ACTIWATCH

K983533 · Mini-Mitter Co., Inc. · GWQ · Mar 23, 1999 · Neurology

Device Facts

• Record ID: K983533
• Device Name: ACTIWATCH
• Applicant: Mini-Mitter Co., Inc.
• Product Code: GWQ · Neurology
• Decision Date: Mar 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Indications for Use

The Actiwatch® is designed for documenting physical movements associated with applications in physiological monitoring. The Actiwatch® is intended for the measurement, storage, and analysis of body activity. The Actiwatch® can be attached to the subjects limb or trunk and through the use of an accelerometer, motion is measured, the activity is stored within the device. The Actiwatch® comes with its own software for data processing and display.

Device Story

Actiwatch is a compact, wrist-worn, battery-operated activity monitor; utilizes an internal accelerometer to detect and measure limb or trunk motion; integrates amplitude and speed of motion to produce activity counts; stores data in on-board memory. Device is set up and data is retrieved via a reader interface connected to an IBM-compatible PC running Sleepwatch software. Software programs the device, downloads stored activity counts, displays data, and stores records for analysis. Used by clinicians to document physical movement, analyze circadian rhythms, and score sleep parameters. Provides objective activity data to assist healthcare providers in physiological monitoring and clinical decision-making.

Clinical Evidence

Bench testing only. Sensitivity to motion was validated using a DC motor-driven lever to produce uniform simple harmonic motion; activity counts were compared against calculated maximum acceleration across a range of 0.01 g to 10 g. Inter-device variability was assessed using a sample of five devices, demonstrating minimal variation in the 1G range typical of human movement.

Technological Characteristics

Dimensions: 37x29x9 mm; Weight: 17g. Materials: Titanium frame/battery cover, polycarbonate frame cover, nylon wrist band. Sensing: Accelerometer (sensitivity <0.01 g-force). Energy: CR 2025 coin cell battery. Memory: 16 KB (AW-16) or 64 KB (AW-64). Connectivity: RS-232 serial interface via Actiwatch Reader. Sampling: 2 seconds to 15 minutes. Water resistant.

Indications for Use

Indicated for use as an ultra-compact, lightweight, wrist-worn activity and ambient light monitor 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.

Regulatory Classification

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.

Predicate Devices

• Mini-Motionlogger Actigraph (K854030)

Submission Summary (Full Text)

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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

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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.

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### 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 | <.01 g-force |
| Frame and battery cover | Titanium |
| Frame cover | Polycarbonate plastic |
| Wrist band | Nylon with buckle |
| Moisture susceptibility | Water resistant |
| Sampling intervals | 2 seconds to 15 minutes |
| Recording time | 1.4 to 365 days, depending upon epoch |
| Memory | 16 KB in AW-16 |
| | 64 KB in AW-64 |
| Storage Temperature | -10 C to 50 C at 0-95% relative humidity |
| Operating Temperature | 0 C to 40 C |

## 10.2 Statement of intended use

The Actiwatch® is designed for documenting physical movements associated with applications in physiological monitoring. The Actiwatch® is intended for the measurement, storage, and analysis of body activity. The Actiwatch® can be attached to the subjects limb or trunk and through the use of an accelerometer, motion is measured, the activity is stored within the device. The Actiwatch® comes with its own software for data processing and display.

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510(k) Premarket Notification Actiwatch® January 8, 1999

### 10.2.1 Technological characteristics of this device and predicate device

Both the Actiwatch® and the predicate device, Mini-Motionlogger Actigraph, use an accelerometer to detect accelerated motion in the range 0.01 g and upwards. The Actiwatch® detects motion and measures amount and duration of motion. The Mini-Motionlogger Actigraph is advertised to detect motion and the duration of motion. Each device records data on a computer board and the data can later be downloaded to a PC for analysis and storage. Both devices are battery operated.

#### 10.3 Assessment of Performance Data

#### 10.3.1 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 oneminute 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. Attachment No. 1 shows the results of this test. Motion as low as 0.01 g and as large as 10 g can be measured.

#### 10.3.2 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. The results are shown in Attachment No. 2. 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1999

Jack E. McKenzie, Ph.D. Vice President of Market Development Mini Mitter Company, Inc. P.O. Box 3386 Sunriver, Oregon 97707

Re: K983533 Trade Name: Actiwatch® Regulatory Class: II Product Code: GWQ Dated: January 8, 1999 Received: January 12, 1999

Dear Dr. McKenzie:

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 regulations affecting your device can be found in the Code of Federal Regulations, 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 Regulation (QS) for Medical Devices: General regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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 - Jack E. McKenzie, 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia 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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Mini-Mitter Co., Inc.

510(k) Premarket Notification Actiwatch® January 8, 1999

## INDICATIONS FOR USE 2.0

| 510(k) Number (if known): | K983533 |
|---------------------------|------------|
| Device Name: | Actiwatch® |

## 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.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span> <span style="text-decoration: overline;">X</span> </span> </div> | OR | Over-The-Counter Use | |
|--------------------------|-------------------------------------------------------------------------------|----|----------------------|--|
| (Per 21 CFR 801.109) | | | | |
| (Optional Format 1-2-96) | | | | |


| (Division Sign-Off) |
|-----------------------------------------|
| Division of General Restorative Devices |

K983533510/k) Numbe