(9 days)
Not Found
No
The description focuses on standard electronic control and programming of wheelchair parameters, with no mention of AI, ML, or related concepts.
No
The device is a controller for powered wheelchairs, designed to activate and control movement, not to directly treat or diagnose a disease or condition.
No
The device is described as activating and controlling powered wheelchair motion and selecting operational parameters, not as diagnosing any medical condition.
No
The device description explicitly states it is an "electronic microcomputer based motor control device" and a "single module that includes both the joystick and the motor controller," indicating it is a hardware device with embedded software, not a software-only 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 "activate and control powered wheelchair motion" and "selecting the type of operational parameters which best suit the particular control needs of the wheelchair user." This clearly relates to controlling a physical device (a wheelchair) for mobility, not performing tests on biological samples to diagnose conditions.
- Device Description: The description details an "electronic microcomputer based motor control device for power wheelchairs." It focuses on controlling motors and adjusting performance characteristics of the wheelchair. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document 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 screening of diseases or conditions
The device is a control system for a power wheelchair, which falls under the category of medical devices for mobility assistance, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the Invacare INT /DL40i Controller is to activate and control powered wheelchair motion. Additionally, it provides a method of selecting the type of operational parameters which best suit the particular control needs of the wheelchair user.
Product codes
ITI
Device Description
The INT /DL40i controller is an electronic microcomputer based motor control device for power wheelchairs intended to activate and control the wheelchair motion. It also provides the means for selecting, adjusting and programming the type of wheelchair operation parameters and performance characteristics to meet the particular control needs of the wheelchair user.
The INT/DL40i controller consists of a single module that includes both the joystick and the motor controller. It has two drive modes and twelve performance adjustment settings in its program menu. Programming the controller requires the use of a separate programming device since it does not have "Through the Joystick Programming" (TTJP) capability. Also, the INT/DL40i controller does not include any additional motion control activation devices such as "Sip N Puff" or seat reclining.
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 performance data found in this submission shows that the INT /DL40i Controller performs as intended and in a manner that is substantially equivalent to the predicate device.
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
Image /page/0/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in a bold, sans-serif font. The word is set inside of a black oval shape. There is a small trademark symbol to the right of the word.
510(K) SUMMARY FOR THE INT/DL40i MICRO COMPUTER CONTROL FOR POWER WHEELCHAIRS
This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92
The assigned 510(k) number is
Date: November 5, 2007
Submitted by: Invacare Corporation Registration No. 1525712 One Invacare Way Elyria, Ohio 44035-4190
NOV 1 6 2007
Telephone: 440-326-6356 Fax: 440-326-3458
Contact Person: Mr. Carroll Martin
Trade Name: INT/DI.40i Micro Computer Control for Power Wheelchairs
Common Name: Power Wheelchair controller and Joystick
Classification Name: Wheelchair, powered per 21 CFR 890.3860
Legally Marketed Predicate Device(s): INT/DL40i Micro Computer Control for Power Wheelchairs; K950724, August 7, 1995
Device Description: The INT /DL40i controller is an electronic microcomputer based motor control device for power wheelchairs intended to activate and control the wheelchair motion. It also provides the means for selecting, adjusting and programming the type of wheelchair operation parameters and performance characteristics to meet the particular control needs of the wheelchair user.
The INT/DL40i controller consists of a single module that includes both the joystick and the motor controller. It has two drive modes and twelve performance adjustment settings in its program menu. Programming the controller requires the use of a separate programming device since it does not have "Through the Joystick Programming" (TTJP) capability. Also, the INT/DL40i controller does not include any additional motion control activation devices such as "Sip N Puff" or seat reclining.
Intended Use: The intended use of the Invacare INT /DL40i Controller is to activate and control powered wheelchair motion. Additionally, it provides a method of selecting the type of operational parameters which best suit the particular control needs of the wheelchair
INVACARE CORPORATION
Special 510(k) for Invacare's INT/DL40i Integrated Controller
Page 16
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Image /page/1/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in bold, white letters against a black oval background. The oval is outlined with a thin white line, and the word "INVACARE" is centered within the oval.
Substantial Equivalence:
| Features | The Modified Model INT/DL40i | Predicate Device
Model INT/DL40i |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | TBD | K950724 |
| Date Cleared | TBD | 08/07/1995 |
| Intended Use | To activate and control powered wheelchair
motion. Additionally, it provides a method of
selecting the type of operational parameters which
best suit the particular control needs of the
wheelchair user. | To activate and control powered wheelchair
motion. Additionally, it provides a method of
selecting the type of operational parameters which
best suit the particular control needs of the
wheelchair user. |
| Electronics | Digital Based | Digital Based |
| Drive Control | Microprocessor | Microprocessor |
| PC Boards | Surface and Through Hole Mounted | Surface and Through Hole Mounted |
| Drive Modes | 2 | 1 |
| Controller Module | Integrated with Joystick | Integrated with Joystick |
| Sip 'N' Puff Module
Option | No | No |
| ECU Module Option | No | No |
| Recliner Module Option | No | No |
| RIM Control Option | No | No |
| Remote Programmer
Option | Yes | Yes |
| LCD Joystick Option | No | No |
| TTJP Capability | No | No |
| Performance Adjustments | 12 | 6 |
| Enclosures | Pressure Die Cast Aluminum- Bottom
Injection Molded Polymer - Top | Pressure Die Cast Aluminum |
| Manufacturer | Dynamic Controls, Ltd.,
Christchurch, New Zealand | Dynamic Controls, Ltd.,
Christchurch, New Zealand |
INVACARE CORPORATION
Special 510(k) for Invacare's
INT/DL40i Integrated Controller
2
Image /page/2/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in a bold, sans-serif font. The word is placed inside of a black oval shape. The oval shape has a white outline.
As the chart above shows, the modified INT /DL40i Controller is substantially equivalent to the INT /DL40i Controller, cleared on August 7, 1995 under 510(K) Accession Number K950724. The reading subject to this Special 510(k) consists only of testing to allow the use of the controller on a different model of Invacare's Pronto wheelchairs, the M41.
The intended use of activating and controlling powered wheelchair motion and providing a method of selecting the type of operational parameters which best suit the particular control needs of the wheelchair user remains the same.
| Standard or Agency | Title |
|---|---|
| ANSI/RESNA WC/Vols. 1&2, 1998 | |
| Section 1 | Determination of Static Stability |
| Section 2 | Determination of Dynamic Stability of Electric Wheelchairs |
| Section 3 | Test Methods and Requirements for the Effectiveness of Braking |
| Section 4 | Determination of Energy Consumption of Electric Wheelchairs |
| and Scooters -- Theoretical Range | |
| Section 5 | Determination of Overall Dimensions, Mass and Turning Space |
| Section 6 | Determination of Maximum Speed, Acceleration and Retardation |
| of Electric Wheelchairs | |
| Section 7 | Method of Measurement of Seating and Wheel Dimensions |
| Section 8 | Requirements and Test Methods for Static, Impact and Fatigue |
| Strengths | |
| Section 9 | Climatic Tests for Electric Wheelchairs – Requirements and Test |
| Methods | |
| Section 10 | Determination of Obstacle Climbing Ability of Electric |
| Wheelchairs | |
| Section 14 | Power and Control Systems for Electric Wheelchairs |
| Section 21 | Requirements and Test Methods for Electromagnetic |
| Compatibility |
INVACARE CORPORATION
Special 510(k) for Invacare's INT/DL40i Integrated Controller
3
Image /page/3/Picture/0 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in bold, sans-serif font. The word is enclosed in a black oval shape with white outlines. The logo is simple and recognizable.
CISPR 11
Industrial, Scientific and Medical (ISM) Radio Frequency Equipment-Electromagnetic Disturbance Characteristics-Limits and Methods of Measurement
Performance Data: The performance data found in this submission shows that the INT /DL40i Controller performs as intended and in a manner that is substantially equivalent to the predicate device.
Conclusion: The data presented in this submission shows that the INT /DL40i Controller performs as intended and in a manner that is substantially equivalent to the predicate devices.
INVACARE CORPORATION
Special 510(k) for Invacare's INT/DL40i Integrated Controller
4
Public Health Service
Image /page/4/Picture/2 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-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2007
Invacare Corporation % Mr. Carroll Martin One Invacare Way Elyria, OH 44035-4190
Re: K073134
Trade/Device Name: INT/DL40i Micro Computer Control for Power Wheelchairs Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: November 5, 2007 Received: November 7, 2007
Dear Mr. Martin:
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, 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.
5
Page 2 - Mr. Carroll Martin
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Invacare INT /DL40i Controller
Indications for Use: The intended use of the Invacare INT /DL40i Controller is to activate and control powered wheelchair motion. Additionally, it provides a method of selecting the type of operational parameters which best suit the particular control needs of the wheelchair user.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use -------(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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number L073134
Special 510(k) for Invacare's
INT/DL40i Integrated Controller
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