(139 days)
The Respire Pink Series - Herbst is indicated to treat mild to moderate OSA.
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.
The provided document is a 510(k) summary for the Respire Pink Series-Herbst device. It assesses the device's substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance metrics for the novel device.
The summary states that the Respire Pink Series - Herbst is considered substantially equivalent to the Respire Blue Series (K111207) and SUAD (K023836) in terms of intended use, indication for use, technological characteristics, performance, and user interface.
Therefore, the information you've requested regarding acceptance criteria, a specific study proving it meets those criteria, sample sizes, expert qualifications, etc., is not explicitly available in this document for the Respire Pink Series-Herbst device itself, as the submission focuses on demonstrating equivalence to previously cleared devices.
However, based on the information provided, here's what can be extracted and inferred regarding the basis for the substantial equivalence claim, which implicitly serves as the "study" proving the device meets the criteria by comparing it to established devices:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are not quantitative performance targets for the new device but rather a demonstration that its characteristics are similar enough to predicate devices to not raise new questions of safety or effectiveness. The "reported device performance" is a comparative assessment.
| Criteria | Acceptance Principle (Implicit) | Reported Device Performance (Comparison) |
|---|---|---|
| Intended Use | Identical or highly similar to predicate devices. | Respire Pink Series - Herbst: Indicated to treat mild to moderate OSA. Predicate Devices (Respire Blue Series, SUAD): Indicated to treat mild to moderate OSA or reduce/alleviate nighttime snoring and obstructive sleep apnea. Verdict: Substantially equivalent. |
| Technological Characteristics (Design/Functionality) | Similar design principles, materials, and functional mechanism to predicate devices, without introducing new risks. | Respire Pink Series - Herbst: Customized device, two Acrylic trays (upper/lower), Telescopic Herbst Hardware, Ball Clasp. Works by mandibular advancement, adjustable using titration keys. Mandibular Advancement Range: Up to 8 mm. Predicate Devices (Respire Blue Series): Orthodontic Acrylic trays, Expansion Screws, Wire with Ball Clasp. Works by mandibular advancement, adjustable using titration keys. Up to 6 mm. Predicate Device (SUAD): Orthodontic Acrylic trays, Telescopic Herbst Hardware, Ball Clasp. Works by mandibular advancement, adjustable using titration keys. Up to 8 mm. Verdict: Similar design principles and functionality. Differences (e.g., expansion screws vs. Herbst hardware, increased tongue space design, adjustment mechanism, mandibular advancement range) are addressed as not raising new safety/effectiveness issues. |
| Raw Materials | Same or equivalent biocompatible materials as predicate devices. | Respire Pink Series - Herbst: Acrylic (polyethyleneterephthalate) for trays, Stainless Steel for metal components. Predicate Devices: Acrylic (polyethyleneterephthalate) for trays, Stainless Steel for metal components. Verdict: Identical. |
| Performance (Safety & Effectiveness) | Demonstrated to be as safe and effective as predicate devices through non-clinical data, bench testing, and clinical evaluation. | Respire Pink Series - Herbst: Risk Assessment performance demonstrated no new safety/effectiveness issues. Bench testing results met "all test method acceptance criteria" and "demonstrated equivalent results to the predicated devices." Clinical evaluation demonstrated "success rate of reduction of snoring and the success rate of reduction of apneic events measured by polysomnograms." Verdict: Equivalent. |
| Biocompatibility | Meets recognized standards for biocompatibility. | Respire Pink Series - Herbst: Reference to ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry. Verdict: Meets recognized standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size for the Respire Pink Series - Herbst in the context of an independent clinical trial to establish its performance. Rather, it refers to:
- Bench testing: Performed to demonstrate equivalence to predicate devices. No sample sizes are given for this testing.
- Clinical evaluation and observation: Results mentioned generally for "reduction of snoring and reduction of apneic events measured by polysomnograms." This implies existing clinical data or clinical observations related to the type of device or predicate devices, rather than a specific prospective study with a defined sample size for the Respire Pink Series - Herbst.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The clinical evaluation mentioned seems to be a summary of existing knowledge or observations, not a new clinical trial for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. As the submission relies on demonstrating substantial equivalence, it does not detail a process for establishing ground truth for a novel "test set" in the way a de novo device would. The clinical evaluation mentioned is referenced generally, without detailing expert involvement or qualifications.
4. Adjudication Method
This information is not provided. The document does not describe the methodology of any specific clinical study that would require an adjudication method.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study is not mentioned or implied. The document focuses on demonstrating substantial equivalence through component and functional similarity, as well as general performance statements (bench testing and clinical evaluation), not a human reader improvement study.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This device is a physical intraoral device, not an algorithm or software. Therefore, the concept of a "standalone" algorithmic performance study does not apply.
7. Type of Ground Truth Used
For the clinical evaluation and observation mentioned:
- The "ground truth" for effectiveness appears to be based on polysomnograms measuring apneic events and observed reduction of snoring. This is a standard objective and subjective measurement for sleep apnea devices.
- For the equivalence claim, the ground truth is essentially the established safety and effectiveness of the predicate devices (Respire Blue Series and SUAD) as cleared by the FDA.
8. Sample Size for the Training Set
This device is not an AI/ML algorithm that requires a training set. This information does not apply.
9. How the Ground Truth for the Training Set Was Established
This device is not an AI/ML algorithm that requires a training set. This information does not apply.
In summary: The provided document is a 510(k) summary demonstrating substantial equivalence. It does not contain the details of a specific clinical trial with defined acceptance criteria, sample sizes, expert involvement, or adjudication methods for the novel device, as it leverages the clearance of predicate devices to establish its safety and effectiveness. The "study" here is the comparative analysis against the predicate devices, supported by bench testing and general clinical evaluation, confirming that no new safety or effectiveness concerns are raised.
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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 CorrespondentContact Person | Sterling Medical RegistrationDaniela Levy - Regulatory Consultant22817 Ventura blvd. #161Woodland Hills, CA 91364, USAPhone 213-787-3026Fax 213-447-5297Web 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 devicesfor 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 :
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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
. •
| SubstantialEquivalentTable | Respire Blue Series(Hard/Soft Surface) | Respire Blue Series(Hard Surface) | Respire Pink Series -Herbst | SUAD |
|---|---|---|---|---|
| 510K | K111207 | K111207 | K023836 | |
| CompanyName | Respire Medical LLC | Respire Medical LLC | Respire Medical LLC | Strong Dental Inc. |
| RegulationDescription | Intraoral devices forsnoring and intraoraldevices for snoringand obstructive sleepapnea (OSA) | Intraoral devices forsnoring and intraoraldevices for snoring andobstructive sleep apnea(OSA) | Intraoral devices forsnoring and intraoraldevices for snoring andobstructive sleep apnea(OSA) | Intraoral devices forsnoring and intraoraldevices for snoring andobstructive 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 BlueSeries is indicated totreat mild to moderateOSA. | The Respire BlueSeries is indicated totreat mild to moderateOSA. | The Respire PinkSeries - Herbst isindicated to treat mildto moderate OSA. | A custom fittedmandibularrepositioning deviceintended to reduce oralleviated nighttimesnoring and obstructivesleep apnea |
| Single orMultiple use | Multiple use | Multiple use | Multiple use | Multiple use |
| Targetpopulation | Adults Patients | Adults Patients | Adults Patients | Adults Patients |
| Prescription /OTC Use | Prescription only | Prescription only | Prescription only | Prescription only |
| DeviceComponents | Orthodontic Acrylictrays, ExpansionScrews, Wire withBall Clasp | Orthodontic Acrylictrays, ExpansionScrews, Wire with BallClasp | Orthodontic Acrylictrays, TelescopicHerbst Hardware andBall Clasp | Orthodontic Acrylictrays, TelescopicHerbst Hardware andBall Clasp |
| ApplianceDesign | Customized deviceRigid tray two piecesUpper/Lower acrylic | Customized deviceRigid tray two piecesUpper/Lower acrylic | Customized deviceRigid tray two piecesUpper/Lower acrylic | Customized deviceRigid tray two piecesUpper/Lower acrylic |
| DeviceFunctionality | Allows to increasepharyngeal opening,and to improve theability to exchange airduring sleep.Upper and lower trayunhook for easyremoval from mouth.Works by mandibularadvancement.Adjustable usingtitration keys. | Allows to increasepharyngeal opening,and to improve theability to exchange airduring sleep.Upper and lower trayunhook for easyremoval from mouth.Works by mandibularadvancement.Adjustable usingtitration keys. | Allows to increasepharyngeal opening,and to improve theability to exchange airduring sleep.Upper and lower trayunhook for easyremoval from mouth.Works by mandibularadvancement.Adjustable usingtitration keys. | Allows to increasepharyngeal opening,and to improve theability to exchange airduring sleep.Upper and lower trayunhook for easyremoval from mouth.Works by mandibularadvancement.Adjustable usingtitration keys. |
| MandibularAdvancementrange | Up to 6 mm | Up to 6 mm | Up to 8 mm | Up to 8 mm |
| Raw Material:Upper andLower Trays | Acrylic(polyethyleneterephthalate) | Acrylic(polyethyleneterephthalate) | Acrylic(polyethyleneterephthalate) | Acrylic(polyethyleneterephthalate) |
| Raw Material:MetalComponents | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel |
| Colorants | Red/Blue | Red/Blue | Pink | No colorant |
12 Substantial Equivalence
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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}------------------------------------------------
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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
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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
PDF processed with CutePDF evaluation edition www.CutePDF.com
§ 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.”