(28 days)
Unknown
The description mentions "post-image processing software option" for Bone Suppression Image (BSI) which "suppresses bone anatomy to enhance visualization of chest pathology". While this is image processing, the summary does not explicitly state whether this processing utilizes AI/ML techniques. The lack of mention of AI, ML, DNN, training sets, or performance metrics typically associated with AI/ML models makes it difficult to definitively confirm or deny the presence of AI/ML.
No
The device is described as an X-ray imaging system used for generating radiographic images for diagnosis, and explicitly states it is "not intended for mammographic applications." It captures images and aids in diagnosis, but does not provide therapy.
No
Explanation: The device is described as an X-ray imaging system that generates radiographic images of human anatomy for a doctor or technician. While a post-processing option (BSI) assists diagnosis by enhancing visualization, the core device itself produces images, which are then used for reading and potentially diagnosis, but it does not perform the diagnosis itself.
No
The device description clearly outlines a hardware component (GM85 Digital Mobile X-ray imaging System) that captures images by transmitting X-rays. While it includes a software option (BSI), the overall device is a hardware system with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- Device Function: The GM85 Digital X-ray imaging System is an imaging device that generates radiographic images by transmitting X-rays through the human body. It captures and processes these images for diagnostic purposes.
- No Specimen Examination: The device does not examine specimens (blood, tissue, etc.) derived from the human body. It directly images the internal anatomy.
Therefore, the GM85 Digital X-ray imaging System falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The GM85 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.
Product codes
IZL, MOB
Device Description
The GM85 Digital Mobile X-ray imaging System is the equipment that captures 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 Bone Suppression Image (BSI) is a post-image processing software option which provides companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol. The BSI 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.
The BSI option is designed to be exclusively installed in S-station, SAMSUNG digital Xray operation software, while it uses the radiological image as an input and do not depend on how the image is acquired or which radiology device is used.
Mentions image processing
The Bone Suppression Image (BSI) is a post-image processing software option which provides companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained doctor or technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Non-clinical 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 has same detectors so it shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device #1 and #2. BSI installed in S-Station of GM85 has been verified and validated through GM85 Software System Test Case.
The application of BSI, cleared with K163115, to the proposed device GM85 does not require clinical data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2017
Samsung Electronics Co., Ltd. % Chulsin Kim Regulatory Affairs Manager 129, Samsung-ro, Yeongtong-gu Suwon-si. 16677 Gveonggi-do REPUBLIC OF KOREA
Re: K171119
Trade/Device Name: GM85 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL. MOB Dated: April 7, 2017 Received: April 14, 2017
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
Image /page/0/Picture/11 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 right, stacked on top of each other, forming a single abstract shape.
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ResourcesforYou/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,
Michael D. O'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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name GM85
Indications for Use (Describe)
The GM85 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) |
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3
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: April 7, 2017
2. Submitter
- Company Name: SAMSUNG ELECTRONICS Co., Ltd. A.
- Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, B. Republic of Korea
3. Primary Contact Person
- A. Name: ChulSin Kim
- 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, Regulatory & Quality
- C. Phone Number: 978-564-8503
- D. FAX Number: 978-750-6677 E-Mail: ngujar@samsungneurologica.com
5. Proposed Device
- A. Trade Name: GM85
- B. Device Name: GM85
- C. Common Name: Digital Diagnostic Mobile X-ray System
- D. Classification Name: Mobile X-ray System
- Product Code: IZL & MQB ட்
- ட் Regulation: 21 CFR 892.1720
6. Predicate Devices
| Predicate Device #1 | Predicate Device #2 | |
|---|---|---|
| Device Name | GM85 | GC70 |
| Classification | ||
| Name | MobileX-ray system. | Stationary |
| X-ray System | ||
| Product Code | IZL | KPR |
| Regulation | 21 CFR 892.1720 | 21 CFR 892.1680 |
| 510(K)# | K162278 | K163115 |
| 510(K) Decision Date | November 15, 2016 | December 07, 2016 |
4
510(k) Premarket Notification - Traditional
7. Device Description
The GM85 Digital Mobile X-ray imaging System is the equipment that captures 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 Bone Suppression Image (BSI) is a post-image processing software option which provides companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol. The BSI 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.
The BSI option is designed to be exclusively installed in S-station, SAMSUNG digital Xray operation software, while it uses the radiological image as an input and do not depend on how the image is acquired or which radiology device is used.
8. Intended Use
The GM85 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.
9. Summary of Technological characteristic of the proposed device compared with the predicate devices
The proposed device GM85 applies a post-image processing software feature as BSI (Bone Suppression Image), which was cleared with K163115, to the predicate device GM85 (K162278) without changes in technical characteristics, materials, energy sources and biocompatibility such as High Voltage Generator(HVG), X-ray Tube Assembly and Detectors.
Comparisons of technological characteristics were executed and demonstrate the substantial equivalence to the predicates.
A. Comparing with Predicate Device #1 and #2
The proposed device is shown as its parts are identical or equivalent with predicate device #1 or #2 while the BSI is applied, which does not show significant difference in safety and effectiveness.
| Specification | Predicate Device #1 | Proposed Device | Predicate Device #2 | Discussion |
|---|---|---|---|---|
| Device | ||||
| Name | GM85 | GM85 | GC70 | |
| Manufacture | SAMSUNG | SAMSUNG | SAMSUNG | |
| ELECTRONICS co., ltd. | ELECTRONICS co., ltd. | ELECTRONICS co., ltd. | ||
| 510(k) | ||||
| Number | K162278 | - | K163115 |
5
510(k) Premarket Notification - Traditional
| Appearances | Image: Samsung GM85 Digital Mobile X-ray | Image: Samsung GM85 Digital Mobile X-ray | Image: GC70 Digital X-ray Imaging System | Same as
PD#1 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Intended
Use | The GM85 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 GM85 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 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. | Same as
PD#1 |
| Manufacturer Contents | Predicate Device #1 | Proposed Device
GM85 | Predicate Device
#2 | Discussion |
|---------------------------------------|---------------------|-------------------------|------------------------|-----------------|
| Software Feature | | | | |
| SimGrid | SimGrid | SimGrid | SimGrid | Same as
PD#1 |
| Tube & Line
Enhancement(TLE) | TLE | TLE | - | Same as
PD#1 |
| Pediatric Exposure
Management(PEM) | PEM | PEM | - | Same as
PD#1 |
| S-DAP | S-DAP | S-DAP | S-DAP | Same |
| S-Align | S-Align | S-Align | S-Align | Same as
PD#1 |
| S-Share | S-Share | S-Share | S-Share | Same |
| BSI | - | BSI | BSI | Same as
PD#2 |
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 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 has same detectors so it shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device #1 and #2. BSI installed in S-Station of GM85 has been verified and validated through GM85
6
510(k) Premarket Notification - Traditional Software System Test Case.
D. Clinical data
The application of BSI, cleared with K163115, to the proposed device GM85 does not require clinical data.
E. Conclusions
The non-clinical demonstrates that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate devices.