(24 days)
The Jumong General is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
This device represents a combination of an already cleared solid state digital x-ray acquisition panel with software and diagnostic x-ray components required to make a complete system. Film cassettes may be employed in place of the x-ray generator has been changed to a Delta Electronics Delta DMP 100R The collimator has been changed to a Fairy Medical Electronics model CRUX FR04. The tubehead has been changed to a Hangzhou Kailong Medical Instruments Co., Ltd H1074X. The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1 and IEC 60601-1-2.
The provided text is a 510(k) Pre-market Notification document for the "Jumong General" stationary x-ray system. This document is a submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device.
It's important to understand that in this context, "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the demonstration of substantial equivalence, primarily through non-clinical performance testing and comparison to an established predicate device, rather than a clinical study with human-in-the-loop performance measurement of an AI algorithm.
The document states:
- "5. Safety and Effectiveness, comparison to predicate device. This combination device has the same indications for use and very similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels and software."
- "No software modifications were made to the imaging chain."
- "8. Summary of clinical testing: Not applicable."
This clearly indicates that this submission does not involve an AI algorithm that requires a separate performance study with human readers or standalone algorithm performance assessment. The device is a conventional x-ray imaging system, albeit with some updated components compared to its predicate.
Therefore, many of the requested points related to AI performance, such as MRMC studies, standalone AI performance, ground truth establishment for AI training/testing, and expert adjudication, are not applicable to this specific submission.
However, I can still interpret how the concept of "acceptance criteria" and "proof" apply to this device based on the provided text, focusing on its non-clinical performance and substantial equivalence demonstration.
Acceptance Criteria and Study for Jumong General X-Ray System
Given that the Jumong General is a stationary x-ray system (Product Code: KPR, MQB) and not an AI-powered diagnostic device, the "acceptance criteria" and "proof" focus on demonstrating substantial equivalence to a previously cleared predicate device (K150816, Jumong Series Stationary Radiographic System). This is achieved primarily through non-clinical performance testing, safety standards compliance, and direct comparison of functional characteristics. The document explicitly states "No software modifications were made to the imaging chain," and "Clinical testing: Not applicable."
The "acceptance criteria" for demonstrating substantial equivalence primarily revolve around meeting recognized performance standards, electrical safety, EMC compliance, and demonstrating comparable image quality and intended use to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated Equivalency) | Reported Device Performance / Proof |
|---|---|---|
| Intended Use | Identical Indications for Use as the predicate device. | UNCHANGED from K150816, Jumong Series Stationary Radiographic System: "Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography." (page 4, section 3 & page 5, "Intended Use" row) |
| Technological Characteristics | Functional equivalence of modified components (Generator, Collimator, Tubehead) to predicate components, while retaining existing cleared digital panels and software. | The device combines an "already cleared solid state digital x-ray acquisition panel with software and diagnostic x-ray components." (page 4, section 4). The new components are: - Generator: Delta Electronics DMP 100R (same kVp range as CPI CMP 200 DR predicate) - Collimator: Fairy Medical Electronics CRUX FR04 (changed from Ralco Model R225) - Tubehead: Hangzhou Kailong Medical Instruments Co., Ltd H1074X (changed from Varian RAD14) Digital Panel Models, Image acquisition panel specifications, DICOM, Image acquisition software, and Power Source are all SAME as predicate. (page 5, comparison chart). Conclusion: "This combination device has the same indications for use and very similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels and software." (page 4, section 5) |
| Safety & Performance Standards | Compliance with relevant US Radiation Safety Performance Standards and IEC standards for medical electrical equipment. | - Conforms to the US Performance Standard. (page 6, section 7) - New generator complies with: IEC 60601-2-54:2009+A1+A2, IEC 60601-1:2005+Corrigendum 1+Corrigendum 2+A1, IEC 60601-1-3:2008+A1, and IEC 60601-1-6:2010+A1. (page 6, section 7) - EMC testing complies with IEC 60601-1-2:2014. (page 6, section 7) - New collimator tested for compliance with EN/IEC 60601-2-54 for radiation leakage. (page 6, section 7) - New tubehead tested to IEC 60613:2010 and IEC 60336:2005. (page 6, section 7) - "Every unit is tested for electrical safety, input power, display of operation and exposure factors, collimator operation, reproducibility, and accuracy." (page 6, section 7) |
| Image Quality | Image quality should be diagnostically acceptable and comparable to the predicate device. | "Test images were acquired which showed excellent diagnostic quality." (page 6, section 7) |
| Risk Analysis | Assessment of risks associated with modifications and demonstration of acceptable risk profile. | "A risk analysis was performed with regard to the modifications. No software modifications were made to the imaging chain." (page 6-7, section 7) The conclusion states the device is "as safe and effective as the predicate device." (page 7, section 9) |
As this is a conventional X-ray system submission and not an AI/CADe device, the following points are largely "Not Applicable."
2. Sample size used for the test set and the data provenance
- Not Applicable in the traditional sense of a clinical test set for an AI algorithm. The "test set" here refers to the physical system undergoing non-clinical verification and validation tests. The document references "test images" acquired for image quality assessment, but the sample size or specific provenance of these images is not detailed as it would be for a clinical AI study. The testing is described as non-clinical ("integration and image quality testing").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of diagnostic accuracy for AI, is not relevant here. The "diagnostic quality" of images was assessed, presumably by qualified personnel, but this is a standard engineering and quality assurance assessment for image generators, not an AI ground truth establishment process.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. This pertains to clinical AI studies for diagnostic accuracy.
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. This is specific to AI-assisted diagnostic devices. The document explicitly states "Summary of clinical testing: Not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is specific to the performance of an AI algorithm. The device is a hardware x-ray system, and no AI algorithm's standalone performance is being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. Ground truth for diagnostic accuracy is not relevant here as it's a hardware device demonstrating fundamental imaging capability and safety, not a diagnostic interpretation tool.
8. The sample size for the training set
- Not Applicable. There is no AI algorithm being trained for this device as per the submission details ("No software modifications were made to the imaging chain").
9. How the ground truth for the training set was established
- Not Applicable. As there is no AI algorithm being trained by the applicant, this point is not relevant.
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February 23, 2023
SG Healthcare CO LTD % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES, FL 34114
Re: K230241
Trade/Device Name: Jumong General Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR, MOB Dated: January 30, 2023 Received: January 30, 2023
Dear Mr. Daniel Kamm:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 medical devices and radiation-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 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) K230241
Device Name Jumong General
Indications for Use (Describe)
The Jumong General is intended for use by a qualified/trained doctor or technician on both adult and pediatic subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
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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510(K) Summary, 510(k) K230241 Submitter: SG Healthcare Co., Ltd. 10 Yangnyeong-ro, Moga-myeon, Icheon-Si, Gyeonggi-do 17408, KOREA Tel : +82-70-7011-6161 FAX : +82-31-737-4954 Contact: YOSEP PARK, sales@sghealthcare.com Date Prepared: February 1, 2023
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- Identification of the Device: System.Trade/Device Name: Jumong General Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB
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- Equivalent legally marketed device: K150816, System.Trade/Device Name: Jumong Series Stationary Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB.
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- Indications for Use The Jumong General is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest. abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
-
- Description of the Device: This device represents a combination of an already cleared solid state digital x-ray acquisition panel with software and diagnostic x-ray compnents required to make a complete system. Film cassettes may be employed in place of the x-ray generator has been changed to a Delta Electronics Delta DMP 100R The collimator has been changed to a Fairy Medical Electronics model CRUX FR04. The tubehead has been changed to a Hangzhou Kailong Medical Instruments Co., Ltd H1074X. The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1 and IEC 60601-1-2.
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- Safety and Effectiveness, comparison to predicate device. This combination device has the same indications for use and very similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels and software.
-
- Substantial Equivalence Chart: Please see the next page.
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| Characteristic | K150816, Jumong Series StationaryRadiographic System SG Healthcare, Co.Ltd., | Modified: Jumong General |
|---|---|---|
| Intended Use: | Jumong Series is intended for use by aqualified, trained doctor or technician onboth adult and pediatric subjects fortaking diagnostic radiographic exposuresof the skull, spinal column, chest.abdomen, extremities, and other bodyparts. Applications can be performedwith the patient sitting, standing, or lyingin the prone or supine position. Not formammography. | Jumong General is intended for use by aqualified/trained doctor or technician onboth adult and pediatric subjects for takingdiagnostic radiographic exposures of theskull, spinal column, chest. abdomen,extremities, and other body parts.Applications can be performed with thepatient sitting, standing, or lying in theprone or supine position. Not formammography. UNCHANGED |
| Generator | CPI CMP 200 DR kVp range: 40 to 150kVp, depending on model | Delta Electronics DMP 100R kVp range: 40to 150 kVp SAME |
| Collimator | Ralco Model R225 | Fairy Medical Electronics CRUX FR04 |
| Tubehead | Varian RAD14 | Hangzhou Kailong Medical Instruments Co.,Ltd H1074X |
| Digital PanelModels andtheir clearancenumbers | VieworksK122865 Vivix-S WirelessK122866 Vivix-S With VxvueK120020 Vivix-S | SAME |
| Imageacquisitionpanelspecifications | FXRD-1717SA, FXRD-1717SB3,072 x 3,072, 140μm orFXRD-1417SA, FXRD-1417SB2560 x 3072, 140μmWireless: FXRD-1417WA, FXRD-1417WB,2560 x 3072, 140μm | SAME |
| DICOM | DICOM 3 | SAME |
| Imageacquisitionsoftware | Vieworks as cleared in K122866 Vivix-S WithVxvue | SAME |
| Power Source | AC Line, various voltages available | SAME |
| Characteristic | K150816, Jumong Series StationaryRadiographic System SG Healthcare, Co.Ltd., | Modified: Jumong General |
| Photo, floormount | Image: Photo, floor mount | Image: Photo, floor mount |
| Photo, ceilingmount | Image: Photo, ceiling mount | Image: Photo, ceiling mount |
| PerformanceStandard | US Radiation Safety PerformanceStandard | SAME |
| Electricalsafety/EMCStandardscompliance | IEC 60601-1, IEC 60601-1-2 | SAME |
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-
- Summary of non-clinical testing: We performed integration and image quality testing. The device conforms to the US Performance Standard. The new generator was tested by an NRTL to comply with: IEC 60601-2-54:2009+A1+A2, IEC 60601-1:2005+Corrigendum 1+Corrigendum 2+A1, IEC 60601-1-3:2008+A1, and IEC 60601-1-6:2010+A1. EMC testing complies with IEC 60601-1-2:2014. The new collimator was tested for compliance with EN/IEC 60601-2-54 for radiation leakage. The new tubehead was tested to IEC 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis and IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics. Test images were acquired which showed excellent diagnostic quality. Note that the digital x-ray receptor panels and software have not changed from the predicate.
Every unit is tested for electrical safety, input power, display of operation and exposure factors, collimator operation, reproducibility, and accuracy. A risk analysis was performed with regard to the
- Summary of non-clinical testing: We performed integration and image quality testing. The device conforms to the US Performance Standard. The new generator was tested by an NRTL to comply with: IEC 60601-2-54:2009+A1+A2, IEC 60601-1:2005+Corrigendum 1+Corrigendum 2+A1, IEC 60601-1-3:2008+A1, and IEC 60601-1-6:2010+A1. EMC testing complies with IEC 60601-1-2:2014. The new collimator was tested for compliance with EN/IEC 60601-2-54 for radiation leakage. The new tubehead was tested to IEC 60613:2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis and IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics. Test images were acquired which showed excellent diagnostic quality. Note that the digital x-ray receptor panels and software have not changed from the predicate.
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modifications. No software modifications were made to the imaging chain.
-
- Summary of clinical testing: Not applicable.
-
- Conclusion: The results of a review of bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device. After analyzing safety testing data, final checkout, and test images, it is the conclusion of SG Healthcare that the modified "Jumong General" is as safe and effective as the predicate device, has few technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.