(224 days)
No
The device description and performance studies focus on a physical implant and its clinical evaluation, with no mention of AI/ML algorithms for diagnosis, treatment planning, or data analysis beyond standard statistical methods. The use of a database by "trials.ai" for data collection does not indicate AI/ML is part of the device itself.
Yes
The device is intended to treat snoring by stiffening soft palate tissue, which aligns with the definition of a therapeutic device as it provides a medical benefit or treatment.
No
The device is intended for treatment (stiffening the soft palate tissue to reduce snoring severity), not for diagnosing a condition.
No
The device description clearly states it is comprised of physical components: sterile, absorbable, and barbed, polydioxanone (PDO) sutures and corresponding disposable, sterile, single use suturing needles.
Based on the provided information, the Elevo® Kit Snoring Intervention Device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to stiffen soft palate tissue to reduce snoring. This is a direct intervention on the patient's anatomy, not a test performed on a sample taken from the patient.
- Device Description: The device is comprised of sutures and needles, which are used for a surgical or procedural intervention. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Anatomical Site: The device is applied to the soft palate tissue, which is within the patient's body. IVDs are used to analyze samples from the body.
- Performance Studies: The performance studies evaluate the reduction in snoring severity based on bed partner observations and surveys, not on the analysis of biological samples.
In summary, the Elevo® Kit is a medical device used for a therapeutic procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LRK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft palate tissue
Indicated Patient Age Range
Adult patients >= 22 years (no maximum age)
Intended User / Care Setting
Physician's office intervention.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The S.I.LE.N.C.E. Study was a single group compared to Baseline, non-randomized, multi-center, prospective, safety and efficacy study.
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)
§ 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.”
0
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.
1
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
2
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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3
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 200
La Jolla, CA 92037 |
|-----------------|-----------------------------------------------------------------------------------------------|
| CONTACT PERSON: | David C. Humbert, RAC
Vice President, Regulatory and Clinical Affairs
650.763.8282 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-Snoring |
| 872.5570, intraoral devices for snoring |
Section 807.92(a)(3):
| PREDICATE DEVICE: | Pillar™ Palatal Implant System
Manufactured by Medtronic XOMED, Inc. |
|--------------------------|-----------------------------------------------------------------------------------------------|
| PREDICATE DEVICE 510(k): | K110623 |
| REFERENCE DEVICE: | Quill™ Absorbable Suture
Manufactured by Surgical Specialties Corporation dba
Angiotech |
| REFERENCE DEVICE 510(k): | K132268 |
4
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.
5
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
6
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
7
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.
8
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 Snoring
Intervention Device | Predicate Device:
Pillar™ Palatal Implant
System | Reference Device:
Quill™ Synthetic
Absorbable Barbed Suture |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K181107 | K110623 | K071989
K113744
K123877
K132268 |
| Indications for Use | 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. | The Pillar™ System is
intended for use in
stiffening the soft palate
tissue, which may reduce
the severity of snoring in
some individuals. | Quill™ Synthetic
Absorbable Barbed Sutures
are indicated to close
easily approximated edges
of dermis where use of
absorbable sutures is
appropriate. |
| Common/Usual Name | Device, Anti-Snoring | Device, Anti-Snoring | Polydioxanone Absorbable
Surgical 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 polydioxanone
surgical 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 Snoring
Intervention Device | Predicate Device:
Pillar™ Palatal Implant
System | Reference Device:
Quill™ Synthetic
Absorbable Barbed Suture |
| Labeling: Sterile,
Single Use | Yes | Yes | Yes |
| Implant Materials | Absorbable Polydioxanone
(PDO) | Woven polyester fiber
filament | Absorbable Polydioxanone
(PDO) |
| Implant Component
Description | Absorbable Surgical Suture | Non-absorbable,
permanent, polyester
filament | Absorbable Surgical Suture |
| Outpatient - Office
Based Procedure | Yes | Yes | Device is indicated for soft
tissue approximation
where use of an
absorbable suture is
appropriate. |
| Mechanism of Action
Delivery Method | Disposable, sterile, single
use, handheld suturing
needle and proprietary
suture implant technique | Disposable, sterile, single
use, handheld pellet
delivery needle | Handheld suturing needle |
| Implant
Manufacturing
Method | Injection molded | Multiple polyester fibers
woven & fused with
two ultrasonic welds | Injection molded and/or
machine extruded |
| Biocompatible | Yes | Yes | Yes |
| Device Description -
General | The kit is intended as a
treatment option for
snoring and consists of an
implant and a delivery tool.
The 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 system is intended as a
treatment option for
snoring and consists of an
implant and a delivery tool.
The 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 device is a synthetic
absorbable suture
available in various suture
length and needle
configurations in USP Sizes
3-0 and 4-0. Each suture
has bi-directional barbs
along the axis of the suture
strand. Barbs allow for
tissue approximation
without the need for
surgical 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
9
| | | Table 5-2-a: Device Technological Characteristics | Procedure | Elevo® Kit Snoring Intervention Device | Predicate Device:
Pillar™ Palatal Implant System | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Elevo® Kit Snoring
Intervention Device | Predicate Device:
Pillar™ Palatal Implant
System | Reference Device:
Quill™ Synthetic
Absorbable Barbed Suture | Preparation | Antibiotic not required
Prepare site with a short-acting oral
antiseptic
Inject site with no more than 0.75 cc
total lidocaine in up to 3 locations
around the soft palate in order to avoid
hydro-dissection. | An appropriate broad-spectrum
antibiotic should be given
Prepare site with an oral antiseptic
Inject site with a local anesthetic (2 – 3
cc) nine injections 1 cm apart, starting 1
mm anterior to the hard palate
junction. |
| Device Description –
Implant | The implant is a barbed,
absorbable suture that is
injection molded of
polydioxanone (PDO). The
barbs are designed to
allow for a knotless
application during implant
of the device. The distal
stirrup shape and the
proximal circular shape
facilitate loading of the
device onto the suturing
needle during final
packaging. The delivery
tool is designed with a
crochet-hook at the distal
end and is manufactured
from stainless steel that
has been fabricated with a
60 degree curve to
facilitate implant of the
barbed suture. | The implant is a cylindrical
shaped segment of braided
polyester filaments. The
delivery tool is comprised
of a handle and needle
assembly that allows for
positioning and placement
of the implant
submucosally in the soft
palate. The implant is
permanent while the
delivery tool is disposable. | The implanted suture is a
barbed, absorbable suture
that is extruded from
polydioxanone (PDO). The
bi-directional barbs are
designed to allow for a
knotless application during
implant of the suture. | Insertion | Place needle slightly to the side of the
soft palate midline raphe. | Place needle high in the palate.
Insertion points should be as close to
the junction of the hard and soft palate
as possible – 1 mm anterior to the
junction is ideal. |
| Performance Testing | Dimensional integrity,
mechanical performance
and reliability,
biocompatibility, insertion
ability and pre-clinical
performance. Elevo™ is a
suture and was tested for
tensile strength (as
applicable) and needle
attachment. Elevo™ was
also tested for in vitro post
hydrolysis tensile strength. | Dimensional integrity,
mechanical performance
and reliability,
biocompatibility, insertion
ability and pre-clinical
performance. | USP Monograph for
absorbable sutures for
tensile strength (as
applicable) and needle
attachment. In vitro post
hydrolysis 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 delivery
device in a gentle arch motion through
the uvula and the levetor palatine
muscles. Reverse direction and retract
the needle. The barbed suture is
deployed. Pull on each disposable
tension suture to effect mild tissue
apposition and lift the soft palate tissue. | Advance slider from start position. Stop
advancing slider when it reaches
halfway deployment position.
Withdraw the needle. |
| | | Pillar™ Palatal Implant System | Quill™ Synthetic Absorbable Barbed Suture | Inspection | Cut the disposable tension sutures with
scissors, and inspect the implant region. | Inspect the needle insertion site. If a
portion of the implant is exposed, it
must be gently removed with forceps to
mitigate risk of infection or extrusion. |
| Delivery Tool | Image: Delivery Tool | Image: Delivery Tool
Thumb switch
Slider lock insert
Full insertion depth marker
Half-way marker
Needle tip marker
Handle | Image: Quill Synthetic Absorbable Barbed Suture | | | |
| Implant Length | Image: Implant | Image: Implant Length
Implant Length
Diameter
1.8 cm | Image: Barbed Suture
Length Not Applicable | | | |
| In Vivo Delivery | Image: In Vivo Delivery | Image: Insertion point | Not Applicable | | | |
10
Table 5-2-b: Device Technological Characteristics
11
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.
12
| Table 5-4: Clinical Technique Comparison | ||
|---|---|---|
13
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:
-
. 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)
14
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 was
clinically evaluated in human subjects during the
S.I.LE.N.C.E. Study (Snoring Intervention via
Elevoplasty in a Non-surgical Clinical Environment).
The study was designated a Non-Significant Risk clinical
trial by FDA and was conducted between March and
September 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) with
simple snoring; an apnea-hypopnea index (AHI) score
of