Evogue Dental Unit series are intended for the Dentists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.

Device Description

This product is an active therapeutic device intended to administer or exchange energy of electric, air and water for the exclusive use for diagnoses, treatments and relative procedures of dentistry, and its characteristic is not in a potentially hazardous way between such energy and human body, taking account of the nature, the density and site of application of the energy. The product must be operated or handled by the qualified dentists or by dental staffs under the supervision of the dentist. Such dentists or dental staffs should instruct and/or assist the patients to approach to and leave from the product. Patients should not be allowed to operate or handle the product unless he/she is so instructed. The air unit system uses compressed air to drive air motor and air scaler. The new Evogue Dental Unit is air unit system. The function and components used for Evogue Dental Unit are very similar to X-Calibur unit (Belmont Model 2000 Series, K000799). Though the Evogue Dental Unit is typical air system, it does have upgrade ability to use micro motor with external touch pad (MX2 Optima) and integrated type electric scaler (Cavitron). The foot control regulates drive air to the active handpiece to control the rotation speed of turbine and air motor. Also controls the frequency of air scaler. It provides an air signal that activates air coolant and water coolant flow. The foot control is equipped with a wet/dry toggle to turn the water coolant on or off.

AI/ML Overview

Here's an analysis of the provided text regarding the Evogue Dental Unit, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Based on the provided document, there is no study that proves the device meets specific performance acceptance criteria in the traditional sense of a clinical or analytical performance study.

The document is a 510(k) Premarket Notification, which primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device. This means the manufacturer is asserting their new device is as safe and effective as a legally marketed device and does not require a new Pre-Market Approval (PMA) process.

Instead of a study proving a device meets performance criteria, the document refers to performance standards applied, which are international standards (ISO and IEC) that the device should comply with or was tested against to ensure its safety and basic functionality.

Therefore, many of your requested points will either be "Not Applicable" or inferable from the context of a 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Applied Standards):

Criterion Category	Specific Standard/Requirement	Reported Device Performance (Implied Compliance)
Safety	IEC 60601-1-2 (Electromagnetic Compatibility): Requires that the device's electromagnetic emissions are limited and that it is immune to specified electromagnetic disturbances, ensuring no hazardous interaction in its operating environment.	The device is expected to meet the electromagnetic compatibility requirements of IEC 60601-1-2, ensuring it does not interfere with other devices and is not unduly affected by external electromagnetic fields.
	ISO 7405 (Biocompatibility): Specifies test methods for evaluating the biological effects of medical devices used in dentistry, ensuring the materials in contact with patients are not harmful.	The device's materials in contact with patients are expected to meet the biocompatibility standards outlined in ISO 7405, indicating they are not toxic or irritating.
Functionality	ISO 7494-1 (Dental units - General requirements and test methods): Specifies general requirements and test methods for dental units, covering aspects like design, construction, and basic operational features.	The device is expected to meet the general functional and structural requirements for dental units as specified in ISO 7494-1.
	ISO 7494-2 (Dental units - Water and air supply): Specifies requirements for materials, design, and construction of water and air supply within dental units, including provisions for preventing retraction of oral fluids into the water supply. It is important to note that the standard does not address prevention of contamination/proliferation of micro-organisms within the unit itself.	The device's water and air supply systems are expected to comply with ISO 7494-2, ensuring appropriate quality of compressed water and air and preventing backflow of oral fluids.
Interchangeability/ Compatibility	ISO 9168 (Hose connectors for air driven dental handpieces): Applicable for achieving reliable interchangeability between hoses from dental units and dental handpieces. Specifies four types of hose connectors.	The device's hose connectors for air-driven dental handpieces are expected to conform to ISO 9168, ensuring compatibility with standard dental handpieces.
	ISO 14457 (Handpieces and motors): Applicable to handpieces and motors used in dentistry for patient contact. Specifies requirements, test methods, manufacturer's information, marking, and packaging for various types of handpieces (straight, geared angle, high-speed air turbine, air motors, electrical motors, prophy handpieces).	While the dental unit itself, the handpieces and motors it uses are expected to comply with ISO 14457 for their design, performance, and interfacing requirements. (Note: The Evogue Dental Unit is the unit, not the handpieces, but it must be compatible with compliant handpieces).
Intended Use	"Evogue Dental Unit series are intended for the Dentists, Hygienists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory." This is the fundamental intended use for which substantial equivalence is being claimed.	The Evogue Dental Unit is designed and demonstrated to be suitable for its stated intended use, functioning adequately for general patient treatment procedures by dental professionals, similar to the predicate device.

Summary of Device Performance (from the 510(k) perspective):

The Evogue Dental Unit is represented as having the same intended use and technology characteristics as the predicate device (Belmont Unit, Model 2000 Series). The conclusion drawn by the manufacturer is that the "proposed device is substantially equivalent to the noted predicate," implying that its performance is comparable and acceptable for the given indication based on compliance with the listed performance standards and the comparison of features.

Detailed Answers to Your Specific Questions:

A table of acceptance criteria and the reported device performance:
- See the table above. The "acceptance criteria" here are the requirements outlined in the cited international standards (IEC 60601-1-2, ISO 7405, ISO 7494-1, ISO 7494-2, ISO 9168, ISO 14457) and the stated "intended use." The "reported device performance" is a general affirmation that the device meets these standards and functions equivalently to the predicate. Specific quantitative performance metrics are not provided in this summary.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable (N/A) / Not provided. This document does not describe a clinical or performance study with a "test set" in terms of patient data or a specific number of units tested to achieve a statistical outcome. The testing performed would have been against the cited engineering/material standards, typically involving a representative number of units or materials for compliance testing, but the specifics are not detailed in this 510(k) summary. The data provenance would be from internal testing by the manufacturer, likely in Japan (country of origin of Takara Belmont Corporation, LTD).
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):
- N/A. This is not a study requiring expert-established ground truth on diagnostic or clinical outcomes. The "ground truth" for the device's safety and effectiveness relies on its compliance with established engineering and biocompatibility standards, and its functional similarity to a predicate device. This typically involves engineers and quality control personnel.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods like 2+1 or 3+1 are used in clinical trials to resolve discrepancies in expert interpretations of medical data. This type of study was not conducted for this 510(k) submission.
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:
- N/A. This device (a dental operative unit) is not an AI-powered diagnostic tool, and no MRMC study was performed. The concept of "human readers improving with AI assistance" is entirely irrelevant to this device submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not involve an algorithm that performs tasks independently. It's a manual dental unit operated by humans (dentists, hygienists, assistants).
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this 510(k) submission is primarily based on:
  - Compliance with recognized international standards (engineering, electrical safety, biocompatibility, mechanical function). This is established through laboratory testing.
  - Demonstration of substantial equivalence to a predicate device. This is established through a feature-by-feature comparison and by confirming the new device shares the same fundamental technology and intended use as the predicate.
  - Manufacturer's internal testing and quality control data to ensure the device meets its design specifications and the applied standards.
The sample size for the training set:
- N/A. This device is not an AI/machine learning device that requires a "training set."
How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human face in profile, with three overlapping profiles suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the face, indicating the department's name and national affiliation.

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

January 22, 2016

Takara Belmont Corporation c/o Dr. Robert Schiff President 1120 Bloomfield Avenue, Suite 103 West Caldwell, New Jersey 07006

Re: K152100

Trade/Device Name: Evogue Dental Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: December 11, 2015 Received: December 15, 2015

Dear Dr. Schiff:

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.

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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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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.

Tina
Kiang -S

for Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

To be assigned K152100

Device Name

BELMONT, Evogue Dental Unit series

Indications for Use (Describe)

Evogue Dental Unit series are intended for the Dentists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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) Summarv (as required by 807.92)

(1) SUBMITTER: Takara Belmont Corporation, LTD. Address: 1-1-2 Chome, Higashi-Shinsaibashi, Chuo-ku Telephone: 81-6-6213-5945 Contact person: Toshinori Kiyomatsu Date prepared: July 2015

(2) DEVICE NAME: Unit, Operative Dental Trade Name: Evoque Dental Unit Common Name: Dental Unit Classification Name: Unit, Operative Dental Regulation Number: 872.6640
(3) PREDICATE DEVICE: Substantial equivalence is based on following legally marketed

K000799 Belmont Unit, Model 2000 Series (Approved 05/17/2000)

(4) DESCRIPTION OF THE DEVICE: This product is an active therapeutic device intended to administer or exchange energy of electric, air and water for the exclusive use for diagnoses, treatments and relative procedures of dentistry, and its characteristic is not in a potentially hazardous way between such energy and human body, taking account of the nature, the density and site of application of the energy.
The product must be operated or handled by the qualified dentists or by dental staffs under the supervision of the dentist.

Such dentists or dental staffs should instruct and/or assist the patients to approach to and leave from the product.

Patients should not be allowed to operate or handle the product unless he/she is so instructed.

The air unit system uses compressed air to drive air motor and air scaler. The new Evogue Dental Unit is air unit system. The function and components used for Evogue Dental Unit are very similar to X-Calibur unit (Belmont Model 2000 Series, K000799). Though the Evogue Dental Unit is typical air system, it does have upgrade ability to use micro motor with external touch pad (MX2 Optima) and integrated type electric scaler (Cavitron).

The foot control regulates drive air to the active handpiece to control the rotation speed of turbine and air motor. Also controls the frequency of air scaler.

It provides an air signal that activates air coolant and water coolant flow. The foot control is equipped with a wet/dry toggle to turn the water coolant on or off.

(5) INTENDED USE: Evogue Dental Unit series are intended for the Dentists, Hygienists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.

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510(k) Premarket Notification for Evogue Dental Unit Takara Belmont Corporation, Ltd.

(6) COMPARISON WITH PREDICATE DEVICES: Following table is a comparison of our new Evogue Dental Unit and predicate device Belmont Unit, Model 2000 Series.

Evogue Dental Unit (New model)	Belmont Model 2000 Series Dental Unit &Accessories (X-Calibur Unit)
Applying	K000799
Chair, Cabinet Mounting	Chair, Cabinet & Cart Mounting
IFU Statement: Evogue Dental Unit series areintended for the Dentists, Hygienists, and Dentalassistants for traditional and normal patienttreatment procedures in the dental operatory.***	IFU Statement: Evogue Dental Unit series areintended for the Dentists, Hygienists, and Dentalassistants for traditional and normal patienttreatment procedures in the dental operatory.The design function, and positioning of the unitand accessories are similar to most all otherdental units manufactured for this specificpurpose over the past twenty years
***PLEASE NOTE that the IFU's are similar in how they are used for traditional patient dentaltreatment; however, the IFU's for the predicate device provides a more descriptive comparisonto other traditional dental units. This detail does not affect the intended use of the device.
Autoclavbable H.V.E. & Saliva Ejectors arestandard	Autoclavbable H.V.E. & Saliva Ejectors arestandard
Foot Control is standard	Foot Control is standard
Utility Box with manual air & water shut-offvalves, pilot operated shut-off valves, regulators,gages, and air & water filters	Utility Box with manual air & water shut-offvalves, pilot operated shut-off valves, regulators,gages, and air & water filters
Three cutting handpieces and automaticcontrols are standard, up to five handpieces areoptional	Three cutting handpieces and automaticcontrols are standard, up to four handpieces areoptional
Non-retracting water system for handpieces andsyringes standard	Non-retracting water system for handpieces andsyringes standard
3-way syringe with quick disconnect tip andautoclavable tips standard. Asepsis tubingstandard	3-way syringe with quick disconnect tip andautoclavable tips standard. Asepsis tubingstandard
Aseptic baggable type instrument holdersstandard	Aseptic baggable type instrument holdersstandard
Cuspidor with cup filler is standard. Gravity drain	Cuspidor with cup filler is standard. Gravity drain
H.V.E. & Saliva ejector asepsis tubing withautoclavable instrument holders, standard withbrake-away safety feature	H.V.E. & Saliva ejector asepsis tubing withautoclavable instrument holders, standard withbrake-away safety feature

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(7) PERFORMANCE STANDARDS APPLIED:

IEC 60601-1-2, IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
ISO 7405 (Dentistry Evaluation of biocompatibility of medical devices used in dentistry, Second Edition 12/15/08),
ISO 7405:2008 specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
ISO 7405:2008 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
ISO 7494-1 (Dentistry Dental units Part 1: General requirements and test methods, Second Edition 8/15/11)
This part of ISO 7494 specifies requirements and test methods for dental units, regardless of whether or not they are electrically powered.
It also specifies requirements for the manufacturer's instructions, marking and packaging.

ISO 7494-2 (Dentistry - Dental units - Part 2: Water and air supply, First Edition 03/01/2003)

This part of ISO 7494 specifies requirements and test methods for materials, design and construction of the water and air supply within dental units in order to ensure that compressed water and air supplied via the dental unit are of appropriate quality. It includes provisions for the prevention of retraction of oral fluids into the water supply f the dental unit.
This part of ISO 7494 does not address prevention of contamination and/or proliferation of hazardous micro-organisms (for example bacteria, viruses) in the dental unit.
ISO 9168 (Dentistry Hose connectors for air driven dental handpieces, Third Version 07/15/2009)
ISO 9168:2009 is applicable for achieving reliable interchangeability between hoses from dental units and dental handpieces.
ISO 9168:2009 specifies four types of hose connector for use between air driven dental handpieces and the flexible hoses of the dental unit which supply the handpieces with water, air and light, and provide for exhaust.

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ISO 14457 (Dentistry Handpieces and motors, First Edition 09/15/2012)
ISO 14457:2012 is applicable to handpieces and motors used in dentistry for patient contact, regardless of their construction. It specifies requirements, test methods, manufacturer's information, marking and packaging.
ISO 14457:2012 is applicable to:
1. straight and geared angle handpieces, including handpiece attachments;
1. high-speed air turbine handpieces;
1. air motors
1. electrical motors
1. prophy handpieces
(8) CONCLUSION: The Evogue Dental Unit has the same intended use and technology characteristics as the predicate device Belmont Unit, Model 2000 Series. The proposed device is substantially equivalent to the noted predicate.

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.