(74 days)
Not Found
No
The document describes a mechanical intraoral device for treating sleep apnea and snoring. There is no mention of AI, ML, or any computational analysis of data for diagnosis, treatment planning, or device adjustment. The adjustment is manual by a dentist or physician.
Yes
The device is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea, which are conditions that require therapeutic intervention.
No
The device is an intraoral appliance intended for the treatment of snoring and sleep apnea, functioning as a mandibular repositioner to increase pharyngeal space. It does not mention any diagnostic capabilities or functions.
No
The device description explicitly states it is an "intraoral device" and describes its physical function as a "mandibular repositioner," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SomnoDent Herbst Function: The SomnoDent Herbst is an intraoral device that physically repositions the mandible to treat snoring and sleep apnea. It works mechanically within the patient's mouth and does not involve the analysis of any biological specimens.
The description clearly states its function as a "mandibular repositioner" and its use in increasing "pharyngeal space." This is a physical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The SomnoDent Herbst 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 Herbst 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 Herbst is a modification to the SomnoDent Classic (K050592) and SomnoDent Flex (K073004). The labeling is a modification to the SomnoDent G2 (K121340). The SomnoDent Herbst is identical to SomnoDent Classic and SomnoDent Flex, except for differences in the adjustment mechanism (which is a Herbst style titration 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
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, 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 Herbst style titration 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 Herbst, is as safe, as effective, and performs as well as or better than the predicate devices, the SomnoDent Classic and 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, a company that specializes in dental, sleep, and medical solutions. The logo features a stylized graphic above the company name, with the words "Dental - Sleep - Medical" appearing in smaller font beneath the name. The overall design is clean and professional, reflecting the company's focus on healthcare and well-being.
510(k) Summary (21 CFR 807.92)
MAY 1 7 2013
Page 1 of 3
510(k) Number: K (3 0558
Submission Owner:
Date Prepared:
Common Name:
Product Code:
Class:
Panel:
Trade Name:
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 March 1, 2013 SomnoDent® Herbst Intraoral device for snoring and mild to moderate obstructive sleep apnea (OSA) Classification Name: Device. Anti-Snoring Regulation Number: 21 CFR 872.5570 LRK . Dental Predicate Devices: K050592, SomnoDent Classic K073004, SomnoDent Flex K121340, SomnoDent G2
Description of the device:
The SomnoDent Herbst 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 Herbst is a modification to the SomnoDent Classic (K050592) and SomnoDent Flex (K073004). The labeling is a modification to the SomnoDent G2 (K121340). The SomnoDent Herbst is identical to SomnoDent Classic and SomnoDent Flex, except for differences in the adjustment mechanism (which is a Herbst style titration mechanism). Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.
Indications for Use:
The SomnoDent Herbst is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.
1
Image /page/1/Picture/0 description: The image shows the logo for SomnoMed. The logo consists of a stylized black 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
:
: .
| | SomnoDent
Herbst | SomnoDent
Classic
K050592 | SomnoDent
Flex
K073004 | SomnoDent
G2
K121340 |
|------------------------------------------------------------------------------------------|----------------------------|---------------------------------|------------------------------|----------------------------|
| Intended Use | | | | |
| Intended as an intraoral
device | Yes | Yes | Yes | Yes |
| Intended to reduce
snoring or help alleviate
snoring | Yes | Yes | Yes | Yes |
| Treatment of mild to
moderate obstructive
sleep apnea | Yes | Yes | Yes | Yes |
| Intended for nighttime use | Yes | Yes | Yes | Yes |
| Indicated for single
patient multiuse | Yes | Yes | Yes | Yes |
| Indicated for use at home
or sleep laboratories | Yes | Yes | Yes | Yes |
| Target population: adults | Yes | Yes | Yes | Yes |
| Prescription device | Yes | Yes | Yes | Yes |
| Design | | | | |
| Customized fit for each
patient (patient specific) | Yes | Yes | Yes | Yes |
| Separate upper and lower
tray pieces | Yes | Yes | Yes | Yes |
| Works by mandibular
advancement | Yes | Yes | Yes | Yes |
| Can be adjusted or refit | Yes | Yes | Yes | Yes |
| Lower jaw adjustment
using supplied
components | Yes | Yes | Yes | Yes |
| Permits patient to breathe
through mouth | Yes | Yes | Yes | Yes |
| Upper and lower trays
disengage for easy
removal | Yes | Yes | Yes | Yes |
| Cleaned and inspected
daily by patient | Yes | Yes | Yes | Yes |
| | SomnoDent Herbst | SomnoDent Classic
K050592 | SomnoDent Flex
K073004 | SomnoDent G2
K121340 |
| Material | | | | |
| Trays constructed from a
soft lining material
adhered to a hard surface
acrylic | Yes (Flex)
No (Classic) | No | Yes | Yes (Flex)
No (Classic) |
| Advancement mechanism
constructed of surgical
grade stainless steel | Yes | Yes | Yes | No |
・
2
Image /page/2/Picture/0 description: The image shows the logo for SomnoMed, a company specializing in dental, sleep, and medical solutions. The logo features a stylized graphic above the company name, resembling two overlapping shapes. Below the name, the words "Dental • Sleep • Medical" are printed in a smaller font, indicating the company's areas of focus.
510(k) Summary (21 CFR 807.92)
Page 3 of 3
Substantial equivalence discussion:
The SomnoDent Herbst is considered to be substantially equivalent to the SomnoDent Classic, Flex, and G2 device. The SomnoDent Herbst 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 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 Herbst is identical to SomnoDent Classic, Flex, and G2 except for differences in the adjustment mechanism (which is a Herbst style titration mechanism. The SomnoDent Herbst 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 Herbst style titration 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 Herbst, is as safe, as effective, and performs as well as or better than the predicate devices, the SomnoDent Classic and SomnoDent Flex.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized waves or curves, stacked vertically.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2013
Ms. Kathryn A. Jayne SomnoMed, Incorporated 7460 Warren Parkway, Suite 190 FRISCO TX 75034
Re: K130558
Trade/Device Name: SomnoDent Herbst 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: April 5, 2013 Received: April 17, 2013
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 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
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Kwame O. Ulmer -S for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/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 above the company name, with the words "Dental - Sleep - Medical" written in a smaller font below. The logo is simple and modern, and it conveys the company's focus on health and wellness.
Indications for Use
510(k) Number (if known): K130558
Device Name: SomnoDent Herbst
Indications for Use:
The SomnoDent Herbst 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 _ X 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)
Susan Runner, DDSMA
Digitally signed by Mary S. Runner -S
DN: US/o=U.S. Government, ou=HHS,
Our FDA, ou People, cn=Mary S. Runner
0.9.2342.19200300.100.1.1-1300087950
Date: 2013.05.17 11:39:00-04'00'
ivision Sign-Offi on of Anesthesiology, General Hospital Infection Control. Dent
510(k) Number: K120558
SomnoMed Herbst Special 510(k) Submission