(53 days)
The Siesta Medical, Inc. PRELUDE II 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 II 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 II 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, a bone screw lock tool, and size 1 monofilament polypropelyne suspension suture.
The provided document is a 510(k) summary for the Siesta Medical, Inc. PRELUDE II Tongue Suspension System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or specific study results that would prove the device meets such criteria in terms of clinical performance or effectiveness.
The "studies" mentioned are in vitro tests conducted to evaluate the performance characteristics of the PRELUDE II Tongue Suspension System compared to a predicate device, focusing on mechanical properties rather than clinical outcomes. These are:
- Suture Endurance Test
- Bone Screw Torque Strength Test
- Bone Screw Fixation Strength Test
Therefore, I cannot provide a table of acceptance criteria for clinical performance or details of a study proving the device meets those criteria, as this information is not present in the provided text.
Based on the provided text, I can only state the information that is present:
1. A table of acceptance criteria and the reported device performance:
The document mentions three in vitro tests and states: "The data presented demonstrate that the performance characteristics of the PRELUDE II Tongue Suspension System compare favorably to the predicate device." No specific quantitative acceptance criteria or detailed performance data from these tests are provided in this summary.
| Test Type | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Summary) |
|---|---|---|
| Suture Endurance Test | (Not specified in document) | Performance characteristics compare favorably to predicate. |
| Bone Screw Torque Strength Test | (Not specified in document) | Performance characteristics compare favorably to predicate. |
| Bone Screw Fixation Strength Test | (Not specified in document) | Performance characteristics compare favorably to predicate. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the in vitro tests.
- Data Provenance: The in vitro studies were conducted as part of the 510(k) submission process, likely by the manufacturer (Siesta Medical, Inc.). No country of origin is specified. The studies are described as in vitro, meaning they were laboratory tests, not human or animal studies, and thus are not retrospective or prospective in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the studies described are in vitro mechanical tests, not clinical studies requiring expert ground truth for diagnosis or outcome assessment.
4. Adjudication method for the test set:
Not applicable, as the described studies are in vitro mechanical tests.
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:
Not applicable. This device is a medical implant (a tongue suspension system), not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a medical implant, not an algorithm.
7. The type of ground truth used:
For the in vitro tests, "ground truth" would refer to established engineering and material science standards for evaluating suture endurance, screw torque strength, and fixation strength. The document only states that the performance "compare favorably to the predicate device," implying a comparison against an already approved device's characteristics, which serves as a benchmark rather than a "ground truth" in the clinical sense.
8. The sample size for the training set:
Not applicable. This document describes in vitro mechanical tests, not machine learning or AI algorithm development which would have training sets.
9. How the ground truth for the training set was established:
Not applicable, for the same reasons as above.
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Image /page/0/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, block letters.
Image /page/0/Picture/1 description: The image contains a handwritten string of alphanumeric characters. The string appears to be "K103179". The characters are written in a casual, slightly slanted style, with varying stroke thicknesses. The background is plain and white.
DEC 2 0 2010
Attachment 2 510(k) Summary (per 21CRF 807.92)
| 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: | 408-399-7600 | |
| Date Prepared: | December 1, 2010 | |
| General Device Information | ||
| Product Name: | PRELUDE II Tongue Suspension System | |
| Common Name: | Bone Screw System | |
| Classification: | 21CFR872.5570; Intraoral devices for snoring and intraoraldevices 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 TongueSuspension System | K101060 |
| Description | The PRELUDE II Tongue Suspension System is designed for anterior tongue base suspension by fixationof the soft tissue of the tongue base to the mandible bone using a bone screw and suture. The PRELUDEII Tongue Suspension System consists of a pair of suture passers pre-loaded with size 2.0 braidedpolyester suture, a titanium bone screw that is pre-mounted on an inserter, a bone screw lock tool, andsize 1 monofilament polypropelyne suspension suture. | |
| Intended Use (Indications) | The Siesta Medical, Inc. PRELUDE II Tongue Suspension System is intended to be used for anterioradvancement of the tongue base by means of a bone screw threaded with suture. It is indicated for thetreatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring. | |
| Substantial Equivalence | This submission supports the position that the Siesta Medical, Inc. PRELUDE II Tongue SuspensionSystem is substantially equivalent to the PRELUDE Tongue Suspension System [K101060].The 510(k) notice contains summaries of in vitro studies (Suture Endurance Test, Bone Screw TorqueStrength Test, and Bone Screw Fixation Strength Test) that were conducted to evaluate the performancecharacteristics of the PRELUDE II Tongue Suspension System. The data presented demonstrate that theperformance characteristics of the PRELUDE II Tongue Suspension System compare favorably to thepredicate device. The single patient use components of the PRELUDE II Tongue Suspension System areprovided sterile. | |
| Conclusions | Siesta Medical, Inc. believes that the information provided demonstrates that the proposed device issubstantially 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 II Tongue Suspension System has been shown to be substantially equivalent to predicatedevice as described under the Federal Food, Drug and Cosmetic Act. |
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
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
DEC 2 0 2010
Re: K103179
Trade/Device Name: Siesta Medical, Incorporated PRELUDE II 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: OR Y Dated: December 6, 2010
Received: December 7, 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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Page 2 - Mr. Kolber
Enclosure
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/ReportalProblem/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,
Jh 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
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Image /page/3/Picture/0 description: The image shows the words "SIESTA MEDICAL" stacked on top of each other. The word "SIESTA" is in a larger font than the word "MEDICAL". There is a line above the word "SIESTA". The text is in all caps.
Indications for Use
DEC 2 0 2010
510(k) Number (if known): K103179
Device Name: Siesta Medical, Inc PRELUDE II Tongue Suspension System
Indications for Use: The Siesta Medical, Inc. PRELUDE II 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(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) | |
|---|---|---|---|---|
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Division of Anesthesiology, General Hospital
Division of Device Evaluations (ODE)
Infection Control, Dental Devices
| 510(k) Number: | K103179 |
|---|---|
| ---------------- | --------- |
Page 5
§ 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.”