(109 days)
The MPowRx™ Snoring Solution is intended for the treatment of mild to moderate snoring.
The MPowRxTM Snoring Solution is a simple one-piece, one-size-fits-all oral appliance used to prevent mild to moderate snoring. The MPowRx™ Snoring Solution is comfortably retained within the mouth while sleeping.
The MPowRx™ Snoring Solution is fabricated from a common oral appliance material, fits between the lips and teeth, and has an aperture with a protrusion for holding the tongue. Once the protrusion is squeezed to reduce the air volume, a vacuum is formed which keeps the tongue comfortably retained within the protrusion. Forward retention of the tongue helps keep the upper respiratory air passages open to relieve snoring.
The provided 510(k) summary for the MPowRx™ Snoring Solution (K081965) does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The core of this 510(k) submission is a claim of substantial equivalence to predicate devices, rather than a presentation of new performance data or efficacy studies. Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not specify any performance-based acceptance criteria for the MPowRx™ Snoring Solution, nor does it report any specific device performance metrics from a study. The substantial equivalence argument relies on the predicate devices' established safety and effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No test set or data provenance is mentioned as part of this 510(k) submission.
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)
- Cannot be provided. There is no mention of a test set, ground truth establishment, or experts for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication method is described.
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
- Cannot be provided. This device is an oral appliance, not an AI-assisted diagnostic tool or imaging device that would typically involve MRMC studies or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Cannot be provided. This is not a software algorithm; it is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. No ground truth establishment is described for this device, as no new clinical study data is presented.
8. The sample size for the training set
- Cannot be provided. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established
- Cannot be provided. This is not a machine learning or AI device.
Summary from the document:
The 510(k) for the MPowRx™ Snoring Solution (K081965) primarily asserts substantial equivalence to existing predicate devices (Snor-X Mouth Guard K954324, Tongue Stabilizer Device K993381, Nose Breathe Mouthpiece for Heavy Snorer K013687).
The argument for safety and effectiveness is based on:
- Having the same indications for use (treatment of mild to moderate snoring).
- No substantial differences in design or materials that would raise new questions of safety or effectiveness compared to the predicate devices.
- The device is described as a "simple one-piece, one-size-fits-all oral appliance" made from "a common oral appliance material," functioning similarly by comfortably retaining the tongue to keep air passages open.
Therefore, the submission does not include data from a new study demonstrating specific performance metrics against pre-defined acceptance criteria, but rather leverages the established safety and efficacy of the predicate devices.
{0}------------------------------------------------
510(k) Summary (per 21 CFR 807.92(c))
OCT 2 7 2008
1. Applicant
Tech Avenue Ventures d/b/a MPowRx Health and Wellness Products Inc. #510 3553-31 St. NW Calgary, Alberta T2L 2K7 Canada
Contact Person: Gijs van Rooijen, PhD, Principal Tel: 403-475-8324 Fax: 403-282-1238 E-mail: vanro@taventures.ca Date Prepared: June 30, 2008
2. Device Name
| Trade Name: | MPowRx™ Snoring Solution |
|---|---|
| Common/Usual Name: | Device, Anti-Snoring |
| Classification Name: | Intraoral devices for snoring and intraoral devices forsnoring and obstructive sleep apnea |
| Regulation Number: | 872.5570 |
| Product Code: | LRK |
| Classification: | II |
| Panel: | Dental |
3. Predicate Devices
The MPowRx™ Snoring Solution is substantially equivalent to the following devices:
| 510(k)Number | Device | Applicant |
|---|---|---|
| K954324 | Snor-X Mouth Guard | Snorex, Inc. |
| K993381 | Tongue Stabilizer Device | University of Otago |
| K013687 | Nose Breathe Mouthpiece for Heavy Snorer | Steven K. Sue |
{1}------------------------------------------------
4. Intended Use
The MPowRx™ Snoring Solution is intended for the treatment of mild to moderate snoring.
5. Description of the Device
The MPowRxTM Snoring Solution is a simple one-piece, one-size-fits-all oral appliance used to prevent mild to moderate snoring. The MPowRx™ Snoring Solution is comfortably retained within the mouth while sleeping.
The MPowRx™ Snoring Solution is fabricated from a common oral appliance material, fits between the lips and teeth, and has an aperture with a protrusion for holding the tongue. Once the protrusion is squeezed to reduce the air volume, a vacuum is formed which keeps the tongue comfortably retained within the protrusion. Forward retention of the tongue helps keep the upper respiratory air passages open to relieve snoring.
6. Safety & Effectiveness
There are no substantial differences between the MPowRx™ Snoring Solution defined in this 510(k) submission and the predicate devices. They have the same indications for use and any differences in technological characteristics do not raise issues of safety and effectiveness.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2008
MPowRx Health and Wellness Products Incorporated C/O Ms. Jean Asquith Senior Regulatory Affairs Consultant Emergo Group Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746
Re: K081965
Trade/Device Name: MPowRxTM Snoring Solution 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: October 10, 2008 Received: October 14, 2008
Dear Ms. Asquith:
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.
{3}------------------------------------------------
Page 2 - Ms. Asquith
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 proctice 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, 1 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 Center for Devices and Radiological Health's (CDRH's) (CDRH's) of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Marmuels-lending for "
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation . Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: MPowRx™ Snoring Solution
Indications for Use:
The MPowRx™ Snoring Solution is intended for the treatment of mild to moderate snoring.
Caution: Federal law restricts this device to sale by or on the order of a physician, dentist or other licensed practitioner.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rose
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: kaf 165
§ 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.”