K Number
K991033
Device Name
ACTIWATCH-SCORE
Date Cleared
1999-06-23

(86 days)

Product Code
Regulation Number
882.1400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Actiwatch-Score® is a compact, lightweight, wrist-worn activity monitor that can be used to analyze circadian rhythms, automatically collect and analyze data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable. In addition, the Actiwatch-Score® has a built-in score pad that allows the subject to subjectively assign and enter a score from 0 to 9. The score pad can be used as a substitute or in addition to the traditional patient diary used in conjunction with activity monitoring.
Device Description
The Actiwatch-Score® 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-Score® is intended for the measurement, storage, and analysis of body activity. The Actiwatch-Score® 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 Actiwatch-Score® to collect data. This program is called Actiware-Sleep and runs on an IBM-compatible personal computer (PC). The major functions of Actiware-Sleep are to create a patient score schedule, 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-Score® 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-Score® 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. In addition, the patient self-score data are stored as integer values within memory.
More Information

Not Found

No
The description focuses on basic activity monitoring using an accelerometer and a computer program for data management and analysis, with no mention of AI or ML techniques for data interpretation or prediction.

No.
The device is used for analyzing data related to circadian rhythms, sleep parameters, and physical motion, and includes a score pad for subjective input. Its function is to measure, store, and analyze body activity, not to provide therapy or treatment.

Yes.
The device is used to "automatically collect and analyze data for sleep parameters," "analyze circadian rhythms," and "assess activity," which are diagnostic purposes. The retrieved data is displayed and stored for "future reference and comparison," implying its use in diagnosis and monitoring of conditions related to these parameters.

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 buzzer. While it uses software (Actiware-Sleep) for data management, the core medical device is a piece of hardware.

Based on the provided text, the Actiwatch-Score® is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Actiwatch-Score® Function: The Actiwatch-Score® measures and records physical activity and allows for subjective score entry. It does not analyze biological specimens.
  • Intended Use: The intended use focuses on analyzing circadian rhythms, sleep parameters, and general physical motion. This is related to physiological function, not the analysis of in vitro samples.
  • Device Description: The description details the use of an accelerometer to measure motion and a score pad for subjective input. There is no mention of handling or analyzing biological samples.

Therefore, the Actiwatch-Score® falls outside the scope of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Actiwatch-Score® is a compact, lightweight, wrist-worn activity monitor that can be used to analyze circadian rhythms, automatically collect and analyze data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable. In addition, the Actiwatch-Score® has a built-in score pad that allows the subject to subjectively assign and enter a score from 0 to 9. The score pad can be used as a substitute or in addition to the traditional patient diary used in conjunction with activity monitoring.

Product codes

GWQ

Device Description

The Actiwatch-Score® 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-Score@is intended for the measurement, storage, and analysis of body activity. The Actiwatch-Score@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 Actiwatch-Score® to collect data. This program is called Actiware-Sleep and runs on an IBM-compatible personal computer (PC). The major functions of Actiware-Sleep are to create a patient score schedule, 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-Score® 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-Score@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. In addition, the patient self-score data are stored as integer values within memory.

Pertinent physical characteristics of the Actiwatch-Score®:
Size: 37x35x10 mm
Weight: 25 grams
Battery type: CR 2025 coin cell
Battery life: 6 months, typical
Accelerometer sensitivity:

§ 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

Mini-Mitter Co, Inc.

JUN 23 1999

510(k) Premarket N Actiwatch-Score® March 26, 1999

10.0 510(K) SUMMARY

10.1 Summary Information

10.1.1 Submitter's Name and Address

Jack E. McKenzie, Ph.D.

Mini-Mitter Co., Inc.

P.O. Box 3386

Sunriver, Oregon 97707

Date summary was prepared:

March 26, 1999

10.1.2 Name of Device

Actiwatch-Score® Trade Name: Common Name: Activity Recording Device System, Telemetry, Physiological Signal Conditioner Classification Name:

10.1.3 Identification of predicate device

Number K983533 - Wrist Actigraph - Mini Mitter Co., Inc. - Product Code GYE

1

510(k) Premarket Notification Actiwatch-Score® March 26, 1999

10.1.4 Device Description

Functions of the device 10.1.4.1

The Actiwatch-Score® 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-Score@is intended for the measurement, storage, and analysis of body activity. The Actiwatch-Score@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 Actiwatch-Score® to collect data. This program is called Actiware-Sleep and runs on an IBM-compatible personal computer (PC). The major functions of Actiware-Sleep are to create a patient score schedule, 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-Score® and the PC. The Actiwatch® Reader is connected to the serial communications port of the PC via a standard 9-conductor RS-232 cable.

10.1.4.2 Basic scientific concepts

The Actiwatch-Score@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. In addition, the patient self-score data are stored as integer values within memory.

2

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ParameterValue
Size37x35x10 mm
Weight25 grams
Battery typeCR 2025 coin cell
Battery life6 months, typical
Accelerometer sensitivity
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Division of General Restorative Devices
510(k) NumberK991033