(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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January 27, 2022
Zelegent, Inc. David Humbert Vice President, Clinical and Regulatory Affairs 4250 Executive Square, Suite 675 La Jolla, California 92037
Re: K213475
Trade/Device Name: Elevo Snoring Intervention Set 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: October 28, 2021 Received: October 29, 2021
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.
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213475
Device Name
Elevo Snoring Intervention Set
Indications for Use (Describe)
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.
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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Image /page/3/Picture/0 description: The image contains the logo for "Zelegent". The logo features a stylized letter "Z" in two colors: green and blue. The green part of the "Z" is on the left, and the blue part is on the right, with an arrow pointing upwards. Below the symbol is the word "Zelegent" in blue, with the registered trademark symbol. Underneath "Zelegent" is the tagline "SILENCE IS HEALTHY" in smaller, red letters.
Section 5 – 510(k) Summary - K213475
This summary of 510(k) safety and effectiveness information is being submitted pursuant to the requirements of 21 CFR 807.92.
| SUBMITTER: | Zelegent, Inc.4250 Executive Square, Suite 675La Jolla, CA 92037 |
|---|---|
| CONTACT PERSON: | David C. Humbert, RACVice President, Regulatory and Clinical Affairs |
| DATE PREPARED: | October 28, 2021 |
| TRADE NAMES: | Elevo® Snoring Intervention Set |
| TRADE NAMES (OTHER): | Elevo® KitElevo® Kit Snoring Intervention DeviceElevo® SetElevo® Set Snoring Intervention Device |
| COMMON NAME: | Anti-Snoring Device |
| CLASSIFICATION: | Class II |
| PRODUCT CODE: | LRK - Device, Anti-Snoring872.5570, intraoral devices for snoring |
| PREDICATE DEVICE: | Elevo® Kit Snoring Intervention Device (K181107) |
| DEVICE DESCRIPTION: | The Elevo® Snoring Intervention Set is comprised ofthree (3) sterile, absorbable, barbed, poly(L-lactide-co-D L-lactide) sutures and three (3) correspondingdisposable, sterile, single use suturing needles. A silkdisposable tension suture (DTS) is attached to theproximal end of each of the poly(L-lactide-co-D L-lactide) barbed suture implants. The proximal end ofthe DTS is secured to the suturing needle handle duringdevice assembly. One (1) Pilot Hole Initiation Tool(PHIT) completes the contents of the set. |
| INDICATIONS FOR USE: | The Elevo® Snoring Intervention Set is intended for usein stiffening the soft palate tissue, which may reduce theseverity of snoring in some individuals. |
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Image /page/4/Picture/1 description: The image is a logo for Zelegent. The logo features a stylized letter Z in green and blue, with the blue portion forming an arrow pointing upwards and to the right. Below the symbol, the word "Zelegent" is written in blue, with the registered trademark symbol to the right. Underneath "Zelegent", the phrase "SILENCE IS HEALTHY" is written in smaller, red letters.
EQUIVALENCE TESTING:
INTENDED USE:
The Elevo® Snoring Intervention Set is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring due to palatal flutter in some individuals.
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. The comparative results demonstrate that the subject device material characteristics are equivalent to the material characteristics of the predicate device.
The Elevo® Snoring Intervention Set with sterile, absorbable, barbed, poly(L-lactide-co-D L-lactide) sutures is substantially equivalent to the Elevo® Kit Snoring Intervention Device (K181107) with sterile polydioxanone (PDO) sutures. The device is indicated for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals.
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.
CONCLUSION:
§ 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.”