The Respire Blue Series – EF (Endurance Frameworks) – is available with a hard device fitting surface. The hard surface consists of Acrylic (side plates / trays) and chrome - Wironit material (upper / Palatal and lower / Lingual plates / trays). Refer to Figure 1 Representative Drawing. The device is retained with ball and clasps which are used to hold elastic bands which guide the jaw to the desired position. In addition there are expansion screws inside the Acrylic side plates / trays that allows for device expansion based on patient needs.

The upper and lower components are connected by an adjustable hinge, thus the patient can open and close the mouth while wearing the appliances

AI/ML Overview

The provided text describes the Respire Blue Series - EF intraoral device, indicated for treating mild to moderate Obstructive Sleep Apnea (OSA). The 510(k) submission (K152292) is for a modification to a previously cleared device (K111207), specifically the material used for the top and bottom plates/trays.

Based on the provided text, the acceptance criteria and study information can be summarized as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
Biocompatibility	ISO 10993 Standards	"The results of testing determined that the material didn't cause skin irritation or allergenic sensitization."
Cytotoxicity	MEM Elution testing	"The testing passed with a reactivity of 0 (zero) or none."
Material Integrity (Strength)	Specimen elongation and load-bearing force to break	"The amount of energy shown in the results, still far exceeds the amount of energy required by biting to create such a failure which occurred at an average of 275.6 Ibf using five (5) sample devices. Thus, the proposed Wironit/Acrylic parts are sufficient to survive a load exposure exerted by a human oral cavity."

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

Sample Size: For the Material Integrity testing, five (5) sample devices were used.
Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It is assumed to be part of the manufacturer's internal testing as described in the 510(k) submission.

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

The document does not mention the use of experts to establish ground truth for the non-clinical tests described. The tests appear to be laboratory-based material science tests.

4. Adjudication Method for the Test Set

This information is not applicable as the described tests are laboratory-based material science tests, not clinical studies involving interpretation by multiple experts.

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

No MRMC comparative effectiveness study was done. This device is a physical intraoral device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance study was done. This device is a physical intraoral device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For biocompatibility and cytotoxicity, the "ground truth" is defined by the ISO 10993 standards and the specific reactivity thresholds of the MEM Elution test.
For material integrity, the "ground truth" is established by the mechanical properties (elongation, load-bearing force) of the material compared to a benchmark (the predicate device and the force exerted by a human bite).

8. The sample size for the training set

A "training set" is not applicable for the type of non-clinical tests described for this physical device. These are material characterization and performance validation tests, not machine learning model training.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for a machine learning model.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 7, 2015

Respire Medical Holding c/o Mr. Stephen Inglese Founder and CEO Quality Solutions and Support, LLC PO Box 8271 Holland, Michigan 49422

Re: K152292

Trade/Device Name: Respire Blue Series-EF 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: September 7, 2015 Received: September 8, 2015

Dear Mr. Inglese:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 4.0

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K152292

Device Name Respire Blue Series - EF

Indications for Use (Describe)

The Respire Blue Scries - EF is indicated to treat mild to moderate OSA (Obstructive Sleep Apnea)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

* DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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K152292 510(k) Summary

Device Common Name: D Device, Anti-Snoring

Device Proprietary Name: Respire Blue Series - EF

Submitter: Respire Medical, LLC 18 Bridge St Ste 4J Brooklyn. NY 10021 Phone: 718-643-7326
Contact: Stephen Inglese Consultant Quality Solutions and Support, LLC Phone: 561-251-0876 Email: swi@qss-llc.com

Date Prepared: December 8, 2015

Classification Regulation: 21 CFR §872.5570, Class II - Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

Panel:	Dental
Product Code:	LRK
Predicate Device:	K111207 – Submitter's own previously cleareddevice
Indication for Use:	The Respire Blue Series – EF is indicatedto treat mild to moderate OSA (Obstructive SleepApnea)

Device Description:

The upper and lower components are connected by an adjustable hinge, thus the patient can open and close the mouth while wearing the appliances

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Figure 1 - Respire Blue Series - EF - Front View

Image /page/4/Picture/2 description: The image shows a dental device, likely a mouthguard or retainer, with a clear central section and colored (red and blue) side components. The device appears to be designed to fit over both the upper and lower teeth simultaneously. The clear part is likely made of a transparent plastic material, while the colored parts are made of a more rigid material. The device is likely used to protect the teeth from grinding or clenching during sleep.

Performance Data:

The subject of this 510(k) is a modification to the material used for the manufacturing of the top and bottom plates / trays of the device. The material "Wironit" is a widely used dental material, demonstrated via biocompatibility and cytotoxicity testing. The following nonclinical tests were performed:

Biocompatibility testing was accomplished according to the standards of ● ISO 10993. The results of testing determined that the material didn't cause skin irritation or allergenic sensitization.
Minimal Essential Medium (MEM) Elution testing was designed to ● determine the cytotoxicity of extractable substances. The testing passed with a reactivity of 0 (zero) or none.
Material Integrity testing demonstrates the strength of the Wironit material . as compared to the Acrylic material. The predicate device consisted of only Acrylic. The Wironit / Acrylic and Acrylic only (predicate device) were tested together to determine substantial equivalence as it relates to specimen elongation (stretching) and load bearing force to break. In both tests the points of failure were identified at the same location; yet the amount of energy required to cause failure was less for Wironit /Acrylic. However, the amount of energy shown in the results, still far exceeds the amount of energy required by biting to create such a failure which occurred at an average of 275.6 Ibf using five (5) sample devices. Thus, the proposed Wironit/Acrylic parts are sufficient to survive a load exposure exerted by a human oral cavity. In addition the intended use of this device is indicated to treat mild to moderate OSA (Obstruction Sleep Apnea) and not applying the necessary force for biting.

Substantial Equivalence:

The modification of the added material to the originally cleared device is demonstrated in Chart 1. The device function remains the same, the option for the Wironit material for the upper and lower plates / trays provides the patient with a more comfortable fit and durability. Therefore the modified device is substantially equivalent to the previously cleared Respire Blue Series.

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Respire Blue Series – EF Traditional 510(k) Respire Medical

Chart 1

SubstantialEquivalence Topic	Respire Blue Series	Respire Blue Series -EF
510(k)	K111207	K152292
Company Name	Respire Medical	Respire Medical
Regulation Description	Intraoral devices forsnoring and intraoraldevices for snoring andobstructive sleep apnea(OSA)	Intraoral devices forsnoring and intraoraldevices for snoring andobstructive sleep apnea(OSA)
Device Name	Device, Anti Snoring	Device, Anti Snoring
Product Code	LRK	LRK
Classification	Class II	Class II
Intended Use	The Respire Blue Seriesis indicated to treat mild tomoderate OSA.	The Respire Blue Series -EF is indicated to treat mildto moderate OSA.
Single or Multiple Use	Multiple Use	Multiple Use
Target Population	Adult Patients	Adult Patients
Prescription or OTC Use	Prescription	Prescription
Device Components	Orthodontic Acrylic plates/ trays, TelescopicHardware and Ball Clasp	Orthodontic Acrylic plates/ trays, and Wironit plates/ trays, TelescopicHardware and Ball Clasp
Appliance Design	Customized device Rigidplates / trays two piecesUpper/Lower and sidesAcrylic.	Customized device Rigidplates and trays / two pieces /Upper and Lower/ Acrylic and Wironit andsides Acrylic
Device Functionality	Allows to increasepharyngeal opening, and toimprove the ability to exchangeair during sleep. Upper andlower plates / trays unhook foreasy removal from mouth.Works by mandibularadvancement. Adjustableusing titration keys.	Allows to increasepharyngeal opening, and toimprove the ability toexchange air during sleepUpper and lower plates / traysunhook for easy removal frommouth Works by mandibularadvancement Adjustableusing titration keys
Mandibular AdvancementRange	6mm	6mm
Raw Material: Side /Upper and Lower Trays	Acrylic (side and upperand lower plates / trays)	Acrylic (side plates / trays)and Wironit (upper andlower / plates / trays)
Raw Material: MetalComponents	Stainless Steel	Stainless Steel
Colorants	Blue	Blue

Note: Bold "Substantial Equivalence Topic" – Difference between the cleared device and the Subject Device

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.”