GC70

K163115 · Samsung Electronics Co., Ltd. · KPR · Dec 7, 2016 · Radiology

Device Facts

• Record ID: K163115
• Device Name: GC70
• Applicant: Samsung Electronics Co., Ltd.
• Product Code: KPR · Radiology
• Decision Date: Dec 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

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.

Device Story

GC70 is a stationary digital X-ray imaging system; captures radiographic images of human anatomy. X-rays pass through patient body to detector; converted to electrical signals; amplified and digitized in signal process device. Data sent to S-Station software; saved as DICOM files; transmitted to PACS server for clinical review. Operated by qualified doctors or technicians in clinical settings. Includes SimGrid software to compensate for contrast loss from scatter radiation and Bone Suppression software to enhance chest pathology visualization. System configuration includes high voltage generator, wall stand, and patient table. Output images assist clinicians in diagnostic decision-making; provides diagnostic information for patient care.

Clinical Evidence

No human clinical trials. Bench testing included phantom image evaluations performed per FDA guidance for Solid-State X-ray Imaging Devices. Evaluations by a professional radiologist confirmed equivalence to the predicate device. Non-clinical data includes MTF and DQE measurements per IEC 62220-1.

Technological Characteristics

Stationary digital X-ray system. Components: High voltage generator, wall stand, patient table, digital detector. Standards: ES 60601-1, IEC 60601-1-2 (EMC), IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO 14971, 21 CFR 1020.30/31. Connectivity: DICOM, PACS. Software: SimGrid (scatter compensation), Bone Suppression (image processing).

Indications for Use

Indicated for generating radiographic images of human anatomy in patients requiring diagnostic X-ray imaging. Not intended for mammographic applications. Use by qualified/trained doctors or technicians.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• GC85A (K160997)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 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 to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 7, 2016

SAMSUNG ELECTRONICS Co., Ltd. % Mr. Chulsin Kim Regulatory Affairs Manager 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do 16677 REPUBLIC OF KOREA

Re: K163115

Trade/Device Name: GC70 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 31, 2016 Received: November 7, 2016

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.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'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)

K163115

Device Name GC70

Indications for Use (Describe)

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.

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) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

> "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue oval background. The oval is tilted slightly to the right.

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

- 1. Date: Oct 31, 2016
# 2. Submitter

- Company Name: SAMSUNG ELECTRONICS Co., Ltd. A.
- Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, B. Republic of Korea

## 3. Primary Contact Person

- A. Name: KIM, CHULSIN
- B. Title: Regulatory Affairs Manager
- Phone Number: [phone] ﻥ
- FAX Number: [phone] D. E-Mail: [e-mail]

# 4. Secondary Contact Person

- A. Name: Ninad Gujar
- B. Title: Director of Regulatory Affairs
- C. Phone Number: 978-564-8503
- FAX Number: 978-750-6677 D. E-Mail: [e-mail]

## 5. Proposed Device

- A. Trade Name: GC70
- B. Device Name: GC70
- C. Common Name: Digital Diagnostic X-ray System
- Classification Name: Stationary x-ray system D.
- E. Product Code: KPR
- F. Regulation: 21 CFR 892.1680

## 6. Predicate Devices

- A. Trade Name: GC85A
- B. Device Name: GC85A
- Common Name: Digital Diagnostic X-ray System ﻥ
- D. Classification Name: Stationary x-ray system
- Product Code: KPR ய்
- ட் Regulation: 21 CFR 892.1680
- G. 510(k): K160997

## 7. Device Description

The GC70 digital X-ray imaging system is used to capture images by transmitting X-ray

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded rectangle.

#### 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 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.

# 8. Intended Use

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.

# 9. Summary of Technological characteristic of the proposed device compared with the predicate devices

The proposed device, GC70, has same detectors and image processing as the predicate device so it does not have significant changes in imaging performance in comparison to the predicate device, and has few configuration options more as HVG(High Voltage Generator), Wall Stand and Patient Table are added.

| Specification | Predicate Device | Proposed Device | Discussion |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Device Name | GC85A | GC70 | |
| Manufacturer | SAMSUNG ELECTRONICS<br>Co., Ltd. | SAMSUNG ELECTRONICS<br>Co., Ltd. | Same |
| 510(k) Number | K160997 | None | |
| Appearances | Image: GC85A X-ray machine | Image: GC70 X-ray machine | Difference(1) |
| Intended Use | The GC85A digital X-ray<br>imaging system is intended<br>for use in generating<br>radiographic images of<br>human anatomy by a<br>qualified/trained doctor or<br>technician. This device is not<br>intended for mammographic<br>applications. | The GC70 Digital X-ray<br>Imaging System is intended<br>for use in generating<br>radiographic images of<br>human anatomy by a<br>qualified/trained doctor or<br>technician. This device is<br>not intended for<br>mammographic<br>applications. | Same |
| Manufacturer Contents | GC85A<br>(K160997) | GC70 | Discussion |
| (1)High Voltage Generator | | | |

#### A. Comparing with Predicate Device

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the Samsung logo. The logo is a blue oval with the word "SAMSUNG" in white letters. The letters are bold and sans-serif. The logo is simple and recognizable.

510(k) Premarket Notification - Traditional

| Manufacturer Contents | GC85A<br>(K160997) | GC70 | Discussion | |
|-----------------------|--------------------|-------------|--------------------------|--------------------------|
| Max. Power | 82kW | 52kW | Same &<br>Differences(2) | |
| Output<br>RANGE | Tube Voltage | 40-150kV | 40-150kV | Same |
| | Tube Current | 10-1000mA | 10-640mA | Same &<br>Differences(3) |
| | Exposure Time | 1msec-10sec | 1msec-10sec | Same |

| Manufacturer Contents | | | GC85A (K160997) | GC70 | Discussion |
|-----------------------|---------------|-----------|-----------------|----------------|----------------|
| (3) Wall Stand | | | | | |
| Vertical<br>Movement | Mechanis<br>m | Motorized | Motorized | Same | |
| | Range(m<br>m) | 280~1850 | 412~1838 | Differences(4) | |
| Detec<br>tor | Tilting | Motorized | Motorized | Motorized | Same |
| | | -20~+90 | -20~+90 | -30~+90 | Differences(5) |

| Manufacturer Contents | GC85A<br>(K160997) | GC70 | Discussion | | |
|-------------------------------------|--------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------|------------------------------------------------------|
| (4)Patient Table | | | | | |
| Table<br>Top | Size(mm) | 2410 X 812 | 2410 X 812 | 2200 X 810 | Same |
| | Range<br>(mm) | Lateral<br>±140<br>Longitudinal<br>±480 | Lateral<br>±140<br>Longitudinal<br>±480 | Lateral<br>±125<br>Longitudinal<br>±500 | Same &<br>Differences(6)<br>Same &<br>Differences(7) |
| Table<br>height | Mechanism | DC Motor,<br>Ball screw | DC Motor,<br>Ball screw | DC Motor,<br>Ball screw | Same |
| | Range(mm) | 545 ~ 900 | 545 ~ 900 | 565 ~ 850 | Same &<br>Differences(8) |
| Horizontal range of<br>detector(mm) | | 688 | 688 | 290 | Same &<br>Differences(9) |
| Maximum Patient<br>Weight(kg) | | 350<br>(Static, Center<br>load) | 350<br>(Static, Center<br>load) | 300<br>(Static,<br>Center load) | Same &<br>Differences(10) |

| Manufacturer<br>Contents | GC85A (K160997) | GC70 | Discussion | | | | |
|---------------------------------------------|--------------------------------|---------------------------------|--------------------------------|--------------------------------|---------------------------------|--------------------------------|------|
| (6) Detector (already cleared with K160997) | | | | | | | |
| Name | S4335-<br>W | S4343-<br>W | S3025-<br>W | S4335-<br>W | S4343-<br>W | S3025-<br>W | Same |
| MTF | 84%<br>(0.5 lp/mm,<br>Typical) | 85 %<br>(0.5 lp/mm,<br>Typical) | 86%<br>(0.5 lp/mm,<br>Typical) | 84%<br>(0.5 lp/mm,<br>Typical) | 85 %<br>(0.5 lp/mm,<br>Typical) | 86%<br>(0.5 lp/mm,<br>Typical) | Same |
| DQE | 73%<br>(0.1 lp/mm,<br>Typical) | 80 %<br>(0.1 lp/mm,<br>Typical) | 78%<br>(0.1 lp/mm,<br>Typical) | 73%<br>(0.1 lp/mm,<br>Typical) | 80 %<br>(0.1 lp/mm,<br>Typical) | 78%<br>(0.1 lp/mm,<br>Typical) | Same |

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the Samsung logo. The logo is white text on a blue background. The text is in a sans-serif font and is slightly italicized.

510(k) Premarket Notification - Traditional

| Manufacturer<br>Contents | GC85A (K160997) | GC70 | Discussion |
|------------------------------------------------------|------------------------|------------------------|------------|
| (8) Software Features (already cleared with K160997) | | | |
| Feature Names | SimGrid | SimGrid | Same |
| | Bone Suppression Image | Bone Suppression Image | Same |
| Description | | | |

The SimGrid 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.

The Bone Suppression Software features that will be made to Samsung Digital X-ray imaging Systems are adding Samsung's new post image processing algorithm. This SW can provide companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol. The Bone Suppression 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.

| No | Differences | Explanation |
|------|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (1) | Appearance | The table and stand of the proposed device is a basic model in<br>comparison with the predicate device's one, which does not<br>contribute any adverse impacts to the device's safety and<br>performance and image quality. |
| (2) | Max. Power | The difference of max power rate does not contribute any adverse<br>impacts to the device's safety and performance and image quality. |
| (3) | Tube Current | The difference of tube current does not contribute any adverse<br>impacts to the device's safety and performance and image quality. |
| (4) | Vertical<br>Movement -<br>Range | The difference of vertical Moving range does not contribute any<br>adverse impacts to the device's safety and performance and image<br>quality. |
| (5) | Detector - Tilting | The difference of Detector - Tilting does not contribute any adverse<br>impacts to the device's safety and performance and image quality. |
| (6) | Table Top -<br>Lateral | The difference of lateral moving range does not contribute any<br>adverse impacts to the device's safety and performance and image<br>quality. |
| (7) | Table Top -<br>Longitudinal | The difference of table top longitudinal moving range does not<br>contribute any adverse impacts to the device's safety and<br>performance and image quality. |
| (8) | Table Height -<br>range | The difference of Table Height - range does not contribute any<br>adverse impacts to the device's safety and performance and image<br>quality. |
| (9) | Horizontal range<br>of detector. | The difference of horizontal range of detector does not contribute<br>any adverse impacts to the device's safety and performance and<br>image quality. |
| (10) | Maximum Patient<br>Weight | The difference of maximum patient weight does not contribute any<br>adverse impacts to the device's safety and performance and image<br>quality. |

#### B. Difference Table

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is sans-serif and bold, and the letters are evenly spaced. The blue oval is tilted slightly to the left.

510(k) Premarket Notification - Traditional

# 10. Safety, EMC and Performance Data

Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1.JEC 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.

## 11. Non-clinical data

Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 62220-1.

The proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device.

The software contained in the proposed device has been developed & tested in the S/W development procedure on IEC62304, and the Guidance for Content of Premarket Submissions for Software Contained in Medical Devices.

The dosimetry performance has been evaluated with IEC60601-1, and the recommened exposure chart is provided in the user manual.

## 12. Clinical data

In clinical data, phantom image evaluations were performed 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 found to be equivalent to the predicate device.

## 13. Conclusions

The non-clinical and clinical data demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed devices.