(116 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the materials used in a physical oral appliance. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated to "treat mild to moderate OSA (Obstructive Sleep Apnea)," which is a medical condition, making it a therapeutic device.
No
The device is described as treating existing mild to moderate OSA, not diagnosing it.
No
The device description explicitly details physical components made of Acrylic and chrome-Wironit material, including side plates, trays, palatal and lingual plates, ball and clasps, elastic bands, and expansion screws. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat mild to moderate OSA (Obstructive Sleep Apnea)". This is a therapeutic purpose, not a diagnostic one. IVDs are used to diagnose diseases or conditions.
- Device Description: The device is a physical appliance designed to be worn in the mouth to treat a condition. It does not involve the analysis of biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological markers or parameters for diagnostic purposes.
Therefore, the Respire Blue Scries - EF is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Respire Blue Series - EF is indicated to treat mild to moderate OSA (Obstructive Sleep Apnea)
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
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
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
Intended User / Care Setting
Not Found
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)
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 lbf 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are depicted in a single, continuous line. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
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.
1
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
2
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."
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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 cleared |
| device | |
| Indication for Use: | The Respire Blue Series – EF is indicated |
| to treat mild to moderate OSA (Obstructive Sleep | |
| Apnea) |
Device Description:
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
4
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.
5
Respire Blue Series – EF Traditional 510(k) Respire Medical
Chart 1
| Substantial
| Equivalence Topic | Respire Blue Series | Respire Blue Series -EF |
|---|---|---|
| 510(k) | K111207 | K152292 |
| Company Name | Respire Medical | Respire Medical |
| Regulation Description | Intraoral devices for | |
| snoring and intraoral | ||
| devices for snoring and | ||
| obstructive sleep apnea | ||
| (OSA) | Intraoral devices for | |
| snoring and intraoral | ||
| devices for snoring and | ||
| obstructive 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 Series | |
| is indicated to treat mild to | ||
| moderate OSA. | The Respire Blue Series - | |
| EF is indicated to treat mild | ||
| to 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, Telescopic | ||
| Hardware and Ball Clasp | Orthodontic Acrylic plates | |
| / trays, and Wironit plates | ||
| / trays, Telescopic | ||
| Hardware and Ball Clasp | ||
| Appliance Design | Customized device Rigid | |
| plates / trays two pieces | ||
| Upper/Lower and sides | ||
| Acrylic. | Customized device Rigid | |
| plates and trays / two pieces / | ||
| Upper and Lower | ||
| / Acrylic and Wironit and | ||
| sides Acrylic | ||
| Device Functionality | Allows to increase | |
| pharyngeal opening, and to | ||
| improve the ability to exchange | ||
| air during sleep. Upper and | ||
| lower plates / trays unhook for | ||
| easy removal from mouth. | ||
| Works by mandibular | ||
| advancement. Adjustable | ||
| using titration keys. | Allows to increase | |
| pharyngeal opening, and to | ||
| improve the ability to | ||
| exchange air during sleep | ||
| Upper and lower plates / trays | ||
| unhook for easy removal from | ||
| mouth Works by mandibular | ||
| advancement Adjustable | ||
| using titration keys | ||
| Mandibular Advancement | ||
| Range | 6mm | 6mm |
| Raw Material: Side / | ||
| Upper and Lower Trays | Acrylic (side and upper | |
| and lower plates / trays) | Acrylic (side plates / trays) | |
| and Wironit (upper and | ||
| lower / plates / trays) | ||
| Raw Material: Metal | ||
| Components | Stainless Steel | Stainless Steel |
| Colorants | Blue | Blue |
Note: Bold "Substantial Equivalence Topic" – Difference between the cleared device and the Subject Device