(166 days)
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No
The description focuses on accelerometer-based motion sensing and basic data storage and display. There is no mention of AI, ML, or complex algorithms beyond simple integration and counting of motion signals.
No.
The device is intended for monitoring and data collection (analyzing circadian rhythms, collecting sleep parameters, assessing activity) rather than directly treating or preventing a disease or condition.
No
The device collects and stores data to analyze circadian rhythms, sleep parameters, and physical motion. While this data can be used to inform a diagnosis, the device itself does not interpret the data to provide a diagnosis or identify a disease state. It is a data collection and monitoring device.
No
The device description clearly states it is a "compact, wrist-worn, battery-operated activity monitor" with physical components like an accelerometer, memory, and a reader device, in addition to the software.
Based on the provided information, the Actiwatch® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Actiwatch® Function: The Actiwatch® measures and records physical activity and ambient light directly from the subject's limb. It does not analyze biological specimens.
- Intended Use: The intended use focuses on analyzing circadian rhythms, sleep parameters, and general physical motion. These are physiological measurements, not diagnostic tests performed on biological samples.
- Device Description: The description details the use of an accelerometer to measure motion, storage of data, and analysis via a computer program. This aligns with a physiological monitoring device, not an IVD.
Therefore, the Actiwatch® falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Actiwatch® is an ultra-compact, lightweight, wrist-worn activity and ambient light monitor that can be used to analyze circadian rhythms, automatically collect and score data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable.
Product codes (comma separated list FDA assigned to the subject device)
GWQ
Device Description
The Actiwatch® 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 disposable wrist band.
The Actiwatch® is intended for the measurement, storage, and analysis of body activity. The Actiwatch® 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 un the Actiwatch® to collect data. This program is called Sleepwatch and runs on an IBM-compatible personal computer (PC). The major functions of Sleepwatch 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 Actiwatch® Reader is a compact interface device that provides a communications link between the Actiwatch® and the PC. The Actiwatch® Reader is connected to the serial communications port of the PC via a standard 9-conductor RS-232 cable.
The Actiwatch® utilizes a motion sensor known as an "accelerometer" to monitor the occurrence and degree of motion. This type of sensor integrates the amplitude and speed of motion and produces a small 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.
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
Subject's limb or trunk
Indicated Patient Age Range
Not Found
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)
Counts vs. motion: The most important performance characteristic of the Actiwatch® is its sensitivity to motion. This characteristic was measured by programming the device to collect data on one-minute intervals. The device was then subjected to a uniform, simple harmonic motion produced by a DC motor moving a lever at a constant speed. From the rotational speed of the motor and the length of the lever arm, the maximum acceleration can be calculated. Activity counts were compared to the maximum acceleration. Motion as low as 0.01 g and as large as 10 g can be measured.
Variation between devices: Due to small variations between device characteristics and also due to variations in experimental control, there will be small differences between the activity counts measured with separate devices. These differences have been measured for a sample of five devices. Movement acceleration in the range of 1G is typical for human subjects; this is the region where the Actiwatch® has its smallest variation between devices.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
Image /page/0/Picture/0 description: The image shows the date 3/25/99 and the text "Mini-Mitter Co, Inc.". The date is written in a handwritten style, with the month, day, and year separated by forward slashes. The text "Mini-Mitter Co, Inc." is written in a more formal font and is located below the date. The image appears to be a scan of a document.
K9f3533
510(k) Premarket Notification Actiwatch® January 8, 1999
10.0 510(K) SUMMARY
10.1 Summary Information
Submitter's Name and Address 10.1.1
Jack E. McKenzie, Ph.D. Mini-Mitter Co., Inc. P.O. Box 3386
Sunriver, Oregon 97707
Date summary was prepared:
January 8, 1999
10.1.2 Name of Device
Trade Name:
Common Name: Classification Name: Actiwatch® Activity Recording Device System, Telemetry, Physiological Signal Conditioner
10.1.3 Identification of predicate device
Number K854030 - Wrist Actigraph - Ambulatory Monitoring, Inc. - Product Code GWQ
1
510(k) Premarket Notification Actiwatch® January 8, 1999
10.1.4 Device Description
10.1.4.1 Functions of the device
The Actiwatch® 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 disposable wrist band.
The Actiwatch® is intended for the measurement, storage, and analysis of body activity. The Actiwatch® 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 un the Actiwatch® to collect data. This program is called Sleepwatch and runs on an IBM-compatible personal computer (PC). The major functions of Sleepwatch 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 Actiwatch® Reader is a compact interface device that provides a communications link between the Actiwatch® and the PC. The Actiwatch® Reader is connected to the serial communications port of the PC via a standard 9-conductor RS-232 cable.
Basic scientific concepts 10.1.4.2
The Actiwatch® utilizes a motion sensor known as an "accelerometer" to monitor the occurrence and degree of motion. This type of sensor integrates the amplitude and speed of motion and produces a small 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.
2
10.1.4.3 Pertinent physical characteristics of the Actiwatch ®:
| Parameter | Value |
|---|---|
| Size | 37x29x9 mm |
| Weight | 17 grams |
| Battery type | CR 2025 coin cell |
| Battery life | 6 months, typical |
| Accelerometer sensitivity | X |
| -------------------------- | ------------------------------------------------------------------------------- |
| (Per 21 CFR 801.109) | |
| (Optional Format 1-2-96) |
| (Division Sign-Off) |
|---|
| Division of General Restorative Devices |
K983533510/k) Numbe