(29 days)
The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
The GF85 digital X-ray imaging system is used to capture images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process 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 sent to the Picture Archiving & Communication System (PACS) sever for reading images. The GF85 Digital X-ray Imaging System includes two models, namely the GF85-3P and GF85-SP. These two models differ primarily in terms of their respective configurations of High Voltage Generators (HVGs). Specifically, the GF85-3P features capacities of 80 kW, 65 kW and 50 kW with 3 phases, whereas the GF85-SP provides a capacity of 40 kW with a single phase. However, all other specifications remain consistent across both models.
The provided text describes the GF85 Digital X-ray Imaging System and its substantial equivalence to predicate devices (GC85A and GM85). The key study mentioned for demonstrating equivalence is a non-clinical phantom image evaluation.
Here's a breakdown of the requested information based on the provided text, with "N/A" for information not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it relies on a comparison with predicate devices and a general statement that "All test results were satisfying the standards" and that the phantom image evaluations "found to be equivalent to the predicate device."
| Criterion Type | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Dosimetric Performance | Similar characteristics in exposure output and Half Value Layer compared to predicate devices. | "the proposed device has the similar characteristics in the exposure output and Half Value Layer even for different tube combinations." |
| Phantom Image Evaluation | Image quality equivalent to the predicate device. | "The phantom image evaluations were performed in accordance with the FDA guidance for the submission of 510(k)'s for Solid State X-ray Image Devices and were evaluated by three different professional radiologists and found to be equivalent to the predicate device." "These reports show that the proposed device is substantially equivalent to the proposed devices." |
| Electrical Safety | Compliance with ANSI AAMI ES60601-1. | "All test results were satisfying the standards." |
| EMC | Compliance with IEC 60601-1-2. | "EMC testing was conducted in accordance with standard IEC 60601-1-2. All test results were satisfying the standards." |
| Radiation Protection | Compliance with IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, 21 CFR1020.30 and 21 CFR1020.31. | "All test results were satisfying the standards." |
| Software/Cybersecurity | Compliance with "Cybersecurity in Medical Device" and "Content of Premarket Submissions for Device software Functions" guidances. | While compliance with guidances is listed, specific performance results for cybersecurity or software functions are not detailed, beyond stating "All test results were satisfying the standards." |
| Wireless Function | Verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. | "Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards." |
2. Sample size used for the test set and the data provenance
The document states "The phantom image evaluations were performed...".
- Sample size for test set: The document does not specify the number of phantom images used in the evaluation.
- Data provenance: Phantom images are synthetic data, not from human subjects. The country of origin for the data is not specified, but the submission is from Samsung Electronics Co., Ltd. in South Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states, "...and were evaluated by three different professional radiologists..."
- Number of experts: Three.
- Qualifications of experts: "professional radiologists." Specific experience levels (e.g., "10 years of experience") are not provided.
4. Adjudication method for the test set
The document states the images "were evaluated by three different professional radiologists and found to be equivalent to the predicate device." It does not specify a formal adjudication method (e.g., 2+1, 3+1 consensus). It implies a collective agreement on equivalence.
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
- MRMC study: No. The study conducted was a non-clinical phantom image evaluation to compare the device's image quality to a predicate device, as evaluated by radiologists. It was not a comparative effectiveness study involving human readers' performance with and without AI assistance.
- Effect size of human reader improvement with AI: N/A, as no such study was conducted or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The primary evaluation described (phantom image reviews) involved human radiologists assessing images generated by the device. The device itself is an X-ray imaging system, not an AI algorithm performing diagnostic interpretation. While the software features list "Lunit INSIGHT CXR Triage" as a new feature for the GF85, the provided text does not detail any standalone performance study specifically for this AI component or any other algorithmic component of the GF85. The "phantom image evaluations" are about the device's image quality, not an algorithm's diagnostic performance.
7. The type of ground truth used
For the phantom image evaluation, the ground truth is implicitly defined by the known characteristics and standards of the phantom images themselves, as well as the comparison against the predicate device. It is not expert consensus on pathology, or outcomes data.
8. The sample size for the training set
- Training set sample size: N/A. The document describes a traditional X-ray imaging system and its non-clinical evaluation for substantial equivalence. It does not refer to a machine learning model's training set. While there are "Software Features" like "Lunit INSIGHT CXR Triage" which would involve AI, the document does not discuss their training data.
9. How the ground truth for the training set was established
- Ground truth for training set: N/A, as no training set for a machine learning model is directly discussed for the GF85 system itself in the context of its substantial equivalence.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
September 19, 2024
Samsung Electronics Co., Ltd. % Jaesang Noh Regulatory Affairs, Principal Professional 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi 16677 SOUTH KOREA
Re: K242478
Trade/Device Name: Gf85 (models gf85-3p, gf85-sp) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: August 19, 2024 Received: August 21, 2024
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
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assistance/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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostoc X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242478
Device Name GF85 (models GF85-3P, GF85-SP)
Indications for Use (Describe)
"The GF85 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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SAMSUNG
SAMSUNG ELECTRONICS Co., Ltd.
510(k) Premarket Notification - Traditional
K242478 510(k) Summary
This 510k Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
-
- Date: August 19, 2024
2. Submitter
- A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, Republic of Korea
3. Primary Contact Person
- A. Name: JAESANG NOH
- B. Title: Regulatory Affairs, Principal Professional
- C. Phone Number: +82-2-2193-2444
- D. FAX Number: +82-2-2194-0284
- E. E-Mail: jaesang.noh@samsung.com
4. Secondary Contact Person
- A. Name: Ninad Gujar
- B. Title: Vice President, Requlatory Affairs & Quality Control
- C. Phone Number: 978-564-8503
- D. FAX Number: 978-560-0602
- E. E-Mail: ngujar@neurologica.com
Proposed Device 5.
- A. Trade Name: GF85 (models GF85-3P, GF85-SP)
- B. Device Model Names: GF85-3P, GF85-SP
- C. Common Name: Stationary X-ray System
- D. Classification Name: System, X-ray, Stationary
- E. Product Code: KPR
- ட் Regulation: 21 CFR 892.1680
6. Predicate Devices
| Predicate Device #1 | Predicate Device #2 | |
|---|---|---|
| Device Name | GC85A | GM85 |
| Classification Name | Stationary X-ray System | Mobile X-ray System |
| Product Code | KPR | IZL |
| Regulation | 21 CFR 892.1680 | 21 CFR 892.1720 |
| 510(K)# | K181629 | K222353 |
| 510(K) Decision Date | July 20, 2018 | September 29, 2022 |
7. Device Description
The GF85 digital X-ray imaging system is used to capture images by transmitting X-ray
{5}------------------------------------------------
510(k) Premarket Notification - Traditional
to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process 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 sent to the Picture Archiving & Communication System (PACS) sever for reading images. The GF85 Digital X-ray Imaging System includes two models, namely the GF85-3P and
GF85-SP. These two models differ primarily in terms of their respective configurations of High Voltage Generators (HVGs). Specifically, the GF85-3P features capacities of 80 kW, 65 kW and 50 kW with 3 phases, whereas the GF85-SP provides a capacity of 40 kW with a single phase. However, all other specifications remain consistent across both models.
8. Intended Use
The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
9. Summary of Technological characteristic of the proposed device compared with the predicate device
Though the gantry of the proposed device, GF85, is newly designed, it has the same detectors and image processing as predicate devices. Therefore, it does not have significant changes in image characteristics compared to the predicate device #1 and #2, GC85A and GM85.
Comparisons of technological characteristics were executed and demonstrate the substantial equivalence to the predicate devices.
| Attribute | Predicate Device #1 | Proposed Device | Predicate Device #2 | Comparison Results |
|---|---|---|---|---|
| Name | GC85A | GF85(GF85-3P/GF85-SP) | GM85 | |
| Manufacturer | SAMSUNGELECTRONICSCo., Ltd. | SAMSUNGELECTRONICSCo., Ltd. | SAMSUNGELECTRONICSCo., Ltd. | |
| 510(k) Number | K181629 | None | K222353 | |
| Appearances | Image: GC85A | Image: GF85 | Image: GM85 | Similar as PD #1 |
| Intended Use | The GC85A digitalX-ray imagingsystem is intendedfor use in | The GF85 Digital X-ray Imaging Systemis intended for usein generating | The GM85 DigitalMobile X-rayimaging System isintended for use in | Same as PD #1 |
A. Comparing with Predicate Devices
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SAMSUNG
| generatingradiographic imagesof human anatomyby aqualified/traineddoctor or technician.This device is notintended formammographicapplications. | radiographic imagesof human anatomyby aqualified/traineddoctor or technician.This device is notintended formammographicapplications. | generatingradiographic imagesof human anatomyby aqualified/traineddoctor or technician.This device is notintended formammographicapplications. |
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Attribute | Predicate Device #1(GC85A, K181629) | GF85 | Comparison Results | ||
|---|---|---|---|---|---|
| GF85-3P | GF85-SP | ||||
| (1)High Voltage Generator | |||||
| Name | GXR-82 | GXR-52ZR75 PN80ZR75 PN50 | Cetus 80R01Cetus 65R01Cetus 50R01Cetus 40R03 | Different (1) | |
| Max. Power | 82kW | 52kW80kW50kW | 80kW65kW50kW40kW | Different (1) | |
| OutputRANGE | Tube Voltage | 40-150kV | Same | ||
| Tube Current | 10-1000 mA10-640m A10-1000 mA10-630m A | 10 ~ 1000 mA10 ~ 800 mA10 ~ 630 mA10 ~ 500 mA | Different (1) | ||
| Exposure Time | 1msec-10sec | Same | |||
| AEC(AutomaticExposureControl) | Yes | Same | |||
| APR(AnatomicallyProgrammedRadiography) | Yes | Same |
| Attribute | Predicate Device #1(GC85A, K181629) | GF85 | Comparison Results | |||
|---|---|---|---|---|---|---|
| (2) X-ray tube | ||||||
| Name | E7869X | E7252X | H2100XE7254FX | H1080XE7252X | H1086XE7843X | Different (2) |
| Focal spot | 0.6/1.2mm | 0.6/1.2mm | Same | |||
| Target Angle | 12° | 12° | Same | |||
| Target Material | Rhenium-tungsten facedmolybdenum | Rhenium-tungsten facedmolybdenum | Same |
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SAMSUNG
| Attribute | Predicate Device #1(GC85A, K181629) | GF85 | Comparison Results | |
|---|---|---|---|---|
| Max. Anode HU | 600kHU | 400kHU 300kHU 150KHU | Different (2) | |
| Attribute | Predicate Device #1(GC85A, K181629) | GF85 | Comparison Results | |
| (3) Tube Stand | ||||
| Moving Range (mm) | Longitudinal | 1,680~4,180(Varies with room size) | 2,100 | Different (3) |
| Lateral | 1,030~3,030(Varies with room size) | 150 | Different (3) | |
| Vertical | 1,800 | 1,500 | Different (3) | |
| Vertical Tube Moving method | Motorized | Manual & Motorized | Different (3) | |
| Tube Assembly Rotation | -157 ~ +183 | ±90° | Different (3) | |
| Brake locking Method | Electromagnetic | Electromagnetic | Same | |
| Automatic Centering | O | O | Same | |
| Moving Rail Type | Al Extrusion | Steel | Different (3) | |
| Image Preview | O | O | Same | |
| Display Type | Color LCD | Color LCD | Same | |
| Control Switch Type | Button + Touch Screen | Button + Touch Screen | Same | |
| Vertical Sync. | With Table | O | O | Same |
| With Stand | O | O | Same | |
| Tube Support Mounting | Ceiling-mounted | Floor-mounted | Different (3) | |
| Attribute | Predicate Device #1(GC85A, K181629) | GF85 | Comparison Results | |
| Movement | Range(mm) | 280~1,850 | 400~1,900 | Different (4) |
| Detector/tubeservo coupling | Yes | Yes | Same | |
| Detector | Tilting | Motorized | Motorized | Same |
| -20~+90 / N/A | -20~+90 / N/A | Same | ||
| AEC | Conventional | Conventional | Same | |
| Lines/cm | 85/92 | 85 | Same | |
| Grid | Gridmechanism | Stationary | Stationary | Same |
| Removability | Removable | Removable | Same | |
| DetectorSupportMounting | Floor | Floor | Same | |
| Patient SupportDevice | Patient handgrips, lateralsupport bar | Patient handgrips, lateralsupport bar | Same |
| Attribute | Predicate Device #1 (GC85A, K181629) | GF85 | Comparison Results | |
|---|---|---|---|---|
| (4) Wall Stand | ||||
| Vertical | Mechanism | Motorized | Manual & Motorized | Different (4) |
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SAMSUNG
| Attribute | Predicate Device #1(GC85A, K181629) | GF85 | Comparison Results | |
|---|---|---|---|---|
| (5) Patient Table | ||||
| Table Top | Size(mm) | 2,410 X 812 | 2,208 X 800 | Different (5) |
| Range (mm) | $\pm$ 140 | $\pm$ 105 | Different (5) | |
| Range (mm) | $\pm$ 480 | $\pm$ 400 | Different (5) | |
| Table height | Mechanism | Motorized | Motorized / Fixed | Same |
| Range (mm) | 545 ~ 900 | 500 ~770 / 680 (Fixed) | Different (5) | |
| Horizontal range of detector(mm) | 688 | 600 | Different (5) | |
| AEC | Conventional | Conventional | Same | |
| Grid | Lines/cm | 85/92 | 85 | Same |
| Grid mechanism | Stationary | Stationary | Same |
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SAMSUNG
| Attribute | Predicate Device #1(GC85A, K181629) | GF85 | Comparison Results |
|---|---|---|---|
| Removability | Removable | Removable | Same |
| Vertical Sync. | O | O / Fixed | Different (5) |
| Control SwitchType | Foot switch | Foot switch | Same |
| MaximumPatientWeight(kg)(Static, Centerload) | 350 | 350 (CFRP) / 300 (HPL) | Different (5) |
| Attribute | Predicate Device #1(GC85A, K181629) | GF85 | Comparison Results |
|---|---|---|---|
| (6) Collimator | |||
| Name | SDR-OGCL80USDR-OGCL81USDR-OGCL83U | SDR-OGCL20PSDR-OGCL21P | Different (6) |
| Beam LimitingBlade/MovingMethod | Motorized/Manual | Motorized/Manual | Same |
| ManualOperationMethod | Volume | Volume | Same |
| CollimatorRotation | ±45 | -90°/+180° | Different (6) |
| Beam LightSource | LED | LED | Same |
| Light FieldIndicator Timer | O | O | Same |
| Side Lamp | O | O | Same |
| Laser Module | Laser Module | Same | |
| Field Size / SIDDisplay | Color LCD | Color LCD | Same |
| Attribute | Predicate Device #2(GM85, K222353) | GF85 | Comparison Results |
|---|---|---|---|
| (7) Detector | |||
| Name | S4335-WS4343-WS3025-WS4335-AWS4343-AWS4335-AWMS4343-AWMS3025-AWS3025-AWMF4335-AW | S4335-AWS4343-AWS4335-AWMS4343-AWMS3025-AWS3025-AWMF4335-AW | Same |
{10}------------------------------------------------
SAMSUNG
| Attribute | Predicate Device #1(GC85A, K181629) | GF85 | Comparison Results |
|---|---|---|---|
| (8) Weight Distribution Cap | |||
| W x L x H (mm) | 505 X 553 X 37.0 | 505 X 553 X 37.0 | Same |
| Attribute | Predicate Device #1(GC85A, K181629) | GF85 | Predicate Device #2(GM85, (K222353) | Comparison Results |
|---|---|---|---|---|
| (9) Software Features | ||||
| FeatureNames | S-Share | S-Share | S-Share | Same |
| S-Enhance | S-Enhance | S-Enhance | Same | |
| SimGrid | SimGrid | SimGrid | Same | |
| - | PEM | PEM | Same | |
| QAP | QAP | QAP | Same | |
| Bone Suppression | Bone Suppression | Bone Suppression | Same | |
| Remote View | Remote View | Remote View | Same | |
| Smart Stitching | Smart Stitching | - | Same | |
| - | Mirror View | Mirror View | Same | |
| - | RFID | RFID. | Same | |
| - | Vision Live | - | Different (7) | |
| - | Vision Stitching | - | Different (7) | |
| - | Vision Capture | - | Different (7) | |
| - | Virtual RemoteController | - | Different (7) |
{11}------------------------------------------------
SAMSUNG
510(k) Premarket Notification - Traditional
| Attribute | Predicate Device #1(GC85A, K181629) | GF85 | Predicate Device #2(GM85, (K222353) | Comparison Results |
|---|---|---|---|---|
| - | Lunit INSIGHT CXR Triage | - | Different (7) | |
| Attribute | Predicate Device #1(GC85A, K181629) | GF85 | Predicate Device #2(GM85, (K222353) | Comparison Results |
| (10) Image Post-processing Engine | ||||
| Noise reductionalgorithm | Image Post-processing Enginewith an advancednoise reductionalgorithm | Image Post-processing Enginewith an advancednoise reductionalgorithm | Image Post-processing Enginewith an advancednoise reductionalgorithm | Same |
| No | Comparison Results | Discussion |
|---|---|---|
| (1) | High Voltage Generator | The High Voltage Generators are different from thepredicate device, which have various Max. Power andOutput Range for the Tube Current. They do not contributeany adverse impact to the device's safety and effectiveness. |
| (2) | X-ray tube | The X-ray tube are different from the predicate device,which have different Max. Anode HU. They do not contributeany adverse impact to the device's safety and effectiveness. |
| (3) | Tube Stand | The Tube Stand is different from the predicated device,which have different Moving Range, Vertical Tube Movingmethod, Tube Assembly Rotation, Moving Rail Type andTube Support Mounting because it's a floor-mounded typein the proposed device. It does not contribute any adverseimpact to the device's safety and effectiveness. |
| (4) | Wall Stand | The Wall Stand different from the predicate device, whichhave different Vertical Movement. It does not contribute anyadverse impact to the device's safety and effectiveness. |
| (5) | Patient Table | The Patient Table is different from the predicate device,which has different Table Top, Table height, Horizontalrange of detector, Vertical Sync. and Maximum PatientWeight. It does not contribute any adverse impact to thedevice's safety and effectiveness. |
| (6) | Collimator | The Collimator is different from the predicate device, whichhave different Collimator Rotation. It does not contribute anyadverse impact to the device's safety and effectiveness. |
| (7) | Software | New features are provided for user convenience. It does notcontribute any adverse impact to the device's safety andeffectiveness. |
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, ISO 14971, 21 CFR1020.30 and 21 CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Wireless function was tested and
{12}------------------------------------------------
510(k) Premarket Notification - Traditional
verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards.
C. Non-clinical data
In the non-clinical data, the basic dosimetric performance data of the proposed device and predicate device were compared and the proposed device has the similar characteristics in the exposure output and Half Value Layer even for different tube combinations. The phantom image evaluations were performed in accordance with the FDA guidance for the submission of 510(k)'s for Solid State X-ray Image Devices and were evaluated by three different professional radiologists and found to be equivalent to the predicate device. These reports show that the proposed device is substantially equivalent to the proposed devices.
D. Clinical data
This submission does not required clinical data. Testing for image quality has been conducted with image phantoms, as described above.
- E. Summary of the Standards and Guidance Compliance
-
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical Electrical Equipment -Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 4.1 Medical Electrical Equipment Part 1-2: General 2. Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic compatibility - Requirements and Tests
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- IEC 60601-1-3 Edition 2.2 Medical Electrical Equipment – Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation protection in Diagnostic X-ray Equipment
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- 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
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- IEC 60601-2-54 Edition 2.0 Medical Electrical Equipment – Part 2-54: particular Requirements for the Basic Safety and Essential Performance of X-ray Equipment for Radiography and Radioscopy
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- 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
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- Cybersecurity in Medical Device: Quality System Considerations and Content of Premarket Submissions issued on September 27, 2023
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- Content of Premarket Submissions for Device software Functions issued on June 14, 2023
- 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
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- 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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{13}------------------------------------------------
SAMSUNG
SAMSUNG ELECTRONICS Co., Ltd.
510(k) Premarket Notification - Traditional
F. Conclusion
The non-clinical data demonstrates that the proposed device is as safe, as effective, and performs as well as the legally marketed devices indicating substantial equivalence to the predicate.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.