(225 days)
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.
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.
This is a 510(k) summary for a medical device (SonoEye P6/SonoEye V6/SonoEye G6 Digital Color Doppler Palm Ultrasound System) and does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the way typically found for an AI/ML medical device.
The document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria for a novel AI function. As such, many of the requested fields cannot be filled.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific quantitative acceptance criteria or reported performance for the SonoEye P6/SonoEye V6/SonoEye G6 Digital Color Doppler Palm Ultrasound System in terms of diagnostic accuracy (e.g., sensitivity, specificity for detecting particular conditions). Instead, it establishes substantial equivalence by comparing its features and compliance with safety standards to predicate devices.
The comparisons provided are primarily focused on:
- Indications for Use: The submitted device has a more limited set of indications (Cardiac, Abdomen) compared to the predicate devices, but these are "Same" as a subset of the predicate's indications.
- Design and Operating Controls: Features like color processing, Doppler processing, probe types, cine playback, image archiving, gain, focus, ROI adjustment, freeze control, and operation modes are largely deemed "Same" or comparable in design. Differences in value ranges for depth and power requirements are noted but considered substantially equivalent due to compliance with relevant electrical and medical standards.
- Safety Compliance: The device conforms to the same international safety standards (ANSI/AAMI ES60601-1, IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993-1) as the predicate devices.
- Acoustic Output: All devices are Track 3 and have similar maximum ISPTA.3 (≤ 720 mW/cm²) and MI (≤ 1.9), and TI (≤ 6.0 in the submission device's case, continuously displayed for one predicate, but generally aligned within safety limits).
Since this is a substantial equivalence submission for a diagnostic ultrasound system (not an AI/ML algorithm with specific diagnostic performance tasks), direct quantitative "acceptance criteria" for diagnostic accuracy are not presented in this document. The "acceptance criteria" are implicitly the demonstration that the device's characteristics and performance are comparable to (substantially equivalent to) legally marketed predicate devices, particularly concerning safety and effectiveness according to established standards.
2. Sample size used for the test set and the data provenance
Not applicable. The document explicitly states: "No clinical testing was required." Therefore, there is no test set for clinical performance mentioned. The "tests" performed were non-clinical (electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical testing was performed for this submission.
4. Adjudication method for the test set
Not applicable, as no clinical testing was performed for this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a Digital Color Doppler Palm Ultrasound System, not an AI-assisted diagnostic tool in the sense of an AI/ML algorithm for image interpretation that would enhance human reader performance. No MRMC study or AI assistance effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a diagnostic ultrasound system, which inherently involves a human operator acquiring and interpreting images. It is not an "algorithm only" device within the context of AI/ML performance.
7. The type of ground truth used
Not applicable, as no clinical testing for diagnostic performance was conducted. The "ground truth" referenced in the provided text relates to compliance with engineering and safety standards, where the "truth" is whether the device meets the specified technical and safety requirements.
8. The sample size for the training set
Not applicable. This document does not describe the development or training of an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. This document does not describe the development or training of an AI/ML algorithm.
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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
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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
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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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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
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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
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•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
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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 predicatedevice | Referencedevice | Reference device | SubmissionDevice | Remark | |
|---|---|---|---|---|---|---|
| LumifyDiagnosticUltrasoundSystem | ClariusUltrasoundSystem | TE7 DiagnosticUltrasoundSystem | Digital ColorDoppler PalmUltrasoundSystem | |||
| Indications for Use | Fetal/Obstetric,Abdominal,Pediatric,Cephalic,Urology,Gynecological,Cardiac FetalEcho,Small Organ,Musculoskeletal, PeripheralVessel,Carotid | ophthalmic,fetal,abdominal,intraoperative(non-neurological), pediatric,small organ,cephalic(adult),trans-rectal,transvaginal,musculo-skeletal | fetal,abdominal,intra-operative(abdominal, thoracic,and vascular),pediatrics,smallorgan(breast,thyroid, testes),neonatal and adultcephalic,trans-esoph.(Cardiac), trans-vaginal | Cardiac,Abdomen. | Same | |
| Items | Main predicate device | Reference device | Reference device | Submission Device | Remark | |
| LumifyDiagnosticUltrasoundSystemCardiac. | ClariusUltrasoundSystem(conventional,superficial),urology,gynecology,cardiac (adult,pediatric),peripheralvessel, carotid,and proceduralguidance ofneedles intothe body. | TE7 DiagnosticUltrasoundSystemmusculo-skeletal(conventional, superficial),urology,peripheral vessel,adult and pediatriccardiac,ophthalmic exams | Digital ColorDoppler PalmUltrasoundSystem | |||
| Design | Autocorrelationfor colorprocessing andFFT for pulseDopplerprocessing.SupportingLinear, Curve,Phase arrayand Volumeprobes.Cine play backcapabilityImage filearchive | Autocorrelationfor colorprocessingand FFT forpulse Dopplerprocessing.SupportingLinear, Phasearray, Microconvex array,Endocavityprobe andVolume probesCine play backcapabilityImage filearchive | Autocorrelation forcolor processingand FFT for pulseDopplerprocessing.Supporting Linear,convex andphased array.Cine play backcapabilityImage file archive. | Autocorrelationfor colorprocessing andFFT for pulseDopplerprocessing.Supporting MicroConvex probe.Cine play backcapabilityImage filearchive | Same | |
| TGC | TGC | TGC | STC | Same | ||
| OperatingControls | Depth Range:0.003 to >30 cm | Depth Range:5.0 to 10.0cm(Depth dependon probe type) | Depth depend onprobe type | Depth Range:1.0 to 15cm | SEAnalysis1 | |
| 256 shades ofgray | 256 in B-Mode | 30-240 in B mode | 256 shades ofgray | Same | ||
| Gain | Gain | Gain | Gain:0-255,1/step | Same | ||
| Focus | Focus | Focus | Focus: adjustable | Same | ||
| Color boxsize/positioncan be adjust | ROI adjust | ROI adjust | ROI size/position:adjustable | Same | ||
| N/A | Baseline | Baseline | Baseline | Same | ||
| Cine control:drag scroll bar, | Tap the cinecapture buttonto capture the | Cine control | Cine control:step, playbackward, play | Same | ||
| Items | Main predicatedevice | Referencedevice | Reference device | SubmissionDevice | Remark | |
| LumifyDiagnosticUltrasoundSystem | ClariusUltrasoundSystem | TE7 DiagnosticUltrasoundSystem | Digital ColorDoppler PalmUltrasoundSystem | |||
| pressImage: [arrow] or Image: [arrow] | cine as part ofthe exam. | continuously | ||||
| Freeze control:Toggling freezekey | Freeze control:Togglingfreeze key | Freezecontrol:Togglingfreezekey | Freeze control:Toggling freezekey | Same | ||
| SafetyCompliance | ANSI/AAMIES60601-1IEC60601-1IEC60601-2-37IEC60601-1-2ISO 10993-1 | ANSI/AAMIES60601-1IEC60601-1IEC60601-2-37IEC 60601-1-2ISO 10993-1 | ANSI/AAMIES60601-1IEC60601-1IEC60601-2-37IEC60601-1-2ISO 10993-1 | ANSI/AAMIES60601-1IEC60601-1IEC60601-2-37IEC60601-1-2ISO 10993-1 | Same | |
| B mode | B mode | B mode | B mode | Same | ||
| N/A | PW mode | Pulsed waveDoppler mode | PW mode | Same | ||
| M mode | M mode | M mode | B/M mode | Same | ||
| Color mode | Color DopplerMode | 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 | SpatialCompound | Spatial Compound | Compound | Same | ||
| Frequency | Frequency | Frequency | FrequencyScaling | Same | ||
| Freeze | Freeze | Freeze | Freeze/Unfreeze | Same | ||
| OperationMode | 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 measurepackage | Same | ||
| N/A | Small Organ | Abdomen | Abdomenmeasurepackage | Same | ||
| N/A | N/A | Cardiology | Cardiac measurepackage | Same | ||
| Items | Main predicatedevice | Referencedevice | Reference device | SubmissionDevice | Remark | |
| LumifyDiagnosticUltrasoundSystem | ClariusUltrasoundSystem | TE7 DiagnosticUltrasoundSystem | Digital ColorDoppler PalmUltrasoundSystem | |||
| N/A | Report | Report | General report | Same | ||
| N/A | N/A | Vascular ExamReport | Vessel report | Same | ||
| N/A | N/A | Abdomen ExamReport | Abdomen report | Same | ||
| N/A | N/A | Cardiac ExamReport | Cardiac report | Same | ||
| Languagefollow system | N/A | Multi-languageInterface | Multi-languageInterface | Same | ||
| Thumbnail | N/A | Thumbnail window | Clipboard | Same | ||
| N/A | N/A | iTouch | Instant AIO | Same | ||
| Biopsy GuideLine | Biopsy Guide | Biopsy Guide | Biopsy Guide | Same | ||
| Reacts SessionViews | N/A | N/A | SonoRemote | Same | ||
| N/A | N/A | iNeedle | SonoNeedle | Same | ||
| N/A | NeedleEnhance | 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 | ||
| PatientDatabase | Patientinformation | Patient information | Patientmanagement | Same | ||
| N/A | Angle/Baselineon PW | Angle/Baseline onPW | Voice/Angle/Baseline on PW | Same | ||
| N/A | N/A | Physical key | Physical key | Same | ||
| Setting | Setting | Setup | Setting | Same | ||
| PatientDatabase | Patientinformation | Patient datamanagement | Archives | Same | ||
| Walkthrough | Quick StartGuide andVideo Tutorials | Operation Note | Tutorials | Same | ||
| Review | Review | Review | Easyview | Same | ||
| N/A | Demo | iVision | Demo | Same | ||
| About | N/A | Systeminformation | About | Same | ||
| N/A | Adjust sampleGate location | Drag the SV gateto place the SV onthe target | Adjust sampleGate location | Same | ||
| N/A | Adjust size ofsample Gatelocation | Drag the SV gateto place the SV onthe target | Adjust size ofsample Gatelocation | Same | ||
| Items | Main predicate device | Reference device | Reference device | Submission Device | Remark | |
| LumifyDiagnosticUltrasoundSystem | ClariusUltrasoundSystem | TE7 DiagnosticUltrasoundSystem | Digital ColorDoppler PalmUltrasoundSystem | |||
| horizontal | the target | horizontal | ||||
| N/A | Adjust size ofsample Gatevertical | Drag the SV gateto place the SV onthe target | Adjust size ofsample Gatevertical | Same | ||
| N/A | Adjust PWsample gate | Drag the SV gateto place the SV onthe target | Adjust PWsample gate | Same | ||
| DisplayAnnotations | Logo; HospitalName;Examdate;Examtime;MechanicalI index;Thermalindes;Probemodel;TGCCorve;Focusposition;Imaging parameters;Systemstatus;Gray/Color bar | LogoHospitalName(NA)Exam date:Exam time;End exam;MI;TI; TGC; Probemodel;Imagingparameters;System status;Gray/Color bar | Probe model,acoustic outputvalue, MI,TI,iNeedle, iTouch,frequency, TGC,System status,Depth, Gain | Logo; HospitalName;Exam date; Exam time;Mechanicalindex; Thermalindes; Probemodel; STC;Focus position;Imagingparameters;System status;Gray/Color bar | Same | |
| Measurements | 2D mode:DepthDistance ,Area,Circumference | B mode:Depth,Distance,Area,CircumferenceDopplermode:Volume,Velocity, TimeM mode:Distance,Time, HR | 2D mode: Depth,Distance, Area,CircumferenceB/C mode:VolumeDoppler mode:Velocity, Time,M mode: Distance,Time, HR | 2D mode:Depth, Distance,Area, VolumeDoppler mode:D Velocity, Time,B/M mode:Distance, Time,HR | Same | |
| TransducerTypes &Connectors | Convex Array,Phased Array,Linear Array,USB interface | Micro convexarray,Endocavityprobe andVolume probes | Linear, convex andphased array. | Micro ConvexArrayUSB interface | Same | |
| Users /Sites | Hospitals,clinics usage | Hospitals,clinics usage | Hospitals, clinicsusage | Hospitals, clinicsusage | Same | |
| AcousticOutput | Track 3;Ispta.3 ≤ 720mW/cm²MI ≤ 1.9TI ≤ 6.0 | Track 3(ISPTA) of 720mW/ cm²MI: 0.0 to 1.9,TI: This iscontinuously | Track 3Ispta.3 ≤ 720mW/cm²MI ≤ 1.9 | Track 3;Ispta.3 ≤ 720mW/cm²MI ≤ 1.9TI ≤ 6.0 | Same | |
| Items | Main predicatedevice | Referencedevice | Reference device | SubmissionDevice | Remark | |
| LumifyDiagnosticUltrasoundSystem | ClariusUltrasoundSystem | TE7 DiagnosticUltrasoundSystem | Digital ColorDoppler PalmUltrasoundSystem | |||
| displayed overthe range of0.0tomaximumoutput, basedon thescanner andapplication, inincrementsof0.1 | ||||||
| PowerRequirements | Powerrequirements:AC :100V-240V,Frequenzy:50-60HzOperatingtemperature:5-40 °C ; relativehumidity15-95%;Barometricpressure:700 to1060 hPa | Input: 12 VDC,11.5 ATemperature:0°C (50°F) to40°C (113°F)Humidity: 15%to 95%s | Voltage: 100V-240V Temperature:0°C (50°F) to 40°C(113°F)Humidity: 30% to85%sAtmospherepressure: 700 to1060 hPa | Powerrequirements:DC 5V,Operatingtemperature:10-38 °C ; relativehumidity30-75%;Barometricpressure:700to1060 hPa | SEAnalysis2 |
Table 1 Substantial Equivalence Comparisor
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Page 5 of 10
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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
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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.
§ 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.