NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION

K041184 · Nti-Tss, Inc. · LRK · May 3, 2005 · Dental

Device Facts

• Record ID: K041184
• Device Name: NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION
• Applicant: Nti-Tss, Inc.
• Product Code: LRK · Dental
• Decision Date: May 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the treatment of snoring and mild to moderate obstructive sleep apnea.

Device Story

The SnoreHook Discluder is an intraoral device designed to treat snoring and mild to moderate obstructive sleep apnea. It functions by positioning the mandible to maintain airway patency during sleep. The device is intended for use by patients under the guidance of a healthcare provider. It serves as a mechanical intervention to reduce airway obstruction, thereby potentially improving sleep quality and reducing snoring symptoms.

Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

Technological Characteristics

Intraoral device for snoring and obstructive sleep apnea (Regulation 872.5570, Product Code LRK). Mechanical design for mandibular positioning.

Indications for Use

Indicated for patients with snoring and mild to moderate obstructive sleep apnea.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 3 2005

Dr. James P. Boyd CEO NTI-TSS. Incorporated 5327 La Glorieta P.O. Box 2145 Rancho Santa Fe, California 92067-2145

Re: K041184

Trade/Device Name: SnoreHook Discluder Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: April 14, 2005 Received: April 14, 2005

Dear Dr. Boyd:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your early he 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to actric Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin approvisions of the Act. The general controls provisions of the Act include controls provisions of an annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III If your device is elassired (Size h additional controls. Existing major regulations affecting (1 MA), it may of subject to Backed of Federal Regulations. Title 21, Parts 800 to 898. In your device can oo found in ther announcements concerning your device in the Federal Register.

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## Page 2 - Dr. Boyd

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 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/industry/support/index.html.

Sincerely vours,

Jenette y. Michie Dms.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K041184

Indications for Use

510(k) Number:

k0441184

Device Name:

SnoreHook Discluder

Indications for use:

1. For the treatment of snoring and mild to moderate obstructive sleep apnea.

Prescription Use (Part 21 CFR 801 Subpart D)

1. 4. 4. 1. . . . . . . . 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)

Kea Rubey for MSR

ivision Sign-Off) Division of Anesthesiology, General Hospital, Infaction Control. Dental

510(k) Number: K041184

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