(109 days)
Not Found
No
The device description details a physical oral appliance with a mechanical mechanism for tongue retention, and there is no mention of software, data processing, or AI/ML terms.
Yes
The 'Intended Use' section states the device is "intended for the treatment of mild to moderate snoring," which directly indicates a therapeutic purpose.
No
The device is described as an oral appliance used to prevent snoring, which is a treatment, not a diagnostic function.
No
The device description clearly states it is an "oral appliance" fabricated from a material, which is a physical hardware component, not software.
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 "treatment of mild to moderate snoring." This is a therapeutic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical oral appliance that works by mechanically retaining the tongue to keep air passages open. It does not involve analyzing biological samples or performing any diagnostic tests.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of measuring biomarkers or performing any kind of in vitro test.
Therefore, the MPowRx™ Snoring Solution is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MPowRx™ Snoring Solution is intended for the treatment of mild to moderate snoring.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
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.
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)
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.
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 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.”
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 for |
| snoring 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
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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