(125 days)
A customized mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.
The Medley Gold series oral appliance design concept is based upon the use of a standard set of upper and lower trays that have been customized by a dentist that then may have one of three (3) options attached to the trays to act as a Mandibular Repositioning Device (MRD).
The rationale for have a single set of customized trays that may have different MRD methods attached is that some patients have a personal preference and some configurations are more comfortable for them. Therefore rather than having to make another set of custom travs, the dentist may use the same trays and just change the method of MRD, i.e. bands, links, or rods, to the same set of trays.
The principle of advancing a lower tray so that it advances the mandible for the treatment of snoring and / or obstructive sleep apnea is well known and there a number of predicate devices.
The proposed Medley Gold device has three (3) methods of advancing the lower tray based upon the identical designs of 3 already cleared predicate designs.
The provided text describes the Medley Gold series oral appliances, which are intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients. The device comes in three configurations: Band, Link, and Rod, each compared to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The Medley Gold device's acceptance criteria are not explicitly stated as quantitative performance metrics. Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices. The "performance" is implicitly defined by meeting or being similar to the characteristics of these legally marketed predicate devices.
| Feature / Acceptance Criteria (Implicit) | Medley Gold - Band Performance (vs. Frantz EMA K971794) | Medley Gold - Link Performance (vs. ResMed Narval CC K113201) | Medley Gold - Rod Performance (vs. Strong Dental SUAD K023836) |
|---|---|---|---|
| Indications for Use: Reduce/alleviate night-time snoring and mild to moderate OSA in adults 18+. | Substantially equivalent to Frantz EMA (treating snoring and OSA). | Substantially equivalent to ResMed Narval CC (reduce/alleviate snoring and treat OSA). | Substantially equivalent to Strong Dental SUAD (reduce/alleviate snoring and OSA). |
| Technology/Principle of Operation: Mandibular advancement. | Substantially equivalent to Frantz EMA (separate tray design, elastomeric bands for adjustment). Uses identical EMA bands. | Substantially equivalent to ResMed Narval CC (separate tray design, links of different lengths for adjustment). | Substantially equivalent to Strong Dental SUAD (separate tray design, adjustable rods for adjustment). |
| Materials: Standard off-the-shelf dental materials in contact with patient. | Uses Durasoft, Splint Biocryl, Biocryl X glue, supports, nuts, screws, bands. Described as "Similar materials" to predicate. | Uses Durasoft, Splint Biocryl, Biocryl X glue, supports, nuts, screws, links. Described as "Similar materials" to predicate. | Uses Durasoft, Splint Biocryl, Biocryl X glue, supports, nuts, rods, screws. Described as "Similar materials" to predicate. |
| Environment of Use: Home, Dental offices, Sleep laboratories. | Similar to Frantz EMA. | Substantially equivalent to ResMed Narval CC. | Substantially equivalent to Strong Dental SUAD. |
| Patient Population: Adult patients 18 years and older. | Substantially equivalent to Frantz EMA (18 years and older). | Substantially equivalent to ResMed Narval CC (18 years and older). | Substantially equivalent to Strong Dental SUAD (18 years and older). |
| Contraindications: (Central sleep apnea, severe respiratory disorders, loose teeth/advanced periodontal disease, under 18 years). | Identical to Frantz EMA. | Identical to ResMed Narval CC. | Identical to Strong Dental SUAD. |
| Prescription Use: Yes | Yes | Yes | Yes |
| Single patient, multi-use: Yes | Yes | Yes | Yes |
| Limitation of duration of use: No limitation | No limitation | No limitation | No limitation |
| Design (Customized tray): Yes | Yes | Yes | Yes |
| Design (Molded in supports): Yes | Yes (Medley Gold) / No (Frantz EMA) - Not a point of equivalence, but a design difference. | Yes (Medley Gold) / No (ResMed Narval CC) - Not a point of equivalence, but a design difference. | Yes |
| Design (Allows lateral and vertical movement): Yes | Yes | Yes | Yes |
| Protrusion Adjustment Range: | 8 mm in 1 mm increments | 8 mm in 1 mm increments (Medley Gold) / 15 mm in 1 mm increments (ResMed Narval CC) - Difference noted, but still considered substantially equivalent. | 8 mm in 1 mm increments (Medley Gold) / unlimited (Strong Dental SUAD) - Difference noted, but still considered substantially equivalent. |
| Physical Properties of Materials: | Materials for customized tray, bands, links, rods tested to demonstrate performance as intended. Note: Tray materials are standardized dental materials. | Materials for customized tray, bands, links, rods tested to demonstrate performance as intended. Note: Tray materials are standardized dental materials. | Materials for customized tray, bands, links, rods tested to demonstrate performance as intended. Note: Tray materials are standardized dental materials. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" involving human subjects or a particular dataset from patients to demonstrate the device's efficacy or safety. The study relies on non-clinical testing of the device's components and a comparison of its design and features with legally marketed predicate devices to establish substantial equivalence.
Therefore, there is:
- No specific sample size for a test set of human patients.
- No data provenance (e.g., country of origin, retrospective/prospective) for a clinical study because no such study on patients is described.
Instead, the "test set" is the Medley Gold device itself and its components, which underwent "specific tests to validate these components and the method of attachment to the trays" (page 7).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the clearance is based on non-clinical testing and substantial equivalence to predicate devices, not on a human-read clinical study requiring expert ground truth establishment for patient data.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as #3.
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
There was no MRMC comparative effectiveness study and no mention of AI. The Medley Gold device is a physical intraoral appliance, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical intraoral appliance, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this submission is the established safety and effectiveness profile of the predicate devices. The Medley Gold device is considered "substantially equivalent" if it shares similar technological characteristics, indications for use, and performs as safely and effectively as the predicate without raising new safety or performance concerns.
For the non-clinical testing of components, the "ground truth" would be established engineering specifications and material properties, which were tested against.
8. The Sample Size for the Training Set
There is no training set in the context of machine learning or AI models, as this device is a physical medical device.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as #8.
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JUN 2 6 2014
510(k) Summary Page 1 of 8 28-May-14
American Dental Sleep Medicine, IP, LLC 219 Ridgeview Drive Wexford, PA 15090
| Official Contact: | Mary Beth Rogers, President |
|---|---|
| Proprietary or Trade Name: | Medley Gold |
| Common/Usual Name: | Intraoral devices for snoring and obstructive sleep apnea |
| Classification Name: | LRK - Device, anti-snoring, intraoral devices for snoringand intraoral devices for snoring and obstructive sleep apnea21 CFR 872.5570Class 2 |
| Predicate Devices: | K971794 - Frantz - EMAK113201 - ResMed - Narval CCK023836 - Strong Dental - SUAD |
Device Description
The Medley Gold series oral appliance design concept is based upon the use of a standard set of upper and lower trays that have been customized by a dentist that then may have one of three (3) options attached to the trays to act as a Mandibular Repositioning Device (MRD).
The rationale for have a single set of customized trays that may have different MRD methods attached is that some patients have a personal preference and some configurations are more comfortable for them. Therefore rather than having to make another set of custom travs, the dentist may use the same trays and just change the method of MRD, i.e. bands, links, or rods, to the same set of trays.
The principle of advancing a lower tray so that it advances the mandible for the treatment of snoring and / or obstructive sleep apnea is well known and there a number of predicate devices.
The proposed Medley Gold device has three (3) methods of advancing the lower tray based upon the identical designs of 3 already cleared predicate designs.
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510(k) Summary Page 2 of 8 28-May-14
· Indications for Use
A customized mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.
Environment of Use
Home, Dental offices, and Sleep laboratories
Predicate Device Comparison:
We selected a predicate for each style of Medley Gold and present them in Table 1 below.
Table 1 - Rationale for the Predicate Selection
| Medley Gold | FrantzEMA (band)K971749 | ResMedNarval CC (links)K113201 | Strong DentalSUAD (rod)K023836 |
|---|---|---|---|
| Common features | |||
| Indications for use | Anti-snoringMild and moderate OSA | Anti-snoringMild and moderate OSA | Anti-snoringMild and moderate OSA |
| Patient population | 18 yo | 18 yo | 18 yo |
| Customized trays | Yes | Yes | Yes |
| Principle of operation | Mandibularadvancement | Mandibularadvancement | Mandibularadvancement |
| Means of advancement | |||
| Elastomeric bands | Yes | ||
| Link adjustable | Yes | ||
| Rod adjustable | Yes |
As can be seen above there are specific predicates for each configuration of the means to advancement, i.e., links, bands or rods. All the predicates and the proposed Medley Gold have the identical indications for use, patient population and environment of use.
We will discuss in more detail each Medley Gold style and the respective predicate in the following tables.
Table 2 - Medley Gold - Band vs. K971794 - Frantz EMA (Band)
| Medley GoldBand | FrantzEMAK971794 | |
|---|---|---|
| Indications for Use | A customized mandibularrepositioning device intended toreduce or alleviate night-time snoringand mild to moderate obstructive sleepapnea in adult patients 18 years orolder. | Treatment nasal respiratory dysfunctionof obstructive sleep apnea and snoringin those patients where advancement ofthe mandible and opening the bite canincrease the patient's air space. |
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510(k) Summary Page 3 of 8 28-May-14
| Environments of use | Home, dental and Physician offices,Sleep laboratories | Home, dental and Physician offices,Sleep laboratories |
|---|---|---|
| Patient Population | Adult patients 18 years and older | Adult patients 18 years and older |
| Contraindications | have central sleep apnea have severe respiratory disorders have loose teeth or advanced periodontal disease are under 18 years of age | have central sleep apnea have severe respiratory disorders have loose teeth or advanced periodontal disease are under 18 years of age |
| Prescription | Prescription use | Prescription use |
| Single patient, multi-use | Yes | Yes |
| Limitation of duration of use | No limitation | No limitation |
| Principle of operation / means ofmandibular advancement | Adjustment of the relative position ofthe splints by the use of elastic forcepulls the mandible forward andmaintains advancement thus enlargingthe airway. The vertical opening ofthe jaw is not fixed in a single position | Adjustment of the relative position ofthe splints by the use of elastic forcepulls the mandible forward andmaintains advancement thus enlargingthe airway. The vertical opening of thejaw is not fixed in a single position |
| Design | ||
| Customized tray | Yes | Yes |
| Molded in supports | Yes | No |
| Allows lateral and vertical movement | Yes | Yes |
| Buttons attach to frame to attachbands | Yes | Yes |
| Framework (support) inserted intoupper and lower trays | Yes | Yes |
| Maximum protrusion of the device | 8 mm adjusts in 1 mm increments | 8 mm adjusts in 1 mm increments |
| Adjustment method for setting theamount of protrusion | Elastomeric bands | Elastomeric bands |
| Works by holding lower jaw forward | Yes | Yes |
| Cleaned by simple rinsing with water | Yes | Yes |
| Materials of construction | DurasoftSplint BiocrylBiocryl X glueSupports, nuts, screwsBands | Similar materials |
The Medley Gold - Band is viewed as substantially equivalent to the predicate device because:
Indications -
Substantial equivalent to predicate – Frantz EMA – K971794. Indicated for treating snoring and obstructive sleep apnea (OSA).
Technology / Principle of Operation -
Substantial equivalent to predicate -- Frantz EMA - K971794. Both devices use a separate tray
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510(k) Summary Page 4 of 8 28-May-14
design with a means to adjust the lower jaw. The adjustment is a series of elastomeric bands which may be changed by the dentist to alter the mandible advancement. The proposed Medley Gold -Band is using the identical EMA bands.
Materials -
The materials in contact with the patient are standard off-the-shelf dental materials.
Environment of Use -
Similar to predicate - Frantz EMA - K971794. They are used in Home, Dental and Physician offices, and Sleep laboratories.
Patient Population -
Substantial equivalent to predicate -- Frantz EMA -- K971794. 18 years and older
Discussion - The proposed Medley Gold - band design is substantially equivalent to the predicate Frantz EMA (band) K971749 in all respects and does not raise any new safety or performance concerns.
Table 3 - Medley Gold - Link vs. K113201 - ResMed Narval CC
| Medley GoldLink | ResMedNarval CCK113201 | |
|---|---|---|
| Indications for Use | A customized mandibular repositioningdevice intended to reduce or alleviatenight-time snoring and mild to moderateobstructive sleep apnea in adult patients18 years or older. | To reduce or alleviate snoring andmild to moderate obstructive sleepapnea (OSA) in adults. |
| Environments of use | Home, dental and Physician offices,Sleep laboratories | Home, dental and Physician offices,Sleep laboratories |
| Patient Population | Adult patients 18 years and older | Adult patients 18 years and older |
| Contraindications | have central sleep apneahave severe respiratory disordershave loose teeth or advancedperiodontal diseaseare under 18 years of age | have central sleep apneahave severe respiratory disordershave loose teeth or advancedperiodontal diseaseare under 18 years of age |
| Prescription | Prescription use | Prescription use |
| Single patient, multi-use | Yes | Yes |
| Limitation of duration of use | No limitation | No limitation |
| Principle of operation / means ofmandibular advancement | Adjustment of the relative position of thesplints guides the mandible forward andmaintains advancement thus enlargingthe airway. The vertical opening of thejaw is not fixed in a single position | Adjustment of the relative position ofthe splints guides the mandibleforward and maintains advancementthus enlarging the airway. Thevertical opening of the jaw is notfixed in a single position |
| Design | ||
| Customized tray | Yes | Yes |
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510(k) Summary Page 5 of 8 28-May-14
| Molded in supports | Yes | No |
|---|---|---|
| Allows lateral and vertical movement | Yes | Yes |
| Mounting screws attach to frame toattach links | Yes | Yes |
| Framework (support) inserted intoupper and lower trays | Yes | Yes |
| Maximum protrusion of the device | 8 mm adjusts in 1 mm increments | 15 mm in 1 mm increments |
| Adjustment method for setting theamount of protrusion | Adjustable links | Adjustable links |
| Works by holding lower jaw forward | Yes | Yes |
| Cleaned by simple rinsing with water | Yes | Yes |
| Materials | DurasoftSplint BiocrylBiocryl X glueSupports, nuts, screwsLinks | Similar materials |
The Medley Gold - Link is viewed as substantially equivalent to the predicate device because:
Indications -
Substantial equivalent to predicate - ResMed Narval CC - K113201. Indicated to reduce or alleviate night time snoring and treat obstructive sleep apnea (OSA).
Technology / Principle of Operation -
Substantial equivalent to predicate - ResMed Narval CC - K113201. Both devices use a separate tray design with a means to adjust the lower jaw. The adjustment is a series of links of different lengths that the dentist may change out.
Materials -
The materials in contact with the patient are standard off-the-shelf dental materials.
Environment of Use -
Substantial equivalent to predicate - ResMed Narval CC - K113201. They are used in Home, dental and Physician offices, and Sleep laboratories.
Patient Population -
Substantial equivalent to predicate - ResMed Narval CC - K113201. 18 years and older
Discussion - The proposed Medley Gold - link design is substantially equivalent to the predicate ResMed Narval CC (link) K113201 in all respects and does not raise any new safety or performance concerns.
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510(k) Summary
28-May-14
Table 4 – Medley Gold – Rod vs. K023836 – Strong Dental SUAD
| Medley GoldRod | Strong DentalSUADK023836 | |
|---|---|---|
| Indications for Use | A customized mandibular repositioningdevice intended to reduce or alleviatenight-time snoring and mild tomoderate obstructive sleep apnea inadult patients 18 years or older. | A custom-fitted mandibularrepositioning device intended toreduce or alleviate night-time snoringand obstructive sleep apnea. |
| Environments of use | Home, dental and Physician offices,Sleep laboratories | Home, dental and Physician offices,Sleep laboratories |
| Patient Population | Adult patients 18 years and older | Adult patients 18 years and older |
| Contraindications | • have central sleep apnea• have severe respiratory disorders• have loose teeth or advancedperiodontal disease• are under 18 years of age | • have central sleep apnea• have severe respiratory disorders• have loose teeth or advancedperiodontal disease• are under 18 years of age |
| Prescription | Prescription use | Prescription use |
| Single patient, multi-use | Yes | Yes |
| Limitation of duration of use | No limitation | No limitation |
| Principle of operation / means ofmandibular advancement | Adjustment of the relative position ofthe splints guides the mandible forwardand maintains advancement thusenlarging the airway. The verticalopening of the jaw is not fixed in asingle position | Adjustment of the relative position ofthe splints guides the mandibleforward and maintains advancementthus enlarging the airway. Thevertical opening of the jaw is notfixed in a single position |
| Design | ||
| Customized tray | Yes | Yes |
| Molded in supports | Yes | Yes |
| Allows lateral and vertical movement | Yes | Yes |
| Mounting screws attach to frame toattach rods | Yes | Yes |
| Framework (support) inserted intoupper and lower trays | Yes | Yes |
| Maximum protrusion of the device | 8 mm adjusts in 1 mm increments | unlimited |
| Adjustment method for setting theamount of protrusion | Adjustable rods | Adjustable rods |
| Works by holding lower jaw forward | Yes | Yes |
| Cleaned by simple rinsing with water | Yes | Yes |
| Materials | DurasoftSplint BiocrylBiocryl X glueSupports nuts rods screws | Similar materials |
The Medley Gold - Rod is viewed as substantially equivalent to the predicate device because:
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510(k) Summary Page 7 of 8 28-May-14
Indications -
Substantial equivalent to predicate - Strong Dental - SUAD - K023836. Indicated for treating snoring and obstructive sleep apnea (OSA).
Technology / Principle of Operation -
Substantial equivalent to predicate - Strong Dental - SUAD - K023836. Both devices use a separate tray design with a means to adjust the lower jaw. The adjustment is a series of adjustable rods with the mandible adjustment set by the dentist.
Materials -
The materials in contact with the patient are standard off-the-shelf dental materials.
Environment of Use -
Substantial equivalent to predicate - Strong Dental - SUAD - K023836. They are used in Home, dental and Physician offices, and Sleep laboratories.
Patient Population -
Substantial equivalent to predicate - Strong Dental - SUAD - K023836. 18 years and older
Non-clinical Testing -
FDA has suggested that all intra oral devices will have to demonstrate that the physical properties of the materials used to fabricate the devices are equivalent to that of the predicate device. For the proposed Medley Gold customized oral appliance, all the materials for the customized tray are being used as directed by the manufacturer and are unaltered.
The materials are currently used to make customized trays which are identified predicates that also use customized trays as their base design then adds components which are used to advance the lower jaw and hold it in place while the patient sleeps.
These components, bands, links or rods, are similar to the predicates and we performed specific tests to validate these components and the method of attachment to the trays.
However the list of tests, ultimate flexural strength, ultimate flexural modulus, water sorption, water solubility, fracture toughness with modified bending test, relate to the tray materials, all of which are standardized dental materials that are FDA listed.
For those parts of the Medley Gold which are not tray materials, we performed testing to demonstrate that the support components perform as intended
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510(k) Summary Page 8 of 8 28-May-14
Substantial Equivalence Conclusion =
The sponsor has demonstrated through testing and comparison to the proposed device can be found substantially equivalent.
·
: 上一篇:
{8}------------------------------------------------
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2014
American Dental Sleep Medicine, IP, I.L.C. C/O Mr. Paul Dryden ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, FL 34134
Re: K140435
Trade/Device Name: Medley Gold Scries Oral Appliances Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: May 28, 2014 Received: May 29, 2014
Dear Mr. Dryden:
We have reviewed vour 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 cither 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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Page 2 - Mr. Dryden
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/ResourcesforYou/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.
Mary S. Runner -S
Erin I. Keith, M.S. Division 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K140435
Device Name
Medley Gold series oral appliances
Indications for Use (Describe)
A customized mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sieep apnea in adult patients 18 years 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)
Michael E. Adjodha -S 2014.06.25 13:21:00 -04/00'
FORM FDA 3881 (9/13)
PDF Page 2016 97
Scrvices (301) 445-6740
§ 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.”