(200 days)
No reference devices were used in this submission.
No
The description mentions "automatically detect the insert oscillation frequency" and "search and locate the resonant frequency," which are standard signal processing techniques, not necessarily AI/ML. There is no mention of AI, ML, or related terms in the document.
Yes.
The device is used for dental cleaning and periodontal debridement of periodontal diseases, which are therapeutic procedures.
No
The device is described as an ultrasonic scaler for dental cleaning and periodontal debridement, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly lists hardware components such as an ultrasonic generator, handpiece, power supply, and foot pedal.
Based on the provided information, the TTBIO EVOCLEAN Ultrasonic Scaler is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "dental cleaning and periodontal debridement of periodontal diseases." This is a direct treatment procedure performed on a patient's teeth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a device that uses ultrasonic energy to mechanically remove deposits from teeth. This is a physical intervention, not a diagnostic test.
- 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 perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The TTBIO EVOCLEAN Ultrasonic Scaler is a therapeutic device used for a dental procedure.
N/A
Intended Use / Indications for Use
TTBIO EVOCLEAN Ultrasonic Scaler is designed for use during dental cleaning and periodontal debridement of periodontal diseases.
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
TTBIO EVOCLEAN Ultrasonic Scaler consists of an ultrasonic generator, a handpiece, a power supply, a foot pedal and other minor accessories. There are two models of TTBIO EVOCLEAN Ultrasonic Scaler, one is EVOCLEAN and the other is EVOCLEAN+. The specifications of these two models are almost the same; the major difference is the connection type, fix and plug in, between the handpiece and main unit. TTBIO EVOCLEAN Ultrasonic Scaler uses ultrasonic energy to generate mechanical micro-vibration of the available inserts to perform the dental procedures defined in its intended use. TTBIO EVOCLEAN Ultrasonic Scaler is a multi-frequency available device which is compatible with 25 KHz or 30 KHz inserts. The system will automatically detect the insert oscillation frequency, need not to operate it manually. The handpiece is connected directly to the device's ultrasonic generator, from which it receives the functional drive signals, search and locate the resonant frequency of the insert, which varies according to the insert in use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth (dental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professional in the field of general dentistry.
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 Testing:
The functions of TTBIO EVOCLEAN Ultrasonic Scaler were verified according to ISO18397:2016.
Cleaning validation testing is performed in accordance with recommended evaluations as listed in AAMI TIR30, AAMI TIR12, and Guidance for Industry and FDA Staff - Processing/Reprocessing Medical Devices in Health Care Settings.
The biocompatibility evaluation for TTBIO EVOCLEAN Ultrasonic Scaler was conducted in accordance with Guidance for Industry and FDA Staff - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". EMC and Electrical safety testing comply with IEC 60601-1-2:2014 and ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012.
Clinical Testing: No clinical testing was conducted for this submission.
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.
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.
No reference devices were used in this submission.
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
Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
December 4, 2020
Ttbio Corp. Shu-Ching Lee Section Chief 2F, NO.7, 6TH Road Industry Park Taichung, TAIWAN 40755 Taiwan
Re: K201317
Trade/Device Name: TTBIO EVOCLEAN Ultrasonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: November 23, 2020 Received: November 27, 2020
Dear Shu-Ching Lee:
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.
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
1
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 (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 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,
For Srinivas "Nandu" Nandkumar, Ph. D. Director DHT1B: Division of Dental 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)
K201317
Device Name TTBIO EVOCLEAN Ultrasonic Scaler
Indications for Use (Describe)
TTBIO EVOCLEAN Ultrasonic Scaler is designed for use during dental cleaning and periodontal debridement of periodontal diseases.
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)
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3
Image /page/3/Picture/0 description: The image shows the logo for "TT BIO". The logo consists of two stylized "T" letters, one in blue and the other in green, connected to each other. To the right of the "T" letters, the word "BIO" is written in gray, with each letter in a bold, sans-serif font.
510(K) SUMMARY FOR K201317
TTBIO EVOCLEAN Ultrasonic Scaler
1. Submitter Information
510(k) Owner: TTBIO CORP.
2F, No.7, 6th Road, Industry Park, Taichung, Taiwan, R.O.C. 40755
Contact Person: Shu-Ching Lee/Section Chief
Phone: 886-4-23595958
Email: jo@ttbio.com
-
- Date Prepared: November 23, 2020
3. Device Name
Trade Name: TTBIO EVOCLEAN Ultrasonic Scaler Common Name: Ultrasonic Scaler Classification Name: Ultrasonic Scaler (21 CFR 872.4850) Regulatory Class: II Product Code: ELC
4. Predicate Device
Primary predicate device: BONART ART-M3II Ultrasonic Scaler UNITS WITH ACCESSORIES made by BONART CO.LTD. (K052028) No reference devices were used in this submission.
5. Device Description
TTBIO EVOCLEAN Ultrasonic Scaler consists of an ultrasonic generator, a handpiece, a power supply, a foot pedal and other minor accessories. There are two models of TTBIO EVOCLEAN Ultrasonic Scaler, one is EVOCLEAN and the other is EVOCLEAN+. The specifications of these two models are almost the same; the major difference is the connection type, fix and plug in, between the handpiece and main unit. TTBIO EVOCLEAN Ultrasonic Scaler uses ultrasonic energy to generate mechanical micro-vibration of the available inserts to perform the dental procedures defined in its intended use. TTBIO EVOCLEAN Ultrasonic Scaler is a multi-frequency available device which is compatible with 25 KHz or 30 KHz inserts. The system will automatically detect the insert oscillation frequency, need not to operate it manually. The handpiece is connected directly to the device's ultrasonic generator, from which it receives the functional drive signals, search and locate the resonant frequency of the insert, which varies according to the insert in use.
4
Image /page/4/Picture/0 description: The image shows the logo for TT BIO. The logo consists of two stylized "T" shapes, one in blue and one in green, followed by the word "BIO" in gray. The "T" shapes are interconnected and have rounded edges, giving the logo a modern and sleek appearance. The overall design is simple yet eye-catching, with the use of contrasting colors adding visual interest.
6. Indications for Use
TTBIO EVOCLEAN Ultrasonic Scaler is designed for use during dental cleaning and periodontal debridement of periodontal diseases.
7. Substantial Equivalence
| Substantial Equivalence Comparison Table | ||||
|---|---|---|---|---|
| Proposed Device | Primary Predicate Device | Variations | ||
| 510 (k) Number | K201317 | K052028 | N/A | |
| Device Trade | ||||
| Name | TTBIO EVOCLEAN Ultrasonic Scaler | BONART ART-M3II Ultrasonic | ||
| scaler Unit with accessories | Analysis (1) | |||
| Regulation | ||||
| Intended Use | "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." | "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." | Identical | |||
| Indications for use | The device is designed for use during | |||
| dental cleaning and periodontal | ||||
| debridement of periodontal diseases. | Ultrasonic procedures: | |||
| -Removal of calculus and plaque | ||||
| during dental prophylaxis. | ||||
| -General supra and sub-gingival | ||||
| scaling applications. | ||||
| -Periodontal debridement for all | ||||
| types of periodontal diseases. | ||||
| -Endodontic procedures. | Similar | |||
| contraindications | -Do not use TTBIO EVOCLEAN | |||
| Ultrasonic Scaler for amalgam | ||||
| restorative dental procedures. | ||||
| -Do not use this device if the patient or | ||||
| operator is wearing a pacemaker. | -Do not use the BONART | |||
| ART-M3II for amalgam restorative | ||||
| dental procedures. | ||||
| -Do not use the BONART | ||||
| ART-M3II if the patient or operator | ||||
| is wearing a pacemaker. | Identical | |||
| Prescription/ | ||||
| over-the-counter | ||||
| use | Prescription use | Prescription use | Identical | |
| Components | -Main Unit | |||
| -Handpiece | ||||
| -Foot pedal | ||||
| -Power supply, AC power cord | ||||
| -Water supply line with quick | ||||
| disconnect | ||||
| -Directions For Use | -Main Unit | |||
| -Handpiece | ||||
| -Foot control / Foot switch | ||||
| -AC power cord set | ||||
| -PU water tubing, quick | ||||
| disconnect | ||||
| -User Manual | ||||
| -Inserts | Analysis (1) | |||
| Direct | ||||
| patient-contacting | ||||
| Material | No | Insert: Plastic, Metal | Analysis (1) | |
| Proposed Device | Primary Predicate Device | Variations | ||
| User Contact | ||||
| Material | Case : ABS and PC | Case : Ferrous cover | Analysis (2) | |
| Others : PA, TPU and PVC | Others : Unknown | |||
| Treatment | Ultrasonic Scaling | Ultrasonic Scaling | Identical | |
| Mechanism of | ||||
| treatment | application of an ultrasonic | |||
| vibrating scaler tip to the teeth | application of an ultrasonic | |||
| vibrating scaler tip to the teeth | Identical | |||
| Input Power | 100-240 VAC , 50/60 Hz | 115V±5% ~50/60Hz | Analysis (3) | |
| 230V±5% ~50/60Hz | ||||
| Power (Max) | 60 W | 92 VA | Analysis (3) | |
| Scaler tip | ||||
| frequency | 25 / 30 KHz | 25 / 30 KHz | Identical | |
| Water supply | ||||
| pressure | 25 to 40 psi (172 to 275 kPa) | 25 to 60 psi (172~414KPa) | Similar | |
| Weight | 4.4 lbs (2kg) | 3.5kg (include handpiece) | Analysis (4) | |
| Dimensions | 15cm(D)x12.5cm(W)x 8.5cm(H) | 26cm(L)x 18.5cm(W)/x 7cm(H) | Analysis (4) | |
| Handpiece Cable: 250cm | Handpiece Cable: 250cm | |||
| Foot Pedal Cable: 250cm | Footswitch Cable: 250cm | |||
| Operating Mode | Intermittent, Boost, Purge and Cruise | Continuous Operation | Analysis (5) | |
| Flow rate | ||||
| adjustment | Mechanical regulator | Mechanical regulator | Identical | |
| Housing | Stand alone device | Stand alone device | Identical |
Substantial Equivalence Comparison Table
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Image /page/5/Picture/0 description: The image shows the logo for "TT BIO". The logo consists of two stylized "T" letters, one in blue and the other in green, followed by the word "BIO" in gray. The "T" letters are connected and have a modern, curved design.
TTBIO CORP. 2F, NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196
TTBIO EVOCLEAN ultrasonic scaler is same with primary predicate device which intended for cleaning and periodontal therapy, and the device is only for operation by a trained professional in the field of general dentistry. The proposed device is essentially identical or similar to the primary predicate device in indications for use, principles of operation, energy source and technological characteristics. The minor differences are:
Analysis (1) The insert is not included in proposed device as its accessories.
Analysis (2) The material of proposed device is different from primary predicate device. However, the biocompatibility for proposed device has been evaluated, so no new issue of biocompatibility is raised with regard to the proposed devices.
Analysis (3) The electrical safety for proposed device has been tested and the test result is acceptable. This difference does not affect substantially equivalence.
Analysis (4) The proposed device has lighter weight and smaller size, these differences are negligible.
Analysis (5) The software validation report was provided to ensure these operating modes fulfills its intended purpose.
Based on performance testing methods and results, there is no significant difference in accordance with international standard ISO 18397:2016 (Dentistry - Powered scaler).
6
Image /page/6/Picture/0 description: The image shows the logo for TT BIO. The logo consists of two stylized "T" letters, one in blue and the other in green, followed by the word "BIO" in gray. The two "T" letters are connected at the top, forming a single shape. The logo is simple and modern, and the colors are bright and eye-catching.
8. Non-clinical Testing:
The functions of TTBIO EVOCLEAN Ultrasonic Scaler were verified according to ISO18397:2016.
Cleaning validation testing is performed in accordance with recommended evaluations as listed in AAMI TIR30, AAMI TIR12, and Guidance for Industry and FDA Staff -
Processing/Reprocessing Medical Devices in Health Care Settings.
The biocompatibility evaluation for TTBIO EVOCLEAN Ultrasonic Scaler was conducted in accordance with Guidance for Industry and FDA Staff - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". EMC and Electrical safety testing comply with IEC 60601-1-2:2014 and ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012.
9. Clinical Testing:
No clinical testing was conducted for this submission.
10. Conclusion:
TTBIO EVOCLEAN Ultrasonic Scaler, model EVOCLEAN and model EVOCLEAN+, is substantially equivalent to the primary predicate device. They are same as the primary predicate device in terms of its intended use, operating principles and functions.