PRELUDE III TONGUE SUSPENSION SYSTEM
Device Facts
| Record ID | K110127 |
|---|---|
| Device Name | PRELUDE III TONGUE SUSPENSION SYSTEM |
| Applicant | Siesta Medical, Inc. |
| Product Code | ORY · Dental |
| Decision Date | Apr 8, 2011 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 872.5570 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Siesta Medical, Inc. PRELUDE III 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.
Device Story
PRELUDE III Tongue Suspension System facilitates anterior tongue base advancement to treat OSA and snoring. System components include titanium bone screw, bone screw inserter, bone screw lock tool, integrated suture passer pre-loaded with #2-0 braided polyester suture, and #1 monofilament polypropylene suspension suture. Physician uses system to fixate tongue base soft tissue to mandible. Unlike predicate (PRELUDE II) which uses rigid curved needle for intramuscular suture pass from oral cavity, PRELUDE III utilizes flexible needle to pass suture submucosally without entering oral cavity. Suture passer and loops transfer polypropylene suture from posterior to anterior tongue position; suture is then attached to bone screw. Procedure advances tongue anteriorly to maintain airway patency. Provided sterile for single patient use.
Clinical Evidence
Bench testing only. Suture Pass Reliability Test demonstrated suture passage with at least 95% confidence and 90% reliability. Suture Loop Pull-Out Force testing showed no significant difference in average pull-out force between PRELUDE III and predicate PRELUDE II.
Technological Characteristics
Titanium bone screw; #2-0 braided polyester suture; #1 monofilament polypropylene suspension suture. Flexible needle delivery system. Sterile, single-patient use. Mechanical fixation principle.
Indications for Use
Indicated for patients with mild or moderate obstructive sleep apnea (OSA) and/or snoring requiring anterior advancement of the tongue base.
Regulatory Classification
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.
Special Controls
*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.”
Predicate Devices
- PRELUDE II Tongue Suspension System (K103179)
Submission Summary (Full Text)
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#### APR - 8 2011 510(k) Summary (per 21CRF 807.92) Section 5
| 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 7, 2011 | |
| General Device Information | | |
| Product Name: | PRELUDE III™ 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 II Tongue<br>Suspension System | K103179 |
#### Description
The PRELUDE III 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 PRELUDE III 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 size 1 monofilament polypropelyne suspension suture.
Similar to the PRELUDE II System, the PRELUDE III 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 PRELUDE II uses a rigid curved needle to make an intramuscular suture pass from the oral cavity while the PRELUDE III uses a flexible needle to make an intramuscular suture pass without entering the oral cavity. The PRELUDE III uses a Suture Passer and suture loops to pass a polypropylene suture from the posterior to anterior position in the tongue. The PRELUDE III advances the tongue in the anterior direction with #1 polypropylene suture, which is passed through the base of the tongue and attached to the bone screw.
### Intended Use (Indications)
The Siesta Medical, Inc. PRELUDE III 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. PRELUDE III Tongue Suspension System is substantially equivalent to the PRELUDE II Tongue Suspension System (K103179). The 510(k) notice contains summaries of in vitro studies Suture Pass Reliability Test and Suture Loop
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# KI10127
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510(k) for the Siesta Medical, Inc PRELUDE III Tongue Suspension System April 7, 2011
Pull Out Force used to evaluate the performance characteristics of the PRELUDE III Tongue Suspension System. The Suture Pass Reliability Test demonstrated, that with at least 95% confidence and 90% reliability, the suture is able to be passed from one Suture Passer to the other. The Suture Loop Pull-Out Force showed that there was no significant difference between the average pull out force for the suspension suture loops made with the PRELUDE II and PRELUDE III devices. The data demonstrate that the performance characteristics of the PRELUDE III Tongue Suspension System compare favorably to the predicate device. The single patient use components of the PRELUDE III Tongue Suspension System are provided sterile.
#### 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 predicate device, the PRELUDE III Tongue Suspension System has been shown to be substantially equivalent to the 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
APR - 8 2011
Re: K110127
Trade/Device Name: PRELUDE III™ 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: March 10, 2011 Received: March 11, 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.
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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 l'ederal 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,
h for
Anthony 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
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## Indications for Use
510(k) Number (if known): KIO127
Device Name: Siesta Medical, Inc. PRELUDE III™ Tongue Suspension System
Indications for Use: The Siesta Medical, Inc. PRELUDE III 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)
Susa Ruaises
(Division Sign-OH)
Division of Anesthesiology, General Hospitad
Infection Control and Dental Devices
510(k) Number:
K162227
