(114 days)
No reference devices were used in this submission.
No
The document describes standard ultrasound technology and image processing without mentioning AI or ML capabilities.
No
The device is intended for diagnostic ultrasound echo imaging, measurement, and analysis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The SONON Ultrasound Imaging System (Model: SONON 300C) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications." Additionally, the "Device Description" labels it as a "hand-held diagnostic ultrasound system."
No
The device description explicitly states that the system consists of a battery-operated, hand-held SONON Ultrasound Imaging System transducer, which is a hardware component responsible for emitting and receiving ultrasound waves.
Based on the provided information, the SONON Ultrasound Imaging System (Model: SONON 300C) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body ("in vitro").
- SONON's Function: The SONON Ultrasound Imaging System uses ultrasound technology to create images of internal structures within the human 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 describes an in vivo (within the living body) diagnostic process, not an in vitro one.
- Device Description: The description details the components and operation of an ultrasound imaging system, which is a non-invasive imaging modality.
Therefore, the SONON Ultrasound Imaging System falls under the category of a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SONON Ultrasound Imaging System (Model: SONON 300C) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The SONON Ultrasound Imaging System, Model: SONON 300C, is a wireless ultrasound system that uses pulsed-echo technology (frequency: 3.5 MHz; module: convex) to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS or Android operating system.
The SONON Ultrasound Imaging System is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS or Android mobile device. (ii) the SONON Ultrasound Imaging System software that runs as an app on the mobile device, (iii) the battery-operated, hand-held SONON Ultrasound Imaging System transducer that communicates wirelessly with iOS or Android mobile devices, and (iv) the instructions for use manual, battery, charger, and power cords.
The SONON software can be downloaded to an iOS or Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image capture and review. controls for time gain, dynamic range, display of mirror image, focal length, brightness, contrast, linear/elliptical measurement, and image annotation, as well as storage and email transmission of images and videos. The SONON Ultrasound Imaging System allows the user to image in real time and review cine or freeze-frame images on the screen in a B-Mode. 2dimensional scan format. All images and data collected are stored in the mobile app. If the app is removed and reinstalled, all stored information is lost and cannot be recovered.
The SONON 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 pulsed echo imaging system
Anatomical Site
human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging.
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)
Non-clinical performance data included testing for compliance with electrical safety, EMC, and RF Wireless Capabilities (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359), acoustic output levels (NEMA UD2-2004 (R2009)), clinical measurement range and accuracies (using a phantom with vertical, dead zone, horizontal and linear groups, results met performance criteria), display performance (assessed using various mobile devices, met specifications), usability (usability engineering process, found reasonably safe and effective), failure mode and risk analyses (ISO 14971, identified hazards reduced to acceptable levels), biocompatibility (ISO 10993-1, patient-contacting surfaces are biocompatible), and software evaluation/cybersecurity management (IEC 62304, passed performance requirements and met specifications).
Clinical tests and animal studies were not conducted as the device does not introduce new indications, modes, features, or technologies that would require such evaluation.
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.
No reference devices were used in this submission.
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or banner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2015
Healcerion Co., Ltd. % Ms. Carmelina G. Allis The Allis Law Firm, PLLC 2437 Bav Area Blvd.. #30 HOUSTON TX 77058
Re: K151339
Trade/Device Name: SONON Ultrasound Imaging System (Model: SONON 300C) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: August 10, 2015 Received: August 14, 2015
Dear Ms. Allis:
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 (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Ocks
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
Indications for Use
510(k) Number (if known) K151339
Device Name
SONON Ultrasound Imaging System (Model: SONON 300C)
Indications for Use (Describe)
The SONON Ultrasound Imaging System (Model: SONON 300C) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging.
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
Diagnostic Ultrasound Indications for Use Form
510(k) Number: K151339 Device Name: SONON Ultrasound Imaging System (Model: SONON 300C) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Ophthalmic | |||||||
| Fetal | N | |||||||
| Abdominal | N | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Gynecology) | N | |||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health
XX Prescription Use -- Yes (Part 21 CFR 801 Subpart D)
4
510(k) Summary of Safety and Effectiveness
Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: SONON 300C
1) Submitter's name, address, telephone number; Contact person
| Submitter: | Jaeyeob Jung
RA Manager
HEALCERION Co., Ltd.
(Guro-dong, Changup Jiwon
Center)
72, Digital-ro 26-gil, Guro-gu
Seoul, South Korea
Ph: +82 70-7569-6326
Email: onair0816@healcerion.com | Contact Person: | Carmelina G. Allis
The Allis Law Firm, PLLC
2437 Bay Area Blvd., #30
Houston, TX 77058
Ph: 281-819-0216
Email: CAllis@TheAllisLawFirm.com |
| ------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
August 10, 2015 Date prepared:
2) Name of the device, including the trade or proprietary name, if applicable, the common or usual name, and the classification name, if known
| Device Common/Usual Name: | Diagnostic Ultrasound System and Transducer |
|---|---|
| Device Proprietary Name: | SONON Ultrasound Imaging System, Model: SONON 300C |
| Device Classification: | Class II |
| 21 C.F.R. Section | Classification Name | Product Code |
|---|---|---|
| 892.1560 | System, Imaging, Pulsed Echo, Ultrasonic | 90-IYO |
| 892.1570 | Transducer, Ultrasonic, Diagnostic | 90-ITX |
3) Substantially Equivalent Devices
| Device Name | 510(k) Number |
|---|---|
| MobiUS Ultrasound Imaging System (Mobisante, Inc.) | K102153 |
| Penrith Elettra Diagnostic Ultrasound System (Penrith Corp.) | K100598 |
Healcerion is not aware of any design-related recalls regarding the predicate devices. No reference devices were used in this submission.
4) Device Description
The SONON Ultrasound Imaging System, Model: SONON 300C, is a wireless ultrasound system that uses pulsed-echo technology (frequency: 3.5 MHz; module: convex) to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS or Android operating system.
5
510(k) Summary of Safety and Effectiveness
Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: SONON 300C
The minimum requirements for the mobile devices that utilize the iOS or Android operating system for use with the SONON Ultrasound Imaging System. Model: SONON 300C are as follows:
| Item | Minimum requirements |
|---|---|
| iPhone 5 / 5S / 6 / 6 plus | |
| iPad 3rd / 4th Generation / Air / Mini or later | |
| Target Device | Galaxy S3 / S4 / S5 / Note 3, Note 4 |
| Galaxy Note Tablet 10.1 2013 version or later | |
| Galaxy Tab Pro 8.4 2014 version or later | |
| Mobile OS Version | iOS 7.0 or later |
| Android 4.3 or later |
The SONON Ultrasound Imaging System is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS or Android mobile device. (ii) the SONON Ultrasound Imaging System software that runs as an app on the mobile device, (iii) the battery-operated, hand-held SONON Ultrasound Imaging System transducer that communicates wirelessly with iOS or Android mobile devices, and (iv) the instructions for use manual, battery, charger, and power cords.
The SONON software can be downloaded to an iOS or Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image capture and review. controls for time gain, dynamic range, display of mirror image, focal length, brightness, contrast, linear/elliptical measurement, and image annotation, as well as storage and email transmission of images and videos. The SONON Ultrasound Imaging System allows the user to image in real time and review cine or freeze-frame images on the screen in a B-Mode. 2dimensional scan format. All images and data collected are stored in the mobile app. If the app is removed and reinstalled, all stored information is lost and cannot be recovered.
The SONON 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.
6
510(k) Summary of Safety and Effectiveness
Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: SONON 300C
The device components are not supplied sterile and do not require sterilization prior to use.
5) Indications for Use
The SONON Ultrasound Imaging System (Model: SONON 300C) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging.
6) Technological Comparison to Predicate Devices
The SONON Ultrasound Imaging System and its predicate devices, the MobiUS and Penrith Elettra, are Track 3 systems that employ the same basic scientific technology for the acquisition and display of ultrasound images. They all operate in the same manner in that piezoelectric material in the transducer is used as a 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 2-dimensional images. The SONON Ultrasound Imaging System and the predicate devices allow for the visualization and measurement of body structures. All devices are intended to be used in clinical environments, including hospitals, clinics, and medical office settings, for the diagnosis of patients.
All devices are compact, portable, general-purpose, software-controlled diagnostic ultrasound imaging systems with hand-held probes. Both the SONON Ultrasound Imaging System and the Penrith Elettra devices utilize wireless network connectivity to run software and display images. Both the MobiUS and the SONON Ultrasound Imaging System are available in a 3.5 MHz ultrasound probe.
The patient-contacting surfaces of the subject and predicate devices have been found to be biocompatible for their intended application. The SONON Ultrasound Imaging System is manufactured and designed to the same electrical and safety standards as the predicate devices.
The SONON Ultrasound Imaging System display ranges from 4 to 10 inches depending on whether a mobile phone or tablet is used. This is similar to the range of display options available for the MobiUS and Penrith Elettra predicate devices.
| Characteristic | Healcerion Co., Ltd.
SONON Ultrasound Imaging
System | Predicate Device
Mobisante, Inc.
MobiUS Ultrasound Imaging System
K102153 | Predicate Device
Penrith Corporation
Penrith Elettra Diagnostic
Ultrasound System
K100598 |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications for
Use | The SONON Ultrasound Imaging
System (Model: SONON 300C) is
intended for diagnostic ultrasound
echo imaging, measurement, and
analysis of the human body for
general clinical applications | Indicated for ultrasound imaging,
measurement, and analysis of the human
body for the following clinical
applications: fetal/OB, abdominal,
cardiac, pelvic, pediatric,
musculoskeletal, and peripheral vessel | Intended for diagnostic imaging
or fluid flow analysis of the
human body including: fetal,
abdominal, intraoperative,
intraoperative neurological,
pediatric, small organ, neonatal |
| | Healcerion Co., Ltd. | Predicate Device | Predicate Device |
| Characteristic | SONON Ultrasound Imaging
System | Mobisante, Inc.
MobiUS Ultrasound Imaging System
K102153 | Penrith Corporation
Penrith Elettra Diagnostic
Ultrasound System
K100598 |
| | including obstetrics (OB),
gynecology (GY) and general
(abdominal) imaging. | imaging. Its compact size, portability,
and user interface enable it for use in
primary care and special care areas. | cephalic, cardiac, peripheral
vessel, musculoskeletal
(conventional), musculoskeletal
(superficial). |
| Environment of Use | Hospital, clinic, and medical office
settings | Hospital, clinic, and medical office
settings | Hospital, clinic, and medical
office settings |
| Acoustic Output
Levels | Below Track 3 FDA limits in
accordance with Sept. 2008
ultrasound systems guidance
document | Below Track 3 FDA limits in
accordance with Sept. 2008 ultrasound
systems guidance document | Below Track 3 FDA limits in
accordance with Sept. 2008
ultrasound systems guidance
document |
| Imaging Capabilities | pulsed-echo ultrasound
•
Mode B (2D) scan | pulsed-echo ultrasound
•
Mode B (2D) scan | pulsed-echo and Doppler
•
ultrasound
Mode B (2D), Color,
•
Amplitude Doppler |
| Patient Population | For use in all patients | For use in all patients | For use in all patients |
| Anatomic
Structures/Clinical
applications | General clinical applications,
including fetal/obstetrics,
gynecology, abdominal | General clinical applications, including,
but not limited to fetal/obstetrics,
gynecology, abdominal, cardiac, pelvic,
pediatric, musculoskeletal, and
peripheral vessel imaging | General clinical applications,
including fetal, abdominal,
intraoperative, pediatric, small
organ, cephalic, cardiac,
peripheral vessel, and
musculoskeletal |
| Users | Healthcare professionals | Healthcare professionals | Healthcare professionals |
| 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. |
| Image Display Unit | Mobile device (4 to 10 inches
approximately) | PC/Host computer (4.1 inches
approximately) | Video display (unknown size) |
| Probe Characteristics | Convex, 3.5 MHz frequency | Mechanic, 3.5 MHz to 12 MHz
frequency | L8-3 linear, L12-5 linear, and C5-
2 curvilinear |
| Probe Connection to
Display | Wireless | Wired (USB) | Wireless or wired |
| Off-the-shelf operating
system | iOS / Android | Win CE | Unknown |
| Software | Runs as an app on off-the-shelf
mobile device | Runs in host computer | Unknown |
| System Components | • Commercial off-the-shelf iOS
or Android mobile device,
• SONON Ultrasound Imaging
System software that runs as
an app on the mobile device,
• SONON Ultrasound Imaging
System battery-operated,
hand-held ultrasound
diagnostic transducer that
communicates wirelessly with | • Host computer,
• USB 2.0 interface, and
• Portable, handheld, compact
ultrasound probe | • System console housing
electronic circuitry
• Video display
• Power supply
• User controls
• Transducers (L8-3 linear,
L12-5 linear, C5-2
curvilinear) that
communicate wirelessly or
via wire with system console |
| Characteristic | Healcerion Co., Ltd.
SONON Ultrasound Imaging
System | Predicate Device
Mobisante, Inc.
MobiUS Ultrasound Imaging System
K102153 | Predicate Device
Penrith Corporation
Penrith Elettra Diagnostic
Ultrasound System
K100598 |
| | iOS or Android mobile
devices | | |
| Patient-Contacting
Materials | All materials with patient contact
are biocompatible and can be
disinfected | All materials with patient contact are
biocompatible and can be disinfected | All materials with patient contact
are biocompatible |
Comparison of Technological Characteristics with Predicate Devices
7
510(k) Summary of Safety and Effectiveness
Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: SONON 300C
8
510(k) Summary of Safety and Effectiveness
Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: SONON 300C
7) Determination of Substantial Equivalence
The SONON Ultrasound Imaging System is substantially equivalent to the predicate devices identified above with respect to intended use, principles of operation, and technological characteristics. As described below, the system has been evaluated for acoustic output. biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, and has been found to conform to applicable standards and product specifications that demonstrate that the SONON Ultrasound Imaging System is substantially equivalent to the predicate devices.
Non-clinical performance data
Non-clinical tests relied on this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards.
Electrical safety, EMC, and RF Wireless Capabilities
Electrical safety, electromagnetic compatibility, and RF wireless capabilities were evaluated per international standards and the device complies with the following standards:
- . IEC 60601-1: Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance
- . IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
- IEC 60601-2-37: Medical electrical equipment Part 2-37: Particular requirements for . the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- IEC 62359: Ultrasonics – Field Characterization – Test Methods for the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields
9
510(k) Summary of Safety and Effectiveness
Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: SONON 300C
Acoustic Output Levels
The acoustic output exposure levels were measured and calculated following the NEMA UD2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3. Acoustic Output Level Test Results are as follows:
| Transducer | Ispta.3 | TIS | MI | Ipa.3@MImax |
|---|---|---|---|---|
| Convex only | 0.0627[W/cm2] | 0.2535 | 0.7861 | 11.6369[W/cm2] |
Clinical Measurement Range and Accuracies
Clinical Measurement Range and Accuracies were tested using a phantom with vertical, dead zone, horizontal and linear groups. The length and the vertical and horizontal resolutions were evaluated and results met performance criteria.
Display Performance Testing
The SONON Ultrasound Imaging System (Model: SONON 300C) displays ranges from 4 to 10 inches depending on whether a mobile phone or tablet is used. This is similar to the range of display options available for the predicate devices. The display performance of the device was assessed using various mobile devices, and the test results demonstrate that the device meets performance specifications.
Usability Report
The usability engineering process was conducted by Healcerion to assess and mitigate risks caused by usability problems associated with the correct use of the device as well as user errors. The test results demonstrate that the product has been found to be reasonably safe and effective for the intended users, intended uses, and intended use environments through usability engineering process.
Failure Mode and Risk Analyses
Healcerion conducted a Failure Mode and Effects Analysis and a risk analysis in accordance with ISO 14971. The risk analysis of SONON 300C was performed by taking into account the risks of the device, such as design, production, storage, related international standards, state of art of risk management, and the foreseeable risks related to the intended use of the device. The hazards were identified, the risks were estimated, and procedures were implemented to control them. All identified hazards were reduced to acceptable levels.
Biocompatibility
Biocompatibility testing was conducted in accordance with the international standard below. The patient-contacting surfaces of the device (probe nosepiece and lens) were evaluated for cytotoxicity, skin irritation and skin sensitization. Test results demonstrate that the patientcontacting surfaces of the probe are biocompatible in accordance with the following standard:
- . ISO 10993-1: Biological Evaluation of Medical Devices
10
510(k) Summary of Safety and Effectiveness
Healcerion Co., Ltd. SONON Ultrasound Imaging System, Model: SONON 300C
Software Evaluation and Cybersecurity Management
Furthermore, Healcerion conducted validation and verification activities on the SONON Ultrasound Imaging System software. Cybersecurity evaluation was also conducted. The software passed its performance requirements and met specifications per the following standard:
- IEC 62304: Medical Device Software - Software Life-Cycle Processes
Additional Standards
Healcerion also relied on the following standards to ensure the substantial equivalence of the SONON Ultrasound Imaging System to predicate devices:
- ISO 14971: Application of Risk Management to Medical Devices
- ISO 15223-1: Symbols to be used with Medical Device Labels I
Healcerion applied quality assurance measures to the system design and development, including, but not limited to:
- Risk Analysis
- 트 Product Specifications
- 트 Design Reviews
- 트 Verification and Validation Activities
Clinical tests and animal studies - not conducted
The Healcerion SONON Ultrasound Imaging System ultrasound system does not introduce new indications for use, modes, features, or technologies relative to the predicate devices that would require evaluation through clinical or animal testing. The clinical safety and effectiveness of ultrasound systems with characteristics similar to those of the SONON 300C are well accepted for the predicate and subject devices.
8) Conclusion
In conclusion, the tests conducted, as well as all verification and validation activities, demonstrate that the design specifications and technological characteristics of the SONON Ultrasound Imaging System (Model: SONON 300C) 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 predicate and proposed devices, but those differences only indicate that the predicate devices may have secondary or added functionalities as compared to the SONON Ultrasound Imaging System, such as additional probe models or imaging capabilities as in the case of Doppler ultrasound. The testing and validation activities conducted demonstrate that any differences between the devices do not raise new or different questions of safety or effectiveness as compared to the predicate devices. Therefore, the SONON Ultrasound Imaging System (Model: SONON 300C) is substantially equivalent to the predicate devices.