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510(k) Data Aggregation
(90 days)
The Elevo® Snoring Intervention Set is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals.
The Elevo® Snoring Intervention Set is comprised of three (3) sterile, absorbable, barbed, poly(L-lactide-co-D L-lactide) sutures and three (3) corresponding disposable, sterile, single use suturing needles. A silk disposable tension suture (DTS) is attached to the proximal end of each of the poly(L-lactide-co-D L-lactide) barbed suture implants. The proximal end of the DTS is secured to the suturing needle handle during device assembly. One (1) Pilot Hole Initiation Tool (PHIT) completes the contents of the set.
The provided text describes a medical device, the "Elevo Snoring Intervention Set," and its FDA 510(k) submission for substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-driven diagnostic or assistive device.
The document focuses on:
- The FDA's 510(k) clearance letter.
- The Indications for Use for the device.
- A 510(k) summary detailing the device description, intended use, and its comparison to a predicate device.
The "Equivalence Testing" section mentions that "The material characteristics of the poly(L-lactide-co-D L-lactide) suture implant have been evaluated for equivalence to the material characteristics of the polydioxanone (PDO) suture implant of the predicate device (Elevo® Kit Snoring Intervention Device K181107), including tensile strength and absorption profile." It also states, "In vitro bench test data demonstrate that the Elevo® Snoring Intervention Set with poly(L-lactide-co-D Llactide) sutures performs as anticipated, and the device raises no new questions of safety and effectiveness when compared to the predicate device."
This indicates that the study performed was a bench test comparing physical characteristics of the new device's material to the predicate device's material to establish substantial equivalence, rather than a clinical study or a study with specific performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/ML diagnostic.
Therefore, I cannot provide the requested information for an AI/ML-driven device's acceptance criteria and study in the format specified because such details are not present in the provided text. The device described is a physical implant for stiffening soft palate tissue, not an AI/ML system.
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(224 days)
The Elevo® Kit Snoring Intervention Device is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals.
Indications for use of the Elevo® Kit Snoring Intervention Device include symptomatic, habitual, and social snoring due to palatal flutter.
The Elevo® Kit Snoring Intervention Device is comprised of three (3) sterile, absorbable, and barbed, polydioxanone (PDO) sutures and three (3) corresponding disposable, sterile, single use suturing needles. A disposable tension suture (DTS) is attached to the proximal end of each of the barbed PDO suture implants. The proximal end of the DTS is secured to the suturing needle handle during device assembly.
This document describes the premarket notification (510(k)) for the Elevo® Kit Snoring Intervention Device, which aims to stiffen the soft palate tissue to reduce snoring. The acceptance criteria and the study proving the device meets these criteria are detailed below, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The device's acceptance criteria are primarily demonstrated through equivalence testing against a predicate device (Pillar™ Palatal Implant System) and a reference device (Quill™ Absorbable Suture), and through clinical safety and efficacy studies with statistically significant results. The "acceptance criteria" here are interpreted as the demonstrated performance that deems the device substantially equivalent to the predicate.
| Acceptance Criteria (Demonstrated Equivalence/Performance) | Reported Device Performance (Elevo® Kit Snoring Intervention Device) |
|---|---|
| Indications for Use Equivalence | Identical: "The Elevo® Kit Snoring Intervention Device is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals." |
| Material Equivalence (Implant) | Absorbable Polydioxanone (PDO). Identified as identical to the Reference Device (Quill™ Synthetic Absorbable Barbed Suture). |
| Sterilization Method Equivalence | Ethylene Oxide (EtO). Identical to predicate and reference devices. |
| Labeling: Sterile, Single Use Equivalence | Yes. Identical to predicate and reference devices. |
| Outpatient - Office Based Procedure Equivalence | Yes. Identical to predicate device. |
| Biocompatibility | Yes. Stated as biocompatible. Identical to predicate and reference devices. |
| Mechanism of Action/Delivery Method Equivalence | Disposable, sterile, single use, handheld suturing needle and proprietary suture implant technique (similar to predicate's handheld pellet delivery needle). |
| Tensile Strength (Implant) | Comparable to reference device (Quill™ PDO Synthetic Absorbable Barbed Suture), demonstrated by in vitro pull-force testing in bovine material. Specific quantitative results are mentioned as being in Section 12, Table 12-5, but not provided in this excerpt. |
| Device Description (General) | Designed to stiffen the tissue of the soft palate and reduce dynamic flutter without interfering with normal function. Identical concept to predicate device. |
| Anatomic Target Location | Nearly identical to predicate device: 5-6 mm distal (posterior) to the soft palate/hard palate junction. |
| Clinical Safety | Equivalent to or exceeds predicate device (Pillar™ Palatal Implant System). |
| Adverse Events | Zero unanticipated adverse events reported. Four anticipated events (dysphagia, sore throat, palpable suture, oral hematoma) observed and prospectively defined as Common Treatment Events. |
| Clinical Efficacy (Snoring Severity Reduction) | Snoring severity (0-10 VAS by bed partner) reduced by average 25% or more at Day 30, Day 90, and Day 180 post-procedure. (Day 30: 25.9% reduction from 7.81 to 5.79; Day 90: 30.6% reduction from 7.81 to 5.42; Day 180: 30.8% reduction from 7.81 to 5.40). p |
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