(80 days)
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.
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.
The provided text describes a 510(k) submission for the SNORE-CURE Anti-snoring Appliance, which is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
The 510(k) process does not typically involve a formal study with acceptance criteria and device performance evaluation in the same way a clinical trial for a new drug or novel medical device would. Instead, the primary focus is on establishing substantial equivalence to a predicate device. Therefore, a table of acceptance criteria and reported device performance, and details about associated studies as requested in the prompt, are not explicitly present in the provided document.
However, based on the information provided, we can infer some details related to "device testing" and "equivalence."
Here's an analysis of the provided text with respect to your questions, highlighting what is present and what is not:
1. A table of acceptance criteria and the reported device performance
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Not explicitly provided. The document states that the SNORE-CURE appliance is "substantially similar in design, materials and function" to the predicate device (Snore-Guard). The "performance" is described in terms of its mechanism and physical advancement characteristics, not as a quantified outcome against specific acceptance criteria for snoring alleviation.
- Inferred Performance Description (from "DEVICE TESTING" section):
- SNORE-CURE: Advances the mandible 6-7mm anteriorly with an average overjet of 4mm and opens the mandible 8mm.
- Predicate Device (Snore-Guard): Advances the mandible about 6-8mm anteriorly and opens the mandible 7-8mm.
These are presented to show mechanical similarity, not clinical efficacy metrics against pre-defined acceptance criteria.
- Inferred Performance Description (from "DEVICE TESTING" section):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The 510(k) summary does not detail any clinical study or test set with a specific sample size. The "DEVICE TESTING" section focuses on mechanical characteristics comparison rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This type of detail is relevant to studies with expert adjudicated ground truth, which is not described in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No adjudication method is mentioned as no specific test set or clinical study requiring adjudication is detailed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. MRMC studies are typically for evaluating diagnostic imaging or AI-assisted interpretation, which is not the nature of this device. This is a physical anti-snoring appliance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to an AI algorithm's performance, which is not relevant to this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided. No ground truth (in the context of clinical outcomes or diagnostic accuracy) is mentioned because no clinical efficacy study is detailed. The "ground truth" for the 510(k) is the established performance and characteristics of the predicate device.
8. The sample size for the training set
- Not applicable/Not provided. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
Summary of Device Acceptance (510(k) Context):
The acceptance criteria for a 510(k) submission revolve around demonstrating substantial equivalence to a predicate device. For the SNORE-CURE, this was achieved by showing:
- Similar Intended Use: Both SNORE-CURE and Snore-Guard are intended as aids in the alleviation of snoring by repositioning the lower jaw.
- Similar Design and Materials: The SNORE-CURE is stated to be "substantially similar in design, materials and function" to the Snore-Guard.
- Similar Mechanism of Action and Mechanical Characteristics:
- Both devices advance the mandible anteriorly and open it vertically.
- SNORE-CURE: mandible advancement 6-7mm anteriorly, average overjet 4mm, mandible opening 8mm.
- Snore-Guard: mandible advancement 6-8mm anteriorly, mandible opening 7-8mm.
The "study" that proves the device meets "acceptance criteria" (of substantial equivalence) is the comparison presented in the "DEVICE TESTING" section. No formal clinical trial data is presented in this summary to demonstrate the device's efficacy in alleviating snoring against specific metrics, but rather its mechanical similarity to a previously cleared device. The FDA's clearance letter (K980952, June 1, 1998) confirms that they found the device "substantially equivalent" for the stated indications for use.
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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)
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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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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
§ 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.”