(174 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a mandibular advancement splint. There is no mention of AI or ML in the text.
Yes
The device is indicated to treat mild to moderate Obstructive Sleep Apnea (OSA), which is a medical condition. Therefore, it is a therapeutic device.
No
The device is described as a mandibular advancement splint used to treat mild to moderate OSA, not to diagnose it.
No
The device description explicitly details physical components made of Acrylic and chrome - Wironit material, and the performance studies focus on material properties and mechanical testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a physical device, a mandibular advancement splint, that is worn in the mouth to treat sleep apnea. It is a mechanical device that physically alters the position of the jaw and tongue.
- Intended Use: The intended use is to treat mild to moderate OSA, which is a clinical condition, not to perform a diagnostic test on a biological sample.
The device is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Respire Pink Series - Herbst - EF is indicated to treat mild to moderate OSA.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The Respire Pink Series - Herbst - EF (Endurance Frameworks) - is available with a hard device fitting surface. The hard surface consists of Acrylic (side plates) and chrome - Wironit material ( upper / Palatal and lower / Lingual plates). Refer to Figure 1 Representative Drawing. The device is retained with ball and clasps which allows the device to be tightened if it becomes loose. The device is a mandibular advancement splint that holds the jaw in a forward position to help keep the tongue and supporting tissues in a position to help maintain an open airway, which helps in the treatment of snoring and mild to moderate obstructive sleep apnea. The Herbst hardware on the side of the device allows the patient to move forward and left and right, but not backwards. These movements give the patient some freedom to move which is important for their comfort and overall success of the device. The upper and lower components are connected by an adjustable hinge, thus patient can open and close 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)
The subject of this 510(k) is a modification to the material used for the manufacturing of the top and bottom trays of the device. The material "Wironit" is a widely used dental material and demonstrated via biocompatibility and cytotoxicity testing. Material integrity testing was also accomplished. 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 where identified at the same location yet the amount of energy to cause failure was less for the Wironit /Acrylic. The amount energy shown in the results, still far exceeds the amount of energy required by an oral cavity to create such a failure which occurred at an average of 275.6 lbf using five (5) sample devices.
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 Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping profiles of human faces, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2015
Respire Medical Holding c/o Mr. Stephen Inglese Ouality Solutions and Support, LLC PO Box 8271 Holland, MI 49422
Re: K150572
Trade/Device Name: Respire Pink Series-Herbst-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: July 27, 2015 Received: July 30, 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 -S
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) NA K150572
Device Name Respire Pink Series - Herbst - EF
Indications for Use (Describe) The Respire Pink Series - Herbst - EF is indicated to treat mild to moderate OSA.
| Type of Use (Select one or both, as applicable) | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14) in the context of the user query. The model should not assume the values of the keys. The model should only generate the JSON based on the image and the schema. The model should not generate any comments inside the json block. The model should not generate any control token (such as
and
) at any places. If a user requests multiple JSON, always return a single parseable JSON array. Do not include any extra text outside of the JSON string.
3
Respire Pink Series - Herbst - EF
March 1, 2015
- Submitter: Respire Medical LLC 18 Bridge St Ste. 4J Brooklyn, 11201 NY Phone: 718-643-7326
Contact:
Stephen Inglese Consultant Quality Solutions and Support, LLC Phone: 561-251-0876 Email: swi@qss-llc.com
This submission contains CONFIDENTIAL material and information and should be restricted in its distribution. Do NOT copy without the permission of the Submitter.
4
510(k) Summary 5.0
ln accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Respire Pink Series - Herbst - EF is provided below:
Device Common Name: Device, Anti-Snoring
Device Proprietary Name: Respire Pink Series - Herbst - 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@gss-llc.com |
.March 1st 2015 Date Prepared:
Classification Regulation: 21 CFR §872.5570, Class II - Device Anti-Snoring
| Panel: | Dental |
|---|---|
| -------- | -------- |
| Product Code: | LRK |
|---|---|
| --------------- | ----- |
K131138 - Submitter's own previously cleared Predicate Device: device
Indication for Use: The Respire Pink Series - Herbst - EF is indicated to treat mild to moderate OSA (Obstruction Sleep Apnea)
Device Description:
The Respire Pink Series - Herbst - EF (Endurance Frameworks) - is available with a hard device fitting surface. The hard surface consists of Acrylic (side plates) and chrome - Wironit material ( upper / Palatal and lower / Lingual plates). Refer to Figure 1 Representative Drawing. The device is retained with ball and clasps which allows the device to be tightened if it becomes loose. The device is a mandibular advancement splint that holds the jaw in a forward position to help keep the tongue and supporting tissues in a
5
position to help maintain an open airway, which helps in the treatment of snoring and mild to moderate obstructive sleep apnea
The Herbst hardware on the side of the device allows the patient to move forward and left and right, but not backwards. These movements give the patient some freedom to move which is important for their comfort and overall success of the device. The upper and lower components are connected by an adjustable hinge, thus patient can open and close while wearing the appliances.
Figure 1 - Respire Pink Series - Herbst - EF - Front View
Image /page/5/Picture/4 description: The image shows a dental device, likely a mandibular advancement device (MAD), used to treat sleep apnea or snoring. The device consists of two clear, acrylic-like trays that fit over the upper and lower teeth. These trays are connected by metal bars on each side, which can be adjusted to move the lower jaw forward, opening the airway 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 trays of the device. The material "Wironit" is a widely used dental material and demonstrated via biocompatibility and cytotoxicity testing
Material integrity testing was also accomplished. The following is a summary of the testing:
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 where identified at the same location yet the amount of energy to cause failure was less for the Wironit /Acrylic. The amount energy shown in the results, still far exceeds the amount of energy required by an oral cavity to create such a failure which occurred at an average of 275.6 Ibf using five (5) sample devices. 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.
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The determination from the tests demonstrated that the Respire Pink Series -Herbst - EF doesn't raise new issues of effectiveness, therefore the Respire Pink Series - Herbst - EF is substantially equivalent to the predicate Respire Pink Series - Herbst.
Based on the completed risk analysis which determined the added material showed the risks were mitigated to acceptable levels in addition to the testing accomplished, the device performance is similar to that of the originally cleared predicate device.
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 tray provides the patient with a more comfortable fit and durability. Therefore the modified device is substantially equivalent to the previously cleared Respire Pink Series -Herbst.
Chart 1
| Substantial
Equivalence Topic | Respire Pink
Series - Herbst | Respire Pink
Series - Herbst -
EF |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K131138 | NA |
| 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 Pink
Series - Herbst is
indicated to treat
mild to moderate
OSA. | The Respire Pink
Series - Herbst -
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 | Prescription | Prescription |
| Substantial
Equivalence Topic | Respire Pink
Series - Herbst | Respire Pink
Series - Herbst -
EF |
| Use
Device
Components | Orthodontic Acrylic
trays, Telescopic
Herbst Hardware
and Ball Clasp | Orthodontic Acrylic
trays, Telescopic
Herbst Hardware
and Ball Clasp |
| Appliance Design | Customized device
Rigid tray two
pieces Upper/Lower
acrylic. | Customized device
Rigid tray / two
pieces / Upper and
Lower / Acrylic and
Wironit |
| Device
Functionality | Allows to increase
pharyngeal
opening, and to
improve the ability
to exchange air
during sleep.
Upper and lower
tray 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
tray 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
trays) | Acrylic (side) and
Wironit (upper and
lower trays) |
| Raw Material: Metal
Components | Stainless Steel | Stainless Steel |
| Colorants | Pink | Pink |
7
Note: Bold "Substantial Equivalence Topic" – Difference between the cleared device and the modifications called out in this submission
8
11.0 Substantial Equivalence Discussion
Technological Comparison
The Respire Pink Series - Herbst - EF device that is the subject of this 510(k) is substantially equivalent to the previously cleared version of Respire Pink Series - Herbst in K131138. The only modification to the device is the material the patent now has the option to use. The upper and lower trays which can be made of Acrylic (cleared under K131138) can now be made of Wironit. Chart 2 demonstrates the comparison between the previously cleared device and the modification for the device identified in this submission.
Design Material Substantial Equivalence
Figure 3 demonstrates the originally cleared device of full Acrylic material that is both the sides and upper and lower trays are made of Acrylic. This figure shows the Herbst hardware, ball, and clasp on the sides.
Image /page/8/Picture/6 description: This image is labeled as Figure 3 and shows a dental appliance. The appliance is made of a clear pink plastic material and has metal bars and screws attached to it. The appliance appears to be designed to fit over the upper and lower teeth.
Figure 4 demonstrates the modified device. The sides remain Acrylic as in the orginal cleared submission but the upper and lower trays are replaced with Wironit. This figure demonstrates the Herbst hardware and ball and clasp on the sides.
Figure 4
Image /page/8/Picture/9 description: The image shows a dental device, likely a sleep apnea appliance, featuring a clear acrylic base that conforms to the upper and lower dental arches. Pink acrylic blocks are attached to the sides, connected by metal rods with adjustable screws. The device appears to be designed to maintain jaw alignment and open the airway during sleep.
Substantial Equivalence Conclusion
The modification of the Respire Pink Series - Herbst to Respire Pink Series - Herbst - EF as demonstrated in the above chart is to only provide the patent with an option to have the upper and lower trays utilize the Wironit material instead of Acrylic. The modified device even though with the added material, the device through performance testing is substantially equivalent to the previously cleared Respire Pink Series -Herbst device. The device still remains effective as originally cleared.