(159 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description focuses on mechanical and hydroacoustic functions.
No.
The device is used to prepare, clean, and irrigate teeth for root canal therapy, which is a preparatory and hygiene function, not a direct therapeutic treatment itself.
No
This device is intended to "prepare, clean and irrigate" molar teeth for root canal therapy, which are therapeutic functions. It does not mention any diagnostic capabilities such as disease detection, measurement, or analysis for the purpose of diagnosis.
No
The device description explicitly states it is comprised of a Console, Foot Pedal, and Molar Procedure Kit with a Handpiece, indicating hardware components are included.
Based on the provided information, the Sonendo Endotherapy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "prepare, clean and irrigate 1st and 2nd molar teeth indicated for root canal therapy." This describes a procedure performed on the patient's teeth, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The device components (Console, Foot Pedal, Molar Procedure Kit with Handpiece) are consistent with a system used for a dental procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Sonendo Endotherapy System's function is a therapeutic procedure performed directly on the patient's teeth.
N/A
Intended Use / Indications for Use
The Sonendo Endotherapy System is intended to prepare, clean and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
Product codes
ELC
Device Description
The Sonendo Endotherapy System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo Endotherapy System is comprised of a Console, Foot Pedal and Molar Procedure Kit with a Handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
1st and 2nd molar 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 Endotherapy System to assure substantial equivalence to the predicate devices and demonstrate the devices perform as intended. All testing was performed on test units representative of finished devices. Testing included:
- . Simulated Use
- EMC and Electrical Safety .
- Thermal Safety .
- Hydroacoustics .
- Apical Extrusion and Pressure ●
- Cleaning .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EMS Piezon Master 700 (K093000), Sonic Air MM 1500+ (MID) (K081268)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
Section 6
510(k) Summary
JUN 1 1 2013
6. 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: | December 29, 2012 | |
| CONTACT PERSON: | Dan W. Miller | |
| Sonendo, Inc. | ||
| 26061 Merit Circle, Suite 101 | ||
| Laguna Hills, CA 92653 | ||
| Phone: (949) 766.3636 x 544 | ||
| TRADE NAME: | Sonendo Endotherapy 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: | EMS Piezon Master 700 (K093000) | |
| Sonic Air MM 1500+ (MID) (K081268) |
Substantially Equivalent To:
The Sonendo Endotherapy System is substantially equivalent in intended use, principal of operation and technological characteristics to the EMS Piezon Master 700 (K093000) and the Sonic Air MM 1500+ (MID) (K081268).
Description of the Device Subject to Premarket Notification:
The Sonendo Endotherapy System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo Endotherapy System is comprised of a Console, Foot Pedal and Molar Procedure Kit with a Handpiece.
Indication for Use:
The Sonendo Endotherapy System is intended to prepare, clean and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
Technical Characteristics:
The Sonendo Endotherapy System has similar physical and technical characteristics to the predicate devices. These characteristics are tabulated below:
Sonendo, Inc. Sonendo Endotherapy System
Page 11 of 85 Deficiencies Response 130610
1
| Characteristics | Sonendo Endotherapy
System | EMS Piezon Master 700
(K093000) | Sonic Air MM 1500 +
(MID) (K081268) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Function | Preparation cleaning and
irrigation of root canals | Various, including
preparation, cleaning and
irrigation of root canals | Preparation cleaning and
irrigation of root canals |
| Principle of
Operation | Generation of
hydroacoustic waves and
fluid motion.
The tip of the device is
placed inside the tooth
during cleaning.
Hydroacoustics is 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. | Generation of
hydroacoustic waves and
fluid motion.
The tip of the device is
placed inside the tooth
during cleaning.
A piezoelectric element is
used to create vibration in
the tip of the device
creating hydrodynamics
(fluid motion) within the
tooth. | Generation of
hydroacoustic waves and
fluid motion.
The tip of the device is
placed inside the tooth
during cleaning.
Air is used to create
vibration in the tip of the
device creating
hydrodynamics (fluid
motion) within the tooth.
The tip of the device
discontinues moving if it
comes in contact with the
walls of a canal. |
| Treatment Site | Root canal | Various, including Root
canal | Root canal |
| Components | Control Unit
Irrigation reservoirs
Foot pedal
Handpiece
Accessories | Control Unit
Irrigation reservoirs
Foot pedal
Handpiece
Instruments | Handpiece
Instruments |
Performance Data:
All necessary performance testing has been conducted for the Sonendo Endotherapy System to assure substantial equivalence to the predicate devices and demonstrate the devices perform as intended. All testing was performed on test units representative of finished devices. Testing included:
- . Simulated Use
- EMC and Electrical Safety .
- Thermal Safety .
- Hydroacoustics .
- Apical Extrusion and Pressure ●
- Cleaning .
2
Section 6
Basis for Determination of Substantial Equivalence:
Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Sonendo Endotherapy System is determined by Sonendo, Inc., to be substantially equivalent to existing legally marketed devices.
Sonendo, Inc. Sonendo Endotherapy System
Page 13 of 85 K130025 Deficiencies Response 130610
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 11, 2013
Mr. Dan W. Miller Sonendo, Incorporated 26061 Merit Circle, Suite 101 LAGUNA HILLS CA 92653
Re: K130025
Trade/Device Name: Sonendo Endotherapy System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: May 7, 2013 Received: May 16, 2013
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.
4
Page 2 - Mr. 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 devicerelated 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/ResourcesforYou/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,
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
- Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ K |30 025
Device Name: Sonendo Endotherapy System
Indications for Use:
The Sonendo Endotherapy System is intended to prepare, clean and irrigate 15 and 2nd molar teeth indicated for root canal therapy.
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)
Andrew I. Steen
2013.06.11 11:50:37 -04'00'
Page _________________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Division of Anesthesions 37.
Infection Control, Dental Devices
K130525 510(k) Number:_