The Ultrasonic Endo Activation Device (Model:Actor I pro ) is intended for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

Device Description

The subject device Ultrasonic Endo Activation Device (Model: Actor I pro) is an auxiliary device for dentists to perform root canal treatment. It is mainly used to clean the root canal with the help of ultrasonic cavitation, so as to assist dentists to complete root canal treatment.

The subject device Ultrasonic Endo Activation Device (Model: Actor I pro) configuration consist of the following components:

(1) ultrasonic handpiece (2) ultrasonic working tip (3) Wrench (4) silicone case (5) charging base

(6) Power Adapter(7) wireless foot switch (Optional)

AI/ML Overview

The provided document, K213947, is a 510(k) Pre-market Notification for the "Ultrasonic Endo Activation Device (Model:Actor I pro)". This document describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence.

Based on the content of the document, specifically Sections 8 "Performance Data" and 9 "Conclusion", there was no clinical study conducted to prove the device meets acceptance criteria. The document explicitly states:

Clinical test: "Clinical testing is not required."

Instead, the submission relies on non-clinical data to demonstrate substantial equivalence to a legally marketed predicate device. This means the acceptance criteria are based on compliance with relevant international standards for safety, performance, usability, electromagnetic compatibility, and biocompatibility, as well as software verification and validation.

Therefore, the requested information regarding acceptance criteria and the study that proves the device meets them, specifically pertaining to a clinical study with human data, cannot be extracted from this document, as such a study was not performed or submitted.

However, I can describe the acceptance criteria based on the non-clinical tests that were conducted, and the way the device "met" these criteria:

1. Table of Acceptance Criteria and Reported Device Performance (Non-clinical)

Since no clinical study was conducted, the "performance" here refers to compliance with established non-clinical standards and benchmarks.

Acceptance Criteria (Standard Compliance)	Reported Device Performance (Compliance Status)
Safety and Performance
IEC 60601-1:2005+A1:2012 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance)	Complies
IEC 80601-2-60:2012 (Medical Electrical Equipment - Particular Requirements for Basic Safety and Essential Performance of Dental Equipment)	Complies
Usability
IEC 60601-1-6:2013 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability)	Complies
Electromagnetic Compatibility (EMC)
IEC 60601-1-2:2014 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests)	Complies
Biocompatibility
ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization)	Complies (Test results show no irritation/sensitization risk)
ISO 10993-5:2009 (Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity)	Complies (Test results show no cytotoxicity risk)
ISO 10993-11:2017 (Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity)	Complies (Test results show no systemic toxicity risk, specifically mentions acute systemic toxicity testing and pyrogen testing results show no biocompatibility risk)
Software Verification and Validation
FDA Guidance: "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 2002"	Complies (Software documentation for moderate level of concern provided)
Reprocessing (Cleaning, Disinfection, Sterilization Validation)
FDA Guidance: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"	Complies (Validation per AAMI TIR 30, AAMI TIR 12, ISO 17665-1, ISO17665-2)
Functional Equivalence to Predicate Device
Vibration frequency: Same as Predicate (30 ± 3 kHz vs 27-33 kHz)	Similar (30 ± 3 kHz (27-33 kHz) reported)
Activation method: Same as Predicate	Same (Footswitch (optional), ON/OFF button)
Patient contacting components: Same as Predicate (Ultrasonic working tip)	Same (Ultrasonic working tip)
Intermittent operation cycle time: Similar to Predicate	Similar (3 min vs 1 min/3 min; no new risk raised)
Charger specifications: Similar to Predicate	Similar (Input/Output specs provided; testing shows no new question raised)
Bluetooth version: Different from Predicate but meets standards	Different (BLE 5.0 vs 4.1 Bluetooth; meets EMC standard and FCC)
Power supply: Different (Rechargeable Li-ion battery) but no new safety risk	Different (Rechargeable Li-ion battery vs not specified for predicate; safety test results show no new safety risk)

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

Not applicable. No clinical test set of human subjects was used for this 510(k) submission as clinical testing was not required. The "tests" were non-clinical, involving device testing against engineering and biological standards. Data provenance, in this context, would relate to the laboratory conditions and specific samples used for the engineering and biocompatibility tests (e.g., specific materials tested for cytotoxicity), which are not explicitly detailed in summaries like these but are part of the underlying test reports.

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

Not applicable. No clinical test set with human data requiring expert ground truth establishment was conducted. The ground truth for non-clinical compliance is based on the adherence of the device's measured parameters to internationally recognized standards and safety limits.

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

Not applicable. As no clinical ground truth requiring expert consensus or adjudication was established, no adjudication method was used.

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 an ultrasonic handpiece, not an AI-powered diagnostic imaging tool that would typically undergo an MRMC study.

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

Not applicable. This device is a physical medical instrument, not a standalone algorithm. Its performance is evaluated through its physical and electrical characteristics and biocompatibility, not as an algorithm.

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

For this submission, the "ground truth" for proving substantial equivalence was adherence to established engineering standards, safety standards, and biocompatibility standards. It was not based on clinical "outcomes data" or "expert consensus" on patient cases, as no clinical study was performed.

8. The sample size for the training set:

Not applicable. This device is hardware; it does not involve a "training set" in the machine learning sense.

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

Not applicable. This device is hardware; it does not involve establishing ground truth for a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

September 8, 2022

ChangZhou BoMedent Medical Technology Co.,Ltd Yang Chunyuan Sales Manager No.9 Changyang Road.West Taihu Science & Technology Industrial Park Changzhou, Jiangsu 213100 China

Re: K213947

Trade/Device Name: Ultrasonic Endo Activation Device (Model:Actor I pro) Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: August 11, 2022 Received: August 12, 2022

Dear Yang Chunyuan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213947

Device Name

Ultrasonic Endo Activation Device (Model:Actor I pro )

Indications for Use (Describe)

The Ultrasonic Endo Activation Device (Model:Actor I pro ) is an ultrasonic-handpiece which is intended use for rootcanal cleaning and preparation.

The Ultrasonic Endo Activation Device (Model:Actor I pro ) is intended for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

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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Image /page/3/Picture/1 description: The image shows the logo for BOMEDENT. The logo consists of a stylized graphic to the left of the company name. The graphic is composed of two angled shapes, one in gray and the other in yellow. The company name, "BOMEDENT," is written in gray, sans-serif capital letters.

510(K) Summary K213947

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: September 6, 2022

1. Submitter's Information

The submitter of this pre-market notification is:

Name:	ChangZhou BoMedent Medical Technology Co.,Ltd
Address:	No.9 Changyang Road,West Taihu Science & TechnologyIndustrial Park, Changzhou, Jiangsu China.
Contact person:	Yang Chunyuan
Title:	sales manager
E-mail:	yang.chunyuan@bome-dent.com
Tel:	+86-15161150269

2. Device Identification

Trade/Device Name:	Ultrasonic Endo Activation Device
Models:	Actor I pro
Common name:	Scaler, Ultrasonic
Regulation Number:	21 CFR 872.4850
Regulation Name:	Ultrasonic scaler
Regulation Class:	Class II
Panel:	Dental
Product Code:	ELC

3. Predicate Device

510(K) number:	K202906
Device Name:	EndoPilot²
Manufacturer:	Schlumbohm GmbH & Co. KG
Common name	Dental hand instrument
Regulation Number:	21 CFR 872.4850
Regulation Name:	Ultrasonic Scaler
Regulation Class:	Class II
Panel:	Dental
Product Code:	ELC Ultrasonic scalerEKX direct drive, AC-powered handpieceEKR endodontic plugger, root canalLQY root apex locator (unclassified)

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Image /page/4/Picture/1 description: The image shows the logo for BOMEDENT. The logo consists of two overlapping rectangles, one gray and one yellow, followed by the text "BOMEDENT" in gray. The rectangles are oriented diagonally, with the gray rectangle slightly above and to the left of the yellow rectangle. The text is in a sans-serif font and is aligned to the right of the rectangles.

4. Device Description

The subject device Ultrasonic Endo Activation Device (Model: Actor I pro) configuration consist of the following components:

(1) ultrasonic handpiece (2) ultrasonic working tip (3) Wrench (4) silicone case (5) charging base

(6) Power Adapter(7) wireless foot switch (Optional)

5. Indication for use

The Ultrasonic Endo Activation Device (Model:Actor I pro ) is an ultrasonic-handpiece which is intended use for root-canal cleaning and preparation.

The Ultrasonic Endo Activation Device (Model:Actor I pro ) is intended for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

6. Summary of the device compared to the predicate device

Compared to the predicate device, the subject device has the same intended use, similar product design, same performance as the predicate device, summarized comparison information is listed in the following table:

SEComparisons	Subject Devices	Predicate DeviceK202906	Similarities/Differences
Indication forUse	The Ultrasonic EndoActivation Device(Model:Actor I pro ) is anultrasonic-handpiece whichis intended use for root-canal cleaning andpreparation.The Ultrasonic EndoActivation Device(Model:Actor I pro ) isintended for use by traineddental professionals inprofessional health carefacilities on patients thatneed root-canal-treatment.	The EndoPilot2 systemsare dental devices whichcombine in a single controlunit an endo motor to cleanthe root canal, a dentalobturator to fill andpressurize, an electronicapex locator to assist theoperator to locate the filetip in the root canaland an ultrasonic-handpiece for root-canalcleaning and preparation.The EndoPilot2 is intendedsolely for use by traineddental professionals inprofessional health carefacilities on patientsthat need root-canal-treatment.	SimilarPredicate device includesa single control unit anendo motor to clean theroot canal, a dentalobturator to fill andpressurize, an electronicapex locator to assist theoperator to locate the filetip in the root canaland an ultrasonic-handpiece for root-canalcleaning andpreparation.But Proposed deviceonly include ultrasonic-handpiece which isintended use for root-canal cleaning andpreparation.Function of proposed
			device is one of thefunctions of predicatedevice, there is no riskarise in aspect ofindication for use.
Intermittentoperation	3min	1 min/3 min (endodontictreatment)	SimilarSubject device only hasone mode, it can workfor 3 minutescontinuously.No new risk raised.
Vibrationfrequency	$30\pm3$ kHz(27-33 kHz)	27 to 33 kHz	Same
Activation	By footswitch (optional),ON/OFF button	By footswitch, ON/OFFbutton	same
Patientcontactingcomponents	Ultrasonic working tip	Ultrasonic working tip	same
Power supply	Rechargeable Li-ionbatteryCapacity 1600mAh,3.7V	/	DifferentThe subject devicepowered by arechargeable Li-ionbattery. The safety testresults show no newsafety risk raised.
Charger	Input: AC100-240V,50/60Hz 0.2AOutput: DC5V/1A	AC: 100-240 V, 50/60 HzDC: 12 V, 1.5 A	Similartesting shows no newquestion raised
Bluetooth	BLE 5.0	4.1 Bluetooth	DifferentMeet EMC standard andFCC
Sterilization	Working Tip, Wrench andSilicone Case are usersterilized bysteam sterilization.	handpiece and the tool areuser sterilized bysteam sterilization	Same
ElectricalSafety	IEC 60601-1:2012IEC 80601-2-60:2019	IEC 60601-1:2012IEC 80601-2-60:2019	same
EMC	IEC 60601-1-2:2014	IEC 60601-1-2:2014	same
Biocompatibility	ISO 10993-5:2009ISO 10993-10:2010ISO 10993-11:2017	ISO 10993-5:2009ISO 10993-10:2010	We conducted the acutesystemic toxicity testingand pyrogen testing, testresults show nobiocompatibility risk.

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Image /page/5/Picture/1 description: The image shows the logo for BOMEDENT. The logo consists of a stylized graphic to the left of the company name. The graphic is made up of three angled bars, two in gray and one in yellow. The company name, "BOMEDENT", is in gray, sans-serif font.

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Image /page/6/Picture/1 description: The image shows the logo for BOMEDENT. The logo consists of two overlapping rectangles, one gray and one yellow, that are tilted to the left. To the right of the rectangles is the word "BOMEDENT" in gray, block letters. The logo is simple and modern.

All the differences don't affect substantial equivalence which is concluded after all the required testing.

8. Performance Data

Clinical test:

Clinical testing is not required.

Non-clinical data

The proposed device Ultrasonic Endo Activation Device (Model: Actor I pro) complies with: Safety and performance:

IEC 60601-1:2005+A1:2012 Medical electrical equipment – Part 1: General requirements ー for basic safety and essential performance.

IEC 80601-2-60:2012 Medical electrical equipment - Part 2-60: Particular requirements for 2. the basic safety and essential performance of dental equipment

Usability

IEC 60601-1-6:2013 Medical electrical equipment - Part 1-6: General requirements for basic 3. safety and essential performance - Collateral standard: Usability

Electromagnetic Compatibility:

IEC 60601-1-2:2014 Medical electrical equipment-Part1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances-Requirements and tests

Biocompatibility:

ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation 5. and skin sensitization

ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

Software Verification and Validation:

FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002".

Software documentation for moderate level of concern per the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Cleaning, intermediate level Disinfection, and Sterilization of the components of the subject

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Image /page/7/Picture/1 description: The image shows the logo for BOMEDENT. The logo consists of two angled rectangles, one gray and one yellow, followed by the text "BOMEDENT" in gray. The rectangles are positioned to the left of the text, with the yellow rectangle slightly overlapping the gray one. The text is in a sans-serif font and is aligned horizontally.

device per the FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, AAMI TIR 30, AAMI TIR 12, ISO 17665-1, and ISO17665-2.

9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is substantially equivalent to the legally marketed predicated device.

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.