(57 days)
The Flat Panel Digital X-ray Detector 17HQ701G-B is 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. Not to be used for mammography.
This model is an x-ray imaging device, a system that can acquire and process X-ray images as digital images. It utilizes amorphous silicon and a high-performance scintillator to ensure sharp high-definition image quality with the resolution of 3.6 lp/mm and the pixel pitches of 140 um. This device is a flat panel based X-ray image acquisition device must be used in conjunction with an operating PC and an X-ray generator. This device can be used for digitizing and transferring X-ray images for radiological diagnosis. The data transmission between the Detector and PC can be enabled with a wired (cable) or wireless connection.
This document describes the premarket notification (510(k)) for the LG Electronics Inc. 17HQ701G-B Flat Panel Digital X-ray Detector. The submission aims to demonstrate substantial equivalence to a predicate device, not to prove superiority or innovation. Therefore, the "acceptance criteria" discussed are primarily related to meeting established X-ray device performance standards and demonstrating equivalence to a legally marketed predicate.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed as specific quantitative thresholds for clinical performance but are implied by adherence to general safety, performance, and equivalence standards for X-ray imaging devices. The document focuses on demonstrating that the proposed device performs comparably to its predicate and meets relevant non-clinical standards.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety (ES60601-1) | The 17HQ701G-B complies with ES60601-1 (2005(R)2012 and A1:2012) |
| Electromagnetic Compatibility (IEC 60601-1-2) | The 17HQ701G-B complies with IEC 60601-1-2 (Edition 4.0 2014-02) |
| Radio Frequency Wireless Technology Compliance | Complies with FDA guidance "Radio Frequency Wireless Technology in Medical Devices" (August 14, 2013) |
| Software Validation (Moderate Level of Concern) | Software designed, developed, verified, and validated according to a software development process and FDA guidance "The content of premarket submissions for software contained in medical devices" (May 11, 2005). |
| Biocompatibility (ISO 10993-1) | Complies with ISO 10993-1 and series, "Biological evaluation of medical devices". |
| Imaging Performance (Detective Quantum Efficiency - DQE) | Performance test conducted according to IEC 62220-1. Reported DQE: Typ. 66% @0.1lp/mm (Proposed Device) vs. Typ. 72% @0.1lp/mm (Predicate Device). The gap analysis states this difference is "not related to the device's 'safety and 'performance.'" |
| Imaging Performance (Modulation Transfer Function - MTF) | Performance test conducted according to IEC 62220-1. Reported MTF: Typ. 84% @0.5lp/mm (Proposed Device) vs. Typ. 89% @0.5lp/mm (Predicate Device). The gap analysis states this difference is "not related to the device's 'safety and 'performance.'" |
| Imaging Performance (Limiting Resolution) | Reported High Contrast Limiting Resolution: 3.6 lp/mm (Same as Predicate Device). |
| Cybersecurity | Complies with FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (October 18, 2018) and "Postmarket Management of Cybersecurity in Medical Devices" (December 28, 2016). |
| Labeling | Complies with CFR Part 801 and "Pediatric Information for X-ray Imaging Device Premarket Notifications" (November 28, 2017). |
| Substantial Equivalence to Predicate Device (K182348) | Demonstrated equivalence in Indications for Use, Intended Use, Scintillator type, Pixel Pitch, Resolution, Anatomical Sites, Exposure Mode, Semi Dynamic mode, Wireless standard, and Rating. Differences in Imaging Area, Pixel Matrix, DQE, and MTF are deemed not to adversely affect safety or performance. "Clinical data has been provided... to show that the device works as intended." |
2. Sample size used for the test set and the data provenance
The document states: "Clinical data has been provided according to FDA guidance document 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices'." It further clarifies that this 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."
Crucially, the document does not specify the sample size, data provenance (e.g., country of origin, retrospective or prospective nature), or specific details of the clinical test set. It only broadly mentions that clinical data was provided. This suggests the clinical data was likely used for general verification rather than a specific performance study with a defined test set sample size for "acceptance criteria" in the AI sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information about the number or qualifications of experts used to establish ground truth for any test set. Given that the submission focuses on substantial equivalence to a predicate device and adheres to technical standards, an explicit ground truth establishment by clinical experts for a specific test set is not detailed in the provided text.
4. Adjudication method for the test set
The document does not provide any information regarding an adjudication method for a test set. This type of detail is typically associated with studies involving human interpretation or AI performance assessment against a consensus ground truth, which is not clearly described here.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this document. The purpose of this 510(k) submission is to demonstrate the substantial equivalence of an X-ray detector to a predicate device, not to evaluate the impact of AI assistance on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a Flat Panel Digital X-ray Detector, which is a hardware component for capturing X-ray images. It is not an AI algorithm in itself that would have a "standalone" performance without human-in-the-loop interaction. Its "performance" refers to its imaging characteristics (DQE, MTF, resolution).
The software mentioned is for the device's firmware and functionality, not an AI for image interpretation. Therefore, a standalone algorithm-only performance study as typically understood for AI-powered diagnostic software is not applicable and not reported.
7. The type of ground truth used
For the non-clinical performance tests (DQE, MTF, Resolution), the "ground truth" is established by physical measurements and adherence to international standards like IEC 62220-1.
For the general statement about "clinical data" provided, the type of ground truth used is not specified. Given the context of a 510(k) for an X-ray detector, it likely refers to standard clinical evaluations of image quality for diagnostic purposes, where the "ground truth" would implicitly be the physician's diagnostic conclusion or potentially follow-up information, but this is not explicitly stated.
8. The sample size for the training set
The device is an X-ray detector, not an AI model that requires a distinct "training set" of images for learning. The "software validation" relates to the device's firmware, not a diagnostic AI algorithm trained on a large image dataset. Therefore, the concept of a "training set" for an AI algorithm is not applicable to this submission.
9. How the ground truth for the training set was established
As there is no AI algorithm training set described, the method for establishing ground truth for a training set is not applicable to this document.
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July 13, 2022
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LG Electronics Inc. % Woo Chai Kyoung Senior Consultant GMS Consulting 4th Floor, Digital Cube. 34. Sangamsan-ro Seoul, Mapo-gu 03909 KOREA
Re: K221434
Trade/Device Name: 17HQ701G-B Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: May 16, 2022 Received: May 17, 2022
Dear Woo Chai Kyoung:
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,
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) K221434
Device Name 17HQ701G-B
Indications for Use (Describe)
The Flat Panel Digital X-ray Detector 17HQ701G-B is 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. Not to be used 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
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
May 16, 2022
2. Submitter's Information [21 CFR 807.92(a)(1)]
| • | Name of Sponsor:- Address: | LG Electronics Inc.77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381,Republic of Korea |
|---|---|---|
| • | Name of Manufacturer:- Address: | LG Electronics Inc.77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381,Republic of Korea |
| • | Contact Name:- Telephone No.:- Email Address: | Jinhwan Jun / Chief Research Engineer+82-31-8066-5641jinhwan.jun@lge.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade/Device/Model Name | 17HQ701G-B |
|---|---|
| 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
| ● | 510(k) Number: | K182348 |
|---|---|---|
| ● | Applicant: | LG Electronics Inc. |
| ● | Trade/Device Name: | 14HK701G-W |
| ● | Common Name: | Flat Panel Digital X-ray Detector |
| ● | Classification Name: | Stationary X-ray System |
| ● | Regulation Number: | 21 CFR 892.1680 |
| ● | Classification ProductCode | MQB |
| ● | 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)]
This model is an x-ray imaging device, a system that can acquire and process X-ray images as digital images. It utilizes amorphous silicon and a high-performance scintillator to ensure sharp high-definition image quality with the resolution of 3.6 lp/mm and the pixel pitches of 140 um. This device is a flat panel based X-ray image acquisition device must be used in conjunction with an operating PC and an X-ray generator. This device can be used for digitizing and transferring X-ray images for radiological diagnosis. The data transmission between the Detector and PC can be enabled with a wired (cable) or wireless connection.
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6. Indications for use [21 CFR 807.92(a)(5)]
The Flat Panel Digital X-ray Detector 17HQ701G-B is 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. Not to be used for mammography.
7. Intended Use [21 CFR 807.92(a)(5)]
The Flat Panel Digital X-ray Detector 17HQ701G-B is a prescription device, and it is not intended to be used for mammography.
- The detector is indicated for digital imaging solution designed for general radiographic system for human anatomy
- The detector is indicated to replace film or screen based radiographic systems in all general purpose diagnostic procedures.
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8. 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 17HQ701G-B and the predicate devices:
| Proposed Device | Predicate Device | Note | |
|---|---|---|---|
| K Number | TBD | K182348 | - |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | Same |
| Trade Name | 17HQ701G-B | 14HK701G-W | - |
| Common Name | Flat Panel Digital X-ray Detector | Flat Panel Digital X-ray Detector | Same |
| Product Code | MQB | MQB | Same |
| RegulationNumber | 21 CFR 892.1680 | 21 CFR 892.1680 | Same |
| 510(k) ReviewPanel | Radiology | Radiology | Same |
| Indications forUse | The Flat Panel Digital X-ray Detector17HQ701G-B is indicated for digitalimaging solution designed for generalradiographic system for humananatomy. It is intended to replacefilm or screen based radiographicsystems in all general purposediagnostic procedures. Not to beused for mammography. | Flat Panel Digital X-ray Detectors areindicated for digital imaging solutiondesigned for general radiographicsystem for human anatomy. It isintended to replace film or screenbased radiographic systems ingeneral purpose diagnosticprocedures all and not to be used formammography. | Same |
| Intended use | The Flat Panel Digital X-ray Detector17HQ701G-B is a prescription device,and it is not intended to be used formammography.- The detector is indicated fordigital imaging solutiondesigned for generalradiographic system forhuman anatomy- The detector is indicated toreplace film or screen basedradiographic systems in allgeneral purpose diagnosticprocedures. | The Flat Panel Digital X-ray Detector14HK701G-W is a prescription device,and it is not intended to be used formammography.- The detector is indicated fordigital imaging solutiondesigned for generalradiographic system forhuman anatomy- The detector is indicated toreplace film or screen basedradiographic systems in allgeneral purpose diagnosticprocedures. | Same |
| Detector | |||
| Scintillator | CsI | CsI | Same |
| Imaging Area | 17 x 17 inches | 13.7 x 16.8 inches | Different |
| Pixel Matrix | 3,072 x 3,072 pixels | 2,500 x 3,052 pixels | Different |
| Pixel Pitch | 140 um | 140 um | Same |
| High ContrastLimitingResolution(LP/mm) | 3.6 lp/mm | 3.6 lp/mm | Same |
| Communication | Wired/Wireless | Wired/Wireless | Same |
| DQE | Typ.66% @0.1lp/mm | Typ.72% @0.1lp/mm | Different |
| MTF | Typ.84% @0.5lp/mm | Typ.89% @0.5lp/mm | Different |
| [Table 1. Comparison of Proposed Device to Predicate Device] | |||
|---|---|---|---|
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| Proposed Device | Predicate Device | Note | |
|---|---|---|---|
| Resolution | 3.6lp | 3.6lp | Same |
| Anatomical Sites | General | General | Same |
| Exposure Mode | Manual, Auto (AED) | Manual, Auto (AED) | Same |
| Semi Dynamicmode | O | O | Same |
| Wireless | Standard:802.11 a/b/g/n/ac complianceFrequency: 2.4 GHz/5GHzBandwidth: 20MHz/40MHz/80MHzMIMO: 2x2 | Standard:802.11 a/b/g/n/ac complianceFrequency: 2.4 GHz/5GHzBandwidth: 20MHz/40MHz/80MHzMIMO: 2x2 | Same |
| Rating | 24V --- 2.1A | 24V --- 2.1A | Same |
| Gap Analysis | There is some difference in the 'Image Area', 'Pixel Matrix', 'DQE' and 'MTF'. ImageArea, Pixel Matrix, DQE and MTF are not related to the device's 'safety and'performance.' So Proposed device (17HQ701G-B) and Predicate Device (14HK701G-W) are substantially same. |
** Semi Dynamic mode is a function that can transmit five images per second to the PC.
There are no significant differences between the 17HQ701G-B and the predicate device 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, 17HQ701G-B 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.
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9. Non-Clinical Test summary
The 17HQ701G-B comply with voluntary standards for electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:
- Electrical Safety, Electromagnetic Compatibility and Performance:
The 17HQ701G-B 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 17HQ701G-B 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 October 18, 2018
- Postmarket Manaqement of Cybersecurity in Medical Devices, on December 28, 2016 ●
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-
- Label
- CFR Part 801
- Pediatric Information for X-ray Imaging Device Premarket Notifications, on November 28, 2017
10. Clinical Test Summary
Clinical data has been provided according to FDA quidance 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 17HQ701G-B and the predicate device, K182348 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 17HQ701G-B is substantially equivalent in safety and effectiveness to the predicate device 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.