(51 days)
No
The description details a mechanical and electrical system with simple logic based on proximity and tilt sensors, not AI/ML.
No.
The device is designed to provide powered elevation for a wheelchair seat to assist with daily activities, transfers, and general accessibility. This is a functional aid, not a device intended to diagnose, cure, mitigate, treat, or prevent disease.
No
The Invacare Elevating Seat is a medical device designed to provide powered elevation for wheelchair users to assist with daily activities and accessibility, not to diagnose a medical condition.
No
The device description clearly outlines hardware components including a pedestal actuator, mounting weldments, mounting hardware, a toggle control, a DC brush type motor controller, a double throw momentary position switch, a proximity switch, and potentially a two-actuator control (MIV TAC). While there are control aspects, the core of the device involves physical components for powered elevation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide powered elevation of a wheelchair seat to assist with daily activities, transfers, and general accessibility. This is a mechanical function related to mobility and assistance, not diagnostic testing of biological samples.
- Device Description: The description details mechanical components (actuator, weldments, control) and electrical components (motor controller, switch, sensors) that facilitate the elevating function. There is no mention of reagents, assays, or analysis of biological specimens.
- Lack of IVD Characteristics: The text 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 diagnosis, monitoring, or prognosis of a disease or condition
- Using techniques like immunoassays, molecular diagnostics, or clinical chemistry
The device is clearly a mobility aid designed to improve the functionality of a power wheelchair.
N/A
Intended Use / Indications for Use
The intended function and use of the Invacare Elevating Seat is to provide powered elevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility.
Product codes
ITI
Device Description
The Invacare Elevating Seat consists of a pedestal actuator, mounting weldments with mounting hardware, and a toggle control. The intended function and use of the elevating seat is to provide powered elevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility.
The bottom of the actuator assembly is mounted to the base of the wheelchair via the seat support weldment, which is specific to the particular wheelchair model. The top of the actuator assembly mounts to the wheelchair seat assembly via the seat mount bracket, which is specific to the seat assembly of the wheelchair. The ball drive pedestal actuator has a load capacity of 500 pounds and a maximum stroke of 8 inches. The elevating seat is available for select models of power wheelchair as a factory installed option.
The MIV Elevating Seat Toggle is standard with the elevating seat option. It is a DC brush type motor controller that is used to control the elevating actuator on power wheelchair systems with the elevating seat option installed. A double throw momentary position switch is used to drive the actuator. Current through the motor is limited and drive speed reduction occurs when the chair is in an elevated position.
The MIV Elevating Seat Toggle connects to the Power Take Off (PTO) connector of the wheelchair battery harness. Therefore, the power supply for the elevating seat toggle is taken directly from the wheelchair battery harness through a 15 amp fused power block, and the elevate function can be activated even when the wheelchair drive controls are turned off.
The MIV Elevating Seat Toggle also connects to a proximity switch, which senses when the seat is elevated. When the switch senses that the seat is elevated more than .75 inches, the speed of the wheelchair is reduced to 20% of the maximum possible speed of the chair. However, the reduced speed will not exceed the user-programmed speed.
For certain wheelchair models, the MIV TAC, a two-actuator control, is available as an option to the MIV Elevating Seat Toggle. The MIV TAC allows the elevating seat to be combined with the tilt feature of the wheelchair seating system and it allows the elevating seat to be controlled through the joystick of the wheelchair.
In addition to the features described under the MIV Elevating Seat Toggle, the MIV TAC has an additional tilt sensor that detects the overall back angle of the seating system. If the seat is tilted more than 20 degrees the elevating seat will not elevate. Also, if the seat is elevated more than .75 inches, the seat will not tilt.
The MIV Elevating Seat Toggle and the MIV TAC are to be used in conjunction with the Invacare Model MCC-MKIV Motor Controller , Joystick and options.
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 Elevating Seat meets 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)
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
510(k) SUMMARY
DEC 1 3 2001
Invacare Corporation's Invacare Elevating Seat Option
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Invacare Corporation One Invacare Way PO Box 4028 Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Contact Person:
Rae Ann Farrow Manager, Regulatory Compliance
Date Prepared: October 19, 2001
Name of Device and Name/Address of Sponsor
Invacare Elevating Seat Option
Invacare Corporation One Invacare Way Elyria, Ohio 44036-2028 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Common or Usual Name
Elevating Seat
Classification Name
Wheelchair, Powered
Predicate Devices
Accelerated Rehab Designs, Inc. "E-2000 Power Elevating Seat System" (K992828, 2/3/2000)
Intended Use
The intended function and use of the Invacare Elevating Seat is to provide powered elevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility.
1
Technological Characteristics and Substantial Equivalence
A. Device Description
The Invacare Elevating Seat consists of a pedestal actuator, mounting weldments with mounting hardware, and a toggle control. The intended function and use of the elevating seat is to provide powered elevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility.
The bottom of the actuator assembly is mounted to the base of the wheelchair via the seat support weldment, which is specific to the particular wheelchair model. The top of the actuator assembly mounts to the wheelchair seat assembly via the seat mount bracket, which is specific to the seat assembly of the wheelchair. The ball drive pedestal actuator has a load capacity of 500 pounds and a maximum stroke of 8 inches. The elevating seat is available for select models of power wheelchair as a factory installed option.
The MIV Elevating Seat Toggle is standard with the elevating seat option. It is a DC brush type motor controller that is used to control the elevating actuator on power wheelchair systems with the elevating seat option installed. A double throw momentary position switch is used to drive the actuator. Current through the motor is limited and drive speed reduction occurs when the chair is in an elevated position.
The MIV Elevating Seat Toggle connects to the Power Take Off (PTO) connector of the wheelchair battery harness. Therefore, the power supply for the elevating seat toggle is taken directly from the wheelchair battery harness through a 15 amp fused power block, and the elevate function can be activated even when the wheelchair drive controls are turned off.
The MIV Elevating Seat Toggle also connects to a proximity switch, which senses when the seat is elevated. When the switch senses that the seat is elevated more than .75 inches, the speed of the wheelchair is reduced to 20% of the maximum possible speed of the chair. However, the reduced speed will not exceed the user-programmed speed.
MKIV TAC
For certain wheelchair models, the MIV TAC, a two-actuator control, is available as an option to the MIV Elevating Seat Toggle. The MIV TAC allows the elevating seat to be combined with the tilt feature of the wheelchair seating system and it allows the elevating seat to be controlled through the joystick of the wheelchair.
In addition to the features described under the MIV Elevating Seat Toggle, the MIV TAC has an additional tilt sensor that detects the overall back angle of the seating system. If the seat is tilted more than 20 degrees the elevating seat will not elevate. Also, if the seat is elevated more than .75 inches, the seat will not tilt.
2
The MIV Elevating Seat Toggle and the MIV TAC are to be used in conjunction with the Invacare Model MCC-MKIV Motor Controller , Joystick and options. FDA granted this controller marketing clearance on June 2, 1994, under 510(k) Accession Number K940972.
B. Substantial Equivalence
The Invacare Elevating Seat is substantially equivalent to the Accelerated Rehab Designs, Inc. "E-2000 Power Elevating Seat System" (K992828, 2/3/2000).
PERFORMANCE DATA
The Invacare Elevating Seat meets 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."
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2001
Rae Ann Farrow Manager, Regulatory Compliance Invacare Corporation One Invacare Way Elvria, Ohio 44036-2125
Re: K013516
Trade Name: Invacare Elevating Seat Option ESS6 Regulation Number: 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: II Product Code: ITI Dated: October 19, 2001 Received: October 23, 2001
Dear Ms. Farrow:
We have reviewed your Section 510(k) premarket 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) 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 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.
4
Page 2 - Ms. Rae Ann Farrow
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Sincerely yours,
Mark N. Mclherson
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
5
510(k) Number (if known): TBD
Device Name: Invacare Elevating Seat Option
Indications For Use:
The intended function and use of the Invacare Elevating Seat is to provide powered elevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility..
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR
(Per 21 CFR 801.109)
Over-The-Counter Use _
estorative
510(k) Number
(Optional Format 1-2-96)