(140 days)
Not Found
No
The device description focuses on mechanical components and surgical procedure, with no mention of AI/ML or data processing capabilities.
Yes
The device is intended for the treatment of mild or moderate obstructive sleep apnea (OSA) and/or snoring, which indicates a therapeutic purpose.
No
The device is described as a system for anterior advancement of the tongue base for treating obstructive sleep apnea and snoring, which is a treatment not a diagnostic function.
No
The device description explicitly lists multiple hardware components including a bone screw, suture passer, inserter, bone screw lock tool, threading tool, and various suspension lines.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Siesta Medical, Inc. ENCORE Tongue Suspension System is a surgical implant designed to physically suspend the tongue base to treat sleep apnea and snoring. It involves a bone screw, suture, and suspension lines.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples. Its function is purely mechanical and therapeutic.
Therefore, the ENCORE Tongue Suspension System falls under the category of a surgical device or implant, not an In Vitro Diagnostic.
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 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 pre-mounted on an inserter, a bone screw 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, and 4) a size #2 braided polyester suspension line.
Similar to the predicate ENCORE System, the modified ENCORE Tongue Suspension System 1) uses a bone screw, 2) a bone screw inserter to place a bone screw into the bone, and 3) a needle to pass a suspension suture submucosally through the base of the tongue. The ENCORE uses a Suture Passer and working suture loops to pass a suture from the posterior to anterior position in the tongue. The ENCORE advances the tongue in the anterior direction with a suspension line. A Threading Tool is provided to ease passage of the suspension line through the bone screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tongue base, mandible
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 510(k) includes a test report to support extension of the shelf-life to 2 years.
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.”
0
NOV 7 2012
Image /page/0/Picture/2 description: The image shows the logo for Siesta Medical. The word "Siesta" is in large, bold, black letters with a curved line above it. Below "Siesta" is the word "Medical" in smaller, bold, black letters. The logo is simple and professional.
510(k) for the Siesta Medical, Inc. ENCORE Tongue Suspension System August 3, 2012
Appendix 3: 510(k) Summary
| General Company Information | ||
|---|---|---|
| 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: | July 31, 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 | K111179 |
| Suspension System |
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 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 pre-mounted on an inserter, a bone screw 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, and 4) a size #2 braided polyester suspension line.
Similar to the predicate ENCORE System, the modified ENCORE Tongue Suspension System 1) uses a bone screw, 2) a bone screw inserter to place a bone screw into the bone, and 3) a needle to pass a suspension suture submucosally through the base of the tongue. The ENCORE uses a Suture Passer and working suture loops to pass a suture from the posterior to anterior position in the tongue. The ENCORE advances the tongue in the anterior direction with a suspension line. A Threading Tool is provided to ease passage of the suspension line through the bone screw.
1
Image /page/1/Picture/0 description: The image contains the words "SIESTA MEDICAL" in a bold, sans-serif font. The word "SIESTA" is larger and positioned above the word "MEDICAL". There is a curved line above the word "SIESTA". The text is black against a white background.
510(k) for the Siesta Medical, Inc. ENCORE Tongue Suspension System August 3, 2012
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.
Substantial Equivalence
The ENCORE Tongue Suspension System has the following similarities to the previously cleared predicate device: the same intended use, operating principle, technology, and manufacturing process. This submission supports the position that the Siesta Medical, Inc. modified ENCORE Tongue Suspension System is substantially equivalent to the predicate ENCORE Tongue Suspension System (K111179). The 510(k) includes a test report to support extension of the shelf-life to 2 years.
Conclusions
Siesta Medical, Inc. believes that the information provided demonstrates that the modified device is substantially equivalent to the predicate device and does not raise any new issues of safety or efficacy. Based on the indications for use, technological characteristics, and comparison to the predicate device, the modified ENCORE Tongue Suspension System has been shown to be substantially equivalent to predicate device as described under the Federal Food, Drug and Cosmetic Act.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 7, 2012
Mr. Michael Kolber Vice President, Regulatory Affairs Siesta Medical, Incorporated 101 Church Street, Suite 3 Los Gatos. California 95030
Re: K121814
Trade/Device Name: ENCORETM 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 8, 2012
Received: October 9, 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.
3
Page 2 - Mr. Kolber
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for Kwame O. Ulme
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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510(k) for the Siesta Medical, Inc. ENCORE Tongue Suspension System June 19, 2012
Indications for Use
510(k) Number (if known): K1218/Y
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.
Susan Reenn
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
X | 2 | 8 | 4 510(k) Number:
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)