Ultrasonic Endo Activation Device (Model:Actor I pro)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | <span style="font-size:100%;"> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> | |--------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size:100%;"> <span> <span style="">□</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 & Technology<br>Industrial 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 scaler<br>EKX direct drive, AC-powered handpiece<br>EKR endodontic plugger, root canal<br>LQY root apex locator (unclassified) | {4}------------------------------------------------ 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) 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) ### 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: | SE<br>Comparisons | Subject Devices | Predicate Device<br>K202906 | Similarities/Differences | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for<br>Use | The Ultrasonic Endo<br>Activation Device<br>(Model:Actor I pro ) is an<br>ultrasonic-handpiece which<br>is intended use for root-<br>canal cleaning and<br>preparation.<br>The Ultrasonic Endo<br>Activation Device<br>(Model:Actor I pro ) is<br>intended for use by trained<br>dental professionals in<br>professional health care<br>facilities on patients that<br>need root-canal-treatment. | The EndoPilot2 systems<br>are dental devices which<br>combine in a single control<br>unit an endo motor to clean<br>the root canal, a dental<br>obturator to fill and<br>pressurize, an electronic<br>apex locator to assist the<br>operator to locate the file<br>tip in the root canal<br>and an ultrasonic-<br>handpiece for root-canal<br>cleaning and preparation.<br>The EndoPilot2 is intended<br>solely for use by trained<br>dental professionals in<br>professional health care<br>facilities on patients<br>that need root-canal-<br>treatment. | Similar<br>Predicate device includes<br>a single control unit an<br>endo motor to clean the<br>root canal, a dental<br>obturator to fill and<br>pressurize, an electronic<br>apex locator to assist the<br>operator to locate the file<br>tip in the root canal<br>and an ultrasonic-<br>handpiece for root-canal<br>cleaning and<br>preparation.<br>But Proposed device<br>only include ultrasonic-<br>handpiece which is<br>intended use for root-<br>canal cleaning and<br>preparation.<br>Function of proposed | | | | | device is one of the<br>functions of predicate<br>device, there is no risk<br>arise in aspect of<br>indication for use. | | Intermittent<br>operation | 3min | 1 min/3 min (endodontic<br>treatment) | Similar<br>Subject device only has<br>one mode, it can work<br>for 3 minutes<br>continuously.<br>No new risk raised. | | Vibration<br>frequency | $30\pm3$ kHz(27-33 kHz) | 27 to 33 kHz | Same | | Activation | By footswitch (optional),<br>ON/OFF button | By footswitch, ON/OFF<br>button | same | | Patient<br>contacting<br>components | Ultrasonic working tip | Ultrasonic working tip | same | | Power supply | Rechargeable Li-ion<br>battery<br>Capacity 1600mAh,3.7V | / | Different<br>The subject device<br>powered by a<br>rechargeable Li-ion<br>battery. The safety test<br>results show no new<br>safety risk raised. | | Charger | Input: AC100-240V,<br>50/60Hz 0.2A<br>Output: DC5V/1A | AC: 100-240 V, 50/60 Hz<br>DC: 12 V, 1.5 A | Similar<br>testing shows no new<br>question raised | | Bluetooth | BLE 5.0 | 4.1 Bluetooth | Different<br>Meet EMC standard and<br>FCC | | Sterilization | Working Tip, Wrench and<br>Silicone Case are user<br>sterilized by<br>steam sterilization. | handpiece and the tool are<br>user sterilized by<br>steam sterilization | Same | | Electrical<br>Safety | IEC 60601-1:2012<br>IEC 80601-2-60:2019 | IEC 60601-1:2012<br>IEC 80601-2-60:2019 | same | | EMC | IEC 60601-1-2:2014 | IEC 60601-1-2:2014 | same | | Biocompatibility | ISO 10993-5:2009<br>ISO 10993-10:2010<br>ISO 10993-11:2017 | ISO 10993-5:2009<br>ISO 10993-10:2010 | We conducted the acute<br>systemic toxicity testing<br>and pyrogen testing, test<br>results show no<br>biocompatibility risk. | {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 6. ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity 7. 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 {7}------------------------------------------------ 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.