(122 days)
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No
The description focuses on a microcomputer-based control system with preprogrammed functions and user input processing, without mentioning AI or ML capabilities.
No.
The device's intended use is to activate and control power wheelchair motion, which is not a therapeutic function for the patient.
No
The device is described as a motion control device for power wheelchairs, not for diagnosing medical conditions. Its function is to control wheelchair movement and performance characteristics.
No
The device description explicitly states it includes hardware components such as a motor controller power module with a microprocessor housed in an aluminum enclosure, and various joystick options and accessories.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "activate and control power wheelchair motion." This is a mechanical and control function, not a diagnostic one.
- Device Description: The description focuses on controlling wheelchair movement, adjusting performance characteristics, and processing user inputs to command motors. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Using reagents or calibrators.
The device is clearly designed to assist with mobility by controlling a power wheelchair, which falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Model DX Micro-Computer Control is to activate and control power wheelchair motion.
Product codes
89ITI
Device Description
The Model Dx Controller is a series of electronic, microcomputer based, motion control devices for use with power wheelchairs. Their intended function and use is to activate and control power wheelchair motion. Additionally, they provide a method of adjusting, selecting and programming the type of power wheelchair performance characteristics which best suit the specific control needs of the wheelchair user.
The Dx product line includes a motor controller power module with microprocessor, and a variety of joystick options and accessories which are used to perform various functions. The power module, which contains the system microprocessor, is housed in a pressure die cast aluminum enclosure. The power module stores preprogrammed operating functions, processes user inputs and issues commands to the wheelchair motors. The joystick options are used to engage wheelchair motion and to steer the chair. The options and accessories are used to program the wheelchair performance parameters and to perform additional functions as needed by the wheelchair user.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Dx Controller has been tested for compliance with ISO 7176:1993(E) entitled ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs." Results indicate that the Dx Controller meets the requirements of this standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
9771 MAY 1 2 1997 510(k) SUMMAR
Invacare Corporation's Model Dx Micro Computer Controls for Power Wheelchairs
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Invacare Corporation 899 Cleveland Street Elyria, Ohio 44035 Phone: (216) 329-6000 Facsimile: (216) 366-9724
Contact Person:
Edward A. Kroll Director, TQM and Regulatory Affairs
January 10, 1997 Date Prepared:
Name of Device and Name/Address of Sponsor
Model Dx Micro-Computer Control for Power Wheelchairs
Invacare Corporation 899 Cleveland Street Elyria, Ohio 44035 Phone: (216) 329-6000 Facsimile: (216) 366-9724
Common or Usual Name
Power Wheelchair
Classification Name
Wheelchair, Powered - 89ITI
Predicate Devices
The Model Dx Micro-Computer Controls are substantially equivalent to Invacare Corporations' Model MCC MKIV Micro Computer Controls (K940972 June 2, 1994), and Invacare's Model INT DL40i Wheelchair control (K950274, August 7, 1995).
Intended Use
The intended use of the Model DX Micro-Computer Control is to activate and control power wheelchair motion.
1
Technological Characteristics and Substantial Equivalence
A. Device Description
The Model Dx Controller is a series of electronic, microcomputer based, motion control devices for use with power wheelchairs. Their intended function and use is to activate and control power wheelchair motion. Additionally, they provide a method of adjusting, selecting and programming the type of power wheelchair performance characteristics which best suit the specific control needs of the wheelchair user.
The Dx product line includes a motor controller power module with microprocessor, and a variety of joystick options and accessories which are used to perform various functions. The power module, which contains the system microprocessor, is housed in a pressure die cast aluminum enclosure. The power module stores preprogrammed operating functions, processes user inputs and issues commands to the wheelchair motors. The joystick options are used to engage wheelchair motion and to steer the chair. The options and accessories are used to program the wheelchair performance parameters and to perform additional functions as needed by the wheelchair user.
B. Substantial Equivalence
Products which are substantially equivalent to the Dx Controls are; Invacare's Model MCC-MKIV Micro Computer Controls (K940972) and Invacare's (Dynamic Controls) Model INT DL 40i Micro Computer Controls for Power Wheelchairs (K950724).
Each of these products are electronic microcomputer based motor control devices for use with power wheelchairs with the same intended function and use which is to activate and control power wheelchair motion. Additionally, all provide the means for selecting, adjusting and programming the type of wheelchair operation parameters and performance characteristics which best suit the particular needs of the wheelchair user. Finally, all of these devices have been granted marketing clearance by FDA under prior submissions.
None of the differences between the Dx Controller and its' predicate devices alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness.
PERFORMANCE DATA
The Dx Controller has been tested for compliance with ISO 7176:1993(E) entitled ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs." Results indicate that the Dx Controller meets the requirements of this standard.