(290 days)
The specific intended use of the power wheelchair, which is the subject device, is identical to pre-existing or predicate devices. I.H.S. CHIPS POWER CHAIR helps promote mobility, both indoors, for the intended user commonly lacking full use of lower extremities. This limited use could be of short or long duration and caused by numerous medical conditions, ranging from spinal cord injuries to temporary broken bones in a lower extremity.
Powered Wheelchair. Our subject device provides mobility by incorporating a joy stick type controller which sends power to electric gear motors, which in turn are directly driving two rear wheels which propel the device. The controller on the subject device, similar to predicate devices, incorporates safety features such as, speed control, sensitivity control, battery life indicator and power on and off indicator light. The main product components include a steel tubular welded frame which supports a sitting surface. Both the seat and the back support are made of a durable nylon material. In addition, the frame incorporates adjustable and removable armrests, providing support for the user, and is removable to facilitate transfer into and out of the wheelchair. Both leg rests and foot rests are designed to be fully adjustable to accommodate a variety of anatomical differences. All leg rests and foot rests assembly are designed to swing away to facilitate entry and exit to the power chair and are removable to facilitate transportation of the device. Power is supplied to the device by incorporating two 12 volt wet or gel cell batteries providing a 24 volt system. This in turn supplies power to two rear mounted direct drive motors, both incorporating electromechanical automatic brakes. The motors in turn provide power to a sealed gear box which transfers power to the rear wheels. The fully programmable control system provides reliable, precise control and conforms to the latest International Standards. It has plenty of drive to cope with curbs or hill climbing by continually monitoring motor voltage and current. It readily maintains constant speed over demanding uneven terrain and prevents unwanted rolling on slopes. It handles currents from 20 Amps per channel, is fully programmable, incorporates true charge battery level indicator, has user speed and response controls, and a horn to alert others. It incorporates sophisticated diagnostics to facilitate repair and provides speed stability on slopes for safety. It incorporates hand tremor dampening for users who have poor motor control.
The provided document is a 510(k) summary for a powered wheelchair, the "CHIPS Powered Wheelchair," submitted by I.H.S. International Healthcare Solutions, Inc. in 1995. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for the device itself. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, or MRMC studies for AI devices.
The document primarily describes the device's features and intended use, comparing them to existing powered wheelchairs (predicate devices) to claim substantial equivalence for regulatory approval.
Here's a breakdown of why this document doesn't provide the requested information:
- Type of Device: The device is a "Powered Wheelchair," a physical medical device. The requested information format (acceptance criteria, test sets, ground truth, MRMC studies) is typically associated with the evaluation of AI/ML-driven software as a medical device (SaMD) or AI-enabled medical devices.
- Regulatory Pathway: The 510(k) pathway for medical devices focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through performance testing, comparison of technological characteristics, and intended use. It is not designed to evaluate novel AI algorithms.
- Content of the Document: The document details the physical components (frame, seat, armrests, leg rests), power system (batteries, motors), control system (joystick, speed control, safety features), and mentions compliance with International Standards (ISO 9001, ISO 7176/14, TUV, Swedish Handicap Institute Approval) as evidence of safety and effectiveness, similar to predicate devices. It references "Technical Specifications and Test Reports" in Sections 4 and 5, but these reports are not included in the provided text.
In summary, none of the requested information regarding acceptance criteria and a study proving their fulfillment for an AI/ML device is present in the provided 510(k) summary for a powered wheelchair.
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Image /page/0/Picture/0 description: The image shows a logo for I.H.S. International. The text "I.H.S. INTERNATIONAL" is written in a bold, sans-serif font. Below the text is a stylized image of the world, with the continents outlined in black and the oceans represented by a grid of lines. The logo is simple and professional, and it conveys a sense of global reach.
HEALTHCARE SOLUTIONS, INC.
Image /page/0/Picture/2 description: The image shows the text "SEP 20 1988". The text is in a bold, sans-serif font. The letters and numbers are all capitalized. The text is likely part of a date, with "SEP" being an abbreviation for September, "20" being the day of the month, and "1988" being the year.
510(K) SUMMARY Powered Wheelchair
November 29, 1995
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
- . Name of Device: Wheelchair, Powered
- Proprietary Name: CHIPS Powered Wheelchair
- Common Name : Powered Wheelchair .
- . Classification Name: Wheelchair, Powered
- Legally marketed device to which our company is claiming equivalence: Invacare Corp., trade name, . Action, located at 899 Cleveland Street, Elyria, Ohio 44035, Sunrise Medical, trade name, Quickie, located at 2842 Business Park Ave., Fresno, CA 93727-1328, and 21st Century Scientific Inc., trade name, Bounder, located at 4915 Industrial Way, Coeur d'Alene, ID 83814.
- . Description of Device: Powered Wheelchair. See attached letter
- Intended Use of Device: See attached description letter. .
- . Summary of technological characteristics of our device compared to the predicate device: Refer to Section 4 - Technical Specifications and Test Reports.
- Brief description of the nonclinical tests and how their results support a determination of substantial . equivalence: Refer to, Section 4 - Technical Specifications and Test Reports.
Very truly yours.
Paul Witz
Fred DiVito President
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Image /page/1/Picture/0 description: The image shows a logo for I.H.S. International. The logo features the text "I.H.S. INTERNATIONAL" in a curved, bold font at the top. Below the text is a black and white illustration of the world, depicted as a grid of lines forming the continents and oceans. The overall design is simple and classic, with a focus on the global reach of the organization.
HEALTHCARE SOLUTIONS, INC.
CHIPS POWER WHEELCHAIR DESCRIPTIVE INFORMATION
510(K) Pre Market Notification
The specific intended use of the power wheelchair, which is the subject device, is identical to pre-existing or predicate devices.
I.H.S. CHIPS POWER CHAIR helps promote mobility, both indoors, for the intended user commonly lacking full use of lower extremities. This limited use could be of short or long duration and caused by numerous medical conditions, ranging from spinal cord injuries to temporary broken bones in a lower extremity.
Our subject device provides mobility by incorporating a joy stick type controller which sends power to electric gear motors, which in turn are directly driving two rear wheels which propel the device.
This is very typical and common to predicate devices like those manufactured by Sunrise Medical, 2842 Business Park Avenue, Fresno, CA 93727 and Invacare, 899 Cleveland Street, Elyria, OH 44036. (Refer to Section 3 for details).
The controller on the subject device, similar to predicate devices, incorporates safety features such as, speed control, sensitivity control, battery life indicator and power on and off indicator light.
The above controller features are typically customized by the rehabilitation dealer, who has been instructed in the use and function of the product and who in turn instructs the end user in the use and function of the power chair. (Refer to Section 4 for details).
The main product components include a steel tubular welded frame which supports a sitting surface. (Refer to Section 4 for details).
Both the seat and the back support are made of a durable nylon material. In addition, the frame incorporates adjustable and removable armrests, providing support for the user, and is removable to facilitate transfer into and out of the wheelchair.
Both leg rests and foot rests are designed to be fully adjustable to accommodate a variety of anatomical differences.
All leg rests and foot rests assembly are designed to swing away to facilitate entry and exit to the power chair and are removable to facilitate transportation of the device.
All of the above described features are typical and common in predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for I.H.S. International. The text "I.H.S. INTERNATIONAL" is at the top of the logo. Below the text is a black and white image of the world.
HEALTHCARE SOLUTIONS, INC.
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CHIPS POWER WHEELCHAIR (cont. )
Power is supplied to the device by incorporating two 12 volt wet or gel cell batteries providing a 24 volt system. This in turn supplies power to two rear mounted direct drive motors, both incorporating electromechanical automatic brakes. The motors in turn provide power to a sealed gear box which transfers power to the rear wheels.
The fully programmable control system provides reliable, precise control and conforms to the latest International Standards. It has plenty of drive to cope with curbs or hill climbing by continually monitoring motor voltage and current. It readily maintains constant speed over demanding uneven terrain and prevents unwanted rolling on slopes. It handles currents from 20 Amps per channel, is fully programmable, incorporates true charge battery level indicator, has user speed and response controls, and a horn to alert others. (Refer to Sections 4 and 5 for details).
It incorporates sophisticated diagnostics to facilitate repair and provides speed stability on slopes for safety.
It incorporates hand tremor dampening for users who have poor motor control.
It has been manufactured to meet or exceed ISO 9001 and design to ISO 7176/14 and has been approved by International Regulations known as TUV and has surpassed Swedish Handicap Institute Approval. (All Test Criteria - Please Refer to Sections 4 and 5).
Edak Ontto
pre.
Fred Di Vito November 29, 1995
N/A