(44 days)
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 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.
The provided text describes the Somnowell Mandibular Advancement Appliance (Somnowell MAA) and its submission for FDA clearance. The document focuses on demonstrating substantial equivalence to a predicate device, TheraSom-CAST (K113516), rather than on presenting a study with specific acceptance criteria and performance metrics for the Somnowell MAA itself.
Therefore, many of the requested details about a study proving the device meets acceptance criteria, such as clinical performance, sample sizes, expert ground truth, adjudication methods, and MRMC studies, are not available in this document. The submission explicitly states "Clinical testing - No clinical data is included in this submission."
However, I can extract information regarding non-clinical testing (bench testing) and the general claims of substantial equivalence based on technological characteristics and performance compared to the predicate.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no specific quantitative acceptance criteria or clinical performance metrics for the Somnowell MAA are provided, I'll list the general performance claims and the results of the bench testing. The "acceptance criteria" here are implicitly linked to demonstrating equivalence to the predicate's performance in mechanical tests.
| Acceptance Criterion (Implicit) | Reported Device Performance (Somnowell MAA) |
|---|---|
| Withstand mechanical forces without distortion or fracture (Static Arch-Compression Test) | Test results demonstrated that Somnowell MAA is capable of withstanding the applied horizontal forces without distortion or fracture. |
| Fixing part joints capable of withstanding forces without distortion or breakage | Test results demonstrated that the fixing part joints were capable of withstanding the applied horizontal forces without distortion or breakage. |
| Biocompatibility (ISO 10993-5 Cytotoxicity Test) | Results demonstrated no evidence of causing cell lysis or toxicity related to Somnowell's raw material. No risk is raised by the used raw material. |
| Mechanical performance for intended use (implied, by comparison to predicate) | "Test results have proven that the device performance and its intended use are as safe and as effective as its predicate devices." "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." 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. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Bench Testing): Not specified.
- Data Provenance: Not specified, but generally refers to laboratory bench testing conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was bench testing, not a clinical study requiring expert diagnosis or ground truth establishment in that context.
4. Adjudication method for the test set:
- Not applicable for bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC clinical study was conducted. The submission explicitly states "Clinical testing - No clinical data is included in this submission." This device is a physical appliance, not an AI or imaging diagnostic tool, so an MRMC study is not relevant to its type of evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not an algorithm or AI device. Standalone performance as commonly understood in AI/software evaluation is not applicable.
7. The type of ground truth used:
- For the bench tests, the "ground truth" would be the engineering specifications and expected mechanical properties, tested against established laboratory methods. For biocompatibility, it's compliance with ISO 10993-5 (absence of cytotoxicity).
8. The sample size for the training set:
- Not applicable, as this is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
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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.
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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
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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)
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)
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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 DirectorIdeas HouseStation EstateLondonE18 1BYUnited KingdomTel: +44 (0) 208 123 0432Fax: +44 (0) 208 082 5164Email: simon.ash@somnowell.com | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2 Official CorrespondentContact Person | Sterling Medical RegistrationDaniela Levy - Regulatory Consultant22817 Ventura blvdWoodland Hills, CA 91364, USAPhone 213-787-3026Email: daniela@sterlingmedicalregistration.com | |||||||||||||||
| 3 Submission Date | 29 March 2015 | |||||||||||||||
| 4 Device Trade Name | Somnowell MAA | |||||||||||||||
| 5 Regulation Description | Intraoral devices for snoring and intraoral devicesfor 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 EquivalentTable | 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 MandibularAdvancement Appliance(Somnowell MAA) is intended forthe treatment of night timesnoring and mild to moderateobstructive sleep apnea (OSA) inpatients 18 years of age or older. | The TheraSom-CAST is usedto reduce or alleviate theoccurrence of snoring and/orfor the treatment of mild tomoderate obstructive sleepapnea (OSA) inpatients 18 years of age or older. |
| Reusable / Single Use | Reusable | Reusable |
| Environment Use | Indicated for use at homeor sleep laboratories | Indicated for use at homeor sleep laboratories |
| Target population | Adults patients | Adults patients |
| Prescription Device/ OTC | Prescription Device | Prescription Device |
| Design | Customized deviceCompromised from upper andlower trays.Upper and lower tray unhookfor easy removal from mouth. | Customized deviceCompromised from upper andlower trays.Upper and lower tray unhook foreasy removal from mouth. |
| Connection of trays | Herbst mechanismStainless steel | Locking mechanismStainless steel tension springs. |
| Functionality | The device functions as amandibular repositioner,maintaining the lower jaw in aforward position during sleep.To be Placed in patient moutheach eveningEasily removed by patient.Permits patients to breathethrough mouth. | The device functions as amandibular repositioner,which acts to improve thepatient's ability to breathewithout obstruction of thepharyngeal airway.To be Placed in patient moutheach eveningEasily removed by patient.Permits patients to breathethrough mouth. |
| Adjustment | It has an adjustmentmechanism enabling theamount of mandibular | The springs may vary in lengthsand may be moved to adjust therelative positions of the |
| advancement to be set oraltered using titration key. | upper and lower componentsso as to set the distance of themandibular advancement. | |
| The maximum protrusion andallowable increments ofadjustment are 5mm. | The maximum protrusionand allowable increments ofadjustment are 5mm. | |
| Cleaning Instructions | Daily cleaning by patient | Daily cleaning by patient |
| Used Raw Material forUpper and Lower Trays | Chrome Cobalt | Chrome Cobalt |
| Used Raw Material forfixation parts | Stainless Steel | Stainless Steel |
| Provided Sterile/ NonSterile | Non Sterile | Non Sterile |
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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.
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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
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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.
§ 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.”