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.

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 ●

AI/ML Overview

The provided text describes a 510(k) summary for the iBOT® Personal Mobility Device ("iBOT® PMD"). This document focuses on demonstrating substantial equivalence to a predicate device (Next Generation iBOT®, K172601) and a reference device (Permobil F5 Corpus VS, K191874) rather than presenting a standalone study with acceptance criteria and a detailed breakdown of device performance against those criteria in a typical clinical study format.

However, based on the information provided, I can infer and summarize some "acceptance criteria" through the standards the device was tested against and the performance characteristics listed in the comparison tables. The study that "proves" the device meets these criteria is the performance testing and bench testing conducted.

Here's a breakdown of the requested information, understanding that this is a regulatory submission for substantial equivalence and not a standalone clinical trial report:

1. Table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the recognized standards the device complied with and the performance characteristics being similar to or better than the predicate device. The "reported device performance" is essentially the device's compliance with these standards and its characteristics as described.

Acceptance Criteria (Inferred from Standards/Predicate)	Reported Device Performance (iBOT® PMD)
Safety and Effectiveness (General)	Demonstrated through compliance with numerous ISO and IEC standards for wheelchairs, batteries, and biological evaluation, along with software and usability testing.
Indications for Use (similar to predicate)	Intended to provide indoor and outdoor mobility to persons restricted to a sitting position who meet user assessment and training certification program requirements. Allows for stair climbing (optional). Occupied Transport option (new) is indicated for persons unable to transfer from their wheelchair into a standard factory motor vehicle seat, allowing transportation while seated in the iBOT® PMD.
Contraindications (Clarity)	Updated for clarity, no new risks identified, maintaining safety profile: not for users weighing less than 50 lbs (22.5 kg) or more than 300 lbs (136 kg); at risk for seizure or loss of consciousness; at risk of fracture while driving over rough terrain or during rapid iBOT® PMD transitions; not for those who haven't completed training; not for those needing a mechanical ventilator.
Static Stability (ISO 7176-1)	Complies with ISO 7176-1:2014.
Dynamic Stability (ISO 7176-2)	Complies with ISO 7176-2:2017. Dynamic stability: 10 degrees (standard), 12 degrees (4 wheel), 8 degrees (balance). (No change from predicate)
Effectiveness of Brakes (ISO 7176-3)	Complies with ISO 7176-3:2012.
Energy Consumption / Driving Range (ISO 7176-4)	Complies with ISO 7176-4:2008. Driving Range: 15.5 miles. (No change from predicate)
Dimensions, Mass, Maneuvering Space (ISO 7176-5)	Complies with ISO 7176-5:2008. Weight (including batteries): 242.5 lb. (No change from predicate). Turning Radius: 24.5 in. – 33.8 in. (dependent on mode). (No change from predicate)
Max Speed, Acceleration & Retardation (ISO 7176-6)	Complies with ISO 7176-6:2018. Max Speed Settings by Mode: Standard: 6.7 mph, 4-Wheel: 5.1 mph, Balance: 3.5 mph, Docking: 0.6 mph. (Docking mode added, other speeds similar or slightly adjusted).
Static, Impact & Fatigue Strengths (ISO 7176-8)	Complies with ISO 7176-8:2014.
Climatic tests (ISO 7176-9)	Complies with ISO 7176-9:2009.
Obstacle-climbing ability (ISO 7176-10)	Complies with ISO 7176-10:2008. Obstacle Climbing: 5 in. (in 4 wheel mode). (No change from predicate)
Power & Control Systems (ISO 7176-14)	Complies with ISO 7176-14:2008.
Information Disclosure, Documentation, Labeling (ISO 7176-15)	Complies with ISO 7176-15:1996.
Wheeled Mobility Devices for Use as Seats in Motor Vehicles (ISO 7176-19)	Complies with ISO 7176-19:2008 for the Occupied Transport option. Testing allowed tie-down loops to be used while device is occupied in vehicle, and interface to docking system added for alternate method of securing occupied device. Risks specific to occupied transport mitigated and verified/validated.
Electromagnetic Compatibility (ISO 7176-21)	Complies with ISO 7176-21:2009.
Set Up Procedures (ISO 7176-22)	Complies with ISO 7176-22:2014.
Batteries and Chargers for Powered Wheelchairs (ISO 7176-25)	Complies with ISO 7176-25:2013, IEC 62133:2012, UL 2054:2004, and UN 38.3. Batteries: Four or Six Li-ion batteries, each rated 57.6 VDC, 5.1 Ah. (No change from predicate for battery type, but standards updated).
Requirements And Test Methods For Stair-Climbing Devices (ISO 7176-28)	Complies with ISO 7176-28:2012.
Biological Evaluation of Materials (ISO 10993 series)	Complies with ISO 10993-1:2009, -3:2014, -5:2014, -10:2010.
Software Safety (IEC 62304/FDA Guidance)	Software development and validation conducted according to IEC 62304 and FDA guidance for Major level of concern. Cybersecurity risks assessed per FDA guidance.
Usability (Human Factors)	Usability evaluation conducted on new elements (docking mode selection, pin and loop interfaces for occupied transportation) comparing to predicate. No new risks emerged in use.
Maximum User Weight Capacity	300 lb. (No change from predicate)

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 testing conducted for regulatory compliance (bench testing, software testing, usability testing). It does not provide specific sample sizes for these tests in terms of human subjects or a large dataset in the way a traditional clinical study would for efficacy.

Bench Testing: These tests are typically conducted on a representative sample of devices or components, but specific numbers are not provided. The provenance is implied to be from the manufacturer's testing facilities as part of a regulatory submission.
Software Testing: This involves testing the software code for functionality, reliability, and security. No sample size of users or data is mentioned.
Usability Testing: The text states 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." It does not specify the number of participants nor their characteristics.
Data Provenance: Not explicitly stated as country of origin, but implied to be from the manufacturer's internal testing as part of the 510(k) submission process. Such tests are generally prospective for the specific purpose of the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For device regulatory submissions like this, "ground truth" often refers to adherence to established engineering standards rather than expert consensus on medical images or diagnoses. For usability, the "ground truth" would be the successful use of the device without significant errors or hazards, which is evaluated by the testing team and potentially observed users, but specific expert qualifications are not listed.

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

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy to resolve discrepancies among multiple expert readers. This document describes performance and safety testing of a physical device, which typically relies on objective measurements against standards or pass/fail criteria, not expert adjudication in the medical imaging sense.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a personal mobility device (stair-climbing wheelchair), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable here.

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

This question is not applicable as the iBOT® PMD is a physical, human-operated mobility device, not an algorithm, and its performance inherently involves human interaction. Even for software components, "standalone" in this context refers to the software's function within the device, not an isolated algorithm without human control.

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

For the iBOT® PMD, the "ground truth" is primarily based on:

Compliance with recognized industry standards: (e.g., ISO, IEC, UL, UN, RESNA WC-1). These standards define objective test methods and acceptable performance limits for various device characteristics (stability, speed, obstacle climbing, safety, etc.).
Engineering specifications and safety analysis: The design is verified against internal specifications and risk assessments (FMEA - Failure Mode and Effects Analysis mentioned for occupied transport) to ensure safety and effectiveness.
Functional performance: Testing to confirm the device performs its intended functions (e.g., driving range, maximum speed, obstacle climbing) as specified.
Usability: Evaluation focuses on whether users can safely and effectively operate the device, particularly the new features.

There is no mention of ground truth established by expert consensus (e.g., radiologists for diagnosis), pathology, or long-term outcomes data in the context of this 510(k) summary.

8. The sample size for the training set

This information is not applicable. The iBOT® PMD is a physical, mechanical, and software-controlled device. It does not appear to utilize machine learning or AI that would require a "training set" of data in the common sense (e.g., for image recognition or predictive analytics). The "training" referred to in the document relates to the human user's certification program for operating the device, not an algorithm's training data.

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

This question is not applicable as there is no "training set" for an algorithm. The "training certification program" for users implies that the "ground truth" for successful user operation would be adherence to the prescribed procedures and demonstrating competency as defined by Mobius Mobility, but the details of this program's evaluation are not discussed.

Summary

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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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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

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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)

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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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.

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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:

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 ●

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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.

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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 toprovide indoor and outdoor mobility topersons restricted to a sitting position whomeet the requirements of the userassessment and training certificationprogram. The device is intended to climbstairs. Companions who are required toprovide assistance during Assisted StairClimbing Mode must meet the requirementsof the training certification program.	The iBOT® Personal Mobility Device("iBOT® PMD") is intended to provide indoorand outdoor mobility to persons restricted to asitting position who meet the requirements ofthe user assessment and training certificationprogram. The device allows for the option toclimb stairs. Companions who are required toprovide assistance during Assisted StairClimbing Mode must meet the requirements ofthe training certification program.The iBOT® Personal Mobility Device("iBOT® PMD") Occupied Transport option isindicated for providing persons, unable totransfer from their wheelchair into a standardfactory motor vehicle seat, the option fortransportation while seated in their iBOT®PMD wheelchair.	The modifications to theIndications for Use to make thestair-climbing functionsoptional and to add the(optional) Occupied Transportcapability do not constitute anew intended use and do notintroduce new issues of safetyand effectiveness.
Manufacturer	DEKA Research & Development	Mobius Mobility, LLC	Product continues to bedesigned by DEKA and is nowdistributed by Mobius Mobility.
Product Code	IMK	IMK, ITI	No product difference, applyingfor additional code for non-stairclimbing version

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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 morethan 300 lbs. (136kg)• Have lost consciousness or had a seizurein the past 90 days (there are someexceptions, ask your clinician for details)• Have a condition where jarring forcescould cause fractures• Have not successfully completed the usertraining program• Need a mechanical ventilator	• Weigh less than 50 lbs. (22.5 kg) or morethan 300 lbs. (136kg)• Are at risk for seizure or loss ofconsciousness.• Are at risk of fracture while driving overrough terrain or while experiencing jarringforces related to rapid iBOT® PMDtransitions.• Have not successfully completed the usertraining 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 suspensionassembly	Standard caster wheel with suspensionassembly	No change
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(Next Generation iBOT®)(K172601)	Proposed(iBOT® PMD)	Assessment of difference(if applicable)
Physical Characteristics
Communication withexternalapplications/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	Standard, 4-Wheel, Balance, Stair-climbing,Remote, Docking	One additional mode option(docking) available. Designfollows structure for othermodes available in thecontroller and does not involveadditional safety risk.Confirmation done throughhuman factors testing to ensureno 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 drivenoise. 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 mph4-Wheel: 5.2 mphBalance: 3.3 mph	Standard: 6.7 mph4-Wheel: 5.1 mphBalance: 3.5 mphDocking: 0.6 mph	Docking mode added.
Maximum user weightcapacity	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, includingangles and heightsThey 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 reductionwheel, and optional toggle switches. Theuser controller incorporates user assistconfirmation. Power off request buttonlocated on the powerbase.	User controller with integrated joystick,display, buttons, speed setting reductionwheel, and optional toggle switches. Theuser controller incorporates user assistconfirmation. Power off request buttonlocated on the powerbase.	No change
Transportation	Unoccupied Transport Option	Unoccupied Transport OptionOccupied Transport Options	Equivalent in:Both have 4 tie down loops tosecure device in vehicle Differences: Testing done to allow tiedown loops to be used whiledevice is occupied in vehicle Interface to docking systemadded to allow alternatemethod of securing occupieddevice in vehicle Occupied Transport versioncomplies with ISO 7176-19. Risks specific to the occupied transportoption were identified via FMEA. Allrisk mitigations were successfullyverified/validated with no impact tosafety or effectiveness of the device.

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Table of Comparisons from Predicate Device to Proposed Device

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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 indoorand outdoor mobility, including stand-up feature, to personslimited to a seating position that are capable of operating apowered wheelchair.	The iBOT® Personal Mobility Device ("iBOT® PMD") isintended to provide indoor and outdoor mobility to personsrestricted to a sitting position who meet the requirements ofthe user assessment and training certification program. Thedevice allows for the option to climb stairs. Companionswho are required to provide assistance during Assisted StairClimbing Mode must meet the requirements of the trainingcertification program.The iBOT® Personal Mobility Device ("iBOT® PMD")Occupied Transport option is intended to provide persons,unable to transfer from their wheelchair into a standardfactory motor vehicle seat, the option for transportationwhile 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 withexternal 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 weightcapacity	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 OptionOccupied Transport Options• 4 Point Tie-DownDocking	Unoccupied Transport OptionOccupied Transport Options• 4 Point Tie-DownDocking

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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:

1. 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
1. 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
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
ISO 7176-5:2008 Wheelchairs Part 5: Determination of dimensions, mass and 6. maneuvering space
1. ISO 7176-6:2018 Wheelchairs Part 6: Determination of Maximum Speed, Acceleration & Retardation for Electric Wheelchairs
1. 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. ISO 7176-16:2012 Wheelchairs Part 16: Resistance to Ignition of Postural Support Devices
1. ISO 7176-19: 2008 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 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 10993-5:2014 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
1. UL 2054:2004 Household and Commercial Batteries

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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. 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.

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.