(84 days)
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.
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.
The Siesta Medical, Inc. PRELUDE Tongue Suspension System is a medical device designed for anterior tongue base suspension to treat mild or moderate obstructive sleep apnea (OSA) and/or snoring. The 510(k) submission (K101060) describes the device and the studies conducted to demonstrate its substantial equivalence to predicate devices, focusing on its performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes the performance tests conducted but does not explicitly define "acceptance criteria" as quantifiable thresholds. Instead, it states that the performance compares favorably to predicate devices. The reported device performance is qualitative, indicating successful completion of the tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Suture tensile strength meets or exceeds predicate devices. | Post-Sterilization Suture Tensile Strength Test: Data presented demonstrates favorable comparison to predicate devices. |
| Suture endurance meets or exceeds predicate devices. | Suture Endurance Test: Data presented demonstrates favorable comparison to predicate devices. |
| Bone screw insertion torque is appropriate for clinical use and comparable to predicate devices. | Bone Screw Insertion Torque Test: Data presented demonstrates favorable comparison to predicate devices. |
| Bone screw torque strength is sufficient for intended use and comparable to predicate devices. | Bone Screw Torque Strength Test: Data presented demonstrates favorable comparison to predicate devices. |
| Bone screw fixation strength is sufficient for intended use and comparable to predicate devices. | Bone Screw Fixation Strength Test: Data presented demonstrates favorable comparison to predicate devices. |
| Device components are supplied sterile. | The single patient use components of the PRELUDE Tongue Suspension System are provided sterile. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided 510(k) summary does not specify the sample sizes used for each of the in vitro mechanical tests. It only states that the tests were "conducted to evaluate the performance characteristics." The data provenance for these in vitro tests would typically be from laboratory testing performed by or for the manufacturer, Siesta Medical, Inc. The document does not specify country of origin for the data, but since the company is based in Los Gatos, CA, it's likely the testing was conducted in the USA or by labs commissioned by them. The study is an in-vitro performance evaluation, not a clinical study, so the terms "retrospective" or "prospective" do not directly apply in the same way they would to human subject research.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the studies described are in vitro mechanical performance tests. They do not involve human interpretation or subjective assessment that would require expert ground truth establishment in the way an AI diagnostic or image analysis system would. The "ground truth" for these tests is based on objective physical measurements and engineering principles.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in clinical studies or expert review processes, typically for establishing consensus ground truth for subjective data (e.g., image interpretation). The mechanical tests performed for this device rely on objective measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The PRELUDE Tongue Suspension System is a physical medical device (an implantable system), not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is entirely irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is an implantable physical system, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the in vitro mechanical tests, the "ground truth" is established through objective physical measurements using calibrated testing equipment and adherence to standard engineering test methodologies (e.g., tensile strength, torque, fixation strength). It is based on the inherent physical properties and performance limits of the materials and design, not on expert consensus, pathology, or clinical outcomes data in the traditional sense.
8. The sample size for the training set:
This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles, material science, and preclinical testing, rather than data-driven machine learning models.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.
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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 KolberVice President, Regulatory Affairs | |
| Address: | 101 Church Street, Suite 3Los 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: | 21CFR872.5570Intraoral devices for snoring and intraoral devices forsnoring and obstructive sleep apnea. | |
| Device Class: | The PRELUDE Tongue Suspension System has not yetbeen classified. Based on FDA's classification of bonefixation devices, the PRELUDE Tongue SuspensionSystem should be classified as a class II device. | |
| Product Code: | ORY | |
| Predicate Devices | ||
| Manufacturer | Device Name | 510(k) Number |
| Influence, Inc. | Sleep-In Bone ScrewSystem | 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 suspensionby fixation of the soft tissue of the tongue base to the mandible bone using a bone screw andsuture. 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 aninserter and size 1 monofilament polypropelyne suspension suture. | ||
| Intended Use (Indications) | ||
| The Siesta Medical, Inc. PRELUDE Tongue Suspension System is intended to be used foranterior advancement of the tongue base by means of a bone screw threaded with suture. It isindicated 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 TongueSuspension 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:
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- Post-Sterilization Suture Tensile Strength Test
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- Suture Endurance Test
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- Bone Screw Insertion Torque Test
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- Bone Screw Torque Strength Test
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- 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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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.
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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.
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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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
Page 1
§ 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.”