(59 days)
The DT-703 is a portable dental X-ray system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use DT-703 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.
DT-703 is a handheld X-ray system powered by a rechargeable Li-ion polymer battery pack. DT-703 is an extra source X-ray generating device that is mainly designed for dental examination (on teeth, etc.). DT-703 is composed of X-ray generator with X-ray tube including device controller, power controller, user interface, beam limiting part, backscatter shielding glass, and optional remote exposure switch. DT-703 is designed to diagnose teeth and jaw through X-ray irradiation using an intra-oral image receptor. DT-703 is controlled by software (firmware) and the software level of concern is Moderate. The x-ray image detector (an integral part of a complete dental diagnostic system) is not part of the DT-703 X-ray device.
The provided text describes a 510(k) premarket notification for the DT-703 dental X-ray system. It details the device's characteristics, intended use, and comparison to a predicate device (KaVo NOMAD Pro 2). However, it explicitly states:
"Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."
Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets clinical acceptance criteria, a multi-reader multi-case (MRMC) study, or standalone performance, because no clinical studies were performed. The submission relies solely on non-clinical (engineering and safety) testing and comparison to a predicate device.
Here's a breakdown of what can be extracted or inferred based on the provided text, while acknowledging the explicit lack of clinical performance data:
Clinical Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The document explicitly states that "Clinical testing has not been conducted on this product." Therefore, there are no acceptance criteria related to clinical performance, nor any clinical study to prove the device meets such criteria.
The substantial equivalence determination for this device (DT-703) is based on non-clinical test data that characterize performance, and a comparison of its technological characteristics, intended use, and principle of operation to a legally marketed predicate device (KaVo NOMAD Pro 2).
Non-Clinical Acceptance Criteria and Supporting Information
While no clinical acceptance criteria or studies are presented, the submission implies acceptance criteria based on compliance with various electrical, safety, and electromagnetic compatibility (EMC) standards.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria (from standards compliance) | Reported Device Performance (Compliance Claim) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1:2005, AMD 1:2012 | Complies with IEC 60601-1:2005, AMD 1:2012 |
| Electrical Safety (US Equivalent) | Compliance with AAMI ES60601-1:2005/(R)2012 And A1:2012 | Complies with AAMI ES60601-1:2005/(R)2012 And A1:2012 (Implied by equivalence to predicate) |
| EMC (EMI/EMS) | Compliance with IEC 60601-1-2: Ed. 4.1 | Complies with IEC 60601-1-2: Ed. 4.1 |
| Radiation Protection | Compliance with IEC 60601-1-3 Edition 2.1 2013-04 | Complies with IEC 60601-1-3 Edition 2.1 2013-04 |
| Dental X-Ray Specific Safety | Compliance with IEC 60601-2-65 Edition 1.0 2012-09 | Complies with IEC 60601-2-65 Edition 1.0 2012-09 |
| Risk Management | Compliance with ISO 14971 Third Edition 3 2019 | Complies with ISO 14971 Third Edition 3 2019 |
| Battery Safety | Compliance with IEC 62133 Edition 2.0 2012-12 | Complies with IEC 62133 Edition 2.0 2012-12 |
| Design/Performance Equivalence to Predicate | Similar intended use, indications, technological characteristics, principle of operation, and acceptable performance compared to KaVo NOMAD Pro 2 (K173319). | DT-703 found substantially equivalent to KaVo NOMAD Pro 2. Key characteristics like X-ray tube (70 kV, 3 mA vs 60 kVp, 2.5 mA), battery (22.2 V Li-ion 1.0 Ahr vs 21.6 V Li-ion 1.7 Ahr), exposure time range (0.02-0.5s vs 0.02-1.0s), and physical dimensions are presented for comparison. |
| Software Concern Level | Moderate | Software level of concern declared as Moderate. (Implicitly met by review) |
| Radiation Safety (Handheld) | Follows "Radiation Safety Considerations for X-ray Equipment Designed for Hand-Held Use, issued December 24, 2008" | Utilized FDA Guidance (implied compliance). |
2. Sample sized used for the test set and the data provenance:
- Sample Size: The document does not specify sample sizes for individual non-clinical tests (e.g., how many units were subjected to electrical safety testing). The assumption is that standard engineering testing practices were followed, which typically involve a limited number of test units to demonstrate compliance with standards.
- Data Provenance: The testing was "performed in accordance with the following international standards." This indicates the tests were likely conducted in a controlled laboratory environment, presumably by or for the manufacturer (ECOTRON Co., Ltd, based in South Korea) or a certified testing body. The data is non-clinical, related to product design and safety specifications.
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):
- This question is not applicable as the document explicitly states "Clinical testing has not been conducted on this product" and relies on non-clinical data. Therefore, no medical experts (like radiologists) were involved in establishing "ground truth" for a test set in the conventional sense of a clinical study. The "ground truth" for non-clinical testing refers to compliance with established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable as clinical testing, which would involve reader adjudication, was not performed.
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 MRMC study was done. The device (DT-703) is a conventional dental X-ray system, not an AI-powered image analysis tool. The submission states, "Clinical testing has not been conducted on this product."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone performance study was done in the context of an algorithm or AI. The device is a hardware X-ray system. The "performance" assessment refers to its compliance with safety and electrical standards, not the diagnostic accuracy of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is defined by the specifications within the international standards (e.g., acceptable leakage current, proper radiation shielding, electromagnetic compatibility limits, battery performance). The device either meets these predefined technical criteria or it does not. There is no biological or diagnostic "ground truth" involved.
8. The sample size for the training set:
- This question is not applicable. The device is a hardware X-ray system, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This question is not applicable as no training set for an AI/ML algorithm was used.
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June 27, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ECOTRON Co., Ltd % Mr. Dave Kim Regulatory Affairs Mtech Group 7505 Fannin St, Suite 610 HOUSTON TX 77054
Re: K221233
Trade/Device Name: DT-703 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: April 20, 2022 Received: April 29, 2022
Dear Mr. Kim:
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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health 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) K221233
Device Name DT-703
Indications for Use (Describe)
The DT-703 is a portable dental X-ray system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use DT-703 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.
Type of Use (Select one or both, as applicable)
| ü 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/0 description: The image shows the logo for eco & electronics eddTRON. The logo is composed of a blue square with the letters "edd" in white, followed by the text "eco & electronics" in black. Below this is the word "TRON" in gray. The logo is simple and modern, and it is likely used to represent a company that specializes in electronics.
510(k) Summary K221233
This summary of 510(k) is being submitted in accordance with requirements of SMDA 1990 and 21 CFR Part 807.92.
Date 510(k)submitted: 4/25/2022
| 1. | Submitter Information: | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sumitter's Name:ECOTRON Co., LtdAddress:404, 504, 505Ho, Hanshin IT Tower II, 47,Digital-ro 9-gil, Geumcheon-Gu,Seoul, Republic of Korea 08511Contact Person:Sang Bong Lee, R&D ManagerTelephone Number:(02)-2025-3760Email:lsb@ecotron.co.krOfficial Correspondent:Dave Kim, MBAMtech GroupAddress:7505 Fannin St. Suite 610, Houston, TX 77054Tel:713-467-2607Email:davekim@mtech-inc.net | Sumitter's Name: | ECOTRON Co., Ltd | Address: | 404, 504, 505Ho, Hanshin IT Tower II, 47, | Digital-ro 9-gil, Geumcheon-Gu, | Seoul, Republic of Korea 08511 | Contact Person: | Sang Bong Lee, R&D Manager | Telephone Number: | (02)-2025-3760 | Email: | lsb@ecotron.co.kr | Official Correspondent: | Dave Kim, MBA | Mtech Group | Address: | 7505 Fannin St. Suite 610, Houston, TX 77054 | Tel: | 713-467-2607 | Email: | davekim@mtech-inc.net | ||||
| Sumitter's Name: | ECOTRON Co., Ltd | ||||||||||||||||||||||||
| Address: | 404, 504, 505Ho, Hanshin IT Tower II, 47, | ||||||||||||||||||||||||
| Digital-ro 9-gil, Geumcheon-Gu, | |||||||||||||||||||||||||
| Seoul, Republic of Korea 08511 | |||||||||||||||||||||||||
| Contact Person: | Sang Bong Lee, R&D Manager | ||||||||||||||||||||||||
| Telephone Number: | (02)-2025-3760 | ||||||||||||||||||||||||
| Email: | lsb@ecotron.co.kr | ||||||||||||||||||||||||
| Official Correspondent: | Dave Kim, MBA | ||||||||||||||||||||||||
| Mtech Group | |||||||||||||||||||||||||
| Address: | 7505 Fannin St. Suite 610, Houston, TX 77054 | ||||||||||||||||||||||||
| Tel: | 713-467-2607 | ||||||||||||||||||||||||
| Email: | davekim@mtech-inc.net | ||||||||||||||||||||||||
| 2. | Device Name: |
| Device Name: |
|---|
| Proprietary Name: |
| Manufacturer Name: | |
|---|---|
| Common Name: | |
| Classification Name: | |
| CFR Number: | |
| Device Class: | |
| Product Code: |
DT-703 ECOTRON Handheld X-ray System Extraoral Source X-ray System 872.1800 II EHD
3. Predicate Device:
Proprietary Name: Manufacturer Name: Common Name: Classification Name: CFR Number: Device Class: Product Code:
KaVo NOMAD Pro 2 Handheld X-ray System (K173319) Aribex Handheld X-ray System Extraoral Source X-ray System 872.1800 II EHD
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Image /page/4/Picture/0 description: The image shows the logo for "eco & electronics edotron". The logo has a blue square design on the left side, followed by the text "eco & electronics" in black font. Below this text is the word "edoTRON" in a larger, gray font. The logo appears to be for an electronics company with an eco-friendly focus.
4. Description of Device:
DT-703 is a handheld X-ray system powered by a rechargeable Li-ion polymer battery pack. DT-703 is an extra source X-ray generating device that is mainly designed for dental examination (on teeth, etc.). DT-703 is composed of X-ray generator with X-ray tube including device controller, power controller, user interface, beam limiting part, backscatter shielding glass, and optional remote exposure switch. DT-703 is designed to diagnose teeth and jaw through X-ray irradiation using an intra-oral image receptor. DT-703 is controlled by software (firmware) and the software level of concern is Moderate. The x-ray image detector (an integral part of a complete dental diagnostic system) is not part of the DT-703 X-ray device.
Optional parts available:
- Remote Exposure Switch
- . Backscatter Shield
- . Rectangular Cover (FOV 2x3)
- . Rectangular Cover (FOV 3x4)
5. Indications for Use:
DT-703 is a portable dental X-ray system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use DT-703 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.
6. Description of Substantial Equivalence: Technological Characteristics:
DT-703 has similar design components andoperating features as the predicate device, KaVo NOMAD Pro 2 Handheld X-ray System (K173319).
The handheld device features a main unit (tube head), rechargeable battery (handset) and charger. The main components of the tube head including X-ray tube (70 kV, 3 mA), internal shielding and external backscatter shielding are similar to the predicate device. The functionality of the user interface is also similar to the predicate device.
The power is supplied by a rechargeable Lithium Ion battery core pack built into a handset. The design for DT-703 is equipped with a 22.2 VDC, 1.0 Ahr battery core pack compared to the predicate device (KaVo NOMAD Pro 2 Handheld X-ray System - K173319) design of 21.6 VDC, 1.7 Ahr. The DT-703 battery core pack is compliant with IEC 62133-2.
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Image /page/5/Picture/0 description: The image shows the logo for "eco & electronics eddotron". The logo has a blue square design on the left side of the logo. The text "eco & electronics" is in black and is above the word "eddotron", which is in gray.
Testing has been completed on basic safety and essential performance and the device complies with IEC 60601-1; IEC 60601-1-2 (Ed. 4.1); IEC 60601-1-3, and IEC 60601-2-65.
| DT-703 HandheldDental X-ray System(Subject Device) | KaVo NOMAD Pro2Handheld X-ray System(K173319) | |
|---|---|---|
| INDICATIONSFOR USE: | DT-703 is a portable dental X-ray system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use DT-703 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children. | The KaVo NOMAD Pro 2 Handheld X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. |
| MECHANICAL: | ||
| Size: Body (mm/inch) | 259 x 277 x 165 mm(10"L x 11"H x 6.5"W) | 11"L x 10.5"H x 5.5"W |
| Weight | 1.5 kg (3.3 lbs) | 6.0 lbs. |
| Source to skin distance | 20 cm | 21 cm |
| Cone diameter | 6 cm | 6 cm |
| User Interface | Same, plus several user-selectable preset times. | |
| Backscatter radiation protection | 165mm (6.5") dia. Pb-filled acrylic plastic, backscatter shield | 6.75" dia. Pb-filled acrylic plastic scatter shield |
| Exposure switch | Trigger located on handset / optional remote switch | Trigger located on handset |
| Tubehead mounting | Handheld | Handheld |
| ELECTRICAL: | ||
| Tubehead | CEI OX/70-3 | Cyprus PSOC CY8C29866 |
| Energy Source | Rechargeable 22.2 V Li-ion polymer battery pack | Rechargeable 21.6 V DC Li-ion battery core pack |
| Capacity | 1.0 A-hr | 1.7 A-hr |
| Exposure Time | 0.02 – 0.5 seconds in 0.01 increments | 0.02 – 1.0 seconds in 0.01 increments |
| mA | 3 mA fixed | 2.5 mA fixed |
| kVp | 70 kVp fixed | 60 kVp fixed |
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| Image: edotron logo | ||
|---|---|---|
| Electrical SafetyStandards | IEC 60601-1:2005, AMD1:2012 | AAMI ES60601-1:2005/(R)2012 AndA1:2012 |
| EMI Standards | IEC60601-1-2: Ed. 4.1 | IEC60601-1-2 Ed. 4 |
| X-RAYPERFORMANCE: |
Similar technological characteristics for the proposed device DT-703 and the predicate device KaVo Nomad Pro2 seem to indicate substantial equivalence.
Non-Clinical Test Data:
Testing was performed in accordance with the following international standards:
IEC 60601-1:2005, AMD 1: 2012
IEC 60601-2-65 Edition 1.0 2012-09 Medical Electrical Equipment - Part 2-65: Particular Requirements for the Basic Safety And Essential Performance of Dental Intra-Oral X-Ray Equipment
IEC 60601-1-2 Edition 4.1 2014-02 Medical Electrical Equipment – Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - 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
ISO 14971 Third Edition 3 2019 Medical Devices – Application Of Risk ManagementTo Medical Devices
IEC 62133 Edition 2.0 2012-12 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From them, For Use In Portable Applications [Including: Corrigendum 1 (2013)]
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Image /page/7/Picture/0 description: The image is a logo for "eco & electronics edotron". The logo has a blue icon on the left, followed by the text "eco & electronics" in a smaller font. Below the text is the word "edoTRON" in a larger, gray font. The logo is simple and modern, with a focus on the company's name and its association with eco-friendly electronics.
FDA Guidance Documents Utilized:
Radiation Safety Considerations for X-ray Equipment Designed for Hand-Held Use, issued December 24, 2008
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005
Pediatric Information for X-ray Imaging Device Premarket Notifications, issued May 10, 2012
Clinical Performance Data:
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on wellestablished scientific and engineering principles. Clinical testing has not been conducted on this product.
Conclusion as to Substantial Equivalence:
Based on a comparison of intended use, indications, technological characteristics, principleof operation, features and performance data, the sponsor believes that the subject device, DT-703 is deemed to be substantially equivalent to the predicate device, KaVo NOMAD Pro 2.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.