(157 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description focuses on mechanical and hydroacoustic cleaning.
No
A therapeutic device is one that treats a disease or condition. This device is described as preparing, cleaning, and irrigating teeth for root canal therapy, which are preparatory steps rather than direct treatment for the disease itself.
No
The device is described as an endotherapy system for preparing, cleaning, and irrigating teeth for root canal therapy, indicating a therapeutic rather than diagnostic function.
No
The device description explicitly states that the system is comprised of a Console, Foot Pedal, and Molar Procedure Kit with a Handpiece, indicating the presence of hardware components.
Based on the provided information, the Sonendo OmniClean Endotherapy System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "prepare, clean and irrigate 181 and 2nd molar teeth indicated for root canal therapy." This describes a procedure performed on a patient's body (in vivo), not a test performed on a sample taken from a patient's body (in vitro).
- Device Description: The device components (Console, Foot Pedal, Molar Procedure Kit with Handpiece) are consistent with equipment used for a dental procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or the use of reagents typically associated with IVD devices.
Therefore, the Sonendo OmniClean Endotherapy System is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sonendo OmniClean Endotherapy System is intended to prepare, clean and irrigate 15 and 2nd molar teeth indicated for root canal therapy.
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
The Sonendo OmniClean Endotherapy System is a medical device intended to prepare, clean and irrigate 15 and 2nd molar teeth indicated for root canal therapy. The Sonendo OmniClean 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
Root canal (of 1st and 2nd molar 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary performance testing has been conducted for the Sonendo OmniClean Endotherapy System to assure substantial equivalence to the predicate devices and to 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Sonendo Endotherapy System (K130025), EMS Piezon Master 700 (K093000), Sonic Air MM 1500+ (MID) (K081268)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
510(k) Summary
1. 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 4, 2013 |
| CONTACT PERSON: | Dan W. Miller |
| Sonendo, Inc. | |
| 26061 Merit Circle, Suite 101 | |
| Laguna Hills, CA 92653 | |
| Phone: (949) 766.3636 x544 | |
| TRADE NAME: | Sonendo OmniClean 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: | Sonendo Endotherapy System (K130025) |
| EMS Piezon Master 700 (K093000) | |
| Sonic Air MM 1500+ (MID) (K081268) |
Substantially Equivalent To:
The Sonendo OmniClean Endotherapy System is substantially equivalent in intended use, principle of operation and technological characteristics to the Sonendo Endotherapy System (K130025), the EMS Piezon Master 700 (K093000) and the Sonic Air MM 1500+ (MID) (K081268).
Description of the Device Subject to Premarket Notification:
The Sonendo OmniClean Endotherapy System is a medical device intended to prepare, clean and irrigate 15 and 2nd molar teeth indicated for root canal therapy. The Sonendo OmniClean Endotherapy System is comprised of a Console, Foot Pedal and Molar Procedure Kit with a Handpiece.
Indication for Use :.
The Sonendo OmniClean Endotherapy System is intended to prepare, clean and irrigate 11 and 2nd molar teeth indicated for root canal therapy.
Page 1 of 3 Premarket Notification: K133752
1
Technical Characteristics:
The Sonendo OmniClean Endotherapy System has similar physical and technical characteristics to the predicate devices. These characteristics are tabulated below:
| Characteristics | Sonendo
OmniClean
Endotherapy
System (K133752) | Sonendo
Endotherapy
System (K130025) | EMS Piezon
Master 700
(K093000) | Sonic Air MM
1500 + (MID)
(K081268) |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Function | Preparation,
cleaning and
irrigation of root
canals | 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 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. | 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. | Generation of
hydroacoustic
waves and fluid
motion | Generation of
hydroacoustic
waves and fluid
motion |
| Treatment Site | Root canal | Root canal | Various,
including Root
canal | Root canal |
| Components | Control Unit
Irrigation reservoirs
Foot pedal
Handpiece
Accessories | Control Unit
Irrigation reservoirs
Foot pedal
Handpiece
Accessories | Control Unit
Irrigation
reservoirs
Foot pedal
Handpiece
Instruments | Handpiece
Instruments |
| Flow Rate | 45 +/- 10 ml/min. | 50-70 ml/min. | 0-50 ml/min. | Unspecified. |
| Duration of
Application | Leak test = 1
minute.
Treatment time = 7
minutes and 45
seconds. | Leak test = 1
minute.
Treatment time = 16
minutes. | Unspecified. | Unspecified. |
| Irrigation Fluid | NaOCl | NaOCL | NaOCL | Water |
| | EDTA | Water | Water | |
| | Water | | Chlorhexidine | |
| | | | Hydrogen | |
| | | | peroxide | |
| | | | Citric acid | |
Sonendo, Inc. Sonendo OmniClean Endotherapy System Page 2 of 3 Premarket Notification: K133752
2
Performance Data:
All necessary performance testing has been conducted for the Sonendo OmniClean Endotherapy System to assure substantial equivalence to the predicate devices and to 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
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 OmniClean Endotherapy System is determined by Sonendo, Inc., to be substantially equivalent to existing legally marketed devices.
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 or bird-like symbol with three distinct strokes forming its body and wings. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60
Silver Spring, MD 20993-0002
Public Health Service
May 15, 2014
Sonendo, Incorporated Mr. Dan Miller Vice President of Regulatory, Clinical Affairs, and Quality Assurance 26061 Merit Circle, Suite 101 Laguna Hills, CA 92653
Re: K133752
Trade/Device Name: Sonendo OmniClean Endotherapy System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: April 15, 2014 Received: April 18, 2014
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.
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
4
Page 2 - Mr. Miller
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 (OS) 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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mary|S|Bunner -S
Erin I. Keith, M.S. Acting 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): K133752
Device Name: Sonendo OmniClean Endotherapy System
Indications for Use:
The Sonendo OmniClean Endotherapy System is intended to prepare, clean and irrigate 181 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)
Sheena A. Green-S 2014.05.15 09:02:20 -04'00'
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