(85 days)
The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor and outdoor mobility to persons restricted to a sitting position. The device allows for the option to climb stairs. The operator(s), either the wheelchair occupant or an assistant, must meet the requirements of the training certification program. The wheelchair occupant must meet the requirements of the user assessment.
The proposed device is an update to the previously cleared iBOT® PMD (K210920). The device retains all the following from the original device including:
The device is a multi-mode powered wheelchair that enables users to manewer in confined spaces, climb curbs, stairs, and other obstacles. The device is intended to provide indoor mobility, including stair climbing, to persons limited to a seated position who are capable of operating a powered wheelchair.
The device still includes active stabilization in multiple driving modes and allows for traversing aggressive and difficult terrain and operation at an elevated seat height offers benefits in activities of daily living (e.g., accessing higher shelves) and interaction with other people at "eye level" while either stationary or moving.
The device still utilizes the primary components of a stair climbing drive wheels, frame, sealed electronics, sensors, battery packs, motors, active stability system and battery charger. It can also be produced without the stair climbing function.
The device still allows occupied transportation while an individual is seated in through both a 4-point tie down system and a docking system.
In addition, the device incorporates the following updates to the iBOT® PMD design:
- · Modified the device to add the Motion Concepts Modular Power Positioning Seating System (K150574) as an option / accessory which includes greater degrees of posterior tilt, power recline with shear reduction, and power elevating legrests
- · Adds anterior tilt to the power positioning options available on the product
- · Adds the existing power seat elevation to the Standard Mode of the device
- · Updates that operator of the chair can be the occupant or an attendant to increase clarity
- · Updates contraindications to increase clarity
- · Adds optional seat interface brackets that include seat height and static tilt angle adjustments
- · Minor redesign of front casters and changes of materials / processes in support of design for manufacturing efforts
- · Software revisions / changes
- · Removes the contraindication for a mechanical ventilator mount can be added to the device, when the device is modified to remove stair and balance modes.
This document is an FDA 510(k) summary for a medical device called the "iBOT® PMD," a stair-climbing wheelchair. It describes an updated version of a previously cleared device. The purpose of this 510(k) is to demonstrate that the updated device is substantially equivalent to the predicate device, meaning it is as safe and effective.
Based on the provided text, the device in question is a Stair-Climbing Wheelchair (iBOT® PMD). The context of "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to the regulatory requirement that the updated device must demonstrate substantial equivalence to its predicate device through performance testing and compliance with recognized standards.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly list "acceptance criteria" in a quantitative sense as might be seen for a diagnostic AI device (e.g., target specificity/sensitivity). Instead, the acceptance criteria are implicitly satisfied by demonstrating compliance with a long list of recognized performance standards for wheelchairs and related components. The "reported device performance" is essentially a comparison of the updated iBOT® PMD's specifications against those of its predicate device, as well as the results of compliance testing to the listed standards.
| Characteristic | Predicate Device (iBOT® PMD K210920) | Proposed (iBOT® PMD) | Assessment of Difference (if applicable) |
|---|---|---|---|
| Indications for Use | Provides indoor and outdoor mobility for persons restricted to a sitting position, option to climb stairs. User assessment & training cert. Occupied transport option. | Provides indoor and outdoor mobility for persons restricted to a sitting position, option to climb stairs. Operator (occupant or assistant) and occupant must meet training/assessment. | Clarified that operator can be occupant or assistant, removed occupied transport as it's an option. No new safety/effectiveness issues. |
| Manufacturer | Mobius Mobility, LLC | Mobius Mobility, LLC | No change. |
| Product Code | IMK, ITI | IMK, ITI | No change. |
| Contraindications | Weight 300 lbs. Risk of seizure/loss of consciousness. Risk of fracture from jarring forces. Unsuccessful user training. Need mechanical ventilator. | Weight 300 lb, or >275 lb (with 55-degree tilt/recline/legrest). Uncontrolled seizures/loss of consciousness. Known serious risk of fractures. Unsuccessful user training. | Weight capacity updated for new seating options. Mechanical ventilator mount added (when stair/balance modes removed). Wording updated for clarity. No new issues of safety or effectiveness. |
| Drive Wheel Type | Pneumatic, 5 bolt, 2-inch width. | Pneumatic, 5 bolt, 2-inch or 4-inch width. | Added 4-inch width option. No new issues of safety or effectiveness. |
| Caster Assembly | Standard caster wheel with suspension. | Standard caster wheel with suspension. | Casters redesigned but no functional change. No new issues of safety or effectiveness. |
| Batteries | Four or Six Li-ion, 57.6 VDC, 5.1 Ah. | Four or Six Li-ion, 57.6 VDC, 5.1 Ah. | No change. |
| Communication with External Apps/Devices | Bluetooth 4.2 Low Energy | Bluetooth 4.2 Low Energy | No change. |
| Drive System | Rear wheel, 4-wheel, 2-wheel balancing. | Rear wheel, 4-wheel, 2-wheel balancing. | No change. |
| Operating Modes | Standard, 4-Wheel, Balance, Stair-climbing, Remote, Docking. | Standard, 4-Wheel, Balance, Stair-climbing, Remote, Docking. | No change. |
| Inertial Measurement | MEMS based sensors | MEMS based sensors | No change. |
| Wheel Gear Train | Helical Gear | Helical Gear | No change. |
| Position Monitoring | Internal absolute position sensor | Internal absolute position sensor | No change. |
| System Communication | CAN bus | CAN bus and UART | Added UART for communication to Modular Power Positioning System. No new issues of safety or effectiveness. |
| Weight (incl. batteries) | 242.5 lb. | 242.5 lb. (without Modular Power Positioning System); 295.0 lb. (with Modular Power Positioning System). | Weight with optional Modular Power Positioning System added. No new issues of safety or effectiveness. |
| Driving Range | 15.5 miles | 14.3 miles | Updated testing done with seat changes. No new issues of safety or effectiveness. |
| Dynamic Stability | 10 (standard), 12 (4-wheel), 8 (balance) degrees. | 10 (standard), 12 (4-wheel), 8 (balance) degrees. | No change. |
| Max Speed Settings by Mode | Standard: 6.7 mph; 4-Wheel: 5.1 mph; Balance: 3.5 mph; Docking: 0.6 mph. | Standard: 6.8 mph; 4-Wheel: 5.1 mph; Balance: 3.5 mph; Docking: 0.6 mph. | No change in electronics affecting speed. No new issues of safety or effectiveness. |
| Maximum User Weight Capacity | 300 lb. with Maxx Rehab Seat. | 300 lb. without Modular Maxx Rehab Seat; 275 lb. with Modular Ultra Low Maxx Seat (with power positioning options). | Reduced for devices with seating systems including 55-degree tilt, recline, or elevating leg rests. |
| Obstacle Climbing | 5 in. (in 4-wheel mode) | 6 in. (in 4-wheel mode) | Increased obstacle height. No new issues of safety or effectiveness. |
| Turning Radius | 24.5 in. - 33.8 in. (dependent on mode). | 24.5 in. - 37 in. (dependent on mode). | Due to length of the seating system. |
| Seating | Maxx Rehab Seat | Maxx Rehab Seat; Ultra Low Maxx Rehab Seat with power positioning options. | Added seating options allowing full tilt, recline, and/or elevating leg rests. Risks identified via FMEA, mitigations verified. No impact to safety/effectiveness. |
| Power Seat Elevation | Available in 4-Wheel, Balance and Stair modes. Max 17". | Available in 4-Wheel, Balance, Stair, and Standard modes. Max 17". | Added existing functionality to Standard mode. Risks identified via FMEA, mitigations verified. No impact to safety/effectiveness. |
| User Controller, Joystick, etc. | User controller with integrated joystick, display, buttons, speed setting reduction wheel, optional toggle switches. User assist confirmation. Power off request button on powerbase. | Color Joystick (user controller) with integrated joystick, display, buttons, speed setting reduction wheel, optional toggle switches. User assist confirmation. Power off request button on powerbase. | Updated terminology. No change to design or function. |
| Transportation | Unoccupied and Occupied Transport Options. | Unoccupied and Occupied Transport Options. | No change. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists performance standard compliance (e.g., ISO 7176 series, IEC 62133-2) and general statements like "The following performance testing was conducted to demonstrate that the proposed device complies..." and "A summary of the testing performed is provided below."
- Sample Size: The document does not specify the sample size for object testing (e.g., number of wheelchairs tested). This type of testing typically involves a small number of production units (e.g., 1-3 devices) to demonstrate compliance with engineering standards.
- Data Provenance: Not specified, but generally, such regulatory testing is performed in controlled lab environments as part of the device manufacturer's design verification and validation activities. It is inherently prospective testing against predefined specifications and standards. Country of origin for testing is not mentioned but would typically be where the manufacturer or their chosen test labs are located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a physical medical device (stair-climbing wheelchair), not an AI/ML-based diagnostic imaging device. Therefore, the concept of "ground truth" established by human experts (like radiologists for imaging) is not applicable in the same way. The "ground truth" for this device's performance is established by engineering standards and direct physical testing against those standards. The expertise comes from the engineers and technicians performing the tests and validating the design against the requirements of the standards (e.g., ISO, IEC).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device's performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic imaging AI where human readers might disagree. For device performance testing, results are typically objective measurements against a standard.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device. The study described is an engineering performance validation and comparison to a predicate device, not a human reader study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-only device. Its performance is demonstrated through its physical functions and safety features.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device lies in its compliance with internationally recognized performance and safety standards (e.g., ISO 7176 series for wheelchairs, IEC 62133-2 for batteries) and its demonstrated substantial equivalence to the previously cleared predicate device. This is primarily a technical and objective "ground truth" established through physical testing and measurement.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for physical device performance validation.
§ 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.