(27 days)
Not Found
No
The summary describes a mechanical intraoral device for sleep apnea and snoring. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical testing.
Yes
The device is intended for the treatment of medical conditions (nighttime snoring and obstructive sleep apnea) and functions by increasing the patient's pharyngeal space, which is a therapeutic action.
No
The device is intended for treatment (therapy) of snoring and sleep apnea, not for diagnosis.
No
The device description clearly states it is an "intraoral device" and describes physical components and materials, indicating it is a hardware device.
Based on the provided information, the SomnoDent G2 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SomnoDent G2 Function: The SomnoDent G2 is an intraoral device that physically repositions the mandible to increase the pharyngeal space. It is a mechanical device used for treatment, not a test performed on a biological sample.
- Intended Use: The intended use is for the treatment of snoring and sleep apnea, not for diagnosis.
Therefore, the SomnoDent G2 falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SomnoDent G2 is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The SomnoDent G2 device is an intraoral device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The device 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 is customized for each patient and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent G2 is a modification to the SomnoDent Flex (K073004). The SomnoDent G2 is identical to SomnoDent Flex, except for differences in the adjustment mechanism (which is an addition of a material of construction, which is biocompatible), and a change in adjustable range from 6 to 10mm. Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharyngeal space
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
dentist or physician, at 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)
To demonstrate substantial equivalence, bench testing was conducted on the advancement mechanism to ensure the device performed as intended and is safe and effective. Testing included a mechanical force test to simulate bruxism, which was determined worst case use, to ensure the wings functioned as designed and withstood appropriate pressures. The results indicated that the subject device performs as well or better than the predicate device. Mechanical testing was conducted on the winglet bond of the subject device. Testing results indicate that the bonds withstand applicable pressures, ensuring the device is safe and effective. In addition, comparative testing around the coupling mechanism was conducted between the subject and predicate devices. The testing concluded that the advancement of the subject device is substantially equivalent to the predicate device with regards to mechanical performance. Testing demonstrates that the subject device, the SomnoDent G2, is as safe, as effective, and performs as well as or better than the predicate device, the SomnoDent Flex.
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.
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
Image /page/0/Picture/0 description: The image shows the logo for SomnoMed. The logo consists of a stylized graphic above the company name. Below the company name, in smaller font, is the text "Dental * Sleep * Medical".
MAY 3 0 2012
510(k) Summary (21 CFR 807.92) Page 1 of 3
510(k) Number: K121340
| Submission Owner: | SomnoMed, Inc.
7460 Warren Parkway
Suite 190
Frisco, TX 75034
Phone: 888-447-6673 | |
|-------------------------|-----------------------------------------------------------------------------------------------|--|
| | Fax: 972-377-3404 | |
| | Email: kjayne@somnomed.com | |
| Official Correspondent: | Kathryn A. Jayne | |
| Date Prepared: | February 15, 2012 | |
| Trade Name: | SomnoDent® G2 | |
| Common Name: | Intraoral device for snoring and mild to moderate obstructive
sleep apnea (OSA) | |
| Classification Name: | Device, Anti-Snoring | |
| Regulation Number: | 21 CFR 872.5570 | |
| Product Code: | LRK | |
| Class: | II | |
| Panel: | Dental | |
| Predicate Devices: | K073004, SomnoDent Flex | |
Description of the device: ~
The SomnoDent G2 device is an intraoral device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The device 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 is customized for each intient and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent G2 is a modification to the SomnoDent Flex (K073004). The SomnoDent G2 is identical to SomnoDent Flex, except for differences in the adjustment mechanism (which is an addition of a material of construction, which is biocompatible), and a change (which to an dadition of a fifterences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.
Indications for Use:
The SomnoDent G2 is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.
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Image /page/1/Picture/0 description: The image shows the logo for SomnoMed. The logo consists of a stylized graphic above the company name. Below the name, in smaller font, are the words "Dental - Sleep - Medical".
510(k) Summary (21 CFR 807.92)
Page 2 of 3
Substantial Equivalence:
Substantial Equivalence Table
| Substantial Equivalence Table | ||
|---|---|---|
| SomnoDent G2 | SomnoDent Flex | |
| K073004 | ||
| Intended Use | ||
| Intended as an intraoral device | Yes | Yes |
| Intended to reduce snoring or help | ||
| alleviate snoring | Yes | Yes |
| Treatment of mild to moderate | ||
| obstructive sleep apnea | Yes | Yes |
| Intended for nighttime use | Yes | Yes |
| Indicated for single patient multiuse | Yes | Yes |
| Indicated for use at home or sleep | ||
| laboratories | Yes | Yes |
| Target population: adults | Yes | Yes |
| Prescription device | Yes | Yes |
| Design | ||
| Customized fit for each patient | Yes | Yes |
| Separate upper and lower tray pieces | Yes | Yes |
| Works by mandibular advancement | Yes | Yes |
| Can be adjusted or refit | Yes | Yes |
| Lower jaw adjustment using supplied | ||
| components | Yes | Yes |
| Permits patient to breathe through | ||
| mouth | Yes | Yes |
| Upper and lower trays disengage for | ||
| easy removal | Yes | Yes |
| Cleaned and inspected daily by patient | Yes | Yes |
| Material | ||
| Trays constructed from a soft lining | ||
| material adhered to a hard surface | ||
| acrylic | Yes | Yes |
| Advancement mechanism constructed | ||
| of surgical grade stainless steel | No | Yes |
| Advancement mechanism constructed | ||
| of biocompatible, medical grade | ||
| polycarbonate | Yes | No |
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Image /page/2/Picture/0 description: The image shows the logo for SomnoMed. The logo consists of a black abstract shape above the company name. Below the name, it says "Dental - Sleep - Medical" in a smaller font.
510(k) Summary (21 CFR 807.92) Page 3 of 3
Substantial equivalence discussion:
The SomnoDent G2 is considered to be substantially equivalent to the SomnoDent Flex device. The SomnoDent G2 and predicate device function 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 devices are customized for each patient and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent G2 is identical to SomnoDent Flex, except for differences in the adjustment mechanism (which is an addition of a material of construction, which is biocompatible), and a change in adjustable range from 6 to 10mm. Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.
Summary of Testing:
To demonstrate substantial equivalence, bench testing was conducted on the advancement mechanism to ensure the device performed as intended and is safe and Testing included a mechanical force test to simulate bruxism, which was effective. determined worst case use, to ensure the wings functioned as designed and withstood appropriate pressures. The results indicated that the subject device performs as well or better than the predicate device. Mechanical testing was conducted on the winglet bond of the subject device. Testing results indicate that the bonds withstand applicable pressures, ensuring the device is safe and effective. In addition, comparative testing around the coupling mechanism was conducted between the subject and predicate The testing concluded that the advancement of the subject device is devices. substantially equivalent to the predicate device with regards to mechanical performance. Testing demonstrates that the subject device, the SomnoDent G2, is as safe, as effective, and performs as well as or better than the predicate device, the SomnoDent Flex.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
MAY 3 0 2012
Somnomed Inc. C/O Mr. Jeff D. Rongero Responsible Third Party Official Underwriters Laboratories 12 Laboratory Drive Research Triangle, North Carolina 27709
Re: K121340
Trade/Device Name: SomnoDent G2 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 Code: LRK Dated: May 21, 2012 Received: May 25, 2012
Dear Mr. Rongero:
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.
4
Page 2 - Mr. Rongero
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 proportive 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/Industry/default.htm.
Sincerely yours,
h for
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
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Image /page/5/Picture/0 description: The image is a logo for SomnoMed, a company that specializes in dental, sleep, and medical solutions. The logo features a stylized graphic element above the company name, "SomnoMed," which is written in a bold, sans-serif font. Below the company name, the words "Dental - Sleep - Medical" are written in a smaller, sans-serif font.
Indications for Use
510(k) Number (if known):
Device Name: SomnoDent G2
Indications for Use:
The SomnoDent G2 is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C) ·
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swan Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
CONFIDENTIAL
12334