(68 days)
The device is intended to provide mobility to persons restricted to a seated position or who are mobility impaired.
The Rascal "We Go 250" Powered Wheelchair is an indoor/outdoor use battery operated wheelchair. It has a frame with four (4) wheels, a seat, two (2) arm rests and a seat belt. The primary technology advantage of this device is that the movement of the wheelchair can be controlled by the rider or an attendant using hand controls located at the top of steering column to adjust the speed and direction of the wheelchair with occupant therein. These hand controls for the attendant are the same controls used for most electric scooters (Motorized Three Wheeled Vehicles - Regulation Number 890.3800). We currently market electric scooters with that same technology (510k K002616). The brake mechanism is activated or deactivated dependant upon the use of the hand controls located at the top of the steering column.
The base of the wheelchair is same base currently used on 510k approved device (K013788)
This document describes the 510(k) submission for the Rascal "We Go 250" Powered Wheelchair. Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Requirement | Reported Device Performance |
|---|---|
| Conformance to FDA Recognized Consensus Standards for Powered Wheelchairs | "All testing indicates that the Rascal 'We Go 250' meets its performance requirements." |
| Substantial Equivalence to Predicate Device (Merits K011687) in Intended Use | "The Rascal 'We Go 250' has the same intended use as the legally marketed device(s)" |
| Substantial Equivalence to Predicate Device (Merits K011687) in Technological Characteristics (no new safety/effectiveness questions) | "Technological characteristics that do not raise questions on the safety and effectiveness during use." "non-clinical testing and the predicate comparisons... demonstrate that any differences in their technological characteristics do not raise any questions as to safety and effectiveness." |
2. Sample Size for Test Set and Data Provenance
The document does not specify a quantitative "test set" in terms of number of units or patients. The testing appears to be focused on meeting recognized consensus standards for powered wheelchairs (Product Code ITI, Regulation Number 890-3860). This implies a series of engineering and performance tests on the device itself.
The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin for patient data. Given the nature of a powered wheelchair, the "test set" most likely refers to the manufactured device(s) undergoing physical and functional testing, not data from human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. For a powered wheelchair, "ground truth" would relate to the performance specifications and safety standards, which are established by regulatory bodies and engineering standards, not typically by clinical experts in the same way as, for example, diagnostic imaging. The "experts" involved would likely be engineers, quality assurance personnel, and regulatory specialists.
4. Adjudication Method for the Test Set
This information is not provided. Given that the testing is centered on meeting recognized consensus standards, the adjudication method would likely be compliance verification against those standards through direct measurement, inspection, and functional testing, not a consensus-based adjudication as seen in clinical studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or mentioned. This type of study is typically relevant for diagnostic or interpretive devices where human reader performance is a key metric. For a powered wheelchair, the focus is on safety, functionality, and performance in meeting established engineering standards.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study was not performed in the context of an "algorithm only" or AI system. This device is a physical powered wheelchair, not an AI-driven system that would have an "algorithm only" performance. The performance testing refers to the physical device's capabilities.
7. Type of Ground Truth Used
The "ground truth" used for this device is compliance with FDA Recognized Consensus Standards for Powered Wheelchairs. This means the device's performance was measured against established safety, functionality, and durability benchmarks defined by these standards, not against pathology, expert consensus on clinical cases, or long-term outcomes data in the typical sense.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. The "We Go 250" is a physical medical device (powered wheelchair), not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided, for the same reasons as point 8.
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SEP 2 1 2009 1 :
510(k) Submission Summary - "We Go 250" Powered Wheelchair
In accordance with 21 CFR 807.92, the following information constitutes the summary of safety and effectiveness of the Rascal "We Go 250".
Submitter's Name: Electric Mobility (d.b.a. The Rascal Company) 591 Mantua Blvd., Sewell NJ 08080 FDA Registration Number: 3005191512 Owner/Operation Number: 2244608 Official Contact: Steve Beversluis - Director of OA/Regulatory
Date Summary Prepared: July 6, 2009
- Device Identification:
Proprietary Name: Rascal "We Go 250" Generic Name: Powered Wheelchair Predicate Device: Merits Powered Wheelchair K011687 Classification of Predicate Device: Powered Wheelchair, Class II 21 CFR 890.3860 Product Code: ITI Classification Name: Powered Wheelchair, Class II 21 CFR 890.3860
- Intended Use:
The device is intended to provide mobility to persons restricted to a seated position or who are mobility impaired.
3. Device Description:
The Rascal "We Go 250" Powered Wheelchair is an indoor/outdoor use battery operated wheelchair. It has a frame with four (4) wheels, a seat, two (2) arm rests and a seat belt. The primary technology advantage of this device is that the movement of the wheelchair can be controlled by the rider or an attendant using hand controls located at the top of steering column to adjust the speed and direction of the wheelchair with occupant therein. These hand controls for the attendant are the same controls used for most electric scooters (Motorized Three Wheeled Vehicles - Regulation Number 890.3800). We currently market electric scooters with that same technology (510k K002616). The brake mechanism is activated or deactivated dependant upon the use of the hand controls located at the top of the steering column.
The base of the wheelchair is same base currently used on 510k approved device (K013788)
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4. Predicate Device:
The Rascal Company believes that the Rascal "We Go 250" is substantially equivalent to the following predicate device:
Merits Health Products Company Ltd. K011687
5. Technological Characteristics:
This device has the same intended use as the legally marketed device(s), as shown in the substantial equivalence table, with technological characteristics that do not raise questions on the safety and effectiveness during use.
6. Performance Testing:
An extensive collection of tests has been conducted and successfully completed, including all testing in accordance with FDA Recognized Consensus Standards for Powered Wheelchairs. Product Code ITI, Regulation Number 890-3860. All testing indicates that the Rascal "We Go 250" meets its performance requirements.
7. Conclusion:
The Rascal "We Go 250" Powered Wheelchair has the same intended use and similar technological characteristics as the legally marketing device Merits Powered Wheelchair Moreover, the non-clinical testing and the predicate comparisons MP3 (P320). demonstrate that any differences in their technological characteristics do not raise any questions as to safety and effectiveness. Thus, the Rascal "We Go 250" is substantially equivalent to the predicate device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 2 1 2009
Electric Mobility Corporation % Mr. W. Stephen Beversluis Director of Quality/Regulatory 1 Mobility Plaza Sewell, New Jersey 08080
Re: K092130
Trade/Device Name: Rascal "We Go 250" Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: July 6. 2009 Received: July 15, 2009
Dear Mr. Beversluis:
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. W. Stephen Beversluis
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510k Number: _________________________________________________________________________________________________________________________________________________________________
Device Name: Rascal "We Go 250" Powered Wheelchair
Indications for Use:
The Rascal "We Go 250" Powered Wheelchair is intended to provide mobility to persons restricted to a seated position or who are mobility impaired.
Prescription Use _ × (Per 21 CFR 801 Subpart D) and/or
Over-The Counter Use _ X (Per 21 CFR 801 Subpart C)
Please do not write below this Line – Continue on another Page, IF Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Of (Division Sign-cical, Orthopedic, and Restorative Devices
510(k) Number K092130
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).