(225 days)
No
The document describes standard ultrasound imaging modes and processing techniques (autocorrelation, FFT) and does not mention AI, ML, or related terms. There is no description of training or test sets, which are typically associated with AI/ML development.
No
The device is described as a "diagnostic ultrasound imaging" system, and its intended use is for "diagnostic ultrasound imaging." This indicates it is for diagnosis, not therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging..." and the 'Device Description' further specifies it as "...a mobile, general purpose, software-controlled, diagnostic ultrasound system."
No
The device description explicitly states that the system includes a commercial off-the-shelf (COTS) Android mobile device and a Convex array transducer, in addition to the software. These are hardware components essential to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that this device is a "Digital Color Doppler Palm Ultrasound System" intended for "diagnostic ultrasound imaging." Ultrasound imaging is a non-invasive technique that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use is for "diagnostic ultrasound imaging" of the "Cardiac, Abdomen." This is consistent with in-vivo imaging, not in-vitro testing.
Therefore, the function and intended use of this device fall under the category of medical imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, CFM, Combined(B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for Cardiac, Abdomen. The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The SonoEye P6/SonoEye V6/SonoEye G6 Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The SonoEye P6/SonoEye V6/SonoEye G6 is a portable system facilitating point of care ultrasound applications.
The Digital Color Doppler Palm Ultrasound System includes:
- A commercial off-the-shelf (COTS) Android mobile device.
- CHISON Ultrasound software is running as an app (Android) on the COTS device.
- The SonoEye P6/SonoEye V6/SonoEye G6 support Convex array transducer.
Mentions image processing
Autocorrelation for color processing and FFT for pulse Doppler processing.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, Abdomen.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals / environments where healthcare is provided by healthcare professionals.
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 Tests:
The Digital Color Doppler Palm Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.
The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility.
The product fulfils the requirement of:
ANSI/AAMI ES60601-1:2005Medical Electrical Equipment - Part 1: General Requirements for Safety
IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests
IEC 60601-2-37: 2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
Clinical Test:
No clinical testing was required.
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
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 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. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 25, 2021
CHISON Medical Technologies Co., Ltd. % Mr. Qifei Liu Regulatory Affairs Manager No.228, Changjiang East Road, Block 51 and 53, Phase 5, Shuofang Industrial Park, Xinwu District Wuxi. Jiangsu 214142 CHINA
Re: K201969
Trade/Device Name: SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 13, 2021 Received: January 27, 2021
Dear Mr. Liu:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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 medical devices and radiation-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) K201969
Device Name
SonoEye P6/SonoEye V6/SonoEye G6 Digital Color Doppler Palm Ultrasound System
Indications for Use (Describe)
The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, CFM, Combined(B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for Cardiac, Abdomen. The Digital Color Doppler Palm Ultrasound System is 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
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
1. Submitter:
| Submitter: | CHISON Medical Technologies Co., Ltd. |
|---|---|
| Address: | No.228, Changjiang East Road, Block 51 and 53, Phase 5, Shuofang |
| Industrial Park, Xinwu District, Wuxi, Jiangsu, China 214142 | |
| Contact: | Mr. Liu Qifei |
| Tel: | +86-510-85310019 |
| Fax: | +86-510-85310021 |
| Date Prepared: | July 3, 2020 |
2. Device :
Trade Name: SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System
Common Name: Diagnostic Ultrasound System with Transducers
Classification: Regulatory Class: II Review Category: Tier II
| Classfication Name | 21 CFR Section | Product Code |
|---|---|---|
| Ultrasonic pulsed doppler imaging system | 892.1550 | 90-IYN |
| Ultrasonic pulsed echo imaging system | 892.1560 | 90-IYO |
| Diagnostic ultrasonic transducer | 892.1570 | 90-ITX |
3. Predicate Device(s):
| Device | Model | Product Code | 510(k)Number |
|---|---|---|---|
| 1.Main predicate device | Lumify Diagnostic Ultrasound System | IYN, IYO,ITX | K192226 |
| 2.Reference device | Clarius Ultrasound System | IYN,ITX,IYO | K192107 |
| 3.Reference device | TE7 Diagnostic Ultrasound System | IYN,ITX,IYO | K160381 |
4. Device Description:
The SonoEye P6/SonoEye V6/SonoEye G6 Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of
4
operation. The SonoEye P6/SonoEye V6/SonoEye G6 is a portable system facilitating point of care ultrasound applications.
The Digital Color Doppler Palm Ultrasound System includes:
- A commercial off-the-shelf (COTS) Android mobile device.
- CHISON Ultrasound software is running as an app (Android) on the COTS device.
- The SonoEye P6/SonoEye V6/SonoEye G6 support Convex array transducer.
5. The requirement of commercial off-the-shelf (COTS) devices
All models need to comply with IEC55032, IEC60950-1, among which we have selected typical models to do verification testing with SonoEye on ANSI/AAMI ES60601-1 and IEC60601-1-2, such as Samsung Galaxy A70s or Huawei MatePad Pro.
● Electrical Safety
The transducer and software, along with a representative device, have been verified as compliant with IEC 60601-1. The transducers meet Type BF isolated applied part requirements. When the transducer and software are used in conjunction with a device(COTS devices) compliant with IEC 60950-1, the system meets IEC 60601-1 requirements for Class II equipment.
● Electromagnetic Compatibility
The transducer and representative Android device are classified as Group 1, Class A equipment in accordance with international standard CISPR 11 for radiated and conducted electromagnetic disturbances. When the transducer and software are used in conjunction with a device(COTS devices) compliant with IEC 55032, the system meets IEC 60601 - 1-2 requirements for Group1,Class A equipment.
● Android devices' output current and voltage The representative Android devices' output current is 1.5A and voltage is 5V. A COTS device connected to our transducer and system should meet the current and voltage range, the output current is greater than or equal to 1.5A, and the output voltage is 5V±5%.
- Full compliance with USB 2.0 standard The representative Android devices are full compliance with USB 2.0 standard. A COTS device connected to our transducer and system should meet the standard.
- Representative Android devices Representative Android devices are Samsung Galaxy A70s and Huawei MatePad Pro.The configuration is as follows.
Samsung Galaxy A70s:
•CPU frequency 2.0GHz (big quad core), 1.7GHz (small quad core),Octa-core
5
•RAM capacity 8GB
·ROM capacity 128GB
•Main screen resolution 2400x1080 pixels
•WLAN function Dual-band WIFI, IEEE 802.11 a/b/g/n/ac (support 2.4G and 5GHz)
•Operating System: Android 9
•Support Bluetooth 5.0
•Huawei MatePad Pro: •CPU frequency 2 x Cortex-A76 Based 2.86 GHz+ 2 x Cortex-A76 Based 2.09 GHz+ 4 x Cortex-A55 1.86 GHz,Octa-core •RAM capacity 8GB •ROM capacity 128GB •Main screen resolution 2560x1600 pixels ·WiFi function supports dual frequency (2.4GHz+5GHz) ·Bluetooth function supports Bluetooth 5.1 module •Operating System: Android 9
6. Indications for Use:
The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, CFM,Combined(B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for Cardiac, Abdomen.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where healthcare is provided by healthcare professionals.
7. Summary of Non-Clinical Tests:
The Digital Color Doppler Palm Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.
The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility.
The product fulfils the requirement of:
ANSI/AAMI ES60601-1:2005Medical Electrical Equipment - Part 1: General Requirements for Safety
IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests IEC 60601-2-37: 2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and
6
monitoring equipment
ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
The device has been found to conform to applicable FDA medical device guidance documents titled as followings:
- Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Document ● issued on: June 27, 2019)
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical ● Devices (Document Issued on: October 2, 2014)
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (Document issued on: June 16, 2016)
8. Clinical Test:
No clinical testing was required.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document,"Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on May 11, 2005", is also included as part of this submission.
9. Comparison to Predicate Device:
| Items | Main predicate
device | Reference
device | Reference device | Submission
Device | Remark | |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|--------|
| | Lumify
Diagnostic
Ultrasound
System | Clarius
Ultrasound
System | TE7 Diagnostic
Ultrasound
System | Digital Color
Doppler Palm
Ultrasound
System | | |
| Indication
s for Use | Fetal/Obstetric,
Abdominal,
Pediatric,
Cephalic,
Urology,
Gynecological,
Cardiac Fetal
Echo,
Small Organ,
Musculoskeletal
, Peripheral
Vessel,
Carotid | ophthalmic,
fetal,
abdominal,
intraoperative
(non-neurologi
cal), pediatric,
small organ,
cephalic
(adult),
trans-rectal,
transvaginal,
musculo-skeletal | fetal,
abdominal,
intra-operative(abd
ominal, thoracic,
and vascular),
pediatrics,
small
organ(breast,
thyroid, testes),
neonatal and adult
cephalic,
trans-esoph.(Cardi
ac), trans-vaginal | Cardiac,
Abdomen. | Same | |
| Items | Main predicate device | Reference device | Reference device | Submission Device | Remark | |
| | Lumify
Diagnostic
Ultrasound
System
Cardiac. | Clarius
Ultrasound
System
(conventional,
superficial),
urology,
gynecology,
cardiac (adult,
pediatric),
peripheral
vessel, carotid,
and procedural
guidance of
needles into
the body. | TE7 Diagnostic
Ultrasound
System
musculo-
skeletal(conventio
nal, superficial),
urology,
peripheral vessel,
adult and pediatric
cardiac,
ophthalmic exams | Digital Color
Doppler Palm
Ultrasound
System | | |
| Design | Autocorrelation
for color
processing and
FFT for pulse
Doppler
processing.
Supporting
Linear, Curve,
Phase array
and Volume
probes.
Cine play back
capability
Image file
archive | Autocorrelation
for color
processing
and FFT for
pulse Doppler
processing.
Supporting
Linear, Phase
array, Micro
convex array,
Endocavity
probe and
Volume probes
Cine play back
capability
Image file
archive | Autocorrelation for
color processing
and FFT for pulse
Doppler
processing.
Supporting Linear,
convex and
phased array.
Cine play back
capability
Image file archive. | Autocorrelation
for color
processing and
FFT for pulse
Doppler
processing.
Supporting Micro
Convex probe.
Cine play back
capability
Image file
archive | Same | |
| | TGC | TGC | TGC | STC | Same | |
| Operating
Controls | Depth Range:
0.003 to >30 cm | Depth Range:
5.0 to 10.0cm
(Depth depend
on probe type) | Depth depend on
probe type | Depth Range:
1.0 to 15cm | SE
Analysis
1 | |
| | 256 shades of
gray | 256 in B-Mode | 30-240 in B mode | 256 shades of
gray | Same | |
| | Gain | Gain | Gain | Gain:0-255,1/step | Same | |
| | Focus | Focus | Focus | Focus: adjustable | Same | |
| | Color box
size/position
can be adjust | ROI adjust | ROI adjust | ROI size/position:
adjustable | Same | |
| | N/A | Baseline | Baseline | Baseline | Same | |
| | Cine control:
drag scroll bar, | Tap the cine
capture button
to capture the | Cine control | Cine control:
step, play
backward, play | Same | |
| Items | Main predicate
device | Reference
device | Reference device | Submission
Device | Remark | |
| | Lumify
Diagnostic
Ultrasound
System | Clarius
Ultrasound
System | TE7 Diagnostic
Ultrasound
System | Digital Color
Doppler Palm
Ultrasound
System | | |
| | press
Image: [arrow] or Image: [arrow] | cine as part of
the exam. | | continuously | | |
| | Freeze control:
Toggling freeze
key | Freeze control:
Toggling
freeze key | Freeze
control:
Toggling
freeze
key | Freeze control:
Toggling freeze
key | Same | |
| Safety
Complian
ce | ANSI/AAMI
ES60601-1
IEC60601-1
IEC60601-2-37
IEC60601-1-2
ISO 10993-1 | ANSI/AAMI
ES60601-1
IEC60601-1
IEC
60601-2-37
IEC 60601-1-2
ISO 10993-1 | ANSI/AAMI
ES60601-1
IEC60601-1
IEC60601-2-37
IEC60601-1-2
ISO 10993-1 | ANSI/AAMI
ES60601-1
IEC60601-1
IEC60601-2-37
IEC60601-1-2
ISO 10993-1 | Same | |
| | B mode | B mode | B mode | B mode | Same | |
| | N/A | PW mode | Pulsed wave
Doppler mode | PW mode | Same | |
| | M mode | M mode | M mode | B/M mode | Same | |
| | Color mode | Color Doppler
Mode | Color mode | CFM mode | Same | |
| | N/A | N/A | IQ | FHI | Same | |
| | Gain | Gain | Gain | Gain | Same | |
| | Depth | Depth | Depth | Depth | Same | |
| | TGC | TGC | TGC | STC | Same | |
| | N/A | Spatial
Compound | Spatial Compound | Compound | Same | |
| | Frequency | Frequency | Frequency | Frequency
Scaling | Same | |
| | Freeze | Freeze | Freeze | Freeze/Unfreeze | Same | |
| Operation
Mode | Zoom | Zoom | Zoom | Zoom | Same | |
| | 2D distance | 2D distance | distance | B-distance | Same | |
| | Circumference | Circumference | Circumference | B-Circumference | Same | |
| | Area | Area | Area | B-Area | Same | |
| | N/A | Volume | Volume | B-Volume | Same | |
| | N/A | Distance | Distance | B/M-Distance | Same | |
| | N/A | M-Time | Time | B/M-Time | Same | |
| | N/A | M-HR | HR | B/M-HR | Same | |
| | N/A | Velocity | Velocity | PW-Velocity | Same | |
| | N/A | Time | Time | PW-Time | Same | |
| | N/A | Vascular | Vascular | Vessel measure
package | Same | |
| | N/A | Small Organ | Abdomen | Abdomen
measure
package | Same | |
| | N/A | N/A | Cardiology | Cardiac measure
package | Same | |
| Items | Main predicate
device | Reference
device | Reference device | | Submission
Device | Remark |
| | Lumify
Diagnostic
Ultrasound
System | Clarius
Ultrasound
System | TE7 Diagnostic
Ultrasound
System | | Digital Color
Doppler Palm
Ultrasound
System | |
| | N/A | Report | Report | | General report | Same |
| | N/A | N/A | Vascular Exam
Report | | Vessel report | Same |
| | N/A | N/A | Abdomen Exam
Report | | Abdomen report | Same |
| | N/A | N/A | Cardiac Exam
Report | | Cardiac report | Same |
| | Language
follow system | N/A | Multi-language
Interface | | Multi-language
Interface | Same |
| | Thumbnail | N/A | Thumbnail window | | Clipboard | Same |
| | N/A | N/A | iTouch | | Instant AIO | Same |
| | Biopsy Guide
Line | Biopsy Guide | Biopsy Guide | | Biopsy Guide | Same |
| | Reacts Session
Views | N/A | N/A | | SonoRemote | Same |
| | N/A | N/A | iNeedle | | SonoNeedle | Same |
| | N/A | NeedleEnhanc
e | iNeedle | | SuperNeedle | Same |
| | Save Loop | Save Cine | Save Clip | | Save Cine | Same |
| | Save Image | Save Image | Save Image | | Save Image | Same |
| | Playing Loops | Cine Loop | CineReview | | Cine Loop | Same |
| | Annotation | Annotation | Annotation | | Annotation | Same |
| | N/A | Bodymark | Bodymark | | Bodymark | Same |
| | N/A | N/A | Arrow | | Arrow Mark | Same |
| | Patient
Database | Patient
information | Patient information | | Patient
management | Same |
| | N/A | Angle/Baseline
on PW | Angle/Baseline on
PW | | Voice/Angle/Bas
eline on PW | Same |
| | N/A | N/A | Physical key | | Physical key | Same |
| | Setting | Setting | Setup | | Setting | Same |
| | Patient
Database | Patient
information | Patient data
management | | Archives | Same |
| | Walkthrough | Quick Start
Guide and
Video Tutorials | Operation Note | | Tutorials | Same |
| | Review | Review | Review | | Easyview | Same |
| | N/A | Demo | iVision | | Demo | Same |
| | About | N/A | System
information | | About | Same |
| | N/A | Adjust sample
Gate location | Drag the SV gate
to place the SV on
the target | | Adjust sample
Gate location | Same |
| | N/A | Adjust size of
sample Gate
location | Drag the SV gate
to place the SV on
the target | | Adjust size of
sample Gate
location | Same |
| Items | Main predicate device | Reference device | Reference device | Submission Device | Remark | |
| | Lumify
Diagnostic
Ultrasound
System | Clarius
Ultrasound
System | TE7 Diagnostic
Ultrasound
System | Digital Color
Doppler Palm
Ultrasound
System | | |
| | | horizontal | the target | horizontal | | |
| | N/A | Adjust size of
sample Gate
vertical | Drag the SV gate
to place the SV on
the target | Adjust size of
sample Gate
vertical | Same | |
| | N/A | Adjust PW
sample gate | Drag the SV gate
to place the SV on
the target | Adjust PW
sample gate | Same | |
| Display
Annotations | Logo; Hospital
Name;Exam
date;Exam
time;Mechanical
I index;Thermal
indes;Probe
model;TGC
Corve;Focus
position;Imagin
g parameters;
System
status;Gray/Col
or bar | Logo
Hospital
Name(NA)
Exam date:
Exam time;
End exam;MI;
TI; TGC; Probe
model;
Imaging
parameters;
System status;
Gray/Color bar | Probe model,
acoustic output
value, MI,TI,
iNeedle, iTouch,
frequency, TGC,
System status,
Depth, Gain | Logo; Hospital
Name;
Exam date; Exam time;
Mechanical
index; Thermal
indes; Probe
model; STC;
Focus position;
Imaging
parameters;
System status;
Gray/Color bar | Same | |
| Measurements | 2D mode:
Depth
Distance ,Area,
Circumference | B mode:
Depth,
Distance,
Area,
Circumference
Doppler
mode:
Volume,
Velocity, Time
M mode:
Distance,
Time, HR | 2D mode: Depth,
Distance, Area,
Circumference
B/C mode:
Volume
Doppler mode:
Velocity, Time,
M mode: Distance,
Time, HR | 2D mode:
Depth, Distance,
Area, Volume
Doppler mode:
D Velocity, Time,
B/M mode:
Distance, Time,
HR | Same | |
| Transducer
Types &
Connectors | Convex Array,
Phased Array,
Linear Array,
USB interface | Micro convex
array,
Endocavity
probe and
Volume probes | Linear, convex and
phased array. | Micro Convex
Array
USB interface | Same | |
| Users /
Sites | Hospitals,
clinics usage | Hospitals,
clinics usage | Hospitals, clinics
usage | Hospitals, clinics
usage | Same | |
| Acoustic
Output | Track 3;
Ispta.3 ≤ 720
mW/cm²
MI ≤ 1.9
TI ≤ 6.0 | Track 3
(ISPTA) of 720
mW/ cm²
MI: 0.0 to 1.9,
TI: This is
continuously | Track 3
Ispta.3 ≤ 720
mW/cm²
MI ≤ 1.9 | Track 3;
Ispta.3 ≤ 720
mW/cm²
MI ≤ 1.9
TI ≤ 6.0 | Same | |
| Items | Main predicate
device | Reference
device | Reference device | Submission
Device | Remark | |
| Lumify
Diagnostic
Ultrasound
System | Clarius
Ultrasound
System | TE7 Diagnostic
Ultrasound
System | Digital Color
Doppler Palm
Ultrasound
System | | | |
| | | displayed over
the range of
0.0
to
maximum
output, based
on the
scanner and
application, in
increments
of
0.1 | | | | |
| Power
Requirem
ents | Power
requirements:
AC :100V-
240V,
Frequenzy:50-6
0Hz
Operating
temperature:5-4
0 °C ; relative
humidity
15-95%;
Barometric
pressure:700 to
1060 hPa | Input: 12 VDC,
11.5 A
Temperature:
0°C (50°F) to
40°C (113°F)
Humidity: 15%
to 95%s | Voltage: 100V-
240V Temperature:
0°C (50°F) to 40°C
(113°F)
Humidity: 30% to
85%s
Atmosphere
pressure: 700 to
1060 hPa | Power
requirements:
DC 5V,
Operating
temperature:10-
38 °C ; relative
humidity
30-75%;
Barometric
pressure:700
to
1060 hPa | SE
Analysis
2 | |
Table 1 Substantial Equivalence Comparisor
7
Page 5 of 10
8
9
10
11
Comparison Analysis
SE Analvsis 1:
Operation Controls, compared with the predicate device, the subject device employs the same operation controls design and has some differences in value range. But both of them comply with the requirements of IEC60601-1 & IEC60601-2-37 and meet clinical requirements. Therefore, they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
SE Analysis 2:
Operation Controls, compared with the predicate device, the subject device employs the same operation controls design and has some differences in presenting voltage, humidity and temperature.
For voltage, the voltage of subject device is different with predicate device since hardware configuration is different. The subject device has passed the hardware test and complied with requirement of IEC60601-1 & IEC60601-2-37 and also meets clinical requirements For temperature, compared with predicate device, the temperature of subject device is lower than it, but still in a normal range. The subject device has passed temperature test and 510(k) Summary Page 9 of 10
12
complied with requirement of IEC60601-1 & IEC60601-2-37 and meet clinical requirements For humidity, compared with predicate device, the humidity of subject device is in a normal range and complied with requirement of IEC60601-1 & IEC60601-2-37 and meet clinical requirements
Therefore, they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
10. Substantially Equivalent Conclusion:
In accordance with the Act. 21 CFR Part 807 and based on the information provided in this premarket notification, CHISON Medical Technologies Co., Ltd. concludes that the SonoEye P6/ SonoEye V6/ SonoEye G6 - Digital Color Doppler Palm Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.