(419 days)
No reference devices were used in this submission.
No
The description focuses on the physical characteristics and mechanism of action of a mandibular advancement device, with no mention of AI or ML technologies.
Yes
Explanation: The device is intended for the "treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults," which classifies it as a therapeutic device.
No
The device is described as a treatment for snoring and sleep apnea, not for diagnosing these conditions. Its function is to hold the mandible in a protruded position to maintain an open airway during sleep, which is a therapeutic action.
No
The device description clearly states it is a "home-use mouthpiece" made of "thermoflexible and biocompatible material" and includes physical accessories like a storage box and spatula. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- HypnosPad Function: The HypnosPad is a physical device that is placed in the mouth to mechanically adjust the position of the mandible. It does not perform any tests on biological samples.
- Intended Use: The intended use is for the treatment of snoring and sleep apnea, which is a therapeutic function, not a diagnostic one.
The description clearly indicates it's a physical appliance used for treatment, not for analyzing samples to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
The HypnosPad of mandibular advancement devices is intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Product codes
LRK
Device Description
- HypnosPad (HP01) is a home-use mouthpiece and indicated for the treatment of night-time snoring. It is suitable for mild to moderate obstructive sleep apnea (OSA) patients in adults.
- The accessories of HyponsPad are a storage box and a spatula.
- The device is made by thermoflexible and biocompatible material.
- The usage method of HyponsPad is custom fit after hot water bathing.
- The duration of HypnosPad is about 8-10 hours contacting in patient's oral cavity.
- The HyponsPad is intended for holding the mandible in a protruded position thus maintaining the airway open during sleep.
- The HypnosPad will be used the spatula help to operate the device during boil and bite process.
- The HypnosPad will be stored in the storage box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity
Indicated Patient Age Range
Adults
Intended User / Care Setting
At home or clinic setting (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: Bench test for performance for fitting process and mechanical strength, Material property evaluation, Thermal property test, Usability test.
- Sample Size: Not Found
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key Results: Comparative testing was done between the new device and the noted predicate device for the material property evaluation, thermal property and the fitting process and mechanical strength. These performance data of the new device are demonstrated that the new device performed as well as the noted predicate. Based on the results of performance testing, HypnosPad was found to be as safe and as effective as the predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 9, 2016
Somnics Inc. Tsung-Min Hsieh Manager, QA & RA 5F, No. 22, Sec. 2, Sheng Yi Rd., Hsinchu Science Park, Zhubei City Hsinchu County TAIWAN
Re: K152660
Trade/Device Name: HypnosPad Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: LRK Dated: September 30, 2016 Received: October 3, 2016
Dear Tsung-Min Hsieh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely. Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting 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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
HypnosPad
Indications for Use (Describe)
The HypnosPad of mandibular advancement devices is intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(k) Summary
1. SUBMITTER
Company Name: Somincs Inc. Address: 5F, No.22, Sec. 2, Sheng Yi Rd, Hsinchu Science Park, Zhubei City, Hsinchu County 30261, Taiwan(R.O.C.) Contact Person: Tsung-Min Hsieh, QA/RA manger, Somnics, Inc. Phone: +886-3-550-9623-190 Fax: +886-3-550-3633 Email: tsungmin@somnics.com
Summary Preparing Date: October 11, 2016
II. DEVICE
Name of Device: HypnosPad, Model HP01 Common or Usual Name: Anti-Snoring / Sleep Apnea Device Classification Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea (21 CFR 872.5570) Device Classification: II Product Code: LRK Prior Submission: no prior submissions for the same device
III. PREDICATE DEVICE
SomnoGuard, K061688 This predicate has not been subject to a design-related recall in US.
No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
- HypnosPad (HP01) is a home-use mouthpiece and indicated for the treatment of night-time snoring. It is suitable for mild to moderate obstructive sleep apnea (OSA) patients in adults.
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- The accessories of HyponsPad are a storage box and a spatula. ●
- The device is made by thermoflexible and biocompatible material. ●
- The usage method of HyponsPad is custom fit after hot water bathing.
- The duration of HypnosPad is about 8-10 hours contacting in patient's oral cavity.
- The HyponsPad is intended for holding the mandible in a protruded position thus maintaining the airway open during sleep.
- The HypnosPad will be used the spatula help to operate the device during boil and bite process.
- The HypnosPad will be stored in the storage box.
- INDICATION FOR USE V.
The HypnosPad of mandibular advancement devices is intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
- COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE
The proposed "HypnosPad" and the predicate are intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. Their indications for use, fundamental design, and technological characteristics are also comparable, as listed in the following table:
| Device | HypnosPad (Model: HP01) – The Subject | Predicate Device SomnoGuard in SomnoGuard Series | Comparison | |||
|---|---|---|---|---|---|---|
| Intended Use & Indications for Use | Treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. | Treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. | Identical | |||
| Mechanism of Action | Extend the lower jaw, thereby opening the upper airway and reducing snoring and | Extend the lower jaw, thereby opening the upper airway and reducing snoring and | Identical | |||
| K152660/S001 additional information response | ||||||
| the breathing arrests | ||||||
| due to obstructive | ||||||
| sleep apnea. | the breathing arrests | |||||
| due to obstructive | ||||||
| sleep apnea. | ||||||
| OTC/Prescription | ||||||
| Use | Prescription Use | Prescription Use | Identical | |||
| Device | ||||||
| Composition | MAD Device, | |||||
| Spatula | ||||||
| Storage box | MAD Device | |||||
| Spatula | ||||||
| Storage box | Identical | |||||
| Single Patient | Single patient | Single patient | Identical | |||
| Multiple Use | Multiple use | Multiple use | Identical | |||
| Treatment Time | Everyday overnight | Everyday overnight | Identical | |||
| Where Used | At home or clinic | |||||
| setting(Sleep | ||||||
| Laboratories) | At home or clinic | |||||
| setting(Sleep | ||||||
| Laboratories) | Identical | |||||
| Design Concept | One piece design | |||||
| Ready-to-Use | ||||||
| Upper and low trays | One piece design | |||||
| Ready-to-Use | ||||||
| Upper and low trays | Identical | |||||
| Personal | ||||||
| Interface of | ||||||
| Custom | ||||||
| Fabricated | Boil and bite fitting for | |||||
| Personalized | ||||||
| products as a single | ||||||
| patient multiple use | Boil and bite fitting for | |||||
| Personalized products | ||||||
| as a single patient | ||||||
| multiple use | Identical | |||||
| Design - Patient | ||||||
| Contacting | ||||||
| Materials | Thermoplastic | |||||
| elastomer | Thermoplastic | |||||
| elastomer | Purpose: Identical; | |||||
| Technology/spec: | ||||||
| Difference, there is | ||||||
| no additional risk | ||||||
| based on material | ||||||
| property evaluation | ||||||
| (Appendix K), and | ||||||
| Performance | ||||||
| Testing Report for | ||||||
| Fitting Process and | ||||||
| Mechanical Strength | ||||||
| (Appendix F). | ||||||
| Adjustable | Re-mold with lower | |||||
| jaw extended but not | ||||||
| in mechanism adjust. | Re-mold with lower jaw | |||||
| extended but not in | ||||||
| mechanism adjust. | Identical | |||||
| K152660/S001 additional information respc | ||||||
| Material Thermal | ||||||
| properties | Optimal thermoplastic | |||||
| condition is large than | ||||||
| 67°C | Optimal thermoplastic | |||||
| condition is large than | ||||||
| 60°C | Purpose: Identical; | |||||
| Technology/spec: | ||||||
| Difference, there is | ||||||
| no additional risk | ||||||
| based on Thermal | ||||||
| Property Test | ||||||
| Report (Appendix | ||||||
| H). | ||||||
| Human Factors | Use during sleep | |||||
| period. User operates | ||||||
| boil and bite fitting at | ||||||
| first time to use. | Use during sleep | |||||
| period. User operates | ||||||
| boil and bite fitting at | ||||||
| first time to use. | Purpose: Identical | |||||
| Technology/spec: | ||||||
| Difference, there is | ||||||
| no additional risk | ||||||
| based on usability | ||||||
| test (Appendix D). | ||||||
| Design – Oral | ||||||
| appliance size | ||||||
| and outward | 52mm x62.5mm x | |||||
| 20.5mm | ||||||
| Fillet cushion | ||||||
| Lip seal curve | 44.5mm x 63mm x25.5 | |||||
| mm | ||||||
| NA | ||||||
| NA | Purpose: Identical | |||||
| Technology/spec: | ||||||
| Difference, there is | ||||||
| no additional risk | ||||||
| based on usability | ||||||
| test (Appendix D). | ||||||
| Design – | ||||||
| Mandibular | ||||||
| Advancement | ||||||
| Range | Up to 10 mm | |||||
| Limited mandibular | ||||||
| advancement. | ||||||
| Patients with OSA | ||||||
| should be able to | ||||||
| extend their lower jaw | ||||||
| forward at least 7mm | Limited mandibular | |||||
| advancement. Patients | ||||||
| with sleep apnea | ||||||
| should be able to | ||||||
| extend their lower jaw | ||||||
| forward at least 7mm | Purpose: Identical; | |||||
| Technology/spec: | ||||||
| Difference, there is | ||||||
| no additional risk | ||||||
| based on | ||||||
| Performance | ||||||
| Testing Report for | ||||||
| Fitting Process and | ||||||
| Mechanical Strength | ||||||
| (Appendix F). | ||||||
| Sterility | ||||||
| Requirement | Non-sterile | Non-sterile | Identical | |||
| Biocompatibility | Biocompatibility | |||||
| testing based on ISO | ||||||
| 10993-1 | Biocompatibility testing | |||||
| based on ISO 10993-1 | Identical |
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Based on the testing results and relative technical information, the new device through these performance testing is substantially equivalent to the predicate.
VII. PERFORMANCE DATA
This device conforms to the standards and testing listed below:
- · ISO 10993-1:2009: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- · ISO 10993-5:2009: Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- · ISO 10993-10:2010: Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- Usability test (Based on IEC 62366:2007: Medical devices Application of usability engineering to medical device)
- . Bench test for performance for fitting process and mechanical strength
- Material property evaluation .
- · Thermal property test
- Comparative testing was done between the new device and the noted predicate device for . the material property evaluation, thermal property and the fitting process and mechanical strength. These performance data of the new device are demonstrated that the new device performed as well as the noted predicate.
Summary:
Based on the results of performance testing, HypnosPad was found to be as safe and as effective as the predicate.
VIII. CONCLUSION
The indication for use for the subject device is identical to the predicate device. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness. The performance data provided demonstrate that the device performs as intended and is as safe and as effective as the predicate device.