The miniMaster LED is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls and displays, ultrasonic generator, and a bottle-fed irrigation system. A 2-step footswitch is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord, with irrigant flow control located on the cord itself. Instruments designed for specific dental procedures are attached to the distal end of the handpiece.

The miniMaster LED is a modification of the miniMaster Ultrasonic Scaler that was the subject of K050710. The overall design of the miniMaster LED is identical to the design of the miniMaster. The introduction of Piezon handpiece LED, materials changes to the peristaltic pump tubing, and design modifications implemented for the miniMaster LED were made to improve the functional performance and ease of use of the ultrasonic scaler. These design changes are listed in Table 1.

AI/ML Overview

The provided text describes the 510(k) summary for the miniMaster LED Ultrasonic Scaler, which is a medical device. The information below is extracted and organized to answer your specific questions.

Acceptance Criteria and Device Performance Study for miniMaster LED Ultrasonic Scaler

The miniMaster LED Ultrasonic Scaler is a modified version of the miniMaster Ultrasonic Scaler (K050710), with enhancements primarily focused on illumination and material changes for improved functional performance and ease of use. The acceptance criteria for this device were met through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Electrical Safety	UL 60601-1, "Medical Electrical Equipment—Part 1: General Requirements for Safety" (2nd edition including amendments 1&2)	The device met the general requirements for safety as defined by UL 60601-1.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2, "Medical electrical equipment. Part 1 General requirements for safety - Part 2 Collateral standard: Electromagnetic compatibility: Requirements and Tests" (1993)	The device met the electromagnetic compatibility requirements as defined by IEC 60601-1-2.
Package Integrity	ISTA 2A, "Packaged-Products 150 lb (68 kg) or Less"	The packaging met the standards for integrity during transport as defined by ISTA 2A.
Sterilization Validation	ANSI/AAMI ST79:2006, "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" (for reprocessing instructions)	Reprocessing instructions for reusable components (handpiece, instruments, accessories) were validated to ensure sterility assurance.
	ANSI/AAMI/ISO 17665-1:2006 "Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices" (for steam sterilization process)	The steam sterilization process was validated to achieve a Sterility Assurance Level (SAL) of $10^{-6}$ using a half-cycle method.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical data, as no clinical testing was submitted. For the non-clinical tests, the sample size is not explicitly mentioned, but it would typically involve a statistically relevant number of devices or components to demonstrate compliance with the referenced standards. The data provenance is derived from non-clinical laboratory and engineering testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No clinical testing was performed, and therefore, no expert-established ground truth for a clinical test set was required or reported. The ground truth for the non-clinical tests were the measured values and compliance with the specified engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. As no clinical testing was performed, there was no need for an adjudication method by medical experts. Compliance with non-clinical engineering and safety standards is typically determined through direct measurement and comparison to predefined thresholds.

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. The miniMaster LED is an ultrasonic scaler, a physical dental device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm-only) performance study was not relevant or performed. This device is a physical, electromechanical tool used by a human operator, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device was engineering standards compliance and objective measurements during non-clinical safety, performance, and sterilization validation tests.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product and does not involve a "training set" in the machine learning sense. The "training" in the context of a medical device refers to the design, development, and iterative testing process, not a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no "training set" in the AI/ML context, there is no ground truth established for it. The performance of the device is assessed against established engineering and safety standards.

Summary

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510(k) Summary For miniMaster LED Ultrasonic Scaler

1. SPONSOR

SEP 0 8 2010

E.M.S. Electro Medical Systems SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland

Contact Person: Suzanne Fassio-Hardy Telephone: 022 994 47 00 Date Prepared September 3, 2010

2. DEVICE NAME

Proprietary Name: miniMaster LED Common/Usual Name: Ultrasonic Scaler Ultrasonic Scaler (21 CFR 872.4850, Product Code Classification Name: ELC)

3. PREDICATE DEVICES

. miniMaster Ultrasonic Scaler (K050710)
Piezon Master 700 (K093000) .

4. INTENDED USE

Removing supra and subgingival calculus deposits and stains from the teeth .
Periodontal pocket lavage with simultaneous ultrasonic tip movement �
Scaling and root planning .
Releasing crowns, bridges, inlays and posts as well as condensing gutta percha .
Plugging for amalgam condensation .
Amalgam burnishing �
Preparing, cleaning, and irrigating root canals .
Preparing approximal cavities .
Cementing inlays and onlays .
. Retrograde preparation of root canals

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5. DEVICE DESCRIPTION

Ultrasonic Scaler. Component/Accessory(Part Reference)	Design Modification
Piezon handpiece LED (EN-060/A)	Compatibility with Piezon handpiece LED which includes a lightguide and 6 LEDs placed under the nozzle to improve illumination ofthe treatment area.
Handpiece LED cord (EM-113A/A)	Handpiece cords adapted to integrate LEDs
Cord connector (EK-300)	Cord connectors adapted to support LED
Water adjustment ring	Water adjustment ring relocated to handpiece side of handpiece cord
Electronics	Electronic PCB upgraded to drive the LED
Peristaltic Pump tubing*	Internal irrigation tubing replaced with fluorocarbon rubber material

Table 1. Design Modifications Incorporated in the miniMaster LED

PCB = printed circuit board

LED = light emitting diode

Peristaltic Pump identical to Piezon Master 700, K093000

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the proposed and predicate devices is provided in Table 2.

11,

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Item forComparison	miniMaster	miniMaster LED
Intended Use	Ultrasonic scaler intended for use in dental and periodontal cleaning, preparatory, endo andrestorative procedures.
Operationalenvironment	Stand alone	Stand alone
Power supply	• External transformer 24 V• 100-240V/50-60 Hz	• External transformer 24 V• 100-240V/50-60 Hz
Water supply	• Irrigating liquid bottle• Peristaltic pump	• Irrigating liquid bottle• Peristaltic pump
Ultrasonicpoweradjustment	Ten discrete power settings	Same
Wateradjustment	• Flow regulator on handpiece cord• Flow rate: 0-50 ml/min. minimum	• Flow regulator on handpiece cord• Flow rate: 0-50 ml/min. minimum
Dry/Wet workcapability	• miniMaster: Both Wet and Dry Work• ULTRAPIEZON: Wet Work only	• miniMaster: Both Wet and Dry Work
Outputperformancespecifications	0-8 W Standard Mode0-4.5 W Soft (Endo) Mode24-32 kHz (nominal)	Same(Soft mode identified as "ENDO mode")
Footswitch	Electrical command, two positions for independentcontrol of water flow and ultrasonic tip movement	Same
Materials:Handpiece	• Autoclavable plastic	• Autoclavable plastic
Instruments	• Stainless steel	• Stainless steel
Main ChassisWeight andDimensions	Weight: 1.3 kgHeight: 96 mmWidth: 213 mmLength: 80 mm	Weight: 1.3 kg:Height: 96 mmWidth: 213 mmLength: 80 mm

Table 2. Comparison of Technological Characteristics of Proposed and Predicate Devices

7. NON-CLINICAL TESTING

The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Hazard Analysis. Testing conducted on the proposed miniMaster LED included the following:

· UL 60601-1, "Medical Electrical Equipment—Part 1: General Requirements for Safety" (2nd edition including amendments 1&2)
· IEC 60601-1-2, "Medical electrical equipment. Part 1 General requirements for safety - Part 2 Collateral standard: Electromagnetic compatibility: Requirements and Tests" (1993)
ISTA 2A, ''Packaged-Products 150 lb (68 kg) or Less''

The reprocessing instructions for the reusable handpiece, instruments, and accessories were validated in accordance with ANSI/AAMI ST79:2006, "Comprehensive guide

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to steam sterilization and sterility assurance in health care facilities". The steam sterilization process was validated to an SAL of 106 using a half cycle method in accordance with ANSI/AAMI/ISO 17665-1:2006 "Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices".

8. CLINICAL TESTING

No clinical testing was submitted to support the claim of substantial equivalence.

9. CONCLUSIONS

The proposed and predicate devices have the same general intended use and principles of operation. The overall design of the proposed and predicate devices is similar. The differences between these devices are limited to design modifications implemented to replace the ultrasonic module and improve the product's ease of use. These design modifications are minor and raise no new issues of safety or effectiveness.

The miniMaster LED met all defined acceptance criteria for the non-clinical testing listed in Section 7. The information provided confirms that the miniMaster LED is safe and effective for its intended use and performs as well or better than the miniMaster.

CONFIDENTIAL Page 4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

EMS Electro Medical Systems SA C/O Ms. Cynthia J.M. Nolte Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K093723

Trade/Device Name: miniMaster LED Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: August 30, 2010 Received: August 31, 2010

Dear Ms. Nolte:

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

SEP 0 8 2010

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Page 2- Mr. Nolte

lease 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance 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.

Sincerely vours.

Jus. J. S

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

Enclosure

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Indications for Use

510(k) Number (if known):

miniMaster LED Device Name:

K193723 SEP 0 8 2010 .

Indications for Use:

The miniMaster LED is an ultrasonic scaler that is intended for the following:

. Removing supra and subgingival calculus deposits and stains from the teeth
Periodontal pocket lavage with simultaneous ultrasonic tip movement .
Scaling and root planning .
Releasing crowns, bridges, inlays and posts as well as condensing gutta percha .
Plugging for amalgam condensation .
Amalgam burnishing .
Preparing, cleaning, and irrigating root canals ●
Preparing approximal cavities .
Cementing inlays and onlays .
Retrograde preparation of root canals ●

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)

Susan Russo

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K092363

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.