ERI Handheld Dental X-ray System (Model AG100)

{0}------------------------------------------------ April 4, 2022 Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". Energy Resources International Co., Ltd. Hsinchu Branch % Ms. Judy Chiang QA&RA Specialist 2F-2, No. 6-1, Sec. 2, Zhengyi Rd Zhubei City. Hsinchu County 30261 TAIWAN ### Re: K213282 Trade/Device Name: ERI Handheld Dental X-ray System (Model AG100) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD, MUH Dated: September 27, 2021 Received: October 1, 2021 #### Dear Ms. Chiang: 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, Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K213282 #### Device Name ERI Handheld Dental X-Ray System (Model AG100) Indications for Use (Describe) mandheld Dental X-Ray System (Model AG100) is intended for the purpose of using it for both adult and pediatric patients by qualified operators (e.g. dentist and/ or radiographer, etc.) regulated by competent authority of each country for producing diagnostic dental X-ray images. | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--|--| | 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<br>time to review instructions, search existing data sources, gather and maintain the data needed and comblete<br>and review the collection of information. Send comments regarding this burden estimate or any other aspect<br>of this information collection, including suggestions for reducing this burden, to: | | | | | Food and Drug Administration<br>Office of Chief Information Officer | Department of Health and Human Services<br>Paperwork Reduction Act (PRA) Staff | | | | PRAStaff(@fda.hhs.gov | | | | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ # ENERGY RESOURCES INTERNATIONAL CO., LTD. 510(k) Submission AG100 # Section 5 510(k) Summary {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a document with the logo of Energy Resources International Co., Ltd. Hsinchu Branch. The document includes a table with the following information: Product: AG100, 510(k) Summary, page: 5-2, and Version: 2.0. The document appears to be a summary related to the product AG100. The assigned 510(K) number: K213282 Date Prepared: 09/27/2021 #### Submitter Information I. | Submitter: | |--------------------------------------------------------------------------------------------------| | ENERGY RESOURCES INTERNATIONAL CO., LTD. Hsinchu Branch | | Address: 2F-2, No.6-1, Sec. 2, Zhengyi Rd., Zhubei City, Hsinchu County 30261,<br>Taiwan(R.O.C.) | | Phone Number: +886-3-6585156 | | Fax Number: +886-3-6585802 | | Contact Person: Judy Chiang | | Email: judy.chiang@eriray.com | | Phone Number: +886-3-6585156 ext.112 | | Fax Number: +886-3-6585802 | #### Subject Device II. Trade Name: ERI Handheld Dental X-Ray System (Model AG100) Regulation Name and Classification: | No. | Product<br>Code | Regulation Name | Regulatory<br>Class | Regulation<br>Number | Panel | |-----|-----------------|-------------------------------|---------------------|----------------------|-----------| | 1 | EHD | Extraoral Source X-Ray System | II | 872.1800 | Radiology | | 2 | MUH | Extraoral Source X-Ray System | II | 872.1800 | Radiology | #### III. Predicate Device | 510(K) Number | K173319 | |-------------------|----------------------------------------| | Manufacturer | Aribex | | Device Name | KaVo NOMAD Pro 2 Handheld X-Ray System | | Regulation Name | Extraoral Source X-Ray System | | Regulation Number | 872.1800 | | Product Code | EHD | | Regulatory Class | II | ### IV. Device Description It can be used with computed radiography (CR) detection film, digital radiography (DR) detection film or traditional film (dental film) to take intraoral X-rays and provide the information needed by the dentist for diagnosis. As a preoperative, intraoperative, and postoperative evaluation for identifying dental caries or auxiliary root canal treatment, as well as confirming the position of the implant during dental implant surgery. It can take pictures of the front and back teeth, as well as the bite of {5}------------------------------------------------ | 能 資 國 際 股 份 有 限 公 司 新 竹 分 公 司<br>Energy Resources International Co., Ltd. Hsinchu Branch | | | | | |------------------------------------------------------------------------------------------|-------|----------------|---------|-----| | Product | AG100 | 510(k) Summary | page | 5-3 | | | | | Version | 2.0 | the back teeth. Applicable objects include adults and children. Due to the medical software included in radiation-emitting device. ERI handheld system is of Moderate level of concern. The AG100 device, as well as, the predicate device (Trade Name: KaVo NOMAD Pro 2 Handheld X-Ray System manufactured by Aribex (K173319)) utilize a fixed tube current and voltage (KVp) to achieve their intended use. #### v. Indications for Use ERI Handheld Dental X-Ray System (Model AG100) is intended for the purpose of using it for both adult and pediatric patients by qualified operators (e.g. dentist and/ or radiographer, etc.) regulated by competent authority of each country for producing diagnostic dental X-ray images. #### VI. Comparison of Technology Characteristics with the Predicate Device Energy Resources International claims that the AG100 device is substantially equivalent to the KaVo NOMAD Pro 2 Handheld X-Ray System cleared by the FDA in K173319. Energy Resources International claims substantial equivalence because the AG100 has an equivalent intended use, operating principles, and operational specifications as compared to the predicate device. The specific details regarding the similarities and differences between the AG100 and KaVo NOMAD Pro 2 Handheld X-Ray System have been identified and explained in the Comparison Table, see the following table 3. A summary of these similarities and differences is included below. These differences do not present any new issues related to safety and effectiveness. | Device name | Kavo NOMAD Pro 2 Handheld<br>X-ray system<br>(Predicate Device: K173319) | ERI Handheld Dental X-Ray<br>System (Model AG100) | |----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification,<br>regulation<br>number, product<br>code | Extraoral Source X-ray System,<br>21 CFR 872.1800,<br>EHD | Extraoral Source X-ray System,<br>21 CFR 872.1800,<br>EHD/MUH | | Intended Use | The KaVo NOMAD Pro 2<br>Handheld X-ray System is<br>indicated for use only by a trained<br>and qualified dentist or dental<br>technician for both adult and<br>pediatric subjects as an extraoral<br>diagnostic dental X-ray source to<br>produce X-ray images using<br>intraoral image receptors. | ERI Handheld Dental X-Ray<br>System (Model AG100) is intended<br>for the purpose of using it for both<br>adult and pediatric patients by<br>qualified operators (e.g. dentist and/<br>or radiographer, etc.) regulated by<br>competent authority of each country<br>for producing diagnostic dental X-<br>ray images. | {6}------------------------------------------------ | Product | AG100 | 510(k) Summary | page 5-4<br>Version 2.0 | |----------------------------------|------------------------------------------------------|----------------|----------------------------------------------------------------------------------------------------------------------------------| | Source to skin distance | 20 cm | | 20 cm | | Cone diameter | 6 cm | | 6 cm | | Backscatter radiation protection | 6.75" dia. Pb-filled acrylic plastic scatter shield | | 153mm(6.02") dia. Pb-filled acrylic plastic scatter shield | | Exposure switch | Trigger located on handset | | Trigger located on front top | | | Electrical | | | | Energy Source | Rechargeable 21.6 V DC Li-ion battery core pack | | Rechargeable 14.4 V DC Li-polymer battery core pack | | Capacity | 1.7 A-hr | | 2.4 A-hr (34.56Wh) | | Casing | Hard shell case | | Hard shell case | | Recharge capability | 70% remaining capacity after 300 cycles | | After 300 cycles, more than 70% | | Exposure Time | 0.02 – 1.0 seconds in 0.01 increments | | 0.1 – 2.0 seconds in 0.01 increments | | mA | 2.5 mA fixed | | 0.6 mA fixed | | kVp | 60 kVp fixed | | 60 kVp fixed | | Duty Cycle | 1:60 | | maximum 60 sec after previous shot | | Electrical Safety Standards | AAMI ES60601-1:2005/(R)2012 And A1:2012 | | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) | | EMI Standards | IEC60601-1-2 Ed. 4 | | IEC60601-1-2:2014 Ed. 4 | | | X-ray Performance | | | | Performance Standard | 21 CFR 1020.30, 1020.31; IEC60601-1-3; IEC60601-2-65 | | 21 CFR 1020.30, 1020.31; IEC 60601-1-3 Edition 2.1; IEC 60601-2-65 Edition 1.1 CONSOLIDATED VERSION; IEC 61223-3-4 First edition | {7}------------------------------------------------ | Image: Energy Resources International Co., Ltd. Hsinchu Branch logo | | | | | |---------------------------------------------------------------------|-------|----------------|---------|-----| | Product | AG100 | 510(k) Summary | page | 5-5 | | | | | Version | 2.0 | Hence, the subject device is similar to the predicate device in terms of the indications for use and technological application. # VII. Non-clinical Test Data Testing was performed in accordance with the following international standards: - IEC 62304 Edition 1.1 [2015-06] Medical device software - Software life cycle processes - ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD) - IEC 60601-1-2 Edition 4.0 [2014-02] Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests - IEC 60601-1-3 Edition 2.1 [2013-04] Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment - IEC 60601-2-65 Edition 1.1 [2017-05] Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment - IEC 61223-3-4 First edition [2000-03] Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray - ISO14971 Third Edition [2019-12] Medical devices - Applications of risk management to medical devices - ISO10993-2 Second edition [2006-07-15] Biological Evaluation of medical devices - Part 2: Animal welfare requirements - ISO10993-5 Third edition [2009-06-01] Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - ISO10993-10 Third Edition [2010-08-01] Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization - ISO10993-12 Fourth edition [2012-07-01] Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - 21 CFR 1020.30: Diagnostic x-ray system and their major components - 21 CFR 1020.31: Radiographic Equipment ### VIII. Clinical Performance Data The function and performance of the AG100 have been evaluated through non-clinical design verification and validation tests. Testing included electrical performance evaluations and usability test. The results of the AG100 performance evaluations demonstrate that the device design is well suited for its intended use. Clinical testing has not been conducted on this product, and successful bench testing results should be sufficient in demonstrating substantial equivalence for the AG100 handheld system. {8}------------------------------------------------ | 117 | 能 資 國 際 股 份有限公司 新 竹 分 公 司<br>Energy Resources International Co., Ltd. Hsinchu Branch | | | |-----------------|--------------------------------------------------------------------------------------|---------|-----| | Product AG100 | | page | 5-6 | | | 510(k) Summary | Version | 2.0 | #### IX. Conclusions The Energy Resources International AG100 has the same intended use and same basic technology as the predicate device, thus is able to achieve the same effectiveness and safety as the predicate device. The AG100 contains in some combination similar features and design as the predicates. Other differences include device design such as exposure time, size and user interface. The subject device is substantially equivalent to the predicate device with its intended use, mechanical and electrical performance as described.