(148 days)
No
The device description and performance studies focus on mechanical components and material strength, with no mention of AI or ML.
Yes
The device is intended for the treatment of obstructive sleep apnea (OSA) and/or snoring, which are medical conditions, and it is designed to achieve this through physical intervention (anterior advancement of the tongue base and hyoid suspension).
No
This device is designed for anterior advancement of the tongue base and hyoid suspension to treat obstructive sleep apnea, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including a suture passer, bone screws, inserters, a suspension line lock tool, a threading tool, a drill bit, and suspension lines.
Based on the provided information, the Encore System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "anterior advancement of the tongue base and hyoid suspension" and is indicated for the "treatment of obstructive sleep apnea (OSA) and / or snoring." This describes a surgical procedure performed directly on the patient's body for therapeutic purposes.
- Device Description: The components listed (suture passer, bone screws, suspension lines, tools) are all instruments and materials used in a surgical procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Encore System does not interact with or analyze such specimens.
Therefore, the Encore System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Encore System is intended for anterior advancement of the tongue base and hyoid suspension. It is indicated for the treatment of obstructive sleep apnea (OSA) and / or snoring.
Product codes
ORY
Device Description
The Encore System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone and hyoid bone suspension to the mandible bone using a bone screw and suspension lines. The Encore System consists of 1) an integrated suture passer pre-loaded with size #2-0 braided polyester suture, 2) three (3) bone screws and two (2) bone screw inserters, 3) a suspension line lock tool, 4) a threading tool, and 5) a drill bit. In addition, a #2 braided polyethelene suspension line is provided. All components are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tongue base, hyoid bone, mandible bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies
Performance testing was conducted to confirm that the #2 braided polyethelene suspension line has sufficuent strength to suture strength to resist breakage. A Suture Tensile Strength Test was conducted to determine the amount of force applied to the suture until the suture breaks. The results of this test confirmed that the strength of the #2 braided polyethylene suspension is similar to that of the existing #2 braided polyester suspension line.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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October 2, 2020
Siesta Medical, Inc. Michael Kolber Vice President, Regulatory Affairs 101 Church Street. Suite 3 Los Gatos, California 95030
Re: K201238/S001
Trade/Device Name: Encore System 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: ORY Dated: August 31, 2020 Received: September 3, 2020
Dear Michael Kolber:
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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 Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Indications for Use (Describe)
The Encore System is intended for anterior advancement of the tongue base and hyoid suspension. It is indicated for the treatment of obstructive sleep apnea (OSA) and / or snoring.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
| 510(k) Number | K201238 | |
|---|---|---|
| Submitter Name and Address | ||
| Name | Siesta Medical, Inc. | |
| Contact | Michael Kolber | |
| Vice President, Regulatory Affairs | ||
| Address | 101 Church Street, Suite 3 | |
| Los Gatos, CA 95030 | ||
| Telephone | 408-505-6626 | |
| Fax | 408-399-7600 | |
| Date Prepared | August 31, 2020 | |
| General Device Information | ||
| Product Name | Encore™ System | |
| Common Name | Intraoral device for snoring and obstructive sleep apnea | |
| Classification | 21CFR872.5570 | |
| Intraoral devices for snoring and intraoral devices for | ||
| snoring and obstructive sleep apnea. | ||
| Device Class | Class II | |
| Product Code | ORY | |
| Primary Predicate Device | ||
| Manufacturer | Device Name | 510(k) Number |
| Siesta Medical, Inc. | Encore System | K183310 |
| Reference Predicate Device |
Teleflex Medical, Inc Device Description
Manufacturer
The Encore System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone and hyoid bone suspension to the mandible bone using a bone screw and suspension lines. The Encore System consists of 1) an integrated suture passer pre-loaded with size #2-0 braided polyester suture, 2) three (3) bone screws and two (2) bone screw inserters, 3) a suspension line lock tool, 4) a threading tool, and 5) a drill bit. In addition, a #2 braided polyethelene suspension line is provided. All components are provided sterile.
Force Fiber Suture
Intended Use (Indications)
The Encore System is intended for anterior advancement of the tongue base and hyoid suspension. It is indicated for the treatment of obstructive sleep apnea (OSA) and /or snoring.
Comparison to the Predicate Device
The Encore System is now available with #2 braided polyethylene suspension line. It has the same intended use as the predicate device.
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The fundamental scientific technology and technological characteristics of the Encore System are the same as the predicate device including mechanism of action, packaging, biocompatibility, sterilization, and labeling. The Encore System now includes a #2 braided polyethylene suspension line and a drill bit.
Summary of Non-Clinical Testing
Performance testing was conducted to confirm that the #2 braided polyethelene suspension line has sufficuent strength to suture strength to resist breakage. A Suture Tensile Strength Test was conducted to determine the amount of force applied to the suture until the suture breaks. The results of this test confirmed that the strength of the #2 braided polyethylene suspension is similar to that of the existing #2 braided polyester suspension line.
Conclusion
Based on the intended use and technological characteristics together with results from the nonclinical performance testing, we believe that the subject device Encore System is substantially equivalent to the predicate device K183310.