NARVAL CC by RESMED SAS | FDA 510(k) Summary

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.

AI/ML Overview

The provided text is a 510(k) summary for the ResMed Narval CC device, which is an intraoral device for snoring and obstructive sleep apnea. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone study with acceptance criteria and device performance metrics in the way one might find for a novel diagnostic algorithm.

Here's a breakdown of why many of your requested items cannot be found in this specific document:

This is a 510(k) Pre-Market Notification, not a clinical trial report or a performance study for a novel algorithm. The goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective. It generally doesn't require new clinical studies with detailed performance metrics and acceptance criteria for the new device if sufficient evidence of equivalence to a predicate exists.
The device is a physical intraoral device, not an "AI algorithm." Many of your questions are geared towards the evaluation of AI/ML-based diagnostic systems. This product is a custom-fabricated physical medical device.

Therefore, many of your specific questions related to AI algorithm performance evaluation, such as "acceptance criteria," "reported device performance" in a metric table, "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," "type of ground truth," and "training set size/ground truth" are not applicable or not present in this type of regulatory submission for this type of device.

What can be extracted or inferred from the document:

The document primarily focuses on demonstrating substantial equivalence to predicate devices. This is the "study" in this context. The "acceptance criteria" here are met if the FDA agrees that the new device shares sufficient similarities with the predicate devices in terms of intended use, technological characteristics, and does not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence): The device must be demonstrated to be "substantially equivalent" to predicate devices. This is achieved by showing that it has:
- Essentially the same intended use and user population.
- Equivalent technological characteristics.
- Does not raise new questions of safety and effectiveness.
- Is at least as safe and effective as the predicate devices.
Reported Device Performance: Instead of specific quantitative performance metrics, the "performance" is demonstrated by asserting similarity to already cleared devices. The document explicitly states: "it is at least as safe and effective as the predicative devices."

Feature/Criterion	ResMed Narval CC Performance/Assertion
Intended Use (Reduce/alleviate snoring and mild to moderate OSA in adults)	Substantially Equivalent: Same as predicate devices (Somnomed MAS RXA and Frantz Elastic Mandibular Appliance).
Technological Characteristics (Materials, Design, Principle of operation, Removable, Adjustment, Non-sterile, Reusable, Prescription-only)	Substantially Equivalent: Similar to predicate devices, with noted differences (e.g., specific polymers vs. acrylic/stainless steel, different engagement mechanisms) but maintaining the same fundamental operating principle.
Safety and Effectiveness	Asserted Equivalent: Does not raise new questions of safety and effectiveness; it is at least as safe and effective as the predicate devices.

2. Sample size for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable / Not provided. This document does not describe a clinical performance study with a distinct "test set" in the context of an AI algorithm or a novel performance claim. The "study" here is a comparison to predicate devices based on design and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. There is no "ground truth" establishment in the sense of expert annotation for a diagnostic algorithm. The ground truth for the predicate devices' effectiveness would have been established historically through their own clearance processes or clinical use, which are not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No adjudication method for a test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This isn't an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable for this device's evaluation. The evaluation for this device is based on demonstrating similarity to legally marketed devices, whose "ground truth" (i.e., their efficacy and safety) was established through their own regulatory processes (e.g., clinical evidence, long-term use data, or previous equivalence findings).

8. The sample size for the training set:

Not applicable. This isn't an AI/ML device requiring a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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

K||320|

RESMED

5. 510(k) SUMMARY

[As required by 21 CFR 807.92]

Date Prepared	27 October, 2011
Submitter	Ms. Tracey Bullivant,Regulatory Affairs Manager
Official Contact	Mr. David D'CruzV.P., US Medical & Regulatory Affairs9001 Spectrum Centre BlvdSan Diego CA 92123 USATel: (858) 836 5984
Device Trade Name	Narval CCTM
Device CommonName/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 andsleep apnea. It consist of two custom fabricated splints that fit separatelyover the upper and lower teeth and engage by means of adjustable rods.The device functions as a mandibular repositioner, maintaining the lower jawin a forward position during sleep. This mechanical protrusion acts toincrease the patient's pharyngeal space, improving his/her ability toexchange air and reducing the tendency to snore.The device is custom made for each patient and has an adjustmentmechanism enabling the amount of mandibular advancement to be set bythe dentist or physician at the time of fitting.
Intended Use	The Narval CC is intended to reduce or alleviate snoring and mild tomoderate obstructive sleep apnea (OSA) in adults.
TechnologicalCharacteristics	The following table displays the differences and similarities between the newNarval CC device and two other previously marketed (predicate) devices.Equivalence is based on similarities in intended use, materials ofconstruction, design, and operating principles, as summarized in the tableon the following page.

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

RESMED

Feature	Narval CC	Somnomed MAS RXA(K050592)	Frantz Elastic Mandibular(EMA) Appliance (K971794)
Intended Use	To reduce or alleviate snoringand mild to moderateobstructive sleep apnea (OSA)in adults.	To reduce night-timesnoring and mild tomoderate obstructivesleep apnea (OSA) inadults.	Treatment of nasal respiratorydysfunction of obstructivesleep apnea and snoring inthose patients whereadvancement of the mandibleand opening the bite canincrease the patient'sairspace.
Materials ofconstruction	Made from polymers(Polyamide).	Made from acrylic andstainless steel.	Made from thermoplastic andpolymers.
Design	Two customized splints that fitseparately over the upper andlower teeth inside the mouth.The lower splint contains atriangular protrusion, allowingthe splints to engage bymeans of interlocking rods onthe sides.	Two customized splintsthat fit separately over theupper and lower teethinside the mouth. Thelower splint contains a fin-shaped protrusion,allowing the splints toengage by means ofadjustable lugs on thesides.	Two customized splints that fitseparately over the upper andlower teeth inside the mouth.The splints engage each otherby means of retention hooksand interlocking elastic straps.
Principle ofoperation/means of mandibularadvancement.	Adjustment of the relativeposition of the splints guidesthe mandible forward andmaintains advancement thusenlarging the airway. Thevertical opening of the jaw isnot fixed in a single position.	Adjustment of the relativeposition of the splintsguides the mandibleforward and maintainsadvancement thusenlarging the airway. Thevertical opening of the jawis not fixed in a singleposition.	Adjustment of the relativeposition of the splints by theuse of elastic force pulls themandible forward andmaintains advancement thusenlarging the airway. Thevertical opening of the jaw isnot fixed in a single position.
Fixed/removable	Removable	Removable	Removable
Adjustment	Adjusted via the use ofinterlocking rods placed on thesides of the splints. Theshorter the rod, the further themandible is advanced.	Adjusted via the use ofinterlocking lugs andwings placed on the sidesof the splints.	Adjusted via the use ofinterlocking elastic strapsplaced on the sides of thesplints. The shorter the strap,the further the mandible isadvanced.
Suppliedsterile/nonsterile	Non sterile	Non sterile	Non sterile
Singleuse/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

Regulation Number and Section

§ 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.”