SICAT OPTISLEEP

K153291 · Sicat GmbH & Co. KG · LRK · Mar 31, 2016 · Dental

Device Facts

• Record ID: K153291
• Device Name: SICAT OPTISLEEP
• Applicant: Sicat GmbH & Co. KG
• Product Code: LRK · Dental
• Decision Date: Mar 31, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

In adult population - To reduce or alleviate snoring - To reduce or alleviate mild to moderate obstructive sleep apnea (OSA)

Device Story

SICAT OPTISLEEP is a custom-fabricated, removable intraoral mandibular repositioning device. It consists of two splints (maxillary and mandibular) interconnected by exchangeable polyamide connectors of varying lengths. The device is manufactured via CAD/CAM milling at a dental laboratory based on a dentist's or physician's prescription. During sleep, the device maintains the mandible in a forward position, increasing pharyngeal space to reduce mechanical airway obstruction and snoring. The dentist or physician adjusts the degree of mandibular advancement at the time of fitting by selecting appropriate connector lengths. The device is intended for use by adults during sleep and is replaced up to every two years.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, biocompatibility evaluation (ISO 10993 series), and usability testing.

Technological Characteristics

Materials: Polymethylmethacrylate (PMMA) and Polyamide. Principle: Mechanical mandibular repositioning via CAD/CAM milled splints. Connectivity: None (standalone). Sterilization: Not supplied sterile. Adjustment: Exchangeable connectors of varying lengths. Design: Custom-fabricated for individual patient anatomy.

Indications for Use

Indicated for adult patients to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA).

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

• Narval CC (K113201)
• SomnoDent Classic (K050592)

Submission Summary (Full Text)

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

March 31, 2016

Sicat GmbH& Co. KG Dr. Manfred Breuer Head of Quality Management and Regulatory Affairs Brunnenallee 6 Bonn, North Rhine- Westphalia 53177 GERMANY

Re: K153291 Trade/Device Name: SICAT OPTISLEEP 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, LQZ Dated: February 18, 2016 Received: February 19, 2016

Dear Dr. Breuer:

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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K153291 510(k) Number (if known):

Device Name:

SICAT OPTISLEEP

Indications for Use:

In adult population

- · To reduce or alleviate snoring
- To reduce or alleviate mild to moderate obstructive sleep apnea (OSA)

Prescription Use X (Part 21 CFR 801 Subpart D) 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 In Vitro Devices and Radiologic Health (OIR)

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k)________________________________________________________________________________________________________________________________________________________________________

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# 510(k) Summary for SICAT OPTISLEEP

#### Content and format as required by section 21 CFR 807.92

( http://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ HowtoMarket YourDevice/PremarketSubmissions/PremarketNotification510k/ucm142651.htm\

#### 1. SUBMITTER/510(K) HOLDER

SICAT GmbH & Co. KG Brunnenallee 6 53177 Bonn Germany

Establishment Registration Number: 3006098230 Telephone: [phone] Primary Contact: Mr. Dr. Manfred Breuer Secondary Contact: Ms. Dr. Petra Benkel

Date Prepared: Nov. 12th, 2015

#### 2. DEVICE NAME AND DEVICE CLASSIFICATION

| Proprietary Name: | SICAT OPTISLEEP |
|-------------------------|------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Intraoral device for snoring and obstructive sleep<br>apnea |
| Classification Name: | Intraoral devices for snoring and intraoral devices for<br>snoring and obstructive sleep apnea |
| Regulation Number: | 21 CFR 872.5570 |
| Classification Class: | 2 |
| Product Code: | LRK |
| Secondary Product Code: | LOZ |

#### 3. PREDICATE DEVICES

| • Primary Predicate: | Narval CC (K113201) |
|------------------------|-----------------------------|
| • Reference Predicate: | SomnoDent Classic (K050592) |

#### 4. DEVICE DESCRIPTION

SICAT OPTISLEEP is a pure hardware device. It is an oral appliance and will be manufactured by the SICAT dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients.

SICAT OPTISLEEP is fitted on the maxillary and mandibular arch covering all teeth. It consists of two main parts (upper and lower arch each) that are interconnected by exchangeable

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- 5 510(k) Summary
connectors. This device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving the ability to exchange air during sleep by reducing mechanical obstructions of the airway. Further this results in lower tendency to snore. The device has an adjustment mechanism, achieved by exchangeable connectors of different length, to adjust the mandibular advancement to be set by the dentist or physician at the time of fitting. The SICAT OPTISLEEP will be worn only during the sleep. The device will be used before replacement up to two years.

#### 4.1 MATERIAL / PHYSICAL PROPERTIES

The main parts of the device are made of Polymethylmethacrylate. The exchangeable connectors are made of Polyamide.

### 5. INDICATIONS FOR USE

In adult population

- · To reduce or alleviate snoring
- · To reduce or alleviate mild to moderate obstructive sleep apnea (OSA)

### 6. DEVICE COMPARISON TABLE

The following table shows a summary of the intended use, technological characteristics, design and function of SICAT OPTISLEEP and the predicate devices.

| | SICAT OPTISLEEP | Reference Predicate<br>Somnomed MAS RxA (K050592)<br>Last Brand Name: SomnoDent Classic | Primary Predicate<br>Narval CC (K113201) |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Information | | | |
| Product Code | LRK | LRK | LQZ |
| Second<br>Product Code | LQZ | - | - |
| Classification<br>Regulation | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 |
| Device Class | 2 | 2 | 2 |
| Device<br>Classification<br>Name | Device, Anti-Snoring | Device, Anti-Snoring | Device, Jaw-Repositioning |
| Common /<br>Usual Name | Intraoral device for<br>snoring and obstructive<br>sleep apnea. | Mandibular<br>advancement device | Mandibular repositioning<br>device |
| Manufacturer | | | |
| Name | SICAT GmbH & Co. KG | SomnoMed Inc. | ResMed |
| Address | Brunnenallee 6,<br>53177 Bonn,<br>GERMANY | SomnoMed Inc., 20<br>Clarke Street Crows<br>Nest,<br>NSW 2065, Australia | ResMed SAS<br>ResMed Corp.<br>9001 Spectrum Center<br>Boulevard, San Diego, |
| | SICAT OPTISLEEP | Reference Predicate<br>Somnomed MAS RxA<br>(K050592)<br>Last Brand Name:<br>SomnoDent Classic | Primary Predicate<br>Narval CC (K113201)<br>CA 92123, USA |
| | | Indications for Use | |
| | In adult population<br>• To reduce or alleviate<br>snoring<br>• To reduce or alleviate<br>mild to moderate<br>obstructive sleep apnea<br>(OSA) | To reduce night-time<br>snoring and mild to<br>moderate obstructive<br>sleep apnea (OSA) in<br>adults. | The Narval CC is<br>intended to reduce or<br>alleviate snoring and<br>mild to moderate<br>obstructive sleep apnea<br>(OSA) in adults. |
| | | Device Description | |
| Design | SICAT OPTISLEEP is a<br>removable intraoral<br>device used for treating<br>snoring and sleep<br>apnea. It consist of two<br>custom fabricated<br>splints that fit separately<br>over the upper and<br>lower teeth and engage<br>by means of adjustable<br>connectors. The device<br>functions as a<br>mandibular repositioner,<br>maintaining the lower<br>jaw in a forward position<br>during sleep. This<br>mechanical protrusion<br>acts to increase the<br>patient's pharyngeal<br>space, improving his/her<br>ability to exchange air<br>during sleep. The device<br>is customized and<br>patient specific for each<br>patient and has an<br>adjustment mechanism<br>enabling the amount of<br>mandibular<br>advancement to be set<br>by the dentist or<br>physician at the time of<br>fitting. | The Somnomed MAS<br>RxA is an intraoral<br>device used for treating<br>Snoring and Sleep<br>Apnea. It consists of<br>two custom fitted trays<br>which fit over the upper<br>and lower teeth and<br>engage by means of<br>adjustable lugs. The<br>device functions as a<br>mandibular repositioner,<br>which acts to increase<br>the patient's pharyngeal<br>space, improving their<br>ability to exchange air<br>during sleep. The device<br>is custom made for each<br>patient and has the<br>adjustment mechanism<br>enabling the amount of<br>mandibular<br>advancement to be set<br>by the dentist or<br>physician at the time of<br>fitting the device. | The Narval CC is a<br>removable intraoral<br>device used for treating<br>snoring and sleep<br>apnea. It consist of two<br>custom fabricated<br>splints that fit separately<br>over the upper and<br>lower teeth and engage<br>by means of adjustable<br>rods. The device<br>functions as a<br>mandibular repositioner,<br>maintaining the lower<br>jaw in a forward position<br>during sleep. This<br>mechanical protrusion<br>acts to increase the<br>patient's pharyngeal<br>space, improving his/her<br>ability to exchange air<br>and reducing the<br>tendency to snore. The<br>device is custom made<br>for each patient and has<br>an adjustment<br>mechanism enabling the<br>amount of mandibular<br>advancement to be set<br>by the dentist or<br>physician at the time of<br>fitting. |
| Basic design | mandibular repositioner | mandibular repositioner | mandibular repositioner |
| | SICAT OPTISLEEP | Reference Predicate<br>Somnomed MAS RxA<br>(K050592)<br>Last Brand Name:<br>SomnoDent Classic | Primary Predicate<br>Narval CC (K113201) |
| Mandibular<br>advancement | Adjustment of the<br>relative position of the<br>splints guides the<br>mandible forward and<br>maintains advancement<br>thus enlarging the<br>airway. The vertical<br>opening of the jaw is<br>not limited to a single<br>position. | Adjustment of the<br>relative position of the<br>splints guides the<br>mandible forward and<br>maintains advancement<br>thus enlarging the<br>airway.<br>The vertical opening of<br>the jaw is not limited to<br>a single position. | Adjustment of the<br>relative position of the<br>splints guides the<br>mandible forward and<br>maintains advancement<br>thus enlarging the<br>airway. The vertical<br>opening of the jaw is<br>not fixed in a single<br>position. |
| Adjustments | Adjusted via the use of<br>interlocking connectors<br>of different length<br>placed on the sides of<br>the splints, the longer<br>the connector, the<br>further the mandible is<br>advanced. | Adjusted via the use of<br>interlocking lugs and<br>wings placed on the<br>sides of the splints. | Adjusted via the use of<br>interlocking rods placed<br>on the sides of the<br>splints, the shorter the<br>rod, the further the<br>mandible is advanced. |
| | | Properties | |
| Material | • Acrylic (Polymethyl-<br>methacrylate, PMMA)<br>• Polyamide | • Acrylic<br>• Stainless steel | • Polyamide |
| Reusable by<br>same patient | Yes | Yes | Yes |
| | | Method of Manufacture | |
| | Milling at SICAT dental<br>laboratory with<br>CAD/CAM technology | Dental laboratory | Made by selective laser<br>sintering of a polymer<br>material in a dental<br>laboratory with<br>CAD/CAM technology |
| Cleaning, Maintenance, Biocompatibility | | | |
| Cleaning | Toothbrush with water;<br>mild detergent; partial<br>denture cleaner without<br>oxygen | Toothbrush with water;<br>mild detergent; partial<br>denture cleaner without<br>active oxygen by<br>Somnomed | Toothbrush with water;<br>sonic cleaner; Narval<br>cleaner |
| Maintenance | Regular check up with<br>dental medical<br>professional | Regular check up with<br>dental medical<br>professional | Regular check up with<br>dental medical<br>professional |
| | SICAT OPTISLEEP | Reference Predicate<br>Somnomed MAS RxA<br>(K050592)<br>Last Brand Name:<br>SomnoDent Classic | Primary Predicate<br>Narval CC (K113201) |
| Bio-compatible | Yes | Yes | Yes |
| Miscellaneous | | |…