The Respire Blue Series is indicated to treat mild to moderate OSA. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea (OSA).

Device Description

Respire Blue Series is a patented, custom made device for each patient which consists of two dental plates, upper and lower, made of Acrylic. The attachment is at a 65 degree angle to enable movement of the appliances, thus patient can open and close while wearing the appliances. The appliance is open in the front to add comfort by allowing the patient to inhale and exhale more air per breath. Respire Blue Series are offered in two options: (1) Hard/Soft which has a dual laminate layer that provides a soft layer on the tooth surface (2) Hard devices which are all acrylic and retained with ball clasps, this allows the device to be tightened if it becomes loose.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Respire Blue Series device, an intraoral device for snoring and obstructive sleep apnea (OSA). The document focuses on demonstrating substantial equivalence to already marketed predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance studies is not explicitly available in the provided text in the typical format of a clinical trial or performance study report.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means that if the predicate devices were accepted based on certain performance, and the new device is sufficiently similar and raises no new safety or effectiveness concerns, it can also be accepted.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria and their corresponding reported device performance metrics (e.g., sensitivity, specificity, accuracy, AHI reduction percentage) are not defined or explicitly presented in the document for the Respire Blue Series itself.

Instead, the acceptance for market clearance is based on demonstrating substantial equivalence to predicate devices in terms of:

Feature/Criterion	Predicate Devices (Accepted)	Respire Blue Series (Reported Performance - inferred equivalence)
Intended Use	Yes	YES (Treat mild to moderate OSA, reduce/alleviate snoring)
Target Population	Adults patients	YES
Prescription Device	Yes	YES
Design (e.g., Rigid tray pieces, Separate tray pieces, Custom fit, Mandibular advancement, Adjustable, Placed nightly, Cleaned daily, Easily removed, Lower jaw adjustment, Upper/lower tray unhook)	Yes for relevant features	YES for all relevant features (emphasizing added features like jaw movement and anterior opening for comfort)
Material (e.g., molded hard acrylic and ball clasps; soft lining material adhered to hard surface acrylic)	Yes for relevant features	YES for relevant features (Hard/Soft and Hard options)
Non Sterile	Yes	YES
Safety and Effectiveness	Demonstrated effectively	"no new safety and/or effectiveness issues"
Biocompatibility	Standards met (ISO 7405:2008)	Recognized Consensus Standard: ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry

The document states: "Bench testing results have demonstrated that all test method acceptance criteria were met and demonstrated equivalent results to the predicated devices." This implies that physical and mechanical properties were tested against benchmarks established by the predicate devices, but the specific numerical acceptance criteria and results are not provided.

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

Not explicitly provided. The document refers to "Clinical evaluation and observation results" demonstrating the success rate, but it does not specify the sample size, data provenance (e.g., country of origin), or whether the data was retrospective or prospective for the Respire Blue Series. This information would typically be detailed in a separate clinical study report, which is not part of this 510(k) summary. Given the emphasis on substantial equivalence, a full-scale clinical trial might not have been required if adequate existing data supported the predicate devices and the new device's similarity.

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

Not applicable/not provided. Since a specific "test set" with ground truth established by experts is not detailed for the Respire Blue Series itself in this document, this information is not available. The "clinical evaluation and observation results" mentioned are not described in enough detail to ascertain how ground truth was established by experts.

4. Adjudication Method for the Test Set

Not applicable/not provided. As there is no detailed description of a test set and associated ground truth establishment, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's functional equivalence and safety, not on human reader performance with or without AI assistance. This device is a physical intraoral appliance, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The Respire Blue Series is a physical medical device (an intraoral appliance), not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the Respire Blue Series itself, the document states "clinical evaluation and observation results have demonstrated the success rate of reduction of snoring and the success rate of reduction of apneic events measured by polysomnograms."

Therefore, for the "clinical evaluation" mentioned, the ground truth for "reduction of apneic events" would have been established by polysomnography (PSG), which is the gold standard for diagnosing sleep apnea.

8. The Sample Size for the Training Set

Not applicable/not provided. As this is a physical medical device and not an AI/ML algorithm requiring a "training set," this information is not relevant or provided.

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

Not applicable/not provided. This question pertains to AI/ML models, which is not the nature of the Respire Blue Series device.

Summary

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AUG-2 3 2011-

MEDICAL REGISTRATION

SECTION 5.....................................................................................................................................................................

510(k) Number K_1207 Submission Owner ーー Respire Medical® LLC 18 Bridge St., Ste. 4J Brooklyn, 11201 NY Phone 718-643-7326 Fax 718-643-7322 Official Correspondent 2 Sterling Inc. Contact Person Daniela Levy - Regulatory Consultant 607 South Hill st., suite#506 Los Angeles, 90014 CA Phone 213-447-5297 Fax 213-627-0340 Web www.sterlingmedicalregistration.com 3 Submission Date April 2011 4 Device Trade Name Respire Blue Series 5 Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea (OSA) 6 Classification Device Name Device, Anti-Snoring : Product Code гак . • Regulation No 872.5570 : Class 11 : Panel Dental : 7 Reason for the Premarket Notification Submission : New Device

8 Identification of Legally Marketed Predicate Devices :

Respire Blue Series is substantially equivalent to TAP II K060388 ; Somnomed . MAS K050592; Somnomed MAS Flex SK073004 ; OASYS K030440 in terms of intended use, indication for use, technological characteristics, performance and user interface. The predicate devices are Class II medical devices.

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TERLING ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー

MEDICAL REGISTRATION

9 Device Description
Respire Blue Series is a patented, custom made device for each patient which consists of two dental plates, upper and lower, made of Acrylic.

The attachment is at a 65 degree angle to enable movement of the appliances, thus patient can open and close while wearing the appliances. The appliance is open in the front to add comfort by allowing the patient to inhale and exhale more air per breath.

Respire Blue Series are offered in two options: (1) Hard/Soft which has a dual laminate layer that provides a soft layer on the tooth surface (2) Hard devices which are all acrylic and retained with ball clasps, this allows the device to be tightened if it becomes loose.

10 Intended use
- The Respire Blue Series is indicated to treat mild to moderate OSA. .

11 Performance Standards or Special Controls

Recognized Consensus Standard: ISO 7405:2008 Dentistry Evaluation of . biocompatibility of medical devices used in dentistry

Substantial Equivalent Table	Respire Blue Series (Hard/Soft Surface)	Respire Blue Series (Hard Surface)	Somnomed MAS	OASYS	TAP II	Somnomed MAS Flex S
			K050592	K030440	K060388	K073004
Intended Use
Intended as an intraoral device	YES	YES	YES	YES	YES	YES
Intended to reduce snoring or help alleviate snoring	YES	YES	YES	YES	YES	YES
Treatment of mild to moderate obstructive sleep apnea	YES	YES	YES	YES	YES	YES
Indicated for single patient multi-use	YES	YES	YES	YES	YES	YES
Indicated for use at home or sleep laboratories	YES	YES	YES	YES	YES	YES

12 Substantial Equivalence

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MEDICAL REGISTRATION
Substantial Equivalent Table	Respire BlueSeries(Hard/SoftSurface)	Respire BlueSeries(HardSurface)	SomnomedMAS	OASYS	TAP II	SomnomedMAS Flex S
			K050592	K030440	K060388	K073004
Target population - Adultspatients	YES	YES	YES	YES	YES	YES
Prescription Device	YES	YES	YES	YES	YES	YES
Design
Rigid tray pieces	YES	YES	YES	YES	YES	YES
Separate tray pieces	YES	YES	YES	YES	YES	YES
Custom fit for each patient	YES	YES	YES	YES	YES	YES
Works by mandibularadvancement	YES	YES	YES	YES	YES	YES
Can be adjusted or refit	YES	YES	YES	YES	YES	YES
Placed in patient mouth eachevening	YES	YES	YES	YES	YES	YES
Cleaned daily	YES	YES	YES	YES	YES	YES
Easily removed from mouth	YES	YES	YES	YES	YES	YES
Lower jaw adjustment using asupplied adjustment key	YES	YES	YES	YES	YES	YES
Upper and lower tray unhook foreasy removal from mouth	YES	YES	YES	YES	YES	YES
Permits patients to breathe throughmouth	YES	YES	YES	YES	YES	YES
Material
Trays constructed from moldedhard acrylic and ball clasps	YES	YES	YES	NO	NO	NO
Trays constructed from a softlining material adhered to a hardsurface acrylic	YES	NO	NO	NO	NO	YES
Trays constructed from a heatsensitive impermissible materialfor fitting to teeth	NO	NO	NO	YES	YES	NO
Non Sterile	YES	YES	YES	YES	YES	YES

Summary of Equivalence: The Respire Blue Series is considered to be substantially equivalent to TAP II, Somnomed MAS, Somnomed MAS Flex and OASYS devices. As similar to its predicate device Respire Blue Series is a custom made device, consists of two parts, upper and lower trays, made of acrylic. The design differences is that the TAP design holds the jaw in a more fixed position and does not allow for the patient to open and close their mouth, while the Respire Blue Series allow jaw movement and is more comfortable. Respire Blue Series is similar to Somnomed both devices contain expansion screw which enable the device to be titratable and allows simple adjustment and positioning of the device.

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MEDICAL REGISTRATION

Respire Blue Series enables an anterior opening in the front of the device to allow for patient comfort. The design differences emphasis the advantages of Respire Blue Series technology and thus, raise no new safety and/or effectiveness issues. Respire Blue Series shares the same technological characteristics as its predicate devices and raise no new issues of safety or effectiveness, thus, the Respire Blue Series is substantially equivalent to its predicate devices.

Risk Assessment performance has demonstrated no new safety and/or effectiveness issues.

Bench testing results have demonstrated that all test method acceptance criteria were met and demonstrated equivalent results to the predicated devices. Thus, Respire Blue Series shares similarity with its predicate devices and raise no new safety and/or effectiveness issues.

Clinical evaluation and observation results have demonstrated the success rate of reduction of snoring and the success rate of reduction of apneic events measured by polysomnograms. Thus, Respire Blue Series shares similarity in the indication of use and raise no new safety and/or effectiveness issues.

Conclusion:

As verified by clinical and non clinical data, bench testing and substantial equivalence table, Respire Blue Series shares similarity with its predicated device by term of intended use, raw material and technical design. The fundamental scientific technology of the device is identical or very similar to the referenced predicate devices, thus Respire Blue Series is as safe and effective for its intended use and performs as well the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Respire Medical C/O Ms. Daniela Levy Regulatory Consultant Sterling Incorporated (Sterling Medical Registration) 607 South I-lill Street, Suite 506 Los Angeles, California 90014

AUG 2 3 2011

Re: K111207

Trade/Device Name: Respire Blue Series 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: August 2, 2011 Received: August 3, 2011

Dear Ms. Levy:

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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Page 2 -- Ms. Levy

Enclosure

Please be advised that FDA is 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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRFF'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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony V. Mark

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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TERLII MEDICAL-REGISTRATION-

SECTION 4 - Indication for Use Statement

Indications for Use

510(k) Number (if known): KILLZOZ_

Device Name:

Respire Blue Series

Indications for Use:

The Respire Blue Series is indicated to treat mild to moderate OSA.

Prescription Use ✔

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(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 Runn

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of

510(k) Number: K111207

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.”