(275 days)
The device is intended to be used by trained dental technicians as a portable and a mobile, extra-oral X-ray source. This can help producing diagnostic x-ray images by using with various intra-oral image detectors. This x-ray image can be used for dental examination (diagnosis) before or after treatment. Its use is intended for both adult and pediatric subjects.
The portable x-ray system (Model: DHX-70H, XTG-70H), is an x-ray generating device which is designed for dental examination. Each device has an x-ray tube for generating x-ray, a high voltage transformer for generating high voltage, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, an LCD display for saving and displaying the x-ray exposure setting, a power P.C.B with super capacitors for supplying power to the circuit and apparatus in housing, and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patient and operator from unnecessary exposure of radiation. The package includes a remote control switch, a battery charger, and a backscatter shield. And the remote control switch can be used when the device is mounted on optional stands or digital camera tripods.
The provided document is a 510(k) summary for the DHX-70H and XTG-70H portable X-ray systems. It primarily focuses on demonstrating substantial equivalence to a predicate device (Rextar X) based on technological characteristics and compliance with safety and performance standards. It explicitly states that clinical images were provided but "were not necessary in order to establish substantial equivalence." This implies that a clinical study with detailed acceptance criteria for device performance was not a requirement for this 510(k) clearance based on clinical effectiveness.
Therefore, based on the provided document, I cannot fulfill all parts of your request. Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical device performance (e.g., diagnostic accuracy, sensitivity, specificity). Instead, it focuses on technical specifications and compliance with safety and performance standards. The "performance" mentioned refers to adherence to these technical specifications and standards, not clinical outcomes.
| Acceptance Criterion (Technical & Safety Standards Compliance) | Reported Device Performance (as stated in document) |
|---|---|
| EMI standards: EN60601-1-2, IEC60601-1-2, CISPR 11, IEC61000-3-2, IEC61000-3-3 | Complies, test reports provided |
| Performance standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62304 | Complies, test reports provided |
| Time Accuracy: ± (10% + 1 ms) | Meets criterion (listed as part of comparison with predicate) |
| kVp: 70 kV fixed | Meets criterion (listed as part of comparison with predicate) |
| mA: 2 mA fixed | Meets criterion (listed as part of comparison with predicate) |
| Focal spot: 0.4 mm | Meets criterion (listed as part of comparison with predicate) |
| Half-value layer (HVL): Over 1.5 mmAl | Meets criterion (listed as part of comparison with predicate) |
| Source to skin distance (SSD): 200 mm | Meets criterion (listed as part of comparison with predicate) |
| Exposure time: 0.05~1.0 seconds in 0.01 increments | Meets criterion (listed as part of comparison with predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states that "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices." This indicates that a formal clinical test set with a specific sample size and provenance was not required or used for regulatory clearance based on clinical performance evaluation. The evaluation was primarily based on technical specifications and compliance with recognized standards.
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. Since a clinical study for establishing device performance against a ground truth was not deemed necessary for this 510(k) clearance (as per point 2), there is no information about experts or ground truth establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as a clinical test set requiring adjudication was not reported as part of the substantial equivalence determination for clinical performance.
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. The device is an X-ray source, not an AI-powered diagnostic tool. No MRMC study or AI assistance evaluation is mentioned or relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is hardware (an X-ray source), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As a clinical performance study with established ground truth was not detailed as a requirement for this 510(k) clearance, there's no mention of the type of ground truth used.
8. The sample size for the training set
Not applicable. The device is a hardware X-ray system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as it's not a machine learning algorithm.
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Image /page/0/Picture/0 description: The image contains 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.
March 3, 2023
DIGIMED Co., Ltd. % Youngbae Kwon CEO 145. Gasan digital 1-ro. Geumcheon-gu Seoul. SEOUL 08506 SOUTH KOREA
Re: K221587
Trade/Device Name: Dhx-70h, Xtg-70h Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: EHD Dated: January 27, 2023 Received: February 3, 2023
Dear Youngbae Kwon:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of 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) K221587
Device Name DHX-70H, XTG-70H
Indications for Use (Describe)
The device is intended to be used by trained dental technicians as a portable and a mobile, extra-oral X-ray source. This can help producing diagnostic x-ray images by using with various intra-oral image detectors. This x-ray image can be used for dental examination (diagnosis) before or after treatment. Its use is intended for both adult and pediatric subjects.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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 contains the logo for DIGIMED. The logo is in blue and features the word "DIGIMED" in bold letters. Above the logo, in smaller gray letters, is the text "Wellness of Your Life!". The letter "E" in DIGIMED has been modified to include an arrow pointing to the right.
DIGIMED Co., Ltd.
309-311, 318-ho, 145, Gasan digital 1-ro, Geumcheon-gu, Seoul 08506 Rep. of Korea Tel.: +82-2-2624-1551 / Fax: +82-2-2624-1553 / www.digimed.co.kr
510(k) Summary
(Submission number: K221587)
1. Company and Correspondent Making the Submission
| Date Prepared | May 18, 2022 |
|---|---|
| Company Name | DIGIMED Co., Ltd. |
| Address | 309~311, 318-ho,145, Gasan digital 1-ro, Geumcheon-gu,Seoul 08506 Rep. of Korea |
| Telephone number | +82-2-2624-1551 |
| Fax | +82-2-2624-1553 |
| digimed@digimed.co.kr | |
| Contact | Mr. Joonghyun Choi, RA Team manager |
2. Device Information
| Trade name | DHX-70H, XTG-70H |
|---|---|
| Common name | Portable X-Ray System |
| Classification Name | Extra-oral source x-ray system (21CFR 872.1800) |
| Classification | Class II |
| Product Code | EHD |
3. Predicate Device
| 510(k) Owner | Metabiomed, Inc. |
|---|---|
| Trade name of device | Rextar X |
| Common Name | Portable X-Ray System |
| Regulation name | Extra-oral source x-ray system (21CFR 872.1800) |
| 510(k) Number: | K132041 |
| Device Class | Class II |
| Product Code | EHD |
4. Description of Device
The portable x-ray system (Model: DHX-70H, XTG-70H), is an x-ray generating device which is designed for dental examination.
Each device has an x-ray tube for generating x-ray, a high voltage transformer for generating high voltage, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, an LCD display for saving and displaying the x-ray exposure setting, a power P.C.B with super capacitors for
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Image /page/4/Picture/0 description: The image shows the logo for DIGIMED. The text "Wellness of Your Life!" is above the logo. The logo is in blue and has an arrow pointing to the right.
DIGIMED Co., Ltd
9-311, 318-ho, 145, Gasan digital 1-ro, Geumcheon-gu, Seoul 08506 Rep. of Korea Tel .: +82-2-2624-1551 / Fax: +82-2-2624-1553 / www.digimed.co.kr
supplying power to the circuit and apparatus in housing, and beam limiting part (x-ray emitting cone).
The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patient and operator from unnecessary exposure of radiation.
The package includes a remote control switch, a battery charger, and a backscatter shield. And the remote control switch can be used when the device is mounted on optional stands or digital camera tripods.
Operating principle of the device starts from the generation of the high voltage electricity. Once the x-ray exposure button is pressed, the battery power supplied super capacitors on Power P.C.B delivers the electricity to the high voltage transformer. And the 70kV of high voltage generated from the transformer goes into the x-ray tube and makes x-ray source. And this xray source is exposed through the emitting cone. When the x-ray source is exposed to patient's teeth, the x-ray image detectors behind the teeth capture and make x-ray images.
(The image detectors are not part of this submission.)
The device generates high frequency x-ray with the transformed and boosted AC voltage through high voltage generator. And operator is able to obtain visible x-ray images of patients for dental examination with taking advantage of the device performance.
Main features;
- High frequency x-ray generator: 70 kV & 2 mA fixed
- X-ray tube focal spot: 0.4 mm
- Source to skin distance (SSD): 20 cm fixed
- Half value layer (HVL): Over 1.5 mmAl
- Ergonomic design: Natural grip as a digital camera
- Rechargeable battery: 14.8V
- Compatible with most of the x-ray image detectors
- Compact size: 168 x 228 x 118 mm (DHX-70H), 168 x 228 x 109 mm (XTG-70H)
- Light weight: 2 kg
And, the device can be used with below listed intra-oral image detectors (types).
- Analog dental x-ray films
- CCD and CMOS digital sensors (IO sensor)
- Digital phosphor plates (PSP)
5. Intended Use (Indications for Use)
The device is intended to be used by trained dentists and dental technicians as a portable and a mobile, extra-oral x-ray source. This can help producing diagnostic x-ray images by using with various intra-oral image detectors. This x-ray image can be used for dental examination (diagnosis) before or after treatment. Its use is intended for both adult and pediatric subjects.
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Image /page/5/Picture/0 description: The image shows the logo for DIGIMED. The logo is in blue and features the word "DIGIMED" in large, bold letters. Above the logo, in smaller letters, is the phrase "Wellness of Your Life!" The arrow in the logo is pointing to the right.
DIGIMED Co., Ltd.
309-311, 318-ho, 145, Gasan digital 1-ro, Geumcheon-gu, Seoul 08506 Rep. of Korea Tel.: +82-2-2624-1551 / Fax: +82-2-2624-1553 / www.digimed.co.kr
6. Technological Characteristics compared to the predicate device 6.1 DHX-70H
| Device name | DHX-70H | Rextar X |
|---|---|---|
| Intended Use/Indications | The device is intended to be used bytrained dentists and dental techniciansas a portable and a mobile, extra-oral x-ray source. This can help producingdiagnostic x-ray images by using withvarious intra-oral image detectors. Thisx-ray image can be used for dentalexamination (diagnosis) before or aftertreatment. Its use is intended for bothadult and pediatric subjects. | To be used by trained dentists and dentaltechnicians as a mobile, extraoral x-raysource for producing diagnostic x-rayimages using intraoral image receptors. Itis intended for both adult and pediatricsubjects. X-ray system design to provideimages of the patients undergoing dentalprocedures. Clinical uses include Bitewing, periapical, occlusal and panoramicimages. |
| User interfacedisplay | LCD panel display (40 x 60 mm)(2.6 inch, FSTN LCD, 1/4 duty 1/3 BIAS) | LCD panel display(3.5 inch, BTN LCD, 1/4 duty 1/3 BIAS) |
| Exposure switch | Exposure button at front cover on righthand side, or a remote control switch | Exposure button at front cover on righthand side |
| Source toskin distance | 200 mm | 200 mm |
| Cone diameter | 53 mm | 55 mm |
| Half-value layer | Over 1.5 mmAl | Not identified |
| Exposure time | 0.05~1.0 seconds in 0.01 increments | 0.01~1.3 seconds (43 steps) |
| Time Accuracy | ± (10% +1 ms) | ± (10% +1 ms) |
| kVp | 70 kV fixed | 70kV fixed |
| mA | 2 mA fixed | 2 mA fixed |
| Focal spot | 0.4 mm | 0.4 mm |
| Tube type | Stationary | Stationary |
| Waveform | High Frequency DC | High Frequency DC |
| Energy source | Rechargeable 14.8 V DC Lithium Polymerbattery pack | Rechargeable 11.1 V DC |
| Dimension | 168(w) x 228(d) x 118(h) mm | 146(w) x 239(d) x 155(h) mm |
| Weight | 2 kg | 2 kg |
| EMI standards | EN60601-1-2, IEC60601-1-2CISPR 11, IEC61000-3-2IEC61000-3-3 | EN60601-1-2, IEC60601-1-2 |
| Performancestandards | IEC 60601-1, IEC 60601-1-3IEC 60601-1-6, IEC 60601-2-65IEC 62304 | IEC 60601-1, IEC 60601-2-7IEC 60601-2-28, IEC 60601-2-32 |
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Image /page/6/Picture/0 description: The image shows the logo for DIGIMED. The text "Wellness of Your Life!" is above the logo. The logo is in blue and has an arrow pointing to the right.
6.2 XTG-70H
| Device name | XTG-70H | Rextar X |
|---|---|---|
| Intended Use/Indications | The device is intended to be used bytrained dentists and dental techniciansas a portable and a mobile, extra-oral x-ray source. This can help producingdiagnostic x-ray images by using withvarious intra-oral image detectors. Thisx-ray image can be used for dentalexamination (diagnosis) before or aftertreatment. Its use is intended for bothadult and pediatric subjects. | To be used by trained dentists and dentaltechnicians as a mobile, extraoral x-raysource for producing diagnostic x-rayimages using intraoral image receptors. Itis intended for both adult and pediatricsubjects.X-ray system design to provide images ofthe patients undergoing dental procedures.Clinical uses include Bite wing, periapical,occlusal and panoramic images. |
| User interfacedisplay | LCD panel display (60 x 40 mm)(2.6 inch, FSTN LCD, 1/4 duty 1/3 BIAS) | LCD panel display(3.5 inch, BTN LCD, 1/4 duty 1/3 BIAS) |
| Exposure switch | Exposure button at front cover on righthand side, or a remote control switch | Exposure button at front cover on righthand side |
| Source toskin distance | 200 mm | 200 mm |
| Cone diameter | 53 mm | 55 mm |
| Half-value layer | Over 1.5 mmAl | Not identified |
| Exposure time | 0.05~1.0 seconds in 0.01 increments | 0.01~1.3 seconds (43 steps) |
| Time Accuracy | ± (10% +1 ms) | ±(10% +1 ms) |
| kVp | 70 kV fixed | 70kV fixed |
| mA | 2 mA fixed | 2 mA fixed |
| Focal spot | 0.4 mm | 0.4 mm |
| Tube type | Stationary | Stationary |
| Waveform | High Frequency DC | High Frequency DC |
| Energy source | Rechargeable 14.8 V DC Lithium Polymerbattery pack | Rechargeable 11.1 V DC |
| Dimension | 168(w) x 228(d) x 118(h) mm | 146(w) x 239(d) x 155(h) mm |
| Weight | 2 kg | 2 kg |
| EMI standards | EN60601-1-2, IEC60601-1-2CISPR 11, IEC61000-3-2IEC61000-3-3 | EN60601-1-2, IEC60601-1-2 |
| Performancestandards | IEC 60601-1, IEC 60601-1-3IEC 60601-1-6, IEC 60601-2-65IEC 62304 | IEC 60601-1, IEC 60601-2-7IEC 60601-2-28, IEC 60601-2-32 |
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Image /page/7/Picture/0 description: The image shows the logo for DIGIMED, with the tagline "Wellness of Your Life!" above it. The word "DIGIMED" is written in large, bold, blue letters. The letter "D" has an arrow pointing to the right, which is part of the logo. The logo is simple and modern, and the blue color gives it a sense of trust and reliability.
DIGIMED Co., Ltd.
309-311, 318-ho, 145, Gasan digital 1-ro, Geumcheon-gu, Seoul 08506 Rep. of Korea Tel.: +82-2-2624-1551 / Fax: +82-2-2624-1553 / www.digimed.co.kr
7. Safety and Effectiveness, Comparison to Predicate Device
Safety and effectiveness of the subject device is considered with the latest version of test regulations. The subject device was shown to provide an equivalent level of safety and performance as compared to the predicate devices.
"Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices"
8. Safety, EMC and Performance Data:
The subject device complies with the safety and performance standards listed in the chart above. Test reports were provided to demonstrate conformance. All required documents and reports are submitted to the appropriate oversight agency to establish compliance with the applicable requirements.
9. The differences between the subject device and the predicate devices
The subject device has little differences with its design, size, and user interface compare to the predicate devices. Detailed differences can be identified from "Substantial Equivalence Chart".
12. Conclusion
As stated above, the Portable x-ray system (Model: DHX-70H, XTG-70H) is safe and effective and complies with the appropriate medical device standards and is substantially equivalent to the earlier identified predicate devices.
§ 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.