(248 days)
No
The description details a device that uses a CPU to generate ultrasonic frequencies for mechanical vibration, which is a standard engineering process and does not indicate the use of AI or ML. There are no mentions of AI, ML, DNN, image processing, or training/test data sets typically associated with AI/ML devices.
Yes
The device is described as being used for "root canal cleaning" and uses ultrasonic vibration to "wash the root canal," which are therapeutic actions.
No
This device is described for "root canal cleaning" and uses ultrasonic vibration to "wash the root canal," indicating a therapeutic rather than a diagnostic function.
No
The device description explicitly lists hardware components such as a handpiece, sleeve, wrench, adapter, and tip, and describes the physical mechanism of ultrasonic vibration.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For root canal cleaning." This is a procedure performed directly on a patient's tooth, not on a sample taken from the body.
- Device Description: The description details a device that uses ultrasonic vibration to physically clean the root canal. This is a therapeutic or procedural device, not one used for diagnostic testing of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like 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. This device does not fit that definition.
N/A
Intended Use / Indications for Use
For root canal cleaning. The instrument must only be used in hospital environments, clinics or dental offices, by qualified practitioners.
Product codes
ELC
Device Description
The Endo Ultrasonic Activator is mainly used for root canal cleaning.It mainly contain handpiece, sleeve, wrench, adapter and tip. The ultrasonic frequency generated by the CPU is driven by the drive circuit to drive the piezoelectric ceramic transducer, using the reverse piezoelectric effect to produce the ultrasonic vibration, motivating the working tip to produce the resonance, and using the cavitation and sound flow effect generated by the ultrasonic vibration to wash the root canal swing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified practitioners in hospital environments, clinics or dental offices.
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ANSI/AAMI ES60601-1:2005 + A1, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
- IEC 80601-2-60:2019 Medical electrical equipment Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
- ISO 18397:2016 Dentistry-Powered scaler
- IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Specifically:
- Biocompatibility tests performed: Cytotoxicity (ISO 10993-5:2009) and Irritation and Skin Sensitization (ISO 10993-10:2010) on materials in direct contact with mucosal membrane, teeth, and skin.
- Sterilization validation testing performed in accordance with ISO 17665-1:2006. Reprocessing methods also meet FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
- Electrical safety testing per IEC 60601-1 and IEC 80601-2-60.
- Electromagnetic Compatibility testing per IEC 60601-1-2.
- Performance tests of functions verified according to ISO 18397:2016, demonstrating comparable performance (e.g., Operating frequency) to the predicate device.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 23, 2023
Foshan COXO Medical Instrument Co.,Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui. No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 CHINA
Re: K222096
Trade/Device Name: Endo Ultrasonic Activator Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: February 24, 2023 Received: February 24, 2023
Dear Ray Wang:
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 aware 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha -2
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222096
Device Name Endo Ultrasonic Activator
Indications for Use (Describe) For root canal cleaning. The instrument must only be used in hospital environments, clinics or dental offices, by qualified practitioners.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
-
- Date of Preparation:2023/02/24
-
- Sponsor Identification
Foshan COXO Medical Instrument Co., Ltd.
BLDG 4, District A, Guangdong New Light Source Industrial Base, South of Luocun Avenue, Nanhai District, Foshan, 528226 Guangdong, China
Contact Person: Yongjian Zheng Position: Legal Representative Tel: +86-13702544788 Fax: +86-0757-81800058 Email: 13702544788@163.com
- Designated Submission Correspondent 3.
Mr. Ray Wang
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
4
4. Identification of Proposed Device
Trade Name:Endo Ultrasonic Activator Common Name: Scaler,Ultrasonic
Regulatory Information Classification Name: Scaler,Ultrasonic Classification: 2 Product Code: ELC Regulation Number: 872.4850 Review Panel: Dental
Indication For Use Statement:
For root canal cleaning.
The instrument must only be used in hospital environments, clinics or dental offices, by qualified practitioners.
Device description:
The Endo Ultrasonic Activator is mainly used for root canal cleaning.It mainly contain handpiece, sleeve, wrench, adapter and tip. The ultrasonic frequency generated by the CPU is driven by the drive circuit to drive the piezoelectric ceramic transducer, using the reverse piezoelectric effect to produce the ultrasonic vibration, motivating the working tip to produce the resonance, and using the cavitation and sound flow effect generated by the ultrasonic vibration to wash the root canal swing.
న. Identification of Predicate Device(s)
Predicate Device 510(k) Number: K053555 Product Name: Ultrasonic Scaler(Model: UDS-L) Manufacturer: Guilin Woodpecker Medical Instrument Company, Limited
-
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
ANSI/AAMI ES60601-1:2005 + A1, Medical Electrical Equipment Part 1: General requirements > for basic safety and essential performance.
-
EC 60601-1-2:2014, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
-
IEC 80601-2-60:2019 Medical electrical equipment Part 2-60: Particular requirements for the >
5
basic safety and essential performance of dental equipment
-
ISO 18397:2016 Dentistry-Powered scaler
-
IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
-
ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Substantially Equivalent (SE) Comparison 8.
| Item | Proposed Device | Predicate Device
K053555
(Model:UDS-L) | Reference Device
K213947 | Remark |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Name | Endo Ultrasonic
Activator | Ultrasonic Scaler | Ultrasonic
Endo
Activation Device | / |
| Classification
Regulation | 872.4850 | 872.4850 | 872.4850 | SAME |
| Classification
Panel | Dental | Dental | Dental | SAME |
| Product Code | ELC | ELC | ELC | SAME |
| Common Name | Scaler,Ultrasonic | Scaler,Ultrasonic | Scaler,Ultrasonic | SAME |
| Indication
for
use | For root canal
cleaning.
The instrument
must only be
used in hospital
environments,
clinics or dental
offices, by
qualified
practitioners. | 1. Removing supra
and sub gingival
calculus deposits and
stains from the teeth
2. Periodontal pocket
lavage with
simultaneous
ultrasonic tip
movement
3. Preparing,cleaning
and irrigating root | The Ultrasonic Endo
Activation Device
(Model:Actor I pro ) is an
ultrasonic-handpiece
which is intended use for
root canal cleaning and
preparation.
The Ultrasonic Endo
Activation Device
(Model:Actor I pro ) is
intended for use by | SAME |
| | | canals
4. Retrograde
preparation of root
canals | trained dental
professionals in
professional health care
facilities on patients that
needroot-canal-treatment. | |
| Input | Adapter
AC100-240V
50/60Hz | Main Unit 24V 50Hz
1.3A | AC100-240V, 50/60Hz | Analysis(1) |
| Input Power | 10VA | 38VA | Not Available | Analysis(2) |
| Power supply | Battery 3.7V
1200mAh(Li-ion
Battery) | Power source 220V
50HZ | Rechargeable Li-ion
Battery Capacity
1600mAh,3.7V | Analysis(3) |
| Operating
frequency | 30kHz $\pm$ 10% | 28kHz $\pm$ 3kHz | 30 $\pm$ 3kHz(27-33 kHz) | Analysis(4) |
| Primary tip
vibration
excursion |