(244 days)
PureSleep is an intraoral mandibular repositioning device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea in adults.
PureSleep is an intraoral mandibular repositioning device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea in adults. It advances the lower jaw and tongue forward so the airway will remain open during sleep. The PureSleep device has three adjustments for forward mandibular advancement, 4mm apart anteriorly, while maintaining a 9mm inferior placement for patient comfort. The PureSleep device is formed to the upper and lower teeth similar to an athletic mouth guard. When boiled, the outer resin holds its shape, while the inner resin softens, which adapts to the teeth when bitten. To prepare for the fitting, the upper and lower components are attached at the proper setting depending on the patient's bite, using either the two holes closest to the front of the device, the center holes, or the two holes closest to the back of the device. The device is boiled in water for one minute, allowed to cool for 14 to 18 seconds. Holding the mouth open and lower jaw forward, the patient places the PureSleep device in the mouth and bites down firmly for 45 seconds. Upon removal of the device, excess material can be trimmed for greater comfort. The device can be re-boiled up to three times to achieve the best impression. PureSleep is simple to fit and does not require impressions or lab-fabrication.
The provided K113022 document for the PureSleep device does not contain a study with acceptance criteria or reported device performance in the format typically used for studies demonstrating diagnostic accuracy or efficacy against specific metrics for new medical devices.
Instead, this 510(k) submission primarily relies on substantial equivalence to predicate devices and published literature to support the expanded indications for use.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of acceptance criteria for device performance (e.g., sensitivity, specificity for diagnosing sleep apnea, or specific metrics for snoring reduction) nor does it report specific device performance data from a clinical study for these indications.
The key performance information mentioned is:
- Biocompatibility testing: "Biocompatibility testing was performed, according to ISO 10993 Parts 5 and 10, on the proposed device and all tests met specification." This indicates the materials are safe for use, but it's not a performance metric related to the therapeutic effect (snoring or sleep apnea).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No specific test set or clinical study data is presented for the PureSleep device regarding its efficacy in reducing snoring or treating sleep apnea. The submission relies on the "mechanism of action" being unchanged from the predicate device and on "published scientific studies that have shown mandibular repositioning devices effective in treating snoring and mild to moderate obstructive sleep apnea." This implies a reliance on existing literature and clinical evidence for the class of devices, rather than a de novo clinical trial for the PureSleep device itself for these expanded indications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no new clinical study data with a test set requiring ground truth establishment by experts is presented for the PureSleep device in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical study data with a test set is presented.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The PureSleep device is a physical intraoral device, not an AI or imaging diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The PureSleep device is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical study data with a test set requiring ground truth is presented for the PureSleep device itself. The basis for efficacy for the expanded indications appears to stem from the general understanding and previous studies on mandibular repositioning devices (as indicated by "Published literature and the cleared predicate devices justify the rationale for expanding the intended use to treat mild to moderate obstructive sleep apnea"). For such literature, the ground truth for sleep apnea diagnosis would typically be established by polysomnography interpreted by sleep specialists.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm requiring a training set.
Summary of Acceptance Criteria and Study Approach for K113022:
The K113022 submission for the PureSleep device did not involve a specific clinical study with predefined acceptance criteria and reported performance data for the device itself to evaluate its efficacy for snoring reduction or treatment of mild to moderate obstructive sleep apnea.
Instead, the FDA determined substantial equivalence based on the following:
- Identical Design (with one exception): "With the exception of the molding resin used for the upper intraoral piece, the design of the proposed PureSleep device is identical to the currently marketed PureSleep (formerly known as SnoreMaster K954128)."
- Biocompatibility: The new molding resin met ISO 10993 Parts 5 and 10 specifications, ensuring material safety.
- Unchanged Mechanism of Action: The device's fundamental way of working (mandibular repositioning) remained the same as the previously cleared predicate device.
- Reliance on Published Literature: The expanded indication for treating mild to moderate sleep apnea was justified by "published scientific studies that have shown mandibular repositioning devices effective in treating snoring and mild to moderate obstructive sleep apnea." This means the submission leveraged existing clinical evidence for the class of devices rather than providing new clinical evidence specifically for the PureSleep device's expanded use.
- Substantial Equivalence to Predicates: The sponsor successfully argued that the PureSleep device is substantially equivalent to the currently marketed PureSleep device (K954128) and the SomnoGuard (K061688), both of which are intraoral devices for snoring and obstructive sleep apnea.
In essence, the "study" demonstrating the device meets "acceptance criteria" here is not an individual clinical trial with specific performance outcomes, but rather the demonstration of substantial equivalence to legally marketed predicate devices, supported by general scientific understanding and existing literature on the efficacy of the device type for the stated indications, and direct biocompatibility testing of any new materials.
§ 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.”