(30 days)
The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
The GC85A digital X-ray imaging system is a stationary x-ray system designed for general radiography and used to capture images by transmitting X-ray to a patient's body. The Xray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving & Communication System (PACS) sever for reading images.
The GC85A digital X-ray imaging system was previously cleared with K172229, and through this premarket notification, we would like to add more configurations in the previously cleared GC85A as three High Voltage Generators and two detectors are newly added, and three software features are newly added as stated below.
S-Enhance is renamed from Tube & Line Enhancement (TLE), which was cleared before with the predicate device GM85 at K171119, to enhance visibility of tubes and lines and provide enhanced images separately from original images. In this submission, the scope of S-Enhance is expanded from tubes and lines on chest images to foreign body (e.g. tubes, lines and needles) and urinary stones on chest, abdomen, and L-spine. And Pediatric Exposure Management (PEM), which was cleared before with the predicate device GM85 at K171119, is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols, and Remote View to enable the images on the device is being displayed on the remote monitor. It was determined that the level of concern for the software contained in the GC85A digital X-ray imaging system was Moderate in accordance with the FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device".
The provided document, a 510(k) Premarket Notification for the Samsung GC85A digital X-ray imaging system, primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or presenting an in-depth study proving a device meets specific performance criteria for new features. The document describes additions and changes to an already cleared device (GC85A, K172229) and incorporates features from another predicate device (GM85, K171119).
However, based on the Clinical data section (page 8), we can infer the following about acceptance criteria and the study conducted for S-Enhance and the new detectors:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format for new features. Instead, it relies on a qualitative assessment of "equivalence" to predicate devices. For S-Enhance and the new detectors, the acceptance criteria are implicitly based on achieving equivalent image quality to the predicate devices and ensuring S-Enhance provides "clear visibility" for foreign bodies.
| Feature / Aspect | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| New Detectors | Equivalent image quality to predicate detectors (implicitly, general radiographic image quality for human anatomy). No significant difference in average score of image quality evaluation. | "Phantom image evaluations for the new detector...were performed... Anthropomorphic phantom images were provided... They were evaluated by professional radiologists and found to be equivalent to the predicate devices. There is no significant difference in the average score considering the standard deviation of image quality evaluation between the proposed device and the predicate device." |
| S-Enhance (expanded scope: foreign bodies, urinary stones) | Provides clear visibility for foreign bodies (lines, tubes, needles) and urinary stones in chest, abdomen, and L-spine protocol in companion images, while maintaining safety and effectiveness compared to the predicate. No significant difference in average score of image quality evaluation. | "it is confirmed that S-Enhance is able to generate a companion image which provide clear visibility for foreign bodies such as lines, tubes, and needles, and urinary stones in chest, abdomen, and L-spine protocol in addition to the original images." "There is no significant difference in the average score considering the standard deviation of image quality evaluation between the proposed device and the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Anthropomorphic phantom images were provided." This indicates that the images used in the evaluation were of phantoms (physical models representing human anatomy), not actual patient data. The exact number of phantom images is not specified.
- Data Provenance: The data is from "Anthropomorphic phantom images." This implies a controlled, laboratory-based study. No information about country of origin is provided, but Samsung Electronics Co., Ltd. is based in the Republic of Korea. It is a prospective study as these images were generated specifically for this evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated. The document mentions "professional radiologists."
- Qualifications of Experts: "professional radiologists." Specific experience (e.g., "10 years of experience") is not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The phrasing "evaluated by professional radiologists and found to be equivalent" suggests a consensus or majority opinion approach, but the specific method (e.g., 2+1, 3+1) is not detailed. The mention of "average score considering the standard deviation of image quality evaluation" suggests a quantitative assessment that might have been averaged across multiple readers, but the method of handling disagreements is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- A formal MRMC comparative effectiveness study to quantify human reader improvement with vs. without AI assistance was not described in the provided text. The study described focuses on whether the device's image quality (including S-Enhance) is equivalent to predicate devices, and whether S-Enhance provides clear visibility. It does not measure the impact of AI assistance on human reader performance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- The document implies that the S-Enhance feature (an algorithm) was evaluated in terms of its ability to "generate a companion image which provide clear visibility for foreign bodies." This is a form of standalone evaluation of the algorithm's output. However, it's not a standalone diagnostic performance study (e.g., sensitivity/specificity of an AI model to detect foreign bodies). The evaluation relies on human radiologists assessing the quality and visibility provided by the algorithm's output.
7. The Type of Ground Truth Used
- For the phantom images, the "ground truth" for the new detectors and S-Enhance would be the inherent properties and known structures within the anthropomorphic phantoms. The "equivalence" assessment by radiologists serves as the validation of how well the device's images represent this known ground truth. It's essentially an expert consensus on image quality and perceptibility of structures in controlled phantom images.
8. The Sample Size for the Training Set
- Details about the training set for S-Enhance (or any other software feature) are not provided in this document. Given that S-Enhance was "renamed from Tube & Line Enhancement (TLE), which was cleared before with the predicate device GM85 at K171119," it's likely that any training for the core functionality occurred prior to this submission and was part of the K171119 clearance. This submission expands the scope of S-Enhance.
9. How the Ground Truth for the Training Set was Established
- As the training set details are not provided, information on how its ground truth was established is also not available in the document.
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July 20, 2018
Samsung Electronics Co., Ltd. % Jaesang Noh Senior Professional, Regulatory Affairs 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do 16677 REPUBLIC OF KOREA
Re: K181629
Trade/Device Name: GC85A Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: June 15, 2018 Received: June 20, 2018
Dear Jaesang Noh:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 medical devices and radiation-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,
Hole 2. Nils
Robert 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 SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name GC85A
Indications for Use (Describe)
The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Prescription Use (Part 21 CFR 801 Subpart D) ] Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services
Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Premarket Notification - Traditional
Section 5: 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92
-
- Date: June 15, 2018
2. Submitter
- A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, Republic of Korea
3. Primary Contact Person
- A. Name: JAESANG NOH & CHUNSIN KIM
- B. Title: Regulatory Affairs, Senior Professional
- C. Phone Number: +82-2-2193-2444 & +82-2-2193-2437
- D. FAX Number: +82-31-200-6401
- E-Mail: jaesang.noh@samsung.com & chulsin.kim@samsung.com ய்
4. Secondary Contact Person
- A. Name: Genci Omari
- B. Title: Manager, Regulatory Affairs
- C. Phone Number: 978-564-8602
- D. FAX Number: 978-560-0602
- E. E-Mail: gomari@samsungneurologica.com
5. Proposed Device
- A. Trade Name: GC85A
- B. Device Name: GC85A
- C. Common Name: Digital Diagnostic X-ray System
- D. Regulation Name: Stationary X-ray system
- E. Product Code: KPR
- ட் Regulation: 21 CFR 892.1680
6. Predicate Devices
| Predicate Device #1 | Predicate Device #2 | |
|---|---|---|
| Device Name | GC85A | GM85 |
| Classification Name | Stationary X-raySystem | Mobile X-ray System |
| Product Code | KPR | IZL |
| Regulation | 21 CFR 892.1680 | 21 CFR 892.1720 |
| 510(K)# | K172229 | K171119 |
| 510(K) Decision Date | Nov., 22, 2017 | May, 12, 2017 |
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Image /page/4/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed on a blue, rounded, rectangular background.
510(k) Premarket Notification - Traditional
7. Device Description
The GC85A digital X-ray imaging system is a stationary x-ray system designed for general radiography and used to capture images by transmitting X-ray to a patient's body. The Xray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving & Communication System (PACS) sever for reading images.
The GC85A digital X-ray imaging system was previously cleared with K172229, and through this premarket notification, we would like to add more configurations in the previously cleared GC85A as three High Voltage Generators and two detectors are newly added, and three software features are newly added as stated below.
S-Enhance is renamed from Tube & Line Enhancement (TLE), which was cleared before with the predicate device GM85 at K171119, to enhance visibility of tubes and lines and provide enhanced images separately from original images. In this submission, the scope of S-Enhance is expanded from tubes and lines on chest images to foreign body (e.g. tubes, lines and needles) and urinary stones on chest, abdomen, and L-spine. And Pediatric Exposure Management (PEM), which was cleared before with the predicate device GM85 at K171119, is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols, and Remote View to enable the images on the device is being displayed on the remote monitor. It was determined that the level of concern for the software contained in the GC85A digital X-ray imaging system was Moderate in accordance with the FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device".
8. Intended Use
The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
9. Summary of Technological characteristic of the proposed device compared with the predicate device
The proposed device GC85A apply software features as S-Enhance and Pediatric Exposure, which were cleared with K171119, and Remote View to GC85A product which was cleared with K172229 without changes in technical characteristics, materials, energy sources and biocompatibility such as X-ray Tube Assembly except of high voltage generator and detector. Optional high voltage generators and detectors which were improved durability and dust/water-resistance are added to GC85A.
Comparisons of technological characteristics were executed and demonstrate the substantial equivalence to the predicate.
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Image /page/5/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed inside of a blue, oval shape.
510(k) Premarket Notification - Traditional
| Specification | PredicateDevice #1 | ProposedDevice | PredicateDevice #2 | Discussion |
|---|---|---|---|---|
| Device Name | GC85A | GC85A | GM85 | |
| Manufacturer | SAMSUNGELECTRONICSCo., Ltd. | SAMSUNGELECTRONICSCo., Ltd. | SAMSUNGELECTRONICSCo., Ltd. | |
| 510(k) Number | K172229 | None | K171119 | |
| Appearances | Image: GC85A X-ray system | Image: GC85A X-ray system | Image: GM85 Mobile X-ray system | Same as PD#1 |
| Intended Use | The GC85Adigital X-rayimaging systemis intended foruse ingeneratingradiographicimages ofhuman anatomyby aqualified/traineddoctor ortechnician. Thisdevice is notintended formammographicapplications. | The GC85ADigital X-rayImaging Systemis intended foruse ingeneratingradiographicimages ofhuman anatomyby aqualified/traineddoctor ortechnician. Thisdevice is notintended formammographicapplications. | The GM85Digital Mobile X-ray imagingSystem isintended for usein generatingradiographicimages ofhuman anatomyby aqualified/traineddoctor ortechnician. Thisdevice is notintended formammographicapplications. | Same as PD#1 |
| t | Comparing with Predicate Device | |||
|---|---|---|---|---|
| --- | --------------------------------- | -- | -- | -- |
| ManufacturerContents | GC85A(K172229) | GC85A | GM85(K171119) | Discussion |
|---|---|---|---|---|
| (1)High Voltage Generator | ||||
| Max. Power | 82kW | 82kW | 32kW / 40kW | Difference(1) |
| OutputRANGE | 40-150kV | 40 - 150kV | 40-150kV | Same |
| TubeVoltage | ||||
| TubeCurr | 10-1000mA | 10 - 500mA | 10 - 500mA |
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Image /page/6/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded rectangle.
510(k) Premarket Notification - Traditional
| ManufacturerContents | GC85A(K172229) | GC85A | GM85(K171119) | Discussion | |||
|---|---|---|---|---|---|---|---|
| ent | mA | mA | AA | ||||
| ExposureTime | 1msec-10sec | 1msec-10sec | 1msec-10sec | 1msec-10sec | 1msec-10sec | Same | |
| AEC(AutomaticExposureControl) | Yes | Yes | - | Same as PD#1 | |||
| APR(AnatomicallyProgrammedRadiography) | Yes | Yes | - | Same as PD#1 |
| ManufacturerContents | GC85A (K172229) | GC85A | GM85(K171119) | Discussion |
|---|---|---|---|---|
| (2) Detector | ||||
| Name | S4335-WS4343-WS3025-W | S4335-WS4343-WS3025-WS4335-AWS4343-AW | S4335-WS4343-WS3025-W | Difference(3) |
| S4335-W | S4335-AW | S4335-W | ||
| S4343-W | S4343-AW | S4343-W | ||
| Detector Type | Csl | Csl | Csl | Same |
| Indirect | Indirect | Indirect | Same | |
| Detector Area | 14"X17"(345mmX425mm) | 17"X17"(425mmX425mm) | 14"X17"(345mmX425mm) | Same |
| 17"X17"(425mmX425mm) | 14"X17"(345mmX425mm) | 17"X17"(425mmX425mm) | Same | |
| Number of pixels | 2466X3040 | 3036X3040 | 2466X3040 | Same |
| 3036X3040 | 2466X3040 | 3036X3040 | Same | |
| Pixel Pitch(um) | 140 | 140 | 140 | Same |
| High ContrastLimitingResolution(LP/mm) | 3.57 | 3.57 | 3.57 | Same |
| Communication | Wired /Wireless | Wired /Wireless | Wired /Wireless | Same |
| Dust/Water-resistance | IPx1 | IP54 | IPx1 | Difference(3)-1 |
| Max.loadcapacity | 150 kg for uniformload,100 kg for localload (40 mm indiameter disk at | 400 kg for uniformload,200 kg for localload (40 mm indiameter disk at | 150 kg for uniformload,100 kg for localload (40 mm indiameter disk at | Difference(3)-2 |
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510(k) Premarket Notification - Traditional
| ManufacturerContents | GC85A (K172229) | GC85A | GM85(K171119) | Discussion |
|---|---|---|---|---|
| the center) | the center) | the center) |
| ManufacturerContents | GC85A (K172229) | GC85A | GM85(K171119) | Discussion |
|---|---|---|---|---|
| (3) Software Features | ||||
| FeatureNames | SimGrid | SimGrid | SimGrid | Same |
| S-Guide | S-Guide | - | Same asPD#1 | |
| - | S-Enhance | TLE | Difference(4) | |
| - | PEM | PEM | Same asPD#2 | |
| S-DAP | S-DAP | S-DAP | Same | |
| S-Align | S-Align | S-Align | Same | |
| S-Share | S-Share | S-Share | Same | |
| BSI | BSI | BSI | Same | |
| - | Remote View | - | Difference(5) |
| No | Differences | Explanation |
|---|---|---|
| (1) | HVG Power rating | Optional HVGs which are added to the GC85A device have lower max power than the predicate device's max power and these changes do not contribute any adverse impact to the device's safety and effectiveness. |
| (2) | HVG mA range | Optional HVGs which are added to the GC85A device have lower max current than the predicate's max current and these changes do not contribute any adverse impact to the device's safety and effectiveness. |
| (3)-1 | Dust/Water-resistance | The new detectors which are added to the GC85A device have better dust/water-resistance than the predicate device's dust/water-resistance and this change does not contribute any adverse impact to the device's safety and effectiveness. |
| (3)-2 | Max.load capacity | The new detectors which are added to the GC85A device have higher max load capacity than the predicate device's |
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510(k) Premarket Notification - Traditional
| max load capacity and this change does not contribute anyadverse impact to the device's safety and effectiveness. | ||
|---|---|---|
| (4) | S-Enhance | S-Enhance is renamed from Tube & Line Enhancement(TLE), which was cleared with K171119, is to enhancevisibility of tubes and lines and provide enhanced imagesseparately from original images. This software feature isapplied to the GC85A with the scope of application for S-Enhance, which is expanded from tubes and lines on chestimages to foreign body (e.g. tubes, lines and needles) andurinary stones on chest, abdomen and L-spine images.This change is considered low risk and does not contributeany adverse impact to the device's safety andeffectiveness. |
| (5) | Remote View | The function of Remote View, which allows remote accessto view the current image on the workstation through a webbrowser, is applied to the GC85A and this change does notcontribute any adverse impact to the device's safety andeffectiveness. |
B. Safety, EMC and Performance Data
Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1,IEC 60601-1-2,IEC 60601-1-3,IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards.
C. Non-clinical data
Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 62220-1. The proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements form the predicate device.
D. Clinical data
Phantom image evaluations for the new detector and S-Enhance were performed in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. Anthropomorphic phantom images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (note X-ray flat-panel detector similar to the predicate detector) but they provide further evidence in addition to the performance data to show that the complete system works as intended. They were evaluated by professional radiologists and found to be equivalent to the predicate devices. There is no significant difference in the average score considering the standard deviation of image quality evaluation between the proposed device and the predicate device and it is confirmed that S-Enhance is able to generate a companion image which provide clear visibility for foreign bodies such as lines, tubes, and
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Image /page/9/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font. The word is set against a blue, oval-shaped background. The oval is tilted slightly upward from left to right.
510(k) Premarket Notification - Traditional
needles, and urinary stones in chest, abdomen, and L-spine protocol in addition to the original images. Therefore, these changes do not affect either the safety or the effectiveness, compared to the predicated device.
E. Conclusions
The non-clinical and clinical data demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed 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.