(87 days)
No
The description focuses on basic signal processing (amplification, digitization) of accelerometer data and simple analysis of activity counts or milli-g units. There is no mention of AI, ML, or complex algorithms for pattern recognition or prediction beyond direct correlation of movement to sleep parameters.
No
The device is described as an activity monitor used for documenting physical movements, analyzing circadian rhythms, and collecting and scoring data for sleep parameters. Its function is to measure, store, and analyze body activity, acting as a diagnostic or monitoring tool, not for treating any condition.
No
The device is an activity monitor designed for documenting physical movements and analyzing sleep parameters and circadian rhythms. It measures and stores data on body activity for later analysis, but it does not diagnose a specific disease or condition.
No
The device description clearly states it is a "compact, wrist-worn, battery-operated activity monitor" that includes an accelerometer, on-board circuitry for amplification and digitization, and memory for storing data. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the ActiTrac is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- ActiTrac's Function: The ActiTrac measures and analyzes physical movements of a limb using an accelerometer. It collects data on activity counts and acceleration.
- Lack of Specimen Analysis: The device does not analyze any biological specimens (blood, tissue, urine, etc.) derived from the human body. Its function is based on external physical motion.
- Intended Use: The intended use focuses on analyzing circadian rhythms, sleep parameters based on limb movements, and general quantifiable analysis of physical motion. While this information can be used in a clinical context, the device itself is not performing an in vitro diagnostic test on a specimen.
Therefore, the ActiTrac falls under the category of a physiological monitoring device that measures physical activity, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ActiTrac is a small wrist-worn activity monitor designed for documenting physical movements associated with applications in physiological monitoring. The device is intended to be used to analyze circadian rhythms, automatically collect and score data for sleep parameters. These parameters, representing the number and intensity of limb movements, are directly correlated to sleep efficiency. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.
Product codes
GWQ
Device Description
The ActiTrac is a compact, wrist-worn, battery-operated activity monitor whose physical characteristics are similar to a small wristwatch. The monitor consists of the activity monitor itself and a wrist band.
The ActiTrac is intended for the measurement, storage, and analysis of body activity. The ActiTrac can be attached to the subject's limb and through the use of an accelerometer, motion of that limb is measured, the activity stored within the activity monitor.
A computer program is used to set up the ActiTrac to collect data. This program runs on an IBM-compatible personal computer (PC). The major functions of the application software are to program the device to collect data, retrieve the data from the activity monitor, display the data, and to store the data for future reference and comparison.
The ActiTrac uses a smart download cable to provide a communiations link between the ActiTrac and the PC. To download data from the ActiTrac to the PC, one end of the ActiTrac's smart cable is inserted into the ActiTrac's port via a miniature 2.5 mm phone plug and the other end connected to the serial communications port of the PC via a standard 9-pin RS-232 COM port.
The ActiTrac utilizes a motion sensor known as an "accelerometer" to monitor the occurrence and degree of motion. This type of sensor provides an analog signal where the amplitude and speed of motion produces a signal whose magnitude and duration depend on the amount of motion. The activity signals are amplified and digitized by the on-board circuit. This information is stored in memory on board the device as activity counts. Activity can alternatively be stored in units of milli-q.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist, limb
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)
The most important performance characteristic of the ActiTrac is its sensitivity to motion. This characteristic is measured by programming the device to collect data in fixed intervals. For precise calibration, the device is subjected to a uniform, harmonic motion produced by a moving platform set for a constant frequency of 3.968 Hz and an amplitude of 0.2 g. The output of the device is compared to a gold standard accelerometer also placed on the moving platform. From these results, the acceleration is calculated. Activity counts are then computed from the acceleration. Motion as low as 0.01 g can be measured.
Due to small variations between characteristics and also due to variations in experimental control, there will be small differences between the activity counts measured with separate devices. Each ActiTrac is calibrated and checked to meet output specifications at or better than ±1% as compared to our established laboratory standard. Movement acceleration in the range of 0.1g to 1.0g are typical for human subjects; this is the region where the ActiTrac has its smallest variation between devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity to motion: Motion as low as 0.01 g can be measured.
Variation between devices: ±1% as compared to established laboratory standard.
Predicate Device(s)
K983533 - "ACTIWATCH" - MINI-MITTER CO., INC.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
OCT 1 5 1999 510(k) SUMMARY:
"This summary of 510(k) safety and effectivness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
Submitter's Name and Address:
David T. Krausman, Ph.D.
Individual Monitoring Systems, Inc. (DBA IM Systems)
1055 Taylor Ave., Suite 300
Baltimore, MD 21286
Phone: 410-296-7723, Fax: 410-321-0643
Contact person: David T. Krausman, Ph.D.
July 19, 1999 Date summary was prepared:
Name of Device:
Trade Name:
ActiTrac
Activity Recording Device Common Name:
Classification Name: Electroencephalograph
ldentification of predicate device:
Number K983533 - "ACTIWATCH" - MINI-MITTER CO., INC.
Product Code - GWQ
1
Statement of intended use:
The ActiTrac is a small wrist-worn activity monitor designed for documenting physical movements associated with applications in physiological monitoring. The device is intended to be used to analyze circadian rhythms, automatically collect and score data for sleep parameters. These parameters, representing the number and intensity of limb movements, are directly correlated to sleep efficiency. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.
Device Description
Functions of the device:
The ActiTrac is a compact, wrist-worn, battery-operated activity monitor whose physical characteristics are similar to a small wristwatch. The monitor consists of the activity monitor itself and a wrist band.
The ActiTrac is intended for the measurement, storage, and analysis of body activity. The ActiTrac can be attached to the subject's limb and through the use of an accelerometer, motion of that limb is measured, the activity stored within the activity monitor.
13
2
A computer program is used to set up the ActiTrac to collect data. This program runs on an IBM-compatible personal computer (PC). The major functions of the application software are to program the device to collect data, retrieve the data from the activity monitor, display the data, and to store the data for future reference and comparison.
The ActiTrac uses a smart download cable to provide a communiations link between the ActiTrac and the PC. To download data from the ActiTrac to the PC, one end of the ActiTrac's smart cable is inserted into the ActiTrac's port via a miniature 2.5 mm phone plug and the other end connected to the serial communications port of the PC via a standard 9-pin RS-232 COM port.
Basic scientific concepts:
The ActiTrac utilizes a motion sensor known as an "accelerometer" to monitor the occurrence and degree of motion. This type of sensor provides an analog signal where the amplitude and speed of motion produces a signal whose magnitude and duration depend on the amount of motion. The activity signals are amplified and digitized by the on-board circuit. This information is stored in memory on board the device as activity counts. Activity can alternatively be stored in units of milli-q.
14
3
Physical characteristics "ActiTrac" vs. "Actiwatch (Predicate)"
| Parameter: | ActiTrac: | Actiwatch (Predicate): |
|---|---|---|
| Size | 37 x 55 x 12 mm | 37 x 29 x 9 mm |
| Weight | 23 grams | 17 grams |
| Battery type | Lithium Keeper #LTC-7PN | CR 2025 coin cell |
| Battery life | 4 years, typical | 6 months, typical |
| Accelerometer | piezoelectric | piezoelectric |
| Accelerometer sensitivity | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109 OR
Over-The-Counter-Use (Optional Format 1 -
Hooll
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number /L942410