(44 days)
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI or ML algorithms for diagnosis, treatment planning, or device operation.
Yes
The device is intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea (OSA), which are medical conditions, and functions as a mandibular repositioner to improve breathing, indicating a therapeutic purpose.
No
The device is described as a treatment for snoring and sleep apnea, functioning as a mandibular repositioner. It does not mention any diagnostic capabilities but rather a mechanism to improve breathing.
No
The device description clearly states it is a physical, removable intraoral appliance made of chrome cobalt and stainless steel, with a mechanical adjustment mechanism. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Somnowell MAA Function: The Somnowell MAA is a mechanical device that is placed inside the mouth to physically reposition the jaw. It does not analyze any biological samples or provide diagnostic information based on such analysis.
- Intended Use: The intended use is for the treatment of snoring and sleep apnea, not for diagnosis.
- Device Description: The description focuses on the physical components and mechanical action of the device.
- Lack of IVD-related information: There is no mention of analyzing samples, using reagents, or providing diagnostic results.
Therefore, the Somnowell Mandibular Advancement Appliance is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Somnowell Mandibular Advancement Appliance (Somnowell MAA) is intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older.
Product codes
LRK
Device Description
The Somnowell Mandibular Advancement Appliance (Somnowell MAA) is a removable intraoral device used for treating night time snoring and mild to moderate obstructive sleep apnea. It consists of two customized fabricated chrome cobalt (Vitallium 2) frameworks that conform to the patient's dentition in the upper and lower jaws and are connected bilaterally via a stainless steel telescoping Herbst device. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to improve the patient's ability to breathe during sleep without obstruction of the pharyngeal airway. The device is customized according to the prescription of the prescribing dentist for each patient. It has an adjustment mechanism enabling the amount of mandibular advancement to be set or altered by the dentist. The maximum protrusion and allowable increments of adjustment are 5mm.
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
Indicated for use 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)
Non Clinical Testing - Bench testing were carried out : Static Arch-Compression Test and Resistance to fracture and distortion. No used standards. These tests intended to simulate the mechanical force applied by during normal use of the Somnowell appliance is not intended to be worn during mastication of food. Test results have demonstrated that Somnowell MAA is capable of withstanding the applied horizontal forces without distortion or fracture, and that the fixing part joints were capable of withstanding the applied horizontal forces without distortion or breakage. Test results have proven that the device performance and its intended use are as safe and as effective as its predicate devices. The Somnowell MAA shares the same intended use, raw material, design, technological characteristics as its predicate devices and raises no new safety and/or effectiveness issues, thus, the Somnowell MAA is considered to be substantially equivalent to its predicate devices.
Biocompatibility Cytotoxicity Test was carried out with accordance to ISO 10993-5. Results have demonstrated that no evidence of causing cell lysis or toxicity is related to Somnowell used raw material. Test results have proven that in similar to the predicate devices, no risk is raised by the used raw material of Somnowell MAA.
Clinical testing - No clinical data is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2015
Somnowell, Ltd. c/o Mr. David Yungvirt Third Party Review Group, LLC 45 Rockefeller Plaza. Suite 2000 New York, NY 1011
Re: K150941
Trade/Device Name: Somnowell Mandibular Advancement Appliance (MAA) Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: II Dated: May 3, 2015 Received: May 7, 2015
Dear Mr. 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.
Sincerely yours,
Tina
Kiang-S
for 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
2
Indications for Use
510(k) Number (if known)
Device Name
Somnowell Mandibular Advancement Appliance (Somnowell MAA)
Indications for Use (Describe)
The Somnowell Mandibular Advancement Appliance (Somnowell MAA) is intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the Somnowell logo, which includes the letters 'SW' inside of a blue circle. Below the logo is the word 'SOMNOWELL' in a stylized font, followed by the tagline 'A Lifetime of Good Sleep.' The text '510(k) Summary (21 CFR 807.92)' is at the bottom of the image.
510(k) Number K ______________________________________________________________________________________________________________________________________________________________
| 1 Applicant/Submitter | Somnowell Ltd.
Dr. Simon Ash - Managing Director
Ideas House
Station Estate
London
E18 1BY
United Kingdom
Tel: +44 (0) 208 123 0432
Fax: +44 (0) 208 082 5164
Email: simon.ash@somnowell.com | | | | | | | | | | | | | | | |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|---|----------------------|--------------|---|-----|---------------|---|----------|-------|---|----|-------|---|--------|
| 2 Official Correspondent
Contact Person | Sterling Medical Registration
Daniela Levy - Regulatory Consultant
22817 Ventura blvd
Woodland Hills, CA 91364, USA
Phone 213-787-3026
Email: daniela@sterlingmedicalregistration.com | | | | | | | | | | | | | | | |
| 3 Submission Date | 29 March 2015 | | | | | | | | | | | | | | | |
| 4 Device Trade Name | Somnowell MAA | | | | | | | | | | | | | | | |
| 5 Regulation Description | Intraoral devices for snoring and intraoral devices
for snoring and obstructive sleep apnea (OSA) | | | | | | | | | | | | | | | |
| 6 Classification | Device Name:Device, Anti-SnoringProduct Code:LRKRegulation No:872.5570Class:IIPanel:Dental | Device Name | : | Device, Anti-Snoring | Product Code | : | LRK | Regulation No | : | 872.5570 | Class | : | II | Panel | : | Dental |
| Device Name | : | Device, Anti-Snoring | | | | | | | | | | | | | | |
| Product Code | : | LRK | | | | | | | | | | | | | | |
| Regulation No | : | 872.5570 | | | | | | | | | | | | | | |
| Class | : | II | | | | | | | | | | | | | | |
| Panel | : | Dental | | | | | | | | | | | | | | |
| 7 Reason for the Premarket Notification Submission : | New Device | | | | | | | | | | | | | | | |
| 8 Identification of Legally Marketed Predicate Devices : | | | | | | | | | | | | | | | | |
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Image /page/4/Picture/0 description: The image shows the logo for Somnowell, a company focused on sleep solutions. The logo features a stylized blue globe with the letters "SW" intertwined in white at the top. Below the globe, the company name "SOMNOWELL" is written in a bold, sans-serif font. Underneath the name, the tagline "A Lifetime of Good Sleep" is displayed in a smaller, serif font.
- The Somnowell Mandibular Advancement Appliance (Somnowell MAA) is substantially equivalent to K113516 TheraSom-CAST; in terms of intended use, indication for use, technological characteristics and performance.
The predicate devices are a Class II medical device.
ರಿ Device Description
- The Somnowell Mandibular Advancement Appliance (Somnowell MAA) is a . removable intraoral device used for treating night time snoring and mild to moderate obstructive sleep apnea. It consists of two customized fabricated chrome cobalt (Vitallium 2) frameworks that conform to the patient's dentition in the upper and lower jaws and are connected bilaterally via a stainless steel telescoping Herbst device. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to improve the patient's ability to breathe during sleep without obstruction of the pharyngeal airway. The device is customized according to the prescription of the prescribing dentist for each patient. It has an adjustment mechanism enabling the amount of mandibular advancement to be set or altered by the dentist. The maximum protrusion and allowable increments of adjustment are 5mm.
10 Intended use
- The Somnowell Mandibular Advancement Appliance (Somnowell MAA) is intended . for the treatment of night time snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older.
11 Performance Standards or Special Controls
- . Recognized Consensus Standard: ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
- . FDA guidance document: Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA
- . ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
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Image /page/5/Picture/0 description: The image features the logo for Somnowell, a company focused on sleep solutions. The logo consists of a blue sphere with the letters "SW" intertwined in white, positioned above the company name "SOMNOWELL" in a bold, sans-serif font. Below the name is the tagline "A Lifetime of Good Sleep." in a smaller font, emphasizing the company's commitment to improving sleep quality.
12 Substantial Equivalence
| Substantial Equivalent
| Table | Somonwell MAA | TheraSom-CAST |
|---|---|---|
| 510K | K113516 | |
| Company Name | Somnowell Ltd | FAMILY DENTAL SERVICES, |
| P.C. | ||
| Product Code | LRK | LRK |
| Classification | Class II | Class II |
| Indication for Use | The Somnowell Mandibular | |
| Advancement Appliance | ||
| (Somnowell MAA) is intended for | ||
| the treatment of night time | ||
| snoring and mild to moderate | ||
| obstructive sleep apnea (OSA) in | ||
| patients 18 years of age or older. | The TheraSom-CAST is used | |
| to reduce or alleviate the | ||
| occurrence of snoring and/or | ||
| for the treatment of mild to | ||
| moderate obstructive sleep | ||
| apnea (OSA) in | ||
| patients 18 years of age or older. | ||
| Reusable / Single Use | Reusable | Reusable |
| Environment Use | Indicated for use at home | |
| or sleep laboratories | Indicated for use at home | |
| or sleep laboratories | ||
| Target population | Adults patients | Adults patients |
| Prescription Device/ OTC | Prescription Device | Prescription Device |
| Design | Customized device | |
| Compromised from upper and | ||
| lower trays. |
Upper and lower tray unhook
for easy removal from mouth. | Customized device
Compromised from upper and
lower trays.
Upper and lower tray unhook for
easy removal from mouth. |
| Connection of trays | Herbst mechanism
Stainless steel | Locking mechanism
Stainless steel tension springs. |
| Functionality | The device functions as a
mandibular repositioner,
maintaining the lower jaw in a
forward position during sleep.
To be Placed in patient mouth
each evening
Easily removed by patient.
Permits patients to breathe
through mouth. | The device functions as a
mandibular repositioner,
which acts to improve the
patient's ability to breathe
without obstruction of the
pharyngeal airway.
To be Placed in patient mouth
each evening
Easily removed by patient.
Permits patients to breathe
through mouth. |
| Adjustment | It has an adjustment
mechanism enabling the
amount of mandibular | The springs may vary in lengths
and may be moved to adjust the
relative positions of the |
| | | |
| | advancement to be set or
altered using titration key. | upper and lower components
so as to set the distance of the
mandibular advancement. |
| | The maximum protrusion and
allowable increments of
adjustment are 5mm. | The maximum protrusion
and allowable increments of
adjustment are 5mm. |
| Cleaning Instructions | Daily cleaning by patient | Daily cleaning by patient |
| Used Raw Material for
Upper and Lower Trays | Chrome Cobalt | Chrome Cobalt |
| Used Raw Material for
fixation parts | Stainless Steel | Stainless Steel |
| Provided Sterile/ Non
Sterile | Non Sterile | Non Sterile |
6
DOVE
Summary of Equivalence: The Somnowell MAA is considered to be substantially equivalent to K113516 TheraSom-CAST in terms of intended use, indication for use, technological characteristics and performance.
Similar to its predicate device the Somnowell MAA is a customized device, consists of two parts, upper and lower trays. Somnowell MAA uses chrome cobalt (Vitallium 2) which is the same as its predicate device K113516 TheraSom-CAST. The used chrome cobalt (Vitallium 2) has been cleared for marketing within K970205. The chrome cobalt (Vitallium 2) casted framework is substantially equivalent to the cast framework used in dentures used prior to 1976. The dental alloy framework provides strength to the device.
The Somnowell MAA in similar to its predicate device is adjustable using titration keys and a screw which enables the jaw to be brought forward in small advancements.
The difference it that Somnowell MAA uses side placement of buccal locking mechanism -Herbst mechanism, (which can be found in other appliances such as SomnoDent Herbst K130558); and the predicate device K113516 TheraSom-CAST uses locking mechanism of tension springs. This difference raises no safety and/or effectiveness issues as has been demonstrated by bench testing.
The Somnowell MAA shares the same technological characteristics as its predicate device and raises no new issues of safety or effectiveness, thus, the Somnowell MAA is considered to be substantially equivalent to its predicate devices.
7
Image /page/7/Picture/0 description: The image contains the logo for Somnowell, a company focused on sleep solutions. The logo features a blue sphere with the letters "SW" intertwined in white within it. Below the sphere, the company name "SOMNOWELL" is written in a bold, sans-serif font, with the tagline "A Lifetime of Good Sleep." positioned beneath the name.
Risk Assessment was conducted with accordance to ISO 14971 2007. The risk assessment raised all potential risks involved with the use of the device, used raw materials, performance, contraindications, warnings and risks to health. The main risks to health generally associated with the use of Somnowell MAA, as in similar to its predicate device and other intraoral devices for snoring and/or obstructive sleep apnea, are as follow:
- Intraoral gingival, palatal, or dental soreness .
- Temporomandibular Joint (TMJ) Dysfunction Syndrome .
- . Obstruction of oral breathing
- Loosening or flaring of lower anterior teeth or general tooth movement .
Instructions for use addresses these risks by identifying the used raw material, contraindications, warning, precautions and the recommendation on follow up visitation. The Somnowell MAA shares the same intended use, raw material, design, technological characteristics, warnings, contraindications as its predicate devices and raises no new safety and/or effectiveness issues, thus, the Somnowell MAA is considered to be substantially equivalent to its predicate devices.
Performance Testing
Non Clinical Testing - Bench testing were carried out : Static Arch-Compression Test and Resistance to fracture and distortion. No used standards. These tests intended to simulate the mechanical force applied by during normal use of the Somnowell appliance is not intended to be worn during mastication of food. Test results have demonstrated that Somnowell MAA is capable of withstanding the applied horizontal forces without distortion or fracture, and that the fixing part joints were capable of withstanding the applied horizontal forces without distortion or breakage. Test results have proven that the device performance and its intended use are as safe and as effective as its predicate devices. The Somnowell MAA shares the same intended use, raw material, design, technological characteristics as its predicate devices and raises no new safety and/or effectiveness issues, thus, the Somnowell MAA is considered to be substantially equivalent to its predicate devices.
Biocompatibility Cytotoxicity Test was carried out with accordance to ISO 10993-5. Results have demonstrated that no evidence of causing cell lysis or toxicity is related to Somnowell used raw material. Test results have proven that in similar to the predicate devices, no risk is
8
Image /page/8/Picture/0 description: The image contains the logo for Somnowell. The logo features a blue sphere with the letters "SW" in white inside. Below the sphere is the word "SOMNOWELL" in a stylized, sans-serif font, also in blue. Underneath the company name is the tagline "A Lifetime of Good Sleep" in a smaller, simpler font.
raised by the used raw material of Somnowell MAA. The Somnowell MAA shares the same intended use, raw material, design, technological characteristics as its predicate devices and raises no new safety and/or effectiveness issues, thus, the Somnowell MAA is considered to be substantially equivalent to its predicate devices.
Clinical testing - No clinical data is included in this submission.
Conclusion:
Somnowell MAA shares similarity with its predicated devices in terms of intended use, indication for use, raw material, technological characteristics and performance, as also has been demonstrated by bench testing, risk assessment and substantial equivalent table. The fundamental scientific technology of the device is identical or very similar to the referenced predicate devices, thus Somnowell MAA is as safe and as effective for its intended use and performs as well as the predicate devices and thus considered to be substantially equivalent to its predicate devices.