(125 days)
Not Found
No
The summary describes a physical medical device (mandibular repositioning device) and its materials and mechanical properties. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The device's function is based on mechanical principles and existing predicate designs.
Yes
The device is intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea, which are medical conditions, and it repositions the mandible for treatment.
No
Explanation: The device is described as a "customized mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea." Its purpose is to treat or alleviate a condition, not to diagnose it.
No
The device description clearly outlines a physical oral appliance with customizable trays and attached components (bands, links, or rods) for mandibular repositioning. The performance studies focus on the physical properties and testing of these materials and components, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce or alleviate snoring and sleep apnea by repositioning the mandible. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is a physical oral appliance designed to mechanically alter the position of the jaw. It does not involve testing samples from the human body (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LRK
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.
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
Adult patients 18 years or older.
Intended User / Care Setting
Home, Dental offices, and 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 - 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.
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.
K971794 - Frantz - EMA, K113201 - ResMed - Narval CC, K023836 - Strong Dental - SUAD
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
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 snoring |
| and intraoral devices for snoring and obstructive sleep apnea | |
| 21 CFR 872.5570 | |
| Class 2 | |
| Predicate Devices: | K971794 - Frantz - EMA |
| K113201 - ResMed - Narval CC | |
| K023836 - 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.
1
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 | Frantz
EMA (band)
K971749 | ResMed
Narval CC (links)
K113201 | Strong Dental
SUAD (rod)
K023836 |
|------------------------|---------------------------------------|----------------------------------------|----------------------------------------|
| Common features | | | |
| Indications for use | Anti-snoring
Mild and moderate OSA | Anti-snoring
Mild and moderate OSA | Anti-snoring
Mild and moderate OSA |
| Patient population | 18 yo | 18 yo | 18 yo |
| Customized trays | Yes | Yes | Yes |
| Principle of operation | Mandibular
advancement | Mandibular
advancement | Mandibular
advancement |
| 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 Gold
Band | Frantz
EMA
K971794 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Treatment nasal respiratory dysfunction
of obstructive sleep apnea and snoring
in those patients where advancement of
the mandible and opening the bite can
increase the patient's air space. |
2
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 of
mandibular advancement | Adjustment of the relative position of
the splints by the use of elastic force
pulls the mandible forward and
maintains advancement thus enlarging
the airway. The vertical opening of
the jaw is not fixed in a single position | Adjustment of the relative position of
the splints by the use of elastic force
pulls the mandible forward and
maintains advancement thus enlarging
the airway. The vertical opening of the
jaw 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 attach
bands | Yes | Yes |
| Framework (support) inserted into
upper 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 the
amount 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 | Durasoft
Splint Biocryl
Biocryl X glue
Supports, nuts, screws
Bands | 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
3
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 Gold
Link | ResMed
Narval CC
K113201 |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | To reduce or alleviate snoring and
mild to moderate obstructive sleep
apnea (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 advanced
periodontal diseaseare under 18 years of age | have central sleep apneahave severe respiratory disordershave loose teeth or advanced
periodontal 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 of
mandibular advancement | Adjustment of the relative position of the
splints guides the mandible forward and
maintains advancement thus enlarging
the airway. The vertical opening of the
jaw is not fixed in a single position | Adjustment of the relative position of
the splints guides the mandible
forward and maintains advancement
thus enlarging the airway. The
vertical opening of the jaw is not
fixed in a single position |
| Design | | |
| Customized tray | Yes | Yes |
4
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 to | ||
| attach links | Yes | Yes |
| Framework (support) inserted into | ||
| upper 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 the | ||
| amount of protrusion | Adjustable links | Adjustable links |
| Works by holding lower jaw forward | Yes | Yes |
| Cleaned by simple rinsing with water | Yes | Yes |
| Materials | Durasoft | |
| Splint Biocryl | ||
| Biocryl X glue | ||
| Supports, nuts, screws | ||
| Links | 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.
5
510(k) Summary
28-May-14
Table 4 – Medley Gold – Rod vs. K023836 – Strong Dental SUAD
| | Medley Gold
Rod | Strong Dental
SUAD
K023836 |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | A custom-fitted mandibular
repositioning device intended to
reduce or alleviate night-time snoring
and 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 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 of
mandibular advancement | Adjustment of the relative position of
the splints guides the mandible forward
and maintains advancement thus
enlarging the airway. The vertical
opening of the jaw is not fixed in a
single position | Adjustment of the relative position of
the splints guides the mandible
forward and maintains advancement
thus enlarging the airway. The
vertical opening of the jaw is not
fixed 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 to
attach rods | Yes | Yes |
| Framework (support) inserted into
upper and lower trays | Yes | Yes |
| Maximum protrusion of the device | 8 mm adjusts in 1 mm increments | unlimited |
| Adjustment method for setting the
amount of protrusion | Adjustable rods | Adjustable rods |
| Works by holding lower jaw forward | Yes | Yes |
| Cleaned by simple rinsing with water | Yes | Yes |
| Materials | Durasoft
Splint Biocryl
Biocryl X glue
Supports nuts rods screws | Similar materials |
The Medley Gold - Rod is viewed as substantially equivalent to the predicate device because:
6
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
7
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.
9
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
10
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