(90 days)
No
The document describes image post-processing and software updates but does not mention AI, ML, or related terms like deep learning or neural networks. The focus is on hardware configurations and standard image processing techniques.
No
The device is used to generate radiographic images for diagnostic purposes, not for treating any condition.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician." The "Device Description" also mentions that the images are processed and saved in DICOM format, a standard for medical imaging, and sent to a PACS server "for reading images," which implies diagnostic interpretation. Furthermore, the "Summary of Performance Studies" indicates that "Anthropomorphic phantom images were ... evaluated by a professional radiologist," further supporting its role in diagnostic imaging.
No
The device description explicitly states that the system includes hardware components such as a tube, detectors, and exposure switches, in addition to the software.
Based on the provided text, the GM85 Digital Mobile X-ray imaging System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "generating radiographic images of human anatomy." This involves imaging the internal structure of the body using X-rays.
- Device Description: The description details how the device captures X-ray images of a patient's body and processes them for viewing and storage.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body. IVD devices are specifically designed for testing these types of samples.
The device is a medical imaging system that uses X-rays to visualize internal anatomy, which falls under the category of diagnostic imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
IZL
Device Description
The GM85 Digital Mobile 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 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 send to the Picture Archiving & Communication System (PACS) sever for reading images.
The GM85 Digital Mobile X-ray imaging System was previously cleared with K181626, and through this premarket notification, we would like to add more configurations in the previously cleared GM85 as an optional collapsible column type with a manual collimator, a tube, four detectors, and exposure switches (two wired and one wireless types) are optionally added, and software including the Image Post-processing Engine (IPE) is changed in order to support new hardware and apply new software features.
The cleared GM85 (K181626) has two types of columns, collapsible and fixed column having an automatic and manual collimator respectively. A manual collimator is optionally added for a collapsible column in proposed device GM85, where a new tube is available. Four detectors are added in the proposed device GM85; two are new and the others have been cleared with K200418.
It was determined that the level of concern for the software contained in the GM85 Digital Mobile 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" and its level is the same as the predicate device.
Note that when using the Mirror View, image transmitted via Miracast is not available for the purpose of diagnosis.
Mentions image processing
Yes
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)
- Study type: Electrical, mechanical, environmental safety and performance testing, EMC testing, Wireless function testing, non-clinical data review, phantom image evaluations, anthropomorphic phantom images review.
- Sample size: Not Found
- AUC: Not Found
- MRMC: Not Found
- Standalone performance: Not Found
- Key results: All test results were satisfying the standards. The proposed device is as safe, as effective, and performs as well as the legally marketed predicate devices. The new detectors have equivalent image characteristics as the existing ones. Anthropomorphic phantom images were found to be equivalent to the predicate devices by a professional radiologist. There is no significant difference in the average score of image quality evaluation between the proposed device and the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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April 21, 2022
Samsung Electronics Co. Ltd. % Jaesang Noh Senior Professional. Regulatory Affairs 129, Samsung-Ro, Yeongtong-Gu Suwon-Si, Gyeonggi-Do 16677 REPUBLIC OF SOUTH KOREA
Re: K220175
Trade/Device Name: GM85 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: January 14, 2022 Received: January 21, 2022
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220175
Device Name GM85
Indications for Use (Describe)
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.
| 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)
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3
SAMSUNG
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 19, 2022
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
- Name: JAESANG NOH A.
- B. Title: Regulatory Affairs, Senior Professional
- Phone Number: +82-2-2193-2444 ﻥ
- D. FAX Number: +82-2-2194-0272
- E-Mail: jaesang.noh@samsung.com ய்
4. Secondary Contact Person
- Name: Ninad Gujar A.
- B. Title: Vice President, Regulatory Affairs & Quality Control
- C. Phone Number: 978-564-8503
- D. FAX Number: 978-560-0602
- ய் E-Mail: ngujar@neurologica.com
5. Proposed Device
- Trade Name: GM85 A.
- Device Name: GM85 B.
- ﻥ Common Name: Digital Diagnostic Mobile X-ray System
- D. Classification Name: Mobile X-ray System
- Product Code: IZL ய்
- Regulation: 21 CFR 892.1720 ட்
6. Predicate Devices
| Predicate Device | |
|---|---|
| Device Name | GM85 |
| Classification Name | MobileX-ray system. |
| Product Code | IZL |
| Regulation | 21 CFR 892.1720 |
| 510(k)# | K181626 |
| 510(K) Decision Date | July 20, 2018 |
4
510(k) Premarket Notification - Traditional
7. Device Description
The GM85 Digital Mobile 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 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 send to the Picture Archiving & Communication System (PACS) sever for reading images.
The GM85 Digital Mobile X-ray imaging System was previously cleared with K181626, and through this premarket notification, we would like to add more configurations in the previously cleared GM85 as an optional collapsible column type with a manual collimator, a tube, four detectors, and exposure switches (two wired and one wireless types) are optionally added, and software including the Image Post-processing Engine (IPE) is changed in order to support new hardware and apply new software features.
The cleared GM85 (K181626) has two types of columns, collapsible and fixed column having an automatic and manual collimator respectively. A manual collimator is optionally added for a collapsible column in proposed device GM85, where a new tube is available. Four detectors are added in the proposed device GM85; two are new and the others have been cleared with K200418.
It was determined that the level of concern for the software contained in the GM85 Digital Mobile 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" and its level is the same as the predicate device.
Note that when using the Mirror View, image transmitted via Miracast is not available for the purpose of diagnosis.
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, has the same technological characteristics and hardware as its original predicate device, GM85 (K181626), and added an optional collapsible column type with a manual collimator, a tube, four detectors, exposure switches (two wired and one wireless types) and new software features. They do not have significant changes in materials, energy source or technological characteristics compared to the predicate device.
Comparisons of technological characteristics were executed and demonstrate the substantial equivalence to the predicates.
- A. Comparing with Predicate Device
5
510(k) Premarket Notification - Traditional
The proposed device is shown as its parts are identical or equivalent with predicate device while some differences are made as below, which do not show significant difference in safety and effectiveness.
| Specification | Proposed Device | Predicate Device | Discussion |
|---|---|---|---|
| Device Name | GM85 | GM85 | - |
| Manufacturer | SAMSUNG ELECTRONICS | SAMSUNG ELECTRONICS | - |
| 510(k) Number | - | K181626 | - |
| Appearances | Image: [C-Type*] | ||
| *Collapsible | |||
| column type | |||
| (C-Type) | |||
| Image: [F-Type**] | |||
| **Fixed | |||
| column type | |||
| (F-Type) | |||
| Image: [Fit-Type***] | |||
| ***Collapsible | |||
| column type | |||
| (Fit-Type) | Image: [C-Type*] | ||
| *Collapsible column | |||
| type | |||
| (C-Type) | |||
| Image: [F-Type**] | |||
| **Fixed column type | |||
| (F-Type) | Difference(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. | Same |
| Manufacturer Contents | | GM85 | | | GM85
(K181626) | | Discussion |
|-----------------------|-------------------|----------------|--------|----------|-------------------|--------|------------|
| | | C-type | F-type | Fit-type | C-type | F-type | |
| (1)High | Voltage Generator | | | | | | |
| Type | | High Frequency | | | High Frequency | | - |
| Max. Power | | 32kW / 40kW | | | 32kW / 40kW | | Same |
| Output
Range | kVp Range | 40 to 150kVp | | | 40 to 150kVp | | Same |
| | mA Range | 10 - 500mA | | | 10 - 500mA | | Same |
| | Exposure Time | 1msec-10sec | | | 1msec-10sec | | Same |
| Manufacturer Contents | | GM85 | | | GM85
(K181626) | | Discussion | |
|-----------------------|--------------------|----------------|--------------------------|----------------|-------------------|-----------------------|------------|--|
| (2)Tube assembly | | | | | | | | |
| Moving
Range | Horizontal | 7931355mm | | | 7931355mm | | Same | |
| | Vertical | 55020302030
mm | 550
or
1850mm | 55020302030mm | 550~2030 or
mm | 550
1850mm | Same | |
| Rotation
Range | Column | ±315° | | | ±315° | | Same | |
| | Tube
(Arm axis) | ±180° | | | ±180° | | Same | |
| | Tube | -30°~90° | | | -30°~90° | | Same | |
6
SAMSUNG
| Manufacturer Contents | | GM85 | | | GM85
(K181626) | | Discussion |
|-----------------------|-------------------------|--------------------------------------|-----------------------------|-----------------------------|--------------------------------------|-----------------------------|---------------|
| | (Tube axis) | C-type | F-type | Fit-type | C-type | F-type | |
| Tube | Model | LUC-13L,
XRR-3332X | | LUC-11L,
XRR-3332X | LUC-13L,
XRR-3332X | | Difference(2) |
| | Focal spot | 0.6/1.2mm | | 0.6/1.5mm,
0.6/1.2mm | 0.6/1.2mm | | Difference(3) |
| | Target Angle | 14° | | | 14° | | Same |
| | Target Material | Rhenium-tungsten faced
molybdenum | | | Rhenium-tungsten faced
molybdenum | | Same |
| | Nominal Tube
Voltage | 150kVp | | 125kVp | 150kVp | | Difference(4) |
| | Max.Anode HU | 300kHU | | 200kHU | 300kHU | | Same |
| Collimator | | SDR-
OGCL40U | SDR-
OGCL41U | SDR-
OGCL30L | SDR-
OGCL40U | SDR-
OGCL41U | Difference(5) |
| | | Automatic
212X306
X179mm | Manual
222X271
X140mm | Manual
206X230X
139mm | Automatic
212X306X
179mm | Manual
222X271X
140mm | |
| Manufacturer Contents | GM85 | | GM85
(K181626) | Discussion | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-----------|-------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------|
| (3) Detector | | | | | |
| Name | S4335-W
S4343-W
S3025-W
S4335-AW
S4343-AW
S4335-AWM
S4343-AWM
S3025-AW
S3025-AWM | | S4335-W
S4343-W
S3025-W
S4335-AW
S4343-AW | Difference(6) | |
| | S4335-AWM | S4343-AWM | S3025-AW | | |
| | S3025-AW | S3025-AW | S3025-AW | | |
| | S3025-AWM | | | | |
| Detector Type | CsI
Indirect | | CsI
Indirect | Same | |
| Detector Area | 14"X17"
(345mmX425mm) | | 17"X17"
(425mmX425mm)
10"X12"
(251mmX314mm) | 14"X17"
(345mm
X425mm)
17"X17"
(425mm
mX425mm)
10"X12"
(245mm
mX295mm) | Difference(6)-1 |
| Number of pixels | 2466X
3040 | | 3036X3040
2024X 2536 | 2466X3040
3036X3040
1750X2108 | Difference(6)-2 |
| Pixel Pitch(um) | 140 | | 124 | 140 | Difference(6)-3 |
| High Contrast Limiting
Resolution (LP/mm) | 3.57 | | 4.03 | 3.57 | Difference(6)-4 |
| Communication | Wired /
Wireless | | Wireless | Wired / Wireless | Same |
| Dust/Water-resistance | IP54 | | IP67 | IP54 | Difference(6)-5 |
| Max.load capacity
(uniform load / local load,,
40 mm in diameter disk at
the center) | 400 kg/200 kg | | 400 kg/200 kg | 150 kg/100 kg | Difference(6)-6 |
| DQE
(Detective Quantum | 65%
(0lp/
65%
(0lp/ | | 75%
(0lp/
60%
(0lp/ | 76%
(0lp/mm,
76%
(0lp/m
78%
(0.1lp/ | Difference(6)-7 |
7
SAMSUNG
| Manufacturer Contents | GM85 | | | GM85
(K181626) | | | Discussion | |
|------------------------------------------|---------------------------------------|---------------------------------------|---------------------------------------|---------------------------------------|-----------------------------------|-----------------------------------|-----------------------------------|-----------------|
| (3) Detector | | | | | | | | |
| Efficiency) | mm,
Typic
al) | mm,
Typic
al) | mm,
Typic
al) | mm,
Typic
al) | Typical) | m,
Typical) | mm,
Typical) | |
| MTF
(Modulation Transfer
Function) | 88%
(0.5lp
/mm,
Typic
al) | 88%
(0.5lp
/mm,
Typic
al) | 87%
(0.5lp
/mm,
Typic
al) | 90%
(0.5lp
/mm,
Typic
al) | 86%
(0.5lp/m
m,
Typical) | 86%
(0.5lp/
mm,
Typical) | 86%
(0.5lp/
mm,
Typical) | Difference(6)-8 |
| Manufacturer Contents | GM85 | | Fit-type | GM85
(K181626) | | Discussion |
|---------------------------------------|---------------------------------------------------------------|-----------------------------------------|----------|----------------------------------------|-------------------------------------|----------------|
| (4) Grid | C-type | F-type | | C-type | F-type | |
| Lines/cm | 84.6 | | | 84.6 | | Same |
| Grid mechanism | Stationary | | | Stationary | | Same |
| Removability | Removable | | | Removable | | Same |
| (5) Weight Distribution Cap | | | | | | |
| Model Name | SDR-OGWD80U | | | SDR-OGWD80U | | Same |
| Size(mm) | 505x553x37.4 | | | 505x553x37.4 | | Same |
| (6) Exposure Switch | | | | | | |
| Name | C2U-45
C2UW-DS-SA01
L01 4C6M
L03 4C6M
SDR-OGRC30K | TS_CES(SAM)
C2UW-LP-I
SDR-OGRC30K | | C2U-45
C2UW-DS-SA01 | TS_CES(SAM)
C2UW-LP-I | Difference (7) |
| Types | Wired
2 or 3 Buttom
Deadman type | Wireless
Infra-
red/Bluetooth | | Wired
2 or 3 Buttom
Deadman type | Wireless
Infra-
red/Bluetooth | Same |
| (7) Software Features | | | | | | |
| S-Enhance | S-Enhance | | | S-Enhance | | Same |
| Pediatric Exposure
Management(PEM) | PEM | | | PEM | | Same |
| S-DAP
(Dose Area Product) | S-DAP | | | S-DAP | | Same |
| S-Align | S-Align | N/A | | S-Align | N/A | Same |
| S-Share | S-Share | | | S-Share | | Same |
| Bone Suppression
Image(BSI) | BSI | | | BSI | | Same |
| Remote View | Remote View | | | Remote View | | Same |
| Manual Stitching | Manual Stitching | | | Manual Stitching | | Same |
| SimGrid | Upgraded SimGrid | | | SimGrid | | Difference(8) |
| Quick Link | Quick Link | | | Quick Link | | Difference(9) |
8
Image /page/8/Picture/1 description: The image contains the word "SAMSUNG" in a bold, sans-serif font. The word is written in all capital letters and is a dark blue color. The background of the image is white, which provides a strong contrast to the blue text.
| Manufacturer Contents | GM85 | | | GM85
(K181626) | | Discussion |
|-------------------------------|--------|----------------------------|----------|-------------------|--------|----------------|
| | C-type | F-type | Fit-type | C-type | F-type | |
| Mirror View | | Mirror View | | - | | Difference(10) |
| Clinical Parameter
Control | | Clinical Parameter Control | | - | | Difference(11) |
| Value-up Package | | Value-up Package | | - | | Difference(12) |
| Remote Software
Upgrade | | Remote Software Upgrade | | - | | Difference(13) |
| No | Differences | Explanation | |||
|---|---|---|---|---|---|
| (1) | Appearances | The collapsible column type which has a manual collimator is | |||
| added to the proposed device GM85 as an option in comparison | |||||
| with the predicate device's one that has only collapsible column | |||||
| type with an automatic collimator. The collapsible column type has | |||||
| two options about the collimator, automatic and manual in the | |||||
| proposed device GM85 and this change does not contribute any | |||||
| adverse impacts to the device's safety and effectiveness. | |||||
| (2) | Tube Model | Two tubes are available in the optional collapsible column of the | |||
| proposed device GM85. One is the same as the predicate device | |||||
| and the other is newly added. This change does not contribute | |||||
| any adverse impact to the device's safety and effectiveness. | |||||
| (3) | Focal spot | The focal spot size of the new tube used with an optional | |||
| collapsible column of the proposed device GM85 is bigger than | |||||
| the predicate device's focal spot size and this change does not | |||||
| contribute any adverse impact to the device's safety and | |||||
| effectiveness. | |||||
| (4) | Nominal tube | ||||
| voltage | The maximum voltage of tubes used with the optional collapsible | ||||
| column of the proposed device GM85 is limited to lower than the | |||||
| predicate device's maximum tube voltage and these changes do | |||||
| not contribute any adverse impact to the device's safety and | |||||
| effectiveness. | |||||
| (5) | Collimator | The proposed device GM85 has different types of collimator | |||
| depending on column type. The fixed column type has the same | |||||
| collimator (manual, SDR-OGCL41U) applied to the predicate | |||||
| device and the collapsible column type has two collimators. One | |||||
| is the same (automatic, SDR-OGCL40U) as the predicate device | |||||
| and the other is different (manual, SDR-OGCL30L). This change | |||||
| does not contribute any adverse impacts to the device's safety | |||||
| and effectiveness. | |||||
| (6) | Detectors | Four detectors are added to the GM85 device. Two detector | |||
| (S4335-AWM and S4343-AWM) are new and the others (S3025- | |||||
| AW and S3025-AWM) are cleared with K200418. These changes | |||||
| do not contribute any adverse impact to the device's safety and | |||||
| effectiveness. | |||||
| (6)-1 | Detector Area | The new detectors which are added to the GM85 device have the |
9
| | | same (S4335-AWM and S4343-AWM) or similar (S3025-AW and
S3025-AWM) dimension as those of the predicate device and
these changes do not contribute any adverse impact to the
device's safety and effectiveness. | | |
|-------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | (6)-2 | Number of pixels | The new detectors which are added to the GM85 device have the
same (S4335-AWM and S4343-AWM) or higher (S3025-AW and
S3025-AWM) pixel number as those of the predicate device and
these changes do not impact safety and/or effectiveness. |
| | | (6)-3 | Pixel Pitch(um) | The new detectors which are added to the GM85 device have the
same (S4335-AWM and S4343-AWM) or lower (S3025-AW and
S3025-AWM) pixel pitch as those of the predicate device and
these changes do not impact safety and/or effectiveness. |
| | | (6)-4 | High Contrast
Limiting
Resolution
(LP/mm) | The new detectors which are added to the GM85 device have the
same (S4335-AWM and S4343-AWM) or higher (S3025-AW and
S3025-AWM) resolution as those of the predicate device and
these changes do not impact safety and/or effectiveness |
| (6)-5 | Detector
Dust/Water-
resistance | The new detectors which are added to the GM85 device have the
same (S4335-AWM and S4343-AWM) or better (S3025-AW and
S3022-AWM) dust/water-resistance as those of the predicate
device and these changes do not contribute any adverse impact
to the device's safety and effectiveness. | | |
| (6)-6 | Detector
Max.load capacity | The new detectors which are added to the GM85 device have the
same (S4335-AWM and S4343-AWM) or higher (S3025-AW and
S3022-AWM) max load capacity as those of the predicate device
and these changes do not contribute any adverse impact to the
device's safety and effectiveness. | | |
| (6)-7 | DQE (Detective
Quantum
Efficiency) | The new detectors which are added to the GM85 device have
similar (S3025-AW) or a little lower (S4335-AWM, S4343-AWM,
and S3025-AWM) DQE as those of the predicate device but these
changes do not contribute any adverse impact to the device's
safety and diagnostic effectiveness. | | |
| (6)-8 | MTF (Modulation
Transfer
Function) | The new detectors which are added to the GM85 device have
slightly higher (S4335-AWM, S4343-AWM, S3025-AW and
S3025-AWM) MTF as those of the predicate device and these
changes do not contribute any adverse impact to the device's
safety and diagnostic effectiveness. | | |
| (7) | Exposure Switch | Two wired and one wireless exposure switches is added to the
proposed device GM85 as an option, which are from different
manufacturers in comparison with those of the predicate device,
and these changes do not contribute any adverse impact to the
device's safety and effectiveness. | | |
| (8) | SimGrid | The SimGrid in the predicate device, cleared with K181626, 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 of all kinds of
anatomical regions The SimGrid modified to provide a parameter | | |
| | | | | |
| (9) | Quick Link | for controlling strength which is the extent of the compensation of the contrast loss based on the individual preference is available in the proposed device GM85 and this change does not contribute any adverse impact to the device's safety and effectiveness. The function of Quick Link, which allows Quick Link to access to external server such as RIS/PACS server, is applied to the proposed device GM85 and this change does not contribute any impact to the device's safety and effectiveness. | | |
| (10) | Mirror View | The function of the Mirror View, which shares the screen with other displays by using Miracast wireless communication, is applied to the proposed device GM85 and this change does not contribute any impact to the device's safety and effectiveness. | | |
| (11) | Clinical
Parameter
Control | The captured images are tuned up by the preset value of an Image Post-processing Engine (IPE) in the predicate device and it is upgraded in the proposed device GM85 to provide the function, called as Clinical Parameter Control, to compare the editing image with the current image simultaneously during presetting the parameters. This change does not contribute any impact to the device's safety and effectiveness. | | |
| (12) | Value-up
Package | New software features which is an option to provide convenience for use, called as the Value-up Package, is applied to the proposed device GM85 and these changes do not contribute any impact to the device's safety and effectiveness. | | |
| (13) | Remote Software
Upgrade | The function of the Remote Software Upgrade, which enable the authorized user to download and update the software from the server by the user authentication, is applied the proposed device GM85 and this change does not contribute any impact to the device's safety and effectiveness | | |
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510(k) Premarket Notification - Traditional
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 new detectors that have equivalent image characteristics as the existing ones. Specific description is added to make it clear with the non-clinical data and phantom image evaluation report. And those detectors evaluated by Software
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510(k) Premarket Notification - Traditional
System Test Case for verification and validation.
D. Clinical data
In clinical data, phantom image evaluations of the new detectors, upgraded SimGrid and Image Post-processing Engine (IPE) 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 a professional radiologist and found to be equivalent to the predicate devices. There is no significant difference in the average score of image quality evaluation between the proposed device and the predicate device. Therefore, these changes do not affect either the safety or the effectiveness, compared to the predicate device.
E. Summary of the Standards and Guidance Compliance
- AAMI ANSI ES60601-1 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and 1. A2:2010/(R)2012 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-2 Edition 4 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic compatibility - Requirements and Tests
-
- IEC 60601-1-3 Edition 2.1 Medical Electrical Equipment - Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation protection in Diagnostic X-ray Equipment
-
- IEC 60601-2-28 Edition 3 Medical Electrical Equipment – Part 2-28: Particular Requirements for the Basic Safety and Essential Performance of X-ray Tube Assemblies for Medical Diagnosis
-
- IEC 60601-2-54 Edition 1.2 Medical Electrical Equipment – Part 2-54: particular Requirements for the Basic Safety and Essential Performance of X-ray Equipment for Radiography and Radioscopy
-
- IEC 62220-1-1 Edition 1.0 Medical electrical Equipment - Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging
- Content of Premarket Submissions for Management of Cybersecurity in Medical 7. Devices Guidance for Industry and Food and Drug Administration Staff issued on October 2, 2014
-
- Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2015
- Guidance for the Submission for 510(k) for Solid State X-ray Imaging Devices 9. Guidance for Industry and Food and Drug Administration Staff issued on September 1, 2016
-
- Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff issued on November 28, 2017
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510(k) Premarket Notification - Traditional
F. Conclusions
The non-clinical and phantom evaluation data demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate devices.