(320 days)
No
The device description and performance studies focus on the mechanical and material properties of an ultrasonic insert for dental cleaning, with no mention of AI or ML technologies.
Yes
The device is used for dental cleaning and periodontal therapy to remove calculus from the teeth, which are therapeutic interventions.
No
The device is described as being used for dental cleaning and periodontal therapy to remove calculus from the teeth, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components (Tip, Magnetostrictive stack, O-rings, Grip sleeve, external water tube) and mentions hardware-based performance studies (ISO18397:2016, cleaning/sterilization validation, biocompatibility). It is an ultrasonic insert, which is a physical component of a larger ultrasonic scaler system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dental cleaning and periodontal(gum) therapy to remove calculus from the teeth." This is a physical procedure performed directly on the patient's teeth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is an "Ultrasonic Insert" used with an "Ultrasonic Scaler." It physically removes calculus using ultrasonic vibrations. This is a therapeutic and cleaning device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
To be used by dental professionals for dental cleaning and periodontal(gum) therapy to remove calculus from the teeth.
Product codes
ELC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth, periodontal (gum)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
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)
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.
No clinical testing was conducted for this submission.
Key results:
- materials contact with patients and users have passed the biocompatibility test.
- 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.
- the parameters of sterilization and drying have been validated through moist heat sterilization validation test which according to ISO 17665-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
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- 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
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.
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 Trade | |||
| Name | EVOCLEAN CLEANsert | ||
| Ultrasonic Insert | Hu-Friedy Satin Swivel | ||
| Ultrasonic Insert | |||
| 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 | To be used by dental | ||
| professionals for dental | |||
| cleaning and | |||
| periodontal(gum) therapy | |||
| to remove calculus from | |||
| the teeth. | To be used by dental | ||
| professionals for dental | |||
| cleaning and | |||
| periodontal(gum) therapy | |||
| to remove calculus from | |||
| the teeth. | Identical | ||
| Prescription/ | |||
| over-the-count | |||
| er use | Prescription use | Prescription use | Identical |
| Principle of | |||
| Operating | Inserts interact with | ||
| magnetostrictive | |||
| ultrasonic handpiece and | |||
| unit and operate in the | |||
| range of 25,000Hz / | |||
| 30,000Hz. | Inserts interact with | ||
| magnetostrictive | |||
| ultrasonic handpiece and | |||
| unit and operate in the | |||
| range of 25,000Hz / | |||
| 30,000Hz. | Identical | ||
| Material | Scaler Tip: Metal | ||
| Grip Sleeve: | |||
| Silicone, Resin, Metal | |||
| Magnetostrictive stack: | |||
| Nickel | --- | Analysis 1 | |
| Biocompatibili | |||
| ty | ISO 10993-5 | ||
| ISO 10993-10 | --- | ||
| Flow fluid | |||
| pathway | Internal / External | Internal | Analysis 2 |
| Subject Device | Predicate Device | Variations | |
| Sterilization | |||
| Status | Provided non-sterile | Provided non-sterile | Identical |
| Sterilization | Gravity Steam sterilize for | ||
| 30 minutes at | |||
| 250°F/121°C. | --- | Analysis 3 | |
| Drying | Recommend 30 minutes | ||
| dry time after sterilization | |||
| cycle. | --- | ||
| 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 | ||
| Performance | |||
| Testing | Supply of cooling liquid | ||
| Extraction force | |||
| Insertion force | |||
| Frequency 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.