(204 days)
The O2Vent Optima is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.
The O₂Vent Optima is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA).
The O₂Vent Optima consists of the following parts:
Upper tray (upper teeth)
Lower tray (lower teeth)
Connector bands
The upper tray is fitted over the upper teeth, with the breathing port at the front leading to the airways on each side to the rear of the appliance. The upper nylon tray has two side protrusions (lugs) that engage a connector that when attached, extends to the lower tray and attaches to a similar lug stabilizing and advancing the lower jaw. The lower tray, is customized to the bottom teeth, which when attached to the same connector via a side protrusion (lug) preventing the tongue and soft tissues of the throat from collapsing and obstructing the airway. In order to adjust the trays to the specific needs of the user, various length bands (13-21mm) are used to move the lower jaw (i.e. adjust the trays) forward or backward. The shorter the connector band, the further the lower jaw is moved forwards. The O2Vent Optima is delivered fully assembled with the 19mm connector band as the recommended starting titration length for all new users. The upper and lower trays of the O2Vent Optima are made with PA2200 (i.e. Nylon). The straps which connect the upper and lower trays together are made of 100% thermoplastic polyurethane/cured elastomer.
Here's a summary of the O2Vent Optima's acceptance criteria and the study information, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance:
The document provided (an FDA 510(k) summary) acts as a substantial equivalence determination, not a full clinical study report with explicit acceptance criteria and corresponding reported performance metrics (like sensitivity, specificity, accuracy, or specific reductions in AHI).
Instead, the submission argues for substantial equivalence by comparing the technological characteristics of the O2Vent Optima to predicate and reference devices. The "performance" is implicitly demonstrated through this comparison, indicating that the device is "as safe, as effective and performs comparatively" to the predicate and reference devices that are already legally marketed.
Therefore, the table below reflects the characteristics that were compared to establish substantial equivalence rather than numerical acceptance criteria and performance data.
| Feature Compared | O2Vent Optima Characteristics | Primary Predicate (O2Vent W) Characteristics | Reference Device 1 (Panthera Anti-Snoring Device) Characteristics | Reference Device 2 (EMA Appliance) Characteristics | Conclusion (Implicit Acceptance) |
|---|---|---|---|---|---|
| Indications for Use | Reduce/alleviate snoring, mild to moderate OSA. For use during sleep. | Reduce/alleviate snoring, mild to moderate OSA. For use during sleep. | Reduce/alleviate snoring, mild to moderate OSA | Treatment of nasal respiratory dysfunction of OSA and snoring, where repositioning of mandible and opening bite increases airspace. | Similar to predicates/references |
| Product Codes | LRK | LRK | LRK | LRK | Same for all |
| Regulation | 21CFR 872.5570 | 21CFR 872.5570 | 21CFR 872.5570 | 21CFR 872.5570 | Same for all |
| Classification | Class II | Class II | Class II | Class II | Same for all |
| Use of Device | Removable intraoral device, single patient multiple use, prescription use only. | Removable intraoral device, single patient multiple use, prescription use only. | Removable intraoral device, multiple use, prescription use only. | Removable intraoral device, single patient multiple use, prescription use only. | Similar or same for all |
| Target Population | Adults 18+ who snore and/or have sleep apnea. | Adults 18+ who snore and/or have sleep apnea. | Adults | Not indicated (for this specific comparison) | Same or similar |
| Device Functionality | Repositions lower jaw forward, acts by increasing pharyngeal space, permits mouth breathing via built-in airway, retains teeth using rigid trays (separate upper/lower). | Repositions lower jaw forward, acts by increasing pharyngeal space, permits mouth breathing via built-in airway, retains teeth using rigid trays (separate upper/lower). | Mandibular repositioner, maintains lower jaw forward, acts to increase pharyngeal space, retains teeth using customized splints (separate upper/lower). | Advance mandible to anterior/inferior position, pulls tongue forward, increases airspace, decreases obstruction, upper/lower trays for tooth retention (separate). | Description similar for all devices; Airway feature same as primary predicate, different from some references. |
| Mandibular Advancement | Adjusted by attaching connectors of varying lengths. | Adjusted using titration of adjustment screws. | Adjusted via interlocking rods. | Adjusted by attaching connectors of varying lengths. | Same as reference devices; similar to predicate. |
| Adjustment | Clinician and patient adjustable. | Clinician and patient adjustable. | Clinician/patient can select shortened connecting rod. | Clinician and patient adjustable. | Same for all |
| Design (CAD/CAM) | Customized per patient (CAD/CAM, additive manufacturing, laser sintering of PA2200). | Customized per patient (CAD/CAM, plastic laminates/acrylics for main trays, titanium component 3D printed via EBM). | Customized per patient (CAD/CAM, selective laser sintering). | Custom oral appliance available through dental labs. | Same as for reference device; similar to predicate. |
| Adjustment Accessory | Replacement/re-supply connectors (13-21 mm). | NA | Replacement/re-supply connectors (19-36 mm). | Replacement/re-supply connectors. | Similar to reference devices. |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same for all |
| Materials of Construction (Trays) | Polyamide type 12 (Nylon). | Medical grade titanium (air channel), dental plastic laminates and acrylics. | Polyamide type 12 (Nylon). | Proprietary thermoplastic polymer. | Same as reference device; different from predicate due to additive manufacturing. |
| Materials of Construction (Connectors) | 100% thermoplastic Polyurethane/cured elastomer. | NA | Same as above per labeling (assumed same as trays). | 100% thermoplastic Polyurethane/cured elastomer. | Same as reference devices. |
| Biocompatibility | Yes, passed all tests (ISO 10993 Parts 5 & 10). | Not performed (materials identical to K160234). | Statement in K143244: biocompatible based on similarity to predicate. | Information could not be verified. | Same as predicate and reference devices per available information. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document (510(k) summary) does not describe a clinical study of the O2Vent Optima that would involve a "test set" and a specific sample size for performance evaluation. Instead, it relies on demonstrating substantial equivalence to already cleared devices through a comparison of technological characteristics. Therefore, there is no information on sample size or data provenance from a specific test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
As no specific clinical performance study with a test set is described, there's no information regarding experts used to establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as no described test set or clinical performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned or summarized in the provided document. The submission focuses on device characteristics, not reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The O2Vent Optima is an intraoral medical device, not an AI algorithm.
7. Type of Ground Truth Used:
Not applicable. The submission focuses on comparing the physical and functional characteristics of the device and its materials to predicate devices rather than validating an algorithm against a ground truth. Biocompatibility testing was done to established standards (ISO 10993).
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI algorithm.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
§ 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.”