The Cavitron Touch™ Ultrasonic Scaling System is an ultrasonic scaling unit that is used in all general supra and subgingival scaling applications and periodontal debridement for all types of periodontal diseases. The Cavitron Touch™ Ultrasonic Scaling System includes a digital touch screen interface and Bluetooth technology. This device is equipped with the Tap-On™ Wireless Foot Pedal with Tap-On™ technology.

AI/ML Overview

The provided text describes a medical device, the Cavitron Touch™ Ultrasonic Scaling System, and its substantial equivalence to a predicate device, the Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece (K052334). However, the document does not contain specific acceptance criteria or a study proving the device meets those criteria with quantitative performance metrics for the reasons listed below for each criterion. This is a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with explicit acceptance criteria for efficacy.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Not explicitly stated as pass/fail metrics. The submission focuses on demonstrating substantial equivalence to the predicate device.	The design verification and functional testing (listed in Section 7 of the 510(k) Summary) support the substantial equivalence of the proposed device to the predicate device.

2. Sample sized 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 sample sizes for any test sets related to performance characteristics (e.g., number of units tested, duration of tests).
The data provenance is internal testing performed by DENTSPLY International Inc. (Section 7, "Internal specification and testing"). Country of origin is not specified but the company is based in York, Pennsylvania, USA. The testing would be prospective in nature for a new device design.

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. This submission focuses on engineering and performance verification against existing standards and internal specifications, not on establishing ground truth for diagnostic or clinical interpretation using expert readers.

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

Not applicable. As the "ground truth" and "expert" roles are not relevant in this type of engineering and performance verification submission, there is no adjudication method described.

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

No, an MRMC comparative effectiveness study was not done. This device is an ultrasonic scaler; it is a tool used by dental professionals, not an AI-powered diagnostic system that assists human readers in case interpretation. The document explicitly states "No data from human clinical studies has been included to support the substantial equivalence of the Cavitron Touch™ Ultrasonic Scaling System" (Section 9, page 9).

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

Not applicable. This device is an ultrasonic scaler. Its function is to perform ultrasonic scaling procedures, which inherently involves a human operator (a dental professional). It is not an algorithm that functions in a standalone capacity without human intervention.

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

Not applicable/Not explicitly defined in the clinical sense. For a device like an ultrasonic scaler, "ground truth" for non-clinical performance would relate to engineering specifications, safety standards (e.g., electrical safety, electromagnetic compatibility), and functional requirements (e.g., power output, water flow, touch screen responsiveness). The closest to "ground truth" would be the standards themselves (e.g., AAMI ANSI ES 60601-1, IEC 60601-1-2) and the internal specifications against which the device was tested.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning system that requires a "training set" in the conventional sense. The development likely involved iterative design and testing, but not a formally defined "training set" for an algorithm.

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

Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply.

Summary of Study Type:

The document describes non-clinical performance data (Section 7, page 9) which includes:

Verification of design
Ultrasonic scaling performance
Function of the device
Adherence to international standards (AAMI ANSI ES 60601-1, IEC 60601-1-2)
Guidance for software validation (FDA - Guidelines for the Content of Premarket Submissions for Software Contained in Medical Devices- Software Validation)
Internal specification and testing for handpiece operation, autocycle operation, touch screen/user interface, and radio frequency distance for the wireless foot pedal.

This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device through engineering and performance testing, rather than through extensive clinical trials with explicit performance metrics and acceptance criteria for patient outcomes.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like figure with three heads, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

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

June 16, 2015

Dentsply International, Inc. Ms. Helen Lewis Director of Regulatory Affairs 221 West Philadelphia St., Suite 60W York, Pennsylvania 17401

Re: K150535

Trade/Device Name: Cavitron Touch™ Ultrasonic Scaling System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: March 17, 2015 Received: March 19, 2015

Dear Ms. Lewis:

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

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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Appendix A Indications for Use Statement

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SECTION 4. INDICATIONS FOR USE STATEMENT

K150535 510(k) Number (if known):

Device Name: Cavitron TouchTM Ultrasonic Scaling System

Indications for Use:

Used for ultrasonic procedures:

All general supra and subgingival scaling applications .
Periodontal debridement for all types of periodontal diseases .

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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DENTSPLY International

World Headauarters Susquehanna Commerce Center 221 West Philadelphia Street PO Box 872 York, PA 17405-2558 (717) 849-4593 Fax (717) 849-4343

SECTION 5. 510(k) SUMMARY

for

Cavitron Touch™ Ultrasonic Scaling System

1. Submitter Information:

DENTSPLY International Inc. Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17401

Contact Person:	Helen Lewis
Telephone Number:	717-487-1332
Fax Number:	717-849-4343

27 February 2015 Date Prepared:

2. Device Name:

●

Cavitron Touch™ Ultrasonic Scaling System Proprietary Name:
Classification Name: Ultrasonic Scaler
CFR Number: 872.4850 .
Device Class: .
Product Code: ELC .

3. Predicate Device:

Predicate Device Name	510(k)	Company Name
Cavitron® RF UltrasonicScaler System with SterimateHandpiece	K052334	DENTSPLY InternationalInc.

4. Description of Device:

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1. Indications for Use:

Used for ultrasonic procedures:

All general supra and subgingival scaling applications ●
. Periodontal debridement for all types of periodontal diseases

Substantial Equivalence: 6.

Technological Characteristics

Proposed DeviceCavitron Touch™ Ultrasonic ScalingSystem	Predicate DeviceCavitron® RF Ultrasonic Scaler Systemwith Sterimate Handpiece (K052334)
Indications for Use:	Indications for Use:
Used for ultrasonic procedures	Used for ultrasonic procedures
All general supra and subgingivalscaling applications Periodontal debridement for alltypes of periodontal diseases	All general supra and subgingivalscaling applications Periodontal debridement for alltypes of periodontal diseases Endodontic procedures
Features:All functions are touch screenactivated, including the powersetting, power presets, rinse, purge,scaling, and lock/unlock. Allindicators are also visible on thetouch screen, such as battery,service, water filter replacement,boost, manual, and Tap-On.	Features:All functions are controlledthrough the analog power switch ora button located on the front cover.These functions include powersetting, rinse, purge, and scaling.All indicators show on theinformation panel, includingbattery, service, boost, manual, andTap-On.
An adjustment collar on thehandpiece offers the option of finerwater control for precise andconvenient adjustment of lavage onthe handpiece to the preferredsetting.	An adjustment collar on thehandpiece offers the option of finerwater control for precise andconvenient adjustment of lavage onthe handpiece to the preferredsetting.
The power range setting can beactivated in two different ways.The clinician can touch the screento move the circle up or down tothe desired setting, or select one ofthe three power preset buttonoptions that are preset to theclinician's desired power setting.	The power range setting iscontrolled by a knob.
Proposed Device	Predicate Device
Cavitron Touch™ Ultrasonic ScalingSystem	Cavitron® RF Ultrasonic Scaler Systemwith Sterimate Handpiece (K052334)
by lines as well as color on thetouch screen.
Depressing the Tap-On™ WirelessFoot Pedal to the second positionsinitiates Temporary Boost toincrease the stroke of the insert byat least 25% when at min power.	Depressing the Tap-On™ WirelessFoot Pedal to the second positioninitiates Temporary Boost for a10% increase in power.
When the power boost feature isactivated, the word "boost" willshow in the "informationalbubble".	When the power boost feature isactivated, the boost indicator willlight up with a pink colorsignifying that an additional 10%of power is in use.
The handpiece is autoclavable/sterilizable as well as detachablefrom the unit.	The handpiece is autoclavable/sterilizable as well as detachablefrom the unit.
The unit is equipped with a round,battery operated, ergonomicallydesigned, Tap-On™ Wireless FootPedal. If preferred, the Tap-On™Wireless Foot Pedal can beattached by wire. The Tap-On™Wireless Foot Pedal contains twopositions: one to activate the scalerand the other to activate the boostfeature.	The unit is equipped with a round,battery operated, ergonomicallydesigned, Tap-On™ Wireless FootPedal. If preferred, the Tap-On™Wireless Foot Pedal can beattached by wire. The Tap-On™Wireless Foot Pedal contains twopositions: one to activate the scalerand the other to activate the boostfeature.
The battery indicator is alwayspresent on the screen. This allowsthe clinician to see how muchbattery life remains in the wirelessTap-On™ Wireless Foot Pedalbefore it must be recharged.	A battery symbol will light up onthe interface indicating that thebattery in the Tap-On™ WirelessFoot Pedal needs to be replaced.
The Tap-On™ Wireless Foot Pedalallows the clinician to use a singleTap-On™ the foot pedal to activateor deactivate continuous scaling.This permits the clinician to resttheir foot during the procedure.	The Tap-On™ Wireless Foot Pedalallows the clinician to use a singleTap-On™ the Tap-On™ WirelessFoot Pedal to activate or deactivatecontinuous scaling. This permitsthe clinician to rest their footduring the procedure.
When the Tap-On™ Wireless FootPedal technology is engaged, theword "Tap-On" will appear in the"Informational Bubble".
	Proposed Device	Predicate Device
	Cavitron Touch™ Ultrasonic ScalingSystem	Cavitron® RF Ultrasonic Scaler Systemwith Sterimate Handpiece (K052334)
-	To deactivate the Tap-On™technology, the clinician must pushthe Tap-On™ button located on theinterface.	To deactivate the Tap-On™technology, the clinician mustpress the Purge and Turbosimultaneously for a few seconds.
-	The Purge cycle allows theclinician to purge the water linesby pressing the Purge buttonlocated on the touch screen. ThePurge screen appears and displaysthe cycle countdown of 120seconds or 2 minutes. After the 2minute cycle is complete, thescreen will return to the Scalescreen.	The Purge cycle allows theclinician to purge the water lines.A single push button is used toactivate the 2 minute purge cycle.The button will stay illuminateduntil the cycle is completed.
-	The Rinse mode allows theclinician to rinse the area for thepatient where needed without thetip moving. Pressing the Rinsebutton on the touch screen willbring up the Rinse screen. The tipwill not move and the system willonly rinse. Once finished with theRinse mode, the clinician can pressthe Scale button on the touchscreen to return to the Scale screen.	The Rinse mode allows theclinician to rinse the area for thepatient where needed without thetip moving. To initiate the Rinsemode, the clinician will turn theknob to the Rinse icon until theyfeel it click. Once the knob isproperly in place, the tip will notmove and the system will onlyrinse. To return to scaling, turn theknob off of the Rinse icon.
-	Sustained Performance System(SPS), similar to cruise control,will adjust the power when needed.	Sustained Performance System(SPS), similar to cruise control,will adjust the power when needed.
-	The flat surfaces of the devicemake it easy to clean to minimizethe risk of cross-contamination. Adisposable barrier will be providedto cover the screen.	This device is easy to clean. Toclean underneath the knob, simplyremove the knob from the device.
-	When the water filter needs to bereplaced, the Water Filter IndicatorLight will light up on the touchscreen.
-	The device is internally equippedwith a water solenoid, which iswhere the water comes into theunit and continues to flow to the	The device is internally equippedwith a water solenoid, which iswhere the water comes into theunit and continues to flow to the
Proposed Device	Predicate Device
Cavitron Touch™ Ultrasonic ScalingSystem	Cavitron® RF Ultrasonic Scaler Systemwith Sterimate Handpiece (K052334)
handpiece.	handpiece.
- When the device needs to beserviced, the Service IndicatorLight will appear on the touchscreen. The 4 pre-programmedservice indicators are: missinghandpiece, unit over temperature,filter replacement, and batterystatus.	- When the device needs to beserviced, the Service IndicatorLight will illuminate on theinterface.
- This device has Bluetooth wirelesstechnology capabilities.	- This device has radio frequency(RF) wireless technologycapabilities.
- The half-life of a white LEDbacklight, which is used in theLCD Screen of the device, isapproximately 20,000 hours.
- The water range setting indicatorgoes from 1 – 6 with halfmarkings.	- The water range setting indicatorgoes from 1 – 6 with halfmarkings.
- It is recommended the plasticwater filter be replaced once amonth.	- It is recommended the plasticwater filter be replaced once amonth
- The system operates over afrequency range of 28.5 - 31.5kHz.	- The system operates over afrequency range of 28.5 - 31.5kHz.
- The input voltage of the scaler is100 - 240 VAC, 50 to 60 Hz.	- The input voltage of the scaler is100 - 240 VAC, 50 to 60 Hz.
- The system provides a means forcontrol of power (tip stroke) andlavage flow rates.	- The system provides a means forcontrol of power (tip stroke) andlavage flow rates.

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The Cavitron Touch™ Ultrasonic Scaling System is an ultrasonic scaler which is intended to be used for all general supra and subgingival scaling applications as well as periodontal debridement for all types of periodontal diseases. The Cavitron Touch™ Ultrasonic Scaling System has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece cleared under premarket notification K052334. The differences in the table above do not raise any new or different types of questions of safety and effectiveness.

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1. Non-Clinical Performance Data.
  Performance testing focused on verification of design, ultrasonic scaling performance, and function of the Cavitron Touch® Ultrasonic Scaler. Below is a summary of the testing performed:
AAMI ANSI ES 60601-1 Medical Electrical Equipment Part 1: General requirements . for basic safety and essential performance (2005; reapproved 2012)
. IEC 60601-1-2 Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility (2007)
. FDA - Guidelines for the Content of Premarket Submissions for Software Contained in Medical Devices- Software Validation
. Internal specification and testing for handpiece operation, including lavage control
. Internal specification and testing for autocycle operation
Internal specification and testing for touch screen and user interface functionality
. Internal specification and testing for radio frequency distance for Tap-On™ Wireless Foot Pedal (K130862)

The results of these performance tests support the substantial equivalence of the proposed Cavitron Touch™ Ultrasonic Scaling System with the predicate Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece (K052334).

New biocompatibility testing was not required to support the substantial equivalence between the proposed Cavitron Touch™ Ultrasonic Scaling System and the predicate device, Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece (K052334). Biocompatibility testing was submitted with the predicate device, Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece and cleared under premarket notification K052334. The Cavitron® Steri-Mate™ Sterilizable Handpiece was previously cleared as Jet-Mate™ Sterilizable Handpiece under premarket notification K023697.

1. Clinical Performance Data

No data from human clinical studies has been included to support the substantial equivalence of the Cavitron Touch™ Ultrasonic Scaling System.

2. Conclusion Regarding Substantial Equivalence

The Cavitron Touch™ Ultrasonic Scaling System is an ultrasonic scaler which is intended to be used for all general supra and subgingival scaling applications as well as periodontal debridement for all types of periodontal diseases. The Cavitron Touch™ Ultrasonic Scaling System has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece cleared under premarket notification K052334. Testing to verify the performance of the Cavitron Touch™ Ultrasonic Scaling System shows that the key features and performance of the Cavitron Touch™ Ultrasonic Scaling System are substantially equivalent to the predicate device, Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece (K052334).

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.