The proposed device is intended to remove plaque and calculus in the areas of dental scaling, and for use in periodontics, endodontics and prosthetic by dental professionals.

Device Description

The prosed device is used by dental professionals for removal of dental plaque and calculus, and for cleaning in periodontics, endodontics and prosthetics.
To use the device, a hose from a dental unit that supplies the device with compressed air and water is attached to the back end of the device.
The compressed air is the energy source of the device to generate mechanical vibration. Water from the dental unit is used for cooling and cleaning the treatment site.
When compressed air enters inside of the vibrator in the device, it generates mechanical vibration at the working tip attached to the front end of the device. The working tip contacts teeth and in certain cases, gum of the patient.
The removal of plaque and calculus or cleaning is performed by utilizing the vibration. The device consists of the handpiece, connection to a hose and working tips.
The associated accessories include:

tips for removal of plaque and calculus
holder tips to attach endodontics files or tooth cleaning brushes
tooth cleaning brushes
tip replacement wrench
The proposed device and accessories are supplied non sterilized in an autoclave prior to the first use by the end-user.

AI/ML Overview

The Micron Corporation Y-MIC is an air-driven dental scaler for removing plaque and calculus. The provided document is a 510(k) premarket notification. The purpose of this notification is to demonstrate that the Y-MIC is substantially equivalent to a predicate device, the Sybron Dental Specialties, Inc. SONICflex 2003 (K080089).

The acceptance criteria for the Y-MIC are based on its substantial equivalence to the predicate device and compliance with general controls for medical devices. The study conducted to prove the device meets these criteria is a non-clinical performance and safety evaluation. The document explicitly states that no clinical tests were performed or needed because there were no changes in the indication for use compared to the predicate device.

Here's the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and passing specific non-clinical tests. The "reported device performance" reflects the results of these non-clinical tests.

Acceptance Criterion (Implicit)	Reported Device Performance
General Safety and Compliance with Applicable Standards	The device passed all compliance tests in accordance with elements of applicable international standards for medical devices categorized as dental air scalers. This included evaluation of basic safety requirements, risk management, biological evaluation, and reprocessing of medical devices.
Device Performance Features	The device passed all performance criteria for: - Frequency output (about 6,000 Hz, matching predicate) - Amplitude - Resistance to autoclave sterilization - Corrosion
Electrical Safety and Electromagnetic Compatibility (EMC)	Not applicable; the device is air-driven and not electric-powered, similar to the predicate device. Therefore, it is not subject to IEC 60601 standards, and no testing for electrical safety or EMC was performed.
Software Functionality	Not applicable; the device is not software-controlled and incorporates no software, similar to the predicate device. Therefore, there are no concerns about software.
Intended Use	The device is intended to remove plaque and calculus in areas of dental scaling, and for use in periodontics, endodontics, and prosthetics by dental professionals. This matches the intended use of the predicate device, supporting substantial equivalence.
Technological Characteristics	Operates utilizing the same principle as the predicate: vibration generated by compressed air supplied from a dental unit. - No use of electricity as an energy source. - Creation of mechanical vibration by utilizing compressed air. - Use of mechanical vibration to achieve treatment effect. - Frequency output of vibration about 6,000 Hz. - Working tips attached to the front end. - Connector located at the rear end to connect to the dental unit. - Handpiece design like dental handpieces. - No use of software to activate and/or control the devices. - Both supplied non-sterile.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document relates to non-clinical tests on the device itself (hardware), not clinical trials involving human subjects or data sets. Therefore, concepts like "test set sample size" in the context of patient data, data provenance (country of origin), or retrospective/prospective studies are not applicable. The tests were performed on the device prototypes/units in a laboratory setting. The submitting company is Micron Corporation, located in Japan, suggesting the testing likely occurred there or through a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable as there was no "test set" of patient data requiring expert ground truth establishment for a diagnostic or prognostic performance evaluation. The evaluation was a non-clinical assessment of the device's physical and functional performance against engineering standards and comparison to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as there was no "test set" of patient data requiring adjudication of expert interpretations.

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

This question is not applicable. The device is an ultrasonic scaler for dental cleaning and is not an AI-powered diagnostic or assistive tool for human readers/clinicians. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed.

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

This question is not applicable. The device is a physical dental instrument, not an algorithm. Standalone algorithm performance is irrelevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests was based on engineering specifications, performance standards, and comparison to the characteristics of the predicate device. For instance, the "ground truth" for frequency output was the specified approximate 6,000 Hz, verified by measurement. For sterilization resistance, it would be the device maintaining functionality after standard autoclave cycles. There was no biological "ground truth" like pathology or outcomes data in this submission as it was a non-clinical evaluation.

8. The sample size for the training set

This question is not applicable. There was no "training set" as this device is a physical instrument, not a machine learning algorithm.

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

This question is not applicable for the same reason as above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2016

Micron Corporation Takashi Terui Sales Department Section Manager 2-17-7 Ikegami Ota-ku, Tokyo, 146-0082 JAPAN

Re: K161639 Trade/Device Name: Y-MIC Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: June 10, 2016 Received: June 14, 2016

Dear Takashi Terui:

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. 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name Y-MIC

Indications for Use (Describe)

The proposed device is intended to remove plaque and calculus in the areas of dental scaling, and for use in periodontics, endodontics and prosthetic by dental professionals.

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 201.3 Subject D) Over-The-Counter Use (21 CFR 201.3 Subject C)	Prescription Use (Part 21 CFR 201.3 Subject D)	Over-The-Counter Use (21 CFR 201.3 Subject C)
Prescription Use (Part 21 CFR 201.3 Subject D)
Over-The-Counter Use (21 CFR 201.3 Subject C)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (2nd revision)

807.92(a) (1) Sponsor / Submitter

Company name: Micron Corporation Address: 2-17-7 Ikegami, Ota-ku, Tokyo, 146-0082 Country: Japan Phone: +81-3-3755-03964 Fax: +81-3-5747-5396 E-mail: office@micdent.com Contact Person: Takashi Terui (Mr.) Date Prepared: September 27, 2016 510(k) Number: K161639/S001

807.92(a) (2) DEVICE

Name of Device: Y-MIC Common or Usual Name: Dental air scaler Classification Name: Ultrasonic scaler (21 CFR 872.4850) Regulatory Class: II Product Code: ELC

807.92(a) (3) PREDICATE DEVICE

Sybron Dental Specialties, Inc. SONICflex 2003, K080089 No reference devices were used in this submission.

807.92(a) (4) DESCRIPTION OF DEVICE

The prosed device is used by dental professionals for removal of dental plaque and calculus, and for cleaning in periodontics, endodontics and prosthetics.

Both the predicate and the proposed devices are categorized in "Ultrasonic scaler" (FDA Product Code: ELC, Regulation No. 872.4850), but the both devices are not electric powered but air driven same as air-powered dental handpieces (FDA Product Code: EFB, Regulation No. 872.4200).

To use the device, a hose from a dental unit that supplies the device with compressed air and water is attached to the back end of the device.

携鐵顯孢克 1 / 4

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The compressed air is the energy source of the device to generate mechanical vibration. Water from the dental unit is used for cooling and cleaning the treatment site.

When compressed air enters inside of the vibrator in the device, it generates mechanical vibration at the working tip attached to the front end of the device. The working tip contacts teeth and in certain cases, gum of the patient.

The removal of plaque and calculus or cleaning is performed by utilizing the vibration. The device consists of the handpiece, connection to a hose and working tips.

The associated accessories include:

tips for removal of plaque and calculus
holder tips to attach endodontics files or tooth cleaning brushes
tooth cleaning brushes
tip replacement wrench

The proposed device and accessories are supplied non sterilized in an autoclave prior to the first use by the end-user.

807.92(a) (5) INTENDED USE

The proposed device is intended to remove plaque and calculus in the areas of dental scaling, and for use in periodontics, endodontics and prosthetic by dental professionals.

	Proposed device	Predicate device
Product name	Y-MIC	SONICflex 2003
510(k) number	K161639/A001	K080089
Manufacturer / submitter	Micron Corporation	Sybron Dental Specialties
Device type	Dental air scaler	Dental air scaler
Energy source	Compressed air supplied froma dental unit.	Compressed air supplied froma dental unit.
Design	Connects to hose of a dental units.	Connects to hose of a dental units.
Performance	Output frequency about 6,000 Hz.	Output frequency about 6,000 Hz.
Target population	Dental patients.	Dental patients.
Where used	Dental offices or clinics.	Dental offices or clinics.
Human factor	Used by trained dentalprofessionals.	Used by trained dentalprofessionals.
Sterile or non-sterile	Supplied non-sterile.	Supplied non-sterile.

807.92(a) (6) COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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Electrical safety and EMC	An air-driven device. N/A	An air-driven device but themodel with illumination maybe applicable.
Software	Not incorporated.	Not incorporated.

Vibration generated by compressed air supplied from a dental unit is the operating principle for both the proposed and predicate devices.

Both the proposed and predicate devices connect to the dental unit that supplies the devices with compressed air via the connectors at the rear end of the devices.

Dental treatment with the devices is performed by use of this vibration.

At a high level, the predicate and predicate devices are based on the same technological elements below:

Energy source compressed air supplied from a dental unit
No use of electricity as energy source
Creation of mechanical vibration by utilizing the compressed air
Use of the mechanical vibration to achieve the treatment effect
Frequency output of the vibration about 6,000 Hz
Working tips attached to the front end
Connector located at the rear end to connect to the dental unit
Handpiece design like dental handpieces
No use of software to activate and/or control the devices

However, though the predicate has a model with fiber optic illumination, the proposed device has not yet.

807.92(b) (1) NON CLINICAL TESTS

* General

The proposed device was evaluated in accordance with elements of applicable international standards for medical devices in which the proposed device is categorized (dental air scaler). Compliance tests included evaluation of basic safety and requirements, risk management, biological evaluation and reprocessing of medical devices. The device passed all of the compliance tests. Although the standards applied to the predicate are not known to the submitter, but because both the proposed and predicate devices are dental devices of the submitter believes the applicable standards to the predicate should be same as and common to those applicable to the proposed device at a high level.

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* Performance test

The proposed device was evaluated for device performance features including frequency output, amplitude, resistance to autoclave sterilization and corrosson. The device passed all of the performance criteria.

Electrical safety and electromagnetic compatibility (EMC)

The proposed device is not electric-powered but air-driven like the predicate device. It is not subject to the IEC 60601 standards and no testing for electrical safety or EMC according to these standards were performed.

* Software

The proposed device is not software controlled and incorporates no software like the predicate device. The proposed device has no concern about software.

807.92(b) (2) CLINICAL TESTS

Not applicable, no changes in indication for use.

807.92(b) (3) CONCLUSIONS

The proposed device is operated utilizing the same operating principle and used to the same intended use as the predicate device.

The non-clinical data support that the proposed device performs as intended and conforms to the applicable standards.

Thus the submitter believes the information submitted demonstrates that the proposed device is substantially equivalent to the predicate device.

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.