The Noiselezz® Mouthpiece is an Anti-Snoring device consisting of Two trayed plates fitted in front and between the upper and lower teeth and gums and integrated with each other with the same material as the upper and lower plates. The device is made of Thermoplastic elastomer May be used as supplied

AI/ML Overview

This document describes the marketing authorization for a medical device called Noiselezz®, an intraoral device intended for the treatment of nighttime snoring in adults. The submission is a 510(k), which means the FDA determined the device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety from scratch.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The Noiselezz® device is seeking substantial equivalence to the ZQuiet® device (K090503). In a 510(k) submission for a device like this, the "acceptance criteria" are primarily established by demonstrating equivalence in intended use, technological characteristics, and safety and effectiveness compared to the predicate device. The performance is assessed against these equivalency points, rather than specific numerical efficacy thresholds for snoring reduction.

Given the document, here's a table based on the direct comparisons made between the Noiselezz® and its predicate, ZQuiet®, focusing on the aspects where they are considered equivalent or where differences are justified:

Aspect / Acceptance Criteria	Noiselezz® Reported Performance / Characteristic	Comparison to Predicate (ZQuiet®)
Intended Use	Treatment of nighttime snoring in adults.	Equivalent: Both devices are C]intended for the treatment of nighttime snoring in adults.
Target Population	Adults.	Equivalent: Both target adults.
Where Used	Home or sleep laboratories.	Equivalent: Both can be used in home or sleep laboratories.
Prescription Status	Prescription device.	Equivalent: Both are prescription devices.
Device Type	Intraoral device.	Equivalent: Both are intraoral devices.
Function	Intended to reduce snoring or help alleviate snoring.	Equivalent: Both are intended to reduce or alleviate snoring.
Usage Pattern	Single patient multi-use. Placed in patient mouth each evening, cleaned daily, permits breathing through mouth, easily removed.	Equivalent: Both are single patient multi-use, placed in mouth each evening, cleaned daily, permit mouth breathing, and are easily removed.
Sterility	Non-Sterile.	Equivalent: Both are non-sterile.
Design / Components	One-piece design. Upper and lower trays fitted to patient by heating material. No occlusal notches. No saw-tag mechanism at occlusal surface.	Similar with justified differences: Both are one-piece designs. Both have upper and lower trays fitted by heating material. The Noiselezz® lacks occlusal notches and a saw-tag mechanism present in the predicate; the sponsor justifies this by stating a desire for a simpler design, reducing debris accumulation, and facilitating cleaning. This difference is argued not to raise new questions of safety or effectiveness.
Material / Biocompatibility	Thermoplastic elastomer. Cleared for: ISO 10993-5 (Cytotoxicity), ISO 10993-4 (Hemocompatibility), USP 32, NF 27 (88) Biological Reactivity Tests. Registered under FDA DMF #10824. Material specifically intended for tissue exposure (medical tubing, mucosal membrane contact).	Similar / Sufficient: The predicate device lists ISO 10993. Noiselezz® lists specific parts of ISO 10993 and USP Class VI, demonstrating comparable or more detailed biocompatibility testing. The material choice is justified for prolonged mucosal contact.
Physical Properties of Base Material	Tested for Specific Gravity (ASTM D792), Shore A Hardness (ASTM D2240), Tensile Strength (ASTM D412), Elongation (ASTM D412), Viscosity (ASTM D3835), Color.	N/A: No specific physical property metrics are provided for the predicate in this summary document, but testing the physical properties of the material is part of demonstrating safety and performance.
Safety (Shelf-life)	Evaluated through shelf-life test of the finished device.	N/A: No specific shelf-life data for the predicate is provided, but this is a standard safety evaluation for the proposed device.

2. Sample Size Used for the Test Set and the Data Provenance

This document primarily relies on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with a "test set" in the traditional sense of a clinical trial for efficacy.

Test Set: There is no mention of a specific clinical "test set" (e.g., patient cohort for a performance study) for validating the device's efficacy in snoring reduction. The evaluation focuses on non-clinical data (biocompatibility, physical properties, shelf-life) and a comparison to the predicate.
Data Provenance: The biocompatibility and physical property testing of the base material would have been performed in a laboratory setting (in vitro tests and animal safety studies for the base material). There is no explicit mention of the country of origin for these non-clinical tests in the provided text.
Retrospective/Prospective: The non-clinical tests are prospective laboratory studies. No retrospective or prospective clinical studies on human patients are detailed in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. As described above, there was no clinical "test set" involving human patients and expert assessment of outcomes for the Noiselezz® device mentioned in this summary. The "ground truth" for this submission focuses on the technical characteristics and safety of the materials, which are assessed against recognized standards by toxicologists, material scientists, and regulatory bodies (e.g., FDA for DMF and ISO standards).

4. Adjudication Method for the Test Set

Not applicable. Since no clinical "test set" with expert assessment of endpoints (e.g., snoring severity) is described, no adjudication method (like 2+1 or 3+1 consensus) is relevant here.

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 an intraoral appliance to treat snoring, not an imaging device or an AI-powered diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant to its regulatory submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this 510(k) submission relates to:

Safety and Biocompatibility: Established through adherence to international standards (ISO 10993 parts 4 and 5), USP Class VI, and FDA's own evaluation (DMF #10824 for the material).
Performance: Established by demonstrating that the device's design and materials are substantially equivalent to a legally marketed predicate device (ZQuiet®), which itself was previously cleared by the FDA for its intended use. The presumption is that if the new device is sufficiently similar and raises no new safety/effectiveness concerns, its performance will be comparable to the predicate.

8. The Sample Size for the Training Set

Not applicable. As this is a physical device submission and not an AI/machine learning algorithm, there is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is a physical device submission and not an AI/machine learning algorithm, there is no concept of a "training set" or its ground truth establishment.

Summary

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

September 1, 2016

Firma Ingemarsson c/o Mr. Poul Schmidt-Andersen Danish Medical Devices Consulting APS Doktor Mundtsvej 9B Farum, 3520 DENMARK

Re: K160531

Trade/Device Name: Noiselezz® Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: LRK Dated: July 10, 2016 Received: July 26, 2016

Dear Mr. Poul Schmidt-Andersen:

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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for Tina Kiang, Ph.D. Acting 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

510(k) Number (if known) K160531

Device Name

Noiselezz®

Indications for Use (Describe)

Noiselezz® is intended for the treatment of nighttime snoring in adults.

Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW . The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection. including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

807.92(c)

807.92(a)(6)

Submitter		807.92(a)(1)
Company Name	Firma Ingemarsson
ER Number	3002807968
Address	Vilvordevej 61, DK-2920 Charlottenlund, Denmark
Phone	+45 3617 7050
Fax	+45 3617 2348
E-mail	nim@noiselezz.com
Contact person	Natashia Ingemarsson-Matzen
Device Information		807.92(a)(2)
Device Name	Noiselezz®
Common Name	Noiselezz®
Product Code	LRK
Registration Number	21 CFR 872.5570
Classification	Class II
Classification Panel	Dental
Predicate Device		807.92(a)(3)
Legally Marketed Equivalent Device
Company	Product	510(k) #
Sleeping Well LLC	ZQuiet®	K090503
Device Description
The Noiselezz® Mouthpiece is an Anti-Snoring device consisting of
Two trayed plates fitted in front and between the upper and lower teeth and gums and integrated with each other with the same material as the upper and lower plates. The device is made of Thermoplastic elastomer May be used as supplied
Device Intended Use		807.92(a)(5)
Noiselezz® is intended for the treatment of nighttime snoring in adults.

Comparison of Proposed Device vs. Predicate

	Subject Device	Predicate device
Device name	Noiselezz®	Zquiet®
510(k) number	K160531	K090503
Device Classification	Class II	Class II
Classification name	Anti-snoring device	Anti-snoring device
Regulation number	21 CFR 872.5570	21 CFR 872.5570
Regulation panel	Dental	Dental
Product code	LRK	LRK
	Subject Device	Predicate device
Device use
Indication for Use	Noiselezz® is intended for the treatmentof nighttime snoring in adults.	The ZQuiet Anti-Snoring device isintended for the treatment of nighttimesnoring in adults.
Target population	Adults	Adults
Where used	Home or sleep laboratories	Home or sleep laboratories
Prescription	Prescription device	Prescription device
Intended as an intraoral device	Intended as an intraoral device	Intended as an intraoral device
Intended to reduce snoring or helpalleviate snoring	Intended to reduce snoring or helpalleviate snoring	Intended to reduce snoring or helpalleviate snoring
Multiple use	Indicated for singe patient multi use	Indicated for singe patient multi use
Placement of device	Placed in patient mouth each evening	Placed in patient mouth each evening
Cleaning of device	Cleaned daily	Cleaned daily
Patient Use
Breathing	Permits patient to breathe through mouth	Permits patient to breathe through mouth
Cleaning	Cleaned daily	Cleaned daily
Placement	Placed in user's mouth each evening	Placed in user's mouth each evening
Removal	Easily removed from the mouth	Easily removed from the mouth
Materials
Non-Sterile	Non-Sterile	Non-Sterile
Components	One piece design	One piece design
Molding	Upper and lower trays fitted to patient byheating material	Upper and lower trays fitted to patient byheating material
Occlusal notches	None Occlusal notches	Occlusal notches
Saw-tag mechanism at the occlusalsurface closest to the hinge	None saw-tag mechanism at the occlusalsurface closest to the hinge	Saw-tag mechanism at the occlusalsurface closest to the hinge
Biocompatibility
Test method of base material	• ISO 10993-5 (Cytotoxicity)• ISO 10993-4 (Hemocompatibility)• USP 32, NF 27 (88) BiologicalReactivity Tests. In Vivo	ISO 10993

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Substantial Equivalence Discussion

The reason for not adding the occlusal notches is the desire to keep the design as simple as possible. This goes for the saw-tag mechanism too. Furthermore, those extra elements on the occlusal surface of the device increases the risk of accumulation of debris, which might dry in and deteriorate the cleaning process.

The base material is especially intended for exposure to tissue when used for medical tubing and contact to the mucosal membrane.

Nonclinical and Clinical Test

Safety and Effectiveness

Biocompatibility

The material has been cleared with respect to FDA Unspecified Rating, ISO 10993 Part 5 (Cytotoxicity). ISO 10993 Part 4 (Hemocompatibility) and USP Class VI. Furthermore, FDA under DMF #10824 has registered the material

Non-Clinical Performance Data

Physical properties testing of base material has been conducted for the following and the associated standards:

Physical property	Standard/Test Method
SPECIFIC GRAVITY	ASTM D792 (ISO 2781)
SHORE A HARDNESS	ASTM D2240 (ISO 868)
TENSILE STRENGTH	ASTM D412-Die C (ISO 37)
ELONGATION	ASTM D412-Die C (ISO 37)
VISCOSITY	ASTM D3835 (ISO 11443)
COLOR	-

Noiselezz® Anti-Snoring Device has been evaluated for safety through shelf-life test of the finished device and in vitro tests and animal safety studies of base material.

Conclusion

Noiselezz® Anti-Snoring Device is substantially equivalent to the predicate device because they share the same intended use and a similar design.

807.92(b)(3)

807.92(b)

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.”