(189 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of a mouthpiece, with no mention of AI, ML, or data processing capabilities.
Yes.
The device is intended for the "treatment of nighttime snoring in adults," which classifies it as a therapeutic device.
No
The "Intended Use / Indications for Use" states that the device is "intended for the treatment of nighttime snoring in adults," which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states it is a "Mouthpiece" made of "Thermoplastic elastomer," which is a physical, hardware component.
Based on the provided information, the Noiselezz® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of nighttime snoring in adults." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a physical mouthpiece designed to be worn in the mouth. This is a medical device, but not one that performs tests on samples taken from the body (which is the core function of an IVD).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Noiselezz® device does not fit this description.
N/A
Intended Use / Indications for Use
Noiselezz® is intended for the treatment of nighttime snoring in adults.
Product codes
LRK
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraoral
Indicated Patient Age Range
Adults
Intended User / Care Setting
Home or sleep laboratories
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)
Physical properties testing of base material has been conducted for the following and the associated standards:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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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 | |
| 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 treatment | |
| of nighttime snoring in adults. | The ZQuiet Anti-Snoring device is | |
| intended for the treatment of nighttime | ||
| snoring 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 help | ||
| alleviate snoring | Intended to reduce snoring or help | |
| alleviate snoring | Intended to reduce snoring or help | |
| alleviate 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 by | |
| heating material | Upper and lower trays fitted to patient by | |
| heating material | ||
| Occlusal notches | None Occlusal notches | Occlusal notches |
| Saw-tag mechanism at the occlusal | ||
| surface closest to the hinge | None saw-tag mechanism at the occlusal | |
| surface closest to the hinge | Saw-tag mechanism at the occlusal | |
| surface closest to the hinge | ||
| Biocompatibility | ||
| Test method of base material | • ISO 10993-5 (Cytotoxicity) | |
| • ISO 10993-4 (Hemocompatibility) | ||
| • USP 32, NF 27 (88) Biological | ||
| Reactivity 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)