Next Generation iBOT

K172601 · Deka Research & Development Corp. · IMK · Mar 2, 2018 · Physical Medicine

Device Facts

• Record ID: K172601
• Device Name: Next Generation iBOT
• Applicant: Deka Research & Development Corp.
• Product Code: IMK · Physical Medicine
• Decision Date: Mar 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3890
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Next Generation iBOT 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 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.

Device Story

Multi-mode powered wheelchair; enables indoor/outdoor mobility, curb/stair climbing, and elevated seat height for activities of daily living. Input: user joystick/controller commands; MEMS-based inertial sensors for body position. Transformation: control software processes sensor data to maintain active stabilization across multiple modes (Standard, 4-Wheel, Balance, Stair-climbing, Remote). Output: motorized movement; visual feedback via controller display. Used in home/work/community environments; operated by the user or assisted by a trained companion. Benefits: improved mobility, obstacle traversal, and eye-level interaction. Healthcare providers use the device to restore mobility; clinical decision-making involves assessing user capability for safe operation via a mandatory training certification program.

Clinical Evidence

No clinical data. Substantial equivalence is supported by extensive bench testing, including static/dynamic stability, braking effectiveness, energy consumption, obstacle climbing, electromagnetic compatibility, and battery safety per ISO 7176 series and other recognized standards. Usability testing was conducted to validate changes in the user interface.

Technological Characteristics

Powered wheelchair with active stabilization. Materials: pneumatic or foam-filled tires, aluminum/steel frame components. Sensing: MEMS-based inertial sensors. Energy: 57.6 VDC Li-ion batteries. Connectivity: Bluetooth 4.2 Low Energy, CAN bus. Software: embedded control system. Standards: ISO 7176-1 through 7176-28, IEC 62133, UL 2054, UN 38.3.

Indications for Use

Indicated for persons restricted to a sitting position with mobility impairments who meet user assessment and training certification requirements. Intended for indoor/outdoor mobility, including stair climbing. Companions assisting in stair climbing must also meet training certification requirements.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• iBOT 4000 Mobility System (P020033/S002)

Submission Summary (Full Text)

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March 2, 2018

DEKA Research & Development Corp Roger Leroux Director of Regulatory and Clinical Affairs 340 Commercial St. Manchester, New Hampshire 03101

Re: K172601

Trade/Device Name: Next Generation iBOT Regulation Number: 21 CFR 890.3890 Regulation Name: Stair-Climbing Wheelchair Regulatory Class: Class II Product Code: IMK Dated: January 31, 2018 Received: February 1, 2018

Dear Roger Leroux:

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. 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.

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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172601

Device Name Next Generation iBOT

#### Indications for Use (Describe)

The Next Generation iBOT 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 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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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# 6. 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: January 25, 2018

# Submitter's Information

| 510(k) Sponsor: | DEKA Research & Development<br>340 Commercial Street<br>Manchester, NH 03101 |
|-----------------|-----------------------------------------------------------------------------------------------|
| Contact Person: | Roger Leroux<br>Regulatory Affairs Project Manager<br>DEKA Research & Development Corporation |
| | Phone: [phone]<br>Fax: [phone] |
| | rleroux @dekaresearch.com |

# Device Information

| Common/Usual Name: | Stair-climbing wheelchair |
|-------------------------|---------------------------|
| Trade/Proprietary Name: | Next Generation iBOT |
| Classification Name: | Stair-climbing wheelchair |
| Device Classification: | 890.3890 |
| Product Code: | IMK |
| Device Panel: | Physical Medicine |

# Predicate Device

The Next Generation iBOT (Next Gen iBOT) is substantially equivalent to the iBOT 4000 Mobility System (iBOT 4000), which was previously approved under PMA #P020033/S002. Stair-climbing wheelchairs were reclassified into Class II, effective April 14, 2014.

### Device Description

The proposed 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 and outdoor mobility, including stair climbing, to persons limited to a seated position who are capable of operating a powered wheelchair.

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The Next Gen iBOT includes active stabilization in multiple driving modes and allows for traversing aggressive and difficult terrain and operation at an elevated seat height. This 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 incorporates updates to the iBOT 4000 design to take advantage of advances in component and process technology while maintaining the same fundamental capabilities.

# 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.

# Comparison to Predicate Device

The Next Gen iBOT has similar technological characteristics as compared to the predicate device. The proposed device offers substantially the same mobility functions as the iBOT 4000. Many of the design modifications were done to take advantage of improvements in technology since the iBOT 4000 was originally released in 2005. Where appropriate, component design has been maintained from the iBOT 4000; the overall system architecture and fundamental technology from the iBOT 4000 has been maintained. The table below shows the similarities and differences between the predicate and 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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| Characteristic | Predicate<br>(iBOT 4000)<br>(P020033/S002) | Proposed<br>(Next Generation iBOT) | Assessment of difference<br>(if applicable) |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Characteristics | | | |
| Indications for Use | The device is indicated for<br>individuals who have mobility<br>impairments and the use of at<br>least one upper extremity. The<br>device is intended to provide<br>mobility on smooth surfaces<br>and inclines at home, at work,<br>and in other environments;<br>movement across obstacles,<br>uneven terrain, curbs, grass,<br>gravel and other soft surfaces;<br>mobility in a seated position at an<br>elevated height; ascent and<br>decent of stairs with or without<br>assistance; and mobility and<br>transportation. | The Next Generation iBOT is<br>intended to provide indoor and<br>outdoor mobility to persons<br>restricted to a sitting position<br>who meet the requirements of the<br>user assessment and training<br>certification program. The device<br>is intended to climb stairs.<br>Companions who are required to<br>provide assistance during<br>Assisted Stair Climbing Mode<br>must meet the requirements of<br>the training certification<br>program. | The Indications for Use has been<br>modified slightly from that<br>previously cleared in the<br>predicate device to align with the<br>intended use stated in the device<br>regulation (21 CFR 890.3890)<br>and with other powered<br>wheelchairs. These wording<br>changes in the intended use do<br>not alter the therapeutic or<br>diagnostic effect and do not<br>affect safety and effectiveness of<br>the device. |
| Manufacturer | Independence Technology | DEKA Research & Development | N/A |
| Characteristic | Predicate<br>(iBOT 4000)<br>(P020033/S002) | Proposed<br>(Next Generation iBOT) | Assessment of difference<br>(if applicable) |
| Rx/OTC designation | Rx | Rx | No change |
| | Physical Characteristics | | |
| Drive wheel type | Pneumatic. Single mounting<br>point. | Pneumatic or foam-filled. 5 bolt<br>pattern, split rim design. | The change allows for additional<br>tire options, which is standard in<br>the wheelchair industry. The<br>functionality of the wheels has<br>not changed and the change does<br>not affect safety and<br>effectiveness of the device. |
| Caster assembly | Tweel® mounted to caster arm | Standard caster wheel with<br>suspension assembly | This change allows for increased<br>availability of the caster wheels. The driving and suspension<br>functions are maintained. The<br>caster assembly functionality has<br>not changed and does not affect<br>the safety and effectiveness of<br>the device. |
| Characteristic | Predicate<br>(iBOT 4000)<br>(P020033/S002) | Proposed<br>(Next Generation iBOT) | Assessment of difference<br>(if applicable) |
| Batteries | 67.2 VDC 7.2Ah NiCd (2<br>batteries) | Four or Six Li-ion batteries, each<br>rated 57.6 VDC, 5.1 Ah | Li-ion batteries provide lighter<br>weight, higher specific energy,<br>and are the current optimal<br>battery technology. The Li-ion<br>batteries provide similar voltage<br>and current characteristics as the<br>NiCd batteries. A full suite of<br>testing for the Li-ion batteries<br>has been conducted and<br>demonstrates the change in<br>battery type does not affect<br>safety and effectiveness of the<br>device. |

# Table of Comparisons from Predicate Device to Proposed Device

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| Characteristic | Predicate<br>(iBOT 4000)<br>(P020033/S002) | Proposed<br>(Next Generation iBOT) | Assessment of difference<br>(if applicable) |
|--------------------------------------------------------|---------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Communication with<br>external<br>applications/devices | Infrared | Bluetooth 4.2 Low Energy | Bluetooth has become the widely<br>available wireless technology.<br>The change to Bluetooth<br>communication allows for use of<br>Bluetooth encryption and<br>improved communication with<br>mobile devices (i.e. laptop). The<br>change to Bluetooth does not<br>affect the safety and<br>effectiveness of the device. |
| Drive system | Rear wheel drive, 4-wheel drive,<br>2-wheel balancing | Rear wheel drive, 4-wheel drive,<br>2-wheel balancing | No change |
| Operating modes | Standard, 4-Wheel, Balance,<br>Stair-climbing, Remote | Standard, 4-Wheel, Balance,<br>Stair-climbing, Remote | No change |
| Characteristic | Predicate<br>(iBOT 4000)<br>(P020033/S002) | Proposed<br>(Next Generation iBOT) | Assessment of difference<br>(if applicable) |
| Inertial Measurement | Tilt bulbs and early solid state<br>gyros | MEMS based sensors | MEMS sensors have become<br>widely available technology to<br>measure the same physical<br>phenomenon as the predicate-<br>providing the body position<br>information to the controls<br>software. The update allows<br>improved alignment to improve<br>reliability of the measurement.<br>The change does not affect the<br>safety and effectiveness of the<br>device. |
| Position monitoring | External homing sensor | Internal absolute position sensor | The change allows for improved<br>reliability in the homing of the<br>device, by moving it inside.<br>The change does not affect the<br>safety and effectiveness of the<br>device. |
| Characteristic | Predicate<br>(iBOT 4000)<br>(P020033/S002) | Proposed<br>(Next Generation iBOT) | Assessment of difference<br>(if applicable) |
| System Communication | RS485 | CAN bus | The change to CAN Bus<br>supports current electronic<br>hardware and communication<br>with other power wheelchair<br>options. The change does not<br>affect safety and effectiveness of<br>the device. |
| Weight (including<br>batteries) | 280 lb. | 242.5 lb. | The weight is comparable to the<br>predicate device. |
| | Device Performance | | |
| Driving Range | 15.5 miles | 15.5 miles (with 4 batteries) | No change |
| Dynamic stability | 5 degrees (standard)<br>10 degrees (4 wheel)<br>5 degrees (balance) | 10 degrees (standard)<br>12 degrees (4 wheel)<br>8 degrees (balance) | The change represents equivalent<br>or increased dynamic stability<br>when compared to the predicate<br>device. |
| Characteristic | Predicate<br>(iBOT 4000)<br>(P020033/S002) | Proposed<br>(Next Generation iBOT) | Assessment of difference<br>(if applicable) |
| Max Speed Settings by<br>Mode | Standard: 6.8 mph<br>4-Wheel: 4.8 mph<br>Balance: 3.2 mph | Standard: 6.7 mph<br>4-Wheel: 5.2 mph<br>Balance: 3.3 mph | Maximum speed is comparable<br>to the predicate device. |
| Maximum user weight<br>capacity | 250 lb. | 300 lb. | Update allows additional users.<br>All testing performed with<br>expanded weight range. |
| Obstacle Climbing | 5 in. (in 4 wheel mode) | 5 in. (in 4 wheel mode) | No change |
| Turning Radius | 29.5 in. - 38.6 in.<br>(dependent on mode) | 24.5 in. – 33.8 in.<br>(dependent on mode) | Turning radius is comparable to<br>the predicate device |
| User Interface Features | | | |
| Seating | Gen 3 seat | Gen 3 seat | No change |

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| Characteristic | Predicate<br>(iBOT 4000)<br>(P020033/S002) | Proposed<br>(Next Generation iBOT) | Assessment of difference<br>(if applicable) |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User controller,<br>joystick, screen, buttons,<br>etc. | User controller with integrated<br>joystick, display, buttons, and<br>toggle switches. User assist<br>confirmation button on the back<br>of the seat. Power off request<br>button located on the power base. | User controller with integrated<br>joystick, display, buttons, speed<br>setting reduction wheel, and<br>optional toggle switches. The<br>user controller incorporates user<br>assist confirmation. Power off<br>request button located on the<br>powerbase. | The functions that the user<br>controller allows and the number<br>and type of user input devices<br>are nearly identical. Changes<br>simplify user tasks, improve<br>visibility, and improve screen<br>flow. The changes do not affect<br>the safety and effectiveness of<br>the device. |

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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, 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 in particular 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
- 2. ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- 3. ISO 7176-1:2014 Wheelchairs Part 1: Determination of Static Stability
- 4. ISO 7176-2:2001 Wheelchairs Part 2: Determination of Dynamic Stability of Electric Wheelchairs
- 5. ISO 7176-3:2012 Wheelchairs Part 3: Determination of Effectiveness of Brakes
- 6. ISO 7176-4:2008 Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
- 7. ISO 7176-5:2008 Wheelchairs Part 5: Determination of dimensions, mass and maneuvering space
- 8. ISO 7176-6:2001 Wheelchairs Part 6: Determination of Maximum Speed, Acceleration & Retardation for Electric Wheelchairs

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- 9. ISO 7176-8:2014 Wheelchairs Part 8: Requirements & Test Methods for Static, Impact & Fatigue Strengths
- 10. ISO 7176-9:2009 Wheelchairs Part 9: Climatic tests for electric wheelchairs
- 11. ISO 7176-10:2008 Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
- 12. ISO 7176-11: 2012 Wheelchairs Part 11: Test dummies
- 13. ISO 7176-13: 1999 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces
- 14. ISO 7176-14 2008 Wheelchairs Part 14: Power & Control Systems for Electric Wheelchairs-Requirements & Test Methods
- 15. ISO 7176-15:1996 Wheelchairs Part 15: Requirements For Information Disclosure, Documentation And Labeling
- 16. ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
- 17. ISO 7176-22:2014 Wheelchairs-Part 22: Set Up Procedures
- 18. ISO 7176-25:2013 Wheelchairs Part 25: Requirements and test methods for batteries and their chargers for electrically powered wheelchairs and motorized scooters
- 19. ISO 7176-28:2012 Wheelchairs Part 28: Requirements And Test Methods For Stair-Climbing Devices
- 20. RESNA WC-1:2009, Section 7 Wheelchairs Method of measurement of seating and wheel dimensions
- 21. UL 2054:2004 Household and Commercial Batteries
- 22. UN 38.3 United Nations, New York & Geneva, Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, Subsection 38. 3

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# 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 (and particularly the user interaction with the device) which have changed from the iBOT 4000. There have been no changes to the intended use environment, 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 iBOT 4000 Mobility System predicate device. DEKA finds the Next Generation iBOT to be substantially equivalent to the predicate device.