(151 days)
No
The device description and performance studies focus on a mechanical oral appliance and a clinical study comparing it to a predicate device. There is no mention of AI, ML, or any computational analysis of data for diagnosis, treatment planning, or device function.
Yes
The device is intended for the reduction of snoring and mild to moderate obstructive sleep apnea, which are medical conditions, and its mechanism of action involves physical manipulation to improve air exchange, indicating a therapeutic purpose.
No
Explanation: The device description and intended use clearly state that it is a treatment device, specifically a mandibular repositioning oral appliance used to treat snoring and sleep apnea, not to diagnose these conditions. Testing involved pre and post-treatment evaluation, not the device itself performing diagnostic measurements.
No
The device description clearly states it is a physical oral appliance made of trays and stainless steel arms, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Healthy Sleep Appliance Function: The Healthy Sleep Appliance is a physical device that is placed in the mouth to reposition the jaw and improve airflow. It does not analyze any biological specimens.
- Intended Use: The intended use is for the reduction of snoring and mild to moderate obstructive sleep apnea, which is a physical condition treated by a physical intervention.
- Device Description: The description details a mechanical device made of trays and arms, not a system for analyzing biological samples.
The information provided clearly describes a physical medical device used for a therapeutic purpose, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Healthy Sleep Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea.
Product codes
LRK
Device Description
The Healthy Sleep Appliance is a mandibular repositioning oral appliance used to treat snoring and mild to moderate obstructive sleep apnea. It is composed of an upper and a lower tray made to fit the occlusal surface of the teeth. These full arch trays are connected to each other by stainless steel arms that are set to conform to the predetermined occlusal relationship of the upper and lower arches. These arms have an adjusted length that can be adjusted as needed to exert a forward force on the lower jaw and advance the mandible relative to the maxilla. The advancement of the lower jaw increases the patient's pharyngeal space which facilitates improved air exchange.
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 (Adults)
Intended User / Care Setting
Not Found
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
A seven patient clinical study was conducted comparing the Healthy Sleep Appliance vs. the predicate Herbst Splint (K083209). The objective of the study was to determine the success rate of the patient treatment using oral appliance therapy. Patient's underwent polysomnongraphy with pre- and port- treatment endpoints evaluated.
Subjects - 4 - female - age 31 - 55, 3 -males - age 45 - 58
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing Summary:
There have been clinical studies performed with similar device design, device usage, materials of construction, and technological characteristics which support a determination of substantial equivalence.
The cited study Ferguson, et.al., Oral Appliances for Snoring and Obstructive Sleep Apnea: A Review, SLEEP, vol.29, No. 2, 2006:244-262.
In addition we performed a seven patient clinical study was conducted comparing the Healthy Sleep Appliance vs. the predicate Herbst Splint (K083209). The objective of the study was to determine the success rate of the patient treatment using oral appliance therapy. Patient's underwent polysomnongraphy with pre- and port- treatment endpoints evaluated.
Subjects - 4 - female - age 31 - 55, 3 -males - age 45 - 58
Summary of pre- and post OA treatment - AHI:
Subject One (1): Gender / Age - Female / 39, Pre AHI - 101.1, Post AHI - 2.1
Subject Two (2): Gender / Age - Male / 58, Pre AHI - 46.3, Post AHI - 5.2
Subject Three (3): Gender / Age - Female / 55, Pre AHI - 9.9, Post AHI - 4.0
Subject Four (4): Gender / Age - Male / 45, Pre AHI - 34, Post AHI - 1.5
Subject Five (5): Gender / Age - Female / 31, Pre AHI - 30.5, Post AHI - .5
Subject Six (6): Gender / Age - Male / 54, Pre AHI - 9, Post AHI - 1.8
Subject Seven (7): Gender / Age - Female / 45, Pre AHI - 6.2, Post AHI - 0
AHI - Apnea / hypopnea index
Note Subjects # 1, 2, 4, and 5 were diagnosed with severe OSA and Oral Appliance therapy was not recommended for them.
In summary, the Healthy Sleep Appliance was well tolerated and effective with individuals with mild to moderate OSA that had not tolerated CPAP.
Non-clinical Testing Summary:
Biocompatibility of Materials - The materials are standard dental grade materials which have been tested per ISO 10993 and shown to be biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.”
0
5 2013 APR
510(k) Summary Page 1 of 4
| Date Prepared | 2-Apr-13 |
|---|---|
| --------------- | ---------- |
Healthy Sleep Dental Laboratory, Inc.
1271 East Broad Street
Columbus, OH 43205
| Tel | 614-252-4444 |
|---|---|
| Fax | 614-252-6474 |
| Official Contact: | Todd Bacome - Laboratory Manager |
|---|---|
| ------------------- | ---------------------------------- |
| Proprietary or Trade Name: | Healthy Sleep Appliance |
|---|---|
| Common/Usual Name: | Anti-snoring Device |
| Classification Code/Name: | LRK - intraoral devices for snoring and OSA |
| 21 CFR 872.5570 | |
| Class 2 | |
| Predicate Devices: | K083209 - Acrylic Herbst Splint Appliance |
Device Description:
The Healthy Sleep Appliance is a mandibular repositioning oral appliance used to treat snoring and mild to moderate obstructive sleep apnea. It is composed of an upper and a lower tray made to fit the occlusal surface of the teeth. These full arch trays are connected to each other by stainless steel arms that are set to conform to the predetermined occlusal relationship of the upper and lower arches. These arms have an adjusted length that can be adjusted as needed to exert a forward force on the lower jaw and advance the mandible relative to the maxilla. The advancement of the lower jaw increases the patient's pharyngeal space which facilitates improved air exchange.
Indications for Use:
The Healthy Sleep Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea.
Patient Population: 18 years or older (Adults)
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510(k) Summary Page 2 of 4 2-Apr-13
Predicate Device Comparison:
The Healthy Sleep Appliance has been compared to the predicate and is viewed as substantially equivalent because:
Indications -
- . The Healthy Sleep Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea. The predicate Herbst Splint Appliance (K083209) has the identical indications for use.
Discussion - The indications for use are identical to the predicate.
Patient Population -
- The patient population for both the Healthy Sleep Appliance and the predicate Herbst . Splint Appliance (K083209) is patients 18 years or older.
Discussion - The intended patient population is identical to the predicate.
Technology -
- . Both devices utilize an upper and a lower tray which are connected by 2 rods which hold advance the lower jaw.
- The Healthy Sleep Appliance has arms which are adjustable whereas the Herbst Splint . (K083209) are a fixed length.
Discussion - The technology of both the devices are very similar and the difference of an adjustable side arm and the use of elastic bands to hold the mouth closed do not present significant differences. These differences do not raise any new safety risks or concerns.
Materials -
- . The materials are standard dental grade materials which have been used in other cleared oral appliance.
Discussion - The materials are identical to other cleared oral appliance and a Material certification has been provided.
Differences -
There are no differences between the predicate and the proposed device which would raise any new safety or risks and thus can be found to be substantially equivalent.
2
510(k) Summary Page 3 of 4 2-Apr-13
| Attributes | Healthy Sleep Appliance | Predicate |
|---|---|---|
| Herbst Split Appliance K083208 | ||
| Indications for Use | The Healthy Sleep Appliance is | |
| intended for use in patients 18 years of | ||
| age or older for the reduction of snoring | ||
| and mild to moderate obstructive sleep | ||
| apnea. | The Arcylic Splint Herbst Appliance | |
| is intended for use in patients 18 | ||
| years of age or older for the | ||
| reduction of snoring and mild to | ||
| moderate obstructive sleep apnea. | ||
| The Arcylic Splint Herbst Appliance | ||
| is worn while sleeping to support the | ||
| lower jaw in a forward position | ||
| prescribed by the dentist. The | ||
| appliance is removable by the | ||
| patient. | ||
| Patient Population | 18 years of age or older | 18 years of age or older |
| Design | 2 full arch trays (upper and lower) made | |
| to fit the occlusal surface of the teeth | 2 full arch trays (upper and lower) | |
| made to fit the occlusal surface of | ||
| the teeth | ||
| Principle of Operation | Mandibular repositioning with 2 full | |
| arch trays connected to each other by | ||
| side arms to conform to a | ||
| predetermined occlusal relationship of | ||
| the upper and lower arches | Mandibular repositioning with 2 full | |
| arch trays connected to each other by | ||
| rod and tube assembly to conform to | ||
| a predetermined occlusal relationship | ||
| of the upper and lower arches | ||
| Prescriptive | Yes | Yes |
| Removable by the patient | Yes | Yes |
| Mechanism of adjustment | Arms have adjustable length that | |
| repositions the lower jaw forward. | ||
| Adjusted is by the dentist. | Rod and tube assembly has an | |
| adjustable length that repositions the | ||
| lower jaw forward. Adjusted is by | ||
| the dentist. | ||
| Maximum adjustment | 7 mm | 7 mm |
| Materials | ISO 10993 | ISO 10993 |
| Single patient, multi-use | Yes | Yes |
Non-clinical Testing Summary -
Biocompatibility of Materials -
The materials are standard dental grade materials which have been tested per ISO 10993 and shown to be biocompatible.
3
510(k) Summary Page 4 of 4 2-Apr-13
Clinical Testing Summary -
There have been clinical studies performed with similar device design, device usage, materials of construction, and technological characteristics which support a determination of substantial equivalence.
The cited study Ferguson, et.al., Oral Appliances for Snoring and Obstructive Sleep Apnea: A Review, SLEEP, vol.29, No. 2, 2006:244-262.
In addition we performed a seven patient clinical study was conducted comparing the Healthy Sleep Appliance vs. the predicate Herbst Splint (K083209). The objective of the study was to determine the success rate of the patient treatment using oral appliance therapy. Patient's underwent polysomnongraphy with pre- and port- treatment endpoints evaluated.
Subjects - 4 - female - age 31 - 55, 3 -males - age 45 - 58
Summary of pre- and post OA treatment - AHI
| Subject | Gender / Age | Pre AHI | Post AHI |
|---|---|---|---|
| One (1) | Female / 39 | 101.1 | 2.1 |
| Two (2) | Male / 58 | 46.3 | 5.2 |
| Three (3) | Female / 55 | 9.9 | 4.0 |
| Four (4) | Male / 45 | 34 | 1.5 |
| Five (5) | Female / 31 | 30.5 | .5 |
| Six (6) | Male / 54 | 9 | 1.8 |
| Seven (7) | Female / 45 | 6.2 | 0 |
AHI - Apnea / hypopnea index
- Note Subjects # 1, 2, 4, and 5 were diagnosed with severe OSA and Oral Appliance therapy . was not recommended for them
In summary, the Healthy Sleep Appliance was well tolerated and effective with individuals with mild to moderate OSA that had not tolerated CPAP.
Substantial Equivalence Conclusion -
The sponsor has demonstrated through performance testing, design and features, non-clinical, and clinical testing that the proposed device and predicate have been found to substantially equivalent.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The symbol is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2013
Health Sleep Dental Laboratory, Incorporated C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive BONITA SPRINGS FL 34134
Re: K123410
Trade/Device Name: Healthy Sleep Appliance Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II
Product Code: LRK Dated: March 20, 2013 Received: March 21, 2013
Dear Mr. Dryden:
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.
5
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Image /page/5/Picture/8 description: The image shows the name "Kwame O. Ulmer" in bold, black font at the top. Below the name is the acronym "FLA" in a stylized, outlined font. To the left of the acronym is the letter "s" in a smaller font size.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): 11234||0
Device Name: HEALTHY SLEEP APPLIANCE
Indications for Use:
The Healthy Sleep Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart.C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Mary S. Runner -S |
|---|
| Susan Runner, DOSMA |
| 2013.04.03 |
| 10:59:15-04'00' |
Page 1 of __ 1________________________________________________________________________________________________________________________________________________________________
Division Sian-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number: