EASYNET BODY POSITION MODULE

K040932 · Cadwell Laboratories, Inc. · LEL · Jul 1, 2004 · Neurology

Device Facts

• Record ID: K040932
• Device Name: EASYNET BODY POSITION MODULE
• Applicant: Cadwell Laboratories, Inc.
• Product Code: LEL · Neurology
• Decision Date: Jul 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2

Intended Use

The Cadwell Easy Body Position Module is intended for use to detect body positions during physiological recording. It provides output data that corresponds to five body positions (supine, prone, left side, right side and sitting up). It may be used in a clinical or ambulatory setting for both EEG and sleep disorder studies.

Device Story

EasyNet Body Position Module detects patient body position during physiological monitoring; inputs processed to identify five positions: supine, prone, left side, right side, sitting up. Used in clinical or ambulatory settings for EEG and sleep studies; operated by clinicians or technicians. Output data integrated into physiological recording systems to assist in sleep disorder diagnosis and clinical decision-making. Device is not fluid-sealed; not for use in explosive atmospheres.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Body position sensor module; provides digital output for five distinct orientations. Designed for integration with physiological recording systems. Not fluid-sealed. Operates in clinical/ambulatory environments.

Indications for Use

Indicated for patients undergoing EEG or sleep disorder studies requiring body position monitoring. No specific age or gender restrictions. Contraindications: None. Not for life-supporting or life-sustaining use.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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(JUL 0 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chris L. Bolkan Product Safety and Regulatory Specialist Cadwell Laboratories, Inc. 909 N. Kellogg Street Kennewick. Washington 99336

Re: K040932

Trade/Device Name: EasyNet Body Position Module Regulation Number: 21 CFR 868.2375, Unclassified Regulation Name: Breathing frequency monitor, Sleep assessment device Regulatory Class: II Product Code: MNR and LEL Dated: March 17, 2004 Received: April 27, 2004

Dear Mr. Bolkan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Chris L. Bolkan

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

| 510(k) Number: | K040932 |
|----------------|---------|
|----------------|---------|

Device Name: EasyNet Body Position Module

Indications for use: The Cadwell Easy Body Position Module is intended for use to detect body positions during physiological recording. It provides output data that corresponds to five body positions (supine, prone, left side, right side and sitting up). It may be used in a clinical or ambulatory setting for both EEG and sleep disorder studies.

- Contraindications: No absolute contraindications
- Precautions: This product is for diagnostic purposes only and is not to be used in a life supporting or life-sustaining situation.

Warnings: The Easy Body Position Module is NOT sealed against the ingress of fluids. Do not bathe while wearing the module. Do not use if wet.

Not for use in the presence of explosive atmosphere or flammable anesthetics

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** k040932