(63 days)
Not Found
No
The provided text does not mention AI, ML, deep learning, or any related concepts. The description focuses on the mechanical and functional aspects of the device for root canal therapy.
Yes
The device is intended to "prepare, clean, and irrigate teeth indicated for root canal therapy," which is a medical treatment.
No
The device is intended to "prepare, clean, and irrigate teeth indicated for root canal therapy," which are therapeutic functions, not diagnostic ones. There is no mention of analysis, detection, or interpretation of medical conditions.
No
The device description explicitly states the system is comprised of a Console and a disposable single-use Handpiece, indicating hardware components beyond just software.
Based on the provided information, the Sonendo GentleWave(R) System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "prepare, clean, and irrigate teeth indicated for root canal therapy." This is a procedure performed directly on a patient's body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The device is described as a "medical device intended to prepare, clean and irrigate root canals." This further reinforces its use in a clinical setting directly on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Sonendo GentleWave(R) System's function is therapeutic and procedural, not diagnostic.
N/A
Intended Use / Indications for Use
The Sonendo GentleWave® System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave® Molar Handpiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave® Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.
Product codes
ELC
Device Description
The Sonendo GentleWave® System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo GentleWave® System is comprised of a Console, and a disposable single-use Handpiece. The Handpiece is offered in two versions: a Molar Handpiece which is intended to be used on 1st and 2nd molar teeth and an Anterior/Premolar Handpiece which is intended to be used on anterior and pre-molar teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal / tooth
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)
Design control activities and risk analysis were performed in accordance with 21 CFR Part 820.30 and ISO14971:2007, respectively. Based on the changes being made and the risks associated with those changes, the following testing was determined to be necessary:
- Software validation in accordance with ANSI/AAMI/IEC 62304:2006, Medical . device software - Software life cycle processes
Based on the results of this testing, the modified GentleWave System performs as intended and is substantially equivalent 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
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2016
Sonenedo, Inc. Mr. Dan W. Miller Sr. Vice President of Regulatory Affairs, Clinical Affairs, and Quality Assurance 26061 Merit Circle, Suite 102 Laguna Hills, Ca 92653
Re: K160905
Trade/Device Name: Sonendi Gentle Wave System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: May 2, 2016 Received: May 4, 2016
Dear Mr. Miller:
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. Dan W. Miller
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K160905
Device Name Sonendo GentleWave(R) System
Indications for Use (Describe)
The Sonendo GentleWave(R) System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave(R) Molar Handpiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave(R) Anterior/Premolar Handpiece, the System is indicated for and premolar teeth.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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6. 510(k) K160905 Summary
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Sonendo, Inc. |
|---|---|
| DATE PREPARED: | March 31, 2016 |
| CONTACT PERSON: | Dan W. Miller |
| 26061 Merit Circle, Suite 102 | |
| Laguna Hills, CA 92653 | |
| Phone: 949.766.3636 | |
| Fax: 949.305.5201 | |
| TRADE NAME: | Sonendo GentleWave® System |
| COMMON NAME: | Sonic Cleaning and Irrigation System |
| CLASSIFICATION | |
| NAME: | Ultrasonic Scaler |
| DEVICE | |
| CLASSIFICATION: | Class 2, per 21 CFR 872.4850 |
| PRODUCT CODE | ELC |
| PREDICATE DEVICES: | Sonendo GentleWave® System (K153157 |
Description of the Device Subject to Premarket Notification:
The Sonendo GentleWave® System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo GentleWave® System is comprised of a Console, and a disposable single-use Handpiece. The Handpiece is offered in two versions: a Molar Handpiece which is intended to be used on 1st and 2nd molar teeth and an Anterior/Premolar Handpiece which is intended to be used on anterior and pre-molar teeth.
Indication for Use:
The Sonendo GentleWave® System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWaye® Molar Handpiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave® Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.
Substantially Equivalent To:
The Sonendo GentleWave® System is a modified device of the existing Sonendo GentleWave® System. The modified Sonendo GentleWave® System is substantially equivalent in intended use, principal of operation and technological characteristics to the Sonendo GentleWave® System cleared under premarket notification K153157.
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Technical Characteristics:
The Sonendo GentleWave® System has similar physical and technical characteristics to the predicate device. The software controlled user interface has been modified to allow for clinician-determined treatment fluid concentrations with the default fluid concentration setting identical to the concentrations for the predicate K153157 with three setting options to decrease the concentration of the fluids.
| Technical Characteristics | Sonendo GentleWave®
System (modified) | Sonendo GentleWave®
System (K153157) |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Function | Preparation, cleaning and irrigation
or root canal | SAME |
| Principle of Operation | Generation of hydroacoustic
waves and fluid motion. The tip
of the device is placed inside the
tooth during cleaning.
Hydroacoustics are created by the
water stream flowing through the
guide tube and coming into
contact with the fluid inside the
tooth at the distal tip. The fluid
stream is dispersed and deflected
by the distal end plate of the tube
creating hydrodynamics (fluid
motion) within the tooth. | SAME |
| Treatment Site | Root canal | SAME |
| Components | Control Unit
Irrigation reservoirs
Foot pedal
Handpiece
Accessories | SAME |
| Treatment times | Fixed or User selected | SAME |
| Treatment fluid concentration | Default mode at the concentration
value identical to the predicate or
3 setting options to decrease the
concentrations of the fluids | Fixed |
Each of the technical attributes are present in the predicate device. The modification to use treatment fluids at lower concentrations does not affect the substantial equivalent nature of the modified device, as this change merely allows for ability to select the treatment fluid concentration based on clinical evaluation of the treatment site. This change is consistent with traditional root canal procedures in that it enables the User to utilize treatment fluids with varying concentrations.
Performance Data:
Design control activities and risk analysis were performed in accordance with 21 CFR Part 820.30 and ISO14971:2007, respectively. Based on the changes being made and the risks associated with those changes, the following testing was determined to be necessary:
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- Software validation in accordance with ANSI/AAMI/IEC 62304:2006, Medical . device software - Software life cycle processes
Based on the results of this testing, the modified GentleWave System performs as intended and is substantially equivalent to the predicate device.
Basis for Determination of Substantial Equivalence:
The indications for use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The Sonendo GentleWave® System is similar to the predicate device and is determined by Sonendo, Inc. to be substantially equivalent to the predicate device.