(30 days)
The GC70 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 GC70 digital X-ray imaging system is used to capture images by transmitting X-ray to a patient's body. The X-ray 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 device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.
The provided text describes a 510(k) premarket notification for the SAMSUNG GC70 Digital X-ray Imaging System. This document asserts the substantial equivalence of the GC70 to a predicate device (GC85A) and primarily discusses safety, EMC, and performance data based on standard compliance and phantom image evaluations. It does not contain information about acceptance criteria and a study proving the device meets specific clinical performance acceptance criteria in terms of diagnostic accuracy, sensitivity, or specificity for a particular clinical application. Instead, it focuses on demonstrating that the device is safe and performs comparably to its predicate regarding image quality and technical specifications.
Therefore, the following information is not present in the provided text:
- A table of acceptance criteria and the reported device performance: The document does not define specific clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) for the GC70, beyond general safety and imaging quality.
- Sample size used for the test set and the data provenance: No details on the sample size or origin for clinical test data (if any was used beyond phantom evaluations) are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no diagnostic accuracy study on human data is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: The document does not describe an MRMC study or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a digital X-ray system, not an AI algorithm, so this is not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the "clinical data" section, it refers to "phantom image evaluations."
- The sample size for the training set: Not applicable as there is no mention of a training set for an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
However, based on what is available, here's a summary of the stated "acceptance criteria" (which are more focused on technical equivalence and safety) and the studies mentioned:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table of clinical acceptance criteria for diagnostic performance (like sensitivity or specificity). Instead, it focuses on demonstrating technical equivalence and safety to a predicate device (GC85A). The "acceptance" can be inferred from the comparisons made to the predicate and compliance with regulatory standards.
| Acceptance Criterion (Inferred from comparison) | Reported Device Performance (GC70 vs. GC85A) |
|---|---|
| Intended Use Equivalence | Same (GC70 and GC85A are both intended for generating radiographic images of human anatomy, not mammographic applications). |
| Imaging Performance (Detectors) | Same detectors (S4335-W, S4343-W, S3025-W) as the predicate device (GC85A). Reported MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) values for these detectors are identical to those of the predicate device (e.g., S4335-W: MTF 84% (0.5 lp/mm, Typical), DQE 73% (0.1 lp/mm, Typical)). |
| Image Processing Equivalence | Same image processing as the predicate device (GC85A). Specifically mentions "SimGrid" and "Bone Suppression Image" features are the same. SimGrid compensates for contrast loss due to scatter radiation, and Bone Suppression enhances visualization of chest pathology by suppressing bone anatomy in a companion image. |
| Safety, EMC, and Radiation Control Compliance (Electrical, Mechanical, Environmental) | Compliant with: ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30, 21CFR1020.31. EMC testing conducted in accordance with IEC 60601-1-2. Wireless function tested per "Radio frequency Wireless Technology in Medical Devices" guidance. All test results were satisfying the standards. |
| Non-clinical Imaging Performance (MTF and DQE) | Evaluated in conformance with FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices" and tested by IEC 62220-1. The proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device. |
| Software Development & Testing | Developed & tested according to IEC62304 and FDA "Guidance for Content of Premarket Submissions for Software Contained in Medical Devices." |
| Dosimetry Performance | Evaluated with IEC60601-1. Recommended exposure chart provided in the user manual. |
| Clinical Equivalence (based on images) | Phantom image evaluations performed in accordance with FDA guidance for solid-state X-ray imaging devices. Evaluated by a professional radiologist and found to be equivalent to the predicate device. |
| Impact of design differences on safety/performance/image quality (e.g., Max. Power, Tube Current, Wall Stand/Table dimensions, Patient Weight) | The document explicitly states that various differences in maximum power, tube current, vertical/lateral movement ranges, detector tilting, table dimensions, and maximum patient weight "do not contribute any adverse impacts to the device's safety and performance and image quality." This indicates acceptance based on a lack of negative impact from these differences. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The "clinical data" mentioned refers to "phantom image evaluations," not human patient data. Therefore, a sample size for a patient test set is not provided. The data provenance is not specified, but the device manufacturer is based in the Republic of Korea. The phantom studies are inherently retrospective/prospective in the sense that they are conducted in a controlled environment, not on real patients over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
For the "phantom image evaluations," it states they were "evaluated by a professional radiologist." The exact number (e.g., one or more) and specific qualifications (e.g., years of experience) of this radiologist are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified for the phantom image evaluations. Given the mention of "a professional radiologist" (singular), it implies no adjudication method was explicitly used for multiple readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was mentioned. The device is a digital X-ray system, not an AI-assisted diagnostic tool in the context described here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The GC70 is an X-ray imaging system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the "clinical data" section, the ground truth was phantom image evaluations assessed for equivalence to the predicate by a radiologist. This is a technical assessment of image quality using a standardized object rather than diagnostic accuracy against a clinical outcome.
8. The sample size for the training set:
Not applicable. The document describes an X-ray system, not an AI algorithm that would require a training set.
9. How the ground truth for the training set was established:
Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 7, 2016
SAMSUNG ELECTRONICS Co., Ltd. % Mr. Chulsin Kim Regulatory Affairs Manager 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do 16677 REPUBLIC OF KOREA
Re: K163115
Trade/Device Name: GC70 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 31, 2016 Received: November 7, 2016
Dear Mr. Kim:
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
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 GC70
Indications for Use (Describe)
The GC70 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.
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) 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."
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: Oct 31, 2016
2. Submitter
- Company Name: SAMSUNG ELECTRONICS Co., Ltd. A.
- Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, B. Republic of Korea
3. Primary Contact Person
- A. Name: KIM, CHULSIN
- B. Title: Regulatory Affairs Manager
- Phone Number: +82-31-200-7661 ﻥ
- FAX Number: +82-31-200-1199 D. E-Mail: chulsin.kim@samsung.com
4. Secondary Contact Person
- A. Name: Ninad Gujar
- B. Title: Director of Regulatory Affairs
- C. Phone Number: 978-564-8503
- FAX Number: 978-750-6677 D. E-Mail: ngujar@samsungneurologica.com
5. Proposed Device
- A. Trade Name: GC70
- B. Device Name: GC70
- C. Common Name: Digital Diagnostic X-ray System
- Classification Name: Stationary x-ray system D.
- E. Product Code: KPR
- F. Regulation: 21 CFR 892.1680
6. Predicate Devices
- A. Trade Name: GC85A
- B. Device Name: GC85A
- Common Name: Digital Diagnostic X-ray System ﻥ
- D. Classification Name: Stationary x-ray system
- Product Code: KPR ய்
- ட் Regulation: 21 CFR 892.1680
- G. 510(k): K160997
7. Device Description
The GC70 digital X-ray imaging system is used to capture images by transmitting X-ray
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510(k) Premarket Notification - Traditional
to a patient's body. The X-ray 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 device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.
8. Intended Use
The GC70 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 devices
The proposed device, GC70, has same detectors and image processing as the predicate device so it does not have significant changes in imaging performance in comparison to the predicate device, and has few configuration options more as HVG(High Voltage Generator), Wall Stand and Patient Table are added.
| Specification | Predicate Device | Proposed Device | Discussion |
|---|---|---|---|
| Device Name | GC85A | GC70 | |
| Manufacturer | SAMSUNG ELECTRONICSCo., Ltd. | SAMSUNG ELECTRONICSCo., Ltd. | Same |
| 510(k) Number | K160997 | None | |
| Appearances | Image: GC85A X-ray machine | Image: GC70 X-ray machine | Difference(1) |
| Intended Use | The GC85A digital X-rayimaging system is intendedfor use in generatingradiographic images ofhuman anatomy by aqualified/trained doctor ortechnician. This device is notintended for mammographicapplications. | The GC70 Digital X-rayImaging System is intendedfor use in generatingradiographic images ofhuman anatomy by aqualified/trained doctor ortechnician. This device isnot intended formammographicapplications. | Same |
| Manufacturer Contents | GC85A(K160997) | GC70 | Discussion |
| (1)High Voltage Generator |
A. Comparing with Predicate Device
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510(k) Premarket Notification - Traditional
| Manufacturer Contents | GC85A(K160997) | GC70 | Discussion | |
|---|---|---|---|---|
| Max. Power | 82kW | 52kW | Same &Differences(2) | |
| OutputRANGE | Tube Voltage | 40-150kV | 40-150kV | Same |
| Tube Current | 10-1000mA | 10-640mA | Same &Differences(3) | |
| Exposure Time | 1msec-10sec | 1msec-10sec | Same |
| Manufacturer Contents | GC85A (K160997) | GC70 | Discussion | ||
|---|---|---|---|---|---|
| (3) Wall Stand | |||||
| VerticalMovement | Mechanism | Motorized | Motorized | Same | |
| Range(mm) | 280~1850 | 412~1838 | Differences(4) | ||
| Detector | Tilting | Motorized | Motorized | Motorized | Same |
| -20~+90 | -20~+90 | -30~+90 | Differences(5) |
| Manufacturer Contents | GC85A(K160997) | GC70 | Discussion | ||
|---|---|---|---|---|---|
| (4)Patient Table | |||||
| TableTop | Size(mm) | 2410 X 812 | 2410 X 812 | 2200 X 810 | Same |
| Range(mm) | Lateral±140Longitudinal±480 | Lateral±140Longitudinal±480 | Lateral±125Longitudinal±500 | Same &Differences(6)Same &Differences(7) | |
| Tableheight | Mechanism | DC Motor,Ball screw | DC Motor,Ball screw | DC Motor,Ball screw | Same |
| Range(mm) | 545 ~ 900 | 545 ~ 900 | 565 ~ 850 | Same &Differences(8) | |
| Horizontal range ofdetector(mm) | 688 | 688 | 290 | Same &Differences(9) | |
| Maximum PatientWeight(kg) | 350(Static, Centerload) | 350(Static, Centerload) | 300(Static,Center load) | Same &Differences(10) |
| ManufacturerContents | GC85A (K160997) | GC70 | Discussion | ||||
|---|---|---|---|---|---|---|---|
| (6) Detector (already cleared with K160997) | |||||||
| Name | S4335-W | S4343-W | S3025-W | S4335-W | S4343-W | S3025-W | Same |
| MTF | 84%(0.5 lp/mm,Typical) | 85 %(0.5 lp/mm,Typical) | 86%(0.5 lp/mm,Typical) | 84%(0.5 lp/mm,Typical) | 85 %(0.5 lp/mm,Typical) | 86%(0.5 lp/mm,Typical) | Same |
| DQE | 73%(0.1 lp/mm,Typical) | 80 %(0.1 lp/mm,Typical) | 78%(0.1 lp/mm,Typical) | 73%(0.1 lp/mm,Typical) | 80 %(0.1 lp/mm,Typical) | 78%(0.1 lp/mm,Typical) | Same |
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510(k) Premarket Notification - Traditional
| ManufacturerContents | GC85A (K160997) | GC70 | Discussion |
|---|---|---|---|
| (8) Software Features (already cleared with K160997) | |||
| Feature Names | SimGrid | SimGrid | Same |
| Bone Suppression Image | Bone Suppression Image | Same | |
| Description |
The SimGrid is an additional image processing software option which is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical anti-scatter grid.
The Bone Suppression Software features that will be made to Samsung Digital X-ray imaging Systems are adding Samsung's new post image processing algorithm. This SW can provide companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol. The Bone Suppression software option suppresses bone anatomy to enhance visualization of chest pathology in a companion image that is delivered in addition to the original diagnostic image.
| No | Differences | Explanation |
|---|---|---|
| (1) | Appearance | The table and stand of the proposed device is a basic model incomparison with the predicate device's one, which does notcontribute any adverse impacts to the device's safety andperformance and image quality. |
| (2) | Max. Power | The difference of max power rate does not contribute any adverseimpacts to the device's safety and performance and image quality. |
| (3) | Tube Current | The difference of tube current does not contribute any adverseimpacts to the device's safety and performance and image quality. |
| (4) | VerticalMovement -Range | The difference of vertical Moving range does not contribute anyadverse impacts to the device's safety and performance and imagequality. |
| (5) | Detector - Tilting | The difference of Detector - Tilting does not contribute any adverseimpacts to the device's safety and performance and image quality. |
| (6) | Table Top -Lateral | The difference of lateral moving range does not contribute anyadverse impacts to the device's safety and performance and imagequality. |
| (7) | Table Top -Longitudinal | The difference of table top longitudinal moving range does notcontribute any adverse impacts to the device's safety andperformance and image quality. |
| (8) | Table Height -range | The difference of Table Height - range does not contribute anyadverse impacts to the device's safety and performance and imagequality. |
| (9) | Horizontal rangeof detector. | The difference of horizontal range of detector does not contributeany adverse impacts to the device's safety and performance andimage quality. |
| (10) | Maximum PatientWeight | The difference of maximum patient weight does not contribute anyadverse impacts to the device's safety and performance and imagequality. |
B. Difference Table
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Image /page/7/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is sans-serif and bold, and the letters are evenly spaced. The blue oval is tilted slightly to the left.
510(k) Premarket Notification - Traditional
10. Safety, EMC and Performance Data
Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1.JEC 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.
11. 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 from the predicate device.
The software contained in the proposed device has been developed & tested in the S/W development procedure on IEC62304, and the Guidance for Content of Premarket Submissions for Software Contained in Medical Devices.
The dosimetry performance has been evaluated with IEC60601-1, and the recommened exposure chart is provided in the user manual.
12. Clinical data
In clinical data, phantom image evaluations were performed in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. They were evaluated by a professional radiologist and found to be equivalent to the predicate device.
13. 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 devices.
§ 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.