(233 days)
Not Found
No
The summary describes a physical, custom-fabricated oral appliance with mechanical components. There is no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea, which are medical conditions, and thus seeks a therapeutic effect.
No
The device is intended for the reduction of snoring and obstructive sleep apnea, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a physical, intraoral device comprised of polymer splints and a stainless steel mechanism.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reduction of snoring and sleep apnea, which are physiological conditions. IVDs are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is an oral appliance that physically repositions the mandible. This is a mechanical intervention, not a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic procedures typically associated with IVDs.
Therefore, the ASA Oral Appliances are therapeutic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The ASA Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.
Product codes
LRK
Device Description
The American Sleep Association (ASA) Oral Appliances include three devices: the ASA Herbst and Herbst/Hilsen Hybrid devices. All are removable, intraoral devices which reposition the mandible and each is custom-fabricated to individual patient specifications. The devices are comprised of thermoformed polymer splints (copolyester or EVA) which are connected bilaterally via a stainless steel telescoping Herbst mechanism, reclosable fasteners or both.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral
Indicated Patient Age Range
18 years of age or older
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
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
510(k) Summary
.
| Date: | 16 September 2013 |
|---|---|
| Sponsor: | American Sleep Association, LLC |
| OCT 1 8 2013 | |
| 1957 Royal Hunte Drive, Ste. 250 | |
| Cedar City, UT 84720 | |
| Phone: 866.620.3670 | |
| Contact Person: | Ryan Gregerson, Manager |
| Trade Names: | American Sleep Association (ASA) Oral Appliances |
| Device | |
| Classification: | Class II |
| Common Name: | Oral Appliance |
| Classification Name: | Device, Anti-Snoring |
| Regulation: | 872.5570, Intraoral devices for snoring and intraoral devices for |
| snoring and obstructive sleep apnea | |
| Device Product | |
| Code: | LRK |
| Device Description: | The American Sleep Association (ASA) Oral Appliances include |
| three devices: the ASA Herbst and Herbst/Hilsen Hybrid devices. All | |
| are removable, intraoral devices which reposition the mandible and | |
| each is custom-fabricated to individual patient specifications. | |
| The devices are comprised of thermoformed polymer splints | |
| (copolyester or EVA) which are connected bilaterally via a stainless | |
| steel telescoping Herbst mechanism, reclosable fasteners or both. | |
| Intended Use: | The ASA Oral Appliances are intended for the reduction of night time |
| snoring and mild to moderate obstructive sleep apnea (OSA) in | |
| adults 18 years of age or older. | |
| Predicate Devices: | Removable Acrylic Herbst (K070327) |
| Hilsen Anti-Snoring Device (K963591) | |
| Silent Nite® sl (K972424) | |
| Technological | |
| Characteristics: | The ASA Herbst and Herbst/Hilsen Hybrid devices possess the same |
| technological characteristics as one or more of the predicate devices. | |
| These include: | |
| Anatomic location (intraoral), | |
| ● | |
| Basic design (mandibular repositioning using upper and lower | |
| ● | |
| polymer trays with bilateral connecting mechanism), | |
| Materials (polymers and/or stainless steel) and | |
| Manufacture (appliance is fabricated by prescription to the | |
| ● | |
| specific requirements of a single patient) | |
| The fundamental scientific technology of the ASA Herbst and | |
| Herbst/Hilsen Hybrid devices is the same as previously cleared | |
| devices. |
:
1
In comparison to the predicate devices, the ASA Oral Appliances Conclusion: have
- . the same intended use and
- the same technological characteristics and so do not raise . new questions of safety and effectiveness.
Therefore the ASA Herbst and Herbst/Hilsen Hybrid devices can be found substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
October 18, 2013
American Sleep Association, LLC Mr. Ryan Gregerson Manager 1957 Royal Hunte Drive, Suite 250 CEDAR CITY UT 84720
Re: K130504
Trade/Device Name: American Sleep Association (ASA) Oral Appliances 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: September 16, 2013 Received: September 20, 2013
Dear Mr. Gregerson:
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.
3
Page 2 - Mr. Gregerson
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 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,
Mary'S:Runner -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 7 - Indications for Use Statement
510(k) Number: K130504
Device Name: American Sleep Association (ASA) Oral Appliances
Indications for Use:
The ASA Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.
Prescription Use X
OR Over-the-Counter Use_
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew I. 2013.10.18