RESPIRE BLUE SERIES

K111207 · Respire Medical · LRK · Aug 23, 2011 · Dental

Device Facts

• Record ID: K111207
• Device Name: RESPIRE BLUE SERIES
• Applicant: Respire Medical
• Product Code: LRK · Dental
• Decision Date: Aug 23, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Respire Blue Series is indicated to treat mild to moderate OSA.

Device Story

Respire Blue Series is a custom-made, non-sterile intraoral mandibular advancement device (MAD) for treatment of mild to moderate obstructive sleep apnea (OSA). Device consists of two acrylic dental trays (upper and lower) worn by patient during sleep. Attachment mechanism at 65-degree angle allows jaw movement (opening/closing) while maintaining advancement. Anterior opening facilitates mouth breathing. Available in two configurations: Hard (all acrylic with ball clasps for retention/tightening) or Hard/Soft (dual laminate with soft inner layer). Device is titratable via expansion screw for mandibular positioning. Used in home or sleep laboratory settings; patient-operated. Healthcare provider fits device to patient anatomy. Output is mechanical advancement of mandible to maintain airway patency, reducing snoring and apneic events. Benefits include improved comfort and airway management.

Clinical Evidence

Clinical evaluation and observation results demonstrated success in reducing snoring and apneic events as measured by polysomnograms. Bench testing confirmed all test method acceptance criteria were met, demonstrating equivalent results to predicate devices.

Technological Characteristics

Custom-made intraoral device. Materials: Acrylic (Hard) or dual-laminate acrylic with soft lining (Hard/Soft). Biocompatibility per ISO 7405:2008. Features: Expansion screw for titration, 65-degree attachment angle, anterior opening. Non-sterile. Mechanical operation via mandibular advancement.

Indications for Use

Indicated for adult patients with mild to moderate obstructive sleep apnea (OSA). Prescription use only.

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

• TAP II (K060388)
• Somnomed MAS (K050592)
• Somnomed MAS Flex S (K073004)
• OASYS (K030440)

Submission Summary (Full Text)

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AUG-2 3 2011-

#### MEDICAL REGISTRATION

SECTION 5.....................................................................................................................................................................

#### 510(k) Number K_1207 Submission Owner ーー Respire Medical® LLC 18 Bridge St., Ste. 4J Brooklyn, 11201 NY Phone [phone] Fax [phone] Official Correspondent 2 Sterling Inc. Contact Person Daniela Levy - Regulatory Consultant 607 South Hill st., suite#506 Los Angeles, 90014 CA Phone [phone] Fax [phone] Web www.sterlingmedicalregistration.com 3 Submission Date April 2011 4 Device Trade Name Respire Blue Series 5 Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea (OSA) 6 Classification Device Name Device, Anti-Snoring : Product Code гак . • Regulation No 872.5570 : Class 11 : Panel Dental : 7 Reason for the Premarket Notification Submission : New Device

8 Identification of Legally Marketed Predicate Devices :

- Respire Blue Series is substantially equivalent to TAP II K060388 ; Somnomed . MAS K050592; Somnomed MAS Flex SK073004 ; OASYS K030440 in terms of intended use, indication for use, technological characteristics, performance and user interface. The predicate devices are Class II medical devices.

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#### TERLING ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー

## MEDICAL REGISTRATION

- 9 Device Description
Respire Blue Series is a patented, custom made device for each patient which consists of two dental plates, upper and lower, made of Acrylic.

The attachment is at a 65 degree angle to enable movement of the appliances, thus patient can open and close while wearing the appliances. The appliance is open in the front to add comfort by allowing the patient to inhale and exhale more air per breath.

Respire Blue Series are offered in two options: (1) Hard/Soft which has a dual laminate layer that provides a soft layer on the tooth surface (2) Hard devices which are all acrylic and retained with ball clasps, this allows the device to be tightened if it becomes loose.

- 10 Intended use
- The Respire Blue Series is indicated to treat mild to moderate OSA. .

#### 11 Performance Standards or Special Controls

- Recognized Consensus Standard: ISO 7405:2008 Dentistry Evaluation of . biocompatibility of medical devices used in dentistry

| Substantial Equivalent Table | Respire Blue Series (Hard/Soft Surface) | Respire Blue Series (Hard Surface) | Somnomed MAS | OASYS | TAP II | Somnomed MAS Flex S |
|-------------------------------------------------------|-----------------------------------------|------------------------------------|--------------|---------|---------|---------------------|
| | | | K050592 | K030440 | K060388 | K073004 |
| Intended Use | | | | | | |
| Intended as an intraoral device | YES | YES | YES | YES | YES | YES |
| Intended to reduce snoring or help alleviate snoring | YES | YES | YES | YES | YES | YES |
| Treatment of mild to moderate obstructive sleep apnea | YES | YES | YES | YES | YES | YES |
| Indicated for single patient multi-use | YES | YES | YES | YES | YES | YES |
| Indicated for use at home or sleep laboratories | YES | YES | YES | YES | YES | YES |

#### 12 Substantial Equivalence

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| MEDICAL REGISTRATION | | | | | | |
|-------------------------------------------------------------------------------------------|--------------------------------------------------|---------------------------------------------|-----------------|---------|---------|------------------------|
| Substantial Equivalent Table | Respire Blue<br>Series<br>(Hard/Soft<br>Surface) | Respire Blue<br>Series<br>(Hard<br>Surface) | Somnomed<br>MAS | OASYS | TAP II | Somnomed<br>MAS Flex S |
| | | | K050592 | K030440 | K060388 | K073004 |
| Target population - Adults<br>patients | YES | YES | YES | YES | YES | YES |
| Prescription Device | YES | YES | YES | YES | YES | YES |
| Design | | | | | | |
| Rigid tray pieces | YES | YES | YES | YES | YES | YES |
| Separate tray pieces | YES | YES | YES | YES | YES | YES |
| Custom fit for each patient | YES | YES | YES | YES | YES | YES |
| Works by mandibular<br>advancement | YES | YES | YES | YES | YES | YES |
| Can be adjusted or refit | YES | YES | YES | YES | YES | YES |
| Placed in patient mouth each<br>evening | YES | YES | YES | YES | YES | YES |
| Cleaned daily | YES | YES | YES | YES | YES | YES |
| Easily removed from mouth | YES | YES | YES | YES | YES | YES |
| Lower jaw adjustment using a<br>supplied adjustment key | YES | YES | YES | YES | YES | YES |
| Upper and lower tray unhook for<br>easy removal from mouth | YES | YES | YES | YES | YES | YES |
| Permits patients to breathe through<br>mouth | YES | YES | YES | YES | YES | YES |
| Material | | | | | | |
| Trays constructed from molded<br>hard acrylic and ball clasps | YES | YES | YES | NO | NO | NO |
| Trays constructed from a soft<br>lining material adhered to a hard<br>surface acrylic | YES | NO | NO | NO | NO | YES |
| Trays constructed from a heat<br>sensitive impermissible material<br>for fitting to teeth | NO | NO | NO | YES | YES | NO |
| Non Sterile | YES | YES | YES | YES | YES | YES |

Summary of Equivalence: The Respire Blue Series is considered to be substantially equivalent to TAP II, Somnomed MAS, Somnomed MAS Flex and OASYS devices. As similar to its predicate device Respire Blue Series is a custom made device, consists of two parts, upper and lower trays, made of acrylic. The design differences is that the TAP design holds the jaw in a more fixed position and does not allow for the patient to open and close their mouth, while the Respire Blue Series allow jaw movement and is more comfortable. Respire Blue Series is similar to Somnomed both devices contain expansion screw which enable the device to be titratable and allows simple adjustment and positioning of the device.

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# MEDICAL REGISTRATION

Respire Blue Series enables an anterior opening in the front of the device to allow for patient comfort. The design differences emphasis the advantages of Respire Blue Series technology and thus, raise no new safety and/or effectiveness issues. Respire Blue Series shares the same technological characteristics as its predicate devices and raise no new issues of safety or effectiveness, thus, the Respire Blue Series is substantially equivalent to its predicate devices.

Risk Assessment performance has demonstrated no new safety and/or effectiveness issues.

Bench testing results have demonstrated that all test method acceptance criteria were met and demonstrated equivalent results to the predicated devices. Thus, Respire Blue Series shares similarity with its predicate devices and raise no new safety and/or effectiveness issues.

Clinical evaluation and observation results have demonstrated the success rate of reduction of snoring and the success rate of reduction of apneic events measured by polysomnograms. Thus, Respire Blue Series shares similarity in the indication of use and raise no new safety and/or effectiveness issues.

Conclusion:

As verified by clinical and non clinical data, bench testing and substantial equivalence table, Respire Blue Series shares similarity with its predicated device by term of intended use, raw material and technical design. The fundamental scientific technology of the device is identical or very similar to the referenced predicate devices, thus Respire Blue Series is as safe and effective for its intended use and performs as well the predicate device.

סד

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Respire Medical C/O Ms. Daniela Levy Regulatory Consultant Sterling Incorporated (Sterling Medical Registration) 607 South I-lill Street, Suite 506 Los Angeles, California 90014

AUG 2 3 2011

Re: K111207

Trade/Device Name: Respire Blue Series 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: August 2, 2011 Received: August 3, 2011

Dear Ms. Levy:

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 -- Ms. Levy

Enclosure

Please be advised that FDA is 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/ReportalProblem/default.htm for the CDRFF'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.

Anthony V. Mark

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

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## TERLII MEDICAL-REGISTRATION-

SECTION 4 - Indication for Use Statement

Indications for Use

Indications for Use

9

510(k) Number (if known): KILLZOZ_

Device Name:

Respire Blue Series

Indications for Use:

The Respire Blue Series is indicated to treat mild to moderate OSA.

Prescription Use ✔

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runn

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

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510(k) Number: K111207