(133 days)
Not Found
No
The summary describes a physical oral appliance (Mandibular Repositioning Device) and its intended use, design, and performance testing. There is no mention of AI, ML, image processing, or any software-based analytical capabilities that would suggest the use of AI/ML. The performance studies focus on mechanical, biocompatibility, and clinical experience, not algorithmic performance.
Yes
The device is intended to "reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea," indicating a therapeutic purpose to treat a medical condition.
No
The device is described as a mandibular repositioning device for treating snoring and sleep apnea, not for diagnosing these conditions. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is an "oral appliance" and a "mandibular repositioning device," which are physical hardware components. The performance studies also mention mechanical and durability testing, further indicating a physical device.
Based on the provided information, the BluePro® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce or alleviate snoring and sleep apnea by repositioning the mandible. This is a physical intervention, not a diagnostic test performed on biological samples.
- Device Description: It's described as a mandibular repositioning device (oral appliance) that is physically fitted to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The BluePro® does not fit this description.
N/A
Intended Use / Indications for Use
The BluePro is a mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The BluePro oral appliance design concept is based upon the use of a standard set of upper and lower trays, referred also as splints in documentation, that are then customized for fit by a dentist. The design is commonly referred to as a Mandibular Repositioning Device (MRD).
The principle of advancing a lower or upper tray so that it advances the mandible for the treatment of snoring and / or mild to moderate obstructive sleep apnea is well known and there are a number of predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients 18 years or older.
Intended User / Care Setting
Home, Dental and Physician offices, 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)
Non-clinical performance testing:
Commercial experience: The BluePro has been marketed outside the US since October 2014. The results of this experience support the substantial equivalence of the BluePro for the intended use, as compared to the predicate device.
The observations support:
- Cleaning via rinsing with water and use of a toothbrush
- Real-time clinical experience from sales outside the US
- Mechanical and durability after real-time use plus simulated 1 year use via the Braem testing
Biocompatibility of Materials: All the materials are considered per FDA G95-1 as Surface Contacting, Mucosal membrane, with duration of use prolonged > 24 hours
§ 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.”
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol of medicine, with three figures representing health, hope, and well-being. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2016
Bluesom Paul Dryden Consultant BlueSom 24 Rue Leon Gaumont Orvault, 44700 FR
Re: K162192 Trade/Device Name: BluePro® 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: LRK Dated: November 14, 2016 Received: November 15, 2016
Dear Mr. Paul Dryden:
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 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
1
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.
Michael J. Ryan -S
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
2
Indications for Use
510(k) Number (if known)
Device Name
BluePro®
Indications for Use (Describe)
The BluePro® is a mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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BLUESOM
24 rue Léon Gaumont 44700 Orvault FRANCE Tel - +33 2 28 25 61 43
| Official Contact: | Erwan Floch - General Manager | |
|---|---|---|
| Proprietary or Trade Name: | BluePro® | |
| Common/Usual Name: | Intra-oral appliance | |
| Classification Name: | LRK - Device, anti-snoring, Intraoral devices for snoring | |
| and intraoral devices for snoring and obstructive sleep apnea | ||
| 21 CFR 872.5570, Class 2 | ||
| Predicate Device: | K113569 – Apnea Sciences – ApneaRx | |
| Predicate | ||
| ApneaRx | Subject Device | |
| BluePro® | ||
| K113569 | K162192 | |
| Indications for Use | The Apnea Sciences Corporation | |
| "ApneaRx" is intended for use on | ||
| adult patients 18 years of age or older | ||
| as an aid for the reduction of mild to | ||
| moderate obstructive sleep apnea | ||
| (OSA), and/or snoring. | The BluePro® is a mandibular | |
| repositioning device intended to | ||
| reduce or alleviate night-time snoring | ||
| and mild to moderate obstructive | ||
| sleep apnea in adult patients 18 years | ||
| or older. | ||
| Environments of use | Home, dental and Physician offices, | |
| Sleep laboratories | Home, dental and Physician offices, | |
| Sleep laboratories | ||
| Patient Population | Adult patients 18 years and older | Adult patients 18 years and older |
| Contraindications | • have central sleep apnea | |
| • have severe respiratory disorders | ||
| • have loose teeth or advanced | ||
| periodontal disease | ||
| • are under 18 years of age | • have central sleep apnea | |
| • have severe respiratory disorders | ||
| • have loose teeth or advanced | ||
| periodontal disease | ||
| • are under 18 years of age | ||
| Prescription | Prescription use | Prescription use |
| Single patient, multi-use | Yes | Yes |
| Limitation of duration of use | No limitation | No limitation |
| Principle of operation / means of | ||
| mandibular advancement | Adjustment of the relative position of | |
| the trays by the use of fixed | ||
| advancement. | Adjustment of the relative position of | |
| the trays by the use of fixed | ||
| advancement. | ||
| Fixed tray sizes | Yes | Yes |
| Method to advance the mandible | Integral interlocking advancement | |
| method | Integral interlocking advancement | |
| method | ||
| Allows lateral and vertical movement | Yes | Yes |
| Employs boil and bite design | Yes | Yes |
| Maximum adjustment by the user | 10 mm | 10 mm |
| Works by holding lower jaw forward | Yes | Yes |
| Cleaned by simple rinsing with water | Yes | Yes |
| Cleaning with toothbrush | Yes | Yes |
| Biocompatibility and Patient contact | Surface Contacting, Mucosal | |
| membrane, with duration of use | ||
| prolonged > 24 hours 24 hours 24 hours |