SLEEP MANAGEMENT SYSTEM

K981844 · Rmp, Inc. · HCC · Aug 7, 1998 · Neurology

Device Facts

• Record ID: K981844
• Device Name: SLEEP MANAGEMENT SYSTEM
• Applicant: Rmp, Inc.
• Product Code: HCC · Neurology
• Decision Date: Aug 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2

Indications for Use

RMP. Inc.'s Sleep Management System is intended to provide sleep assessment.

Device Story

Sleep Management System (SMS) provides sleep assessment; worn on wrist with strap. Device features two electrodes on front face; user places fingers across electrodes to complete circuit. Principle of operation: galvanic skin resistance (GSR) measurement; device detects presence or absence of current flow between electrodes to determine sleep/wake state. Circuitry includes 1.5V battery, clock, memory, and control/routing circuit. User operates device via three function buttons to display time awake or asleep; thumb-activated switch on back. Three-second delay in timing functions allows finger adjustment without mode changes. Output: display of hours/minutes awake or asleep. Intended for use by individuals to monitor sleep habits; provides data for sleep assessment. Benefits include tracking sleep latency and total sleep time.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological characteristics and principles of operation compared to predicate devices.

Technological Characteristics

Plastic case with wrist strap; two recessed electrodes. Sensing principle: galvanic skin resistance (GSR) via finger-completed circuit. Energy source: 1.5V watch battery. Features: digital display, three function buttons, thumb-activated switch, memory, and clock. Current flow: 45-70 microamps. Connectivity: standalone. No software algorithm class specified; device uses basic timing and circuit-based state detection.

Indications for Use

Indicated for sleep assessment, including measurement of sleep latency and total sleep time, to assess current sleep habits.

Regulatory Classification

Identification

A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.

Predicate Devices

• Thought Technology, Ltd.'s GSR2 Relaxation/Biofeedback Monitor
• Ambulatory Monitoring, Inc.'s Actigraph

Submission Summary (Full Text)

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AUG - 7 1998

K981844

# RMP, Inc. Sleep Management System 510(k) Summary

# Submitter's Name, Address, and Telephone Number

Murray Jarman, President RMP, Inc. 716 Sunset Road Boynton Beach, FL 33435 [phone] Telephone: [phone] Facsimile:

## Contact Person

Terry G. Mahn Fish & Richardson PC Suite 500 601 Thirteenth St., NW Washington, DC 20005 [phone] Telephone: [phone] Facsimile:

as Regulatory Counsel to RMP, Inc.

## Date Prepared

May 21, 1998

# Name of Device

Sleep Management System

#### Classification Name

Biofeedback Device

Common Name

Sleep Assessment or Sleep Timer Device

### Predicate Devices

Thought Technology, Ltd.'s GSR2 Relaxation/Biofeedback Monitor Ambulatory Monitoring, Inc.'s Actigraph

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# Intended Use

RMP. Inc.'s Sleep Management System is intended to provide sleep assessment.

# Substantial Equivalence

The Sleep Management System consists of a slender plastic case with front and back faces and a plastic strap. The user wears the strap around his wrist so that the device will not drop to the floor when the user falls asleep. On the front face, the device has a display, three function buttons, and two electrodes. On the back face, the device has a thumb-activated switch. The display shows either minutes and hours awake or asleep. Two of the three function buttons cause either time awake or time asleep to be displayed and the third function button is the stop/reset button.

The two electrodes are located in a recessed section of the front face. The two electrodes form two ends of a circuit. The circuit is completed by placing fingers across the electrodes. The current in the circuit flows through the user's fingers to pass from one electrode to the other electrode. The switch on the back face of the case and the circuit formed between the two electrodes operate the timing function of the device.

The circuitry of the device includes a 1.5 volt watch battery, power supply, clock, alarm, light, memory, delay and a control and routing circuit. The power supply powers the device using the battery's stored energy. The clock times the user's time awake and time asleep. By pressing the various function buttons, the device will display the time awake or asleep. The memory stores the user's time awake and time asleep. The timing functions have a three second delay for switching between functions so that the user can briefly adjust finger positioning without changing modes.

Thought Technology Ltd.'s GSR2 Biofeedback Monitor is intended to diagnose sleeping disorders and provide biofeedback related to relaxation. The device consists of a plastic case with two recessed sections on the front panel, a retention snap, an earphone or meter jack, an electrode or thermistor jack, and a volume control dial on the side. A stainless steel sensing plate resides within each recessed section. The sensing plates are at ends of a circuit.

Ambulatory Monitoring, Inc.'s cleared Actigraph is a wrist watch-like device intended to provide information regarding length and time of sleep and the number of disruptions and their possible source (i.e., sleep disorders). The device has a velcro or plastic wrist strap. It also has a display panel that displays time and indicators as to whether the device is collecting data, is idle, or has a full memory. The device contains an accelerometer to detect motion and memory to store the data generated. The information stored in the device is downloaded so that it can be analyzed by software provided by the company. The software provides statistics for estimated sleep and wake totals, sleep latency, and nap frequency and duration. It also provides information on sleep quality. The statistics are estimated using sleep estimation algorithms.

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The RMP SMS is substantially equivalent to the GSR2 and Actigraph because they have the same intended use and very similar technological characteristics and principles of operation. For instance, the devices are intended to provide sleep assessment, and they provide information regarding time awake and time asleep.

The RMP SMS and the predicate devices consist of a case worn or pressed against the user's wrist or fingers to measure an indicator of sleep. For instance, the RMP SMS and GSR2 use galvanic skin resistance as an indicator of sleep by measuring the current flowing through the user's finger or fingers between the two electrode. The difference between using one or two fingers does not raise new issues of safety or effectiveness because in either instance the current level is very low and will not harm the patient. Moreover, the estimates of time asleep and time awake are based not on the quantity of the current but on the presence or absence of a current flowing between the two electrodes.

The current flowing through the user of the RMP SMS is 45 microamps or 70 microamps maximum. The GSR2 has a 45 microamp current flowing through the user. These currents are very similar in magnitude. The difference in magnitude does not raise new issues of safety or effectiveness because the difference is very small and the total magnitude is also very small. Any other minor technological differences do not raise any new issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 1998

RMP, Inc. c/o Fish & Richardson, P.C. Mr. Terry G. Mahn Regulatory Counsel 601 Thirteenth Street, N.W., Suite 500 Washington, D.C. 20005

Re: K981844 Trade Name: Sleep Management System Regulatory Class: II Product Code: HCC Dated: May 22, 1998 Received: May 26, 1998

Dear Mr. Mahn:

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 - Mr. Terry G. Mahn

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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K981844

Sleep Management System Device Name:

# Indications For Use:

a parti

To provide sleep assessment. For instance, the device can assess current sleep habits by measuring sleep latency and total sleep time.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K981844 |

Prescription Use (Per 21 C.F.R. 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)