DR GREENBURGS HYBRID VACUUM

K120372 · Always More Marketing, Inc. · LRK · Jun 27, 2012 · Dental

Device Facts

• Record ID: K120372
• Device Name: DR GREENBURGS HYBRID VACUUM
• Applicant: Always More Marketing, Inc.
• Product Code: LRK · Dental
• Decision Date: Jun 27, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dr Greenburgs Hybrid Vacuum Snoring Device is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea.

Device Story

Removable intraoral device; two-piece upper and lower arch tray system; includes elastic component connecting trays posteriorly. Principle: mandibular advancement and tongue retention; elastic impedes tongue from falling back into airway; trays posture lower jaw forward to increase airway passage opening. Used at home or sleep laboratories; patient-operated. Front opening allows emergency breathing. Non-allergenic, latex-free silicone elastic; copolyester trays. Output: physical repositioning of jaw and tongue. Benefit: reduction of snoring and breathing arrests due to obstructive sleep apnea.

Clinical Evidence

Clinical evidence provided via Jonathan Greenburg's Sleep Study Table illustrating patient improvement in sleep apnea disease. Literature review (SLEEP, Vol. 29, 2006) cited to support historical significance and efficacy of oral appliances for snoring and OSA management, noting they are well-tolerated and effective for mild to severe OSA.

Technological Characteristics

Two-piece intraoral tray system; copolyester trays; non-allergenic, latex-free silicone elastic component. Mandibular advancement and tongue retention principle. Dimensions/form factor: custom-fitted arch trays. No electronic components, software, or energy source.

Indications for Use

Indicated for persons 18 years or older to reduce snoring and/or 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.”

Predicate Devices

• Dr Greenburgs Hybrid (K111680)
• SomnoGuard (K061688)
• Respire Blue Series (K111207)
• Full Breath (K091035)
• Silent Nite (K972424)
• EMA (K971794)

Submission Summary (Full Text)

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K120372

Always More Marketing Inc 4535 W. Sahara Ave, Ste. 200 Las Vegas, Nevada 89102 818 414 4817 [e-mail]

JUN 2 7 2012

# 510(k) SUMMARY

Summary Prepared on 2-3-2012

### Contact Person:

Jonathan Greenburg DDS President Always More Marketing Inc 4535 W. Sahara Ave, Ste. 200 Las Vegas, Nevada 89102 818 4144817 [e-mail]

Name of Device: Dr Greenburgs Hybrid Vacuum

Common or Usual Name: Anti-Snoring and Apnea Device

Classification Name: Anti-Snoring Device (21CFR872.5570)

Product Code: LRK

## Predicate Devices:

Dr Greenburgs Hybrid (K111680) SomnoGuard (K061688) Respire Blue Series (K111207) Full Breath (K091035) Silent Nite (K972424) EMA (K971794)

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Always More Marketing Inc 4535 W. Sahara Ave, Ste. 200 Las Vegas, Nevada 89102 818 414 4817 [e-mail]

### Description of the Device:

The Dr Greenburgs Hybrid Vacuum Anti-Snoring Device is a removable intraoral device for
replainle times in reports a routed is riyond vacum Anti-Snoring Device is a removable intraoral device for
repositioning the upper and lower jaw into a prescribed relationship for a single pat multiple times at home or sleep laboratories a
multiple times at home or sleep laboratories.

The Dr Greenburgs Hybrid Vacuum Device is a two piece, upper and lower arch tray system that
includes an additional elastic component which impedes the tongue from of the st includes an additional elastic component which impedes the tongue from falling back they system to
includes an additional elastic component which impedes the tongue from the airvay stem is designed to posture the lower journal from falling back into have in the ray system that into have in the back into he the intent to increase the airway passage opening, while several elimity back into the
the intent to increase the airway passage opening, while component adds in keeping the arreac the arway passage opening, while the additional elastic componentialistic componential

The combined effect of the advancement of the lower jaw, and the elast intending the tongue and the concert of the advancement of the lower jaw, and the elastic impeding the tongue
from falling back into the airway reduces snoring and breathing arrests due to obstr

Dr Greenburgs Hybrid Vacuum has a front area opening that is large enough for emergency
breathing.

Dr Greenburgs Hybrid Vacuum Snoring appliance consists of two independent trays (Top and
Bottom), and an elastic that is connected between the trave least of any and Bottom), and an elatic that is connected between the independent trays (Top and
Dotton), and an elatic that is connected between the tays located posterioriy. The trays cons of The Jan of State mail scoluted, copolyester that gives strength and studio and structures of the crays consisted on the clays of the class of the elastic consisted suppor The eastic onsists of a non-allergenic, atex free silion of Charles stress are a supe consistent and supply of the elastic of alse sonsellers tral a bays constructures from m molar and toneals of a lon-allergence to imped the silicone. The elage strenches from molar a
the arrosy. The flexibility of the elastic the elague from falling back into the comments at the fishing the elatic allows movement of the tongue, as as are lioning to the tonger, and more the ling lines more the ling lines and and on for. The friedioniny of the helps to prevent any tonguointention. The results is weller in swaller in swaller in swallering in swallering e and the includess slicone helps to prevent any tonges inting in swallowing
elastic is held firmly onto the bottom tray via securing buttons and is locked securely between

The top and bottom trays alignment are determined by the length connecting bands that are
fer and see the attached via buttons on the sides of the top and bottom trays. This system moves the fact a
forward to achieve the most the top and bottom trays. This system moves the jaw forward to achieve the most the sides of the top and be

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### Always More Marketing Inc . 4535 W. Sahara Ave, Ste. 200 Las Vegas, Nevada 89102 818 414 4817 [e-mail]

Indications for Use: Dr Greenburgs Hybrid Vacuuniining
years or older, who wish to reduce the include of snoring Device in indicated for persons 18
apnear of the may of e would be for Use: Dr Greenburgs Hybrid Vacuum Anti-Snoring Device is indicated for persons 18
years or older, who wish to reduce the incidence of snoring and/or mild to mo

erate obstructive sleep

Technological Characteristics: Dr Greenburgs Hybrid Vacuum device has the following to
sane intended use. similarities to the previously cleared predicate devices:
Same intended use. Same intended use. Same operating principle.

Same technology.

technology.
Same

Same manufacturing process.

All of the predicates and Dr Greenburgs Hybrid Vacuum act as mandibular repositioners for the
treatment of snoring and mild to moderate Obstructive Sleep Appea and as and predicates and Dr Greenburgs Hybrid Vacuum act as mand.
Dr Greenburgs and mild to moderate Obstructive Sleep Apnea.

Dr Greenburgs Hybrid Vacuum, the Full Breath (K091035), and Dr Greenburgs Hybrid
(K111680) all have tongue retaining components. (K111680) all have tongue retaining components.

Dr Greenburgs Hybrid Vacuum, the Silent Nite (K972424) EMA (K971794) and Dr Greenburgs
g, 1 Hybrid (K111680) use straps/bands held onto button attachments.

Substantial Equivalence is based on non-clinical data.

In addition the 1:

In addition the literature supports the historical significance of oral devices that reposition the
m jaw and reduce and manage supports the historical significance.
Th

The Abstract Oral Appliances for Snoring and
Vol. 20, No. 1

The Abstract Oral Appliances for Snoring and Obstructive Steep Apnea: A Review from SLEEP,
Vol. 2, 2006 Page 259 states. .. "Oveructive Steep Apnea: A Review OS A l Vol. 2018 States Off Shoring and Obstructive Sleep Aprea: A Review from SLE
Vol. 2, 2006 Page 239 states... "Overall, those with mild to severe OSA have a 52%.
effective than - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - e flective than CPAP but may be better accepter asing an mina to severe OSA have a s 2020.
e ffective than CPAP but may be better accepter asmassus and be wholes where subjects used both teatments." Also, "They are well the student of the student of the student were word on word of while where
literature now provides evidence for the treame like and bour treatments." Also, "They are well tolerated by most patients" were world world world wos world world world wouldned world wouldned world model bedished
Downloa

Based on clinical data, it is demonstrated in a...

Based on clinical data, it is demonstrated in a variety of articles that looked at oral appliances
and their use for the treatment of snoring and sleep apnea, oral appliance and the similar data, it is demonstrated in a variety of articles that looked at oral appliances
and the treatment of snoring and sleep and sleep annel opliance therapy is a means as as as the treating and sleep of a ticles mat looked at oral appliances
means by which these conditions can be managed. This effectiveres is embraced from a variety of any by Miron these conditions can be managed.
of aspects including safety, convenience and cost.

Clinical data provided (Jonathan Greenburg's Sleep Study Table) illustrates patients can improve
their sleep apnea disease significantly if they use an intraoral anti-sporin the are and proviced (Johannan Oreenburg's Sleep Study Table) illustrates patients can improve
their sleep apnea disease significantly if they use an intraoral anti-snoring

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Always More Marketing Inc 4535 W. Sahara Ave, Ste. 200 Las Vegas, Nevada 89102 818 414 4817 [e-mail]

A risk assessment concluded that there were no new safety concerns raised by the design of Dr Greenburgs Hybrid Vacuum.

In conclusion, a number of studies have shown improvement of the airway during sleep utilizing imaging associated with the use of oral appliances (also referred to as Oral Airway Dilators), aid in the management and reduction of spensand (also reprea. In addition the clinical data that was provided (Jonathan Greenburg's Sleep Study illustrates patients can improve their sleep apnea disease significantly if they use an intractly intestates patients can improve ther sizes and asease
s significantly if they use an intraoral anti-snoring device with a tongue retain

In summary, the device described in this submission is substantially equivalent to the predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of a stylized eagle with its wings spread. The eagle is facing to the right.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUN 2 7 2012

Jonathan Greenburg, DDS President Always More Marketing, Incorporated 4535 West Sahara Avenue, Suite 200 Las Vegas, Nevada 89102

Re: K120372

Trade/Device Name: Dr Greenburgs Hybrid Vacuum 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: May 29, 2012 Received: June 5, 2012

Dear Dr. Greenburg:

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 Eederal Register.

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Page 2- Dr. Greenburg

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 (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.

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/CDRH/CDRHOffices/ucm115809.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 yours,

ph 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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Klao372

## Indications for Use

510(k) Number (if known):

Device Name: Dr Greenburgs Hybrid Vacuum

Indications For Use:

The Dr Greenburgs Hybrid Vacuum Snoring Device is indicated for persons 18 years or older,

who wish to reduce the incidence of snoring and/or mild to moderate

# obstructive sleep apnea

Image /page/6/Picture/8 description: The image shows the words "Prescription Use (Part 21 CFR 801 Subpart D)" on the left side of the image. On the right side of the image, there is a box with a check mark inside of it. The box is outlined in black, and the check mark is also black. The check mark is large and bold.

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Luang

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

Page 1 of

510(k) Number:

) Number: