(80 days)
K882303/C
Not Found
No
The description focuses on a mechanical appliance for repositioning the jaw and tongue, with no mention of AI/ML terms or data processing.
Yes.
The device is intended to alleviate snoring by repositioning the jaw and tongue to expand the airway, which is a therapeutic purpose.
No
The device is described as an "aid in the alleviation of snoring" by physically repositioning the jaw and tongue, which is a therapeutic function, not a diagnostic one. It does not identify or detect a medical condition.
No
The device description clearly states it is an "Anti-snoring Appliance" that physically repositions the lower jaw and tongue, indicating it is a physical device, not software.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SNORE-CURE Function: The SNORE-CURE Anti-snoring Appliance is a physical device that is placed in the mouth to reposition the jaw and tongue. It does not perform any tests on bodily samples.
- Intended Use: The intended use is to alleviate snoring by physically altering the airway, not by analyzing biological markers.
The description clearly indicates a physical appliance used for a mechanical purpose, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The SNORE-CURE Anti-snoring Appliance is intended as an aid in the alleviation of snoring by repositioning the lower jaw slightly forward and open together with the tongue to expand the patient's airway, thereby decreasing air turbulence.
Product codes
LRK
Device Description
The SNORE-CURE Anti-snoring Appliance is intended as an aid in the The SNORE-COND And-anoring rippinh. lower jaw slightly forward and open alleviation of shoring of repearand the patient's airway, thereby decreasing air turbulence.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The SNORE-CURE Anti-snoring appliance is preformed and is substantially similar in design, materials and function to the Snore-Guard product by Distar Incorporated cleared by FDA on April 14, 1989 under 510(k) K882303/C. The SNORE-CURE, like the predicate device, the Snore-Guard, advances the mandible anteriorly and open the mandible vertically. The SNORE-CURE appliance advances the mandible 6-7mm anteriorly with an average overjet of 4mm and opens the mandible 8mm. The Snore-Guard advances the mandible about 6-8mm anteriorly, and opens the mandible 7-8mm.
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.
K882303/C
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.
Not Found
Predetermined Change Controlled 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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JUN 1 1998
510(k) Summary for SNORE-CURE Anti-snoring Appliance
DATE PREPARED 1.
March 4, 1998
SPONSOR INFORMATION 2.
Main Office
Dr. Earl Bergersen c/o: Ortho-Tain, Inc. Carr. 861, Km. 5.0 Toa Alta, Puerto Rico 00953
Mailing address
Box 4296 Bayamon Gardens Station Bayamon, Puerto Rico 00958
Contact Person: Dr. Earl O. Bergersen
(800) 468-0737 (telephone) (787) 780-5330 (787) 799-5074 (facsimile)
Qutside Regulatory Counsel
McDermott, Will & Emery 600 13th Street, N.W. Washington, D.C. 20005-3096
(202) 756-8075 (telephone) (202) 756-8087 (facsimile)
- ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contact Person: David L. Rosen, R.Ph., J.D.
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DEVICE NAME 3.
SNORE-CURE Anti-snoring Appliance Proprietary Name:
Common/Usual Name: Anti-snoring Appliance
Classification Name: Unclassified
DEVICE DESCRIPTION AND INTENDED USE 4.
The SNORE-CURE Anti-snoring Appliance is intended as an aid in the The SNORE-COND And-anoring rippinh. Iower jaw slightly forward and open alleviation of shoring of repearand the patient's airway, thereby decreasing air turbulence.
PREDICATE DEVICE 5.
The SNORE-CURE Anti-snoring Appliance is substantially equivalent to the Snore-Guard device by Distar Incorporated cleared by FDA on on April 14, 1989 under 510(k) K882303/C in design, materials, and intended use.
DEVICE TESTING 6.
The SNORE-CURE Anti-snoring appliance is preformed and is substantially similar in design, materials and function to the Snore-Guard product by Distar Incorporated cleared by FDA on April 14, 1989 under 510(k) K882303/C. The SNORE-CURE, like the predicate device, the Snore-Guard, advances the mandible anteriorly and open the mandible vertically. The SNORE-CURE appliance advances the mandible 6-7mm anteriorly with an average overjet of 4mm and opens the mandible 8mm. The Snore-Guard advances the mandible about 6-8mm anteriorly, and opens the mandible 7-8mm.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1008 JUN
Ortho-Tain, Incorporated C/O David L. Rosen, R.Ph., J.D. ttorney at Law McDermott, Will & Emery 600 13th Street N.W. Washington, DC 20005-3096
K980952 Re : SNORE-CURE® Anti-Snoring Appliance Trade Name: Unclassified Regulatory Class : LRK Product Code: March 12, 1998 Dated: March 13, 1998 Received:
Dear Mr. Rosen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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.). You may, therefore, market the device, subject to the general The general controls - controls provisions of the Act. provisions of the Act include requirements for annual provisions of the ing 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 (Premarket Approval), it may be subject to such additional controls. Existing major be addice to back and your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਦੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory -------In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Rosen
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification™ (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ÖRIGINAL
510(k) Number (if known): Not assigned yet
Device Name:
Trade Name: SNORE-CURE® Anti-snoring Appliance
Indications for Use: The SNORE-CURE Anti-snoring Appliance is intended as an aid in the alleviation of snoring by repositioning the lower jaw slightly forward and open together with the tongue to expand the patient's airway, thereby decreasing air turbulence.
PLEASE DO NOT WRITE BELOW THIS LINE (Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Seusa Rurels
(Division Six = 11) ivision of Demai. Infection Control, and General Hospital Devices
510(k) Number 16980952
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Or