(137 days)
No
The summary describes a mechanical intraoral device with an adjustable mechanism and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The text states the device is "intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea". Treatment implies a therapeutic purpose.
No
The device description clearly states it is an "intraoral device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea" and "functions as a mandibular repositioner," indicating a therapeutic purpose rather than diagnostic.
No
The device description explicitly states it is an "intraoral device" and a "mandibular repositioner," which are physical hardware components. The performance studies also focus on mechanical testing of the device's mechanism.
Based on the provided information, the SomnoDent Fusion is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is an intraoral device that functions as a mandibular repositioner. It physically alters the patient's anatomy (pharyngeal space) to improve airflow. This is a physical intervention, not a test performed on a sample from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), chemical reactions, or diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SomnoDent Fusion does not fit this description. It is a medical device used for treatment.
N/A
Intended Use / Indications for Use
The SomnoDent Fusion 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 Fusion 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 patient specific (it 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 Fusion is a modification to the SomnoDent Classic (K050592), SomnoDent Flex (K073004), SomnoDent G2 (K121340) and SomnoDent Herbst (K130558). The SomnoDent Fusion is identical to SomnoDent Classic, SomnoDent Flex, SomnoDent G2, and SomnoDent Herbst except for differences in the adjustment mechanism. 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
Not Found
Indicated Patient Age Range
18 years of age or 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, testing was conducted on the advancement mechanism to ensure the device performed as intended and is safe and effective. Mechanical testing was conducted on the calibration mechanism of the subject device. Testing results indicate that the mechanism withstands applicable pressures, ensuring the device is safe and effective. 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 Fusion, is as safe, as effective, and performs as well as or better than the predicate devices, the SomnoDent Classic, SomnoDent Flex, SomnoDent G2, and SomnoDent Herbst.
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/0 description: The image shows the logo for SomnoMed. The logo consists of a stylized graphic above the company name. Below the company name are the words "Dental * Sleep * Medical".
510(k) Summary (21 CFR 807.92)
JUN 2 0 2014
Page 1 of 4
510(k) Number: К | Чб278
| Submission Owner: | SomnoMed, Inc. |
|---|---|
| 7460 Warren Parkway | |
| Suite 190 | |
| Frisco, TX 75034 | |
| Phone: 888-447-6673 x106 | |
| Fax: 972-377-3404 | |
| Email: kjayne@somnomed.com | |
| Official Correspondent: | Kathryn A. Jayne |
| Date Prepared: | January 31, 2014 |
| Trade Name: | SomnoDent® Fusion |
| 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: | K050592, SomnoDent Classic |
| K073004, SomnoDent Flex | |
| K121340, SomnoDent G2 |
Description of the device:
The SomnoDent Fusion 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 patient specific (it 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 Fusion is a modification to the SomnoDent Classic (K050592), SomnoDent Flex (K073004), SomnoDent G2 (K121340) and SomnoDent Herbst (K130558). The SomnoDent Fusion is identical to SomnoDent Classic, SomnoDent Flex, SomnoDent G2, and SomnoDent Herbst except for differences in the adjustment mechanism. Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.
Indications for Use:
The SomnoDent Fusion 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, the words "Dental * Sleep * Medical" are printed in a smaller font.
510(k) Summary (21 CFR 807.92)
Substantial Equivalence:
Substantial Equivalence Table
| | SomnoDent
Fusion | SomnoDent
Classic
K050592 | SomnoDent
Flex
K073004 | SomnoDent
G2
K121340 | SomnoDent
Herbst
K130558 |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------|---------------------------------|------------------------------|------------------------------------------------------|------------------------------------------------------|
| Intended Use | | | | | |
| Intended as an
intraoral device | Yes | Yes | Yes | Yes | Yes |
| Intended to
reduce snoring
or help alleviate
snoring | Yes | Yes | Yes | Yes | Yes |
| Treatment of
mild to
moderate
obstructive
sleep apnea | Yes | Yes | Yes | Yes | Yes |
| Intended for
nighttime use | Yes | Yes | Yes | Yes | Yes |
| Indicated for
single patient
multiuse | Yes | Yes | Yes | Yes | Yes |
| Indicated for
use at home or
sleep
laboratories | Yes | Yes | Yes | Yes | Yes |
| Target
population:
adults | Yes | Yes | Yes | Yes | Yes |
| Prescription
device | Yes | Yes | Yes | Yes | Yes |
| Design | | | | | |
| Customized fit
for each patient
(patient
specific) | Yes | Yes | Yes | Yes | Yes |
| Separate upper
and lower tray
pieces | Yes | Yes | Yes | Yes | Yes |
| Works by
mandibular
advancement | Yes | Yes | Yes | Yes | Yes |
| | SomnoDent
Fusion | SomnoDent Classic
K050592 | SomnoDent Flex
K073004 | SomnoDent G2
K121340 | SomnoDent Herbst
K130558 |
| Can be
adjusted or refit | Yes | Yes | Yes | Yes | Yes |
| Lower jaw
adjustment
using supplied
components | Yes | Yes | Yes | Yes | Yes |
| Permits patient
to breathe
through mouth | Yes | Yes | Yes | Yes | Yes |
| Upper and
lower trays
disengage for
easy removal | Yes | Yes | Yes | Yes | Yes |
| Cleaned and
inspected daily
by patient | Yes | Yes | Yes | Yes | Yes |
| Material | | | | | |
| Trays
constructed
from a soft
lining material
adhered to a
hard surface
acrylic | Yes
(Flex retention)
No
(Classic retention) | No | Yes | Yes
(Flex retention)
No
(Classic retention) | Yes
(Flex retention)
No
(Classic retention) |
| Advancement
mechanism
constructed of
surgical grade
stainless steel | Yes | Yes | Yes | No | Yes |
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Image /page/2/Picture/0 description: The image shows the logo for SomnoMed. The logo consists of a stylized black shape above the name "SomnoMed" in a bold, sans-serif font. Below the name, in a smaller font, are the words "Dental • Sleep • Medical".
510(k) Summary (21 CFR 807.92) Page 4 of 4
SomnoMed SomnoDent Fusion 510(k) Submission
5 - 4
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510(k) Summary (21 CFR 807.92) Page 4 of 4
Substantial equivalence discussion:
The SomnoDent Fusion is considered to be substantially equivalent to the SomnoDent Classic, Flex, G2, and Herbst device. The SomnoDent Fusion and predicate devices 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 patient specific (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 Fusion is identical to SomnoDent Classic, Flex, G2, and SomnoDent Herbst except for differences in the adjustment. The SomnoDent Fusion will be available in one of two material types, acrylic (identical to SomnoDent Classic) or soft lining adhered to acrylic (SomnoDent Flex). 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, testing was conducted on the advancement mechanism to ensure the device performed as intended and is safe and effective. Mechanical testing was conducted on the calibration mechanism of the subject device. Testing results indicate that the mechanism withstands applicable pressures, ensuring the device is safe and effective. 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 Fusion, is as safe, as effective, and performs as well as or better than the predicate devices, the SomnoDent Classic, SomnoDent Flex, SomnoDent G2, and SomnoDent Herbst.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2014
SomnoMed. Incorporated Ms. Kathryn Jayne Regulatory Affairs/Quality Assurance Manager 7460 Warren Parkway, Suite 190 Frisco, TX 75034
Re: K140278
Trade/Device Name: SomnoDent Fusion Classic, Somnodent Fusion Flex Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Il
Product Code: LRK Dated: June 4, 2014 Received: June 5, 2014
Dear Ms. Jayne:
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 10 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.
5
Page 2 - Ms. Jayne
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. 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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Image /page/6/Picture/0 description: The image shows the logo for SomnoMed, a company that specializes in dental, sleep, and medical solutions. The logo features a stylized graphic of two overlapping shapes, one solid black and the other filled with white dots. Below the graphic is the company name, "SomnoMed," in a bold, sans-serif font, with the words "Dental • Sleep • Medical" in a smaller font underneath.
DEPARTMENT OF KEALTH AND HUMAN SERVICES
Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
.
610(k) Number (if known)
Device Name SonnoDent Fusion
Indications for Use (December)
Indications for Use (Decorde)
The Sommonlews Fission is imment of sightines maring and mild to modests obstructive sloep spass in patients 18 years of age or 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) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Sheena A. Green -S |
|---|---|
| 2014.06.20 13:21:29 -04'00' | |
| FORM FDA 3881 (1/14) | Page 1 of 2 |
CONFIDENTIAL SomnoMed SomnoDent Fusion Special 510(k) Submission
4 - 2