(31 days)
Not Found
No
The device description and other sections do not mention any AI or ML components. The device is a mechanical mandibular repositioner.
Yes
The device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA), which are medical conditions, and it functions as a mandibular repositioner to improve air exchange, indicating a therapeutic purpose.
No
Explanation: The device is intended to treat snoring and sleep apnea by repositioning the jaw, not to diagnose these conditions.
No
The device description clearly states it is a "removable intraoral device" consisting of "two custom fabricated splints" and "adjustable rods," indicating it is a physical, hardware-based medical device.
Based on the provided information, the Narval CC™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to reduce or alleviate snoring and mild to moderate obstructive sleep apnea in adults. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a physical, removable intraoral appliance that mechanically repositions the jaw. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or functions related to in vitro testing, sample analysis, or diagnostic measurements.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Narval CC™ does not fit this description.
N/A
Intended Use / Indications for Use
The Narval CC is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Product codes (comma separated list FDA assigned to the subject device)
LQZ
Device Description
The Narval CC is a removable intraoral device used for treating snoring and sleep apnea. It consist of two custom fabricated splints that fit separately over the upper and lower teeth and engage by means of adjustable rods. The 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 his/her ability to exchange air and reducing the tendency to snore. The device is custom made for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Somnomed MAS RxA (K050592), Frantz Elastic Mandibular Advancement (EMA) Appliance (K971794)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
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.(b)
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.”
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, |
| Regulatory Affairs Manager | |
| Official Contact | Mr. David D'Cruz |
| V.P., US Medical & Regulatory Affairs | |
| 9001 Spectrum Centre Blvd | |
| San Diego CA 92123 USA | |
| Tel: (858) 836 5984 | |
| Device Trade Name | Narval CCTM |
| Device Common | |
| Name/Classification Name | Mandibular repositioning device; |
| Classification | 21 CFR 872.5570 (Class II) |
| Product | LQZ |
| Predicate | Somnomed MAS RxA (K050592) |
| Frantz Elastic Mandibular Advancement (EMA) Appliance (K971794) | |
| Description | The Narval CC is a removable intraoral device used for treating snoring and |
| sleep apnea. It consist of two custom fabricated splints that fit separately | |
| over the upper and lower teeth and engage by means of adjustable rods. | |
| The 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 his/her ability to | |
| exchange air and reducing the tendency to snore. | |
| The device is custom made for each patient and has an adjustment | |
| mechanism enabling the amount of mandibular advancement to be set by | |
| the dentist or physician at the time of fitting. | |
| Intended Use | The Narval CC is intended to reduce or alleviate snoring and mild to |
| moderate obstructive sleep apnea (OSA) in adults. | |
| Technological | |
| Characteristics | The following table displays the differences and similarities between the new |
| Narval CC device and two other previously marketed (predicate) devices. | |
| Equivalence is based on similarities in intended use, materials of | |
| construction, design, and operating principles, as summarized in the table | |
| on the following page. |
1
RESMED
| Feature | Narval CC | Somnomed MAS RXA
(K050592) | Frantz Elastic Mandibular
(EMA) Appliance (K971794) |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To reduce or alleviate snoring
and mild to moderate
obstructive sleep apnea (OSA)
in adults. | To reduce night-time
snoring and mild to
moderate obstructive
sleep apnea (OSA) in
adults. | Treatment of nasal respiratory
dysfunction of obstructive
sleep apnea and snoring in
those patients where
advancement of the mandible
and opening the bite can
increase the patient's
airspace. |
| Materials of
construction | Made from polymers
(Polyamide). | Made from acrylic and
stainless steel. | Made from thermoplastic and
polymers. |
| Design | Two customized splints that fit
separately over the upper and
lower teeth inside the mouth.
The lower splint contains a
triangular protrusion, allowing
the splints to engage by
means of interlocking rods on
the sides. | Two customized splints
that fit separately over the
upper and lower teeth
inside the mouth. The
lower splint contains a fin-
shaped protrusion,
allowing the splints to
engage by means of
adjustable lugs on the
sides. | Two customized splints that fit
separately over the upper and
lower teeth inside the mouth.
The splints engage each other
by means of retention hooks
and interlocking elastic straps. |
| Principle of
operation/mean
s of mandibular
advancement. | Adjustment of the relative
position of the splints guides
the mandible forward and
maintains advancement thus
enlarging the airway. The
vertical opening of the jaw is
not fixed in a single position. | Adjustment of the relative
position of the splints
guides the mandible
forward and maintains
advancement thus
enlarging the airway. The
vertical opening of the jaw
is not fixed in a single
position. | Adjustment of the relative
position of the splints by the
use of elastic force pulls the
mandible forward and
maintains advancement thus
enlarging the airway. The
vertical opening of the jaw is
not fixed in a single position. |
| Fixed/
removable | Removable | Removable | Removable |
| Adjustment | Adjusted via the use of
interlocking rods placed on the
sides of the splints. The
shorter the rod, the further the
mandible is advanced. | Adjusted via the use of
interlocking lugs and
wings placed on the sides
of the splints. | Adjusted via the use of
interlocking elastic straps
placed on the sides of the
splints. The shorter the strap,
the further the mandible is
advanced. |
| Supplied
sterile/non
sterile | Non sterile | Non sterile | Non sterile |
| Single
use/reusable | Reusable | Reusable | Reusable |
| Prescription/
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 (800) 638-2041 or (301) 796-7100 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
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