(205 days)
The Vital Sleep Device is intended as an aid in the reduction of snoring for adults at least 18-years old.
The Vital Sleep Device is designed to pull the mandible forward by an adjustable distance, and keep the mouth slightly open during use and reduce snoring. It consists of an arch fitted over the upper teeth and one fitted over the lower teeth. The arches are connected by a flexible hinge that allows a lateral movement (pulling the mandible forward). The arches and hinges form one injection-molded poly-propylene part. In the manufacturing process the semi rigid substrate is over-molded with softer EVA material.
This document describes a 510(k) premarket notification for the "Vital Sleep Device," an intraoral device intended to aid in the reduction of snoring. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria in the manner one might expect for a new AI/ML device or a device requiring significant clinical efficacy data.
Therefore, the information requested in your prompt (acceptance criteria, specific study details like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, etc.) is largely not present in this type of FDA submission for this particular device. This type of device (intraoral device for snoring) typically relies on demonstrating substantial equivalence based on technological characteristics, materials, and intended use, rather than extensive clinical performance studies with quantitative metrics like sensitivity/specificity for a diagnostic AI.
However, I will extract and synthesize the information that is available and clearly state what is missing based on your request.
Device: Vital Sleep Device (Intraoral device for snoring)
K Number: K201719
Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea
Product Code: LRK
Regulatory Class: Class II
1. A table of acceptance criteria and the reported device performance:
This 510(k) submission for the Vital Sleep Device does not present acceptance criteria in the typical format of quantitative performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the submission relies on demonstrating substantial equivalence to predicate devices by comparing technological characteristics, materials, and intended use. The "performance" is implicitly demonstrated by showing similarity to devices already on the market and compliance with biocompatibility standards.
Here's a table based on the "Substantial Equivalence Comparison Table" (Table 5.0) which serves as the primary "proof" of meeting FDA requirements for this type of submission:
| Item | Feature | Vital Sleep (This Submission - K201719) | Vital Sleep (K092942) Reference Predicate | ZQuiet (K180124) Predicate | Equivalency Discussion (Implicit Acceptance) |
|---|---|---|---|---|---|
| 1 | Product Code | LRK | LRK | LRK | Identical |
| 2 | Product Classification | II | II | II | Identical |
| 3 | Regulation | 872.5570 | 872.5570 | 872.5570 | Identical |
| 4 | Technology – Mode of Action | Mandibular advancement to increase pharyngeal space. | Mandibular advancement to increase pharyngeal space. | Mandibular advancement to increase pharyngeal space. | Identical |
| 5 | Indications for Use | The Device is intended as an aid in the reduction of snoring for adults at least 18-years old. | The mandibular advancement device is intended for the treatment of nighttime snoring in adults. | The Device is intended as an aid in the reduction of snoring for adults at least 18-years old. | Identical to the predicate |
| 6 | Product Design Principles | Device pulls mandible forward by adjustable distance, keeps mouth slightly open. Arches connected by flexible hinge for lateral movement. One injection-molded poly-propylene part over-molded with EVA material. | Device pulls mandible forward by adjustable distance, keeps mouth slightly open. Arches connected by flexible hinge for lateral movement. | Upper and lower tray constructed in one piece and joined by a flexible hinge. Lower tray protrudes the mandible to widen upper airway. | Identical to reference predicate and Similar to the predicate with more granularity in design principles. |
| 7 | Prescription Status | OTC | Prescription | OTC | Identical to the predicate (change from reference predicate is due to predicate) |
| 8 | Materials | Injection-molded poly-propylene part over-molded with softer EVA material. | Injection-molded black delrin part over-molded with softer EVA material. | Thermoplastic Elastomer with Blue Colorant. | Similar to the predicate & reference predicate. (Materials were changed but demonstrated biocompatibility) |
| 9 | Testing Performed | ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation/Sensitization) | ISO 10993-5, ISO 10993-10 | ISO 10993-5, ISO 10993-10 | Identical to the predicate & reference predicate |
| 10 | Width | 63mm | 64mm | (Not provided for ZQuiet) | Similar to the reference predicate |
| 11 | Length | 50mm | 51mm | (Not provided for ZQuiet) | Similar to the reference predicate |
| 12 | Height | 29mm | 28mm | (Not provided for ZQuiet) | Similar to the reference predicate |
| 13 | Air Gap | 6mm | 6mm | (Not provided for ZQuiet) | Similar to the reference predicate |
Implicit Acceptance Criteria: The device must be demonstrably similar to existing legally marketed predicate devices, and any differences (like material changes or change in prescription status) must be shown not to negatively impact safety or effectiveness. For this device, the primary "acceptance criteria" are met by demonstrating this substantial equivalence and passing biocompatibility tests.
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of clinical performance testing for this device. The "testing" referred to primarily involves biocompatibility testing (ISO 10993 standards). The document states: "Testing was performed at recognized and qualified testing laboratories (Nelson Labs & Toxikon)." No patient or user sample sizes are mentioned for a performance test set.
- Data Provenance: Not applicable in the context of clinical performance. The data provenance described is related to lab testing for biocompatibility.
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):
- This question is not applicable to this 510(k) submission. No clinical test set with human "ground truth" (e.g., medical image interpretation) was used or required for this device type. The ground truth (or verification) here is based on laboratory standards (ISO 10993) and engineering specifications to ensure that the device functions as intended and is biocompatible.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring expert adjudication was used.
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. This device is an intraoral appliance, not an AI/ML diagnostic tool or software. Therefore, MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is multifaceted and based on:
- Regulatory Standards: Compliance with 21 CFR 872.5570 (regulation for intraoral devices).
- Predicate Device Characteristics: The established design, materials, and performance of the legally marketed predicate devices (K092942 Vital Sleep and K180124 ZQuiet) serve as the "ground truth" for what is considered safe and effective for this product category.
- Biocompatibility Standards: Successful completion of ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation/Sensitization) testing. This is a crucial "ground truth" for material safety.
- Engineering Specifications: Product dimensions (width, length, height, air gap) and functional design (mandibular advancement mechanism) are compared to the reference predicate.
8. The sample size for the training set:
- Not applicable. This submission does not involve an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This submission does not involve an AI/ML algorithm requiring a training set.
Summary of what the document proves:
The document primarily proves that the Vital Sleep Device is substantially equivalent to legally marketed predicate devices by demonstrating:
- Similar intended use (aid in snoring reduction).
- Similar technological characteristics and mode of action (mandibular advancement).
- Compliance with relevant regulatory classifications and product codes.
- That changes in materials (from the reference predicate) and prescription status (from the reference predicate to align with the predicate) do not negatively impact safety or effectiveness, particularly through successful biocompatibility testing per ISO 10993 standards and alignment with the already OTC cleared predicate.
- That physical dimensions are similar to the reference predicate.
- That control over materials and manufacturing processes are in place.
This type of 510(k) clearance does not involve clinical trials with patient cohorts or performance studies with diagnostic metrics like sensitivity/specificity.
§ 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.”