(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 < 0.001 for all time points. Comparable efficacy to predicate device's best comparative study. |
| Study Completion Rate | 87% of patients completed all endpoints (N=45 of 52). Higher than predicate's comparable study (80%). |
| Lost-to-follow-up Rate | 13%. Lower than predicate's comparable study (20%). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study (Test Set): 52 study subjects were enrolled in the trial.
- 18 female, 34 male.
- Age range: 22 to 78 years (mean 44 years).
- Data Provenance: The study was designated a Non-Significant Risk clinical trial and was conducted between March and September 2017. The document does not explicitly state the country of origin, but the FDA submission implies a US-based or FDA-compliant study. It was a prospective, multi-center study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The primary efficacy endpoint, snoring severity, was established by the bed/sleep partners of the study subjects. They were trained on the use of an external outcomes-tracking database (eORO) and entered their objective scoring of each Study Subject's snoring severity. Clinical Coordinators at each investigational site did not obtain these results to minimize bias.
For the assessment of a patient's AHI score (Apnea Hypopnea Index), which was part of the inclusion criteria (AHI < 15), a home sleep study using the SNAP® Diagnostics Model 8 Ventilatory Effort Recorder device was used. The results of these recordings were analyzed by SNAP® Diagnostics, Inc. The qualifications of these analysts are not specified beyond being "SNAP® Diagnostics staff algorithms."
4. Adjudication Method for the Test Set
There was no explicit adjudication method mentioned for the bed partner reported outcome (VAS score) as it was considered an "objective scoring" from the bed partner. For the AHI scores from the home sleep study, the analysis was performed by a single entity (SNAP® Diagnostics, Inc.), suggesting a single read rather than a multi-reader adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly done as typically understood in the context of imaging analysis. The primary efficacy endpoint was a patient-reported outcome (via bed partner) using a Visual Analog Scale, not a diagnostic interpretation by multiple human readers. The study compared the device's efficacy to baseline performance (single group compared to baseline) and also contextualized its efficacy against published data from a predicate device's clinical study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a physical intervention for snoring, not an algorithm or diagnostic tool. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
The primary ground truth for efficacy was:
- Bed Partner's Visual Analog Scale (VAS) 0-10 score assessment of the Study Subject's snoring severity, considered an observer-reported outcome (eORO).
Secondary ground truths were:
- Study Subjects' self-reported Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index (patient-reported outcomes, ePRO).
- Home sleep study results (SNAP® Diagnostics) for AHI score and audio files for snoring noise events, analyzed by SNAP® Diagnostics algorithms.
8. The Sample Size for the Training Set
This document describes a clinical study for device clearance, not the development of an AI algorithm with distinct training and test sets. Therefore, there is no "training set" in the context of machine learning. The clinical study described in Section 807.92(b)(2) is the primary clinical evaluation for regulatory submission.
9. How the Ground Truth for the Training Set Was Established
As there was no training set in the AI/ML context, this question is not applicable. The clinical study described served as the validation (test) set for the device's performance.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters FDA in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 6, 2018
Zelegent, Inc. David Humbert Vice President, Regulatory and Clinical Affairs 5151 California Avenue Irvine, CA 92617
Re: K181107
Trade/Device Name: Elevo® Kit Snoring Intervention Device Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: Class II Product Code: LRK Dated: November 5, 2018 Received: November 6, 2018
Dear David Humbert:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Srinivas Nandkumar -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181107
Device Name
Elevo® Kit Snoring Intervention Device
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5 – 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted pursuant to the requirements of 21 CFR 807.92.
Section 807.92(a)(1):
| SUBMITTER: | Zelegent, Inc.4250 Executive Square, Suite 200La Jolla, CA 92037 |
|---|---|
| CONTACT PERSON: | David C. Humbert, RACVice President, Regulatory and Clinical Affairs650.763.8282 x102 |
| DATE PREPARED: | December 3, 2018 |
Section 807.92(a)(2):
| NAME OF DEVICE: | Elevo® Kit Snoring Intervention Device |
|---|---|
| TRADE NAME: | Elevo® Kit Snoring Intervention Device |
| PROPRIETARY NAME: | Elevo® Kit Snoring Intervention Device |
| COMMON NAME: | Snoring Mitigation Device |
| CLASSIFICATION NAME: | Device, Anti-Snoring |
| PRODUCT CODE: | LRK - Device, Anti-Snoring872.5570, intraoral devices for snoring |
Section 807.92(a)(3):
| PREDICATE DEVICE: | Pillar™ Palatal Implant SystemManufactured by Medtronic XOMED, Inc. |
|---|---|
| PREDICATE DEVICE 510(k): | K110623 |
| REFERENCE DEVICE: | Quill™ Absorbable SutureManufactured by Surgical Specialties Corporation dbaAngiotech |
| REFERENCE DEVICE 510(k): | K132268 |
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Section 807.92(a)(4):
DEVICE DESCRIPTION: 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. HOW THE DEVICE FUNCTIONS: The Elevoplasty® procedure is a minimally-invasive physician's office intervention to treat mild to moderate snoring. It works by stiffening and shortening the soft palate. Elevoplasty® is accomplished by way of a custom designed resorbable suture implant that exerts it effect on the soft palate similarly to the way standard barbed sutures are used in plastic surgery during minimallyinvasive facelift procedures. Its barb configuration and length are optimized for providing tissue apposition specifically in the soft palate. The bi-directional barbs allow for implantation of the suture without the need for surgical knots or swaged needles, and without the need for anchoring to any bone structure. SCIENTIFIC CONCEPT & PERFORMANCE CHARACTERISTICS: The barbed suture implant is deployed into the soft palate by way of a specialized curved suturing needle that is comprised of medical grade stainless steel. Three (3) Elevo® curved suturing needles, each pre-loaded with a resorbable barbed suture implant, are packaged into each Elevo® Kit, with the intention that one kit will be used during each patient's Elevoplasty® procedure. To perform Elevoplasty® the physician first confirms that each Elevo® suture implant is provided pre-loaded into its specialized suturing needle delivery device. Applying gentle pressure on the handle, the physician advances the tip of the suture delivery needle in a gentle arch motion through the uvular and the levator palatine muscles toward the posterior end of the soft palate (i.e., the uvula). The marker band located on the suture delivery needle shaft (the depth insertion marker) may be used as a visual reference. If the physician employs the depth insertion marker as a visual reference, the guideline is to advance the needle far enough that the depth insertion is completely beneath the tissue (i.e., no longer visible). As a general guideline the physician advances the tip distally until it has traveled approximately 25-30 mm through the soft palate to an area approximately 8-10 mm from the distal ridge of the soft palate. The physician then releases the proximal end of the disposable tensioning suture from the handle.
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Once the physician is satisfied with the depth, he/she reverses the direction of motion of the handle, thereby retracting the needle out of the soft palate in a backward re-tracing of the simple arc motion that was just completed. This process results in the resorbable barbed suture implant being left in place in the soft palate, with both sets of barbs enqaged in soft tissue and the disposable tension suture (DTS) protruding out of the patient's palate and mouth.
The physician then repeats this piercing, advancing, and pulling-out sequence with the two (2) remaining Elevo® suture implants included in the kit (or just one [1] more implant if the patient has an unusually narrow palate anatomy and the physician determines that a total of just two [2] implants are needed). A minimum of two (2) and a maximum of three (3) Elevo® suture implants are deployed at the physician's discretion, in each case within the width of the patient's soft palate. If three (3) Elevo® suture implants are placed: one implant is inserted along the patient's midline and is advanced distally. The remaining two (2) implants are generally inserted approximately 5-10 mm laterally on each side and advanced in a slight radiating pattern so that the tip of the suture implant resides approximately 10-15 mm lateral to the distal end of the fully-advanced middle suture implant. Physicians have some discretion over exactly what angle in which to direct the implants, with the quideline simply being using a simple in-and-out motion to achieve some degree of vertical soft palate tension or lift.
Once all implants are placed, the ends of the black silk DTS protrude from the patient's palate and open mouth. For each patient, the physician judges whether some degree of soft palate lift has already been achieved by the upward motion exerted on the implant while the needle is removed, or if some additional upward force on the DTS is indicated. If indicated, the physician gently pulls on each DTS with the goal of causing a mild tissue apposition (i.e., "accordion-ing") of the soft palate tissue. This action is meant to slightly raise, shorten, and stiffen the soft palate with the proximal barb row engaging with the tissue and acting like a gentle ratchet to maintain the tension on the suture. This is the key scientific concept by which the device exerts its therapeutic benefit. This tension is achieved entirely within the soft tissue - there is no need nor occasion for any interaction with hard tissue or palatal bone.
After being satisfied that approximately 1-4 mm of soft palate lift has been achieved, the physician then cuts the extending DTS sutures with scissors. This action tends to cause the suture implants to retract slightly into
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DESIGN, MATERIALS USED & PHYSICAL PROPERTIES:
the tissue, ensuring that the suture does not protrude and result in tongue-mediated awareness for the patient. If the proximal ends of any of the suture implants protrude slightly after the DTS has been cut, which sometimes occurs due to the natural recoil of the soft palate, the physician uses a standard forceps or hemostat tool to tuck the tip back under the soft palate tissue. The mild retraction into the tissue may also serve as a barrier to infection risk as the implant becomes imbedded.
The Elevo® suture implant is comprised of polydioxanone. Polydioxanone has been found to be non-antigenic and to elicit only a slight tissue reaction during absorption. The bi-directional barbs allow for implant of the suture without the need for surgical knots or swaged needles. Each Elevo® suture implant is provided pre-loaded into a specialized suturing needle delivery device. Three (3) such pre-loaded suture implants on delivery devices are packaged into each Elevo® Kit, with the intention that one kit will be used during each patient's Elevoplasty® procedure.
The Elevo® suturing needle is comprised of medical grade stainless steel. The curved ergonomic handle is comprised of ABS plastic over-molded onto the needle for strength.
Section 807.92(a)(5):
INTENDED USE:
The Elevo® Kit Snoring Intervention Device is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring due to palatal flutter in some individuals.
Patients with consistent nighttime snoring without sleep apnea, who wish to avoid uvulopalatalpharyngoplasty ("UPPP") surgery, and are not interested in wearing an anti-snoring dental appliance are eligible for an outpatient in-office Elevoplasty® procedure.
Snoring is an easily-observable symptom that can be caused by a variety of anatomical pathologies. Obstruction of the airway by tissue, either the soft palate or the posterior end of the tongue, results in the build-up of a partial vacuum as the patient's pulmonary diaphragm contracts in an effort to inhale. The negative pressure created by the diaphragm grows until it is enough to make the tissue obstructing the airway "slip" and allow some air to pass. The inflowing air causes a slight reduction of negative pressure, which allows the tissue to fall back into obstruction, and the negative
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pressure builds again. This cycle can repeat twenty (20) or more times per breath during sleep, resulting in the familiar "rat-tat-tat" sound of snoring. Reducing the length of the soft palate, even slightly, may change this dynamic by limiting the amount of tissue causing the transient airway obstruction. Even a small increase in the diameter of the airway may significantly increase free air flow as the cross-sectional area is approximately three times the square of the radius.
Approximately twenty percent (20%) of the adult population of the developed world consistently snores at night at volumes high enough to disturb sleeping partners. This results in strained relationships and the possible breakdown of the family unit, as well as real physiologic harm to the snorer. Of audible snorers, approximately one in six (1/6) suffer from obstructive sleep apnea (OSA), a condition in which tissues of the nasopharynx fall into positions that block the airway, restricting breathing during sleep to an extent that causes the patient repeated cycles of breathing cessation (apnea) and subsequent gasping for air without regaining consciousness. The OSA patient is deprived of restful sleep and suffers from poor tissue oxygenation, impaired memory, cognition, and daytime mental functioning, and in extreme cases runs the risk of sudden death from oxygen deprivation (asphyxiation) during sleep.
INTENDED USE & INDICATIONS FOR USE SUMMARY:
The Intended Use of the Elevo® Kit Snoring Intervention Device is identical to the predicate device identified in K110623:
Indications for use of the Elevo® Kit Snoring Intervention Device include symptomatic, habitual, and social snoring due to palatal flutter.
The Indications for Use of the Elevo® Kit Snoring Intervention Device is identical to the predicate device identified in K110623:
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.
Section 807.92(a)(6):
EQUIVALENCE TESTING:
The material characteristics of the Elevo® suture implant have been evaluated for equivalence to the reference device (Quill™ Absorbable Suture K132268). The comparative results indicate equivalence to the reference device.
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A direct comparison of key characteristics between the Elevo® Kit Snoring Intervention Device and the predicate device (Pillar™ Palatal Implant System K110623) has demonstrated equivalence with respect to clinical utility of the subject device. The following Tables (excerpted and revised1 from Section 12, Substantial Equivalence Discussion of this Premarket Notification) provide a comprehensive summary of equivalence between the two devices:
| Characteristic | Elevo® Kit SnoringIntervention Device | Predicate Device:Pillar™ Palatal ImplantSystem | Reference Device:Quill™ SyntheticAbsorbable Barbed Suture |
|---|---|---|---|
| 510(k) Number | K181107 | K110623 | K071989K113744K123877K132268 |
| Indications for Use | The Elevo® Kit SnoringIntervention Device isintended for use instiffening the soft palatetissue, which may reducethe severity of snoring insome individuals. | The Pillar™ System isintended for use instiffening the soft palatetissue, which may reducethe severity of snoring insome individuals. | Quill™ SyntheticAbsorbable Barbed Suturesare indicated to closeeasily approximated edgesof dermis where use ofabsorbable sutures isappropriate. |
| Common/Usual Name | Device, Anti-Snoring | Device, Anti-Snoring | Polydioxanone AbsorbableSurgical Suture |
| Regulation No. | 21 CFR § 872.5570 | 21 CFR § 872.5570 | 21 CFR § 878.4840 |
| Classification Name | LRK - Device Anti-Snoring | LRK - Device Anti-Snoring | Absorbable polydioxanonesurgical suture |
| Class | II | II | II |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) |
| Material | Absorbable Polydioxanone(PDO) | Braided polyester filaments | Absorbable Polydioxanone(PDO) |
| Characteristic | Elevo® Kit SnoringIntervention Device | Predicate Device:Pillar™ Palatal ImplantSystem | Reference Device:Quill™ SyntheticAbsorbable Barbed Suture |
| Labeling: Sterile,Single Use | Yes | Yes | Yes |
| Implant Materials | Absorbable Polydioxanone(PDO) | Woven polyester fiberfilament | Absorbable Polydioxanone(PDO) |
| Implant ComponentDescription | Absorbable Surgical Suture | Non-absorbable,permanent, polyesterfilament | Absorbable Surgical Suture |
| Outpatient - OfficeBased Procedure | Yes | Yes | Device is indicated for softtissue approximationwhere use of anabsorbable suture isappropriate. |
| Mechanism of ActionDelivery Method | Disposable, sterile, singleuse, handheld suturingneedle and proprietarysuture implant technique | Disposable, sterile, singleuse, handheld pelletdelivery needle | Handheld suturing needle |
| ImplantManufacturingMethod | Injection molded | Multiple polyester fiberswoven & fused withtwo ultrasonic welds | Injection molded and/ormachine extruded |
| Biocompatible | Yes | Yes | Yes |
| Device Description -General | The kit is intended as atreatment option forsnoring and consists of animplant and a delivery tool.The device is designed tostiffen the tissue of thesoft palate and to reducethe dynamic flutter ofthose tissues withoutinterfering with the normalfunction of the soft palate. | The system is intended as atreatment option forsnoring and consists of animplant and a delivery tool.The device is designed tostiffen the tissue of the softpalate and to reduce thedynamic flutter of thosetissues without interferingwith the normal function ofthe soft palate. | The device is a syntheticabsorbable sutureavailable in various suturelength and needleconfigurations in USP Sizes3-0 and 4-0. Each suturehas bi-directional barbsalong the axis of the suturestrand. Barbs allow fortissue approximationwithout the need forsurgical knots. |
Table 5-1: Device Comparative Regulatory Information
4 Revisions include the addition of K181107 to the 510(k) Number row and change to the trademarked status of the device name "Elevo™" to the registered device name "Elevo®" Page 6 of 17
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| Table 5-2-a: Device Technological Characteristics | Procedure | Elevo® Kit Snoring Intervention Device | Predicate Device:Pillar™ Palatal Implant System | |||
|---|---|---|---|---|---|---|
| Characteristic | Elevo® Kit SnoringIntervention Device | Predicate Device:Pillar™ Palatal ImplantSystem | Reference Device:Quill™ SyntheticAbsorbable Barbed Suture | Preparation | Antibiotic not requiredPrepare site with a short-acting oralantisepticInject site with no more than 0.75 cctotal lidocaine in up to 3 locationsaround the soft palate in order to avoidhydro-dissection. | An appropriate broad-spectrumantibiotic should be givenPrepare site with an oral antisepticInject site with a local anesthetic (2 – 3cc) nine injections 1 cm apart, starting 1mm anterior to the hard palatejunction. |
| Device Description –Implant | The implant is a barbed,absorbable suture that isinjection molded ofpolydioxanone (PDO). Thebarbs are designed toallow for a knotlessapplication during implantof the device. The distalstirrup shape and theproximal circular shapefacilitate loading of thedevice onto the suturingneedle during finalpackaging. The deliverytool is designed with acrochet-hook at the distalend and is manufacturedfrom stainless steel thathas been fabricated with a60 degree curve tofacilitate implant of thebarbed suture. | The implant is a cylindricalshaped segment of braidedpolyester filaments. Thedelivery tool is comprisedof a handle and needleassembly that allows forpositioning and placementof the implantsubmucosally in the softpalate. The implant ispermanent while thedelivery tool is disposable. | The implanted suture is abarbed, absorbable suturethat is extruded frompolydioxanone (PDO). Thebi-directional barbs aredesigned to allow for aknotless application duringimplant of the suture. | Insertion | Place needle slightly to the side of thesoft palate midline raphe. | Place needle high in the palate.Insertion points should be as close tothe junction of the hard and soft palateas possible – 1 mm anterior to thejunction is ideal. |
| Performance Testing | Dimensional integrity,mechanical performanceand reliability,biocompatibility, insertionability and pre-clinicalperformance. Elevo™ is asuture and was tested fortensile strength (asapplicable) and needleattachment. Elevo™ wasalso tested for in vitro posthydrolysis tensile strength. | Dimensional integrity,mechanical performanceand reliability,biocompatibility, insertionability and pre-clinicalperformance. | USP Monograph forabsorbable sutures fortensile strength (asapplicable) and needleattachment. In vitro posthydrolysis testing. | Target Zone | Image: The target zone for the point of entry should be approximately 5-6 mm distal (posterior) to the hard/soft palate junction. 5-6 mm | Image: Hard palate/soft palate junction. Target zone. 2 mm. 2 mm |
| Characteristic | Elevo® Kit Snoring Intervention Device | Predicate Device: | Reference Device: | Deployment | Advance the tip of the suture deliverydevice in a gentle arch motion throughthe uvula and the levetor palatinemuscles. Reverse direction and retractthe needle. The barbed suture isdeployed. Pull on each disposabletension suture to effect mild tissueapposition and lift the soft palate tissue. | Advance slider from start position. Stopadvancing slider when it reacheshalfway deployment position.Withdraw the needle. |
| Pillar™ Palatal Implant System | Quill™ Synthetic Absorbable Barbed Suture | Inspection | Cut the disposable tension sutures withscissors, and inspect the implant region. | Inspect the needle insertion site. If aportion of the implant is exposed, itmust be gently removed with forceps tomitigate risk of infection or extrusion. | ||
| Delivery Tool | Image: Delivery Tool | Image: Delivery ToolThumb switchSlider lock insertFull insertion depth markerHalf-way markerNeedle tip markerHandle | Image: Quill Synthetic Absorbable Barbed Suture | |||
| Implant Length | Image: Implant | Image: Implant LengthImplant LengthDiameter1.8 cm | Image: Barbed SutureLength Not Applicable | |||
| In Vivo Delivery | Image: In Vivo Delivery | Image: Insertion point | Not Applicable |
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Table 5-2-b: Device Technological Characteristics
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Image /page/11/Figure/3 description: The image shows the title of a table. The title is "Table 5-3: Device Physical Characteristics". The text is in a sans-serif font and is left-aligned.
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| Table 5-4: Clinical Technique Comparison | ||
|---|---|---|
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Section 807.92(b)(1):
NONCLINICAL TESTING:
A brief discussion/summary of nonclinical testing (excerpted with minor revisions) from Section 18, Performance Testing, Bench from this Premarket Notification for the Elevo® Kit Snoring Intervention Device is provided following:
The Elevo® Kit Snoring Intervention Device is a manually-operated, single-use, tapered needle suture delivery system. There are no mechanical or moving parts in the kit. The tapered needle point is designed to pierce the mucosal tissue of the soft palate without cutting it. The crochet-type tip of the tapered needle facilitates attachment of the Elevo™ implant to the needle. The Disposable Tension Suture (DTS) is attached to the proximal end of the Elevo™ implant. The proximal end of the DTS is attached to the handle cleat during the Kit assembly process.
Performance (bench) testing of the Elevo® Kit Snoring Intervention Device was conducted pursuant to the following standard test methods:
- . STM001, Standard Test Method, Elevo® Implant Tensile Strength (see Appendix 18-1)
- I TM002, Standard Test Method, Elevo® DTS Tensile Strength (see Appendix 18-2)
- . STM003, Standard Test Method, Suturing Needle Proof Load (see Appendix 18-3)
- י STM004, Standard Test Method, Suturing Needle Tip Bending (see Appendix 18-4)
Performance (bench) testing of the packaging system designed for the Elevo® Kit Snoring Intervention Device, the corresponding 6-month shelf life verification, and the Design Verification testing described in the above identified Standard Test Methods are encompassed in the following test protocol:
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. TP002-001, Test Protocol, Packaging Validation and 6-month Shelf Life Verification of the Elevo® Kit Snoring Intervention Device (see Appendix 18-5)
The results of the performance (bench) testing of the Elevo® Kit Snoring Intervention Device are provided in the following test report: -
. TR002-001, Test Report, Packaging Validation and 6-month Shelf Life Verification of the Elevo® Kit Snoring Intervention Device (see Appendix 18-6)
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A comprehensive description of the objectives, test articles, study endpoints, pass/fail criteria, and the shelf life for the Elevo® Kit Snoring Intervention Device packaging system is provided in Section 14 of this submission.
Section 807.92(b)(2):
| CLINICAL TESTING: | The Elevo® Kit Snoring Intervention Device wasclinically evaluated in human subjects during theS.I.LE.N.C.E. Study (Snoring Intervention viaElevoplasty in a Non-surgical Clinical Environment).The study was designated a Non-Significant Risk clinicaltrial by FDA and was conducted between March andSeptember 2017. |
|---|---|
| STUDY TYPE/DESIGN: | Single group compared to Baseline, non-randomized,multi-center, prospective, safety and efficacy study. |
| PATIENT POPULATION STUDIED | Adult patients ≥ 22 years (no maximum age) withsimple snoring; an apnea-hypopnea index (AHI) scoreof <15; no prior surgical treatment for snoring; and witha bed/sleep partner willing and capable of providingInformed Consent. |
PATIENT SUB-POPULATION ANALYSIS:
| Subset Analysis: 31 patientswho began the study withBaseline AHI of 5 or below | |
|---|---|
| Day 30 reduction in Snoring VAS | 24.5% |
| Number of patients' bedpartners' reporting Day 30results | 31 |
| Day 90 reduction in Snoring VAS | 33.6% |
| Number of patients' bedpartners' reporting Day 90results | 27 |
| Day 180 reduction in SnoringVAS | 27.3% |
| Number of patients' bedpartners' reporting Day 180results | 27 |
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Fifty-two (52) Study Subjects were enrolled in the trial, of which eighteen (18) were female and thirty-four (34) were male. The Study Subject's ranged in age from twenty-two (22) years to seventy-eight (78) years, with a mean of forty-four (44) years of age.
Each Study Subject presented with a self-identified snoring problem and tested negative for Obstructive Sleep Apnea pursuant to the literature definition: Apnea Hypopnea Index (AHI) <15.
The Study Subject and the Co-Participant/Bed Partner were consented and were trained on the use of an external outcomes-tracking database. The database was constructed specifically for the S.I.LE.N.C.E. Study by trials.ai, a company that specializes in electronic patient-reported outcomes (ePRO) and electronic observer reported outcomes (eORO). The Bed Partner's objective scoring of each Study Subject's snoring severity at specific time points were entered into the database. The Clinical Coordinators at each investigational site did not obtain snoring results in order to minimize the opportunity for bias.
The Visual Analog Scale (VAS) 0 – 10 score assessment of the Study Subject's snoring severity was entered at four (4) time points during the trial: (1) Prior to the Elevoplasty® procedure (Baseline), (2) thirty (30) days after the procedure, (3) ninety (90) days after the procedure, and (4) one hundred eighty (180) days after the procedure. Hence, with fifty-two (52) Study Subjects treated during the trial, the Bed Partners were required to enter a collective total of two hundred eight (208) VAS scores (52 x 4 = 208). Although not all scores were entered exactly on time due to Study Subject follow-up challenges, most scores were entered within 2-5 days of their scheduled date.
A variety of Secondary Endpoints were also collected during the trial. These included two surveys (Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index) that the Study Subjects themselves were prompted to complete at the same four (4) endpoints discussed above. In addition to the surveys, each Study Subject was required to complete the same home sleep study using the SNAP® Diagnostics Model 8 Ventilatory Effort Recorder device. Results of the SNAP® home sleep study recordings were analyzed by SNAP® Diagnostics, Inc., with a minimum of four (4) hours of recording required for each Study Subject file to be analyzed. Audio files measured for the frequency of four (4) pre-defined types of snoring noise events detected by the SNAP® Diagnostics staff algorithms.
STUDY SUBJECT METRICS:
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SAFETY & EFFECTIVENESS DATA:
The clinical safety of the Elevo® Kit Snoring Intervention Device meets or exceeds the clinical safety of the predicate device (Pillar™ Palatal Implant System), as evidenced by the comparable safety data presented in the Tables provided in Section 12, Substantial Equivalence Discussion of this 510(k). The safety of the Subject Device has been demonstrated in a well-controlled Non-significant Risk (NSR) clinical study, in which zero ("0") adverse events were reported and only two (2) Elevo® suture implants were reported to have been felt by patients. In both cases of palpable Elevo® implants, the extruding section of the implant was treated with a simple trimming of the protruding portion of the implant in a brief follow-up office visit, thereby resolving the issue. This simple trimming with scissors involves no anesthesia, no bleeding, and no pain. By contrast, cases of extruding implants of the Pillar™ Palatal Implant System predicate device cannot be resolved in this simple manner. Instead of a simple trimming of the protruding portion, Pillar implants are too hard to be cut with scissors, so any palpable extrusion necessitates complete explantation of the implant. Explantation of a Pillar implant involves reanesthetizing the patient, and pulling the implant out (or sometimes cutting it out with a #11 scalpel blade) causing tissue trauma – the site typically bleeds.
ANTICIPATED ADVERSE EVENTS: Four (4) anticipated adverse events were reported during the study. Each event was prospectively defined in the S.I.LE.N.C.E. Study Protocol and are described below:
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- Trouble swallowing; sore throat - sharpness feeling on the throat right side.
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- Patient reported that a "stitch" was sticking straight down, was very sharp and was affecting the patient's speech. The patient was brought into the investigational center the same day as the report, examined by the investigating clinician who observed the proximal end of the midline barbed implant protruding from the site of administration. The end of the implant was trimmed by the clinician, at which point the patient reported immediate relief.
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- Patient reported and described dysphagia on postoperative night #1 that was resolved upon waking on Post-operative Day #1.
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- Patient reported superficial bruising in the roof of the mouth. Patient was seen in the office by the investigating clinician, who examined the site and concluded that the event is an expected risk related to participation in the trial.
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Each of the four (4) events meet the definition of Common Treatment Events as prospectively defined in the S.I.LE.N.C.E. Study Protocol (i.e., dysphagia, sore throat, palpable suture, oral hematoma). Based upon this rationale, the Sponsor maintains that there were zero Unanticipated Adverse Events in the S.I.LE.N.C.E. Study.
CLINICAL SAFETY CONCLUSION:
The Sponsor concludes that the clinical safety of the Elevo® Kit Snoring Intervention Device is equivalent to, or exceeds, the clinical safety of the predicate device.
The clinical efficacy of the Elevo® Kit Snoring Intervention Device is comparable to the predicate device, as evidenced by the clinical data presented in the Tables provided in Section 12, Substantial Equivalence Discussion of this 510(k). Snoring severity - as measured by the most meaningful and relevant metric: each patient's bed partner's 0-10 snoring severity rating - was reduced by an average 25% or more at the three follow-up time points measured: Day 30, Day 90, and Day 180 post-procedure. Notably, the duration of snoring severity reduction appears to exceed the resorption time of Elevo® implants. This observation is consistent with the Sponsor's and clinical advisors' theory that the physical tissue apposition of the soft palate caused by the pulling of the implant induces a secondary tissue remodeling and contraction process that persists after the implant has been replaced by scar tissue.
Of the four clinical efficacy results of the Pillar™ Palatal Implant System predicate, the fourth one (the clinical study of 40 patients with chronic primary snoring) appears to be the most relevant benchmark to which to compare the Elevo® Kit Snoring Intervention Device efficacy results. This is because the first study (the one that used a 0-100 VAS score) had only 12 patients. The second study had 106 patients but its efficacy was stated only qualitatively, with no percentage reduction nor p-values. The third study (the one with the biggest drop in bed partner VAS) had only 15 patients.
When comparing the 52-patient Elevo® Kit Snoring Intervention Device efficacy results from the S.I.LE.N.C.E. Study to the 40-patient fourth Pillar study (see Table 5-5), we observe:
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| Characteristic | Elevo® Kit SnoringIntervention DeviceS.I.LE.N.C.E. StudyResults | Subset of S.I.LE.N.C.E.Study Results pertainingonly to those patientswith a pre-procedureAHI score of 5 or below | Predicate Device:Pillar™ Palatal ImplantSystem 4th Study |
|---|---|---|---|
| Number of patients | N = 52 | N=31 | N = 40 |
| Number of Patients Completing AllEndpoints | N = 45 (87%) | N=27 (87%) | N = 32 (80%) |
| Percentage of patients lost tofollow-up | 13% | 13% | 20% |
| Bed Partner Mean Snoring Severity0-10 VAS rating at Baseline | $7.81 \pm 1.59$ | $7.65 \pm 1.58$ | $7.1 \pm 2.0$ |
| Bed Partner Mean Snoring Severity0-10 VAS rating at Day-30 | $5.79 \pm 2.33$ p < 0.001 | $5.77 \pm 2.45$ p < 0.001 | Not measured |
| Bed Partner Mean Snoring Severity0-10 VAS rating at Day-90 | $5.42 \pm 2.33$ p < 0.001 | $5.04 \pm 2.21$ p < 0.001 | Day-90 $4.2 \pm 2.7$ p < 0.05 |
| Bed Partner Mean Snoring Severity0-10 VAS rating at Day-180 | $5.40 \pm 2.28$ p < 0.001 | $5.52 \pm 2.42$ p < 0.001 | Not measured |
Table 5-5: Comparative Clinical Data
Compared to the most extensive known clinical study of the four (4) available for the predicate device, the efficacy results of the Subject Device - measured by the same primary endpoint outcome measurement (bed partner snoring severity 0-10 VAS) - demonstrate a greater degree of statistical significance, and had more patients complete the study with a lower lost-to-followup rate. While it did not alleviate snoring in 100% of the patients, the mean outcome of the Elevoplasty® procedure was so positive that there is less than 1/10th of 1% chance that the alleviation of snoring observed at Day 30, Day 90, and Day 180 post-procedure was due to chance.
CLINCIAL EFFICACY CONCLUSION:
The Sponsor concludes that the clinical efficacy of the Elevo® Kit Snoring Intervention Device is equivalent to the clinical efficacy of the predicate device.
Section 807.92(b)(3):
The Elevo® Kit Snoring Intervention Device has the same Indications for Use and Intended Use as the predicate device, Pillar™ Palatal Implant System.
The implantable component of the Subject Device is manufactured using polydioxanone (PDO), which is the
CONCLUSIONS:
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identical material to the Reference Device Quill™ Synthetic Absorbable Barbed Suture, and the same material acknowledged by the Agency in the FDA Guidance FDA Special Controls: Application of Class II Surgical Sutures Control Guidance (see Section 12, Substantial Equivalence Discussion of this 510(k) (see Section 12, Substantial Equivalence Discussion, Figure 12-1 of this Premarket Notification).
The technological characteristics the Elevo® Kit Snoring Intervention Device are very similar to the predicate device, as the Subject Device is intended as a treatment option for snoring and consists of an implant and a delivery tool. Like the predicate device, the Subject Device is designed to stiffen the tissue of the soft palate and to reduce the dynamic flutter of those tissues without interfering with the normal function of the soft palate.
The anatomic target location for the Subject Device suture implant is nearly identical to the target location of the predicate device: 5-6 millimeters distal (posterior) to the soft palate/hard palate junction.
The tensile strength of the Elevo® suture implant is comparable to the reference device, as is evidenced by the similar in vitro bench test results provided in Section 12, Substantial Equivalence Discussion, Table 12-5 of this Premarket Notification. The force-to-failure test results measured by pull-force testing in bovine material demonstrated that the Elevo® implant suture and the Quill™ PDO Synthetic Absorbable Barbed Suture are equivalent despite the slightly different barb configurations for each device.
The collective clinical safety and efficacy data together with the in vitro non-clinical data presented in this Premarket Notification demonstrate that the Elevo® Kit Snoring Intervention Device performs as anticipated, and the device raises no new questions of safety and effectiveness when compared to the predicate device.
The Elevo® Kit Snoring Intervention Device is substantially equivalent to the Pillar™ Palatal Implant System (K118623), which is indicated for use in stiffening the soft palate tissue, and which may reduce the severity of snoring in some individuals.
§ 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.”