SNORING CONTROL DEVICE

K963591 · Kenneth Hilsen · LRK · Jan 9, 1998 · Dental

Device Facts

• Record ID: K963591
• Device Name: SNORING CONTROL DEVICE
• Applicant: Kenneth Hilsen
• Product Code: LRK · Dental
• Decision Date: Jan 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anti-Snoring Device is intended to alleviate or correct snoring.

Device Story

The Hilsen Anti-Snoring Device is an oral appliance designed to alleviate or correct snoring. It is intended for prescription use. The device functions by physical positioning of oral structures to maintain airway patency during sleep. It is used by patients in a home setting. The healthcare provider evaluates the patient's snoring condition and prescribes the device to improve sleep quality and reduce snoring-related disturbances.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oral appliance for snoring control. Mechanical design; no electronic components, software, or energy source.

Indications for Use

Indicated for individuals who snore to alleviate or correct snoring.

Regulatory Classification

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.

Special Controls

*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.”

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Kenneth Hilsen
Mr. Stephen E. Feldman
C/O Law Office of Stephen E. Feldman, P.C.
12 East 41st Street
New York, New York 10017

Re: K963591
Trade Name: Snoring Control Device
Regulatory Class: Unclassified
Product Code: LRK
Dated: October 17, 1997
Received: October 21, 1997

Dear Mr. Hilsen:

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

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Page 2 - Mr. Hilsen

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.

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,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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1-06-1998 5:25PM FROM
P. 2

# EXHIBIT 5

Page 1 of 1

510(k) Number (if known): Not Known

Device Name: Hilsen Anti-Snoring Device

Indications For Use:

The Anti-Snoring Device is intended to alleviate or correct snoring.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rouse

(Division Sign-Off)

Division of Dental, Infection Control

and General Hospital Devices

510(k) Number R90359

Prescription Use ☑

(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)