(173 days)
No
The device description and intended use focus on a physical oral appliance with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to reduce or alleviate snoring and to prevent bruxing, clenching, and grinding of the teeth, which are all therapeutic interventions for medical conditions.
No
The device's intended use is to reduce or alleviate snoring and prevent bruxing, clenching, and grinding of teeth, which are therapeutic rather than diagnostic purposes. It does not mention identifying, analyzing, or monitoring medical conditions.
No
The device description explicitly states it is composed of physical components: an oval plate and a port. This indicates it is a hardware device, not software-only.
Based on the provided information, the Breathe EZ Anti-Snoring Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Breathe EZ device is a physical appliance worn in the mouth to address snoring and teeth grinding. It does not involve testing biological samples.
- Intended Use: The intended use clearly describes a mechanical function to maintain an open airway and prevent teeth movement, not a diagnostic test.
- Device Description: The description details the physical components of the device, not reagents or testing materials.
Therefore, the Breathe EZ Anti-Snoring Device falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Breathe EZ Anti-Snoring Device is intended to reduce or alleviate snoring and to prevent bruxing, clenching and grinding of the teeth while sleeping.
The Breath EZ Anti-Snoring Device is intended to reduce or alleviate snoring by maintaining an open air way and to prevent bruxing, clenching and grinding of the teeth while sleeping.
Product codes
LRK
Device Description
The Breathe EZ Anti-Snoring/Anti-Grinding Device is composed of:
- · An oval plate fitted in front of and between the upper and lower teeth and gums.
- A port to facilitate normal breathing
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral
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)
K991948, K963063, K962516, K972061
Reference Device(s)
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
THE BREATHE EZ
FEB 1 9 2003
D&S Redhage 5901 Vedder Road. New Haven, MO 63068
Non-Confidential Summary of Safety and Effectiveness
Page 1 or 3 August 19, 2002
The Breathe EZ 5901 Vedder Road New Haven, MO 63068 Telephone - (573) 237-3714
| Official Contact: | Daniel J. Redhage, Designer | ||
|---|---|---|---|
| Proprietary or Trade Name: | The Breathe EZ | ||
| Common/Usual Name: | Oral Appliance: anti-snoring/grinding | ||
| Device Classification Name: | Anti-snoring device | ||
| Predicated Devices: | Snore-Ezzer, LLC – K991948 | Marketing Technologies, Inc. – K963063 | Nellcor Puritan Bennett Inc. – K962516 |
| Dr. Kieth Thornton – K972061 |
Device Description:
The Breathe EZ Anti-Snoring/Anti-Grinding Device is composed of:
- · An oval plate fitted in front of and between the upper and lower teeth and gums.
- A port to facilitate normal breathing
Intended Use:
- Indicated Use: The Breathe EZ Anti-Snoring Device is intended to reduce or alleviate snoring and to prevent bruxing, clenching and grinding of the teeth while sleeping.
Target Population: Adult patients
Environment of Use: Home and sleep laboratories
510(k) Package for The Breathe EZ
1
Non-Confidential Summary of Safety and Effectiveness (continued) Page 2 or 3 August 19, 2002
Comparison to Predicate Devices:
| Attribute | The Breathe EZ | Dr. B's Mouthpiece
K991948 | Marketing T. I
K963063 | Nellcor P.B.
K972061 |
|----------------------------------------------------------------|----------------|-------------------------------|---------------------------|-------------------------|
| Use: | | | | |
| Intended as an
intraoral device | Yes | Yes | Yes | Yes |
| Intended to reduce or
help alleviate snoring | Yes | Yes | Yes | Yes |
| Indicated for use with
persons who snore | Yes | Yes | Yes | Yes |
| Indicated for single
user
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 | Yes | Yes | Yes | Yes |
| Permits user to breath
through mouth | Yes | Yes | Yes | Yes |
| Prevents grinding of
teeth | Yes | Yes | Yes | Yes |
| Attribute | The Breathe EZ | Dr. B's Mouthpiece
K991948 | Marketing T. I
K963063 | Nellcor P.B.
K972061 |
| Materials: | | | | |
| Heat sensitive
impression material | Yes | Yes | Yes | Yes |
| Non-Sterile | Yes | Yes | Yes | Yes |
2
Non-Confidential Summary of Safety and Effectiveness (continued) Page 3 or 3 August 19, 2002
Comparison to Predicate Devices:
Differences Between Other Legally Marketed Predicated Devices
The difference between the intended device and predicates is only the design of the device. The predicate Dr. B's Mouthpiece is very similar in every aspect except that The Breathe EZ has an anti-tongue and lip obstruction component consisting of one port, (tube) that provides an open airway regardless of the position of the tongue and lips.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three overlapping profiles of human faces, with flowing lines extending from the faces, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2003
Mr. Daniel J. Redhage President D & S Redhage 5901 Vedder Road New Haven. Missouri 63068
Re: K022891
Trade/Device Name: The Breathe EZ Anti-Snoring Device Regulation Number: 872.5570 Regulation Name: Anti-Snoring Device Regulatory Class: II Product Code: LRK Dated: December 20, 2002 Received: December 27, 2002
Dear Mr. Redhage:
. . . . . . . . . .
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 vour 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 - Mr. Redhage
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__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: The Breathe EZ anti-snoring device
Indications for Use:
The Breath EZ Anti-Snoring Device is intended to reduce or alleviate snoring by maintaining an open air way and to prevent bruxing, clenching and grinding of the teeth while sleeping.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ken Muling for MSR
(Division Sign-Off)
Division of Dental, Infection Control, And Genereal Hospital Devices
510(k) Number K022891
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)