High Speed Air Turbine Handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations, root canal preparations and polishing teeth.

Device Description

The proposed devices, High Speed Air Turbine Handpiece, is a dental abrasive device that rotates at high speed air as the driving force. It has 11 models: G100, G200, G300, G400, G450, G500, G600, G700, G700L, G800 and G800L. The cooling system includes air/water spray or only water spray. The head types include standard head and miniature head. The angle of the head and shaft include 45℃ and 90°. High Speed Handpieces are able to run from 320,000rmp to 430,000rmp. G450, G700L and G800L have optic light guide for light function, other models don't have the optic light guide. Coupling is the accessory for the some models of the proposed handpiece to connect with tubes of dental unit.

AI/ML Overview

The provided text describes the regulatory clearance of a dental handpiece and references a non-clinical study to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and performance data for a device that typically accompanies a study proving the device meets those criteria, as one would expect for an AI/ML powered device.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was tested per ISO 14457:2017 Dentistry - Handpieces and motors and that "the test result demonstrated that the proposed device complies with the standard requirements." However, the specific acceptance criteria and the quantified reported device performance values are not provided in the text.

The text lists the following parameters that were evaluated, implying these are the areas where acceptance criteria from ISO 14457:2017 were applied:

Parameter Evaluated (Implied Acceptance Criteria from ISO 14457:2017)	Reported Device Performance (Not provided in the text)
Noise level @ Background noise level 56 dB(A)	"complies with the standard requirements"
Flow rate of air supply @ 400kPa	"complies with the standard requirements"
Flow rate of spray air @ 200kPa(2.0 bar)	"complies with the standard requirements"
Flow rate of water supply @ 200kPa(2.0 bar)	"complies with the standard requirements"
The force required to extract the test mandrels from the chuck system for Type 5 test mandrels	"complies with the standard requirements"
Torque @ Type 5 test mandrels	"complies with the standard requirements"
Speed of handpiece @ 0.22MPa	"complies with the standard requirements"
Dynamic eccentricity	"complies with the standard requirements"
Stall torque	"complies with the standard requirements"
The light at the output side of the handpiece (for models with optic light guide)	"complies with the standard requirements"

Missing Information: The specific numerical acceptance limits for each parameter as defined by ISO 14457:2017 and the actual measured performance values of the device for each of these parameters are not detailed in this document.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document mentions "the proposed device" was tested, implying at least one unit of each of the 11 models (G100, G200, G300, G400, G450, G500, G600, G700, G700L, G800, G800L). However, the specific number of units tested for each parameter is not disclosed.
Data Provenance: Not explicitly stated, but based on the applicant's address (Zhongshan, Guangdong, China), the testing was likely performed in China. The study is non-clinical performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as this is a non-clinical performance test for a mechanical dental device, not an AI/ML powered device requiring expert ground truth for interpretation. The "ground truth" for this device's performance comes from physical measurements against an international standard (ISO 14457:2017).

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3.

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

No, a MRMC comparative effectiveness study was not done. This is a clearance for a physical dental handpiece, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This is not an AI/ML software device.

7. The type of ground truth used

For this device, the "ground truth" is defined by the technical specifications and performance requirements outlined in the international standard ISO 14457:2017 Dentistry - Handpieces and motors. The device's performance is measured against these established engineering and safety standards.

8. The sample size for the training set

This information is not applicable as this is a physical device, not an AI/ML "algorithm" that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as this is a physical device, not an AI/ML "algorithm."

Summary

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April 30, 2024

Litu Tech Ltd. % Diana Hong General Manager Mid-Link Consulting Co. Ltd. P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K233122

Trade/Device Name: High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: March 29, 2024 Received: March 29, 2024

Dear Diana Hong:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).

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Sincerely,

Michael E. Adjodha -S

Michael Adjodha, MChE, RAC, 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

Device Name

High Speed Air Turbine Handpiece

(G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Prepared on: 2023-09-27

Contact Details

21 CFR 807.92(a)(1)

Applicant Name	Litu Tech Ltd.
Applicant Address	C1-2 No. 12 Denengxi Road Torch Zone, Zhongshan, Guangdong, ChinaGuangdong 528437 China
Applicant Contact Telephone	+86-760-8697442
Applicant Contact	Mr. Guangzhao Liu
Applicant Contact Email	info@litutechltd.com
Correspondent Name	Mid-Link Consulting Co., Ltd.
Correspondent Address	P.O. Box 120-119 Shanghai 200120 China
Correspondent Contact Telephone	86-21-2281-5850
Correspondent Contact	Diana Hong
Correspondent Contact Email	info@mid-link.net
Device Name21 CFR 807.92(a)(2)
Device Trade Name	High Speed Air Turbine Handpiece(G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
Common Name	Dental handpiece and accessories
Classification Name	Handpiece, Air-Powered, Dental
Regulation Number	872.4200
Product Code	EFB
Legally Marketed Predicate Devices21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K152146	High Speed Handpieces and Accessories	EFB
Device Description Summary		21 CFR 807.92(a)(4)

The proposed device has the following features

The cooling system includes air/water spray or only water spray. .

The head types include standard head and miniature head.

The angle of the head and shaft include 45℃ and 90°. In general, dentist usually uses 90° handpiece having teeth treatment. Except for wisdom teeth 45°handpieces is considered more desirable for wisdom teeth operation .It is because the 45° angle is more appropriate for the angle of eruption of wisdom teeth.

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High Speed Handpieces are able to run from 320,000rmp to 430,000rmp. G450, G700L and G800L have optic light guide for light function, other models don't have the optic light guide. Coupling is the accessory for the some models of the proposed handpiece to connect with tubes of dental unit. G500 and G600 require additional 4-hole coupling, and the 4-hole coupling is included in the product package. G450,G700, G800 and G800. require additional quick coupling is not included in the product package. The user shall purchase the compatible

Intended Use/Indications for Use

coupler for G450,G700, G700L, G800 and G800L.

High Speed Air Turbine Handpiece is intended for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Indications for Use Comparison

The proposed device and predicate device have the same indications for use.

Technological Comparison

The proposed device and predicate device have the same principles of operation, type of chuck, head angle. Both they have cooling system, and some models of them have the fiber optics. Regarding the technological characteristics, there are difference on Light intensity, Speed in rpms and Bur retention the performance test has conducted on the proposed device based on ISO 14457:2017, and the test result demonstrated that the proposed device complies with the standard requirements, the differences on technological characteristics do not affect the safety and effectiveness of the proposed device.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The proposed device, High Speed Air Turbine Handpiece, is tested per tISO 14457-2017 Dentistry - Handpieces and motors, to evaluate the handpiece's following particular performance. Noise level @ Background noise level 56 dB(A) Flow rate of air supply @ 400kPa Flow rate of spray air @ 200kPa(2.0 bar) Flow rate of water supply @200kPa(2.0 bar) The force required to extract the test mandrels from the chuck system for Type 5 test mandrels Torque @ Type 5 test mandrels Speed of handpiece @0.22MPa Dynamic eccentricity Stall torque The light at the output side of the handpiece

The clinical testing is not applicable.

The conclusions drawn from the nonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device K152146.

21 CFR 807.92(a)(6)

21 CFR 807 92(a)(5)

Regulation Number and Section

§ 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.