(84 days)
No
The device description and performance studies focus on mechanical components and their physical properties, with no mention of AI/ML algorithms or data processing.
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 treatment for obstructive sleep apnea (OSA) and snoring, not for identifying or characterizing a disease or condition. It is a therapy device that performs a physical intervention (tongue suspension).
No
The device description explicitly states it consists of physical components: suture passers, suture, a titanium bone screw, and a suspension suture. These are 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 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 human body.
- Device Description: The device consists of surgical components (suture passers, bone screw, sutures) used for a surgical procedure. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Siesta Medical, Inc. PRELUDE 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 PRELUDE 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 Tongue Suspension System consists of a pair of suture passers pre-loaded with size 2.0 braided polyester suture, a titanium bone screw that is pre-mounted on an inserter and size 1 monofilament polypropelyne suspension suture.
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
Descriptions of in vitro studies conducted to evaluate performance:
- Post-Sterilization Suture Tensile Strength Test
- Suture Endurance Test
- Bone Screw Insertion Torque Test
- Bone Screw Torque Strength Test
- Bone Screw Fixation Strength Test
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 510(k) notice contains summaries of in vitro studies that were conducted to evaluate the performance characteristics of the PRELUDE Tongue Suspension System. The data presented demonstrate that the performance characteristics of the PRELUDE Tongue Suspension System compare favorably to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K972023, K930738, K930739, K021019
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.”
0
K 101060
Image /page/0/Picture/1 description: The image shows the logo for Siesta Medical. The logo has the word "SIESTA" in large, bold letters with a line above it. Below "SIESTA" is the word "MEDICAL" in smaller letters. The text is black and the background is white.
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510(k) for the Siesta Medical, Inc PRELUDE Tongue Suspension System July 7, 2010
FJUL -- 8 2010
510(k) Summary (per 21CFR807.92)
| 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: | 408-399-7000 | |
| Date Prepared: | July 7, 2010 | |
| General Device Information | ||
| Product Name: | PRELUDE 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: | The PRELUDE Tongue Suspension System has not yet | |
| been classified. Based on FDA's classification of bone | ||
| fixation devices, the PRELUDE Tongue Suspension | ||
| System should be classified as a class II device. | ||
| Product Code: | ORY | |
| Predicate Devices | ||
| Manufacturer | Device Name | 510(k) Number |
| Influence, Inc. | Sleep-In Bone Screw | |
| System | K972023 | |
| Teleflex Medical, Inc. | Deklene II | K930738, K930739 |
| Teleflex Medical, Inc. | Tevdek II | K021019 |
| Description | ||
| The PRELUDE 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 Tongue Suspension System consists of a pair of suture passers pre- | ||
| loaded with size 2.0 braided polyester suture, a titanium bone screw that is pre-mounted on an | ||
| inserter and size 1 monofilament polypropelyne suspension suture. | ||
| Intended Use (Indications) | ||
| The Siesta Medical, Inc. PRELUDE 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 Tongue | ||
| Suspension System is substantially equivalent to the Influence, Inc. Sleep-In Bone Screw |
System [K972023].
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Image /page/1/Picture/0 description: The image shows the logo for Siesta Medical. The logo is in black and white and features the word "SIESTA" in large, bold letters with a line above it. Below "SIESTA" is the word "MEDICAL" in smaller letters. The font is sans-serif and the overall design is simple and modern.
The 510(k) notice contains summaries of in vitro studies that were conducted to evaluate the performance characteristics of the PRELUDE Tongue Suspension System. The following tests were completed:
-
- Post-Sterilization Suture Tensile Strength Test
-
- Suture Endurance Test
-
- Bone Screw Insertion Torque Test
-
- Bone Screw Torque Strength Test
-
- Bone Screw Fixation Strength Test
The data presented demonstrate that the performance characteristics of the PRELUDE Tongue Suspension System compare favorably to the predicate devices. The single patient use components of the PRELUDE 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 devices and does not raise any new issues of safety or efficacy. Based on the indications for use, technological characteristics, and comparison to predicated devices, the PRELUDE Tongue Suspension System has been shown to be substantially equivalent to predicate devices as described under the Federal Food, Drug and Cosmetic Act.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
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 - 8 2010
Re: K101060
Trade/Device Name: PRELUDE Tongue Suspension System Regulation Number: 21CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: ORY Dated: April 13, 2010 Received: April 15, 2010
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
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.
Wh for
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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Image /page/4/Picture/0 description: The image shows the logo for Siesta Medical. The logo is in black and white and features the word "SIESTA" in large, bold letters. Below "SIESTA" is the word "MEDICAL" in smaller letters. There is a line above the word "SIESTA".
510(k) for the Siesta Medical, Inc PRELUDE Tongue Suspension System July 1, 2010
Indications for Use
510(k) Number (if known): _
Device Name: Siesta Medical, Inc PRELUDE Tongue Suspension System
Indications for Use: The Siesta Medical, Inc. PRELUDE 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)
(Division Sign-Oft)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Ni
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