(196 days)
No
The device description details a mechanical oral appliance with no mention of software, algorithms, or any technology typically associated with AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is intended for use to "reduce or alleviate snoring and obstructive sleep apnea," indicating a therapeutic purpose.
No
This device is an anti-snoring device for treatment and alleviation of snoring and sleep apnea, not for diagnosis.
No
The device description clearly lists physical components such as a lower tray, upper shield, upper molded splint, connecting mechanism, and extensions, indicating it is a physical medical device, not software-only.
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 obstructive sleep apnea. This is a therapeutic purpose, not a diagnostic one. IVDs are used to diagnose diseases or conditions.
- Device Description: The device is a physical oral appliance designed to alter the airway. It does not involve the analysis of biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
Therefore, the OASYS Oral Airway System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OASYS Oral Airway System is intended to reduce or alleviate snoring and obstructive sleep apnea, OSA.
OASYS Oral Airway System is intended for use to reduce or eleviate snoring and obstructive sleep apnea.
Product codes (comma separated list FDA assigned to the subject device)
LRK, LWF
Device Description
The OASYS ORAL AIRWAY SYSTEM Anti-Snoring Device is composed of:
- Lower tray fitted over the lower teeth.
- Upper shield fitting in front of upper anterior teeth.
- Upper molded splint fitted over upper teeth.
- Connecting mechanism joining upper shield and lower tray.
- Extensions off shield which act as nasal dilators .
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.
Intended User / Care Setting
Home 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)
Not Found
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.
K972061, K963063, K963616, K962516
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.
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.”
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Kozouyo
Page 20 of 22
OASYS-ORAL AIRWAY SYSTEM
Mark Abramson 35 Renato Court Redwood City, CA 94061
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 3
April 16, 2003
Mark Abramson 35 Renato Court Redwood City, CA 94061 Tel-(650) 369-9227
Fax-(650) 369-9241
Official Contact: Proprietary or Trade Name: Common/Usual Name: Device: Predicate Devices:
Mark Abramson, D.D.S. OASYS -Oral Airway System Oral Appliance - anti-snoring device OASYS -Oral Airway System Dr. Keith Thorton - K972061 Snore-Ezzer, LLC - K963063 Marketing Technologies, Inc. - K963616 Nellcor Puritan Bennett, Inc. - K962516
Device Description:
The OASYS ORAL AIRWAY SYSTEM Anti-Snoring Device is composed of:
- Lower tray fitted over the lower teeth. ●
- Upper shield fitting in front of upper anterior teeth. .
- Upper molded splint fitted over upper teeth. ●
- Connecting mechanism joining upper shield and lower tray. .
- Extensions off shield which act as nasal dilators .
Intended Use:
| Indicated use: | The OASYS Oral Airway System is intended to reduce or alleviate snoring and obstructive sleep apnea, OSA. |
|---|---|
| ---------------- | ----------------------------------------------------------------------------------------------------------- |
Target population: Adult patients.
1
Non-Confidential Summary of Safety and Effectiveness (continued) Page 2 of 3 April 16, 2003
Environment of Use: Home and sleep laboratories
Comparison to Predicate Devices:
| Attribute | OASYS
K030440 | Breathe EZ
K022891 | Dr. 's Mouthpiece
K991948 | Marketing T.I.
K963063 |
|-------------------------------------------------------------------------|------------------|-----------------------|------------------------------|---------------------------|
| Use: | | | | |
| Intended as an
intraoral device | Yes | Yes | Yes | Yes |
| Intended to reduce or
help snoring | Yes | Yes | Yes | Yes |
| Indicated for use with
persons who snore | Yes | Yes | Yes | Yes |
| Indicated for single
patient
Multi-use | Yes | Yes | Yes | Yes |
| Indicated for use at
home or sleep
laboratories | Yes | Yes | Yes | Yes |
| Design: | | | | |
| Heat sensitive
impressible material
for fitting to teeth | Yes | Yes | Yes | Yes |
| Custom fit for each
user | Yes | Yes | Yes | Yes |
| Can be adjusted or
Refit | Yes | Yes | Yes | Yes |
| Placed in users mouth
each evening | Yes | Yes | Yes | Yes |
| Cleaned daily | Yes | Yes | Yes | Yes |
| Easily removed from
Mouth
Permits user to breath
Through mouth | Yes | Yes | Yes | Yes |
| Attribute | OASYS | Breathe EZ | Dr. 's Mouthpiece
K991948 | Marketing T.I.
K963063 |
| Prevents grinding of
Teeth | Yes | Yes | Yes | Yes |
| Materials: | | | | |
| Heat sensitive
Impression material | Yes | Yes | Yes | Yes |
| Rigid tray | Yes | Yes | Yes | Yes |
| Non-Sterile | Yes | Yes | Yes | Yes |
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Page 22 of 22
Non-Confidential Summary of Safety and Effectiveness (continued) Page 3 of 3 April 16, 2003
Difference Between Other Legally Marketed Predicated Devices
The difference between the intended device and predicates is only the design of the device. All of the predicates act as mandibular repositioners. The OASYS has extensions which act as nasal dilators. This difference does not have a significant effect on the safety or effectiveness of the device.
Literature supports the historical significance of oral devices that reposition the mandible and reduce and manage snoring as well as sleep apnea.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare. The caduceus has a staff with two snakes winding around it and a pair of wings at the top.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2003
Dr. Mark Abramson Mark Abramson, D.D.S. Incorporated 35 Renato Court Redwood City, California 94061
Re: K030440
Trade/Device Name: Oasys Oral Airway System Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK, LWF Dated: July 8, 2003 Received: July 8, 2003
Dear Dr. Abramson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Dr. Abramson
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
510(k) Number (if known): __ K030440
OASYS Oral Airway System Device Name: __
Indications For Use:
OASYS Oral Airway System is intended for use to reduce or eleviate snoring and obstructive sleep apnea.
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: KG38446
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use ----
(Cpuoral Format 1-2-96)