(157 days)
No
The summary describes standard ultrasound technology and image processing without mentioning AI, ML, or related concepts like deep learning, neural networks, or algorithms for automated analysis or interpretation. The performance studies focus on standard device specifications and regulatory compliance, not AI/ML model performance.
No.
The device is intended for diagnostic ultrasound echo imaging, measurement, and analysis, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications." Additionally, the "Device Description" refers to it as a "general purpose, software-controlled, diagnostic ultrasound system."
No
The device description explicitly states that the system consists of a battery-operated ultrasound probe (SC1L), batteries, charger, cable, power cord, and magnetizers, in addition to the software. This indicates the presence of significant hardware components beyond just the software running on a mobile device.
Based on the provided text, the SC1 Handheld Ultrasound Imaging System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality.
- SC1's Function: The SC1 system uses ultrasound technology to create images of internal structures of the human body in vivo (within the living body). 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 is a direct imaging technique, not an analysis of a biological specimen.
- Device Description: The description focuses on the ultrasound probe, software for image display and control, and the technology used to generate and process ultrasound waves reflected from tissues within the body.
Therefore, the SC1 Handheld Ultrasound Imaging System is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SC1 Handheld 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.
SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by appropriately trained healthcare professionals.
Product codes
IYO, 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 (2D); 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:
Recommended Tablet Device: Galaxy Tab S6 or later
Mobile OS Version: Android 9.0 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, (ii) 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, 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) is not intended to provide any function on patient data (entering new patient information, editing patient data saving, or transferring or exporting patient information). It does not have capability to connect to the PACS or equivalent DICOM network or export any patient data via USB cable.
Physician who is responsible for interpreting ultrasound images must be available in the room to provide diagnosis in real time.
The 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
appropriately trained 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. The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1:2005/A1:2012 (3.1 edition) + National Difference, IEC 60601-1-2:2014 (4.0 edition), IEC 60601-1-6:2010/AMD1:2013.
Software was designed, developed, verified, and validated according to a software development process and in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005 and "Premarket Management of Cybersecurity in Medical Devices issued on December 28, 2016" and "ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices".
The part of SCI 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, including 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.
Additional performance tests conducted include Axial, Lateral Resolution, Axial, Lateral distance, B-mode display, and Max depth.
No clinical studies were considered necessary and performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
July 23, 2021
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. % Lee Hee Yeon RA Manager B-620/621, Biz Center, 17, Techno 4-ro Yuseong-gu, Daejeon 34013 REPUBLIC OF KOREA
Re: K210468
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, ITX Dated: May 18, 2021 Received: June 16, 2021
Dear Lee Hee Yeon:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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-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 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-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.
For
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
2
Indications for Use
510(k) Number (if known)
Device Name
SCI Handheld Ultrasound Imaging System (Model SC1)
Indications for Use (Describe)
The SC1 Handheld 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,
SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by appropriately trained 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
FCU Co., Ltd.
510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(a)] 1.
Feb 8, 2021
2. Submitter's Information & Contact Person [21 CFR 807.92(a)(1)]
| - Name of Manufacturer: FCU Co., Ltd | |||
|---|---|---|---|
| -------------------------------------- | -- | -- | -- |
| - Address: | B-620/621, Biz Center, 17, Techno 4-ro, Yuseong-gu, Daejeon, 34013, Republic of Korea |
|---|---|
| - Contact Name: | Lee Hee Yeon/ RA manager |
| - Telephone No.: | +82-42-936-9078 |
| - Fax No.: | +82-42-936-9077 |
| - Email Address: | emma@fcultrasound.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)|
Common name: Handheld ultrasound imaging system Trade name: SC1 Handheld Ultrasound Imaging system (Model: SC1)
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | 21 CFR 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 21 CFR 892.1570 | ITX |
As stated in 21 CFR, parts 892.1560, and 892.1570, each of these generic types of devices has been classified as Class II.
4
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)|
The identified predicate devices within this submission are shown as follow:
Predicate device
| 510(k) Number: | K170085 |
|---|---|
| Applicant: | Healcerion Co., Ltd. |
| Classification Name: | Diagnostic Ultrasound System and Transducer |
| Trade Name: | SONON Ultrasound Imaging System, Model: 300D |
Reference device
| 510(k) Number: | K192226 | |
|---|---|---|
| Applicant: | Philips Healthcare | |
| Classification Name: | Diagnostic Ultrasound System and Transducer | |
| Trade Name: | Lumify Diagnostic Ultrasound System |
ર. Description of the Device [21 CFR 807.92(a)(4)]
The SC1 Handheld ultrasound imaging system, Model: SC1, is a general purpose, software-controlled, diagnostic ultrasound system that uses pulsed-echo technology (B Mode (2D); 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 9.0 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, (ii) 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
5
The SC1 App software allows the user to image in real time and review freeze-frame images on the screen in a B-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) is not intended to provide any function on patient data (entering new patient information, editing patient data saving, or transferring or exporting patient information). It does not have capability to connect to the PACS or equivalent DICOM network or export any patient data via USB cable.
Physician who is responsible for interpreting ultrasound images must be available in the room to provide diagnosis in real time.
The 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 [21 CFR 807.92(a)(5)] 6.
The SC1 Handheld 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.
SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by appropriately trained healthcare professionals.
7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
There are no significant differences in the technological characteristics of this device compared to the predicate device which adversely affect safety or effectiveness. Provided below is a table summaring the technological characteristics of the SC1 and the predicate devices:
| Proposed Device | Predicate Device | Reference Device | SE decision | |
|---|---|---|---|---|
| K Number | To be assigned | K170085 | K192226 | - |
| Manufacturer | FCU Co., Ltd. | Healcerion Co., Ltd. | Philips Healthcare | - |
| Model | SC1 | 300L | Lumify Diagnostic | |
| Ultrasound System | - | |||
| Indications for | ||||
| Use | The SC1 Ultrasound | |||
| Imaging System (Model: | ||||
| SC1) is intended for | Intended for ultrasound | |||
| echo imaging, | ||||
| measurement, and | Philips Lumify Diagnostic | |||
| Ultrasound System is | ||||
| intended for diagnostic | Equivalent* | |||
| Proposed Device | Predicate Device | Reference Device | SE decision | |
| 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. | analysis of the human | |||
| body for general clinical | ||||
| applications including | ||||
| musculoskeletal (MSK), | ||||
| vascular, small parts | ||||
| (breast, thyroid), and | ||||
| thoracic/pleural motion | ||||
| and fluid detection | ||||
| imaging. | 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. | ||||
| Environment of | ||||
| Use | Hospital, clinic, and | |||
| medical office settings | Hospital, clinic, and | |||
| medical office settings | Hospital, clinic, and medical | |||
| office settings | Same | |||
| 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
Sept. 2008 ultrasound
systems guidance
document | - Compliance with IEC
60601-2-37:2007+
AMD1:2015 - Below Track 3 FDA limits
in accordance with Sept.
2008 ultrasound systems
guidance document | Same |
| Imaging
Capabilities | • Mode B (2D) | • pulsed-echo and
Doppler ultrasound
• Mode B (2D), Color
scan | 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 | Same |
| Anatomic
Structures | • Musculoskeletal
(MSK)
• Vascular
• Small parts (breast,
thyroid) | • Musculoskeletal
(MSK)
• Vascular
• Small parts (breast,
thyroid)
• Thoracic/pleural
motion
• Fluid detection | • Fetal/Obstetric
• Abdominal
• Pediatric
• Cephalic
• Urology
• Gynecological
• Cardiac Fetal Echo
• Small Organ | Equivalent* |
| | Proposed Device | Predicate Device | Reference Device | SE decision |
| | | | • Musculoskeletal
• Peripheral Vessel
• Carotid
• Cardiac | |
| Users | Healthcare professionals | Healthcare professionals | Healthcare professionals | Same |
| Principle/Method
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. | Same |
| Probe
Characteristics | Linear, 5 - 13MHz | Linear, 5MHz / 7.5MHz
/ 10MHz frequency | Linear, 4 - 12 MHz
Curved, 2 - 5 MHz
Phased, 1 - 4 MHz | Equivalent** |
| Probe
Connection to
Display | Wired | Wireless | Wired | Equivalent*** |
| Off-the-shelf
operating system | Android | iOS / 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 | Same |
| System
Components | • Ultrasound Probe
• 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 | • Ultrasound Probe
• Battery Charger
(Cradle)
• AC/DC adapter
• Power cable
• Battery Pack
• Tablet (mobile device):
Not provided.
• User Manual | • Ultrasound Probe
• USB transducer cable
• USB-C transducer cable
• USB Micro-B transducer
cable
• Android device (mobile
device):
• User Manual | Equivalent*** |
| Patient-
Contacting | 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 | Same |
| | Proposed Device | Predicate Device | Reference Device | SE decision |
| Materials | | | | |
6
ECJ FCU Co., Ltd.
B-620/621, Biz Center, 17, Techno 4-ro, Yuseong-gu, Daejeon, 34013, Republic of Korea Tel: +82 (42) 936 9078 Fax:+82 (42) 936 9077
7
ECTFCU Co., Ltd.
B-620/621, Biz Center, 17, Techno 4-ro, Yuseong-gu, Daejeon, 34013, Republic of Korea Tel: +82 (42) 936 9078 Fax:+82 (42) 936 9077
8
- 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 predicate device. But the differences do not raise any new potential safety risks and therefore, we believe there is no impact on safety or 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. 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.
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
| 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
(4.0 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 |
2) Software Validation and Cybersecurity Management
The SC1 contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005 and "Premarket Management of Cybersecurity in Medical Devices issued on December 28, 2016" and "ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices".
9
-
- Biocompatibility
The part of SCI 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.
- Biocompatibility
-
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 display
- Max depth
Clinical Test Summary [21 CFR 807.92(b)(2)|
No clinical studies were considered necessary and performed.
8. 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 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 predicates and proposed device, but those differences do not raise new or different questions of safety or effectiveness as compared to the predicate devices. Therefore, the SC1 Handheld ultrasound imaging system (Model: SC1) is substantially equivalent to the currently marketed predicate device.