(27 days)
The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
The GR40CW digital X-ray imaging system consists of Detector, Power supply box, Battery pack, Battery charger, Access point, CIB(Control Interface Box), Workstation, Barcode scanner and Main cable. 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 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.
This document describes the premarket notification for the GR40CW Digital X-ray Imaging System (retrofit kit). The submission focuses on demonstrating substantial equivalence to predicate devices, particularly concerning the performance of a new detector, S4335-WV.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it relies on demonstrating equivalence or improvement compared to predicate devices for key technical specifications and imaging performance metrics.
| Performance Metric / Characteristic | Predicate Device 1 (GR40CW, K152094) / Predicate Device 2 (LLX240AB01, K102587) | Proposed Device (GR40CW with S4335-WV) | Discussion / Equivalence Claim |
|---|---|---|---|
| Detector Type | Predicate 1: CsI / Predicate 2: Gd2O2S | Gd2O2S | Same as 2nd predicate device |
| Detector Area | Predicate 1: 14"X17" (345mmX425mm) / Predicate 2: 17"X17" (439mmX439mm) | 14"X17" (345mmX425mm) | Same as 1st predicate device |
| Pixel Pitch (µm) | Predicate 1: 140 / Predicate 2: 143 | 140 | Same as 1st predicate device |
| High Contrast Limiting Resolution (lp/mm) | Predicate 1: 3.5 / Predicate 2: 3.6 | 3.5 | Same as 1st predicate device |
| MTF (Modulation Transfer Function) | Mentioned for Predicate 2 | Curves and measurements provided | Demonstrates substantially equivalent or improvement to the 2nd predicate device |
| DQE (Detective Quantum Efficiency) | Mentioned for Predicate 2 | Curves and measurements provided | Demonstrates substantially equivalent or improvement to the 2nd predicate device |
| Safety (Electrical, Mechanical, Environmental) | Compliant with ES 60601-1(2012) | Compliant with ES 60601-1(2012) | Satisfying with the standards |
| EMC (Electromagnetic Compatibility) | Compliant with IEC 60601-1-2(2007) | Compliant with IEC 60601-1-2(2007) | Satisfying with the standards |
| Wireless Function | Tested and verified | Tested and verified | Followed guidance for Radio frequency Wireless Technology in Medical Devices |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "clinical images were obtained in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-Ray Imaging Devices." However, it does not specify the sample size for the test set or the data provenance (country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The clinical images were "evaluated by a professional radiologist." The document mentions "a professional radiologist," implying a single expert was used. Their specific qualifications (e.g., years of experience, subspecialty) are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document states the images were "evaluated by a professional radiologist." This suggests no formal adjudication method (like 2+1 or 3+1) was employed, as only one radiologist is mentioned as evaluating the images.
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
No MRMC comparative effectiveness study was done. The device GR40CW is described as a "Digital X-ray Imaging System" and a "retrofit kit" that generates digital images. It is not an AI-powered diagnostic tool, but rather a digital detector replacing analog film systems. Therefore, the question of human reader improvement with AI assistance is not applicable to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. The GR40CW is a digital X-ray imaging system, not an algorithm, so a standalone performance evaluation of an "algorithm only" is not relevant. Its performance is tied to its image acquisition capabilities, which are then interpreted by human readers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical images was established by a professional radiologist's evaluation. It is not explicitly stated whether this involved objective measures like pathology or outcomes data, but rather the radiologist's interpretation of the images.
8. The sample size for the training set
The document does not specify any training set size. The context of the submission is a 510(k) for a device with a new detector, focusing on demonstrating equivalence to existing technology, not on training an AI algorithm.
9. How the ground truth for the training set was established
Not Applicable. As no training set is mentioned in the context of an AI algorithm, the method for establishing ground truth for a training set is not discussed.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2015
SAMSUNG ELECTRONICS CO., LTD. % Ms. Chulsin Kim Regulatory Affairs Manager 129. Samsung-ro. Yeongtong-gu Suwon-si, Gyeonggi-do 443-742 REPUBLIC OF KOREA
Re: K153401
Trade/Device Name: GR40CW Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: November 25, 2015 Received: November 27, 2015
Dear Mr. 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 Ochs
Robert Ochs. Ph.D. 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 GR40CW
Indications for Use (Describe)
The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------- |
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Type of Use (Select one or both, as applicable)
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SAMSUNG ELECTRONICS Co., Ltd.
510(k) Premarket Notification - Traditional
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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: November 20, 2015
2. Submitter
- A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, Republic of Korea
3. Primary Contact Person
- A. Name: KIM, CHULSIN
- B. Title: Regulatory Affairs Manager
- C. Phone Number: +82-31-200-7661
- D. FAX Number: +82-31-200-1199
- E. E-Mail: chulsin.kim@samsung.com
4. Secondary Contact Person
- A. Name: Ninad Gujar
- B. Title: Requlatory Affairs Manager
- C. Phone Number: 978-564-8503
- D. FAX Number: 978-750-6677
- E. E-Mail: ngujar@samsungneurologica.com
5. Proposed Device
- A. Trade Name: GR40CW
- B. Device Name: GR40CW
- C. Common Name: Retrofit Kit
- D. Classification Name: Solid State X-ray Imager (Flat panel/Digital imager)
- E. Product Code: MQB
- F. Regulation: 21 CFR 892.1680
6. Predicate Devices
| The 1st Predicate Device | The 2nd Predicate Device | |
|---|---|---|
| Manufacturer | SAMSUNG ELECTRONICS Co.,Ltd. | SAMSUNG MOBILE DISPLAY Co.,Ltd. |
| Device Name | GR40CW | LLX240AB01 |
| Common Name | Retrofit Kit | Digital Flat Panel X-Ray Detector |
| ClassificationName | Solid State X-ray Imager (Flatpanel/Digital imager) | Solid State X-ray Imager (Flatpanel/Digital imager) |
| Product Code | MQB | MQB |
| Regulation | 21 CFR 892.1680 | 21 CFR 892.1680 |
| 510(k) Number | K152094 | K102587 |
| 510(k) DecisionDate | Oct. 16, 2015 | Dec. 01, 2010 |
7. Device Description
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SAMSUNG ELECTRONICS Co., Ltd.
510(k) Premarket Notification - Traditional
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The GR40CW digital X-ray imaging system consists of Detector, Power supply box, Battery pack, Battery charger, Access point, CIB(Control Interface Box), Workstation, Barcode scanner and Main cable. 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 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.
Integration Information
This is a retrofit system consisting of Detectors, Power supply box, Battery charger, Access point, CIB (Control Interface Box), Workstation, Barcode scanner and Main cable. This retrofit system is designed to generate a digital image while using the current analoque X-ray system by upgrading only the part of an analogue cassette film to the digital panel(detector), and does not get involved in controlling X-ray radiation related parameters, which is still controlled by the existing X-ray system.
The GR40CW retrofit system can be applied to the existing analogue X-ray system by two ways (CIB and AED modes). 1) In CIB mode, CIB is only connected to a signal line of a hand switch for passively detecting the signal, as On or Off, coming out from the hand switch to the X-ray Generator Console, to make the digital detector ready to active or inactive to receive X-ray radiation. 2) In AED (Automatic Exposure Detection) mode, without CIB, the detector is sensing of radiation exposure. Once it recognizes the exposure, it become active right away to receive X-ray radiation. This whole process is independently operated from the existing analogue X-ray system.
Image /page/4/Figure/8 description: The image shows an integration diagram of the GR40CW Retrofit Kit and an existing X-ray system. The GR40CW Retrofit Kit includes a detector, workstation, and CIB, while the existing X-ray system includes an X-ray generator console and a hand switch. The diagram illustrates the connections and signals between the components, including the 'READY' signal from the first step press and the 'EXPOSURE' signal from the second step press. The system is operating in CIB mode.
[Integration Diagram]
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510(k) Premarket Notification - Traditional
Image /page/5/Figure/2 description: The image shows a diagram of the GR40CW Retrofit Kit and the existing X-ray system. The GR40CW Retrofit Kit includes a detector, workstation, and CIB. The existing X-ray system includes an X-ray generator console and a hand switch. The hand switch has two steps: the first step sends a READY signal to the X-ray generator console, and the second step sends an EXPOSURE signal.
In conclusion, this retrofit kit does not either require a modification / alteration or control in the part of X-ray radiation control of the current X-ray system in anyway.
8. Intended Use
The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used. This device is not intended for mammographic applications.
9. Summary of Technological characteristic of the proposed device compared with the predicate device
The proposed GR40CW has a digital X-ray detector (S4335-WV), which type is Gd2O2S as same as the 200 predicate device (LLX240AB01) cleared with 510(k) K102587, to be added into a list of detectors of the 1st predicate device, GR40CW (K152094). The proposed GR40CW has same software feature, workstation and CIB with the 1st predicate device. There is no significant difference in materials, energy source or technological characteristics compared to the predicate devices. The following technological characteristics are compared and the results demonstrate the substantial equivalent to the predicate devices.
| Specification | 1stPredicate Device | 2ndPredicate Device | Proposed Device | Discussion |
|---|---|---|---|---|
| Device Name | GR40CW | LLX240AB01 | GR40CW | - |
| Manufacturer | SAMSUNGELECTRONICS | SAMSUNG MOBILEDISPLAY | SAMSUNGELECTRONICS | - |
| 510(k) Number | K152094 | K102587 | N/A | - |
| Appearance | Image: First predicate device appearance | Image: Second predicate device appearance | Image: Proposed device appearance | Same as 1stpredicatedevice |
| Intended Use | The GR40CW DigitalX-ray ImagingSystem is intendedfor use in generalprojectionradiographic | LLX240AB01 DigitalFlat Panel X-RayDetector is indicatedfor digital imagingsolution designed forproviding general | The GR40CW DigitalX-ray ImagingSystem is intendedfor use in generalprojectionradiographic | Same as 1stpredicatedevice |
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AMSUNG ELECTRONICS Co., Ltd.
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510(k) Premarket Notification - Traditional
| applicationswhereverconventional screen-film systems or CRsystems may beused. This device isnot intended formammographicapplications. | radiographicdiagnosis of humananatomy targetingboth adult andchildren. It isintended to replacefilm basedradiographicdiagnostic systemsand provide a casediagnosis andtreatment planningfor physicians andother health careprofessionals. Not tobe used formammography. | applicationswhereverconventional screen-film systems or CRsystems may beused. This device isnot intended formammographicapplications. |
|---|---|---|
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| ManufacturerContents | GR40CW(K152094) | LLX240AB01(K102587) | GR40CW | Discussion |
|---|---|---|---|---|
| Detector | Note: S4335-WV has not been cleared before. | |||
| Name | S4335-W | LLX240AB01 | S4335-WV | - |
| Detector Type | CsI | Gd2O2S | Gd2O2S | Same as 2nd predicate device |
| Detector Area | 14"X17"(345mmX425mm) | 17"X17"(439mmX439mm) | 14"X17"(345mmX425mm) | Same as 1st predicate device |
| Pixel Pitch (µm) | 140 | 143 | 140 | Same as 1st predicate device |
| High ContrastLimitingResolution(lp/mm) | 3.5 | 3.6 | 3.5 | Same as 1st predicate device |
Since imaging Workstation and CIB(Control Interface Box) are same as the 18t predicate device has, there is no difference.
In non-clinical data, the proposed device's detector shows curves and measurements of MTF and DQE that demonstrate a substantially equivalent or improvement to the 200 predicate device.
10.Safety, EMC and Performance Data
Electrical, mechanical, environmental safety and performance testing were conducted according to standard ES 60601-1(2012), and EMC testing was conducted according to IEC 60601-1-2(2007). Wireless function was tested and verified followed by the guidance for Radio frequency Wireless Technology in Medical Devices. All test results were satisfying with the standards
11.Non-clinical data
Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission
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SAMSUNG ELECTRONICS Co., Ltd.
510(k) Premarket Notification - Traditional
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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 non-clinical testing data such as MTF and DQE measurements from the predicate device.
It conforms to the followings: ISO14971, ISO13485, 21 CFR Subchapter J 1020.30 and 1020.31
12.Clinical data
In clinical data, clinical images were obtained in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-Ray Imaging Devices. They were evaluated by a professional radiologist, and shown equivalent and better than the 20d predicate device. The provided clinical data were determined to be not necessary to establish substantial equivalence with the predicate devices.
13.Conclusions
The results of the non-clinical data & clinical data demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed devices.
§ 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.