(150 days)
No
The description focuses on the mechanical and fluid dynamics of the device (hydroacoustic and hydrodynamic effects) and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
Explanation: The device is intended to "prepare, clean, and irrigate teeth indicated for root canal therapy" and uses chemical solutions (3% Sodium Hypochlorite (NaOCI) and 8% Ethylenediaminetetraacetic (EDTA)) and "hydroacoustic and hydrodynamic effects" to remove debris. These actions directly treat a diseased condition (need for root canal therapy) to restore health.
No
Explanation: The device is intended to "prepare, clean, and irrigate teeth indicated for root canal therapy" and its description focuses on delivering treatment fluids and collecting waste, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines a system consisting of a Console and Handpieces, which are physical hardware components used to deliver fluids and recover waste. The performance studies also include testing on hardware aspects like electrical safety, thermal performance, and mechanical tests (cavitation, hydroacoustics, etc.).
Based on the provided information, the Sonendo GentleWave™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "prepare, clean, and irrigate teeth indicated for root canal therapy." This is a therapeutic procedure performed directly on the patient's tooth, not a test performed on a sample taken from the body.
- Device Description: The device delivers fluids into the tooth to remove debris. This is a physical cleaning and irrigation process, not a diagnostic test that analyzes a sample for a specific condition or marker.
- Lack of Diagnostic Function: There is no mention of the device analyzing any biological sample (blood, tissue, etc.) or providing any diagnostic information about the patient's condition.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Sonendo GentleWave™ System performs a treatment procedure directly on the patient.
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 1 and 200 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 (Console and Handpiece) delivers a stream of degassed treatment fluids into the tooth. The treatment fluids delivered to the tooth include a 3% Sodium Hypochlorite (NaOCI) solution and an 8% Ethylenediaminetetraacetic (EDTA) solution which are commonly utilized in traditional endodontic treatments. The stream of solutions delivered into the tooth come in contact with accumulated fluid and are redirected by a deflection plate, creating hydroacoustic and hydrodynamic effects which result in removal of organic and inorganic debris from the root canals. The Console collects the treatment fluid from the tooth into a waste collection canister.
The GentleWave System requires use with a Sonendo Handpiece which is used to treat 1* and 20 molar teeth or the Anterior/Premolar Handpiece which is used to treat anterior and premolar teeth. The Molar and Anterior/Premolar Handpieces are hand held dental instruments which are connected to the Console and provide treatment fluid delivery and waste fluid recovery. The Molar Handpiece is used with various accessories provided with the System. Both the Molar and Anterior/Premolar Handpieces are provided sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal (teeth)
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
All necessary performance testing has been conducted on the Sonendo GentleWave System to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. The device passed the following tests, which were conducted in accordance with noted standards:
- Sterility: Sterile per ISO 11137-1,-2, Sterilization of health care products - Radiation Sterilization
- Biocompatibility: Biocompatible per ISO 10993-1, -5, -10, -11, Biological Evaluation of Medical Devices
- Electromagnetic Compliance and Electrical Safety: Certified per IEC 60601-1 General Requirements for Basic Safety and Essential Performance and IEC 60601-1-2 Medical Electrical Equipment: Safety, Radiofrequency Emissions and Electromagnetic Immunity.
- Software: Validated per FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 2005.
- Thermal Test: Internal Test Method: Determined the temperature generated on the external surface of the tooth when receiving treatment with the device.
- Cavitation Test: Internal Test Method: Evaluated transient cavitation bubbles which clean root canals.
- Hydroacoustics Test: Internal Test Method: Demonstrated hydroacoustic characteristics of the device.
- Cleaning Test: Internal Test Method: Demonstrated cleaning efficacy of the device on extracted teeth.
- Apical Pressure Test: Internal Test Method: Determined the hydraulic pressure exerted at the apical terminus of the root canal during use of the device.
- Apical Extrusion Test: Internal Test Method: Measured the relative volume of treatment fluid extruded through the apical terminus during use of the device.
Key Metrics
Not Found
Predicate Device(s)
Sonendo OmniClean Endotherapy System (K133752)
Reference Device(s)
EMS Piezon Master 700 (K093000)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2015
Sonendo, Inc. Ms. Jenny Fam Senior Director of Regulatory Affairs 26061 Merit Circle, Suite 101 Laguna Hills, California 92653
Re: K143448
Trade/Device Name: Sonendo GentleWave™ System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: March 30, 2015 Received: March 31, 2015
Dear Ms. Fam:
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.
1
Page 2 - Ms. Jenny Fam
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
2
5.0 Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): __K143448
Device Name: Sonendo GentleWave System
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 1 and 200 molar teeth. When used with the Sonendo GentleWave™ Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.
AND/OR
Prescription Use X (Part 21 CFR 801 Subpart D) 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)
Page 1 of 1_
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Image /page/3/Picture/0 description: The image shows the logo for SONENDO. The logo consists of a stylized blue wave-like symbol on the left, followed by the word "SONENDO" in a bold, sans-serif font. The wave symbol is made up of several parallel lines that curve to create a sense of motion. The word "SONENDO" is in black, and there is a registered trademark symbol to the right of the word.
510(k) Summary K143448
This 510(k) summary information is being submitted in accordance with 21 CFR 807.92
| Applicant | Sonendo, Inc. |
|---|---|
| Date Prepared | April 28, 2015 |
| Contact | Jenny Fam |
| Senior Director, Regulatory Affairs | |
| 26061 Merit Circle, Suite 101 | |
| Laguna Hills, CA 92653 | |
| 949-766-3636 | |
| Trade Name | Sonendo GentleWave™ System |
| Common Name | Sonic Cleaning and Irrigation System |
| Ultrasonic Scaler | |
| Classification | Ultrasonic Scaler |
| Device Classification | Class II per 21 CFR 872.4850 |
| Product Code | ELC |
| Predicate Devices | Primary: Sonendo OmniClean Endotherapy System (K133752) |
| Reference: EMS Piezon Master 700 (K093000) |
Substantial Equivalence:
The Sonendo GentleWave System is substantially equivalent in intended use, principle of operation and technological characteristics to the Sonendo OmniClean Endotherapy System (K133752) and the EMS Piezon Master 700 (K093000).
Description of the Device Subject to Premarket Notification:
The Sonendo GentleWave System (Console and Handpiece) delivers a stream of degassed treatment fluids into the tooth. The treatment fluids delivered to the tooth include a 3% Sodium Hypochlorite (NaOCI) solution and an 8% Ethylenediaminetetraacetic (EDTA) solution which are commonly utilized in traditional endodontic treatments. The stream of solutions delivered into the tooth come in contact with accumulated fluid and are redirected by a deflection plate, creating hydroacoustic and hydrodynamic effects which result in removal of organic and inorganic debris from the root canals. The Console collects the treatment fluid from the tooth into a waste collection canister.
The GentleWave System requires use with a Sonendo Handpiece which is used to treat 1* and 20 molar teeth or the Anterior/Premolar Handpiece which is used to treat anterior and premolar teeth. The Molar and Anterior/Premolar Handpieces are hand held dental instruments which are connected to the Console and provide treatment fluid delivery and waste fluid recovery. The Molar Handpiece is used with various accessories provided with the System. Both the Molar and Anterior/Premolar Handpieces are provided sterile and intended for single use only.
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
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Image /page/4/Picture/0 description: The image shows the logo for SONENDO. The logo consists of a stylized blue wave-like design on the left, followed by the word "SONENDO" in bold, black capital letters. The wave design is made up of several parallel curved lines, and the word "SONENDO" is in a sans-serif font, with a registered trademark symbol next to the "O".
2nd molar teeth. When used with the Sonendo GentleWave Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.
Technological Characteristics:
The Sonendo GentleWave System has similar physical and technological characteristics to the predicate devices. The differences in physical (weight, dimensions) and electrical (power usage) characteristics when compared to the EMS Piezon Master do not affect substantial equivalence.
| Characteristics | Sonendo GentleWave
System (K143448) | Primary Predicate:
Sonendo OmniClean
Endotherapy System
(K133752) | Reference Predicate:
EMS Piezon Master 700
(K093000) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Sonendo GentleWave
System is intended to
prepare, clean and irrigate
teeth indicated for root
canal therapy. When
used with the Molar
Handpiece, the System is
intended to prepare, clean
and irrigate 1st and 2nd
molar teeth indicated for
root canal therapy. When
used with the
Anterior/Premolar
Handpiece, the System is
intended to prepare, clean
and irrigate anterior and
premolar teeth indicated
for root canal therapy. | The Sonendo OmniClean
System is intended to
prepare, clean and irrigate
1st and 2nd molar teeth
indicated for root canal
therapy. | Intended for use in the
following dental and
periodontal applications:
● Preparing, cleaning and
irrigating root canals
● Retrograde preparation
of root canals
● Removing supra and
sub-gingival calculus
deposits and stains from
teeth
● Periodontal pocket
lavage with simultaneous
ultrasonic tip movement
● Scaling and root planning
● Releasing crowns,
bridges, inlays and posts
as well as condensing
gutta percha
● Plugging for amalgam
condensation
● Cavity preparation,
cementing inlays and
onlays |
| Principle of Operation | Generation of
hydroacoustic waves and
fluid motion. The tip of the
device is placed in or on
top of the tooth during
cleaning. Hydroacoustics
are created by the
treatment fluid stream
flowing through the
enclosure and coming into
contact with the fluid
inside the tooth at the
distal tip. The fluid stream
is dispersed and deflected
by the deflection plate of
the enclosure creating
hydrodynamics (fluid
motion) within the tooth. | Generation of
hydroacoustic waves and
fluid motion. The tip of the
device is placed in or on
top of the tooth during
cleaning. Hydroacoustics
are created by the water
treatment fluid stream
flowing through the
enclosure and coming into
contact with the fluid
inside the tooth at the
distal tip. The fluid stream
is dispersed and deflected
by the deflection plate of
the enclosure creating
hydrodynamics (fluid
motion) within the tooth. | Generation of hydroacoustic
waves and fluid motion |
| Characteristics | Sonendo GentleWave
System (K143448) | Primary Predicate:
Sonendo OmniClean
Endotherapy System
(K133752) | Reference Predicate:
EMS Piezon Master 700
(K093000) |
| Treatment Site | Root canal | Root canal | Various, including Root
canal |
| Components | Console (Control Unit),
Irrigation Fluid Reservoirs,
Foot Pedal, Handpiece
and Accessories | Console (Control Unit),
Irrigation Fluid Reservoirs,
Foot Pedal, Handpiece
and Accessories | Control Unit, Irrigation Fluid
Reservoirs, Foot Pedal,
Handpiece and Instruments |
| Irrigation Fluids | 3% Sodium Hypochlorite
(NaOCI) solution and 8%
EDTA solution | 3% Sodium Hypochlorite
(NaOCI) solution and 8%
EDTA solution | Various, including 0.3%
Sodium Hypochlorite
(NaOCI) solution and low
grade acids |
| Handpiece Type | Two (2) Offered: Molar
Handpiece and
Anterior/Premolar
Handpiece | One (1) Offered: Molar
Handpiece | Universal Handpiece with
various attachments. |
| Sterility: Handpiece | Sterile, Single Use Only | Sterile, Single Use Only | User sterilized, Reusable |
| Sterility: Console | Non-Sterile, User
Disinfected, Reusable | Non-Sterile, User
Disinfected, Reusable | Non-Sterile, User
Disinfected, Reusable |
| Materials | Medical Grade Materials | Medical Grade Materials | Medical Grade Materials |
| Flow rate | With Molar Handpiece:
45±10 ml/min
With Anterior/Premolar
Handpiece: 35±10 ml/min | With Molar Handpiece:
50±10 ml/min | 50 ml/min |
| Maximum Ultrasonic
Output | 21 watts | 21 watts | 12 watts |
| Frequency range | With Molar Handpiece:
0.5-14 kHz
With Anterior/Premolar
Handpiece: 0.5-32 kHz | Molar Handpiece: 0.5-14
kHz | 24-32 kHz |
| Supply voltage | 100-240V, 50-60Hz | 100-120V, 50-60Hz
120-240V, 50-60Hz | 100-240 VAC/ 50-60 Hz |
| Power usage | 6 VA | 6 VA | 80 VA |
| EN 60601-1
classification | Class I Applied Part, Type
B, IP 20, unit | Class I Applied Part, Type
B, IP 20, unit | Class I Applied Part, Type
BF, IP 20, unit |
| Weight | 60 kg | 59 kg | 2.4 kg |
| Unit Dimensions (mm) | 305 x 584 x 1066 | 305 x 584 x 1066 | 225 x 280 x 295 |
| Operating conditions | 10°-40°C, 30-75% Rh | 10°-40°C, 30-75% Rh | 10°-40°C, 30-75% Rh |
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Image /page/5/Picture/0 description: The image shows the logo for SONENDO. The logo consists of a stylized blue wave-like design on the left, followed by the word "SONENDO" in bold, black letters. The wave design is made up of several curved lines that create a sense of movement. The word "SONENDO" is in a sans-serif font, and there is a small circle to the right of the word.
The differences do not impact substantial equivalence as the differences in the indications and technical specifications are within the range of the identified predicates.
Performance Data:
All necessary performance testing has been conducted on the Sonendo GentleWave System to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. The device passed the following tests, which were conducted in accordance with noted standards:
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Image /page/6/Picture/0 description: The image shows the logo for SONENDO. The logo consists of a stylized "S" made up of several curved lines on the left, followed by the word "SONENDO" in a bold, sans-serif font. A small circle, likely a registration mark, is present to the upper right of the "O" in "SONENDO". The logo is simple and modern.
| Test | Consensus Standard/FDA Guidance/Description |
|---|---|
| Sterility | Sterile per ISO 11137-1,-2, Sterilization of health care products - Radiation Sterilization |
| Biocompatibility | Biocompatible per ISO 10993-1, -5, -10, -11, Biological Evaluation of Medical Devices |
| Electromagnetic | |
| Compliance and | |
| Electrical Safety | Certified per IEC 60601-1 General Requirements for Basic Safety and Essential |
| Performance and IEC 60601-1-2 Medical Electrical Equipment: Safety, Radiofrequency | |
| Emissions and Electromagnetic Immunity. | |
| Software | Validated per FDA Guidance: Guidance for the Content of Premarket Submissions for |
| Software Contained in Medical Devices, 2005. | |
| Thermal Test | Internal Test Method: Determined the temperature generated on the external surface of |
| the tooth when receiving treatment with the device. | |
| Cavitation Test | Internal Test Method: Evaluated transient cavitation bubbles which clean root canals. |
| Hydroacoustics Test | Internal Test Method: Demonstrated hydroacoustic characteristics of the device. |
| Cleaning Test | Internal Test Method: Demonstrated cleaning efficacy of the device on extracted teeth. |
| Apical Pressure Test | Internal Test Method: Determined the hydraulic pressure exerted at the apical terminus |
| of the root canal during use of the device. | |
| Apical Extrusion Test | Internal Test Method: Measured the relative volume of treatment fluid extruded through |
| the apical terminus during use of the device. |
Basis for Determination of Substantial Equivalence:
Upon reviewing the information provided in this submission and comparing the intended use, principle of operation and overall technological characteristics, the Sonendo GentleWave System is substantially equivalent to existing legally marketed devices.