(148 days)
DVAS is an extra-oral source x-ray system to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic dental radiographic examination and diagnosis of teeth, jaw, and other oral structures using intra-oral image receptors. It is intended for both adult and pediatric subjects.
DVAS, the extra-oral source x-ray system for dentistry is the standard X-ray equipment used to acquire intraoral images of patients during dental diagnosis such as dental caries, periodontal diseases, dental root fracture, and other oral and dental pathologies. DVAS is used to provide anatomic X-ray images of a patient at hospitals or dental clinics using a cone for X-ray exposure. The doctor or dentist can check the acquired X-ray images with chemical films or a PC monitor. DVAS can be used Digital I/O Sensor, Image plate (CR), Film as a Image receptor. The image receptors are not part of this submission.
The provided text is a 510(k) summary for the DVAS (DVAS-M, DVAS-W) extra-oral source x-ray system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with specific acceptance criteria and performance metrics for the device itself in a clinical setting.
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (e.g., sensitivity, specificity, or reader improvement) is not present in the provided document. The document primarily addresses engineering and regulatory compliance.
However, I can extract information related to safety, EMC, performance data comparison, and software validation, which are forms of acceptance criteria for a medical device.
Here's a breakdown of the available information based on your request, highlighting what is implicitly or explicitly stated regarding "acceptance criteria" and "proof":
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of clinical performance acceptance criteria (e.g., specific sensitivity or specificity thresholds) because it is a 510(k) submission focused on substantial equivalence to a predicate device, not clinical efficacy trials for novel AI algorithms.
However, it does describe compliance with various standards and successful completion of validation testing as its "performance criteria" for regulatory clearance.
| Acceptance Criterion (Implicit/Explicit) | Reported Device Performance (Proof) |
|---|---|
| Engineering Bench Testing & Verification/Validation (General) | DVAS successfully completed verification and validation testing per GENORAY quality system and engineering bench testing. All test results were satisfactory. |
| Safety and Electrical Compliance (IEC 60601-1, -1-2, -1-3, -2-65) | The system has been tested and is compliant with IEC 60601-1 (General requirements for basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances - Requirements and tests), IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment), and IEC 60601-2-65 (Particular requirements for the basic safety and essential performance of dental extra-oral x-ray equipment). |
| Radiation Control Compliance (21 CFR 1020.30, 1020.31) | DVAS complies with all applicable 21 CFR performance standards: 21 CFR 1020.30 (Electronic products; general) and 21 CFR 1020.31 (Radiological safety for diagnostic x-ray systems and their major components). |
| Software Validation (FDA Guidance: "Software Contained in Medical Devices") | Software was validated according to the FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical devices" and "Guidance for the content of premarket submissions for management of cyber security." Results demonstrated that all executed verification tests were passed. |
| Pediatric Information in Labeling (FDA Guidance: "Pediatric Information for X-ray Imaging Device Premarket Notifications") | The system has reflected pediatric information in the labeling according to the FDA Guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications," dated November 28, 2017, as DVAS can be used in both adult and pediatric populations. |
| Non-clinical Validation Testing for Intended Use/Claims | Non-clinical validation testing has been performed to validate that DVAS conforms to its intended use, claims, user needs, effectiveness of safety measures, and instructions for use. The bench tests indicate that the new device is as safe and effective as the predicate device. |
| Substantial Equivalence to Predicate Device | Based on comparison information (similar functions, electronic features, indications for use, patient type, mechanical configuration, X-ray field size, target material, electrical power, focal spot, and applied standards), the device is deemed safe and effective as the predicate device and has no new indication for use, therefore it is substantially equivalent to the predicate device (RIX 70 DC, K182206) and reference device (PORT-X IV, K172810). |
2. Sample size used for the test set and the data provenance
The document does not mention a "test set" in the context of clinical images or patient data for evaluating a diagnostic algorithm. The testing described is primarily engineering and regulatory compliance testing, not a clinical performance study involving diagnostic accuracy metrics.
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 needing expert ground truth establishment is mentioned in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set needing adjudication is mentioned.
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 is mentioned. This device is an X-ray system (hardware), not an AI diagnostic algorithm, so such a study would not be relevant for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an X-ray system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the engineering and regulatory compliance tests, the "ground truth" would be the specifications and requirements of the relevant standards (e.g., IEC 60601 series, 21 CFR 1020.30/31).
8. The sample size for the training set
Not applicable. This document does not describe the development or testing of an AI algorithm that would require a training set of data.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI algorithm is mentioned.
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December 8, 2023
GENORAY CO., Ltd % Kaitlynn Min Business Development GENORAY America Inc. 1220 N Simon Circle, Unit B ANAHEIM, CA 92806
Re: K232085
Trade/Device Name: DVAS (DVAS-M, DVAS-W) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: EHD Dated: June 20, 2023 Received: November 3, 2023
Dear Kaitlynn Min:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
DVAS (DVAS-M, DVAS-W)
Indications for Use (Describe)
DVAS is an extra-oral source x-ray system to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic dental radiographic examination and diagnosis of teeth, jaw, and other oral structures using intra-oral image receptors. It 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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Exhibit 5 K232085 510(k) Summary
This 510(k) summary information is prepared in accordance with 21 CFR 807.92
1. Date of Summary Preparation [21 CFR 807.92(a) (1)]
: Jun. 20, 2023
2. Administrative Information [21 CFR 807.92(a) (1)]
| 510(k) Submitter | GENORAY Co.,Ltd |
|---|---|
| Address: 512, 560, Dunchon-daero, Jungwon-gu, | |
| Seongnam-si, Gyeonggi-Do, Korea | |
| Telephone No.: +82-31-5178-5500 | |
| Fax: +82-31-5178-5599 | |
| Contact Person: Inyoung Kim (iykim@genoray.com) | |
| Official Correspondent | GENORAY America Inc. |
| Address: 1220N Simon Circle, Anaheim, B, CA 92806 USA | |
| Telephone No.: +1-855-436-6729 | |
| Fax: +1-714-786-8919 | |
| Contact Person: Kaitlynn Min | |
| (kaitlynn@genorayamerica.com) |
3. Device Information [21 CFR 807.92(a) (2)]
| Trade / Device Name | DVAS (DVAS-M, DVAS-W) |
|---|---|
| Common or Usual Name | Dental X-ray system |
| Classification Name | Extraoral source X-ray system |
| Classification Regulation | 21 CFR 872.1800 |
| Class of Device | Class II |
| Panel | Radiology |
| Product Code | EHD |
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4. Predicate Device Information [21 CFR 807.92(a) (3)]
| * Predicate Device | |
|---|---|
| Name of Device | RIX 70 DC (K182206) |
| Manufacturer | Trident s.r.l., Italy |
| Common or Usual Name | Extraoral source X-ray system |
| Classification Name | Unit, X-ray, Extraoral with Timer |
| Classification Regulation | 21 CFR 872.1800 |
| Class of Device | Class II |
| Panel | Radiology |
| Product Code | EHD |
| * Reference Device | |
|---|---|
| Name of Device | PORT-X IV (K172810) |
| Manufacturer | GENORAY Co., Ltd |
| Common or Usual Name | Extraoral source X-ray system |
| Classification Name | Unit, X-ray, Extraoral with Timer |
| Classification Regulation | 21 CFR 872.1800 |
| Class of Device | Class II |
| Panel | Radiology |
| Product Code | EHD |
5. Description of the Device [21 CFR 807.92(a) (4)]
DVAS, the extra-oral source x-ray system for dentistry is the standard X-ray equipment used to acquire intraoral images of patients during dental diagnosis such as dental caries, periodontal diseases, dental root fracture, and other oral and dental pathologies. DVAS is used to provide anatomic X-ray images of a patient at hospitals or dental clinics using a cone for X-ray exposure.
The doctor or dentist can check the acquired X-ray images with chemical films or a PC monitor.
| No. | Item | Specification |
|---|---|---|
| 1 | Pixel Size | ≤ 40 μm |
| 2 | Active area size | ≥ 19 mm x 26 mm(Size 0) |
| 3 | Resolution | ≥ 10(lm/mm) |
| 4 | Digital sensor plate thickness | ≤ 19 μm * 19 μm |
| 5 | Interface | USB |
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DVAS can be used Digital I/O Sensor, Image plate (CR), Film as a Image receptor. The image receptors are not part of this submission. And the minimum integration requirements for intra-oral detectors when used with this device are:
6. Indications for use [21 CFR 807.92(a) (5)]
DVAS is an extra-oral source x-ray system to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic dental radiographic examination and diagnosis of teeth, jaw, and other oral structures using intra-oral image receptors. It is intended for both adult and pediatric subjects.
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7. Substantial equivalence chart [21 CFR 807.92(a) (6)]
| Proposed device | Predicate device | Reference device | SE Note | |||
|---|---|---|---|---|---|---|
| DVAS-M | DVAS-W | RIX 70 DC | PORT-X IV | |||
| Manufacturer | GENORAY Co., Ltd | Trident s.r.l., Italy | GENORAY Co., Ltd | - | ||
| 510(k) No. | K232085 | K182206 | K172810 | - | ||
| ClassificationName | Extraoral source x-ray system | Extraoral source x-ray system | Extraoral source x-ray system | - | ||
| ProductCode | EHD | EHD | EHD | - | ||
| Regulation Number | 872.1800 | 872.1800 | 872.1800 | - | ||
| Class | Class II | Class II | Class II | - | ||
| Productillustration | Image: DVAS-M and DVAS-W | Image: RIX 70 DC | Image: PORT-X IV | - | ||
| Indication | DVAS is an extra-oral source x-ray | RiX70 DC X-ray Unit is designed for use in | PORT-X IV is a | Same | ||
| s for use | system to be used by trained dentistsand dental technicians as an extra oral x-ray source for producing diagnosticdental radiographic examination anddiagnosis of teeth, jaw, and other oralstructures using intra oral imagereceptors. It is intended for both adultand pediatric subjects. | dental surgery to make endo-oral x-rays fordiagnostic purposes. This equipment can beused to produce traditional x-rays developedusing chemicals or, alternatively, it can be usedwith digital x-ray sensors. | portable X-ray systemto be used by traineddentists and dentaltechnicians as amobile, extraoral x-raysource for producingdiagnostic x-ray imagesusing intraoral imagereceptors. It is intendedfor both adult andpediatric subjects. | Same | ||
| Patienttype | Adult - Child | Adult - Child | Adult - Child | Same | ||
| Mechanical | ||||||
| Mechanicalconfiguration | Floor-mountedtype | Wall-mountedtype | Floor-mountedtype | Wall-mountedtype | Mobile type | Same |
| Minimumsource toskindistance | 200mm | 200mm | - | Same | ||
| X-rayfield Size(default) | 60mm round | 60mm round | 60mm round | Same |
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| Cycle | ||||
|---|---|---|---|---|
| Target material | Tungsten | Tungsten | Tungsten | Same |
| Target angle | 12.5° | 16° | 12.5° | Similar |
| Electrical | ||||
| Electrical power voltage | AC 100-240V | AC 100-240V | AC 100-240V | Same |
| Focal spot | 0.4mm | 0.4mm | 0.4mm | Same |
| Exposure time | 0.05 ~ 1.6s | 0.02~2.0s | 0.05 ~ 1.6s | Similar |
| Tube current | 2.0mA fixed | 7mA fixed | 2mA fixed | Similar |
| Tube voltage | 70kV fixed | 60, 65, 70kV | 70kV fixed | Similar |
| Applied standard | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Same |
| IEC 60601-1-2IEC 60601-1-3IEC 60601-2-6521 CFR 1020.3021 CFR 1020.31 | IEC 60601-1-2IEC 60601-1-3IEC 60601-2-6521 CFR 1020.3021 CFR 1020.31 | IEC 60601-1-2IEC 60601-1-3IEC 60601-2-6521 CFR 1020.3021 CFR 1020.31 |
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8. Safety, EMC and Performance data comparison to Predicate [21 CFR 807.92(b)]
DVAS have been successfully compeleted verification and validation testing per GENORAY quality system as well engineering bench testing in support of successfully completed verification and validation testing per GENORAY quality system and this submission.
The system has been tested and is compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3. IEC 60601-1-6. IEC 60601-2-65. IEC 62366. Also. DVAS complies with all applicable 21 CFR performance standards (21 CFR 1020.30, 21 CFR 1020.31)
And Software was validated according to the FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical devices", FDA Guidance "Guidance for the content of premarket submissions for management of cyber security". Results demonstrated that all executed verification tests were passed.
DVAS can be used not only in adults but also In the pediatric population, and therefore the system has reflected pediatric information in the labeling according to the FDA Guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications," dated November 28, 2017"
Non-clinical validation testing has been performed to validate that DVAS conform to the intended use, claims, user needs, effectiveness of safety measures and instructions for use.
As a results, all test results were satisfactory and the result of bench tests indicates that the new device is as safe and effective as the predicate device.
9. Conclusion
In reference to the comparison information provided in the substantial equivalence chart, and the most of functions and electronic features are similar with the predicate device. We believe that the DVAS are safe and effective as predicate device, and have no new indication for use. Therefore, DVAS are substantially equivalent to predicate device.
§ 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.