(151 days)
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 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.
This looks like a medical device submission, specifically a 510(k) summary for the "Healthy Sleep Appliance." The document describes the device, its indications for use, and a comparison to a predicate device. It also includes a "Clinical Testing Summary" which details a small study.
Here's an analysis of the provided information to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the device's performance in a quantitative way (e.g., "The device must reduce AHI by X% in Y% of patients"). Instead, the study aims to demonstrate substantial equivalence by showing similar outcomes to existing oral appliance therapy and the predicate device.
The reported device performance from the 7-patient study is as follows:
| Subject | Gender / Age | Pre AHI | Post AHI | Reduction in AHI |
|---|---|---|---|---|
| One (1) | Female / 39 | 101.1 | 2.1 | 99.9% |
| Two (2) | Male / 58 | 46.3 | 5.2 | 88.8% |
| Three (3) | Female / 55 | 9.9 | 4.0 | 59.5% |
| Four (4) | Male / 45 | 34 | 1.5 | 95.6% |
| Five (5) | Female / 31 | 30.5 | 0.5 | 98.4% |
| Six (6) | Male / 54 | 9 | 1.8 | 80.0% |
| Seven (7) | Female / 45 | 6.2 | 0 | 100.0% |
Note: The document explicitly states: "Note Subjects # 1, 2, 4, and 5 were diagnosed with severe OSA and Oral Appliance therapy . was not recommended for them." This suggests that while their AHI improved significantly, these specific cases might fall outside the device's intended population for recommendation, which is for mild to moderate obstructive sleep apnea. However, the data is presented, showing the device's effect across these patients.
The overall conclusion is that the device "was well tolerated and effective with individuals with mild to moderate OSA that had not tolerated CPAP."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 7 patients.
- Data Provenance: The document does not specify the country of origin. It appears to be a prospective study, as it describes a "seven patient clinical study was conducted comparing the Healthy Sleep Appliance vs. the predicate Herbst Splint (K083209)." This implies the study was specifically undertaken to gather data for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study involved polysomnography (PSG) for pre- and post-treatment evaluation, which is the standard diagnostic test for OSA. However, the document doesn't detail who interpreted these PSGs or their qualifications.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not an AI device. Therefore, an MRMC study with AI assistance is not applicable and was not performed. The study is a direct comparison of the device (Healthy Sleep Appliance) against a predicate device (Herbst Splint) in terms of patient outcomes (AHI reduction).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not an AI device. Therefore, a standalone algorithm performance study is not applicable and was not performed. The device is a physical oral appliance.
7. The Type of Ground Truth Used
The ground truth for the effectiveness of the device in reducing sleep apnea was established through polysomnography (PSG), which is considered the gold standard for diagnosing and assessing the severity of sleep apnea. The specific metric used was the Apnea/Hypopnea Index (AHI).
8. The Sample Size for the Training Set
There is no training set in the context of an algorithm. This is a physical medical device. The "training" for establishing its effectiveness comes from the clinical study on the 7 patients and a review of existing literature (Ferguson, et.al., Oral Appliances for Snoring and Obstructive Sleep Apnea: A Review).
9. How the Ground Truth for the Training Set Was Established
As this is not an AI device, the concept of a "training set" and its ground truth establishment does not apply in the conventional sense. The "ground truth" for the device's performance evaluation was established by measuring AHI through polysomnography in the 7 human subjects before and after using the device.
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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 OSA21 CFR 872.5570Class 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.
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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 isintended for use in patients 18 years ofage or older for the reduction of snoringand mild to moderate obstructive sleepapnea. | The Arcylic Splint Herbst Applianceis intended for use in patients 18years of age or older for thereduction of snoring and mild tomoderate obstructive sleep apnea.The Arcylic Splint Herbst Applianceis worn while sleeping to support thelower jaw in a forward positionprescribed by the dentist. Theappliance is removable by thepatient. |
| Patient Population | 18 years of age or older | 18 years of age or older |
| Design | 2 full arch trays (upper and lower) madeto fit the occlusal surface of the teeth | 2 full arch trays (upper and lower)made to fit the occlusal surface ofthe teeth |
| Principle of Operation | Mandibular repositioning with 2 fullarch trays connected to each other byside arms to conform to apredetermined occlusal relationship ofthe upper and lower arches | Mandibular repositioning with 2 fullarch trays connected to each other byrod and tube assembly to conform toa predetermined occlusal relationshipof the upper and lower arches |
| Prescriptive | Yes | Yes |
| Removable by the patient | Yes | Yes |
| Mechanism of adjustment | Arms have adjustable length thatrepositions the lower jaw forward.Adjusted is by the dentist. | Rod and tube assembly has anadjustable length that repositions thelower jaw forward. Adjusted is bythe 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.
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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.
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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.
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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 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
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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:
§ 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.”