NARVAL CC

K113201 · Resmed Sas · LQZ · Dec 1, 2011 · Dental

Device Facts

• Record ID: K113201
• Device Name: NARVAL CC
• Applicant: Resmed Sas
• Product Code: LQZ · Dental
• Decision Date: Dec 1, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Narval CC is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Device Story

Narval CC is a custom-fabricated, removable intraoral mandibular repositioning device. It consists of two splints worn over upper and lower teeth, connected by adjustable rods. During sleep, the device maintains the mandible in a forward position, increasing pharyngeal space to improve airflow and reduce snoring. The device is fitted by a dentist or physician, who adjusts the mandibular advancement via the interlocking rods. It is a mechanical device used by patients at home; no software or electronic components are involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Custom-fabricated intraoral device made of polyamide polymers. Features two splints with adjustable interlocking rods for mandibular advancement. Non-sterile, reusable, prescription-only. Mechanical operation; no energy source or software.

Indications for Use

Indicated for adults with 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

• Somnomed MAS RxA (K050592)
• Frantz Elastic Mandibular Advancement (EMA) Appliance (K971794)

Submission Summary (Full Text)

{0}------------------------------------------------

K||320|

RESMED

## 5. 510(k) SUMMARY
[As required by 21 CFR 807.92]

[As required by 21 CFR 807.92]

| Date Prepared | 27 October, 2011 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Ms. Tracey Bullivant,<br>Regulatory Affairs Manager |
| Official Contact | Mr. David D'Cruz<br>V.P., US Medical & Regulatory Affairs<br>9001 Spectrum Centre Blvd<br>San Diego CA 92123 USA<br>Tel: [phone] |
| Device Trade Name | Narval CCTM |
| Device Common<br>Name/Classification Name | Mandibular repositioning device; |
| Classification | 21 CFR 872.5570 (Class II) |
| Product | LQZ |
| Predicate | Somnomed MAS RxA (K050592)<br>Frantz Elastic Mandibular Advancement (EMA) Appliance (K971794) |
| Description | The Narval CC is a removable intraoral device used for treating snoring and<br>sleep apnea. It consist of two custom fabricated splints that fit separately<br>over the upper and lower teeth and engage by means of adjustable rods.<br>The device functions as a mandibular repositioner, maintaining the lower jaw<br>in a forward position during sleep. This mechanical protrusion acts to<br>increase the patient's pharyngeal space, improving his/her ability to<br>exchange air and reducing the tendency to snore.<br>The device is custom made for each patient and has an adjustment<br>mechanism enabling the amount of mandibular advancement to be set by<br>the dentist or physician at the time of fitting. |
| Intended Use | The Narval CC is intended to reduce or alleviate snoring and mild to<br>moderate obstructive sleep apnea (OSA) in adults. |
| Technological<br>Characteristics | The following table displays the differences and similarities between the new<br>Narval CC device and two other previously marketed (predicate) devices.<br>Equivalence is based on similarities in intended use, materials of<br>construction, design, and operating principles, as summarized in the table<br>on the following page. |

{1}------------------------------------------------

## RESMED

| Feature | Narval CC | Somnomed MAS RXA<br>(K050592) | Frantz Elastic Mandibular<br>(EMA) Appliance (K971794) |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To reduce or alleviate snoring<br>and mild to moderate<br>obstructive sleep apnea (OSA)<br>in adults. | To reduce night-time<br>snoring and mild to<br>moderate obstructive<br>sleep apnea (OSA) in<br>adults. | Treatment of nasal respiratory<br>dysfunction of obstructive<br>sleep apnea and snoring in<br>those patients where<br>advancement of the mandible<br>and opening the bite can<br>increase the patient's<br>airspace. |
| Materials of<br>construction | Made from polymers<br>(Polyamide). | Made from acrylic and<br>stainless steel. | Made from thermoplastic and<br>polymers. |
| Design | Two customized splints that fit<br>separately over the upper and<br>lower teeth inside the mouth.<br>The lower splint contains a<br>triangular protrusion, allowing<br>the splints to engage by<br>means of interlocking rods on<br>the sides. | Two customized splints<br>that fit separately over the<br>upper and lower teeth<br>inside the mouth. The<br>lower splint contains a fin-<br>shaped protrusion,<br>allowing the splints to<br>engage by means of<br>adjustable lugs on the<br>sides. | Two customized splints that fit<br>separately over the upper and<br>lower teeth inside the mouth.<br>The splints engage each other<br>by means of retention hooks<br>and interlocking elastic straps. |
| Principle of<br>operation/mean<br>s of mandibular<br>advancement. | Adjustment of the relative<br>position of the splints guides<br>the mandible forward and<br>maintains advancement thus<br>enlarging the airway. The<br>vertical opening of the jaw is<br>not fixed in a single position. | Adjustment of the relative<br>position of the splints<br>guides the mandible<br>forward and maintains<br>advancement thus<br>enlarging the airway. The<br>vertical opening of the jaw<br>is not fixed in a single<br>position. | Adjustment of the relative<br>position of the splints by the<br>use of elastic force pulls the<br>mandible forward and<br>maintains advancement thus<br>enlarging the airway. The<br>vertical opening of the jaw is<br>not fixed in a single position. |
| Fixed/<br>removable | Removable | Removable | Removable |
| Adjustment | Adjusted via the use of<br>interlocking rods placed on the<br>sides of the splints. The<br>shorter the rod, the further the<br>mandible is advanced. | Adjusted via the use of<br>interlocking lugs and<br>wings placed on the sides<br>of the splints. | Adjusted via the use of<br>interlocking elastic straps<br>placed on the sides of the<br>splints. The shorter the strap,<br>the further the mandible is<br>advanced. |
| Supplied<br>sterile/non<br>sterile | Non sterile | Non sterile | Non sterile |
| Single<br>use/reusable | Reusable | Reusable | Reusable |
| Prescription/<br>OTC | Prescription only | Prescription only | Prescription only |

Substantial Equivalence

The new device, the Narval CC, is considered to be substantially equivalent to the predicate devices based on the following: Conclusion

- it has essentially the same intended use and is indicated for the . same user population;
- it has equivalent technological characteristics to the predicates; .
- it does not raise new questions of safety and effectiveness; .
- it is at least as safe and effective as the predicative devices. .

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

DEC - 1 2011

ResMed SAS C/O Mr. David D'Cruz VP, U.S. Medical and Regulatory Affairs ResMed Corp. 9001 Spectrum Center Blvd. San Diego, CA 92123

Re: K113201

Trade Name: Narval CC™ 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 Codes: LQZ Dated: October 27, 2011 Received: October 31, 2011

Dear Mr. D'Cruz:

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.

{3}------------------------------------------------

Page 2 – Mr. D'Cruz

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/Industrv/default.htm.

· Sincerely yours.

Anthony O. Newton

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

{4}------------------------------------------------

RESMED

Narval CC
Abbreviated 510K

·

--- ---

| 510(k) Number (if known): | K113201 |
|---------------------------|------------|
| Device Name: | Narval CC™ |
| Indications for Use: | |

The Narval CC™ is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

| Prescription Use (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use (Part 21 CFR 807 Subpart C) |
|----------------------------------------------|--------|--------------------------------------------------|
| X | | |

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Page 1 of 1

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | K113201 |
|----------------|---------|
|----------------|---------|

October 2011

13

.