(80 days)
The Respire Pink Series intraoral appliances are intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adult patients 18 years of age or older.
Optionally, the DentiTrac® micro-recorder may be incorporated into a Respire Pink Series device. The micro-recorder is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac® system.
The Respire Pink Series with DentiTrac® refers to two devices: Respire Pink Series-Herbst and the Respire Pink Series-Herbst-EF, herein referred to collectively as Respire Pink Series. These devices function as mandibular advancement splints which hold the jaw in a forward position. The forward jaw placement moves the tongue and pharyngeal tissue into a position to help maintain an open airway, which allows the passage of more air per breath and helps in the treatment of snoring and mild to moderate Obstructive Sleep Apnea (OSA). Respire Pink Series appliances are customizable devices which are produced according to the individual patient anatomy and prescription.
The Respire Pink Series-Herbst consists of full hard acrylic upper and lower fitting surfaces, and the Respire Pink Series-Herbst-EF consists of hard acrylic fitting side plates and chrome (BEGO Wironit®) upper palatal and lower lingual plates. The Herbst hardware on the side of the device allows for forward and lateral jaw movement while restricting backward jaw movement, and allows the patient to open and close the mouth. The Herbst hardware contains an expansion screw for mandibular position adjustment, and is attached to the appliance using medical grade stainless steel fixing elements and screws.
This submission is to provide clinicians the option to incorporate a Braebon DentiTrac® micro-recorder into a Respire Pink Series device. The micro-recorder is encapsulated in Loctite epoxy and fully encased into the device acrylic, and is not patient contacting. The micro-recorder is utilized to track patient compliance to prescribed oral appliance therapy by collecting data for wear-time through oral temperature, movement tracking, and head position. The data can be uploaded to a cloud-based web application using the DeniTrac® system which allows clinicians to review the patient data. The inclusion of the microrecorder provides additional treatment information to clinicians without effecting the operating principles of the Respire Pink Series devices.
The provided document is a 510(k) summary for the Respire Pink Series with DentiTrac®, a medical device intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA). The document describes the device, its intended use, comparison to predicate devices, and performance testing. However, it does not contain detailed acceptance criteria and a study proving the device meets those criteria in the typical format of a diagnostic performance study.
Instead, the document details a substantial equivalence determination, which is a different type of regulatory submission. In this context, "acceptance criteria" are related to demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting specific quantifiable performance metrics against a defined ground truth in a clinical study.
Here's an analysis based on the information provided, highlighting what is and is not present:
Key Findings from the Document:
- Device Type: Intraoral appliance for snoring and OSA, with an optional micro-recorder for compliance tracking.
- Regulatory Pathway: 510(k) Premarket Notification, seeking substantial equivalence to predicate devices.
- Predicates:
- Key Difference of the New Device: The addition of the DentiTrac® micro-recorder to the Respire Pink Series (which previously existed without it).
- Performance Testing Focus: Non-clinical. The document explicitly states: "The addition of the DentiTrac® micro-recorder does not adversely affect the original design, therefore, not introducing any new issues of concern. A risk assessment shows that risks are mitigated to acceptable levels, and performance testing related to the DentiTrac® micro-recorder confirms that EMC and electrical safety, biocompatibility, and software elements were evaluated."
Addressing Your Specific Questions:
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A table of acceptance criteria and the reported device performance:
No explicit table of quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity for OSA efficacy) is provided. The "performance" described is largely non-clinical, focusing on safety, electrical compatibility, biocompatibility, and software aspects, evaluated against standards or risk assessments. The goal of a 510(k) is to show substantial equivalence, not to re-prove clinical efficacy against new, explicit performance targets if the predicate device's efficacy is already established.
The "performance" aspect for the DentiTrac® micro-recorder relates to its ability to accurately measure compliance. The document states: "DentiTrac® performance testing is located in the Braebon DentiTrac® Master File MAF 2557. Process validation concerning the incorporation and functionality of the DentiTrac® micro-recorder is certified by Braebon." This implies performance testing for the micro-recorder itself occurred, but the details (acceptance criteria, results) are not in this document.
Acceptance Criterion (Implicit/General for 510(k)) Reported Device Performance (from document) Safety & Efficacy (Overall) Device is substantially equivalent to predicate devices (SomnoDent® with Micro-Recorder and Respire Pink Series-Herbst/Herbst-EF). The addition of the DentiTrac® micro-recorder does not adversely affect the original design or introduce new issues of concern. The new device utilizes the same materials, manufacturing procedures, principles of operation, and overall design as existing Respire Pink Series devices, with the DentiTrac® micro-recorder being identical to that used in the SomnoDent® predicate. Risk Mitigation A risk assessment showed that risks are mitigated to acceptable levels. EMC and Electrical Safety Evaluated (related to DentiTrac® micro-recorder). Specific data not in this document, but implied to meet standards. Biocompatibility Evaluated (related to DentiTrac® micro-recorder). Specific data not in this document, but implied to meet standards based on substantial equivalence claim and previous assessments of the Respire Pink Series. Software Elements Evaluated (related to DentiTrac® micro-recorder). Specific data not in this document. Micro-Recorder Functionality "Process validation concerning the incorporation and functionality of the DentiTrac® micro-recorder is certified by Braebon." Intended to measure patient compliance to oral appliance therapy by collecting data for wear-time through oral temperature, movement tracking, and head position. (Details of validation in Braebon DentiTrac® Master File MAF 2557, not in this document). Respire Medical performs 100% visual and functional inspections. Mechanical Integrity/Manufacturing Respire Medical performs 100% visual and functional inspections throughout the production process to ensure that the device meets manufacturing specifications for the Respire Pink Series device and specifications for the incorporation of the DentiTrac® micro-recorder. The device allows for forward and lateral jaw movement while restricting backward jaw movement, and allows the patient to open and close the mouth. The Herbst hardware contains an expansion screw for mandibular position adjustment. (These are design features, not "performance" in the sense of a clinical outcome metric). -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable/Not provided in this document. This document focuses on substantial equivalence based on technical and non-clinical testing, particularly regarding the addition of the DentiTrac® micro-recorder. It does not describe a clinical performance study with a distinct "test set" of patients or data in the way a diagnostic AI device would. The performance testing for the DentiTrac® micro-recorder itself (which is embedded) is referenced to a Master File (MAF 2557), so details about its own test set would be there, but are not in this 510(k) summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. As there is no clinical "test set" in this document for evaluating the device's diagnostic or clinical efficacy, there's no mention of experts establishing a ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical "test set" or adjudication method is described.
-
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:
Not applicable. This device is an intraoral appliance, not an AI-powered diagnostic tool that assists human readers. Therefore, an MRMC study is irrelevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device (intraoral appliance), not an algorithm. The DentiTrac® micro-recorder tracks compliance data, which is then uploaded to a web application for clinicians to review. It is a data collection tool, not a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable for clinical efficacy in this document. The "ground truth" for the non-clinical testing would be engineering specifications, material standards, electrical safety standards, and risk assessment thresholds. For instance, the "ground truth" for biocompatibility is successful adherence to ISO 10993 standards. For micro-recorder functionality, it would be the accuracy and reliability of its compliance tracking features (details in MAF 2557).
-
The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."
-
How the ground truth for the training set was established:
Not applicable. As above, no training set for an algorithm is involved.
Conclusion based on the provided text:
The document describes a 510(k) submission for a physical medical device (intraoral appliance) that has incorporated a compliance tracking micro-recorder (DentiTrac®). The "acceptance criteria" and "studies" are framed within the context of demonstrating substantial equivalence to existing predicate devices, focusing on non-clinical aspects like materials, manufacturing, design, principles of operation, electrical safety, biocompatibility, and software evaluation of the embedded micro-recorder. This is distinct from a clinical performance study with quantitative diagnostic metrics and explicit acceptance criteria against a defined ground truth, which is typically seen for new diagnostic or AI-driven medical devices. The document references a Master File (MAF 2557) for detailed performance testing of the DentiTrac® micro-recorder, suggesting that more specific performance data for that component exists elsewhere.
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Image /page/0/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized representation of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2017
Respire Medical Holding Mr. Jonathan Sandler Ouality Assurance Manager 18 Bridge Street. Suite 4i Brooklyn. New York 11201
Re: K170692
Trade/Device Name: Respire Pink Series With DentiTrac® Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: Class II Product Code: PLC Dated: March 7, 2017 Received: March 7, 2017
Dear Jonathan Sandler:
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.
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
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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 (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 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.
Lori A. Wiggins -S6
for
Tina Kiang, Ph.D. Acting 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
510(k) Number (if known) K170692
Device Name Respire Pink Series with DentiTrac®
Indications for Use (Describe)
The Respire Pink Series intraoral appliances are intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adult patients 18 years of age or older.
Optionally, the DentiTrac® micro-recorder may be incorporated into a Respire Pink Series device. The micro-recorder is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac® system.
| 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) |
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Image /page/3/Picture/0 description: The image shows the logo for Respire Medical. The logo features a stylized figure with outstretched arms above a green and white structure, all enclosed within a circle. Below the circle, the words "Respire Medical" are written in an elegant, cursive font.
510(k) Summary
510(k) Submission Number: K170692
Submitter
Respire Medical 18 Bridge Street, Suite 4J Brooklyn, NY 11201 Phone: 718-643-7326
Official Contact:
Jonathan Sandler Quality Assurance Manager Phone: 718-360-9209 Email: Jonathan@respiremedical.com
Date Prepared:
May 16, 2017
Device Identification
| Proprietary Name: | Respire Pink Series with DentiTrac® |
|---|---|
| Common Name: | Device, Anti-Snoring |
| Classification Name: | Intraoral devices for snoring and intraoral devices for snoringand obstructive sleep apnea |
| Device Classification: | Class II |
| Product Code: | PLC |
| Regulation Number: | 21 CFR 872.5570 |
Predicate Devices
| Candidate | Predicate | Manufacturer | 510(k) Number |
|---|---|---|---|
| Respire Pink Serieswith DentiTrac® | SomnoDent® with Micro-Recorder | SomnoMed, Inc. | K150369 |
| Respire Pink Series-Herbst | Respire Medical, LLC | K131138 | |
| Respire Pink Series-Herbst-EF | Respire Medical, LLC | K150572 |
The primary predicate device used for substantial equivalence is the SomnoMed SomnoDent® with Micro-Recorder. The reference predicate devices are the Respire Pink Series-Herbst devices which includes both the standard Respire Pink Series-Herbst device and the Respire Pink Series-Herbst-EF.
Device Description
The Respire Pink Series with DentiTrac® refers to two devices: Respire Pink Series-Herbst and the Respire Pink Series-Herbst-EF, herein referred to collectively as Respire Pink Series. These devices function as mandibular advancement splints which hold the jaw in a forward
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Image /page/4/Picture/0 description: The image shows the logo for Respire Medical. The logo features a person with their arms outstretched above a green structure, all enclosed in a circle. Below the circle, the words "Respire Medical" are written in an elegant, cursive font.
position. The forward jaw placement moves the tongue and pharyngeal tissue into a position to help maintain an open airway, which allows the passage of more air per breath and helps in the treatment of snoring and mild to moderate Obstructive Sleep Apnea (OSA). Respire Pink Series appliances are customizable devices which are produced according to the individual patient anatomy and prescription.
The Respire Pink Series-Herbst consists of full hard acrylic upper and lower fitting surfaces, and the Respire Pink Series-Herbst-EF consists of hard acrylic fitting side plates and chrome (BEGO Wironit®) upper palatal and lower lingual plates. The Herbst hardware on the side of the device allows for forward and lateral jaw movement while restricting backward jaw movement, and allows the patient to open and close the mouth. The Herbst hardware contains an expansion screw for mandibular position adjustment, and is attached to the appliance using medical grade stainless steel fixing elements and screws.
This submission is to provide clinicians the option to incorporate a Braebon DentiTrac® micro-recorder into a Respire Pink Series device. The micro-recorder is encapsulated in Loctite epoxy and fully encased into the device acrylic, and is not patient contacting. The micro-recorder is utilized to track patient compliance to prescribed oral appliance therapy by collecting data for wear-time through oral temperature, movement tracking, and head position. The data can be uploaded to a cloud-based web application using the DeniTrac® system which allows clinicians to review the patient data. The inclusion of the microrecorder provides additional treatment information to clinicians without effecting the operating principles of the Respire Pink Series devices.
Image /page/4/Picture/4 description: The image shows two figures of the Respire Pink Series with DentiTrac. Figure 1 shows a front view of the dental device, which is pink and has metal components. Figure 2 shows a side view of the same device, highlighting the DentiTrac component.
Intended Use
The Respire Pink Series intraoral appliances are intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adult patients 18 years of age or older.
Optionally, the DentiTrac® micro-recorder may be incorporated into a Respire Pink Series device. The micro-recorder is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac® system.
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Image /page/5/Picture/0 description: The image shows the logo for Respire Medical. The logo features a circular emblem with a stylized figure with outstretched arms above a green structure, possibly representing a medical facility or a person in a relaxed pose. Below the emblem, the words "Respire Medical" are written in an elegant, cursive font, emphasizing the brand's name and suggesting a focus on respiratory health or well-being.
Comparison to Predicate Devices:
| Substantial | Proposed: | Primary Predicate: | Reference Predicate: |
|---|---|---|---|
| Equivalence Topic | Respire Pink Series with | SomnoMed | Respire Pink Series- |
| DentiTrac® | SomnoDent® with | Herbst / Pink Series- | |
| Micro-Recorder | Herbst-EF | ||
| 510(k) | N/A | K150369 | K131138 / |
| K150572 (EF) | |||
| Company Name | Respire Medical | SomnoMed | Respire Medical |
| Device Name | Device, Anti-Snoring | Device, Anti-Snoring | Device, Anti-Snoring |
| Indications for Use | The Respire Pink Series intraoralappliances are indented to treat | The SomnoDent Intraoral devicesare intended for the treatment of | The Respire Pink Series-Herbst isindicated to treat mild to |
| Statement | snoring and mild to moderate | night time snoring and mild to | moderate OSA. |
| Obstructive Sleep Apnea (OSA) in | moderate obstructive sleep | ||
| adult patients 18 years of age orolder. | apnea in patients 18 years of ageor older | The Respire Pink Series-Herbst-EFis indicated to treat mild to | |
| moderate OSA. | |||
| Optionally, the DentiTrac micro-recorder may be incorporated | Optionally, if the DentiTrac micro-recorder is completely embedded | ||
| into a Respire Pink Series device. | into the SomnoDent device, the | ||
| The micro-recorder is intended to | micro-recorder is intended to | ||
| measure patient compliance tooral appliance therapy in | measure patient compliance tooral device/appliance therapy in | ||
| combination with the DentiTrac | combination with the DentiTrac | ||
| Intended Use | system. | System. | |
| Intended as an | Yes | Yes | Yes |
| intraoral device | |||
| Intended to reduce | Yes | Yes | Yes |
| snoring or help | |||
| alleviate snoring | |||
| Intended for night | Yes | Yes | Yes |
| time use | |||
| Indicated for single | Yes | Yes | Yes |
| patient multiuse | |||
| Indicated for use at | Yes | Yes | Yes |
| home or sleep | |||
| laboratories | |||
| Design | |||
| Separate upper and | Yes | Yes | Yes |
| lower tray pieces | |||
| Works by mandibular | Yes | Yes | Yes |
| advancement | |||
| Can be adjusted or | Yes | Yes | Yes |
| refit | |||
| Lower jaw adjustment | Yes | Yes | Yes |
| using supplied | |||
| components | |||
| Permits patient to | Yes | Yes | Yes |
| breathe through | |||
| mouth | |||
| Upper and lower traysdisengage for easyremoval | Yes | Yes | Yes |
| Cleaned and inspecteddaily by patient | Yes | Yes | Yes |
| Materials | |||
| Advancementmechanism: surgicalgrade stainless steel | Yes | Yes | Yes |
| Acrylic fitting surface | Yes | Yes | Yes |
| Acrylic/Wironit®fitting surfaces | Yes (EF) | No | Yes (EF) |
| Micro-Recorderembedded intodevice | Yes | Yes | No |
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Image /page/6/Picture/0 description: The image shows the logo for Respire Medical. The logo features a circle with a person with their arms raised above a green bridge. Below the circle is the text "Respire Medical" in a cursive font.
Performance Testing
Non-clinical performance testing:
The addition of the DentiTrac® micro-recorder does not adversely affect the original design, therefore, not introducing any new issues of concern. A risk assessment shows that risks are mitigated to acceptable levels, and performance testing related to the DentiTrac® microrecorder confirms that EMC and electrical safety, biocompatibility, and software elements were evaluated. DentiTrac® performance testing is located in the Braebon DentiTrac® Master File MAF 2557. Process validation concerning the incorporation and functionality of the DentiTrac® micro-recorder is certified by Braebon. Respire Medical performs 100% visual and functional inspections throughout the production process to ensure that the device meets manufacturing specifications for the Respire Pink Series device and specifications for the incorporation of the DentiTrac® micro-recorder.
Discussion of Similarities and Differences Between the Subject and Predicate Devices
The Respire Pink Series predicate devices (K131138 and K150572) are identical to the Respire Pink Series with DentiTrac® candidate device apart from the addition of the DentiTrac® micro-recorder. The general characteristics and specifications are unchanged in that each devices utilizes the same materials, manufacturing procedures, principles of operation, and overall design. The DentiTrac® micro-recorder used in the Respire Pink Series with DentiTrac® is identical to that which is used in the SomnoDent® (K150369) predicate device, and the indications for use are similar between the two devices. However, the age population has been added which is not present on K131138 and K150572 predicates.
Conclusion
Based on the similarities in the indications for use, technology, biocompatibility assessment, and non-clinical performance testing, Respire Pink Series with DentiTrac® is substantially equivalent to the SomnoMed SomnoDent® with Micro-Recorder and the Respire Pink Series predicate devices.
§ 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.”