(50 days)
Flat Panel Digital X-ray Detectors are indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in general purpose diagnostic procedures all and not to be used for mammography
The 14HK701G-W is the solid state x-ray imager, which can generate radiographic images of any part of the body. These devices intercept x-ray photons and the scintillator (CSI:TI) emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value, and the images are displayed on monitors. The digital value can be communicated to the operator console via wiring connection.
The 14HK701G-W consists of the following components: Flat Panel Detector, Control Box, battery Charger, 2 packs of battery, power adapter for charger, Calibration Software, power cord and cables. The 14HK701G-W can be used for general X-ray system excluding fluoroscopic, angiographic, and mammographic applications.
The provided document is a 510(k) summary for the LG Electronics Inc. device 14HK701G-W, a Flat Panel Digital X-ray Detector. While it mentions "Clinical Test Summary" and "Clinical data has been provided", it explicitly states that the data "was not necessary to establish substantial equivalence based on the modifications to the device but provided further evidence in addition to the laboratory performance data to show that the device works as intended."
Therefore, based on the provided text, there is no detailed information about an actual clinical study (MRMC study or standalone study) with specific acceptance criteria, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics, non-clinical tests (electrical safety, EMC, software validation, biocompatibility, imaging performance, cybersecurity, and labeling).
The "Performance Test" section refers to IEC 62220-1 for "Determination of the Detective Quantum Efficiency," which is a performance metric for X-ray detectors themselves, not a study evaluating clinical efficacy or diagnostic accuracy with AI.
To answer your request thoroughly, I must highlight that the document does not contain the information you are seeking about a study proving the device meets acceptance criteria related to AI performance, human-in-the-loop improvement, or a standalone algorithm. The device described is a digital X-ray detector, not an AI-powered diagnostic tool.
If this were an AI-powered device, the requested information would be crucial. However, for a digital X-ray detector, the "acceptance criteria" and "study" are typically more focused on physical and technical performance metrics, safety, and equivalence to existing cleared devices, as outlined in the provided 510(k) summary.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor can I answer the questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone studies as the provided text does not describe such a study for this device.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
LG Electronics Inc. Jinhwan Jun Chief Research Engineer 222. LG-Ro Jinwi-Myeon, Pyeongtaek-Si, Gyeonggi-do, 17709 Korea
October 18, 2018
Re: K182348
Trade/Device Name: 14HK701G-W Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: August 22, 2018 Received: August 29, 2018
Dear Jinhwan Jun:
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
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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| Indications for Use | |
| 510(k) Number (if known) | K182348 |
| Device Name | 14HK701G-W |
| Indications for Use (Describe) | Flat Panel Digital X-ray Detectors are indicated for digital imaging solution designed forgeneral radiographic system for human anatomy. It is intended to replace film or screenbased radiographic systems in general purpose diagnostic procedures all and not to beused 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
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510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
July 20, 2018
2. Submitter's Information [21 CFR 807.92(a)(1)]
| ● | Name of Manufacturer: | LG Electronics Inc. |
|---|---|---|
| ● | Address: | 222, LG-ro, Jinwi-myeon, Pyeongtaek-si,Gyeonggi-do, Republic of Korea |
| ● | Contact Name: | Jinhwan Jun / Chief Research Engineer |
| ● | Telephone No.: | +82-31-8066-5641 |
| ● | Email Address: | Jinhwan.jun@lge.com |
| ● | Registration No.: | 3009955829 |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade/Device Name | 14HK701G-W |
|---|---|
| Common Name | Flat Panel Digital X-ray Detector |
| Device Classification Name | Stationary X-ray System |
| Regulation Number | 21 CFR 892.1680 |
| Classification Product Code | MQB |
| Device Class | II |
| 510(k) Review Panel | Radiology |
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4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow;
Predicate Device 1
| ● | 510(k) Number: | K180332 |
|---|---|---|
| ● | Applicant: | LG Electronics Inc. |
| ● | Trade/Device Name: | 17HK700G-W |
| ● | Common Name: | Digital Diagnostic X-ray System |
| ● | Classification Name: | System. X-ray, Stationary |
| ● | Regulation Number: | 21 CFR 892.1680 |
| ● | Classification ProductCode | MQB |
| ● | Device Class: | II |
| ● | 510(k) Review Panel: | Radiology |
Predicate Device 2
| ● | 510(k) Number: | K150165 |
|---|---|---|
| ● | Applicant: | Samsung Electronics Co., Ltd. |
| ● | Trade/Device Name: | S4343-W (of GC85A) |
| ● | Common Name: | Digital Diagnostic X-ray System |
| ● | Classification Name: | System. X-ray, Stationary |
| ● | Regulation Number: | 21 CFR 892.1680 |
| ● | Classification ProductCode | KPR |
| ● | Device Class: | II |
| ● | 510(k) Review Panel: | Radiology |
The predicate devices have not been subject to a design-related recall
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5. Description of the Device [21 CFR 807.92(a)(4)]
The 14HK701G-W is the solid state x-ray imager, which can generate radiographic images of any part of the body. These devices intercept x-ray photons and the scintillator (CSI:TI) emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value, and the images are displayed on monitors. The digital value can be communicated to the operator console via wiring connection.
The 14HK701G-W consists of the following components: Flat Panel Detector, Control Box, battery Charger, 2 packs of battery, power adapter for charger, Calibration Software, power cord and cables. The 14HK701G-W can be used for general X-ray system excluding fluoroscopic, angiographic, and mammographic applications.
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6. Indications for use [21 CFR 807.92(a)(5)]
Flat Panel Digital X-ray Detectors are indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures and not to be used for mammography
7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
There are no significant differences in the technological characteristics of these devices compared to the predicate devices which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the 14HK701G-W and the predicate devices:
| Proposed Device | Predicate Device 1 | Predicate Device 2 | |
|---|---|---|---|
| K Number | Not known | K180332 | K150165 |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | Samsung Electronics Co.,Ltd. |
| Trade Name | 14HK701G-W | 17HK700G-W | S4343-W (of GC85A) |
| Common Name | Flat Panel Digital X-rayDetector | Flat Panel Digital X-rayDetector | Flat Panel Digital X-raySystem |
| Product Code | MQB | MQB | KPR |
| RegulationNumber | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 |
| 510(k) ReviewPanel | Radiology | Radiology | Radiology |
| Indications forUse | Flat Panel Digital X-rayDetectors are indicated fordigital imaging solutiondesigned for generalradiographic system forhuman anatomy. It isintended to replace film orscreen based radiographicsystems in general purposediagnostic procedures alland not to be used formammography. | Flat Panel Digital X-rayDetector is indicated fordigital imaging solutiondesigned for generalradiographic system forhuman anatomy. It isintended to replace film orscreen based radiographicsystems in all generalpurpose diagnosticprocedures. Not to be usedfor mammography. | The GC85A Digital X-rayImaging System is intendedfor use in generatingradiographic images ofhuman anatomy by aqualified/trained doctor ortechnician. This device isnot intended formammographicapplications. |
| Detector | |||
| Scintillator | CsI | CsI | CsI |
| Imaging Area | 13.7 x 16.8 inches | 17 x 17 inches | 17 x 17 inches |
| Pixel Matrix | 2,500 x 3,052 pixels | 3,072 x 3,072 pixels | 3,036 x 3,040 pixels |
| Pixel Pitch | 140 um | 140 um | 140 um |
| High ContrastLimitingResolution(LP/mm) | 3.6 lp/mm | 3.6 | 3.57 |
| Communication | Wired/Wireless | Wired | Wired/Wireless |
| DQE | Typ.72% @0.1lp/mm | Typ.72% @0.1lp/mm | Typ.73% @0.1lp/mm |
| MTF | Typ.89% @0.5lp/mm | Typ.89% @ 0.5lp/mm | Typ.84% @ 0.5lp/mm |
| Resolution | 3.6lp | 3.6lp | 3.57lp |
[Table 1. Comparison of Proposed Device to Predicate Device]
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| Proposed Device | Predicate Device 1 | Predicate Device 2 | |
|---|---|---|---|
| Anatomical Sites | General | General | General |
| Exposure Mode | Manual, Auto(AED) | Manual, Auto(AED) | Manual, Auto(AED) |
| Wireless | Standard:802.11 a/b/g/n/accomplianceFrequency: 2.4 GHz/5GHzBandwidth:20MHz/40MHz/80MHzMIMO: 2x2 | ||
| Rating | 100-240V~, 50/60Hz | 100-240V~, 50/60Hz | 100-240V~, 50/60Hz |
There are no significant differences between the 14HK701G-W and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use. The proposed device, 14HK701G-W has been tested about electrical safety, EMC and performance, and the software has been validated. In addition, the clinical data has been provided to support the substantial equivalence to the predicate devices.
The predicate device 2 (K150165) is the X-ray system but the proposed device provides only a detector. The proposed device is substantially equivalent to the previously cleared detector which is provided as part of the complete imaging system, K150165.
The technological characteristics of the subject detector 14HK701G-W are similar to the predicate 17HK700G-W, and the only major difference is the smaller detector size.
8. Integration Specifications / Requirements for 14HK701G-W
| No. | Item | Specification |
|---|---|---|
| 1 | Power frequency | 50Hz ~ 60Hz |
| 2 | KV | 40kVp ~ 150kVp |
| 3 | mA Range | 10 to 500mA |
| 4 | Exposure Time | 0.001 to 4sec |
| 5 | mAs Range | 0.1 to 500mAs |
| 6 | Accuracy | kV < ±(1%+1kV), mA < ±(3%+1mA) |
The proposed device is provided with the recommended generator specification as follows:
9. Non-Clinical Test summary
The 14HK701G-W comply with voluntary standards for electrical safety, electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:
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- Electrical Safety, Electromagnetic Compatibility and Performance:
The 14HK701G-W comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
| StandardsNo. | StandardsOrganization | Standard Title | Version | PublicationYear |
|---|---|---|---|---|
| ES60601-1 | AAMI | Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And EssentialPerformance (IEC 60601-1:2005, MOD) | ES60601-1:2005(R)2012 andA1:2012 | 2014 |
| 60601-1-2 | IEC | Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety – Collateral Standard:Electromagnetic Compatibility - Requirementsand Tests | 60601-1-2Edition 4.02014-02 | 2016 |
| - | FDA | Radio Frequency Wireless Technology in MedicalDevices | August 14 | 2013 |
2) Software Validation
The 14HK701G-W contains MODERATE level of concern software as firmware. The software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA quidance:
- . The content of premarket submissions for software contained in medical devices, on May 11, 2005
3) Biocompatibility
- ISO 10993-1 and series, Biological evaluation of medical devices
4) Performance Test
Imaging performance test has been conducted according to:
- IEC 62220-1, Medical Electrical Equipment – Characteristics of Digital X-ray Imaging Devices – Part 1-1: Determination of the Detective Quantum Efficiency – Detectors Used in Radiographic Imaging.
5) Cybersecurity
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, on October2, 2014
- Postmarket Management of Cybersecurity in Medical Devices, on December 28, 2016
6) Label
- CFR Part 801
- Pediatric Information for X-ray Imaging Device Premarket Notifications, on November 28, 2017
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10. Clinical Test Summary
Clinical data has been provided according to FDA guidance document "Guidance for the Submission of 510(k)s for Solid Sate X-ray Imaging Devices". The data was not necessary to establish substantial equivalence based on the modifications to the device but provided further evidence in addition to the laboratory performance data to show that the device works as intended.
11. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
There are no significant differences between 14HK701G-W and the predicate devices, K150165 and K180332 that would adversely affect the use of the product. It is substantially equivalent to these devices in indications for use and technology characteristics.
12. Conclusion [21 CFR 807.92(b)(3)]
In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification LG Electronics, concludes that the 14HK701G-W is substantially equivalent in safety and effectiveness to the predicate devices as described herein.
§ 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.