(29 days)
Not Found
No
The provided text does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the mechanical and functional aspects of the root canal system.
Yes
The device is intended to treat a diseased condition (root canal therapy) by cleaning and irrigating teeth, which fits the definition of a therapeutic device.
No
The provided text states that the Sonendo GentleWave System is "intended to prepare, clean, and irrigate teeth indicated for root canal therapy." It is described as a treatment device, not one for diagnosing conditions.
No
The device description explicitly states the system is comprised of a Console and a disposable single-use Handpiece, indicating significant hardware components beyond just software.
Based on the provided information, the Sonendo GentleWave(R) System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- GentleWave System Function: The description clearly states the system is intended to "prepare, clean, and irrigate teeth indicated for root canal therapy." This is a therapeutic procedure performed directly on the patient's teeth, not an analysis of a specimen taken from the body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological samples or providing diagnostic information based on such analysis.
Therefore, the Sonendo GentleWave(R) System falls under the category of a therapeutic medical device used for a dental procedure, not an IVD.
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 Gentle Wave 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
teeth, root canal
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)
All necessary performance testing has been conducted for the Sonendo GentleWave® System to assure substantial equivalence to the predicate device and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Testing included:
- Root Canal Cleaning Efficacy
- Apical Pressure
- Sterilization (Sterility Assurance)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Sonendo, Inc Eric Simon Director, Regulatory Affairs and Quality Assurance 26061 Merit Circle Laguna Hills. California 92653
March 16, 2019
Re: K190359
Trade/Device Name: Sonendo GentleWave System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: February 14, 2019 Received: February 15, 2019
Dear Eric Simon:
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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2019.03.16
10:08:18 -04'00'
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known)
K190359
Device Name Sonendo Gentle Wave(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 Molar Handpiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo Gentle Wave Anterior Premolar Handpiece, the System is indicated for anterior 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)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020
See PRA Statement below.
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Poblishing Services (201) 443-6740
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7. 510(k) 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: | February 14, 2019 |
| CONTACT PERSON: | Eric Simon |
| 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 |
| REVIEWING PANEL: | Dental |
| ESTABLISHMENT | |
| REGISTRATION NO. | 3010817521 |
| PRODUCT CODE | ELC |
PREDICATE DEVICES: Sonendo GentleWave® System (K160905)
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 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.
4
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 K160905.
Technical Characteristics:
The Sonendo GentleWave® System has similar physical and technical characteristics to the predicate device. The modification to the Molar Handpiece design is merely to decrease the footprint in which the end user is currently required to store the device prior to use and to reduce the waste footprint of the device. The modification separates the handle and tip (sealing surface/nozzle) portions of the handpiece with the handle portion changing from a single-use to a reusable/re-sterilizable component whereas the tip portion of the handpiece remains a single-use gamma irradiated sterilized component.
| Technical Characteristics | Sonendo GentleWave® System
(modified) | Sonendo GentleWave®
System (K160905) |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| 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 | SAME |
| Handpiece Sterilization | Molar Handpiece Handle: Steam
sterilized via autoclave
Molar Handpiece Tip: Gamma
Irradiation | Gamma Irradiation |
| Handpiece Sterility
Assurance Level (SAL) | 10-6 | SAME |
| Consumable Shelf Life | 1 Year | SAME |
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Each of the technical attributes are present in the predicate device. The modification to Handpiece does not affect the substantial equivalent nature of the modified device, as this change is merely to increase manufacturability. decrease the footprint in which the end user is currently required to store the device prior to use, and to reduce the waste footprint of the device. The modification separates the handle and tip (sealing interface/ nozzle) portions of the handpiece with the handle portion changing from a single-use to a reusable/re-sterilizable component whereas the tip portion of the handpiece remains a single-use gamma irradiated sterilized component.
Performance Data:
All necessary performance testing has been conducted for the Sonendo GentleWave® System to assure substantial equivalence to the predicate device and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Testing included:
- Root Canal Cleaning Efficacy
- Apical Pressure
- Sterilization (Sterility Assurance)
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.