(139 days)
Not Found
No
The device description focuses on the mechanical design and materials of a mandibular advancement splint, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies described are bench testing and clinical evaluation of the physical device's effectiveness.
Yes
The device is indicated to treat mild to moderate OSA, which is a medical condition.
No
The device is described as a treatment for mild to moderate OSA by physically holding the jaw in a forward position. It is not used to identify or characterize a disease, but rather to treat an existing condition.
No
The device description clearly states it is a physical device consisting of two dental plates made of Acrylic with Herbst hardware. It is a mandibular advancement splint, which is a physical appliance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Respire Pink Series - Herbst is a physical device worn in the mouth (intraoral) to treat a condition (OSA) by physically repositioning the jaw. It does not analyze any biological specimens.
- Intended Use: The intended use is to treat mild to moderate OSA, not to diagnose or monitor a condition through the analysis of biological samples.
Therefore, the Respire Pink Series - Herbst falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Respire Pink Series - Herbst is indicated to treat mild to moderate OSA.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
Respire Pink Series - Herbst is a customized device for each patient which consists of two dental plates, upper and lower, made of Acrylic.
The Respire Pink Series – Herbst 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 in turn helps in the treatment of snoring and mild to moderate obstructive sleep apnea.
The Herbst hardware on the side of the devices allow 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.
Respire Pink Series - Herbst 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 it becomes loose.
As similar to its predicate device Respire Pink Series is a customized device, consists of two parts, upper and lower trays, made of acrylic.
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
Adults Patients
Intended User / Care Setting
Prescription only
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)
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 Pink Series shares similarity with its predicate devices and raise no new safety and/or effectiveness issues.
Clinical testing - 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 Pink Series shares similarity in the indication of use and raise no new safety and/or effectiveness issues.
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
ס״ד
STERLING MEDICAL REGISTRATION
SECTION 5 ......... 510(k) Summary (21 CER 807.92)
510(k) Number K
SEP 09 2013
| 1 | Submission Owner | Respire Medical® LLC | ||
|---|---|---|---|---|
| 18 Bridge St., Ste. 4J | ||||
| Brooklyn, 11201 NY | ||||
| Phone 718-643-7326 | ||||
| Fax 718-643-7322 | ||||
| 2 | Official Correspondent | |||
| Contact Person | Sterling Medical Registration | |||
| Daniela Levy - Regulatory Consultant | ||||
| 22817 Ventura blvd. #161 | ||||
| Woodland Hills, CA 91364, USA | ||||
| Phone 213-787-3026 | ||||
| Fax 213-447-5297 | ||||
| Web www.sterlingmedicalregistration.com | ||||
| 3 | Submission Date | April 2013 | ||
| 4 | Device Trade Name | Respire Pink Series- Herbst | ||
| 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 | : | LRK | ||
| Regulation No | : | 872.5570 | ||
| Class | : | II | ||
| Panel | : | Dental | ||
| 7 | Reason for the Premarket Notification Submission | : | New Device |
- 8 Identification of Legally Marketed Predicate Devices :
1
FERLING MEDICAL REGISTRATION
ರಿ Device Description
Respire Pink Series - Herbst is a customized device for each patient which consists of two dental plates, upper and lower, made of Acrylic.
The Respire Pink Series – Herbst 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 in turn helps in the treatment of snoring and mild to moderate obstructive sleep apnea.
The Herbst hardware on the side of the devices allow 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.
Respire Pink Series - Herbst 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 it becomes loose.
10 Intended use
- The Respire Pink Series Herbst 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) | Respire Pink Series -
Herbst | SUAD |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K | K111207 | K111207 | | K023836 |
| Company
Name | Respire Medical LLC | Respire Medical LLC | Respire Medical LLC | Strong Dental Inc. |
| 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) | 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 | Device, Anti-Snoring | Device, Anti-Snoring |
| Product Code | LRK | LRK | LRK | LRK |
| Classification | Class II | Class II | Class II | Class II |
| Intended Use | The Respire Blue
Series is indicated to
treat mild to moderate
OSA. | The Respire Blue
Series is indicated to
treat mild to moderate
OSA. | The Respire Pink
Series - Herbst is
indicated to treat mild
to moderate OSA. | A custom fitted
mandibular
repositioning device
intended to reduce or
alleviated nighttime
snoring and obstructive
sleep apnea |
| Single or
Multiple use | Multiple use | Multiple use | Multiple use | Multiple use |
| Target
population | Adults Patients | Adults Patients | Adults Patients | Adults Patients |
| Prescription /
OTC Use | Prescription only | Prescription only | Prescription only | Prescription only |
| Device
Components | Orthodontic Acrylic
trays, Expansion
Screws, Wire with
Ball Clasp | Orthodontic Acrylic
trays, Expansion
Screws, Wire with Ball
Clasp | 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/Lower acrylic | Customized device
Rigid tray two pieces
Upper/Lower acrylic | Customized device
Rigid tray two pieces
Upper/Lower acrylic |
| 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. | 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 | Up to 6 mm | Up to 6 mm | Up to 8 mm | Up to 8 mm |
| Raw Material:
Upper and
Lower Trays | Acrylic
(polyethyleneterephth
alate) | Acrylic
(polyethyleneterephtha
late) | Acrylic
(polyethyleneterephtha
late) | Acrylic
(polyethyleneterephtha
late) |
| Raw Material:
Metal
Components | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel |
| Colorants | Red/Blue | Red/Blue | Pink | No colorant |
12 Substantial Equivalence
2
MEDICAL REGISTRATION
,
Summary of Equivalence: The Respire Pink Series - Herbst is considered to be substantially equivalent to Respire Blue Series K111207 ; SUAD K023836 in terms of intended use, indication for use, technological characteristics, performance and user interface.
3
EDICAL REGISTRATION
As similar to its predicate device Respire Pink Series is a customized device, consists of two parts, upper and lower trays, made of acrylic. The difference between the Respire Blue Series and the Respire Pink Series is related to the hardware/components that are used on the buccal aspect to hold the lower jaw in a forward position.
The differences between Respire Pink Series – Herbst to SUAD appliance is that Respire Pink acrylic contour is designed to increase tonque space which is more comfortable for patient use. Respire Pink appliance is adjustable using titration keys and a screw which enables the jaw to be brought forward in small advancements. The design differences emphasis the advantages of Respire Pink Series technology and thus, raise no new safety and/or effectiveness issues. Respire Pink Series the same technological characteristics as its predicate devices and raise no new issues of safety or effectiveness, thus, the Respire Pink 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 Pink Series shares similarity with its predicate devices and raise no new safety and/or effectiveness issues.
Clinical testing - 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 Pink 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 Pink 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 Pink Series is as safe and effective for its intended use and performs as well the predicate device.
4
Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered and appears to be the heading of a document or publication. The font is a simple, sans-serif typeface.
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2013
Respire Medical Limited Liability Company C/O Ms. Daniela Levy Regulatory Consultant Sterling Medical Registration 22817 Ventura Boulevard #161 WOODLAND HILLS CA 91364
Re: K131138
Trade/Device Name: Respire Pink Series-Herbst 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 4, 2013 Received: August 9, 2013
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 four of 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.
5
Page 2 - Ms. Levy
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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/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 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,
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
TERLING MEDICAL REGISTRATION
SECTION 4 - Indication for Use Statement
Indications for Use
Indications for Use
510(k) Number (if known): _|113 |/ 3 8
Device Name:
Respire Pink Series - Herbst
Indications for Use:
The Respire Pink Series - Herbst is indicated to treat mild to moderate OSA.
Prescription Use _ كا (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (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)
Andrew I. Steen -5 2013.09.06 115:11 1:55 -04'00'
'Division Sign-Off) vision of Anesthestology, General Hospital qtion Control, Dental Devices
Page 1 of __
0(k) Number: _ Ki 31138
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