The ELECTROtorque TLC 4893 is intended to convert pneumatic output from a dental treatment center to electrical energy to drive the INTRAmatic KL 702 motor for operation of electricallydriven dental handpieces. These devices are designed for use by a trained professional in the field of general dentistry.

Device Description

The ELECTROtorque TLC 4893 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 a treatment unit at the location preferred by the dentist. The ELECTROtorque TLC 4893 system consists of a base unit with a motor hose, an electrical motor, a transformer, and a power cord. The ELECTROtorque TLC 4893 dental control unit 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 new 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 (see Figure 2.0).

The INTRAmatic KL 702 motor is an electrical low-voltage motor for dental purposes according to ISO 11498 type 2. The motor connects onto the KaVo specific tubing of the dental treatment unit ELECTROtorque. The speed of the INTRAmatic KL 702 is controlled by air pressure of the dental treatment center. The converted pneumatic output signal (electrical energy) from a dental treatment center drives the motor to operate an electrically-driven dental handpiece. Electricallydriven dental handpiece, which conform to ISO 3964, can be attached on the motor. The INTRAmatic KL 702 is intended only for dental treatment by a dental professional.

AI/ML Overview

The provided text describes a medical device, the ELECTROtorque TLC 4893 with INTRAmatic KL 702, which are dental handpieces and accessories. It details the device's function, its similarities and differences to predicate devices, and the non-clinical tests performed. It explicitly states that "Clinical testing has not been conducted on these products."

Therefore, I cannot provide information on acceptance criteria or a study proving the device meets those criteria from the given text, as no clinical studies were performed. The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical testing and functional similarity.

However, I can extract the information provided about the non-clinical testing that was performed:

Non-Clinical Test Data (Acceptance Criteria and Study Details)

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
SAFEdrive Software Function	Capable of detecting electrical handpieces to reduce probability/severity of overheating; minimizing patient burn risk.	The ELECTROtorque TLC 4893 software has been successfully validated to confirm the performance of the device. The software validation included testing of the new SAFEdrive software function to demonstrate that with this added function, the ELECTROtorque TLC 4893 is capable of detective electrical handpieces to reduce the probability or severity of overheating, thus minimizing the risk of burns to the patient.
Electromagnetic Compatibility	In accordance with applicable recognized consensus standards.	Testing of electromagnetic compatibility has been conducted in accordance with applicable recognized consensus standards.
Electrical Safety	In accordance with applicable recognized consensus standards.	Testing of electrical safety has been conducted in accordance with applicable recognized consensus standards.
Sterilization (INTRAmatic KL 702)	Safe and effective.	Sterilization studies were done to determine the safety and effectiveness of the INTRAmatic KL 702.
Biocompatibility (INTRAmatic KL 702)	Safe and effective.	Biocompatibility studies were done to determine the safety and effectiveness of the INTRAmatic KL 702.

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 does not specify the sample size for any of the non-clinical tests.
Data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). The tests were likely conducted internally or by 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)

Not applicable as no clinical studies or human expert ground truth establishment for software validation are detailed in the provided text. The "ground truth" for the non-clinical tests would be defined by engineering specifications, regulatory standards, or predetermined performance parameters.

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

Not applicable; no adjudication method for a test set is mentioned for these non-clinical tests.

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; no clinical studies, and therefore no MRMC studies, were conducted. The device (ELECTROtorque TLC 4893) includes a software feature (SAFEdrive) but is not described as an "AI" system in the context of improving human reader performance.

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

The SAFEdrive software function was validated. This would be a standalone evaluation of the algorithm's performance in monitoring power consumption and detecting overheating. The text states: "The software validation included testing of the new SAFEdrive software function to demonstrate that with this added function, the ELECTROtorque TLC 4893 is capable of detective electrical handpieces to reduce the probability or severity of overheating, thus minimizing the risk of burns to the patient." This implies an algorithm-only performance assessment against predefined overheating conditions.

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

For the SAFEdrive software validation, the ground truth would likely be established through engineered scenarios simulating various power consumption and overheating conditions. This would involve specific temperature and energy parameters as mentioned ("Temperature and energy studies have been conducted to determine the parameters for the new SAFEdrive software function").
For electromagnetic compatibility, electrical safety, sterilization, and biocompatibility, the ground truth is established by adherence to applicable recognized consensus standards.

8. The sample size for the training set

Not applicable; this device is not described as involving a machine learning/AI model that requires a training set in the context of the provided text. The software validation is for a rule-based or algorithmic function.

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

Not applicable for the same reasons as point 8.

Summary

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Section III - 510(k) Summary of Safety and Effectiveness

Image /page/0/Picture/2 description: The image contains a sequence of alphanumeric characters, specifically "K103027". The characters are written in a clear, handwritten style, with each digit and letter distinctly formed. The sequence appears to be a code or identifier, possibly a serial number or a reference code.

Image /page/0/Picture/3 description: The image shows the logo for "sybron dental specialties". The text is in a bold, sans-serif font. A curved line is above the text, possibly representing a smile or dental arch.

Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Drive Orange, CA 92656 Claudia Ortiz - Contact Person Phone number: 714.516.7981 Fax number: 714.516.7488

Date Summary Prepared: May 31, 2011

Device Name:

Trade Name ELECTROtorque TLC 4893 with INTRAmatic KL 702 .
Common Name Dental Handpieces and Accessories .
Classification Name Dental Handpieces and Accessories, per 21 CFR § 872.4200 .

Devices for Which Substantial Equivalence is Claimed:

. Bien Air, Optima MX (K042759)
Sirona Dental Systems GmbH, Sirotorque L (K031584) .
. Kaltenbach & Voigt GmbH, COMFORTtronic 4894 (K080677)

Device Description:

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Intended Use of the Device:

Substantial Equivalence:

The ELECTROtorque TLC 4893 dental control unit is substantially equivalent to other legally marketed devices in the United States. The ELECTROtorque TLC 4893 functions in a manner similar to and is intended for the same use as the COMFORTtronic 4894 marketed by Kaltenbach & Voigt, the Optima MX marketed by Bien Air, and to the Sirotorque L marketed by Sirona Dental Systems.

The ELECTROtorque TLC 4893 is similar to all three predicate devices in that it is a softwaredriven dental control unit consisting of a base unit with a motor hose, an electrical motor, a transformer, and a power cord. As the other three predicate devices, it is integrated in a dental treatment center and it uses the same water system and the same power supply. The software in the ELECTROtorque TLC 4893 device as well as the software of the three predicate devices control the following features: (1) Motor control, (2) Motor start / stop behavior, (3) Motor speed, (4) Motor performance, (5) Measuring power consumption, and (6) Monitoring power consumption. The ELECTROtorque TLC 4893 differs from all three predicate devices in that the ELECTROrorque TLC 4893 software has an added software function called SAFEdrive. This SAFEdrive function monitors the power consumption to reduce the probability or severity of overheating of electrical handpieces, thus minimizing the risk of burns to the patient.

The INTRAmatic KL 702 motor is substantially equivalent to other legally marketed devices in the United States. The INTRAmatic KL 702 functions in a manner similar to and is intended for the same use as the COMFORTdrive 200XDA marketed by Kaltenbach & Voigt, the Mikromotor MX marketed by Bien Air, and to the motor BL ISO marketed by Sirona Dental Systems. The INTRAmatic KL 702 is similar to all three predicate devices in that it is an electrical low-voltage motor for dental purposes according to ISO 11498 type 2. The INTRAmatic KL 702 differs only from the COMFORTdrive 200 XDA in that it can also rotated counterclockwise and it can be used with any electrically-driven dental handpiece that has a handpiece connection that conforms to ISO 3964.

Non-Clinical Test Data:

Temperature and energy studies have been conducted to determine the parameters for the new SAFEdrive software function. The ELECTROtorque TLC 4893 software has been successfully validated to confirm the performance of the device. The software validation included testing of

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the new SAFEdrive software function to demonstrate that with this added function, the ELECTROtorque TLC 4893 is capable of detective electrical handpieces to reduce the probability or severity of overheating, thus minimizing the risk of burns to the patient. Testing of electromagnetic compatibility and electrical safety has been conducted in accordance with applicable recognized consensus standards. Also sterilization and biocompatibility studies were done to determine the safety and effectiveness of the INTRAmatic KL 702.

Clinical Test Data:

Clinical testing has not been conducted on these products.

Conclusion:

Based upon similar technological / performance characteristics as compared to the predicate devices, and successful validation of the ELECTROtorque TLC 4893 software, the clinical performance of the ELECTROtorque TLC 4893 and INTRAmatic KL 702 is deemed to be substantially equivalent to the predicate devices.

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Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble an abstract representation of a human figure or a flowing ribbon. The logo is presented in black and white.

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

Kaltenbach & Voight GmbH C/O Ms. Claudia Ortiz Compliance Director, Regulatory Affairs & Quality Assurance Sybron Dental Specialties, Incorporated 1717 West Collins Orange, California 92687

AUG 1 9 2011

Re: K103027

Trade/Device Name: ELECTROtorque TLC 4893 with INTRAmatic KL 702 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW, EKX Dated: July 22, 2011 Received: July 25, 2011

Dear Ms. Ortiz:

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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Page 2 - Ms. Ortiz

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA $ Issuance of a substantials with other requirements
mean that FDA has made a determination that your her hederal agencies mean that FDA has made a decemination had your administered by other Federal agencies.
of the Act or any Federal statutes and regulations and realigning to: registration of the Act or any Federal statues and reginations and limited to: registration
You must comply with all the Act's requirements, including reporting You must comply with an the Act 3 requirement of an 801); medical device reporting and listing (21 CFR Fall 807), fabeling (21 CFR 803); good manufacturing
(reporting of medical device-related adverse events) (21 CFR Part 87 (reporting of medical device-related ad reros oversions (QS) regulation (21 CFR Part 820);
practice requirements as set forth in the quality systems (Sections 531-542 of practice requirements as set form in the quality systems (2) 3 feetions 531-542 of the Act); 21 CFR 1000-1050. J

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), and if you desire specific advice for your device of control of Co
please go to http://www.fda.gov/AboutFDA/Centers/CDRH/CDRH/s) please go to http://www.ida.gov/Abouts British in the lth 's (CDRH's) Office of
/ucm l 1 5809.htm for the Center for Devices and Ration by reference to Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compliance. Also, please note the regarations regarding the reporting of
premarket notification" (21CFR Part 807.97). For questions regarding of premarket nothication (21 CFR R rail 800 (21 CFR Part 803), please go to adverse events under the MDR regulation (21 Or NaProblem/default.htm for the CDRH's
http://www.fda.gov/MedicalDevices/Safety/Reportallers/2017/11/2019 http://www.ida.gov/Medical/Dometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may obtain other general miorniation your your Assistance at its toll-free Division of Sman Manataeta.com ,
number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Section I - Indications for Use

510(k) Number (if known): K10 3027

Device Name: ELECTROtorque TLC 4893 with INTRAmatic KL 702

Indications for Use:

Suse Runoes
(Division Sign-Off)

Tivision of Anesthesiology, General Hospital nfection Control, Dental Devices

:10(k) Number: K103027

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.