(30 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), Xray 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 document describes a 510(k) premarket notification for the SAMSUNG GM60A Digital Mobile X-ray Imaging System (GM60A-32S & GM60A-40S). The filing is to add a new detector (S3025-W) to the existing device (predicate device K142492). The focus of the study is to demonstrate substantial equivalence to the predicate device, not necessarily to set new performance criteria in an AI context.
Therefore, the acceptance criteria and study detailed below relate to demonstrating the new detector's performance is equivalent to the previously cleared predicate device's detectors. It's important to note this is not an AI device in the sense of an algorithm for diagnosis, but rather an imaging system.
Acceptance Criteria and Reported Device Performance
The core of the acceptance criteria is demonstrating that the new S3025-W detector, when incorporated into the GM60A system, performs comparably to the previously cleared detectors (S4343-W and S4335-W) of the predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance (GM60A with S3025-W) |
|---|---|
| Technological Characteristics | |
| Pixel Pitch (um) | 140 um (Same as predicate detectors) |
| High Contrast Limiting Resolution (LP/mm) | 3.57 LP/mm (Same as predicate detectors) |
| Detector Type | CsI Indirect (Same as predicate detectors) |
| Communication | Wired / Wireless (Same as predicate detectors) |
| Non-clinical Performance | |
| MTF (Modulation Transfer Function) | "do not differ from the predicate device" (Shows curves and measurements are comparable) |
| DQE (Detective Quantum Efficiency) | "do not differ from the predicate device" (Shows curves and measurements are comparable) |
| Other electrical, mechanical, environmental safety, EMC, and wireless function requirements | "All test results were satisfied as the standard" (ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30, 21CFR1020.31, IEC 60601-1-2:2007, and FDA guidance for Wireless Technology in Medical Devices). |
| Clinical Performance (Image Quality) | |
| Clinical image quality evaluation by a qualified radiologist for equivalence to predicate device | "Clinical images were provided... and found to be equivalent to the predicate device." The submission states "these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended." This implies the primary acceptance for clinical performance was a qualitative assessment of equivalence by an expert. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a numerical sample size for the clinical image test set. It states "Clinical images were provided."
- Data Provenance: Not explicitly stated, but it would typically be prospective data collected specifically for the testing of the new detector with the GM60A system prior to submission. There is no mention of country of origin, but the manufacturer is based in the Republic of Korea.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "a radiologist" (singular).
- Qualifications: "with equivalent U.S. board certification."
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Adjudication method for the test set:
- Method: Not applicable in the context of this submission. The evaluation was a qualitative assessment of equivalence by a single radiologist. There was no consensus or multi-reader adjudication process described.
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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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- AI Improvement Effect Size: Not applicable. This device is a mobile X-ray imaging system, not an AI diagnostic algorithm. The comparison is between different detectors within an X-ray system, evaluating their inherent imaging performance, not reader performance with or without AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This document pertains to an X-ray imaging system, not a standalone AI algorithm. The performance evaluation assesses the imaging system's output and characteristics.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: The ground truth for the clinical images was the qualitative assessment of image equivalence by a radiologist with U.S. board certification, comparing images acquired with the new detector to those from the predicate device's detectors. For non-clinical performance (MTF, DQE), the "ground truth" or reference was established by standard measurements conforming to IEC 62220-1 and comparison to the predicate device's established performance.
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The sample size for the training set:
- Sample Size: This device is a hardware imaging system, not an AI algorithm that requires a training set in the typical sense. There is no mention of a training set as would be relevant for machine learning.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm described in this submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2015
Samsung Electronics Co., Ltd. % Chulsin Kim Regulatory Affairs Manager 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do 443-742 REPUBLIC OF KOREA
Re: K150097
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: January 14, 2015 Received: January 20, 2015
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 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)
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) | |||
|---|---|---|---|
| X 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 thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to: | |||
| Food and Druq AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff(@fda.hhs.gov | Department of Health and Human Services |
"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
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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
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- Date: January 14, 2015
- Submitter 2.
- A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, Republic of Korea
Primary Contact Person 3.
- A. Name: KIM, CHULSIN
- 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
Secondary Contact Person 4.
- A. Name: Ninad Gujar
- B. Title: Regulatory Affairs Manager
- C. Phone Number: 978-564-8503
- D. FAX Number: 978-750-6677
E-Mail: ngujar@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
- ட். Product Code: IZL
- F. Regulation: 21 CFR 892.1720
Predicate Device 6.
- A. Manufacturer: SAMSUNG ELECTRONICS Co., Ltd.
- B. Trade Name: GM60A
- C. Device Name: GM60A-32S, GM60A-40S
- D. Classification Name: Mobile X-ray system
- E. Product Code: IZL
- F. 510(k) Number: K142492
- G. 510(k) Decision Date: December 17, 2014
Device Description 7.
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510(k) Premarket Notification - Traditional
The GM60A Digital Mobile X-ray imaging system consists of High voltage generator (HVG), Xray 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.
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- 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.
- Intended Use
9. Summary of Substantial Equivalence Discussion
The proposed GM60A adds a new detector (S3025-W) to the predicate device GM60A (K142492), and it has same materials, energy source or technological characteristics compare to the predicate device. The S3025-W detector has same pixel pitch and resolution from those detectors (S4343-W & S4335-W) used for the predicate device, and has just in differences of size. Comparisons of the following technological characteristics were assessed and the results demonstrate the substantial equivalence to the predicates.
| Specification | Proposed Device | Predicate Device | Discussion |
|---|---|---|---|
| Device Name | GM60A | GM60A | |
| Manufacturer | SAMSUNG ELECTRONICS | SAMSUNG ELECTRONICS | |
| 510(k) Number | N/A | K142492 | |
| Appearances | Image: Proposed Device Appearance | Image: Predicate Device Appearance | Same |
| Intended Use | The GM60A Digital Mobile X-ray ImagingSystem is intended for use in generatingradiographic images of human anatomy bya qualified/trained doctor or technician.This device is not intended formammographic applications. | The GM60A Digital Mobile X-ray ImagingSystem is intended for use in generatingradiographic images of human anatomy bya qualified/trained doctor or technician.This device is not intended formammographic applications. | Same |
| Manufacturer Contents | GM60A | GM60A(K142492) | Discussion | |
|---|---|---|---|---|
| (1)High | Voltage Generator | |||
| Type | High Frequency | High Frequency | Same | |
| Max. Power | 32kW / 40kW | 32kW / 40kW | Same | |
| OutputRANGE | kVp Range | 40 to 150kVp | 40 to 150kVp | Same |
| mA Range | 10 to 500mA | 10 to 500mA | Same |
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510(k) Premarket Notification - Traditional
| Manufacturer | Contents | GM60A | GM60A(K142492) | Discussion |
|---|---|---|---|---|
| Exposure Time | 1msec-10sec | 1msec-10sec | Same |
| Manufacturer Contents | GM60A | GM60A(K142492) | Discussion | |
|---|---|---|---|---|
| (2)Tube assembly | ||||
| MovingRange | Horizontal | 700~1250 | 700~1250 | Same |
| Vertical | 550 | 550 | Same | |
| RotationRange | Column | $\pm$ 315° | $\pm$ 315° | Same |
| Tube(Arm axis) | $\pm$ 180° | $\pm$ 180° | Same | |
| Tube(Tube axis) | -30°~90° | -30°~90° | Same | |
| Collimator | RALCO R221 DHHS | RALCO R221 DHHS | Same |
| ManufacturerContents | GM60A | GM60A(K142492) | Discussion | |
|---|---|---|---|---|
| (3) Detectors*NOTE: S3025-W detector as an option is added in the list of detectors that are S4335-W, S4343-W (cleared with K142492). | ||||
| Name | S4335-W | S4343-W | S3025-W | Different(1) |
| Detector Type | Csl | Csl | Csl | Same |
| Indirect | Indirect | Indirect | Same | |
| Detector Area | 14"X17"(345mmX425mm) | 17"X17"(425mmX425mm) | 10"X12"(245mmX295mm) | Different(2) |
| Number of pixels | 2466X3040 | 3036X3040 | 1750X2108 | |
| Pixel Pitch(um) | 140 | 140 | 140 | Same |
| High ContrastLimiting Resolution(LP/mm) | 3.57 | 3.57 | 3.57 | Same |
| Communication | Wired /Wireless | Wired /Wireless | Wired /Wireless | Same |
| (4) Grid | ||||
| Lines/cm | 84.6 | Same | ||
| Grid mechanism | Stationary | Same | ||
| Removability | Removable | Same |
| Note | Differences | Explanation |
|---|---|---|
| (1) | New detector,S3025-W, isincluded | Small size of new detector, S3025-W is included as an option. |
| (2) | Detector area is different fromthose of predicate device alsonumber of pixels. | Detector area and number of pixels are different from those ofpredicate device but new detector has same technicalcharacteristics, pixel pitch and resolution of detectors ofpredicate device. The new detector has just differences in sizefrom predicate device and these differences do not contributeany adverse impacts to the predicate device's safety andperformance. |
In non-clinical data, the proposed detector shows curves and measurements of MTF and DQE
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510(k) Premarket Notification - Traditional
that do not differ from the predicate device. In clinical data, the proposed GM60A has been shown a substantially equivalent to the predicate device.
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 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 as the standard.
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 nonclinical testing data such as MTF and DQE measurements from the predicate device.
12. Clinical data
Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended. These images were evaluated by a radiologist with equivalent U.S. board certification and found to be equivalent to the predicate device.
13. Conclusions
The non-clinical and clinical data demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in paragraph 6.
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- 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.