(64 days)
Not Found
No
The description mentions a gyroscope control which is a sensor-based system for stabilization, not AI/ML. There is no mention of learning, adaptation, or complex algorithmic processing typically associated with AI/ML.
No
The device is a powered wheelchair intended to provide mobility and transportation, not to treat or cure a disease or condition.
No
The device is described as a powered wheelchair designed to provide mobility and transportation. There is no mention of it being used for diagnosis, disease detection, patient monitoring, or screening.
No
The device description explicitly details physical components like battery-powered motors, frames (folding and rigid), drive mechanisms, and mechanical components. While it mentions a "gyroscope control feature," this is described as an "angular rate sensor," which is a hardware component. The performance studies also refer to testing of the "Power and Control Systems of Electric Wheelchairs," further indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to individuals with limited sitting ability who can operate a powered wheelchair. This is a functional mobility aid, not a diagnostic tool.
- Device Description: The description details a battery-powered, motorized mobility vehicle designed for transportation. It describes mechanical components and a gyroscope control feature for improved maneuverability. None of these functions relate to analyzing biological samples or diagnosing medical conditions.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro analysis.
The device is clearly a medical device intended for mobility assistance, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The intended use of the Storm Series, Power 9000 Series and Power Tiger power wheelchairs with gyroscope control is to provide mobility to persons limited to a seated position.
Product codes
ITI
Device Description
The Invacare Storm Series, Invacare Power 9000 Series, Power Tiger power wheelchairs with gyroscope control are battery powered, motorized mobility vehicles. Their intended function and use is to provide mobility and transportation to physically challenged persons that may be restricted to a seated position.
The various models differ somewhat in design, drive mechanisms, styling, aesthetics and mechanical components. The primary difference between the Power 9000 Series and the Storm Series wheelchairs is in the wheelchair frame style. Where the Power 9000 is a cross brace type folding frame wheelchair, the Storm is a rigid frame non-folding type wheelchair. Additionally, the Power 9000 Series wheelchairs are a basic, economical, more traditional type wheelchair whereas the Storm Series wheelchairs, are designed to have a more sporty, aesthetic appeal.
The gyroscope control feature is an angular rate sensor that measures power wheelchair speed and turning (rotational velocity), and compensates by changing wheel speed to correct for differences. The intended function of this feature is provide a more accurate response to wheelchair joystick user commands, thereby providing a more consistent response of the wheelchair drive wheels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The Invacare Models Storm, Power 9000 and Power Tiger with Gyroscope Control meet the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993 (E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
9934/3
1047
510(k) SUMMARY
INVACARE CORPORATION'S 510(k) PREMARKET NOTIFICATION STORM SERIES, POWER 9000 SERIES AND POWER TIGER POWER WHEELCHAIRS WITH GYROSCOPE CONTROL
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6595 Facsimile: (440) 365-4558
Contact Person: Edward A. Kroll Director, TQM and Regulatory Affairs
Date Prepared: October 7, 1999
Name of Device and Name/Address of Sponsor: Storm Series, Power 9000 Series and Power Tiger power wheelchairs with gvroscope control
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6595 Facsimile: (440) 365-4558
Common or Usual Name Power Wheelchair
Classification Name Wheelchair, Powered
Predicate Devices
Products which are substantially equivalent to the Models Storm, Power 9000 and Power Tiger with gyroscope control are; the Invacare Storm Power wheelchair (K940051), the Invacare Power 9000 Power Wheelchair (K900565) and the Invacare Power Tiger Power Wheelchair (K930676).
Intended Use
The intended use of the Storm Series, Power 9000 Series and Power Tiger power wheelchairs with gyroscope control is to provide mobility to persons limited to a seated position.
1
K9534/3
7052
Technological Characteristics and Substantial Equivalence Device Description
The Invacare Storm Series, Invacare Power 9000 Series, Power Tiger power wheelchairs with gyroscope control are battery powered, motorized mobility vehicles. Their intended function and use is to provide mobility and transportation to physically challenged persons that may be restricted to a seated position.
The various models differ somewhat in design, drive mechanisms, styling, aesthetics and mechanical components. The primary difference between the Power 9000 Series and the Storm Series wheelchairs is in the wheelchair frame style. Where the Power 9000 is a cross brace type folding frame wheelchair, the Storm is a rigid frame non-folding type wheelchair. Additionally, the Power 9000 Series wheelchairs are a basic, economical, more traditional type wheelchair whereas the Storm Series wheelchairs, are designed to have a more sporty, aesthetic appeal.
The gyroscope control feature is an angular rate sensor that measures power wheelchair speed and turning (rotational velocity), and compensates by changing wheel speed to correct for differences. The intended function of this feature is provide a more accurate response to wheelchair joystick user commands, thereby providing a more consistent response of the wheelchair drive wheels.
Substantial Equivalence
Products which are substantially equivalent to the Models Storm. Power 9000 and Power Tiger with gyroscope control Invacare Storm Power wheelchair (K940051), the Invacare Power 9000 Power Wheelchair (K900565) and the Invacare Power Tiger Power Wheelchair (K930676).
PERFORMANCE DATA
The Invacare Models Storm, Power 9000 and Power Tiger with Gyroscope Control meet the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993 (E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping faces suggesting a sense of community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC I 1 2 1999
Mr. Edward A. Kroll Director. TOM and Regulatory Affairs INVACARE Corporation One Invacare Way P.O. Box 4028 Elyria, Ohio 44036-2125
Re: K993413
Trade Name: Storm Series, Power 9000 Series and Power Tiger with Gyroscope Control Regulatory Class: II Product Code: ITI Dated: October 7, 1999 Received: October 12, 1999
Dear Mr. Kroll:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Edward A. Kroll
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Nil R.P. Ogden
James E. Dillard III
for
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
4
510(k) Number (if known): TBD
Device Name: Invacare Power Wheelchairs with Gyroscope Controller
Its intended use is to provide mobility to persons limited to a sitting position, that Indications For Use: have the capability of operating a powered wheelchair.
NRO for
(Division Sign-Off) Division of General Restorative Devices K 993413 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Image /page/4/Picture/9 description: The image shows the text "Over-The-Counter Use" in bold font. To the right of the text is a symbol that looks like an X with a line underneath it. The text and symbol are in black and are set against a white background. The image appears to be a label or sign indicating that the product is available for over-the-counter use.
(Optional Format 1-2-96)