(34 days)
No
The device description and performance studies focus on mechanical function and biocompatibility, with no mention of AI or ML algorithms for diagnosis, treatment planning, or device control.
Yes
The device is intended to reduce simple night-time snoring and mild to moderate obstructive sleep apnea (OSA), which are medical conditions, and it acts by increasing pharyngeal space to improve air exchange.
No
The device description clearly states its function is to increase pharyngeal space to improve air exchange during sleep and reduce symptoms, acting as a "mandibular repositioner." Its intended use is "as an aid in the reduction of simple night time snoring and mild to moderate obstructive sleep apnea (OSA)." These descriptions indicate a therapeutic and symptomatic relief function rather than a diagnostic one. There is no mention of it being used to detect, identify, or characterize a disease.
No
The device description explicitly states it "consists of two generic splints" and an "advancement mechanism," which are physical hardware components. The performance studies also focus on the mechanical properties and biocompatibility of these physical parts.
Based on the provided information, the SomnoDent ALPHA is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to aid in the reduction of snoring and sleep apnea by physically repositioning the mandible. This is a mechanical action within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a mandibular repositioner that fits over the teeth and physically alters the pharyngeal space. This is a physical device for treatment/management, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. Its function is purely mechanical.
- Performance Studies: The performance studies focus on the mechanical integrity, biocompatibility, and in-use performance of the device itself, not on its ability to accurately diagnose a condition.
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 a disease or condition. The SomnoDent ALPHA does not fit this description.
N/A
Intended Use / Indications for Use
The SomnoDent ALPHA is temporarily intended as an aid in the reduction of simple night time snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The SomnoDent ALPHA is a device that functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device consists of two generic splints, which fit over the upper and lower teeth. The lower splint is held in a protrusive position by an advancement mechanism. The device advances the mandible in the sagittal plane to increase the patient's pharyngeal space during sleep and reduce the apnea symptoms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharyngeal space, mouth, jaw
Indicated Patient Age Range
18 years and older.
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)
To demonstrate substantial equivalence risk management [ISO 14971:(R)2010, biocompatibility [ISO 10993-1:(R)2013; 10993-5:(R)2014; and 10993-10:2010], and bench performance testing was conducted to ensure the device performed as intended and is safe and effective. During risk management and performance testing, no new risks were identified. The risk management concluded that the SomnoDent ALPHA is state of the art with acceptable risks.
The testing on the adjustment mechanism demonstrates that the wing/lug, clip lock mechanism can withstand the applicable forces within the mouth, ensuring the device is safe and effective. In addition, the biocompatibility evaluation and testing to ISO 10993 demonstrated that the device is a non-sensitizer, non-irritant and is non-cytotoxic.
Simulated in-use testing was completed with mechanical cyclic force testing during performance testing to support the in use claim.
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.
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.
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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2016
SomnoMed Inc. c/o Dave Yungvirt Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Milburn, NJ 07041
Re: K162306
Trade/Device Name: SomnoDent ALPHA® 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: September 2, 2016 Received: September 6, 2016
Dear Dave Yungvirt:
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.
1
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.
Sincerelv.
Michael J. Ryan -S
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)
Device Name
SomnoDent ALPHA®
Indications for Use (Describe)
The SomnoDent ALPHA is temporarily intended as an aid in the reduction of simple night time
snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older.
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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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510(k) Summary
(As required by 21 CFR 807.92) SomnoDent ALPHA®
1.0 Submitter
SomnoMed, Inc. 7460 Warren Parkway, Ste. 190 Frisco, TX 75034 Telephone: 972-377-3400 Fax: 469-200-7855
Official Contact
Kien Nguyen President-North America Telephone: 972-377-3400, Ext. 101 Email: knguyen@somnomed.com
2.0 Date Prepared
March 29, 2016
3.0 Device Identification
| Proprietary Names: | SomnoDent ALPHA® |
|---|---|
| Common Name: | Device, Anti-Snoring |
| Classification Name: | Intraoral device for snoring and Intraoral devices |
| for snoring and obstructive sleep apnea | |
| Device Classification: | |
| Product Code: | LRK |
| Regulation Number: | 21 CFR 872.5570 |
4.0 Legally Marketed Predicate Device
| Proposed
Candidate | Predicates | Manufacturer | Document
Number |
|-----------------------|---------------------------------------|-------------------|--------------------|
| SomnoDent
ALPHA® | PRIMARY = SomnoDent®
Fusion | SomnoMed Inc. | K140278 |
| | REFERENCE = TOA/myTAP | Airway Management | K972061 |
The SomnoDent ALPHA is substantially equivalent to the predicates listed above, currently in commercial distribution.
5.0 Device Description
The SomnoDent ALPHA is a device that functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device consists of two generic splints, which fit over the upper and lower teeth. The lower splint is held in a protrusive position by an advancement mechanism. The device advances the mandible in the sagittal plane to increase the patient's pharyngeal space during sleep and reduce the apnea symptoms.
6.0 Intended Use
The SomnoDent ALPHA is temporarily intended as an aid in the reduction of simple night time snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older.
4
| 7.0 Comparison to the Predicate
Technological Characteristics | Primary
Predicate
Fusion
K140278 | Reference
Predicate
TOA/MyTap
K972061 | Proposed
SomnoDent
ALPHA® |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------|
| Intended Use | | | |
| Intended as an intraoral device | | | |
| Intended to reduce snoring or help alleviate snoring | | | |
| Indicated for use with patients with mild to moderate
obstructive sleep apnea | | | |
| Intended for night-time use | | Same | |
| Indicated for single patient multiuse | | | |
| Indicated for use at home or sleep laboratories | | | |
| Target population: adults | | | |
| Prescription device | | | |
| In use claim | Difference
3-5 Years | Difference
Not Stated | Difference
90 days |
| Design | | | |
| Operating Principle - Mandibular Advancement | | | |
| Separate upper and lower tray pieces | | | |
| Can be adjusted or refit | | | |
| Placed in patient's mouth each evening | | | |
| Permits patient to breathe through mouth | | | |
| Permits patient to talk and drink with appliance in place | | Same | |
| Permits lateral and/or vertical jaw movement | | | |
| Upper and lower trays disengage for easy removal from mouth | | | |
| Cleaned and inspected daily by patient | | | |
| Customized fit for each patient | | | |
| Lower jaw adjustment mechanism | Similar
Wing/Lug | Difference
Dial Adjustment | Similar
Wing/Lug
Clip Lock |
| Materials | | | |
| Biocompatible tray material | Difference
Soft Liner
Dental Acrylic
(not light cured)
Surgical Stainless
Steel | Both reference predicate and
proposed
use a similar Rigid
Polycarbonate. | |
| Heat sensitive impression material for fitting to teeth | N/A | Proprietary Heat Formable
Lining | |
| Performance Specification | Primary
Predicate
Fusion
K140278 | Reference
Predicate
TOA/MyTap
K972061 | Proposed
SomnoDent
ALPHA® |
| Adjustment Range | 0-8 mm | Same | 0-20 mm |
7.0 Comparison to the Predicate
5
8.0 Performance Testing
To demonstrate substantial equivalence risk management [ISO 14971:(R)2010, biocompatibility [ISO 10993-1:(R)2013; 10993-5:(R)2014; and 10993-10:2010], and bench performance testing was conducted to ensure the device performed as intended and is safe and effective. During risk management and performance testing, no new risks were identified. The risk management concluded that the SomnoDent ALPHA is state of the art with acceptable risks.
The testing on the adjustment mechanism demonstrates that the wing/lug, clip lock mechanism can withstand the applicable forces within the mouth, ensuring the device is safe and effective. In addition, the biocompatibility evaluation and testing to ISO 10993 demonstrated that the device is a non-sensitizer, non-irritant and is non-cytotoxic.
The primary Fusion predicate is made according to an individual bite record to establish a baseline for mandibular adjustment, a larger adjustment range is not clinically necessary. The Fusion is usually produced at 60-70 percent of maximum starting protrusion, and then the adjustment mechanism allows further adjustments. For a one size fits all customizable device (ALPHA/MyTap), a larger adjustment range is necessary to establish a starting protrusion position and still allow for therapeutic adjustment. Since the customizable devices have the same adjustment range and mandibular advancement is already a proven treatment option for snoring and sleep apnea, no additional clinical testing is necessary to support substantial equivalence.
The SomnoDent ALPHA has a similar intended use as its primary and reference predicates, except that it is used temporarily. The temporarily intended use claim does not impact equivalence, as the device enables clinicians to determine if a patient is a good candidate for a mandibular repositioner with a shorter in use claim prior to prescribing a similar device with a longer in use claim. The ALPHA intended use is conservative and supported by biocompatibility and in-use bench testing. Simulated in-use testing was completed with mechanical cyclic force testing during performance testing to support the in use claim.
9.0 Conclusion
The SomnoDent ALPHA device is as safe and as effective for its intended use and performs as well as the predicate devices. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.