August 31, 2021

Samsung Electronics Co., Ltd.

℅ Jaesang Noh
Senior Professional, Regulatory Affairs
129, Samsung-ro, Yeongtong-gu
Suwon-si, Gyeonggi-do 16677
REPUBLIC OF KOREA

Re: K201560
Trade/Device Name: Auto Lung Nodule Detection
Regulation Number: 21 CFR 892.2070
Regulation Name: Medical image analyzer
Regulatory Class: Class II
Product Code: MYN
Dated: July 15, 2021
Received: July 20, 2021

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
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.27
Silver Spring, MD 20993
www.fda.gov
K201560 - Jaesang Noh Page 2

801); medical device reporting (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-reporting-
combination-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 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-devices/medical-device-safety/medical-device-reporting-
mdr-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/medical-
devices/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-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D.

Director
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
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2020
Indications for Use See PRA Statementbelow.

510(k) Number (ifknown)

K201560

Device Name
Auto Lung Nodule Detection

Indications for Use (Describe)

The Auto Lung Nodule Detection is computer-aided detection software to identify and mark regions in relation to
suspected pulmonary nodules from 10 to 30 mm in size. It is designed to aid the physician to review the PA chest
radiographs of adults as a second reader and be used as part of S-Station, which is operation software installed on
Samsung Digital X-ray Imaging systems. Auto Lung Nodule Detection cannot be used on the patients who have lung
lesions other than abnormal nodules.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D) 0 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 Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
"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 FDA 3881 (7/17) Page 1 of 1 PSC Publishing Srvics (301) 443-6740 EF
 K201560

SAMSUNG ELECTRONICS Co., Ltd.

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: August 26, 2021

2. Submitter
A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
B. Address: 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, Senior Professional
C. Phone Number: +82-2-2193-2444
D. FAX Number: +82-31-200-6401
E. E-Mail: [email protected]

4. Secondary Contact Person

A. Name: Ninad Gujar
B. Title: Vice President, Regulatory Affairs & Quality Control
C. Phone Number: 978-564-8503
D. FAX Number: 978-560-0602
E. E-Mail: [email protected]

5. Proposed Device
A. Trade Name: Auto Lung Nodule Detection
B. Device Name: Auto Lung Nodule Detection
C. Common Name: Medical image analyzer
D. Classification Name: Medical image analyzer
E. Product Code: MYN
F. Regulation: 21 CFR 892.2070

6. Predicate Device
A. Manufacturer: Riverain Medical Group, LLC
B. Trade Name: ClearRead Detect

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SAMSUNG ELECTRONICS Co., Ltd.
510(k) Premarket Notification - Traditional
C. Classification: Medical image analyzer
D. Product Code: MYN
E. 510(k) Number or PMA Number: P000041
F. Decision Date: July 12, 2001
Predicate Device
Trade Name ClearRead Detect
Classification Name Medical image analyzer
Product Code MYN
Regulation 21 CFR 892.2070
PMA# P000041
Decision Date July 12, 2001
*The product code MYN has been reclassified from Class III to Class II since February 21, 2020.

7. Device Description
Auto Lung Nodule Detection is a Computer-Aided Detection (CADe) device that is designed to
perform CAD processing in Chest X-ray images for indication of locations for high nodule
probability, which has an effective detection sizes from 10 mm to 30 mm.
Auto Lung Nodule Detection receives images acquired with SAMSUNG Digital X-ray Imaging
Systems as an input and identifies suspected nodules, and then sends information of suspected
nodules to the visualization part of S-Station, which is installed on all kinds of SAMSUNG Digital
X-ray Imaging Systems, to generate output images with circular marks. The CAD performed
images, are displayed on the screen by S-Station without defeat of original images and used as a
second reader only after the initial read is completed.

8. Intended Use
The Auto Lung Nodule Detection is computer-aided detection software to identify and mark regions
in relation to suspected pulmonary nodules from 10 to 30 mm in size. It is designed to aid the
physician to review the PA chest radiographs of adults as a second reader and be used as part of
S-Station, which is operation software installed on Samsung Digital X-ray Imaging systems. Auto
Lung Nodule Detection cannot be used on the patients who have lung lesions other than abnormal
nodules.

9. Summary of Technological characteristic of the proposed device compared with the predicate
device
Samsung believes that the proposed device is substantially equivalent to the predicate device
because some differences in the design and features is considered low risk and do not raise new
questions on safety and effectiveness of the proposed device for its intended use based on the
non-clinical and clinical testing.

A. Comparing with Predicate Device

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SAMSUNG ELECTRONICS Co., Ltd.
510(k) Premarket Notification - Traditional
Predicate Device Proposed Device
Auto Lung Nodule
Device Name ClearRead Detect
Detection
Riverain Medical Group,
Manufacture Samsung Electronics
LLC
PMA Number PMA P000041 -
Indication for use CLEARREAD DETECT is The Auto Lung Nodule
a computer-aided detection Detection is computer-
(CAD) system intended to aided detection software to
identify and mark regions identify and mark regions
of interest (ROIs) on in relation to suspected
digitized frontal chest pulmonary nodules from 10
radiographs. It identifies to 30 mm in size. It is
features associated with designed to aid the
solitary pulmonary nodules physician to review the PA
from 9 to 30 mm in size, chest radiographs of adults
which could represent as a second reader and be
early-stage lung cancer. used as part of S-Station,
The device is intended for which is operation software
use as an aid only after the installed on Samsung
physician has performed Digital X-ray Imaging
an initial interpretation of systems. Auto Lung Nodule
the radiograph. Detection cannot be used
on the patients who have
lung lesions other than
abnormal nodules.
Intended users Physician Physician
Intended body part Chest Chest
Imaging modality X-ray X-ray
Identification of lung Identification of lung
Key feature
nodules nodules
heuristic decision rules,
Technology artificial neural network, and Machine learning
fuzzy logic
Operating systems Standard PC/Windows Standard PC/Windows
Image DICOM
DICOM
type
Input
Applicable Chest PA
Chest PA/AP
Protocols
Information for ROI to be
Output ROI marked on the
marked on the duplicated
type duplicated input image
input image
Output Marker Circular/Adjustable Circular/Fixed
type/size
The number of nodule
Report The number of findings
markers
Reader workflow Second reader workflow Second reader workflow

10. Safety and Effectiveness Information

Software design description, hazard analysis, and labeling information are provided in support of

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SAMSUNG ELECTRONICS Co., Ltd.
510(k) Premarket Notification - Traditional
this premarket notification for the proposed device. The device labeling contains instructions for
use with cautions to provide for safe and effective use of the device. The results of the hazard
analysis with appropriate risk controls indicate the proposed device is of moderate level of concern,
as per the FDA Guidance, “Guidance for the Content of Premarket Submissions for Software
Contained in Medical Device” issued on May 11, 2005.

11. Software Verification and Validation

A. Non-clinical Testing
Non-clinical tests were conducted for Auto Lung Nodule Detection during the device
development in accordance with Samsung verification and validation process complied with
the FDA Quality System Regulations, ISO 13485 requirements, and the following standards.
- ISO14971:2007, Medical devices - Application of risk management to medical devices
(2nd Ed.)
- IEC62304:2006, Medical devices - Software life cycle processes
- IEC62366-1:2015, Medical device – Part1: Application of usability engineering to
medical devices

Verification and validation activities for Auto Lung Nodule Detection were conducted to
provide evidences that the design meets user needs and intended use and application
specification. The testing results support that all the software specifications have met the
acceptance criteria and the claims of substantial equivalence.

B. Clinical Performance Testing

Clinical evaluation was performed to validate the clinical efficacy of Samsung Auto Lung
Nodule Detection (ALND) in helping radiologists find pulmonary nodules on digital chest
radiographs. In this clinical study, nodule detection performances of human readers were
measured using a test dataset containing both normal and diseased images. Readers were
asked to mark their region of nodule suspicion on the images while also providing confidence
scores on each decision they have made. After independent reading, readers were allowed
to adjust their confidence scores after reviewing the ALND's detection results. Nodule
detection performances before and after ALND were measured via sensitivity, false positives
per image (FPPI), and jackknife alternative free response receiver operating characteristic
(JAFROC) figure of merit (FOM). The results have demonstrated that all readers' nodule
detection performances using the proposed device have increased with statistical
significance. Therefore, the proposed device could provide potential assistance for
radiologists in the interpretation and detection of pulmonary nodules when used as an
assistant tool.

12. Conclusions

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510(k) Premarket Notification - Traditional
Results of all conducted testing were found acceptable in supporting the claim of substantial
equivalent to the predicate device.

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