact to safety/effectiveness.
User Controller, Joystick, etc.	User controller with integrated joystick, display, buttons, speed setting reduction wheel, optional toggle switches. User assist confirmation. Power off request button on powerbase.	Color Joystick (user controller) with integrated joystick, display, buttons, speed setting reduction wheel, optional toggle switches. User assist confirmation. Power off request button on powerbase.	Updated terminology. No change to design or function.
Transportation	Unoccupied and Occupied Transport Options.	Unoccupied and Occupied Transport Options.	No change.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists performance standard compliance (e.g., ISO 7176 series, IEC 62133-2) and general statements like "The following performance testing was conducted to demonstrate that the proposed device complies..." and "A summary of the testing performed is provided below."

Sample Size: The document does not specify the sample size for object testing (e.g., number of wheelchairs tested). This type of testing typically involves a small number of production units (e.g., 1-3 devices) to demonstrate compliance with engineering standards.
Data Provenance: Not specified, but generally, such regulatory testing is performed in controlled lab environments as part of the device manufacturer's design verification and validation activities. It is inherently prospective testing against predefined specifications and standards. Country of origin for testing is not mentioned but would typically be where the manufacturer or their chosen test labs are located.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a physical medical device (stair-climbing wheelchair), not an AI/ML-based diagnostic imaging device. Therefore, the concept of "ground truth" established by human experts (like radiologists for imaging) is not applicable in the same way. The "ground truth" for this device's performance is established by engineering standards and direct physical testing against those standards. The expertise comes from the engineers and technicians performing the tests and validating the design against the requirements of the standards (e.g., ISO, IEC).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a physical device's performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic imaging AI where human readers might disagree. For device performance testing, results are typically objective measurements against a standard.

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

Not applicable. This is not an AI-assisted diagnostic device. The study described is an engineering performance validation and comparison to a predicate device, not a human reader study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm-only device. Its performance is demonstrated through its physical functions and safety features.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device lies in its compliance with internationally recognized performance and safety standards (e.g., ISO 7176 series for wheelchairs, IEC 62133-2 for batteries) and its demonstrated substantial equivalence to the previously cleared predicate device. This is primarily a technical and objective "ground truth" established through physical testing and measurement.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for physical device performance validation.

Summary

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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).

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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).

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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) K243442

Device Name iBOT® PMD

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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☒ Prescription Use (Part 21 CFR 801 Subpart D)

☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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 Mobility540 North Commercial Street Suite 310Manchester, NH 03101
Contact Person:	Joseph SullivanQA / RA ManagerMobius MobilityPhone: (833) 346-4268Fax: (603) 621-0789jsullivan@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 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

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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 provideindoor and outdoor mobility to personsrestricted to a sitting position who meet therequirements of the user assessment andtraining certification program. The deviceallows for the option to climb stairs.Companions who are required to provideassistance during Assisted Stair ClimbingMode must meet the requirements of thetraining certification program.The iBOT® Personal Mobility Device("iBOT® PMD") Occupied Transportoption is indicated for providing persons,unable to transfer from their wheelchairinto a standard factory motor vehicle seat,the option for transportation while seatedin their iBOT® PMD wheelchair.	The iBOT® Personal Mobility Device("iBOT® PMD") is intended to provide indoorand outdoor mobility to persons restricted to asitting position. The device allows for theoption to climb stairs. The operator(s), eitherthe wheelchair occupant or an assistant, mustmeet the requirements of the trainingcertification program. The wheelchairoccupant must meet the requirements of theuser assessment.	The modifications to theindications for use were madeto clarify that the trainedoperator in control of thedevice could be either thewheelchair occupant or anassistant. This does notconstitute a new intended useand does not introduce issuesof safety and effectiveness.An additional modification tothe indications for use was toremove the occupied transportbecause 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) ormore than 300 lbs. (136kg)• Are at risk for seizure or lossof consciousness.• Are at risk of fracture whiledriving over rough terrain orwhile experiencing jarringforces related to rapid iBOTPMD transitions.• Have not successfullycompleted the user trainingprogram• Need a mechanical ventilator	• Weigh less than 50 lb (22.5 kg)• Weigh more than 300 lb (136 kg).• Weigh more than 275 lb (125kg) if the device has anycombination of the 55 degreetilt, recline, or elevating legrest.• Have uncontrolled seizures orloss of consciousness.• Have a known serious risk forfractures due to jarring forces.• Have not successfully completedthe user training program.	Weight capacity updated toreflect original seat and newadditional power positioningoptions.Mechanical ventilator mountadded to system.Wording for contraindicationsupdated for clarity.No new issues of safety oreffectiveness.
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. Nonew issues of safety oreffectiveness.
Caster assembly	Standard caster wheel with suspensionassembly	Standard caster wheel with suspensionassembly	Casters redesigned sincepredicate. No functional change.No new issues of safety oreffectiveness.
Batteries	Four or Six Li-ion batteries, each rated57.6 VDC, 5.1 Ah	Four or Six Li-ion batteries, each rated 57.6VDC, 5.1 Ah	No change
Characteristic	Predicate Device(iBOT® PMD K210920)	Proposed(iBOT® PMD)	Assessment of difference(if applicable)
Physical Characteristics
Communication withexternal applications/devices	Bluetooth 4.2 Low Energy	Bluetooth 4.2 Low Energy	No change
Drive system	Rear wheel drive, 4-wheel drive, 2-wheelbalancing	Rear wheel drive, 4-wheel drive, 2-wheelbalancing	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 isused for communication to theModular Power PositioningSystem. No new issues of safetyor effectiveness.
Weight (including batteries)	242.5 lb.	242.5 lb. (without Modular PowerPositioning System)295.0 lb. (with Modular Power PositioningSystem)	Weight of the system with optionalModular Power PositioningSystem added. No new issues ofsafety or effectiveness.
Device Performance
Driving Range	15.5 miles	14.3 miles	Updated testing done with seatchanges. No new issues of safetyor 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 mph4-Wheel: 5.1 mphBalance: 3.5 mphDocking: 0.6 mph	Standard: 6.8 mph4-Wheel: 5.1 mphBalance: 3.5 mphDocking: 0.6 mph	No change in electronics thatimpact speed. No new issues ofsafety or effectiveness.
Maximum user weightcapacity	300 lb. with Maxx Rehab Seat	300 lb. without Modular Maxx Rehab Seat275 lb. with Modular Ultra Low Maxx Seatwith power positioning options.	Maximum weight capacityreduced for devices with seatingsystems that include anycombination 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 newissues 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 seatingsystem.
User Interface Features
Seating	Maxx Rehab Seat	Maxx Rehab SeatUltra Low Maxx Rehab Seat with powerpositioning options.	Added seating options that allowfor full tilt, recline, and/orelevating leg rests.
			Risks specific to the powerpositioning options wereidentified via FMEA. All riskmitigations were successfullyverified / validated with noimpact to safety or effectivenessof the device.
Power Seat Elevation	Available in 4-Wheel, Balance and Stairmodes. Seat elevation height maximum of17"	Available in 4-Wheel, Balance, Stair andStandard modes. Seat elevation heightmaximum of 17"	Added existing functionality inthe powerbase to Standard mode
			Risks specific to adding elevateto Standard mode were identifiedvia FMEA. All risk mitigationswere successfully verified /validated with no impact to safetyor 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 reductionwheel, and optional toggle switches. The usercontroller incorporates user assistconfirmation. Power off request buttonlocated on the powerbase.	Color Joystick (also named user controller)with integrated joystick, display, buttons,speed setting reduction wheel, and optionaltoggle switches. The color joystickincorporates user assist confirmation. Poweroff request button located on the powerbase.	Updated terminology. No changeto design or function.
Transportation	Unoccupied Transport OptionOccupied Transport Options	Unoccupied Transport OptionOccupied 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:

1. 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
1. ISO 7176-1:2014 Wheelchairs Part 1: Determination of Static Stability
1. ISO 7176-2:2017 Wheelchairs – Part 2: Determination of Dynamic Stability of Electrically Powered Wheelchairs
1. ISO 7176-3:2012 Wheelchairs Part 3: Determination of Effectiveness of Brakes
1. ISO 7176-4:2008 Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
1. ISO 7176-5:2008 Wheelchairs Part 5: Determination of dimensions, mass and maneuvering space
1. ISO 7176-6:2018 Wheelchairs Part 6: Determination of Maximum Speed, Acceleration & Retardation for Electric Wheelchairs
1. ANSI RESNA WC-1:2019, Section 7 Wheelchairs Method of measurement of seating and wheel dimensions
1. ISO 7176-8:2014 Wheelchairs Part 8: Requirements & Test Methods for Static, Impact & Fatigue Strengths

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1. ISO 7176-9:2009 Wheelchairs Part 9: Climatic tests for electric wheelchairs
1. ISO 7176-10:2008 Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
1. ISO 7176-11: 2012 Wheelchairs Part 11: Test dummies
1. ISO 7176-13: 1989 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces
1. ISO 7176-14: 2008 Wheelchairs Part 14: Power & Control Systems for Electric Wheelchairs-Requirements & Test Methods
1. ISO 7176-15:1996 Wheelchairs Part 15: Requirements For Information Disclosure, Documentation And Labeling
1. ANSI RESNA WC-1:2019 Section 16 Resistance to Ignition of Postural Support Devices
1. ISO 7176-19: 2022 Wheelchairs- Part 19: Wheeled Mobility Devices for Use as Seats in Motor Vehicles
1. ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
1. ISO 7176-22:2014 Wheelchairs-Part 22: Set Up Procedures
1. ISO 7176-25:2013 Wheelchairs Part 25: Batteries and Chargers for Powered Wheelchairs
1. ISO 7176-28:2012 Wheelchairs Part 28: Requirements and Test Methods For Stair-Climbing Devices
1. ISO 7176-30:2018 Wheelchairs for changing occupant posture
1. ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
1. ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
1. ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in Vitro Cytotoxicity
1. ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization

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1. UL 2054:2021 Household and Commercial Batteries
1. UN 38.3 United Nations, New York & Geneva, Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, Subsection 38.3
1. EN 1021-1:2014 Furniture: Assessment of ignitability of upholstered furniture. Ignition source smouldering cigarette.
1. EN 1021-2:2014 Furniture: Ignition source match flame equivalent.
1. California Technical Bulletin 117-2013 Requirements. Test Procedure and Apparatus for Testing the Smolder Resistance of Materials Used in Upholstered Furniture.
1. 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.

Regulation Number and Section

§ 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.