(26 days)
The EVO 700 series High Speed Handpieces are designed for removing carious material, reducing hard tooth structure, cavity preparation and finishing tooth preparations/ restorations. The devices are only for dental handpieces treatment and used by a trained person in the field of dentistry.
EVO 700 series high speed handpiece, on the scope of 21 CFR 872.4200 Dental handpiece and accessories, product code EFB, is a modification from TTBIO's own legally market predicate device, EVO 500 series high speed handpiece, which is legally marketed on the US dental market per 510(k) clearance, No. K141183.
EVO 700 series high speed handpiece is air-powered dental handpiece that is reusable and ergonomically designed. The handpiece is connected to a dental tubing which delivers driving air, cooling air and water to the cutting bur area. Optional fiber optics deliver light to the cutting area.
This device is to be connected to dental unit and operated by qualified professional (dentist) in the clinic. EVO 700 series high speed handpiece can be connected to couplings that manufactured by TTBIO, KaVo® or NSK®. It is designed in accordance with FDA Recognized Consensus Standards of device-specific guidance document, ISO 14457:2017 Dentistry - Handpieces and motors to ensure its safety and effectiveness and follows ISO 13485:2016 Medical devices – Quality management systems – Requirements for requlatory purpose regarding to the internal design change control procedure to complete the device design steps.
EVO 700 series high speed handpiece is supplied as non-sterile and can be sterilized by gravity-displacement method, at 132°C for 15 minutes and drying for 30 minutes, and dynamic-air-removal (prevacuum) method, at 134°C for 4 minutes and drying for 15 minutes.
The provided text is a 510(k) summary for the EVO 700 series High Speed Handpiece. This document is a premarket notification for a medical device seeking substantial equivalence to a predicate device, not a report of a study proving the device meets specific performance acceptance criteria through clinical trials or comprehensive algorithmic validation studies.
The document primarily focuses on demonstrating that the new device (EVO 700 series) is substantially equivalent to a previously cleared predicate device (EVO 500 series) based on similar indications for use, principle of operation, and technological characteristics.
Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details for AI/ML validation studies is not present in this document. This document is for a Class I dental handpiece, which typically does not require extensive clinical or AI/ML performance studies for 510(k) clearance, especially when demonstrating substantial equivalence to an existing predicate.
The "study" referenced in the document is effectively the comparison of the new device to the predicate device and verification that it meets relevant consensus standards (ISO 14457:2017, ISO 9168:2009, ISO 14971:2019, ISO 10993-1:2018).
Here's a breakdown of what is available and why the requested information is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied): The acceptance criteria are implicitly that the EVO 700 series handpiece's characteristics (e.g., rotation speed, drive air pressure, bur retention force) are either identical or appropriately justified as similar to the predicate device and comply with relevant international standards (ISO 14457:2017).
- Reported Device Performance: The table on page 4-5 compares the subject device (EVO 700 series) to the predicate device (EVO 500 series) across various technical specifications. There are no performance metrics reported in terms of clinical outcomes or diagnostic accuracy, as this is a mechanical dental tool.
- Example from the document's comparison table (page 4-5):
Characteristic Acceptance Criteria (Predicate) Reported Performance (Subject Device) Rotation speed (rpm) T≥300,000, M≥350,000 T: 300,000 360,000, M: 350,000430,000Drive air pressure (bar) 2.6~3.0 2.6~3.0 Bur retention force Up to 24 N-cm Up to 24 N-cm Device standard ISO 14457:2012, ISO 9168:2009 ISO 14457:2017, ISO 9168:2009
- Example from the document's comparison table (page 4-5):
2. Sample size used for the test set and the data provenance
- Not applicable/Not provided. This is a comparison of device specifications and compliance with standards, not a clinical study or AI/ML performance test on a specific dataset. "Test set" in the context of AI/ML validation studies is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No "ground truth" to establish in the AI/ML sense. The "truth" is established by engineering specifications and compliance with recognized standards.
4. Adjudication method for the test set
- Not applicable/Not provided.
5. 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
- Not applicable. This is a mechanical device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML sense. The "ground truth" for this device's safety and effectiveness is established through adherence to engineering standards (ISO 14457:2017, ISO 9168:2009) and the results of specific tests for biocompatibility (ISO 10993-1:2018) and risk management (ISO 14971:2019).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
Summary of what the document does describe as its "study":
The study to prove the device meets acceptance criteria is primarily a comparison and verification study based on engineering standards and design control activities.
- Comparison to Predicate: The document explicitly compares the EVO 700 series to the predicate EVO 500 series across numerous parameters (indications for use, principle of operation, rotation speed, pressures, bur dimensions, etc.).
- Compliance with Standards:
- ISO 14457:2017 Dentistry - Handpieces and motors: The device's design and performance are stated to be in accordance with this standard to ensure safety and effectiveness. The document addresses manufacturing tolerances for rotation speed as per the standard (Analysis 2).
- ISO 9168:2009: Also cited as a standard the device complies with.
- ISO 13485:2016 Medical devices – Quality management systems: Followed for internal design change control.
- ISO 14971:2019 Medical devices - Application of risk management to medical devices: Used for identifying and evaluating risks through Failure Modes and Effects Analysis (FMEA).
- ISO 10993-1:2018 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process: Used to confirm biocompatibility of materials (specifically PEEK).
- Sterilization Validation: The document mentions the specified sterilization parameters (gravity-displacement and dynamic-air-removal methods) imply that these parameters have been validated to ensure the device can be properly sterilized for reuse.
In essence, for this Class I medical device, "acceptance criteria" are met by demonstrating substantial equivalence to a cleared predicate and compliance with relevant, recognized international consensus standards for safety and performance of dental handpieces. No clinical trial or AI/ML validation study, as detailed in your prompt, was conducted or required for this type of device clearance.
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August 23, 2023
Ttbio Corp. Siow Woon Chyi Regulatory Affairs Coordinator 2F., No.7, 6th Road Industry Park Taichung. Taiwan 40755 China
Re: K232243
Trade/Device Name: EVO 700 series high speed handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: July 28, 2023 Received: July 28, 2023
Dear Siow Woon Chyi:
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
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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,
Bobak Shirmohamma વા -ડ
For Michael E.Adjodha, M.ChE.,CQIA 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
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Indications for Use
510(k) Number (if known) K232243
Device Name EVO 700 series high speed handpiece
Indications for Use (Describe)
The EVO 700 series High Speed Handpieces are designed for removing carious material, reducing hard tooth structure, cavity preparation and finishing tooth preparations. The devices are only for dental handpieces treatment and used by a trained person in the field of dentistry.
| 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 one in green, followed by the word "BIO" in gray. The letters are large and bold, and the word "BIO" is smaller and to the right of the letters. The logo is simple and modern, and the colors are bright and eye-catching.
TTBIO CORP. 2F., NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196
K232243 510(k) Summary
EVO 700 series High Speed Handpiece
1. General Information
| 510(k) Owner | TTBIO CORP. (Registration No.: 3010364969) |
|---|---|
| Address | 2F., No.7, 6th Road, Industry Park, Taichung,Taiwan R.O.C. 40755. |
| Applicant | Woon Chyi, Siow/Regulatory Affairs Coordinator |
| Contact Information | Phone: 886-4-2359 5958 Ext. 731Email: siowwoonchyi@ttbio.com |
| Date prepared | July 28, 2023 |
2. Subject Device
| Proprietary Name | EVO 700 series High Speed Handpiece |
|---|---|
| Regulation Number | 21 CFR 872.4200 |
| Regulation Name | Dental handpiece and accessories |
| Regulatory Class | Class I |
| Product Code | EFB |
| Common Name | Handpiece |
3. Predicate Device
| Proprietary Name | EVO 500 series High Speed Handpiece |
|---|---|
| Premarket Notification | K141183 |
| Regulation Number | 21 CFR 872.4200 |
| Regulation Name | Dental handpiece and accessories |
| Regulatory Class | Class I |
| Product Code | EFB |
| Common Name | Handpiece |
4. Device Description
EVO 700 series high speed handpiece, on the scope of 21 CFR 872.4200 Dental handpiece and accessories, product code EFB, is a modification from TTBIO's own legally market predicate device, EVO 500 series high speed handpiece, which is legally marketed on the US dental market per 510(k) clearance, No. K141183.
EVO 700 series high speed handpiece is air-powered dental handpiece that is reusable and ergonomically designed. The handpiece is connected to a dental tubing which delivers driving air, cooling air and water to the cutting bur area. Optional fiber optics deliver light to the cutting area.
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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 the other in green, followed by the word "BIO" in gray. The "T" shapes are connected at the top, forming a continuous design element.
TTBIO CORP 2F., NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL:886-4-23595958 FAX:886-4-23594196
This device is to be connected to dental unit and operated by qualified professional (dentist) in the clinic. EVO 700 series high speed handpiece can be connected to couplings that manufactured by TTBIO, KaVo® or NSK®. It is designed in accordance with FDA Recognized Consensus Standards of devicespecific guidance document, ISO 14457:2017 Dentistry - Handpieces and motors to ensure its safety and effectiveness and follows ISO 13485:2016 Medical devices – Quality management systems – Requirements for requlatory purpose regarding to the internal design change control procedure to complete the device design steps.
EVO 700 series high speed handpiece is supplied as non-sterile and can be sterilized by gravity-displacement method, at 132°C for 15 minutes and drying for 30 minutes, and dynamic-air-removal (prevacuum) method, at 134°C for 4 minutes and drying for 15 minutes.
5. Indications for Use:
The EVO 700 series high speed handpieces are designed for removing carious material, reducing hard tooth structure, cavity preparation and finishing tooth preparations/ restorations. The devices are only for dental handpieces treatment and used by a trained person in the field of dentistry .
6. Substantial Equivalence
Table below provides a comparison of the indications for use and key technological characteristics of EVO 700 series with that of the Primary Predicate, EVO 500 series high speed handpiece (K141183).
| Model | Subject Device | Predicate Device | Comparison(Same/Similar/Different) |
|---|---|---|---|
| ParticularIntendeduse definedunder 21CFR872.4200 | TTBIO EVO 700 seriesHigh speed handpiece | TTBIO EVO 500 seriesHigh speed handpiece | Same |
| Intended | Intended to preparedental cavities for | Intended to preparedental cavities for | |
| use defined | restorations, such as | restorations, such as | |
| under 21 | fillings, and for | fillings, and for | |
| CFR | cleaning teeth. | cleaning teeth. | |
| 872.4200 | |||
| Indicationsfor use | The EVO 700 seriesHigh Speed | The EVO 500 seriesHigh Speed | Same |
| for use | Handpieces are | Handpieces are | |
| designed for removing | designed for removing | ||
| carious material, | carious material, | ||
| reducing hard tooth | reducing hard tooth | ||
| structure, cavity | structure, cavity | ||
| preparation and | preparation and | ||
| finishing toothpreparations/restorations. Thedevices are only fordental handpiecestreatment and used bya trained person in thefield of dentistry. | finishing toothpreparations/restorations. Thedevices are only fordental handpiecestreatment and used bya trained person in thefield of dentistry. | ||
| Principle ofoperation | The handpiece isconnected to a dentaltubing which deliversdriving air, cooling airand water to thecutting bur area.Optional fiber opticsdeliver light to thecutting area. | The handpiece isconnected to a dentaltubing which deliversdriving air, cooling airand water to thecutting bur area.Optional fiber opticsdeliver light to thecutting area. | Same |
| Devicestandard | ISO 14457:2017ISO 9168:2009 | ISO 14457:2012ISO 9168:2009 | Similar(Analysis 1) |
| Rotationspeed(rpm) | T: 300,000 | T≥300,000M≥350,000 | Similar(Analysis 2) |
| Chucksystem | Push button | Push button | Same |
| Coolingspray | Multi-spray | Multi-spray | Same |
| Burdiameter(mm) | Ø1.59~1.60 | Ø1.59~1.60 | Same |
| Bur length(mm) | T: 19 | T: 19 | Same |
| Drive airpressure(bar) | 2.6~3.0 | 2.6~3.0 | Same |
| Waterpressure(bar) | 0.8~2.0 | 0.8~2.0 | Same |
| Chip airpressure(bar) | 1.0~3.0 | 1.0~3.0 | Same |
| Head size(mm) | T: Ø12.2×H13.55M: Ø10.5×H12.4 | T: Ø12.2×H13.55M: Ø10.5×H12.4 | Same |
| Lightsystem | With or without glassrod | With or without glassrod | Same |
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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 logo is simple and modern, and the colors are bright and eye-catching.
TTBIO CORP.
2F., NO.7, 6吨 ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL:886-4-23595958 FAX:886-4-23594196
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Image /page/6/Picture/0 description: The image shows the logo for TR Bio. The logo consists of two stylized "T" shapes, one in blue and one in green, connected to the word "BIO" in gray. The logo is simple and modern, with a clean design.
TTBIO CORP. 2F., NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196
| Materials of body | Light intensity | Bur retention force | |
|---|---|---|---|
| Stainless steel | Approx. 25000 Lux | Up to 24 N-cm | |
| Stainless steel | Approx. 25000 Lux | Up to 24 N-cm | |
| Same | Same | Same |
Substantial Equivalence Discussion
Analysis 1:
The dental handpieces are designed according to FDA recognized consensus standard of device-specific guidance document for dental handpiece, ISO 14457:2017. The update of the guidance or standards did not revise or amend the significant characteristics applicable to EVO 700 series and EVO 500 series high speed handpiece. Therefore, this different technological characteristic does not raise different questions of safety and effectiveness.
Analysis 2:
The FDA recognized consensus standard of device-specific guidance document for dental handpiece, ISO 14457:2017 defines requirement on rotation speed for dental handpiece. According to the standard, the free-running speed of the handpieces shall be within ±10% of that specified in the manufacturer's directions for use, and the given range for rotation speed of EVO 700 series high speed handpiece is within the tolerance of the speed stated on directions for use. Therefore, this different technological characteristic does not raise different questions of safety and effectiveness.
Conclusion
According to the discussion above, the indications for use of subject device, EVO 700 series high speed handpiece is same as predicate device, EVO 500 series high speed handpiece, are identical in the Intended use, Indications for use, Principle of operation, most of the device specifications, and similar, as on the above analysis 1 and 2, in rotation speed (rpm) and complied standards due to the reversion; and, the other differences in nonsignificant characteristics are clarified, the substantial equivalent is claimed. Since the differences of the devices do not raise different questions of safety and effectiveness, EVO 700 series is as safe and effective as legally marketed EVO 500 series.
7. Design Control Activities
The risks arisen from the design modifications activities have been identified and evaluated while controlled through a failure modes and effects analysis
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Image /page/7/Picture/0 description: The image shows the logo for "T2 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 connected at the top, forming a unique design element.
TTBIO CORP. 2F., NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL:886-4-23595958 FAX : 886-4-23594196
(FMEA) that described in FDA-recognized consensus standard, ISO 14971:2019 Medical devices - Application of risk management to medical devices. The safety and effectiveness of EVO 700 series high speed handpiece are also verified and validated according to device-specific, FDA-recognized consensus standard, ISO 14457:2017 Dentistry - Handpieces and motors. The biocompatibility concerns of new material (PEEK) are confirmed by tests determined in ISO 10993-1:2018 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process.
8. Conclusion
Based on the information provided in this premarket notification, the same indications for use with small modifications, EVO 700 series high speed handpiece does not raise different questions of safety and effectiveness and is substantially equivalent to predicate device in terms of safety, effectiveness, and performance.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.