(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.
§ 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.”