(205 days)
Not Found
No
The device description and performance studies focus on mechanical components and their physical properties, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.
Yes
The device is intended for the treatment of mild or moderate obstructive sleep apnea (OSA) and/or snoring by surgically suspending the tongue base.
No
The device is described as a system for anterior advancement of the tongue base to treat obstructive sleep apnea and snoring, which is a treatment, not a diagnostic process.
No
The device description clearly outlines multiple physical components including a bone screw, suture, inserter, suspension line lock tool, threading tool, and various suspension lines. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of mild or moderate obstructive sleep apnea (OSA) and/or snoring by physically suspending the tongue base. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a surgical system consisting of physical components like bone screws, sutures, and tools for implantation. It is designed to be implanted in the body to achieve a physical effect.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Siesta Medical, Inc. ENCORE Tongue Suspension System is intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring.
Product codes (comma separated list FDA assigned to the subject device)
ORY
Device Description
The ENCORE Tongue Suspension System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw and suture. The ENCORE Tongue Suspension System consists of an integrated suture passer pre-loaded with size #2-0 braided polyester suture, a titanium bone screw that is premounted on an inserter, a suspension line lock tool, and a Threading Tool. In addition, the following suspension lines are provided depending on the model number: 1) a size #1 monofilament polypropylene suspension line, 2) a size #1 monofilament polypropylene suspension line with a radiopaque marker, 3) a size #2 monofilament polypropylene suspension line with a radiopaque marker, 4) a size #2 braided polyester suspension line, and 5) a size #2 braided polyester suspension line with a radiopaque marker.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tongue base, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The non-clinical test data provided in this submission demonstrated that the ENCORE Tongue Suspension System meets the performance specifications. The submission includes the following test results: Suture Endurance Test, Bone Screw Fixation Strength Test, Radiographic Visibility of Suspension Line Marker, ENCORE System Removability in . Chronic Porcine Model. The non-clinical data test results confirm the design modifications do not adverse affect the safety and effectiveness.
Clinical testing was not provided in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image shows the logo for Siesta Medical. The word "Siesta" is in large, bold, outlined letters with a curved line above it. Below "Siesta" is the word "Medical" in smaller, bold, outlined letters.
Attachment 2: 510(k) Summary (per 21CFR 807.92)
DEC 0 6 2012
| 510(k) Number | K121440 | |
|---|---|---|
| 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: | October 29, 2012 | |
| General Device Information | ||
| Product Name: | ENCORE™ Tongue Suspension System | |
| Common Name: | Bone Screw System | |
| Classification: | 21CFR872.5570 | |
| Intraoral devices for snoring and intraoral devices for | ||
| snoring and obstructive sleep apnea. | ||
| Device Class: | Class II | |
| Product Code: | ORY | |
| Predicate Device | ||
| Manufacturer | Device Name | 510(k) Number |
| Siesta Medical, Inc. | ENCORE Tongue Suspension System | K111179 |
Device Description
The ENCORE Tongue Suspension System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw and suture. The ENCORE Tongue Suspension System consists of an integrated suture passer pre-loaded with size #2-0 braided polyester suture, a titanium bone screw that is premounted on an inserter, a suspension line lock tool, and a Threading Tool. In addition, the following suspension lines are provided depending on the model number: 1) a size #1 monofilament polypropylene suspension line, 2) a size #1 monofilament polypropylene suspension line with a radiopaque marker, 3) a size #2 monofilament polypropylene suspension line with a radiopaque marker, 4) a size #2 braided polyester suspension line, and 5) a size #2 braided polyester suspension line with a radiopaque marker.
Intended Use (Indications)
The Siesta Medical, Inc. ENCORE Tongue Suspension System is intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring.
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Image /page/1/Picture/0 description: The image shows the logo for Siesta Medical. The word "Siesta" is in large, bold, sans-serif font, with a curved line above it. Below "Siesta" is the word "Medical" in a smaller, sans-serif font. The logo is black and white.
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Comparison to the Predicate Device
The modified ENCORE Tongue Suspension System has the same intended use and fundamental scientifc technology as the predicate device. The technological characteristics of the modified ENCORE Tongue Suspension System are substantially equivalent to the predicate device including packaging, biocompatibility, sterilization, and labeling. Through bench performance testing it was demonstrated that the design modifications do not adversely affect safty and effectiveness.
Summary of Non-Clinical and Clinical Testing
The non-clinical test data provided in this submission demonstrated that the ENCORE Tongue Suspension System meets the performance specifications. The submission includes the following test results: Suture Endurance Test, Bone Screw Fixation Strength Test, Radiographic Visibility of Suspension Line Marker, ENCORE System Removability in . Chronic Porcine Model. The non-clinical data test results confirm the design modifications do not adverse affect the safety and effectiveness.
Clinical testing was not provided in this submission.
Statement of Equivalence
The ENCORE Tongue Suspension System has the same indications for use and the same technological characteristics as the predicate device. Based on this and the data provided in this pre-market notification, the subject device and the predicate device have been shown to be substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble birds in flight or stylized human figures. The logo is rendered in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 6, 2012
Mr. Michael Kolber Vice President, Regulatory Affairs Siesta Medical, Incorporated 101 Church Street, Suite 3 LOS GATOS CA 95030
Re: K121440
Trade/Device Name: ENCORE™ Tongue Suspension System Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II
Product Code: ORY Dated: October 29, 2012 Received: November 1, 2012
Dear Mr. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame ©. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Siesta Medical. The logo is in black and white, with the word "SIESTA" in large, bold letters on the top line. There is a curved line above the word "SIESTA". The word "MEDICAL" is in smaller letters below the word "SIESTA".
Indications for Use
K121440 510(k) Number (if known):
Device Name: Siesta Medical, Inc. ENCORE™ Tongue Suspension System
Indications for Use: The Siesta Medical, Inc. ENCORE Tongue Suspension System is intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2012.12.05 Susan Runner DDS, MA 16:17:34 -05'00'
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number: