(232 days)
No
The document describes standard ultrasound image processing and does not mention AI or ML capabilities.
No
The device is described as an "Ultrasound Imaging System" intended for "diagnostic ultrasound echo imaging, measurement, and analysis of the human body." It is used to acquire and display ultrasound data for real-time diagnosis. Therapeutic devices deliver energy or administer substances to treat a condition, which is not the stated function of this device.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The SC1 Ultrasound Imaging System (Model: SC1) is intended for diagnostic ultrasound echo imaging," and the "Device Description" section repeatedly refers to it as a "diagnostic ultrasound system."
No
The device description explicitly states that the system consists of a battery-operated ultrasound probe (SC1L) that communicates with the mobile device, in addition to the software. This indicates a hardware component is integral to the device's function.
Based on the provided information, the SC1 Ultrasound Imaging System (Model: SC1) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. The testing is performed outside of the living body (in vitro).
- SC1's Function: The SC1 is an ultrasound imaging system. It uses sound waves to create images of internal structures within the human body (in vivo). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "diagnostic ultrasound echo imaging, measurement, and analysis of the human body". This describes an in vivo diagnostic process.
Therefore, the SC1 Ultrasound Imaging System falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The SC1 Ultrasound Imaging System (Model: SC1) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid) through B mode. Flow detection is possible using PWD (Power Doppler) mode.
SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
Product codes (comma separated list FDA assigned to the subject device)
IYO, IYN, ITX
Device Description
The SC1 Handheld ultrasound imaging system, Model: SC1, is a general purpose, software-controlled, diagnostic ultrasound system that uses pulsed-echo technology (B Mode (Power Doppler); Frequency: 5 - 13 MHz; module: linear; depth max: 10 cm) to transmit ultrasound images via wired communication to a mobile device that utilizes the Android operating system. Its function is to acquire ultrasound data and to display the data in operation.
The SC1 Handheld ultrasound imaging system is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) the battery-operated, SC1L (Linear type Ultrasound Probe) that communicates wired with Android mobile device, (ii) the software that runs as an app on the mobile device, (iii) batteries, charger (Cradle), cable, power cord, and magnetizers (option), (iv) the instructions for use manual.
The SC1 App software can be downloaded to an Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image review, controls for depth, gain, linear measurement
The SC1 App software allows the user to image in real time and review freeze-frame images on the screen in a B-Mode and PD-Mode, 2-dimensional scan format.
SC1 Handheld ultrasound system is only intended for acquisition and real time diagnosis. SC1 Handheld ultrasound system (SC1 probe and SC1 app) provides functions on patient data (entering new patient information, editing patient data saving, storing, or transferring patient information). It is possible to connect to the PACS DICOM network (hospital network) to get the list of exams and export recorded exams. However, there is no option to export patient data via a USB cable.
Physician who is responsible for interpreting ultrasound images must be available in the room to provide diagnosis in real time.
SC1 Handheld ultrasound imaging system utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.
The device components are not supplied sterile and do not require sterilization prior to use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
musculoskeletal (MSK), vascular, small parts (breast, thyroid)
Indicated Patient Age Range
For use in all patients
Intended User / Care Setting
healthcare professionals / Hospital, clinic, and medical office settings
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)
Bench tests were conducted to verify that the proposed device met all design specifications for Electrical Safety, Electromagnetic Compatibility Testing, Software Validation and Cybersecurity Management, Biocompatibility Testing, and Performance Testing.
The performance of the SC1 has been defined as follows:
- Axial, Lateral Resolution
- Axial, Lateral distance
- B-mode and Combined(B+PD) mode display
- Max depth
No clinical studies were considered necessary and performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. 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 biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging 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.
0
June 26, 2024
Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
FCU Co., Ltd. % Song Hyuk RA manager B-620/621, Biz Center, 17, Techno 4-ro Yuseong-gu. Daeieon 34013 REPUBLIC OF KOREA
Re: K233579
Trade/Device Name: SC1 Handheld Ultrasound Imaging system (Model: SC1) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, IYN, ITX Dated: May 31, 2024 Received: May 31, 2024
Dear Song Hyuk:
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.
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).
1
Your device is also subject to, among other requirements, the Quality System (QS) 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.
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 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,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
SC1 Handheld Ultrasound Imaging system (Model: SC1)
Indications for Use (Describe)
The SC1 Ultrasound Imaging System (Model: SC1) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid) through B mode. Flow detection is possible using PWD (Power Doppler) mode.
SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
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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3
2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, Republic c Tel: +82 (42) 936 9078 Fax:+82 (42) 936 9077
510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared 1.
May 31, 2024
2. Submitter's Information & Contact Person
-
Name of Manufacturer: FCU Co., Ltd.
-
Address: 2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, Republic of Korea (34014)
-
Contact Name: Song Hyuk/ RA manager
-
Telephone No .: +82-42-936-9078
-
Fax No.: +82-42-936-9077
-
Email Address: h.song(@fcultrasound.com
Trade Name, Common Name, Classification 3.
Common name: Handheld ultrasound imaging system
Trade name: SC1 Handheld Ultrasound Imaging system (Model: SC1)
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Ultrasonic Pulse Doppler Imaging System | 21 CFR 892.1550 | IYN |
| Ultrasonic Pulsed Echo Imaging System | 21 CFR 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 21 CFR 892.1570 | ITX |
As stated in 21 CFR, parts 892.1550, and 892.1570, and 892.1570, each of these generic types of devices has been classified as Class II.
4
2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, Republic of Tel: +82 (42) 936 9078, Fax: +82 (42) 936 9077
4. Predicate Device
The identified predicate devices within this submission are shown as follow:
Primary Predicate device
| 510(k) Number: | K210468 |
|---|---|
| • Applicant: | FCU Co., Ltd. |
| • Classification Name: | Diagnostic Ultrasound System and Transducer |
| • Trade Name: | SC1 Handheld Ultrasound Imaging system (Model: SC1) |
Reference device
| • 510(k) Number: | K192226 |
|---|---|
| • Applicant: | Philips Healthcare |
| • Classification Name: | Ultrasonic Pulse Doppler Imaging System |
| • Trade Name: | Lumify Diagnostic Ultrasound System |
These predicates have not been subject to a design-related recall.
No reference devices were used in this submission.
ട. Device Description
The SC1 Handheld ultrasound imaging system, Model: SC1, is a general purpose, software-controlled, diagnostic ultrasound system that uses pulsed-echo technology (B Mode (Power Doppler); Frequency: 5 - 13 MHz; module: linear; depth max: 10 cm) to transmit ultrasound images via wired communication to a mobile device that utilizes the Android operating system. Its function is to acquire ultrasound data and to display the data in operation.
The minimum requirements for the mobile devices that utilize the Android operating system for use with the SC1 Handheld ultrasound imaging system, Model: SC1 are as follows:
| Item | Minimum Requirement |
|---|---|
| Recommended Tablet Device | Galaxy Tab S6 or later |
| Mobile OS Version | Android 14.0 or later |
The SC1 Handheld ultrasound imaging system is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) the battery-operated, SC1L (Linear type Ultrasound Probe) that communicates wired with Android mobile device, (ii) the software that runs as an app on the mobile device, (iii) batteries, charger (Cradle), cable, power cord, and magnetizers (option), (iv) the instructions for use manual.
5
2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, Republic of Korea (34014) Tel: +82 (42) 936 9078, Fax: +82 (42) 936 9077
The SC1 App software can be downloaded to an Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image review, controls for depth, gain, linear measurement
The SC1 App software allows the user to image in real time and review freeze-frame images on the screen in a B-Mode and PD-Mode, 2-dimensional scan format.
SC1 Handheld ultrasound system is only intended for acquisition and real time diagnosis. SC1 Handheld ultrasound system (SC1 probe and SC1 app) provides functions on patient data (entering new patient information, editing patient data saving, storing, or transferring patient information). It is possible to connect to the PACS DICOM network (hospital network) to get the list of exams and export recorded exams. However, there is no option to export patient data via a USB cable
Physician who is responsible for interpreting ultrasound images must be available in the room to provide diagnosis in real time.
SC1 Handheld ultrasound imaging system utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.
The device components are not supplied sterile and do not require sterilization prior to use.
Indications for Use 6.
The SC1 Ultrasound Imaging System (Model: SC1) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid) through B mode. Flow detection is possible using PD (Power Doppler) mode.
SCI is a transportable ultrasound system intended for use in environments where healthcare is provided by qualified and trained healthcare professionals.
7. Comparison of Technical Characteristics with the Predicate Device.
The subject device does not have any hardware changes compared to primary predicate device. There are only software changes. The intended use and basic technical characteristics are the same.
The following technological differences exist between the subject and predicate devices:
- · Use of Power doppler Mode, flow detection is possible using PD (Power Doppler) mode.
- · Use of DICOM, it provides all the features for patient data (enter new patient information, edit patient data, store, store patient data, send or export patient information). This feature can only connect to the PACS DICOM network (Hospital Network) to get a list of tests and export recorded tests. There is no option to export patient data over a USB cable.
There are no significant differences in the technological characteristics of this device compared to the predicate device which adversely affect safety or effectiveness.
6
8. Determination of Substantial Equivalence
Provided below is a table summarizing and comparing the technological characteristics of the subject device and the predicate devices:
| | Subject Device | Primary Predicate
Device | Reference Device | SE decision |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| K Number | To be assigned | K210468 | K192226 | - |
| Manufacturer | FCU Co., Ltd. | FCU Co., Ltd. | Philips Healthcare | - |
| Model | SC1 | SC1 | Lumify Diagnostic
Ultrasound System | - |
| Indications for
Use | The SC1 Ultrasound
Imaging System (Model:
SC1) is intended for
diagnostic ultrasound echo
imaging, measurement,
and analysis of the human
body for general clinical
applications including
musculoskeletal (MSK),
vascular, small parts
(breast, thyroid) through
B mode.
Flow detection is
possible using PD
(Power Doppler) mode.
SC1 is a transportable
ultrasound system intended
for use in environments
where healthcare is
provided by healthcare
professionals. | The SC1 is intended for
diagnostic ultrasound
echo imaging,
measurement, and
analysis of the human
body for general clinical
applications including
musculoskeletal (MSK),
vascular, small parts
(breast, thyroid).
SC1 is a transportable
ultrasound system intended
for use in environments
where healthcare is
provided by healthcare
professionals. | Philips Lumify Diagnostic
Ultrasound System is
intended for diagnostic
ultrasound imaging in B
(2D), Color Doppler,
Combined (B+Color), and
M modes. It is indicated
for diagnostic ultrasound
imaging and fluid flow
analysis in the following
applications:
Fetal/Obstetric,
Abdominal, Pediatric,
Cephalic, Urology,
Gynecological, Cardiac
Fetal Echo, Small Organ,
Musculoskeletal,
Peripheral Vessel, Carotid,
Cardiac.
Lumify is a transportable
ultrasound system intended
for use in environments
where healthcare is
provided by healthcare
professionals. | Equivalent* |
| Environment
of Use | Hospital, clinic, and
medical office settings | Hospital, clinic, and
medical office settings | Hospital, clinic, and
medical office settings | Equivalent |
| Acoustic
Output
Levels | - Compliance with IEC
60601-2-37:2007+
AMD1:2015
- Below Track 3 FDA
limits in accordance with
June 2019 ultrasound
systems guidance
document | - Compliance with IEC
60601-2-37:2007+
AMD1:2015 - Below Track 3 FDA
limits in accordance with
June 2019 ultrasound
systems guidance
document | - Compliance with IEC
60601-2-37:2007+
AMD1:2015 - Below Track 3 FDA
limits in accordance with
June 2019 ultrasound
systems guidance
document | Equivalent |
| | Subject Device | Primary Predicate
Device | Reference Device | SE decision |
| Imaging
Capabilities | • Mode B (2D)
• Combined (B+Power
Doppler) | • Mode B (2D) | Mode B (2D), Color
Doppler,
Combined (B+Color), and
M modes | Equivalent* |
| Patient
Population | For use in all patients | For use in all patients | For use in all patients | Equivalent |
| Anatomic
Structures | • Musculoskeletal (MSK)
• Vascular
• Small parts (breast,
thyroid) | • Musculoskeletal (MSK)
• Vascular
• Small parts (breast,
thyroid) | • Fetal/Obstetric
• Abdominal
• Pediatric
• Cephalic
• Urology
• Gynecological
• Cardiac Fetal Echo
• Small Organ
• Musculoskeletal
• Peripheral Vessel
• Carotid
• Cardiac | Equivalent* |
| Users | Healthcare professionals | Healthcare professionals | Healthcare professionals | Equivalent |
| Principle/Met
hod of
Operation | Piezoelectric material in
the transducer is used as an
ultrasound source to
transmit sound waves into
the body. Sound waves are
reflected back to the
transducer and converted
to electrical signals that are
processed and displayed as
images of anatomic
structures. | Piezoelectric material in
the transducer is used as an
ultrasound source to
transmit sound waves into
the body. Sound waves are
reflected back to the
transducer and converted
to electrical signals that are
processed and displayed as
images of anatomic
structures. | Piezoelectric material
in
the transducer is used as an
ultrasound source to
transmit sound waves into
the body. Sound waves are
reflected back to the
transducer and converted
to electrical signals that
are processed and
displayed as images
of
anatomic structures. | Equivalent |
| Probe
Characteristics | Linear, 5 - 13MHz | Linear, 5 - 13MHz | Linear, 4 – 12 MHz
Curved, 2 – 5 MHz
Phased, 1 – 4 MHz | Equivalent** |
| Probe
Connection to
Display | Wired | Wired | Wired | Equivalent |
| Off-the-shelf
operating
system | Android | Android | Android | Equivalent |
| Software | Runs as an app on off-the-
shelf mobile device | Runs as an app on off-the-
shelf mobile device | Runs as an app on off-the-
shelf mobile device | Equivalent |
| System
Components | • Ultrasound Probe | • Ultrasound Probe | • Ultrasound Probe
• USB transducer cable | Equivalent*** |
| | Subject Device | Primary Predicate
Device | Reference Device | SE decision |
| | • FCradle (Cradle)
• AC/DC adapter including
Power Cable
• Communication Cable
(USB Cable)
• Batteries
• Tablet (mobile device):
Not provided.
• User Manual
• Magnetizer (Option) - long/short type
- cap cover | • FCradle (Cradle)
• AC/DC adapter including
Power Cable
• Communication Cable
(USB Cable)
• Batteries
• Tablet (mobile device):
Not provided.
• User Manual
• Magnetizer (Option) - long/short type
- cap cover | • USB-C transducer cable
• USB Micro-B transducer
cable
• Android device (mobile
device):
• User Manual | |
| Patient-
Contacting
Materials | Tested by ISO 10993-5
Tested by ISO 10993-10 | Tested by ISO 10993-5
Tested by ISO 10993-10 | Tested by ISO 10993-5
Tested by ISO 10993-10 | Equivalent |
7
ECTFCU Co., Ltd.
2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, Republic of Korea (34014)
8
2F, 62-4. Techno 1-ro. Yuseong-gu. Daeieon. Republic of Korea Tel: +82 (42) 936 9078, Fax: +82 (42) 936 9077
- The technical differences comparing with primary predicate device do not raise any new potential safety risks and therefore, there is no impact on safety or efficacy for the proposed device. The proposed device supports only Mode B (2D) to transport the convenience of moving the device. Therefore, the scope of clinical application is more limited than that of the reference device. But the differences do not rasse any new potential safety risks and therefore, we believe there is no impact on safety or efficacy for the proposed device. This is described in the User's Manual, so the user will be aware of this.
- ** This device supports only linear type probe, and the frequency range of the probe is equivalent with the range of the predicate device and reference device. The differences indicated, do not raise any new potential safety risks and therefore, there is no impact on safety or efficacy for the proposed device.
- *** The technical differences do not raise any new potential safety risks and therefore, there is no impact on safety or efficacy for the proposed device.
9. Performance Data
The following performance data were provided in support of the substantial equivalence determination. Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
-
- Electrical Safety, Electromagnetic Compatibility Testing
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- Electrical Safety, Electromagnetic Compatibility Testing
9
2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, Republic of Korea Tel: +82 (42) 936 9078, Fax: +82 (42) 936 9077
| Standard
(Edition) | Standard Title | Consensus
Standard |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| IEC 60601-1:2005/A1:2012
(3.1 edition) + National
Difference | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance | Yes |
| IEC 60601-1-2:2014
(4.1 edition) | Medical electrical equipment - Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | Yes |
| IEC 60601-1-
6:2010/AMD1:2013 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Yes |
| IEC 60601-2-
37:2007/AMD1:2015 | Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | Yes |
2) Software Validation and Cybersecurity Management
The SC1 contains basic documentation level of concern software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with "IEC 62304:2006+AMD1:2015", "ANSI/UL 2900-1:2017" and FDA guidance: The Content of Premarket Submissions for Device Software Functions, June, 2023 and "Cybersecurity in Medical Devices: Quality System considerations and Content of Premarket Submissions, September, 2023" and "ISO 14971:2019 Medical Devices - Application of Risk Management to Medical Devices".
3) Biocompatibility Testing
The part of SC1 in contact with the patient was verified and demonstrated for the safety of materials through the biocompatibility test in accordance with ISO 10993-1:2018.
- -Cytotoxicity test according to ISO 10993-5:2009
- -Intracutaneous (intradermal) reactivity test according to ISO 10993-10:2010
- -Skin sensitization test according to ISO 10993-10:2010
4) Performance Testing
Through compliance with the identified current standards, the safety and effectiveness of the device is supported.
The additional performance test has been conducted to support the technological characteristics of the SC1. The performance of the SC1 has been defined as follows.
- Axial, Lateral Resolution ।
- Axial, Lateral distance ।
- B-mode and Combined(B+PD) mode display -
- Max depth
10
2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, Republic of K Tel: +82 (42) 936 9078, Fax: +82 (42) 936 9077
Clinical Test Summarv [21 CFR 807.92(b)(2)]
No clinical studies were considered necessary and performed.
10. Conclusion [21 CFR 807.92(b)(3)]
In conclusion, the tests conducted, as well as all verification activities, demonstrate that the design specifications and technological characteristics of the subject SC1 Handheld ultrasound imaging system (Model: SC1) meet applicable requirements and standards for the safety and effectiveness of the device for its intended use. There are some differences in technological characteristics between the subject device, predicate device and reference device, but those differences do not raise new or different questions of safety or effectiveness as compared to the predicate device and reference device. Therefore, the subject SC1 Handheld ultrasound imaging system (Model: SC1) is substantially equivalent to legally marketed predicate device and reference device.