SONA PILLOW by SLEEP DEVICES, INC.

This document is a marketing clearance letter from the FDA for the Sona Pillow, classifying it as an intraoral device for snoring and obstructive sleep apnea. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot provide the requested information based on the input document.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2004

Sleep Devices, Inc. c/o Najeeb A. Zuberi, M.D. President and CEO 720 West Oak Street, Suite 210 Kissimmee, FL 34741

Re: K040161 Trade/Device Name: Sona Pillow Regulation Number: 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: MYB Dated: April 19, 2004 Received: April 23, 2004

Dear Dr. Zuberi:

This letter corrects our substantially equivalent letter of April 30, 2004 regarding the Sona Pillow regulatory classification. At the time of that letter, FDA incorrectly classified the Sona Pillow, as indicated, as an unclassified device. This device is classified under 872.557, Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. The product code will remain as MYB.

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 (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 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.

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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.

This letter will allow you to continue 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Alolph forental

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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, SONA PILLOW ,

INDICATIONS OF USE

510 K 040161 DATED: 4-16-04

· INDICATIONS OF USE OF THE SONA PILLOW; THESE ARE TILE . .

1- MAY STOP OR DECREASE SNORING

2- MAY BE USED TO TREAT MILD OBSTRUCTIVE SLEEP APNEA

3- MAY IMPROVE THE QUALITY OF SLEEP

Karen Salmansohn

(Division Sign-Off) Division of Ophthalmic E Nose and Throat Devis

510(k) Number K040161

Over-the-Counter Use

Regulation Number and Section

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”