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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the TTBIO EVOCLEAN Ultrasonic Scaler. It does not contain information about an AI-powered device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details the substantial equivalence of an ultrasonic scaler to a predicate device, focusing on non-clinical performance and testing. Therefore, I cannot generate a response that includes acceptance criteria and a study proving an AI device meets those criteria based on the provided text.

Specifically, the document focuses on the following:

Device identification: TTBIO EVOCLEAN Ultrasonic Scaler (K201317)
Regulatory classification: Class II, Product Code ELC
Intended Use: Dental cleaning and periodontal debridement.
Comparison to predicate device (BONART ART-M3II Ultrasonic Scaler UNITS WITH ACCESSORIES, K052028): Demonstrates substantial equivalence through detailed comparisons of indications for use, contraindications, components, materials, treatment mechanism, power, frequency, etc.
Non-clinical testing: Refers to testing according to ISO18397:2016, cleaning validation, biocompatibility evaluation (ISO 10993-1), software verification/validation, and electrical safety/EMC testing (IEC 60601-1-2:2014 and ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012).
Absence of clinical testing: Explicitly states "No clinical testing was conducted for this submission."

Since the request is about acceptance criteria and a study for an AI device and the provided text is for an ultrasonic scaler with no AI component, I cannot fulfill the request directly.

Summary

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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

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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

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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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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

1. 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

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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 TradeName	TTBIO EVOCLEAN Ultrasonic Scaler	BONART ART-M3II Ultrasonicscaler Unit with accessories	Analysis (1)
RegulationIntended Use	"for use during dental cleaning andperiodontal (gum) therapy to removecalculus deposits from teeth byapplication of an ultrasonic vibratingscaler tip to the teeth."	"for use during dental cleaningand periodontal (gum) therapy toremove calculus deposits fromteeth by application of anultrasonic vibrating scaler tip tothe teeth."	Identical
Indications for use	The device is designed for use duringdental cleaning and periodontaldebridement of periodontal diseases.	Ultrasonic procedures:-Removal of calculus and plaqueduring dental prophylaxis.-General supra and sub-gingivalscaling applications.-Periodontal debridement for alltypes of periodontal diseases.-Endodontic procedures.	Similar
contraindications	-Do not use TTBIO EVOCLEANUltrasonic Scaler for amalgamrestorative dental procedures.-Do not use this device if the patient oroperator is wearing a pacemaker.	-Do not use the BONARTART-M3II for amalgam restorativedental procedures.-Do not use the BONARTART-M3II if the patient or operatoris wearing a pacemaker.	Identical
	Prescription/over-the-counteruse	Prescription use	Prescription use	Identical
Components	-Main Unit-Handpiece-Foot pedal-Power supply, AC power cord-Water supply line with quickdisconnect-Directions For Use	-Main Unit-Handpiece-Foot control / Foot switch-AC power cord set-PU water tubing, quickdisconnect-User Manual-Inserts	Analysis (1)
	Directpatient-contactingMaterial	No	Insert: Plastic, Metal	Analysis (1)
		Proposed Device	Primary Predicate Device	Variations
	User ContactMaterial	Case : ABS and PC	Case : Ferrous cover	Analysis (2)
		Others : PA, TPU and PVC	Others : Unknown
	Treatment	Ultrasonic Scaling	Ultrasonic Scaling	Identical
Mechanism oftreatment	application of an ultrasonicvibrating scaler tip to the teeth	application of an ultrasonicvibrating 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 tipfrequency	25 / 30 KHz	25 / 30 KHz	Identical
Water supplypressure	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 rateadjustment	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).

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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.

Regulation Number and Section

§ 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.