(86 days)
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.
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.
Acceptance Criteria and Study for Actiwatch-Score®
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Actiwatch-Score® device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes two key performance aspects for the Actiwatch-Score® related to its new "score" feature:
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Audible Signal Timing | 100% timing agreement with a standard chronograph for alerting the patient to enter a score. | Tested using a schedule where the device alerted every 15 minutes. The Actiwatch-Score® audible alarm was in 100% timing agreement with the chronograph standard. (Pass) |
| Patient Score Recording Accuracy | No errors or disagreement between entered scores and recorded scores. | Tested by programming the device to beep hourly from 12:00 noon to 21:00. A score was entered for each beep. Data was downloaded, and recorded scores were compared to entered scores. No errors nor disagreement were noted between the entered scores and the recorded scores. (Pass) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- Audible Signal Timing: "a device" (singular) was used.
- Patient Score Recording Accuracy: "An Actiwatch-score" (singular) was used.
- Data Provenance: The studies appear to be prospective internal validation tests conducted by the manufacturer, Mini-Mitter Co., Inc. The country of origin is implicitly the USA, where Mini-Mitter Co., Inc. is located.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- No external experts are mentioned for establishing ground truth for these specific tests.
- For the audible signal timing test, the ground truth was established by a chronograph standard.
- For the patient score recording accuracy test, the ground truth was the manually entered scores by a tester.
4. Adjudication Method for the Test Set:
- None explicitly stated or implied. The tests relied on direct comparison to a timing standard (chronograph) or the known input of a score.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. The document focuses on the technical functionality of the device's new scoring feature, not on human-in-the-loop performance or comparison with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Yes, the described tests are essentially standalone performance evaluations of the device's ability to accurately time its alerts and record user input. There is no human interpretation of data involved in the evaluation of these specific functionalities.
7. The Type of Ground Truth Used:
- Audible Signal Timing: Mechanical/digital standard (chronograph).
- Patient Score Recording Accuracy: Known user input/entered data.
8. The Sample Size for the Training Set:
- The document does not mention any training set or machine learning components for the described functionalities. The device's core function of sensing motion is based on an accelerometer, and the new score feature involves timing and data storage, which are deterministic operations.
9. How the Ground Truth for the Training Set Was Established:
- Since no training set is mentioned, this information is not applicable.
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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
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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.
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ﺑﻌﺪ ﻣﻨﻪ ﻭﻳﺴﻤﻰ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
| Parameter | Value |
|---|---|
| Size | 37x35x10 mm |
| Weight | 25 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 | 15 seconds to 15 minutes |
| Recording time | 5 to 340 days, depending upon epoch |
| Storage Temperature | -10 C to 50 C at 0-95% relative humidity |
| Operating Temperature | 0 C to 40 C |
Pertinent physical characteristics of the Actiwatch-Score®: 10.1.4.3
10.2 Statement of 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.
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510(k) Premarket Notification Actiwatch-Score® March 26, 1999
10.3 Technological characteristics of this device and predicate device
· Both the Actiwatch-Score® and the predicate device, Actiwatch®, use an accelerometer to detect accelerated motion in the range 0.01 g and upwards. The Actiwatch-Score® detects motion and measures amount and duration of motion. The Actiwatch® also detects motion and the duration of motion. Each device records data and the data can later be downloaded to a PC for analysis and storage. Both devices are battery operated.
10.4 Assessment of Performance Data
The Actiwatch-Score® audibly signals the patient to enter a self-score in accordance with a pre-arranged score schedule. The signal is a beep provided by an on-board digital buzzer. The device must consistently send the audible signal to the patient to enter his/her score on time. To test this timing capability, a device was programmed with a score schedule that alerted the subject to enter a score every 15 minutes. A chronograph was used as a timing standard in a sideby-side test to determine the device timing capability. The results of this test are shown in Attachment 1. The horizontal axis is the timing schedule while the vertical axis is the response result. The Actiwatch-Score® audible alarm was in 100% timing agreement with the chronograph standard.
In addition to the score timing test, the device was also tested to determine the accuracy with which it records patient scores. An Actiwatch-score was programmed to beep an alarm once per hour beginning at 12:00 noon and ending at 21:00. For each hour's beep, a score was entered. The data were downloaded at the end of the session and the recorded scores compared to the entered scores. Results of this test are shown in Attachment No. 2. No errors nor disagreement were noted between the entered scores and the recorded scores.
10.5 Patient Scoring Schedule
A standard default scoring schedule appears during setup and this schedule can be programmed into the device.Alternatively, during device setup, a patient scoring schedule can be
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Mini-Mitter Co, Inc.
. . . . .
510(k) Premarket Notification Actiwatch-Score® March 26, 1999
: 、
created or loaded from PC storage and programmed into the device. A typical scoring schedule is shown in Attachment 3.
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Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1999
Jack E. McKenzie, Ph.D. Vice President of Market Development Mini-Mitter Company, Inc. P.O. Box 3386 56885 Enterprise Drive Sunriver, Oregon 97707
Re: K991033 Trade Name: Actiwatch-Score® Regulatory Class: II Product Code: GWQ Dated: March 26, 1999 Received: March 29, 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 (301) 594-4595. 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,
Colin M. Wittner, 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-Score® March 26, 1999
2.0
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Actiwatch-Score®
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use ______ |
|---|---|---|---|
| (Per 21 CFR 801.109) | |||
| (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K991033 |
§ 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).