(8 days)
The intended function and use is to provide mobility to persons limited to a sitting position that have the capability of operating a powered wheelchair.
The Power Wheelchair consists of two basic sections to complete the finished component.
-
The powerbase containing motors, batteries, charger and wheels.
-
The body support system containing contoured adjustable seating and the joystick dual integrated controller.
The UB 114 consists of two motor gearbox combinations that power two 14" diameter front drive wheels. The electrical power source comes from two gel-cell type batteries placed in electrical series for a 24-volt direct current application. Motor control and the battery recharging monitoring is from a Joystick Controller. As part of the electrical system the UB114 employs a battery charger which is mounted "onboard" the power base.
Rear weight, rear balance and rear force load distribution is achieved by two vertical articulating caster wheels. These wheels are mounted directly to the power base. The caster wheels rotate a full 360-degree movement about the vertical mount axis while supporting the rear force load.
Constructed fully from Aluminum Alloy this Power Chair is the first in its class to have a Uni-Body style frame. All key electrical components, batteries, motor gearboxes, battery charger and wiring are enclosed within the Uni-body frame. The exterior is finished in a high performance and durable epoxy type paint.
The UB114 also employs a set of front stabilizer wheels that are placed to the front centerline of the drive wheels. The stabilizer wheels aid the user if they encounter a situation that may create an unsafe situation and help keep the Powered Wheelchair from tipping forwards or to the front left or front right sides.
The front stabilizer wheels and support arms also aid in the protection for the user's feet and legs.
All electrical components (motor gearbox combinations, batteries, battery charger, and internal wring) are housed/enclosed within a solid aluminum alloy Unibody frame.
The body support system contains contoured adjustable seating with a full 180degree tilt back for the user. A puff-bladder style or cam-lock style lumbar support is standard for all seating in the UB114.
The joystick controller attached to the seating system with a combination length adjustment and tilt angle plate system. This allows the user to totally custom fit the angle and length of position for the joystick.
The provided text is a 510(k) summary for a powered wheelchair (UB 114) and does not describe an AI/ML medical device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, study details, ground truth, or expert involvement for an AI/ML device.
The document focuses on demonstrating substantial equivalence of the UB 114 powered wheelchair to a predicate device based on non-clinical tests.
Here's a breakdown of the information that is present, relating to the non-AI device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to a list of tests from a Guidance Document for Premarket Notification for wheelchairs. It states that the device was tested against these standards.
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| ANSI/RESNA WC/02 1991 Static Stability | Not explicitly stated, but implied to have met the standard as it forms the basis for concluding substantial equivalence. |
| ANSI/RESNA WC/02 1991 Dynamic Stability | Not explicitly stated, but implied to have met the standard as it forms the basis for concluding substantial equivalence. |
| ANSI/RESNA WC/Vol. 2-1998 EMC Testing | Not explicitly stated, but implied to have met the standard as it forms the basis for concluding substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable for a non-AI physical device. The testing would have been performed on the physical wheelchair prototype.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable for a non-AI physical device. The "ground truth" for a physical device is its performance against engineering and safety standards.
4. Adjudication Method:
Not applicable for a non-AI physical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable as this is not an AI device aimed at assisting human readers/interpreters.
6. Standalone Performance:
The "standalone" performance for this physical device is its ability to directly meet the ANSI/RESNA standards. The conclusion states: "The non-clinical testing and predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." This implies the device performed adequately in these tests on its own.
7. Type of Ground Truth Used:
For this type of physical device, the "ground truth" is adherence to established engineering and safety standards (ANSI/RESNA WC/02 1991 for Static Stability, Dynamic Stability, and WC/Vol. 2-1998 for EMC Testing).
8. Sample Size for the Training Set:
Not applicable for a non-AI physical device. There is no concept of a "training set" for physical product testing in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for a non-AI physical device.
Summary of missing information specifically for an AI/ML device (as requested in the prompt, but not present in the document):
- Details on dataset sizes (test, training).
- Data provenance for clinical data (country, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication methods for clinical ground truth.
- MRMC study details and effect size.
- Standalone algorithm performance metrics (e.g., sensitivity, specificity, AUC).
- Specific types of ground truth for clinical endpoints (e.g., pathology reports, long-term outcomes).
- Methods for establishing ground truth for training data.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows a series of handwritten characters and numbers. The first part of the sequence appears to be 'KO33827'. Below this sequence, there is another line that reads '1 or 2'. The handwriting is somewhat stylized, with some characters having distinct loops and strokes.
510K Summary of Safety and Effectiveness 7.1
River Trail, Inc
369 FACTORY RD. Clinton , AR 72031 Ph (501) 745-6790 Fax (501) 745-6792
Manufacture: RiverTrail Mobility 369 Factory Rd. Clinton AR 72031 Voice: 1-501-745-6790 Fax: 1-501-745-6792
Date Prepared: October 02, 2003 FDA Registration number: None at this time. Contact Person: Clark Stancil Proprietary Name of New Device: UB 114 Generic Name of Device: Powered Wheelchair Classification of the Predicate Device: Class II, ITI 890.3860 Powered Wheelchair
K945936
Jazzy
Proposed regulatory code from 21CFR890.3860: Class II
890.3860 Powered Wheelchair
Panel Code for the Device: 89 Physical Medicine ITI
Intended Use
The intended function and use is to provide mobility to persons limited to a sitting position that have the capability of operating a powered wheelchair.
Description of Device
The Power Wheelchair consists of two basic sections to complete the finished component.
-
The powerbase containing motors, batteries, charger and wheels.
-
The body support system containing contoured adjustable seating and the joystick dual integrated controller.
The UB 114 consists of two motor gearbox combinations that power two 14" diameter front drive wheels. The electrical power source comes from two gel-cell type batteries placed in electrical series for a 24-volt direct current application. Motor control and the battery recharging monitoring is from a Joystick Controller. As part of the electrical system the UB114 employs a battery charger which is mounted "onboard" the power base.
Rear weight, rear balance and rear force load distribution is achieved by two vertical articulating caster wheels. These wheels are mounted directly to the power base. The caster wheels rotate a full 360-degree movement about the vertical mount axis while supporting the rear force load.
{1}------------------------------------------------
K033827
2 OF 2
Constructed fully from Aluminum Alloy this Power Chair is the first in its class to have a Uni-Body style frame. All key electrical components, batteries, motor gearboxes, battery charger and wiring are enclosed within the Uni-body frame. The exterior is finished in a high performance and durable epoxy type paint.
Technological Characteristics/Comparison Summary
The UB114 is substantially equivalent to the predicate device in as they are both Joystick controlled. Utilize onboard battery charger and batteries. They are both midwheel drive power chairs with rear casters and front anti-tip wheels.
Non-Clinical tests performed for determination of Substantial Equivalence
Tests listed in the Guidance Document for the Preparation of Premarket Notification 510K Applications for Mechanical and Powered Wheelchairs and Motorized Three Wheeled Vehicles.
ANSI/RESNA WC/02 1991 Wheelchair Standard for Static Stability ANSI/RESNA WC/02 1991 Wheelchair Standard for Dynamic Stability ANSI/RESNA WC/Vol. 2-1998 Wheelchair Standard for EMC Testing
Conclusions of Non-Clinical Tests
The UB114 has the same intended use and similar technological characteristics as the Predicate Device. The non-clinical testing and predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.
510K Summary of Safety and Effectiveness
The UB114 also employs a set of front stabilizer wheels that are placed to the front centerline of the drive wheels. The stabilizer wheels aid the user if they encounter a situation that may create an unsafe situation and help keep the Powered Wheelchair from tipping forwards or to the front left or front right sides.
The front stabilizer wheels and support arms also aid in the protection for the user's feet and legs.
All electrical components (motor gearbox combinations, batteries, battery charger, and internal wring) are housed/enclosed within a solid aluminum alloy Unibody frame.
The body support system contains contoured adjustable seating with a full 180degree tilt back for the user. A puff-bladder style or cam-lock style lumbar support is standard for all seating in the UB114.
The joystick controller attached to the seating system with a combination length adjustment and tilt angle plate system. This allows the user to totally custom fit the angle and length of position for the joystick.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes extending upwards. The bird is positioned above wavy lines, possibly representing water or movement. Encircling the bird is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2003
Rivertrail Mobility c/o Entela, Inc. N. E. Devinc 3033 Madison Avenue, SF Grand Rapids, Michigan 49548
Re: K033827
Trade/Device Name: UB 114 Regulation Number: 890.3860 Regulation Name: Wheckchair, powered Regulatory Class: II Product Codes: ITI Dated: December 10, 2003 Received: December 10, 2003
Dear: Mr. Devine:
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. Ilsting 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 such 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); good manufacturing practice requirements as set 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.
{3}------------------------------------------------
Page 2 - Mr. Devine:
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millican
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
7.2 Indication for Use
510k Number (if known)
Device Name: UB114
Indications For Use: The intended function and use is to provide motility to persons limited to a sitting position that have the capability of operating a porvered wheelchair.
| Prescription Use (Part 21 CFR 801 SubPart D) | AND/OR | Over-The-Counter Use X (21 CFR 807 Subpart C) |
|---|---|---|
| ---------------------------------------------- | -------- | ------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for
Division Sign-Off)
Division of General, I torative
Neurological. Devices
Number:_________________
§ 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).