(65 days)
Not Found
No
The device description focuses on mechanical components and surgical procedure, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the treatment of mild or moderate obstructive sleep apnea (OSA) and/or snoring, which indicates its therapeutic purpose.
No
The device is a tongue suspension system designed for treating obstructive sleep apnea and snoring, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details multiple physical components including a bone screw, suture, suture passer, inserter, bone screw lock tool, and threading tool. These are all hardware components, not software.
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 surgical treatment of obstructive sleep apnea and snoring by physically suspending the tongue base. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device consists of surgical tools and implants (bone screw, sutures, inserter, etc.) used to perform a surgical procedure. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is mechanical and surgical.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. 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
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 pre-mounted on an inserter, a bone screw lock tool. and a Threading Tool. In addition, one of the following suspension sutures are provided depending on the model number: 1) a size #1 monofilament polypropylene suspension suture, 2) a size #1 monofilament polypropylene suspension suture with a radiopaque marker, 3) a size #2 monofilament polypropylene suspension suture with a radiopaque marker, or 4) a size #2 braided polyester suspension suture.
Similar to the PRELUDE III System, the ENCORE Tongue Suspension System 1) uses a bone screw, 2) uses a bone screw inserter to place a bone screw into the bone, and 3) uses 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 position in the tongue. The ENCORE advances the tongue in the anterior direction with a suspension suture. A Threading Tool is provided to ease passage of the suspension suture 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 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 510(k) notice contains a summary of the Suture Endurance Test and the Bone Screw Fixation Strength Test, which were used to evaluate the performance characteristics of the ENCORE Tongue Suspension System. This data demonstrate that the suture was able to endure 10.5 million cycles Suspension System. This the bone screw to suture attachment strengths were no worse than the writtion ordaings and that the performance characteristics of the ENCORE Tongue Suspension System compare favorably to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/11 description: The image shows a logo with the word "SIESTA" in large, bold letters. Below "SIESTA" is the word "MEDICAL" in smaller, but still bold, letters. The logo is black and white and appears to be a cropped portion of a larger document or advertisement.
510(k) for the Siesta Medical, Inc ENCORE Tongue Suspension System April 26, 2011
510(k) Summary (per 21CFR 807.92) Section 5
JUL - 1 2011
| 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: | April 26, 2011 | |
| General Device Information | ||
| Product Name: | ENCORETM 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. | PRELUDE III Tongue | |
| Suspension System | K110127 |
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 pre-mounted on an inserter, a bone screw lock tool. and a Threading Tool. In addition, one of the following suspension sutures are provided depending on the model number: 1) a size #1 monofilament polypropylene suspension suture, 2) a size #1 monofilament polypropylene suspension suture with a radiopaque marker, 3) a size #2 monofilament polypropylene suspension suture with a radiopaque marker, or 4) a size #2 braided polyester suspension suture.
Similar to the PRELUDE III System, the ENCORE Tongue Suspension System 1) uses a bone screw, 2) uses a bone screw inserter to place a bone screw into the bone, and 3) uses 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 position in the tongue. The ENCORE advances the tongue in the anterior direction with a suspension suture. A Threading Tool is provided to ease passage of the suspension suture through the bone screw.
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
This submission supports the position that the Siesta Medical, Inc. ENCORE Tongue Suspension System is substantially equivalent to the PRELUDE III Tongue Suspension System (K110127). The 510(k) notice contains a summary of the Suture Endurance Test and the Bone Screw Fixation
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Strength Test, which were used to evaluate the performance characteristics of the ENCORE Tongue Suspension System. This data demonstrate that the suture was able to endure 10.5 million cycles Suspension System. This the bone screw to suture attachment strengths were no worse than the writtion ordaings and that the performance characteristics of the ENCORE Tongue Suspension System compare favorably to the predicate device.
Conclusions
Siesta Medical, Inc. believes that the information provided demonstrates that the proposed 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 entially. Based the 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Mr. Michael Kolber Vice President, Regulatory Affairs Siesta Medical, Incorporated 101 Church Street, Suite 3 Los Gatos, California 95030
JUL - 1 2011
Re: K111179
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: June 1, 2011 Received: June 2, 2011 .. . . . . . . . . . . . .
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 requrements, 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/ucm 115809.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.
Anthony D. Watson
Clostformy D. Only .. Oninton
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Venner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
-111179 510(k) Number:
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