(106 days)
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Not Found
No
The description focuses on data acquisition and transfer, with no mention of AI/ML algorithms for analysis or interpretation.
No
The device measures angular range of motion and velocity to compile information and compare performance profiles, but it does not initiate or control movement, induce forces, or provide any therapy.
Yes
The device measures angular range of motion and velocity to "compile information related to tests devised by the AMA to measure impairment of wrist joints, and to compare performance profiles of normal and injured populations," which are diagnostic purposes.
No
The device description explicitly states it is a "bi-axial wrist-joint movement assessment device mounted on a forearm and hand" and mentions "real-time data... immediately transferred from the W-Tracker to the computer via an A/D conversion device to a serial port," indicating the presence of physical hardware components beyond just software.
Based on the provided information, the W-Tracker is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The W-Tracker measures the physical movement of a wrist joint. It does not analyze blood, tissue, urine, or any other biological sample.
- The intended use is to assess wrist joint movement and compare performance profiles. This is a physical assessment, not a diagnostic test performed on a biological sample.
The W-Tracker is a device used for physical assessment and measurement of movement, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The W-Tracker is a bi-axial wrist-joint movement assessment device mounted on a forearm and hand. Specifically, it measures angular range of motion and velocity in two planes. The Clinical Analysis protocol requires the subject to perform a series of wrist movements, including wrist flexion/extension and ulnar/radial deviation, each to be performed by the subject at his/her preferred speed. The data obtained during the Clinical Analysis protocol is real-time data, and is immediately transferred from the W-Tracker to the computer via an A/D conversion device to a serial port.
The goals of the device when performing the Clinical Analysis protocol is to compile information related to tests devised by the AMA to measure impairment of wrist joints, and to compare performance profiles of normal and injured populations.
The W-Tracker does not initiate or control any movement during a test and it does not induce any forces on the subject. It is, therefore, a passive device. The only forces acting on the subject are the negligible inertial forces of the W-Tracker generated by the subject's wrist movements. The device is fail-safe in design to obviate safety concerns for the subject.
Product codes
KQX
Device Description
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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
wrist-joint, forearm, hand
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1500 Goniometer.
(a)
Identification. A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.(b)
Classification. (1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.(2) Class II (special controls) for a goniometer that uses electrode lead wires and patient cables. The special controls consist of:
(i) The performance standard under part 898 of this chapter, and
(ii) The guidance entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.
0
Image /page/0/Picture/1 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 image of an eagle or other bird-like figure, depicted with stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Donald R. McIntyre, Ph.D. ·Vice President and Chief Operating Interlogics, Inc. P.O. Box 1239 Hillsborough, North Carolina 27278
Re: K971079 Interlogics W-Tracker and Wristworks Software Requlatory Class: I Product Code: KQX JUL - 9 1997 Dated: June 6, 1997 Received: June 9, 1997
Dear Dr. McIntyre:
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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Requlation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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.
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Page 2 - Donald R. McIntyre, Ph.D.
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 requlation (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,
la M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K971079 Device Name: W-Tracker and WristWorks software Indications for Use:
The W-Tracker is a bi-axial wrist-joint movement assessment device mounted on a forearm and hand. Specifically, it measures angular range of motion and velocity in two planes. The Clinical Analysis protocol requires the subject to perform a series of wrist movements, including wrist flexion/extension and ulnar/radial deviation, each to be performed by the subject at his/her preferred speed. The data obtained during the Clinical Analysis protocol is real-time data, and is immediately transferred from the W-Tracker to the computer via an A/D conversion device to a serial port.
The goals of the device when performing the Clinical Analysis protocol is to compile information related to tests devised by the AMA to measure impairment of wrist joints, and to compare performance profiles of normal and injured populations.
The W-Tracker does not initiate or control any movement during a test and it does not induce any forces on the subject. It is, therefore, a passive device. The only forces acting on the subject are the negligible inertial forces of the W-Tracker generated by the subject's wrist movements. The device is fail-safe in design to obviate safety concerns for the subject.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
to colle
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971079
Prescription Use (per 21 CFR 801.109)
OR
Over-The-Counter Use