The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to drive the COMFORT drive motor handpiece and the INTRA LUX KL 703 LED motor for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry

Device Description

The ELECTROmatic dental control unit is a stand-alone system for operating electrically-driven KaVo handpieces. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip /cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at the location preferred by the dentist. The ELECTROmatic system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "ELECTROmatic." This document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a study demonstrating the device meets specific acceptance criteria in the way a novel AI or diagnostic device might.

The ELECTROmatic is a dental control unit, and the "acceptance criteria" discussed are largely related to meeting established industry standards for safety and performance, as well as demonstrating that its technological characteristics do not raise new concerns compared to the predicate device.

Here's an analysis based on your requested information, acknowledging that many of the points you asked for are not applicable to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (a dental control unit), acceptance criteria are primarily defined by compliance with recognized international and national standards for medical electrical equipment, dental instruments, and biocompatibility. The document states that performance bench testing was conducted to demonstrate conformance to these standards.

Acceptance Criterion (Standard Compliance)	Reported Device Performance
ISO 9168:2009 (Dentistry – Hose connectors for air-driven dental handpieces)	Performance bench testing conducted to determine conformance. (Implicit: Device meets requirements)
ISO 14457:2012 (Dentistry – Handpieces and motors)	Performance bench testing conducted to determine conformance. (Implicit: Device meets requirements)
IEC 60601-1:2005 (Medical electrical equipment – General requirements for basic safety and essential performance)	Performance bench testing conducted to determine conformance (IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)). (Implicit: Device meets safety and essential performance requirements)
IEC 60601-1-2:2007 (Medical electrical equipment – Electromagnetic compatibility)	Performance bench testing conducted to determine conformance (IEC 60601-1-2:2007 / EN 60601-1-2:2007). (Implicit: Device meets EMC requirements)
ANSI/AAMI ES60601-1:2005/A2:2010 (Medical electrical equipment – General requirements for basic safety and essential performance)	Performance bench testing conducted to determine conformance. (Implicit: Device meets safety and essential performance requirements)
IEC 62304:2006 (Medical device software – Software life cycle processes)	Performance bench testing conducted to determine conformance (IEC 62304:2006 -First edition). (Implicit: Software development followed recognized life cycle processes, ensuring safety and performance)
ISO 7405:2008 & ISO 10993-1:2009 (Biocompatibility of medical devices)	Biocompatibility studies completed for the applicable components. (Implicit: Materials are biocompatible)
Sterilization Studies (for applicable components)	Sterilization studies completed for the applicable components. (Implicit: Applicable components can be effectively sterilized)
Substantial Equivalence (General)	The performance tests demonstrate that the differences in technological characteristics do not raise different concerns regarding substantial equivalence to the predicate device. The device satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: (1) Indications for Use, (2) Technological Characteristics and (3) Performance Data. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantially equivalent.

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

This document describes a premarket notification for a medical device that converts pneumatic output to electrical energy to drive dental handpieces. It is not a study involving patient data or a test set in the context of clinical performance of a diagnostic or AI device.

Test Set Sample Size: Not applicable. The "tests" described are bench tests against engineering standards, not tests on a dataset of patient samples.
Data Provenance: Not applicable. The "data" involves engineering measurements and compliance with standards.

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

Not applicable. There is no "ground truth" in the clinical sense being established by experts for a test set in this 510(k) submission. The design and performance verification are conducted by engineers and specialists in accordance with specified standards.

4. Adjudication method for the test set

Not applicable. There is no multi-reader or adjudication process for interpreting results in this submission. Compliance is determined through objective measurements against engineering and safety standards.

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 device is a dental control unit, not an AI diagnostic tool or system that assists human readers. No MRMC study was conducted.

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

Not applicable. This is not an algorithm-only device. It's a hardware device with embedded software for controlling motor functions. Its "performance" refers to its ability to meet engineering specifications and safety standards, not a diagnostic output.

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

Not applicable in the clinical sense. The "ground truth" for this device's performance evaluation is its adherence to the specified technical and safety standards (e.g., ISO, IEC, ANSI/AAMI) through bench testing. The device is expected to operate within defined electrical, mechanical, and safety parameters, which are objectively measurable.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The software mentioned controls motor functions based on deterministic algorithms, not learned patterns from data.

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

Not applicable. As there is no training set for a machine learning model, no ground truth needed to be established in this context. The software's functionality is designed based on known physics and engineering principles, not derived from labeled data.

In summary:

The ELECTROmatic is a Class I dental control unit that demonstrated substantial equivalence to a predicate device by showing compliance with a range of recognized international and national standards for medical electrical equipment, dental instruments, software lifecycle processes, and biocompatibility through non-clinical bench testing. The evaluation focused on engineering performance and safety compliance, rather than clinical performance based on patient data or the development of a diagnostic AI algorithm.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on health and human well-being.

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

February 21, 2017

Kaltenbach & Voigt GmbH Stefan Trampler Director Regulatory Affairs Bismarckring 39 88400 Biberach Germany

Re: K163317

Trade/Device Name: ELECTROmatic Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EBW Dated: November 22, 2016 Received: November 23, 2016

Dear Stefan Trampler:

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.

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) K163317

Device Name ELECTROmatic

Indications for Use (Describe)

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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FORM FDA 3881 (8/14)

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Image /page/3/Picture/0 description: The image contains the logo for KaVo Dental Excellence. The logo features the letters "KaVo" in a stylized font, with the "K" and "V" connected. Below the logo, the words "KaVo. Dental Excellence." are written in a smaller font. The logo is in a blue color.

Section V - 510(k) Summary

Submitter:

Kaltenbach & Voigt GmbH Bismarckring 39 88400 Biberach Stefan Trampler - Contact Person 49 (7351) 56 3515 - Phone number +49 (7351) 56 7 3515 - Facsimile

Date Summary Prepared: Jan, 27th 2017

Device Name:

Trade Name - ELECTROmatic
. Common Name - Dental Handpiece and Accessories
. Classification Name - Dental Handpiece and Accessories, per 21 CFR § 872.4200
. Device Class - Class I
. Product Code - EBW

Devices for Which Substantial Equivalence is claimed:

ELECTROtorque TLC 4893 with INTRAmatic KL 702 (K103027) marketed by Kaltenbach & Voigt GmbH.

Trade Name ELECTROtorque TLC 4893 with INTRAmatic KL 702 ●
. Common Name - Dental Handpiece and Accessories
Classification Name Dental Handpiece and Accessories, per 21 CFR § 872.4200 ●
. Device Class - Class I
. Product Code - EBW

Device Description:

Per the Guidance for Industry and FDA Staff; Bundling Multiple Devices or Multiple Indications in a Sinqle Submission, dated June 22, 2007, Kaltenbach & Voigt GmbH is bundling the ELECTROmatic models listed below as the models do not differ significantly in purpose, design, materials, energy source, function or any other feature related to substantial equivalence. The device description and intended use are identical for all models listed below. The differences between the models and mounting configurations are cosmetic in nature such as size/shape of the device, length of the tubings, amount of motors, design of display, etc. All critical components within the ELECTROmatic are common.

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The ELECTROmatic is available in the following models:

ELECTROmatic M/C(M-S, M-L, C-S, C-L)	This model represents the basic model availablewith either the INTRA LUX KL 703 LED motor (M)or the COMFORTdrive (C). Both configurationscan be equipped with a short tubing (S) or longtubing (L).
ELECTROmatic PM/PC(PM-S, PM-L, PC-S, PC-L)	This model represents the push button version(P) available with either the INTRA LUX KL 703LED motor (M) or the COMFORTdrive (C). Bothconfigurations can be equipped with a shorttubing (S) or long tubing (L).
ELECTROmatic TM(TM-S, TM-L)	This model represents the touch display version(T) equipped with the INTRA LUX KL 703 LEDmotor (M). This configurations can be equippedwith a short tubing (S) or long tubing (L).
ELECTROmatic TMM/TMC(TMM-S, TMM-L, TMC-S, TMC-L)	This model represents the touch display version(T) available with either two INTRA LUX KL 703LED motors (MM) or one INTRA LUX KL 703 LEDmotor and one COMFORTdrive (MC). Bothconfigurations can be equipped with a shorttubing (S) or long tubing (L).

The various mounting configurations for the ELECTROmatic are illustrated within the instructions for use. The differences between the models are the ELECTROmatic TM and ELECTROmatic TMM are the premier level devices and ELECTROmatic M/C and PM/PC are the mid-level devices.

Accessories:

Optional accessories (devices) that are attached to the ELECTROmatic are part of this submission and have already been cleared by the FDA. These optional accessories (devices) can be attached to the ELECTROmatic as indicated in their respective 510(k) summary statements. They are also attached to the predicate device (ELECTROtroque TLC 4893 with INTRAmatic KL 702) marketed by Kaltenbach & Voigt GmbH. Below are the accessories of the ELECTROmatic:

Accessory	Product Code	Comment
INTRA LUX KL 703 LED (motor)	EBW	FDA cleared under K103027
COMFORTdrive (motor handpiece)	EIA	FDA cleared under K080677

Principle of Operation / Mechanism of Action:

The ELECTROmatic device is a software-driven device. The software controls the following features: (1) Motor control, (2) Motor start / stop behavior, (3) Motor speed, (4) Motor performance, (5) Measuring power consumption, (6) Monitoring power consumption, and (7) SAFEdrive. The SAFEdrive software feature monitors the power consumption of electrical hand pieces to reduce the probability or severity of overheating, thus minimizing the risk of burns to the patient. The user can navigate through the software menu via the control panel. The electrical low-voltage motor (INTRA LUX KL 703 LED) and the COMFORTdrive motor handpiece are connected onto the KaVo specific tubing of the ELECTROmatic. The speed of the motor / motor handpiece is controlled by air pressure of the dental treatment center. The converted pneumatic output signal (electrical energy) from a dental treatment center drives either the motor to operate

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an electrically-driven dental handpiece or the COMFORTdrive motor handpiece. Electrically-driven dental handpieces, which conform to ISO 3964, can be attached on the motor.

Statement of Intended Use:

The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy to drive the COMFORTdrive motor handpiece and the INTRA LUX KL 703 LED motor for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.

Substantial Equivalence:

The ELECTROmatic function in a manner similar to and is intended for the same use as the ELECTROtorque TLC 4893 with INTRAmatic KL 702 (K103027) marketed by Kaltenbach & Voigt GmbH. The ELECTROmatic is similar to the predicate device (K103027) in that it is a software driven dental control unit consisting of a base unit with a motor hose, an electrical motor, a transformer and a power cord. Both the ELECTROmatic and the ELECTROtorque TLC 4893 with INTRAmatic KL 702 (K103027) have a motor connection for dental handpieces which are equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) and they are intended to be used by a trained professional in the field of general dentistry. The ELECTROmatic is substantially equivalent in design, technological characteristics, application and function to the predicate device (K103027). Both the ELECTROtorque TLC 4893 with INTRAmatic KL 702 (K103027) and the ELECTROmatic have the same principle of operation and the devices can be attached to a dental treatment unit using the same water and air system. The software in the ELECTROmatic as well as the software in the ELECTROtorque TLC 4893 with INTRAmatic KL 702 (K103027) control the following features: (1) Motor control, (2) Motor start / stop behavior, (3) Motor speed, (4) Motor performance, (5) Measuring power consumption, (6) Monitoring power consumption, and (7) SAFEdrive.

The ELECTROmatic differs from the ELECTROtorque TLC 4893 with INTRAmatic KL 702 (K103027) in that they have different technological characteristics (motor / motor tubings, user interface, display and media). These differences are shown in the table below (Summary of the Technological Characteristics). The ELECTROmatic can also be equipped with the COMFORTdrive motor handpiece and the motor tubings can be removed via a quick connector. A TFT / touch display can be selected for the ELECTROmatic. An integrated valve unit supports the two tubings models with media (air, spray air, spray water).

The performance tests demonstrate that the differences in technological characteristics do not raise different concerns reqarding substantial equivalence to the predicate device. Hence, the ELECTROmatic is substantial equivalent to the ELECTROtorque TLC 4893 with INTRAmatic KL 702 (K103027) marketed by Kaltenbach & Voigt GmbH.

In summary, the ELECTROmatic indications for use described in this submission is substantially equivalent to the ELECTROtorque TLC 4893 with INTRAmatic KL 702 cleared under K103027. It also satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: (1) Indications for Use, (2) Technological Characteristics and (3) Performance Data. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent.

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Summary of the Technological Characteristics:

DescriptiveInformation	ELECTROtorque TLC 4893 withINTRAmatic KL 702 (K103027)	ELECTROmatic
Indications forUse	The ELECTROtorque TLC 4893 is intendedto convert pneumatic output from a dentaltreatment center to electrical energy todrive the INTRAmatic KL 702 motor foroperation of electrically-driven dentalhandpieces. They are designed for use bya trained professional in the fieldofgeneral dentistry	The ELECTROmatic is intended to convertpneumatic output from a dental treatmentcenter to electrical energy to drive theCOMFORTdrive motor handpiece and theINTRA LUX KL 703 LED motor for operationof electrically-driven dental handpieces.This device is designed for use by a trainedprofessional in the field of generaldentistry
DeviceComponents	Control unit with hose and electricalmotor	Control unit with hose and electricalmotor
Installation	Attached to a dental treatment center	Attached to a dental treatment center
Power and UtilitySupply	120V/230V AC electrical supply,compressed air and water provided fromunit	120V/230V AC electrical supply,compressed air and water provided fromunit
Compatibility	Compatible with industry standard dentalhose connector for turbines	Compatible with industry standard dentalhose connector for turbines
User Interface	Membrane keys	Foot switch, touch keys / screen
Display	Dot matrix display	TFT / touch display
CompatibleMotors	INTRAmatic KL 702	INTRA LUX KL 703 LEDCOMFORTdrive
Motor Tubings	Fixed to the unit	Quick connector, removable
Water System	Water is supplied from unit	Water is supplied from unit
Media (air, sprayair, spray water)	Single hose connections	Integrated valve unit
Cleaning System	Cleaning System is supplied from unit	Cleaning System is supplied from unit
Software	Main part of the software is the KaVomotor control algorithm, which iscontrolling:- Motor control- Motor start / stop behavior- Motor speed- Motor performanceMeasuring power consumption- Monitoring power consumption(SAFEdrive function)	Main part of the software is the KaVomotor control algorithm, which iscontrolling:- Motor control- Motor start / stop behavior- Motor speed- Motor performance- Measuring power consumption- Monitoring power consumption(SAFEdrive function)
Intended Users	Dentists, Dental Hygienists	Dentists, Dental Hygienists

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Non-Clinical Test Data:

Performance bench testing according to international standards has been conducted to determine conformance. Biocompatibility and sterilization studies has been completed for the applicable components. Hence the ELECTROmatic demonstrates substantial equivalence.

The performance of the ELECTROmatic has been verified utilizing the following standards:

ISO 9168 2009-07-15 Dentistry Hose connectors for air driven dental handpieces -
-ISO 14457 First edition 2012-09-15 - Dentistry - Handpieces and motors
-IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007))
-IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for safety: Collateral standard: Electromagnetic compatibility; Requirements and tests (IEC 60601-1-2:2007 / EN 60601-1-2:2007)
-ANSI/AAMI ES60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (ANSI/AAMI ES60601-1: 2005 / A2:2010)
-IEC 62304 - Medical device software - Software life cycle processes (IEC 62304:2006 -First edition)
-ISO 7405 Second edition 2008-12-15 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry / ISO 10993-1 - 2009-10-00 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system
-ISO 10993-1 - 2009-10-00 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system

Clinical Test Data:

Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on wellestablished scientific and engineering principles. Clinical testing has not been conducted on this product.

Conclusion:

Based on a comparison of intended use, indications, technological characteristics, principle of operation, features and performance data, the ELECTROmatic is deemed to be substantially equivalent to the predicate device.

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.