(184 days)
P020033/S002
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on mechanical and software updates to an existing device.
No
The device is a powered wheelchair that provides mobility, but it is not described as treating, diagnosing, curing, or preventing any disease or condition; it primarily assists with daily living activities for disabled individuals.
No
The device description clearly states it is a "multi-mode powered wheelchair" intended for "mobility" and "stair climbing," and the intended use indicates it's for "indoor and outdoor mobility to persons restricted to a sitting position." There is no mention of it being used to diagnose any disease or condition.
No
The device description clearly states it is a "multi-mode powered wheelchair" and mentions hardware components like batteries and physical mobility features (climbing curbs, stairs). While it includes software, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to individuals restricted to a sitting position, including stair climbing. This is a physical function, not a diagnostic test performed on biological samples.
- Device Description: The device is described as a multi-mode powered wheelchair. This is a medical device used for physical assistance and mobility, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly a mobility aid, falling under the category of medical devices used for physical support and assistance.
N/A
Intended Use / 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.
Product codes
IMK
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Bench Testing: The proposed device has been demonstrated to comply with 22 standards, including ISO 7176 series for wheelchairs (static stability, dynamic stability, brakes, energy consumption, dimensions, maximum speed, acceleration & retardation, static, impact & fatigue strengths, climatic tests, obstacle-climbing ability, test dummies, coefficient of friction, power & control systems, information disclosure, documentation and labeling, electromagnetic compatibility, set up procedures), IEC 62133, ISO 10993-1, RESNA WC-1:2009, UL 2054, and UN 38.3.
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.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P020033/S002
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3890 Stair-climbing wheelchair.
(a)
Identification. A stair-climbing wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use.
(2) Performance testing must demonstrate adequate mechanical performance under simulated use conditions and environments. Performance testing must include the following:
(i) Fatigue testing;
(ii) Resistance to dynamic loads (impact testing);
(iii) Effective use of the braking mechanism and how the device stops in case of an electrical brake failure;
(iv) Demonstration of adequate stability of the device on inclined planes (forward, backward, and lateral);
(v) Demonstration of the ability of the device to safely ascend and descend obstacles (i.e., stairs, curb); and
(vi) Demonstration of ability to effectively use the device during adverse temperatures and following storage in adverse temperatures and humidity conditions.
(3) The skin-contacting components of the device must be demonstrated to be biocompatible.
(4) Software design, verification, and validation must demonstrate that the device controls, alarms, and user interfaces function as intended.
(5) Appropriate analysis and performance testing must be conducted to verify electrical safety and electromagnetic compatibility of the device.
(6) Performance testing must demonstrate battery safety and evaluate longevity.
(7) Performance testing must evaluate the flammability of device components.
(8) Patient labeling must bear all information required for the safe and effective use of the device, specifically including the following:
(i) A clear description of the technological features of the device and the principles of how the device works;
(ii) A clear description of the appropriate use environments/conditions, including prohibited environments;
(iii) Preventive maintenance recommendations;
(iv) Operating specifications for proper use of the device such as patient weight limitations, device width, and clearance for maneuverability; and
(v) A detailed summary of the device-related adverse events and how to report any complications.
(9) Clinician labeling must include all the information in the Patient labeling noted in paragraph (b)(8) of this section but must also include the following:
(i) Identification of patients who can effectively operate the device; and
(ii) Instructions on how to fit, modify, or calibrate the device.
(10) Usability studies of the device must demonstrate that the device can be used by the patient in the intended use environment with the instructions for use and user training.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
---|---|
Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
340 Commercial Street
Manchester, NH 03101 |
|-----------------|-----------------------------------------------------------------------------------------------|
| Contact Person: | Roger Leroux
Regulatory Affairs Project Manager
DEKA Research & Development Corporation |
| | Phone: (603) 669-5139
Fax: (603) 624-0573 |
| | 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
(iBOT 4000)
(P020033/S002) | Proposed
(Next Generation iBOT) | Assessment of difference
(if applicable) |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Characteristics | | | |
| Indications for Use | The device is indicated for
individuals who have mobility
impairments and the use of at
least one upper extremity. The
device is intended to provide
mobility on smooth surfaces
and inclines at home, at work,
and in other environments;
movement across obstacles,
uneven terrain, curbs, grass,
gravel and other soft surfaces;
mobility in a seated position at an
elevated height; ascent and
decent of stairs with or without
assistance; and mobility and
transportation. | The Next Generation iBOT is
intended to provide indoor and
outdoor mobility to persons
restricted to a sitting position
who meet the requirements of the
user assessment and training
certification program. The device
is intended to climb stairs.
Companions who are required to
provide assistance during
Assisted Stair Climbing Mode
must meet the requirements of
the training certification
program. | The Indications for Use has been
modified slightly from that
previously cleared in the
predicate device to align with the
intended use stated in the device
regulation (21 CFR 890.3890)
and with other powered
wheelchairs. These wording
changes in the intended use do
not alter the therapeutic or
diagnostic effect and do not
affect safety and effectiveness of
the device. |
| Manufacturer | Independence Technology | DEKA Research & Development | N/A |
| Characteristic | Predicate
(iBOT 4000)
(P020033/S002) | Proposed
(Next Generation iBOT) | Assessment of difference
(if applicable) |
| Rx/OTC designation | Rx | Rx | No change |
| | Physical Characteristics | | |
| Drive wheel type | Pneumatic. Single mounting
point. | Pneumatic or foam-filled. 5 bolt
pattern, split rim design. | The change allows for additional
tire options, which is standard in
the wheelchair industry. The
functionality of the wheels has
not changed and the change does
not affect safety and
effectiveness of the device. |
| Caster assembly | Tweel® mounted to caster arm | Standard caster wheel with
suspension assembly | This change allows for increased
availability of the caster wheels. The driving and suspension
functions are maintained. The
caster assembly functionality has
not changed and does not affect
the safety and effectiveness of
the device. |
| Characteristic | Predicate
(iBOT 4000)
(P020033/S002) | Proposed
(Next Generation iBOT) | Assessment of difference
(if applicable) |
| Batteries | 67.2 VDC 7.2Ah NiCd (2
batteries) | Four or Six Li-ion batteries, each
rated 57.6 VDC, 5.1 Ah | Li-ion batteries provide lighter
weight, higher specific energy,
and are the current optimal
battery technology. The Li-ion
batteries provide similar voltage
and current characteristics as the
NiCd batteries. A full suite of
testing for the Li-ion batteries
has been conducted and
demonstrates the change in
battery type does not affect
safety and effectiveness of the
device. |
Table of Comparisons from Predicate Device to Proposed Device
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7
8
| Characteristic | Predicate
(iBOT 4000)
(P020033/S002) | Proposed
(Next Generation iBOT) | Assessment of difference
(if applicable) |
|--------------------------------------------------------|---------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Communication with
external
applications/devices | Infrared | Bluetooth 4.2 Low Energy | Bluetooth has become the widely
available wireless technology.
The change to Bluetooth
communication allows for use of
Bluetooth encryption and
improved communication with
mobile devices (i.e. laptop). The
change to Bluetooth does not
affect the safety and
effectiveness of the device. |
| Drive system | Rear wheel drive, 4-wheel drive,
2-wheel balancing | Rear wheel drive, 4-wheel drive,
2-wheel balancing | No change |
| Operating modes | Standard, 4-Wheel, Balance,
Stair-climbing, Remote | Standard, 4-Wheel, Balance,
Stair-climbing, Remote | No change |
| Characteristic | Predicate
(iBOT 4000)
(P020033/S002) | Proposed
(Next Generation iBOT) | Assessment of difference
(if applicable) |
| Inertial Measurement | Tilt bulbs and early solid state
gyros | MEMS based sensors | MEMS sensors have become
widely available technology to
measure the same physical
phenomenon as the predicate-
providing the body position
information to the controls
software. The update allows
improved alignment to improve
reliability of the measurement.
The change does not affect the
safety and effectiveness of the
device. |
| Position monitoring | External homing sensor | Internal absolute position sensor | The change allows for improved
reliability in the homing of the
device, by moving it inside.
The change does not affect the
safety and effectiveness of the
device. |
| Characteristic | Predicate
(iBOT 4000)
(P020033/S002) | Proposed
(Next Generation iBOT) | Assessment of difference
(if applicable) |
| System Communication | RS485 | CAN bus | The change to CAN Bus
supports current electronic
hardware and communication
with other power wheelchair
options. The change does not
affect safety and effectiveness of
the device. |
| Weight (including
batteries) | 280 lb. | 242.5 lb. | The weight is comparable to the
predicate device. |
| | Device Performance | | |
| Driving Range | 15.5 miles | 15.5 miles (with 4 batteries) | No change |
| Dynamic stability | 5 degrees (standard)
10 degrees (4 wheel)
5 degrees (balance) | 10 degrees (standard)
12 degrees (4 wheel)
8 degrees (balance) | The change represents equivalent
or increased dynamic stability
when compared to the predicate
device. |
| Characteristic | Predicate
(iBOT 4000)
(P020033/S002) | Proposed
(Next Generation iBOT) | Assessment of difference
(if applicable) |
| Max Speed Settings by
Mode | Standard: 6.8 mph
4-Wheel: 4.8 mph
Balance: 3.2 mph | Standard: 6.7 mph
4-Wheel: 5.2 mph
Balance: 3.3 mph | Maximum speed is comparable
to the predicate device. |
| Maximum user weight
capacity | 250 lb. | 300 lb. | Update allows additional users.
All testing performed with
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.
(dependent on mode) | 24.5 in. – 33.8 in.
(dependent on mode) | Turning radius is comparable to
the predicate device |
| User Interface Features | | | |
| Seating | Gen 3 seat | Gen 3 seat | No change |
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10
11
12
| Characteristic | Predicate
(iBOT 4000)
(P020033/S002) | Proposed
(Next Generation iBOT) | Assessment of difference
(if applicable) |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User controller,
joystick, screen, buttons,
etc. | User controller with integrated
joystick, display, buttons, and
toggle switches. User assist
confirmation button on the back
of the seat. Power off request
button located on the power base. | User controller with integrated
joystick, display, buttons, speed
setting reduction wheel, and
optional toggle switches. The
user controller incorporates user
assist confirmation. Power off
request button located on the
powerbase. | The functions that the user
controller allows and the number
and type of user input devices
are nearly identical. Changes
simplify user tasks, improve
visibility, and improve screen
flow. The changes do not affect
the safety and effectiveness of
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:
-
- IEC 62133:2012 Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
-
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
- ISO 7176-1:2014 Wheelchairs Part 1: Determination of Static Stability
-
- ISO 7176-2:2001 Wheelchairs Part 2: Determination of Dynamic Stability of Electric Wheelchairs
-
- ISO 7176-3:2012 Wheelchairs Part 3: Determination of Effectiveness of Brakes
-
- ISO 7176-4:2008 Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
-
- ISO 7176-5:2008 Wheelchairs Part 5: Determination of dimensions, mass and maneuvering space
-
- ISO 7176-6:2001 Wheelchairs Part 6: Determination of Maximum Speed, Acceleration & Retardation for Electric Wheelchairs
14
-
- ISO 7176-8:2014 Wheelchairs Part 8: Requirements & Test Methods for Static, Impact & Fatigue Strengths
-
- ISO 7176-9:2009 Wheelchairs Part 9: Climatic tests for electric wheelchairs
-
- ISO 7176-10:2008 Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
-
- ISO 7176-11: 2012 Wheelchairs Part 11: Test dummies
-
- ISO 7176-13: 1999 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces
-
- ISO 7176-14 2008 Wheelchairs Part 14: Power & Control Systems for Electric Wheelchairs-Requirements & Test Methods
-
- ISO 7176-15:1996 Wheelchairs Part 15: Requirements For Information Disclosure, Documentation And Labeling
-
- ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
-
- ISO 7176-22:2014 Wheelchairs-Part 22: Set Up Procedures
-
- ISO 7176-25:2013 Wheelchairs Part 25: Requirements and test methods for batteries and their chargers for electrically powered wheelchairs and motorized scooters
-
- ISO 7176-28:2012 Wheelchairs Part 28: Requirements And Test Methods For Stair-Climbing Devices
-
- RESNA WC-1:2009, Section 7 Wheelchairs Method of measurement of seating and wheel dimensions
-
- UL 2054:2004 Household and Commercial Batteries
-
- UN 38.3 United Nations, New York & Geneva, Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria, Subsection 38. 3
15
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.