EVOCLEAN CLEANsert Ultrasonic Insert is used with EVOCLEAN Ultrasonic Scaler that was cleared under K201317. It is used by dental professionals for dental cleaning and periodontal (gum) therapy to remove calculus from the teeth. EVOCLEAN CLEANsert Ultrasonic Inserts are available in three models (ELITE IF-50 Universal Slim, PRO IF-50 Universal Slim and CLASSIC P-10 Universal). Each model has two oscillating frequencies (25KHz and 30KHz), three different grip sleeves and two water supply methods (internal/external). EVOCLEAN CLEANsert Ultrasonic Insert consists of a Tip, a Magnetostrictive stack, an Inner O-ring, a Grip sleeve and an Outer O-ring. CLASSIC P-10 Universal has an external water tube.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: EVOCLEAN CLEANsert Ultrasonic Insert

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
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."
Indications for Use	To be used by dental professionals for dental cleaning and periodontal (gum) therapy to remove calculus from the teeth.
Prescription/OTC Use	Prescription use
Principle of Operating	Inserts interact with magnetostrictive ultrasonic handpiece and unit and operate in the range of 25,000Hz / 30,000Hz.
Material	Scaler Tip: Metal; Grip Sleeve: Silicone, Resin, Metal; Magnetostrictive stack: Nickel. (See "Analysis 1" for performance details.)
Biocompatibility	Passed biocompatibility tests: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10), Acute toxicity, and Pyrogenicity (as per ISO 10993-1 and relevant FDA Guidance).
Flow fluid pathway	Internal / External. (See "Analysis 2" for performance details.)
Sterilization Status	Provided non-sterile.
Sterilization	Gravity Steam sterilize for 30 minutes at 250°F/121°C. (Validated via moist heat sterilization validation test according to ISO 17665-1, as per "Analysis 3".)
Drying	Recommend 30 minutes dry time after sterilization cycle.
Treatment	Ultrasonic Scaling.
Mechanism of treatment	Application of an ultrasonic vibrating scaler tip to the teeth.
Performance Testing	Completed performance tests for Supply of cooling liquid, Extraction force, Insertion force, Frequency and Amplitude. (Passed, concluding differences do not raise safety or performance concerns, as per "Analysis 2" and verified according to ISO18397:2016.) Cleaning validation performed in accordance with AAMI TIR30 and FDA Reprocessing Guidance.

Study Details:

This submission (K210832) is a 510(k) Premarket Notification, which demonstrates substantial equivalence to a legally marketed predicate device (Hu-Friedy Satin Swivel Ultrasonic Insert, K012060). The bulk of the proof that the device meets acceptance criteria comes from non-clinical testing and a comparison of technical characteristics to the predicate device, rather than a traditional clinical study with human patients.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of human subjects or cases for AI. The "test sets" here refer to samples of the device and its components used for engineering, material, and sterilization validation. Specific quantities of inserts or materials tested in these non-clinical studies are not provided in the summary.
- Data Provenance: The tests were conducted by TTBIO CORP. or their contracted labs. The provenance is internal (Taiwan, where the company is located) and pertains to manufactured devices/materials, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of establishing ground truth for a diagnostic AI model. The "ground truth" here is defined by the technical standards (ISO, AAMI, FDA guidance) and the performance of the predicate device. Expert involvement would be in the form of engineers, material scientists, and microbiologists conducting and interpreting the non-clinical tests. Their specific numbers and qualifications are not detailed in this summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not a diagnostic imaging study or a clinical trial requiring human expert adjudication of cases. The "adjudication" is based on meeting predefined engineering specifications, material biocompatibility standards, and validation protocols outlined in recognized international standards.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done, as this device (an ultrasonic insert for dental scaling) does not involve AI assistance or human "readers" in the context of diagnostic interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not an AI algorithm. Its performance is evaluated through its physical characteristics, material safety, and functional capabilities.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is established by:
  - Industry Standards: ISO 18397:2016 (functions), ISO 10993-1, -5, -10 (biocompatibility), ISO 17665-1 (sterilization).
  - Regulatory Guidance: AAMI TIR30 and FDA Reprocessing Guidance (cleaning and sterilization validation).
  - Performance Equivalence: Demonstrating that the subject device's performance (e.g., flow of cooling liquid, extraction/insertion force, frequency, and amplitude) is comparable to or meets the requirements implied by the predicate device and safe clinical use.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI that would require a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

Summary

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February 2, 2022

TTBIO CORP. Shu-Hui Lin Assistant Engineering 2F, No.7, 6th Road, Industry Park Taichung, TAIWAN 40755 Taiwan

Re: K210832

Trade/Device Name: EVOCLEAN CLEANsert Ultrasonic Insert Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: December 30, 2021 Received: January 5, 2022

Dear Shu-Hui Lin:

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 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

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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.

For 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 Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K210832

Device Name

EVOCLEAN CLEANsert Ultrasonic insert

Indications for Use (Describe)

To be used by dental professionals for dental cleaning and periodontal(gum) therapy to remove calculus from the teeth.

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)

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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, followed by the word "BIO" in gray. The two "T" letters are connected at the top, forming a single shape.

TTBIO CORP. 2F, NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196

510(K) SUMMARY - K210832

EVOCLEAN CLEANsert Ultrasonic Insert

1. Submitter Information

510(k) Owner: TTBIO CORP.

2F, No.7, 6th Road, Industry Park, Taichung, Taiwan, R.O.C. 40755 Contact Person: Helen Hsu/Assistant Engineering Phone: 886-4-23595958 Email: helen@ttbio.com

1. Date Prepared: Jan 28, 2022

3. Device Name

Trade Name: EVOCLEAN CLEANsert Ultrasonic Insert Common Name: Ultrasonic Insert Classification Name: Ultrasonic Scaler (21 CFR 872.4850) Requlatory Class: II Product Code: ELC

4. Predicate Device

Satin Swivel Ultrasonic Insert made by Hu-Friedy Mfg. Co., Inc. (K012060)

5. Device Description

6. Indications for Use

To be used by dental professionals for dental cleaning and periodontal(gum) therapy to remove calculus from the teeth.

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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" letters, one in blue and the other in green, followed by the word "BIO" in gray. The two "T" letters are connected and form a single, visually striking design element.

TTBIO CORP. 2F, NO.7, 6* ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL:886-4-23595958 FAX:886-4-23594196

7. Substantial Equivalence

	Subject Device	Predicate Device	Variations
510 (k)Number	K210832	K012060	N/A
Device TradeName	EVOCLEAN CLEANsertUltrasonic Insert	Hu-Friedy Satin SwivelUltrasonic Insert
RegulationIntended Use	"For use during dentalcleaning and periodontal(gum) therapy to removecalculus deposits fromteeth by application of anultrasonic vibrating scalertip to the teeth."	"For use during dentalcleaning and periodontal(gum) therapy to removecalculus deposits fromteeth by application of anultrasonic vibrating scalertip to the teeth."	Identical
Indicationsfor use	To be used by dentalprofessionals for dentalcleaning andperiodontal(gum) therapyto remove calculus fromthe teeth.	To be used by dentalprofessionals for dentalcleaning andperiodontal(gum) therapyto remove calculus fromthe teeth.	Identical
Prescription/over-the-counter use	Prescription use	Prescription use	Identical
Principle ofOperating	Inserts interact withmagnetostrictiveultrasonic handpiece andunit and operate in therange of 25,000Hz /30,000Hz.	Inserts interact withmagnetostrictiveultrasonic handpiece andunit and operate in therange of 25,000Hz /30,000Hz.	Identical
Material	Scaler Tip: MetalGrip Sleeve:Silicone, Resin, MetalMagnetostrictive stack:Nickel	---	Analysis 1
Biocompatibility	ISO 10993-5ISO 10993-10	---
Flow fluidpathway	Internal / External	Internal	Analysis 2
	Subject Device	Predicate Device	Variations
SterilizationStatus	Provided non-sterile	Provided non-sterile	Identical
Sterilization	Gravity Steam sterilize for30 minutes at250°F/121°C.	---	Analysis 3
Drying	Recommend 30 minutesdry time after sterilizationcycle.	---
Treatment	Ultrasonic Scaling	Ultrasonic Scaling	Identical
Mechanismoftreatment	Application of anultrasonic vibrating scalertip to the teeth	Application of anultrasonic vibrating scalertip to the teeth	Identical
PerformanceTesting	Supply of cooling liquidExtraction forceInsertion forceFrequency and Amplitude	---	Identical

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Image /page/5/Picture/0 description: The image shows the TT BIO logo. 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.

TTBIO CORP. 2F, NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196

Analysis 1: materials contact with patients and users have passed the biocompatibility test.

Analysis 2: supply of cooling liquid, extraction force, insertion force, frequency and amplitude have passed the performance test which concludes these differences do not raise any safety or performance concerns.

Analysis 3: the parameters of sterilization and drying have been validated through moist heat sterilization validation test which according to ISO 17665-1.

EVOCLEAN CLEANsert Ultrasonic Insert is the same as the predicate device which is to be used by dental professionals for dental cleaning and periodontal(gum) therapy to remove calculus from the teeth. The proposed device is the same as the predicate device in indications for use, materials and technological characteristics. We performed applicable tests to support biocompatibility, including Cytotoxicity, Sensitization and Irritation. The differences do not raise additional questions regarding safety and effectiveness.

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Image /page/6/Picture/0 description: The image contains a logo with the letters "TT" in blue and green, followed by the word "BIO" in gray. The "TT" letters are stylized and connected, with the first "T" in blue and the second "T" in green. The word "BIO" is in a simple, sans-serif font and is positioned to the right of the "TT" letters. The logo appears to be for a biotechnology company or organization.

8. Non-clinical Testing

The functions of EVOCLEAN CLEANsert Ultrasonic Insert were verified according to ISO18397:2016.

Cleaning and sterilization validation testing is performed in accordance with recommended evaluations as listed in AAMI TIR30 and Guidance for Industry and FDA Reprocessing Guidance titled: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff."

The biocompatibility evaluation for EVOCLEAN CLEANsert Ultraonic Insert 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". The insert passed testing for cytotoxicity, sensitization, irritation testing, acute toxicity and pyrogenicity.

9. Clinical Testing

No clinical testing was conducted for this submission.

10.Conclusion

The differences between the proposed subject device and the predicates do not raise any different questions safety or effectiveness. We can conclude that EVOCLEAN CLEANsert Ultrasonic Insert can be considered substantially equivalent to the predicate.

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.