(104 days)
The GM60A Digital Mobile 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 GM60A Digital Mobile X-ray imaging system consists of High voltage generator (HVG), X-ray tube, Collimator, Detector, DAP and Barcode scanner. This 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 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 the 510(k) summary for the GM60A Digital Mobile X-ray Imaging System. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in comprehensive clinical study reports. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval.
Here's an analysis of the information that is present and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Missing: The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for sensitivity, specificity, accuracy, or image quality metrics) that the device was required to meet for regulatory approval.
- Present (Implicit Performance Comparison): The "Summary of Technological characteristic of the proposed device compared with the predicate device" table ({5}-{6}) provides a comparison of technical specifications (e.g., Max. Power, kVp Range, mA Range, Exposure Time, Tube Moving Range, Rotation Range, Detector Area, Number of pixels, Pixel Pitch, High Contrast Limiting Resolution, Communication, Grid Lines/cm). For many of these, the proposed device's performance is stated as "Same as" or "Same or better" than the predicate device. This indirectly suggests that the performance observed for the predicate device forms an implicit benchmark for acceptance.
- Present (Non-clinical Data): "MTF and DQE were tested and measured by IEC 62220-1. The proposed device shows same curves and measurements of MTF and DQE than the predicate device (K140334) at all spatial frequencies tested." This indicates that the MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) performance of the proposed device were found to be equivalent to the predicate device, serving as a non-clinical performance benchmark.
- Present (Clinical Data): "clinical images were obtained in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. They were evaluated by professional radiologists and found to be equivalent to the predicate device." This indicates a clinical performance outcome of "equivalence" to the predicate.
2. Sample size used for the test set and the data provenance:
- Missing: The sample size for the clinical test set (i.e., number of images or patients) is not specified.
- Missing: The data provenance (e.g., country of origin, retrospective or prospective) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Present (Partial): "They were evaluated by professional radiologists".
- Missing: The exact number of radiologists is not specified.
- Missing: The qualifications of the radiologists (e.g., years of experience, subspecialty) are not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Missing: The adjudication method used for the radiologists' evaluation is not specified.
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:
- Missing: This document describes an X-ray imaging system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and not mentioned. The clinical data section only states that images were "evaluated by professional radiologists and found to be equivalent to the predicate device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Missing: This is an X-ray imaging system, not a standalone AI algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned. The performance reported relates to the imaging system's ability to produce images comparable to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Present (Implicit, for clinical evaluation): The "ground truth" for the clinical evaluation seems to be the interpretations by professional radiologists, who assessed the "equivalence" of the images from the proposed device to those of the predicate device. This suggests a form of expert consensus or comparison against an established benchmark (the predicate device's image quality).
- Missing (Definitive Ground Truth): The document does not describe a definitive "ground truth" derived from pathology, long-term outcomes, or a strict consensus process, which would be more typical for diagnostic accuracy studies of an AI algorithm. For this type of imaging device, the focus is on image quality and its diagnostic adequacy.
8. The sample size for the training set:
- Missing: This document pertains to the regulatory submission for an X-ray imaging system itself, not an AI algorithm that requires a training set. Therefore, a training set and its sample size are not applicable and not mentioned.
9. How the ground truth for the training set was established:
- Missing: As no training set for an AI algorithm is mentioned, this information is not applicable.
In summary:
The provided text focuses on demonstrating the substantial equivalence of the GM60A X-ray system to legally marketed predicate devices based on technical specifications and a general statement of clinical image equivalence as assessed by radiologists. It does not provide the detailed parameters of a study (like sample size, specific acceptance criteria, expert qualifications, or adjudication methods) that would be expected for a comprehensive performance study of an AI diagnostic device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design element below them.
December 17, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Samsung Electronics Co., Ltd. % Chulsin Kim Regulatory Affairs Manager 129. Samsung-ro Yeongtong-gu Suwon-si, Gyeonggi-do, 443742 REPUBLIC OF KOREA
Re: K142492
Trade/Device Name: GM60A-32S, GM60A-40S Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: November 20, 2014 Received: November 24, 2014
Dear Chulsin 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,
Robert A Ochs
Robert A. Ochs, Ph.D. Acting 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) K142492
Device Name GM60A-32S, GM60A-40S
Indications for Use (Describe)
The GM60A Digital Mobile 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) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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Image /page/3/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 bold and sans-serif, and the letters are evenly spaced. The oval is tilted slightly upwards from left to right.
510(k) Premarket Notification - Traditional
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92
-
- Date: November 19, 2014
-
- Submitter
- A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, Republic of Korea
3. Primary Contact Person
- Name: KIM, CHULSIN A.
- B. Title: Regulatory Affairs Manager
- C. Phone Number: +82-31-200-7661
- D. FAX Number: +82-31-200-1199 E-Mail: chulsin.kim@samsung.com
4. Secondary Contact Person
- A. Name: Donald D. Fickett
- B. Title: Vice President Regulatory & Quality Assurance
- C. Phone Number: 978-564-8523
- D. FAX Number: 978-750-6677 E-Mail: dfickett@samsungneurologica.com
5. Identification Device
- A. Trade Name: GM60A
- B. Device Name: GM60A-32S, GM60A-40S
- C. Common Name: Digital Diagnostic Mobile X-ray System
- D. Classification Name: Mobile X-ray System
- ய் Product Code: IZL
- F. Regulation: 21 CFR 892.1720
6. Predicate Device
- 6.1 Predicate Device I
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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 inside of a blue, rounded, oval shape.
510(k) Premarket Notification - Traditional
- A. Manufacturer: Sedecal, Inc. SEDECAL SA
- Device Name: Easy Moving Plus, SM-XXHF-YY B.
- C. Classification Name: Mobile X-ray system, Solid State X-Ray Imager(Flat Panel/Digital Imager)
- D. Product Code: IZL
- E. 510(k) Number: K090322
- 510(k) Decision Date: March 17, 2009 ட
6.2 Predicate Device II
- Manufacturer: SAMSUNG ELECTRONICS Co., Ltd. G.
- Trade Name: XGEO GC80 H.
-
- Classification Name: System, X-ray, Stationary
- J. Product Code: KPR
- 510(k) Number: K140334 K.
- L. 510(k) Decision Date: May 28, 2014
7. Device Description
The GM60A Digital Mobile X-ray imaging system consists of High voltage generator (HVG), X-ray tube, Collimator, Detector, DAP and Barcode scanner.
This 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 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 GM60A Digital Mobile 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.
-
- Summary of Technological characteristic of the proposed device compared with the predicate device
The GM60A' system does not have significant changes in materials, energy source or
- Summary of Technological characteristic of the proposed device compared with the predicate device
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Image /page/5/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 oval is tilted slightly, giving the logo a dynamic appearance.
510(k) Premarket Notification - Traditional
technological characteristics compared to the predicate device, Easy moving plus(K090322), and the detectors that GM60A uses are same as the one that the predicate device of XGEO GC80(K140334) uses. Comparisons of the following technological characteristics were assessed and the results demonstrate the substantial equivalence to the predicates.
| Specification | Predicate Device I | Proposed Device | Predicate Device II | Discussion |
|---|---|---|---|---|
| Device Name | Sedecal Easy moving plus | GM60A | XGEO GC80 | |
| Manufacturer | Sedecal SA | SAMSUNG ELECTRONICS | SAMSUNG ELECTRONICS | |
| 510(k) Number | K090322 | N/A | K140334 | |
| Appearances | Image: Sedecal Easy moving plus | Image: GM60A | Image: XGEO GC80 | Same |
| Intended Use | Intended for use by aqualified/trained doctor ortechnician on both adultand pediatric subjects fortaking diagnosticradiographic exposures ofthe skull, spinal column,chest, abdomen,extremities, and other bodyparts.Applications can beperformed with the patientsitting, standing, or lying inthe prone or supine | The GM60A Digital MobileX-ray Imaging System isintended for use ingenerating radiographicimages of human anatomyby a qualified/traineddoctor or technician.This device is not intendedfor mammographicapplications. | The XGEO GC80 digital X-ray imaging system isintended for use ingenerating radiographicimages of human anatomyby a qualified/traineddoctor or technician. Thisdevice is not intended formammographicapplications. | Same |
| Manufacturer Contents | Sedecal Easy moving plus(K090322) | GM60A | XGEO GC80(K140334) | Discussion | |
|---|---|---|---|---|---|
| (1)High | Voltage Generator | ||||
| Type | High Frequency | High Frequency | High Frequency | Same | |
| Max. Power | 20/32/40/50kW | 32kW / 40kW | 80kW | Same asK090322 | |
| OutputRANGE | kVp Range | 40 to 150kVp | 40 to 150kVp | 40 to 150kVp | Same |
| mA Range | 20kW : 10 to 320mA32/40/50kW : 10 to 500mA | 10 to 500mA | 10-1000mA | Same asK090322 | |
| Exposure Time | 1msec-10sec | 1msec-10sec | 1msec-6.3sec | Same or above |
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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
| Manufacturer Contents | SedecalEasy moving plus(K090322) | GM60A | XGEO GC80(K140334) | Discussion | |
|---|---|---|---|---|---|
| (2)Tube assembly | |||||
| MovingRange | Horizontal | 700~1250 | 700~1250 | 1030~3030 | Same asK090322 |
| Vertical | 550 | 550 | $\triangle$ 1,840 | Same asK090322 | |
| RotationRange | Column | $\pm$ 315° | $\pm$ 315° | -157° ~ +183° | Same or better |
| Tube(Arm axis) | $\pm$ 180° | $\pm$ 180° | $\pm$ 120° | Same or better | |
| Tube(Tube axis) | -30°~90° | -30°~90° | N/A | Same or better | |
| Collimator | RALCO R221 DHHS | RALCO R221 DHHS | SAMSUNGElectronics | Same asK090322 |
| ManufacturerContents | SedecalEasy movingPlus(K090322) | GM60A | XGEO GC80 (K140334) | Discussion | ||
|---|---|---|---|---|---|---|
| (3) Detectors | ||||||
| Name | CanonCXDI-50G | S4335-W | S4343-W | S4335-W | S4343-W | |
| GOS | Csl | Csl | Csl | Csl | Same or better | |
| Detector Type | Indirect | Indirect | Indirect | Indirect | Indirect | Same |
| Detector Area | 14"X17"(353mmX430mm) | 14"X17"(345mmX425mm) | 17"X17"(425mmX425mm) | 14"X17"(345mmX425mm) | 17"X17"(425mmX425mm) | Similar |
| Number of pixels | 2208X2688 | 2466X3040 | 3036X3040 | 2466X3040 | 3036X3040 | |
| Pixel Pitch(um) | 160 | 140 | 140 | 140 | 140 | Same or better |
| High ContrastLimiting Resolution(LP/mm) | N/A | 3.57 | 3.57 | 3.57 | 3.57 | Same or better |
| Communication | Wired | Wired /Wireless | Wired /Wireless | Wired /Wireless | Wired /Wireless | Same or better |
| (4) Grid | ||||||
| Lines/cm | 40 | 84.6 | 84.6 | Same or better | ||
| Grid mechanism | Stationary | Stationary | Stationary | Same | ||
| Removability | Removable | Removable | Removable | Same |
10. 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
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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-shaped background. The font is sans-serif and bold, and the oval is tilted slightly upwards from left to right.
510(k) Premarket Notification - Traditional
conducted in accordance with standard IEC 60601-1-2:2007. Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfied.
11. Non-clinical data
In non-clinical data, MTF and DQE were tested and measured by IEC 62220-1. The proposed device shows same curves and measurements of MTF and DQE than the predicate device (K140334) at all spatial frequencies tested.
12. Clinical data
In clinical data, clinical images were obtained in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. They were evaluated by professional radiologists and found to be equivalent to the predicate device.
13. Conclusions
The non-clinical and clinical data that demonstrate that the device is as safe, as effective, and performs as well as or better than the leqally marketed device identified in paragraph 6, above.
-
- Samsung Electronics Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.