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.

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

AI/ML Overview

The provided text is a 510(k) premarket notification for "The Breathe EZ" anti-snoring device. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics. Therefore, the document does not contain specific acceptance criteria for device performance or a study that rigorously proves the device meets such criteria in the way a clinical trial would.

Instead, the submission focuses on comparing the new device's features and intended use to those of legally marketed predicate devices. The "acceptance" in this context refers to the FDA's acceptance of the claim of substantial equivalence.

Here's an analysis based on the information provided, highlighting why many aspects of your request cannot be fulfilled by this type of regulatory document:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) premarket notification for "The Breathe EZ" anti-snoring device does not present traditional acceptance criteria for performance metrics (e.g., a specific reduction in AHI, a percentage of patients achieving a certain snoring reduction). Instead, the "acceptance criteria" are implied by the FDA's criteria for substantial equivalence to legally marketed predicate devices. The device 'meets' these criteria if the FDA determines it is as safe and effective as a predicate device.

The "study" or justification for meeting these criteria is a comparative analysis against predicate devices, rather than a clinical trial demonstrating new performance.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied by Substantial Equivalence Determination)	Reported Device Performance / Justification
Intended Use: - Reduce or alleviate snoring - Prevent bruxing, clenching, and grinding of teeth while sleeping - Target Population: Adult patients - Environment of Use: Home and sleep laboratories	The BREATHE EZ has the same intended use as predicate devices. The presence of an anti-tongue and lip obstruction component (a port/tube) facilitates an open airway, supporting the anti-snoring claim.
Technological Characteristics: - Intraoral device - Heat-sensitive impressible material for fitting - Custom fit - Adjustable/refittable - Placed in mouth each evening, cleaned daily, easily removed - Permits user to breathe through mouth - Non-sterile	The BREATHE EZ shares these characteristics with predicate devices (Dr. B's Mouthpiece, Marketing Technologies Inc., Nellcor Puritan Bennett Inc./Dr. Kieth Thornton). The primary difference is the design (addition of an anti-tongue/lip obstruction component: one port).
Material Safety: - Made of heat-sensitive impression material	Materials are implied to be similar to legally marketed predicate devices, none of which are sterile.
No new questions of safety or effectiveness raised.	The design difference (the port for an open airway) is presented as a modification that doesn't raise new safety or effectiveness concerns, but rather enhances the function. The FDA's letter of substantial equivalence confirms this.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable. This submission is a 510(k) premarket notification, which typically relies on demonstrating substantial equivalence to existing devices rather than new clinical testing with a "test set" of patients. No clinical study data with a test set is presented.
Data Provenance: Not applicable, as no new clinical data from human subjects is provided. The provenance of information comes from comparisons to predicate devices (Dr. B's Mouthpiece – K991948, Marketing Technologies, Inc. – K963063, Nellcor Puritan Bennett Inc. – K972061, Dr. Kieth Thornton – K972061).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. No ground truth was established by experts for a test set in this submission. The "ground truth" for regulatory clearance is based on the established safety and effectiveness of the predicate devices as determined by the FDA.

4. Adjudication Method for the Test Set:

Not applicable. There was no test set or clinical data requiring adjudication by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. No MRMC study was performed or described. This type of study demonstrates human reader performance with and without AI, which is not applicable to a physical anti-snoring device being cleared via substantial equivalence.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is an oral appliance, not an algorithm. Therefore, no standalone performance study in the context of AI algorithms was performed.

7. Type of Ground Truth Used:

The "ground truth" for the purpose of this 510(k) clearance is the established safety and effectiveness of legally marketed predicate devices as previously determined by the FDA. The submission argues that "The Breathe EZ" shares the same intended use and similar technological characteristics, thereby making it as safe and effective.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI model. Therefore, no training set for an algorithm was used.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there was no training set for an algorithm.

Summary

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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. – K962516Dr. 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

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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 MouthpieceK991948	Marketing T. IK963063	Nellcor P.B.K972061
Use:
Intended as anintraoral device	Yes	Yes	Yes	Yes
Intended to reduce orhelp alleviate snoring	Yes	Yes	Yes	Yes
Indicated for use withpersons who snore	Yes	Yes	Yes	Yes
Indicated for singleuserMulti-use	Yes	Yes	Yes	Yes
Indicated for use athome or sleeplaboratories	Yes	Yes	Yes	Yes
Design:
Heat sensitiveimpressible materialfor fitting to teeth	Yes	Yes	Yes	Yes
Custom fit for eachuser	Yes	Yes	Yes	Yes
Can be adjusted orrefit	Yes	Yes	Yes	Yes
Placed in users moutheach evening	Yes	Yes	Yes	Yes
Cleaned daily	Yes	Yes	Yes	Yes
Easily removed frommouth	Yes	Yes	Yes	Yes
Permits user to breaththrough mouth	Yes	Yes	Yes	Yes
Prevents grinding ofteeth	Yes	Yes	Yes	Yes
Attribute	The Breathe EZ	Dr. B's MouthpieceK991948	Marketing T. IK963063	Nellcor P.B.K972061
Materials:
Heat sensitiveimpression material	Yes	Yes	Yes	Yes
Non-Sterile	Yes	Yes	Yes	Yes

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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.

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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.

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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

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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)

Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.”