(22 days)
Not Found
No
The device description focuses on mechanical and electrical components (tracks, motor, leadscrew, toggle switch) and does not mention any AI/ML algorithms or data processing for decision making.
No
The "Intended Use / Indications for Use" section explicitly states, "Track Corporation makes no claims as to the therapeutic effectiveness of this device. our only claims relate to the ability of the device to provide safe and reliable change in positioning capability on the equipment that it is installed."
No
The information provided describes a power tilt seating system for wheelchairs, designed to change a user's position for comfort, stability, and pressure relief. It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description clearly details multiple hardware components including steel tracks, mounting hardware, an aluminum seat pan, a Fasco motor, a steel leadscrew, a tilt drive assembly, and a micro-switch. It is a physical system with mechanical and electrical parts, not solely software.
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 positioning changes for individuals using power wheelchairs for mobility. This is a mechanical function related to patient comfort, stability, and pressure relief.
- Device Description: The device is a power tilt seating system that attaches to a power wheelchair. It uses mechanical components like tracks, a motor, and a leadscrew to achieve tilting and positioning.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens taken from the human body.
- Performance Studies: The performance studies focus on durability and meeting ISO standards for wheelchairs, not on diagnostic accuracy or clinical outcomes related to a disease.
IVD devices are used to perform tests on samples (like blood, urine, or tissue) to get information about a person's health. This device does not perform any such tests.
N/A
Intended Use / Indications for Use
The K-Tech 2 is appropriate for use by individuals that use a power wheelchair for mobility and require positioning changes without the aid of an attendant. These positioning changes are needed for, but not limited to:
- Comfort for increased sitting tolerance
- Positioning to enable upper body stability
- Pressure relief or reduction by shifting the end user's body weight from the buttocks to the back
Track Corporation makes no claims as to the therapeutic effectiveness of this device. Our only claims relate to the ability of the device to provide safe and reliable change in positioning capability on the equipment that it is installed.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The Track Corporation K-Tech Power Tilt Seating System is an aftermarket, center of gravity design power tilt in space system for power wheelchairs. The K-Tech 2 is designed to be able to be installed in the field by qualified dealerships on to most commercially available power wheelchairs appropriate for power seating accommodation. The standard system configuration consists of two sets of steel tracks, an inner and outer set. This track configuration has been used in the automotive industry very successfully for many years, under more rigorous conditions than wheelchairs experience. The outer tracks of the K-Tech 2 are attached to the power wheelchair via mounting hardware that is designed to interface to each specific power chair.
The outside tracks also provide the quide tracks for the inside tracks to tilt and slide forward, creating the center of gravity movement. The aluminum seat pan and the inside tracks support the back support uprights. The K-Tech 2 utilizes an automotive seat adjuster motor manufactured by Fasco and has a maximum load capacity of 500 pounds. The Fasco motor has an integrated overload protection to protect the motor from current overload and over use by the end user. The tilt drive assembly found integrated into the back end of the inner tracks follows a steel leadscrew attached inside of each of the outer tracks. This creates a dual screw drive which is much more efficient and does not put the users weight directly on the tilt adjuster, unlike on the actuators that are found on the predicate device(s). This is a significant improvement in durability and safety in power wheelchair seating. If the motor should ever fail, the tilt drive assembly will not change its relationship to the leadscrew. The end user is protected from the system either falling backward or free falling back down to the neutral seated position due to motor failure. An additional benefit of using the tilt drive assembly and ball screw is the tilting of the system is achieved by the movement of the screw quide on the ball screw. This allows the device to tilt and slide forward without exerting great stress and opposing forces on the frame, which exist on the predicate devices and all other available tilt power seating systems. Over time, these opposing forces cause undue strain on the frame, leading to possible serious failure. The K-Tech 2 is activated with a standard low amp toggle switch. It can also be activated by running the system through commercially available optional specialty controls for the end user that does not have the ability to activate a toqgle switch. As the toqgle switch is activated, the K-Tech 2 will beqin to tilt and simultaneously move forward to center the end user's weight over the power chair base, maintaining stability of the base and end user while tilted.
The K-Tech has a standard infinitely adjustable tilt range of zero to 55 degrees and custom tilt ranges are available. There is a micro-switch attached to the frame, which is activated once the end user tilts past 20 degrees, locking out the driving capabilities of the power chair for safety.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Cycle/Durability Test:: Completed 18,000 tilt cycles satisfactorily without failure. Results are found in appendix D.
The K-Tech 2 in its standard confiquration meets the applicable requirements specified in ISO 7176.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
'OCT 3 1 2003
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510(K) Summary
| Submitted by: | Track Corporation, Inc. |
|---|---|
| 17024 Taft Road | |
| Spring Lake, MI 49456 | |
| Phone: 616-8442471 | |
| Fax: 616-844-2476 | |
| e-mail: | |
| Contact: | Jon Emery |
| Date: | 09/20/02 |
| Name of Device: | K-Tech 2 Power Tilt Seating System |
| Trade Name: | K-Tech 2 Power Tilt Seating System |
| Common Name: | Power Tilt-in-Space Seating System, Center of Gravity, |
| Power Tilt in Space. | |
| Classification Name: | Wheelchair, Powered |
| Product Code: | ITI |
| Regulation Number: | 890.3860 |
| Type: | Traditional |
1
Substantial Equivalence:
| K981837: | Motion Concepts, TRx-CG Center of Gravity Shifting Power Tilt |
|---|---|
| K972564: | Tiltmaster Center of Gravity Power Tilt System |
Description:
The Track Corporation K-Tech Power Tilt Seating System is an aftermarket, center of gravity design power tilt in space system for power wheelchairs. The K-Tech 2 is designed to be able to be installed in the field by qualified dealerships on to most commercially available power wheelchairs appropriate for power seating accommodation. The standard system configuration consists of two sets of steel tracks, an inner and outer set. This track configuration has been used in the automotive industry very successfully for many years, under more rigorous conditions than wheelchairs experience. The outer tracks of the K-Tech 2 are attached to the power wheelchair via mounting hardware that is designed to interface to each specific power chair.
The outside tracks also provide the quide tracks for the inside tracks to tilt and slide forward, creating the center of gravity movement. The aluminum seat pan and the inside tracks support the back support uprights. The K-Tech 2 utilizes an automotive seat adjuster motor manufactured by Fasco and has a maximum load capacity of 500 pounds. The Fasco motor has an integrated overload protection to protect the motor from current overload and over use by the end user. The tilt drive assembly found integrated into the back end of the inner tracks follows a steel leadscrew attached inside of each of the outer tracks. This creates a dual screw drive which is much more efficient and does not put the users weight directly on the tilt adjuster, unlike on the actuators that are found on the predicate device(s). This is a significant improvement in durability and safety in power wheelchair seating. If the motor should ever fail, the tilt drive assembly will not change its relationship to the leadscrew. The end user is protected from the system either falling backward or free falling back down to the neutral seated position due to motor failure. An additional benefit of using the tilt drive assembly and ball screw is the tilting of the system is achieved by the movement of the screw quide on the ball screw. This allows the device to tilt and slide forward without exerting great stress and opposing forces on the frame, which exist on the predicate devices and all other available tilt power seating systems. Over time, these opposing forces cause undue strain on the frame, leading to possible serious failure. The K-Tech 2 is activated with a standard low amp toggle switch. It can also be activated by running the system through commercially available optional specialty controls for the end user that does not have the ability to activate a toqgle switch. As the toqgle switch is activated, the K-Tech 2 will beqin to tilt and simultaneously move forward to center the end user's weight over the power chair base, maintaining stability of the base and end user while tilted.
The K-Tech has a standard infinitely adjustable tilt range of zero to 55 degrees and custom tilt ranges are available. There is a micro-switch
2
attached to the frame, which is activated once the end user tilts past 20 degrees, locking out the driving capabilities of the power chair for safety.
Intended Use:
The K-Tech 2 is appropriate for use by individuals that use a power wheelchair for mobility and require positioning changes without the aid of an attendant. These positioning changes are needed for, but not limited to:
- . Comfort for increased sitting tolerance
- . Positioning to enable upper body stability
- . Pressure relief or reduction by shifting the end user's body weight from the buttocks to the back
Track Corporation makes no claims as to the therapeutic effectiveness of this device. Our only claims relate to the ability of the device to provide safe and reliable change in positioning capability on the equipment that it is installed.
The above indications are identical to those of Motion Concepts K981837 and Mechanical Application Designs K972564.
Technological Characteristics:
The Track Corporation K-Tech 2 Power Tilt Seating System is a battery powered motorized seating system for power wheelchairs. It is designed as an aftermarket seating system that can be mounted onto a variety of currently available power wheelchairs that are suitable to accommodate power seating. The K-Tech 2 incorporates two sets of tracks that allow the system to be configured to accommodate a wide range of end user sizes from very small individuals up to the bariatric end user using the same sets of tracks. The K-Tech 2 incorporates the use of an automotive seat adjuster motor to tillt the system, creating a "dual drive," by turning the Tilt Drive Assembly on the right and left leadscrew. If the motor should ever fail, the Tilt Drive Assembly will not change its relationship to the leadscrew (no back drive), hence the end user is protected from the system either falling backward or free falling back down to the neutral seated position due to motor failure. This provides both efficiency and safety not found on the predicate devices or on other available power seating. This also enables the system to be tilted without any opposing forces on the frame, as is the case with the predicate devices.
Performance Data:
Cycle/Durability Test:: Completed 18,000 tilt cycles satisfactorily without failure. Results are found in appendix D.
The K-Tech 2 in its standard confiquration meets the applicable requirements specified in ISO 7176.
3
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2003
Track Corporation, Inc. C/o Mr. Ned Devine Entela, Inc 3033 Madison Avenue SE Grand Rapids, Michigan 49548
Re: K033263
Trade/Device Name: K-Tech 2 Power Tilt Seating System Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: October 24, 2003 Received: October 27, 2003
Dear Mr. Devine:
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 (OS) 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 - Mr. Ned Devine
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 Office of Compliance at (301) 594-1308. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Wilkerson
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
Applicant: Track Corporation Applicant: Track Corporation!
510(k) Number (if known): TBD K 033 26 3 Device Name: K-Tech 2 Power Tilt Seating System Indications For Use:
The K-Tech 2 is appropriate for use by individuals that use a power wheelchair for mobility and require positioning changes without the aid of an attendant. These positioning changes are needed for, but not limited to:
- Comfort for increased sitting tolerance .
- Positioning to increase upper body stability .
- Pressure relief or reduction to shift the end user's body weight from the buttocks to the back .
Track Corporation makes no claims as to the therapeutic effectiveness of this device. our only claims relate to the ability of the device to provide safe and reliable change in positioning capability on the equipment that it is installed.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109) (Optional Format 1-2-96)
fo Mark A. Milkerson
Rest rative