(161 days)
The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature.
This submission covers the Q700-UP M which includes the following new components to the Sunrise Medical Quickie® Pulse 6SC:
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- Requires a knee block that was a previous option
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- Adds a stand-up actuator (PG Drives Technology) to power the stand-up feature
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- Requires a different version of the power center leg-rest to support the patient's weight when standing.
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- Adds a CSXM power seating control module (PG Drives Technology) to control the seating during standing
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- A caster / suspension lock-out system to stabilize the base when stand-up is actuated.
The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature.
The Sunrise Medical Quickie® Q700-UP M power wheelchairs provide seating and standing function for patients who cannot stand on their own.
The document does not describe a study involving a medical device with "acceptance criteria" and "reported device performance" in the typical sense of diagnostic test performance (e.g., sensitivity, specificity, accuracy).
Instead, the document is a 510(k) summary for a medical device called the Quickie® Q700-UP M (a stand-up wheelchair). The "acceptance criteria" and "reported device performance" are presented as compliance with various recognized industry standards and a comparison of technical features to predicate devices to demonstrate substantial equivalence.
Here's the information extracted and formatted according to your request, with clarifications where the terms need to be adapted to the context of a wheelchair 510(k) submission:
1. A table of acceptance criteria and the reported device performance
In the context of this 510(k) submission for a stand-up wheelchair, "acceptance criteria" refers to compliance with recognized consensus standards (primarily ISO 7176 series and RESNA WC-1) and demonstrating substantial equivalence to predicate devices based on technical features. The "reported device performance" is the outcome of testing against these standards and the listed technical specifications.
| Acceptance Criteria (Standard / Feature) | Reported Device Performance (Outcome / Specification) |
|---|---|
| ISO 7176-1 [ANSI/RESNA WC-1/1]: Determination of Static Stability | Pass |
| ISO 7176-2 [ANSI/RESNA WC-2/2]: Determination of Dynamic Stability of Electrically Powered Wheelchairs | Pass |
| ISO 7176-3 [ANSI/RESNA WC-2/3]: Determination of effectiveness of brakes | Pass |
| ISO 7176-4 [ANSI/RESNA WC-2/4]: Energy consumption for determination of theoretical distance | Pass |
| ISO 7176-5 [ANSI/RESNA WC-1/5]: Determination of dimensions, mass and maneuvering space | Pass |
| ISO 7176-6 [ANSI/RESNA WC-2/6]: Determination of maximum speed, acceleration and deceleration | Pass |
| ISO 7176-7 [ANSI/RESNA WC-1/7]: Method of measurement of seating and wheel dimensions | Pass |
| ISO 7176-8 [ANSI/RESNA WC-1/8]: Requirements and test methods for static, impact and fatigue strengths | Pass |
| ISO 7176-9 [ANSI/RESNA WC-2/9]: Climatic tests for electrically powered wheelchairs | Pass |
| ISO 7176-10 [ANSI/RESNA WC-2/10]: Determination of obstacle-climbing ability | Pass |
| ISO 7176-14 [ANSI/RESNA WC-2/14]: Power and control systems - Requirements and test methods | Pass |
| ISO 7176-15 [ANSI/RESNA WC-1/15]: Requirements for information disclosure, documentation and labeling | Pass |
| ISO 7176-16 [ANSI/RESNA WC-1/16]: Resistance to ignition of upholstered parts | Pass |
| ISO 7176-19 [ANSI/RESNA WC-4/19]: Wheeled mobility devices for use as seats in motor vehicles | Pass |
| ISO 7176-21 [ANSI/RESNA WC-2/21]: Electromagnetic compatibility | Pass |
| ISO 10993-5: Biological evaluation of medical devices | Pass (for materials common to many wheelchairs) |
| ISO 7176-25: Batteries and chargers for powered wheelchairs | Pass |
| RESNA WC-1:2009 Section 20: Determination of the Performance of Stand-up Type Wheelchairs | Pass |
| Technical Feature Comparison to Predicate Devices: | |
| Product Code (LeVo C3) | IPL 890.3900 (Identical) |
| Device Description (LeVo C3) | Center-wheel-drive, battery-powered, motor-driven, controlled by PG Drives Technology; functions indoors/outdoors (Equivalent) |
| Picture (in standing mode, LeVo C3) | Wheelchair in standing mode (Equivalent) |
| Seat width (LeVo C3) | 16-22" (Equivalent to predicate's 12.6-20.5 inches) |
| Total width (LeVo C3) | 25" (Equivalent to predicate's 24.8 inches) |
| Total length (LeVo C3) | 36" (Functionally Equivalent to predicate's 41.3 inches) |
| Seat plate depth (LeVo C3) | 16-22" (Functionally Equivalent to predicate's 13.8–24.8 inches) |
| Armrest height (LeVo C3) | 6.3"-12" (Functionally Equivalent to predicate's 5.9-14.1 inches) |
| Turning circle (LeVo C3) | 43 inches (Identical) |
| Speed (LeVo C3) | 6 or 8 mph options (Functionally Equivalent to predicate's 3.7/5/6.2 mph options) |
| Range (LeVo C3) | 21 miles (Functionally Equivalent to predicate's 15.5 miles) |
| Manageable gradient (LeVo C3) | 10° (18%) (Functionally Equivalent to predicate's 15° (33%) actually 28%) |
| Max. curb height (LeVo C3) | 4 inches (Identical) |
| Max. chair weight (LeVo C3) | 375 lbs. (Equivalent to predicate's 407 lbs.) |
| Max. user weight (LeVo C3) | 265 lbs. (Reduced weight capacity compared to predicate's 310 lbs.) |
| Transport volume max. (LeVo C3) | 41"x 25"x 29" (Functionally Equivalent to predicate's 37.8 x 24.8 x 27.1 inches) |
| Controller(s) (Reference device: Quickie Pulse 6SC) | PGDT R-Net Controller Std. (Equivalent) |
| Joystick Mounting (Reference device: Quickie Pulse 6SC) | Standard, Swing-away, Retractable (Equivalent) |
| Attendant Controls (Reference device: Quickie Pulse 6SC) | Optional, for R-Net (Equivalent) |
| Batteries (Reference device: Quickie Pulse 6SC) | Group 24 – 73Ahr; Group 34 -50 Ahr (Equivalent) |
| Power stand-up feature (Reference device: Quickie Pulse 6SC) | Chest support and knee support standard (Identical) |
| Light kit option (Reference device: Quickie Pulse 6SC) | Front & Rear with Turn Signal (Identical) |
| User Weight (Max) (Reference device: Quickie Pulse 6SC) | 265 lb. (Equivalent, limited by standup feature) |
| Structural Materials (Reference device: Quickie Pulse 6SC) | Steel and aluminum frame structure, welded and powder coated, standard foams/covers (Identical) |
| Biocompatibility (Reference device: Quickie Pulse 6SC) | Uses materials common to many Wheelchairs (Identical) |
| Maximum speed (Reference device: Quickie Pulse 6SC) | 6.0 mph, with 8.0 mph option (Equivalent) |
| Overall dimensions (Reference device: Quickie Pulse 6SC) | 25" x 36" (Equivalent) |
| Maximum total weight of base (Reference device: Quickie Pulse 6SC) | 152 lbs. (Equivalent) |
| Batteries (Reference device: Quickie Pulse 6SC) | 24V (2x12V) / 73 Ah/20h; 24V (2x12V) / 60 Ah/20h, Maintenance free (Equivalent) |
| Drive wheels (Reference device: Quickie Pulse 6SC) | 14" diameter (Equivalent) |
| Caster wheels (Reference device: Quickie Pulse 6SC) | 6" Front & Rear (Equivalent) |
| Motors/gearbox (Reference device: Quickie Pulse 6SC) | 6.0 Motor Package (1026W @120A), 8.0 mph Motor Package (1293W @120A) (Equivalent) |
| Anti-pitch mechanism for climbing (Reference device: Quickie Pulse 6SC) | Additional anti-pitch lock-out (Identical) |
| Cosmetic (Reference device: Quickie Pulse 6SC) | Steel tubular box frame, cast aluminum front and rear caster arms, shrouded with ABS plastic covers (Equivalent) |
| Seat options (Reference device: Quickie Pulse 6SC) | SEDEO UP Recline (required by stand-up feature) (Equivalent) |
| Minimum seat height (Reference device: Quickie Pulse 6SC) | 16.2" (Identical) |
| Lift, tilt, recline range (Reference device: Quickie Pulse 6SC) | Lift 0-12", Tilt 0-50°, Recline 0-172° (Identical) |
| Lift, tilt, recline capacity (Reference device: Quickie Pulse 6SC) | Lift 265 lbs., Tilt 265 lbs., Recline 265 lbs. (Equivalent, limited by stand-up feature) |
| Seat dimensions (Reference device: Quickie Pulse 6SC) | Width 16-22", Depth 16-22" (Equivalent) |
| Controller type (Reference device: Quickie Pulse 6SC) | R-Net from PGDT (Equivalent, limited by stand-up feature) |
| Supply voltage (Reference device: Quickie Pulse 6SC) | 24 V dc (Identical) |
| Operating voltage (Reference device: Quickie Pulse 6SC) | 35 V dc (Identical) |
| Reverse battery voltage (Reference device: Quickie Pulse 6SC) | -40 V dc (Identical) |
| PWM frequency (Reference device: Quickie Pulse 6SC) | 19.5 kHz ± 1% (Identical) |
| Brake voltage / current (Reference device: Quickie Pulse 6SC) | Harness with in-line connector; Min 100 mA, Max 1 A (Identical) |
| Charging current (Reference device: Quickie Pulse 6SC) | 12 A rms max (Identical) |
| Charger connection (Reference device: Quickie Pulse 6SC) | Only Neutrik NC3MX (Identical) |
| Actuator current (Reference device: Quickie Pulse 6SC) | Maximum 10 A (Identical) |
| Maximum drive current (Reference device: Quickie Pulse 6SC) | RNet 120A Controller (Equivalent with additional max current output) |
| Moisture resistance (Reference device: Quickie Pulse 6SC) | Compliant with ANSI RESNA WC-9 (Identical) |
| Operating temperature (Reference device: Quickie Pulse 6SC) | -25°C to 50°C (Identical) |
| Storage temperature (Reference device: Quickie Pulse 6SC) | -40°C to 70°C (Identical) |
| Joystick Mount (Reference device: Quickie Pulse 6SC) | Fixed mount, Height adjustable, Swing-away (Identical) |
| Controller Connector (Reference device: Quickie Pulse 6SC) | Harness with in-line connector (Identical) |
| Number of drive profiles (Reference device: Quickie Pulse 6SC) | 5 (Identical) |
| User input (Reference device: Quickie Pulse 6SC) | Joystick and hand control buttons (Identical) |
| On/off button, Speed up/down, Horn button (Reference device: Quickie Pulse 6SC) | Yes (Identical) |
| Actuator control (Reference device: Quickie Pulse 6SC) | Versions available with and without actuator control buttons (Identical) |
| Number of actuators for lift, tilt, recline (Reference device: Quickie Pulse 6SC) | 6 (tilt, stand-up, recline (2), power legrests (2), lift) (Equivalent) |
| Battery state indicator (Reference device: Quickie Pulse 6SC) | LEDs (Identical) |
| Electronics package (Reference device: Quickie Pulse 6SC) | Electronics in both hand control module and motor control module (Identical) |
| Programming tool (Reference device: Quickie Pulse 6SC) | Hand held programmer (Identical) |
| External drive inhibit input (Reference device: Quickie Pulse 6SC) | Yes (Identical) |
| Attendant control (Reference device: Quickie Pulse 6SC) | Option with R-Net system (Identical) |
| Bluetooth PC mouse replacement (Reference device: Quickie Pulse 6SC) | Option with R-Net system (Identical) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify a "sample size" in terms of many individual devices tested for each standard. Instead, it states that "All verification and validation testing conducted demonstrate that the Quickie® Q700-UP M is substantially equivalent..." This implies that at least one device (or a representative number of units) was tested to each listed standard. Standard compliance testing typically involves a small number of units (e.g., 1-3 units) unless otherwise specified by the standard or regulatory body.
- Data Provenance: The document does not explicitly state the country of origin of the test data or whether it was retrospective or prospective. However, given that Sunrise Medical (US) LLC is listed with a Fresno, California address, and the submission is to the U.S. FDA, it is implied that the testing was conducted to meet U.S. regulatory requirements. It is a premarket notification (510(k)), so the testing would have been conducted as part of the development and validation process before market entry, making it prospective testing in anticipation of regulatory submission.
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 section is Not Applicable to this submission. The "ground truth" for a medical device like a wheelchair is not established by expert consensus in the same way as an AI diagnostic tool. Instead, the "ground truth" or acceptable performance is defined by adherence to internationally recognized performance standards for wheelchairs (ISO, RESNA). The experts involved would be engineers and technical specialists performing the tests and verifying compliance with these standards, not clinicians establishing a "diagnosis."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in reading medical images for AI ground truth). For physical device testing against standards, the results are typically objectively measured and either pass or fail the specified criteria.
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
This section is Not Applicable. This is a physical medical device (wheelchair), not an AI diagnostic tool involving human "readers" or AI assistance. No MRMC study would be relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by compliance with recognized international and national consensus standards (listed in Table 4) for wheelchair safety, performance, and functionality. These standards define the acceptable range of physical, mechanical, and electrical performance characteristics. The comparison to predicate devices also serves as a benchmark for demonstrating substantial equivalence based on established features of legally marketed devices.
8. The sample size for the training set
This section is Not Applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This section is Not Applicable. As it's not an AI model, there is no "training set" or corresponding ground truth to establish.
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).