APNEA GUARD

K111110 · Advanced Brain Monitoring, Inc. · LRK · Jul 22, 2011 · Dental

Device Facts

• Record ID: K111110
• Device Name: APNEA GUARD
• Applicant: Advanced Brain Monitoring, Inc.
• Product Code: LRK · Dental
• Decision Date: Jul 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apnea Guard is a mandibular repositioning device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older. The Apnea Guard is intended to be fitted with assistance from a healthcare professional, and used during sleep for less than 30-nights.

Device Story

Apnea Guard is a temporary, single-patient, multi-use mandibular repositioning device (MRD) for snoring and mild to moderate OSA. Device consists of interlocking upper and lower trays filled with silicone impression material; fitted to patient by healthcare professional. Mechanism involves manual advancement of mandible to maintain airway patency during sleep. Used in home, dental/physician offices, sleep labs, or hospitals. Intended for short-term use (<30 nights). Healthcare providers use device to provide non-invasive airway support; patient benefits from reduced AHI, hypoxemia, and snoring.

Clinical Evidence

Prospective IRB-approved study of 18 patients comparing Apnea Guard to predicate. Primary endpoints included Apnea Index, Apnea-Hypopnea Index (AHI), hypoxemia, snoring, and sympathetic arousals. Results showed statistically significant reduction in overall and supine AHI, with 56% and 63% of patients respectively showing >50% reduction. Performance found equivalent to predicate in reducing sleep-disordered breathing and associated symptoms.

Technological Characteristics

Mandibular repositioning device; silicone impression material; manual protrusion adjustment with clip locking mechanism. Biocompatibility tested per ISO 10993-1. Bench testing evaluated tray design, strength, compression, extension, collapse, impression material retention, and temperature stability. One-size-fits-all form factor.

Indications for Use

Indicated for patients 18 years and older with snoring or mild to moderate obstructive sleep apnea (OSA). Contraindicated for patients with loose or infected teeth, temporary crowns or fillings, or TMJ dysfunction.

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.”

Predicate Devices

• Airway Management – TAP III (K062951)

Submission Summary (Full Text)

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# 111110

## JUL 2 2 2011

| 510(k) Summary<br>Page 1 of 4<br>12-Jul-11 | | JUL 22 2011 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Company | Advanced Brain Monitoring, Inc.<br>2237 Faraday Avenue, Suite 100<br>Carlsbad, CA 92008<br>Tel - [phone]<br>Fax - [phone] | |
| Official Contact: | Daniel J. Levendowski | |
| Proprietary or Trade Name: | Apnea Guard | |
| Common/Usual Name: | Device, anti-snoring<br>Intraoral devices for snoring and intraoral devices for snoring<br>and obstructive sleep apnea | |
| Classification / CFR: | LRK - CFR 872.5570 | |
| Device: | Apnea Guard | |
| Predicate Devices: | K062951 - Airway Management – TAP III | |

## Device Description:

The Apnea Guard is a Mandibular Repositioning Device (MRD) which consists of interlocking upper and lower trays filled with silicone retention material fitted to the patient. The useful life of the retention material will limit the Apnea Guard's used to a temporary appliance, less than 30 days. The trays are locked into a position that advances the mandible for the treatment of snoring and / or obstructive sleep apnea. The one-size-fits-all appliance is able to accommodate the full range of dental etiologies, including wide and narrow arches, missing or compromised teeth and gums, etc.

## Indications for Use:

The Apnea Guard is a mandibular repositioning device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older. The Apnea Guard is intended to be fitted with assistance from a healthcare professional, and used during sleep for less than 30-nights.

## Patient Population:

Patients 18 years or older who snore or have mild to moderate obstructive sleep apnea (OSA)

## Environment of Use:

Home, dental and physician offices, sleep laboratories as well as hospitalized patients where the Apnea Guard may be appropriate.

## Contraindications:

Missing. Loose, infected teeth, Temporary crowns or fillings, TMJ

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| Comparison of Proposed Device vs. Predicate | | |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| | Apnea Guard | Airway Management<br>TAP III - K062951 |
| Attributes | | |
| Indications for Use | The Apnea Guard is a mandibular<br>repositioning device intended to reduce or<br>alleviate snoring and mild to moderate<br>obstructive sleep apnea (OSA) in patients<br>18 years and older. The Apnea Guard is<br>intended to be fitted with assistance from a<br>healthcare professional, and used during<br>sleep for less than 30-nights. | To reduce or alleviate night time snoring<br>and mild to moderate obstructive sleep<br>apnea (OSA) |
| Environments of use | Home, dental and physician offices, sleep<br>laboratories as well as hospitalized patients<br>where the Apnea Guard may be appropriate. | Home, Dental offices, Sleep laboratories |
| Patient Population | Patients 18 years and older | Adult patients 18 years and older |
| Contraindications | Missing, infected, loose teeth Temporary crowns or fillings Temporomadibular Joint (TMJ) dysfunction | Missing, infected, loose teeth Temporary crowns or fillings Temporomadibular Joint (TMJ) dysfunction |
| Prescription | Prescription use | Prescription use |
| Single patient, multi-use | Yes | Yes |
| Limitation of duration of use | < 30 days | No limitation |
| Design | | |
| Upper and lower trays fitted to the patient | Yes | Yes |
| Tray filled with impression material | Yes | Yes |
| Adjustment method for setting the amount of<br>protrusion | Yes<br>Manual and then held in place with a clip | Yes<br>Screw mechanism |
| Works by holding lower jaw forward | Yes | Yes |
| Cleaned by simple rinsing with water | Yes | Yes |
| Performance | | |
| Materials used | Silicone impression material | Acrylic for trays<br>Dental grade impression material |
| Biocompatibility | Testing according to ISO 10993-1 | |
| Sleep study performance<br>Reduced AHI | Statistically significant reduction in overall and<br>supine position found to be equivalent to<br>custom appliance, 56% and 63% showed > 50%<br>reduction in overall and supine AHI,<br>respectively. | 72% |
| Bench Testing | Environmental, Mechanical, Device specific | |

## Comparison of Proposed Device vs. Predicate

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## Discussion of Substantial Equivalence

The Apnea Guard is viewed as substantially equivalent to the predicate device because:

#### Indications -

Substantially equivalent to predicate -- K062951 -- Airway Management TAP III -- Indicated to reduce or alleviate night time snoring and treat mild to moderate obstructive sleep apnea (OSA).

#### Technology -

Substantially equivalent to predicate - K062951 - Airway Management TAP III - both devices use a separate tray design with a means to adjust the lower jaw. Each is filed with an impression material to assure a tight fit for the user.

## Materials -

The materials in contact with the patient have been tested per ISO 10993.

#### Environment of Use -

Substantially equivalent to predicate - K062951 - Airway Management TAP III - except we have added the use in hospitals and sub-acute care settings which are all under supervised care and observation.

#### Patient Population -

Identical to predicate -Airway Management TAP III - 18 years and older

#### Performance Testing

Bench testing included:

- Design performance was evaluated looking at tray design, strength, compression, . extension and collapse and Locking mechanism
- Impression Material Retention .
- Storage temperature at elevated and low temperatures .
- User fit and comfort evaluation .

#### Clinical testing included:

A sleep study comparing the proposed vs. predicate device was performed. This study included eighteen patients who underwent a prospective IRB approved study. Patients were studied to assess outcomes when compared with the predicate device. Patients successfully complete a two-night Qualification Home Sleep Test (HST). Measurement and recording of Apnea Index, Apnea-Hypopnea Index, Hypoxemia, Snoring, and Sympathetic Arousals was done and compared to the predicate.

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## Conclusions of Performance Testing

The bench demonstrated that the Apnea Guard design and performance meets is design requirements and was found to be equivalent in performance to the predicate for the intended use.

The clinical study with the Apnea Guard demonstrated that it was equivalent to the predicate in reducing sleep disordered breathing, hypoxemia, snoring, and sympathetic arousals in patients with mild to moderate OSA

The Apnea Guard was found to be substantially equivalent and does not raise any new safety or efficacy issues.

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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Advanced Brain Monitoring, Incorporated C/O Mr. Paul Dryden President, Regulatory Consultant Promedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

## JUL 222 2011

Re: K111110

Trade/Device Name: Apnea Guard Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: II

Product Code: LRK Dated: June 28, 2011 Received: June 29, 2011

Dear Mr. Dryden:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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Page 2 - Mr. Dryden

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of · the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CD RH/CDRHOffices/ucm1 l 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Richard C. Chapman for

Anthony D. Watson, B.S., M.S., M.B.A. 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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## Indications for Use Statement

#### KI11110 510(k) Number:

Device Name:

Apnea Guard

Indications for Use:

The Apnea Guard is a mandibular repositioning device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and The Apnea Guard is intended to be fitted with assistance from a healthcare older. professional, and used during sleep for less than 30 nights.

## Environment of Use:

Home, Dental and Physician offices, Sleep laboratories as well as hospitalized patients where the Apnea Guard may be appropriate.

| Prescription Use XX_ | or | Over-the-counter use_ |
|-----------------------------|----|------------------------|
| (Part 21 CFR 801 Subpart D) | | (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)

Sinor Quare

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111110