(226 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 Abdominal, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where is provided by healthcare professionals.
The SonoEye P3/ SonoEye V3/ SonoEye G3 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 P3/ SonoEye V3/ SonoEye G3 Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound applications. The SonoEye P3 Series 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 P3, SonoEye V3, SonoEye G3 Phase array USB transducer
The provided text does not include information about AI/ML models or clinical studies involving human readers and AI assistance. Instead, it describes a 510(k) Premarket Notification for a medical device (Digital Color Doppler Palm Ultrasound System) and demonstrates its substantial equivalence to predicate devices, primarily through non-clinical testing and comparison of technical specifications.
Therefore, many of the requested categories for AI/ML model acceptance criteria and study design cannot be filled from the provided document. The document explicitly states: "No clinical testing was required." This indicates that the FDA clearance for this device was based on demonstrating similar technical and safety characteristics to already approved devices, rather than a clinical effectiveness study involving human users or AI.
However, I can extract the information that is present according to the prompt's structure:
Device: SonoEye P3/ SonoEye V3/ SonoEye G3 Digital Color Doppler Palm Ultrasound System
1. A table of Acceptance Criteria and the Reported Device Performance
Based on the provided document, the acceptance criteria are adherence to recognized medical device safety and performance standards and demonstration of substantial equivalence to predicate devices. The "reported device performance" is primarily the statement of compliance with these standards and the comparison of specifications.
| Category | Acceptance Criteria (Stated Requirements/Standards Met) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|---|
| General Compliance | Substantial equivalence to legally marketed predicate devices. | Concluded as substantially equivalent to predicate devices (Lumify Diagnostic Ultrasound System K192226, Clarius Ultrasound System K192107, TE7 Diagnostic Ultrasound System K160381) with regard to safety and effectiveness. |
| Electrical Safety | Compliance with IEC 60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety) and ANSI/AAMI ES60601-1:2005. Transducers to meet Type BF isolated applied part requirements. When used with IEC 60950-1 compliant COTS devices, the system meets IEC 60601-1 Class II requirements. | Transducer and software, with representative device, verified compliant with IEC 60601-1. Transducers meet Type BF isolated applied part requirements. When used with IEC 60950-1 compliant COTS devices, the system meets IEC 60601-1 requirements for Class II equipment. The subject device passed hardware test for voltage and complied with IEC60601-1 & IEC60601-2-37 requirements. Passed temperature test and complied with IEC60601-1 & IEC60601-2-37 requirements. Complied with humidity requirements (IEC60601-1 & IEC60601-2-37) and within normal range. |
| EMC | Compliance with IEC 60601-1-2: 2014 (Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests). Classified as Group 1, Class A equipment per CISPR 11 for radiated and conducted electromagnetic disturbances. When used with IEC 55032 compliant COTS devices, the system meets IEC 60601-1-2 requirements for Group 1, Class A. | Transducer and representative Android device classified as Group 1, Class A equipment in accordance with CISPR 11. When used with IEC 55032 compliant COTS devices, the system meets IEC 60601-1-2 requirements for Group 1, Class A equipment. |
| Biocompatibility | Compliance with ISO 10993-1:2009 (Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process) and FDA guidance "Use of International Standard ISO 10993-1..." | Device found to conform to applicable medical device safety standards in regards to biocompatibility, and conforms to ISO 10993-1. |
| Ultrasound Specific | Compliance with 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) and FDA guidance "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers". Acoustic Output: Track 3; Ispta.3 ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0. | Device found to conform to applicable medical device safety standards in regards to thermal and mechanical safety, and fulfills the requirement of IEC 60601-2-37. Acoustic output meets criteria (Track 3; Ispta.3 ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0). |
| Software | Compliance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern) and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". COTS Android devices: output current ≥ 1.5A, output voltage 5V±5%, full compliance with USB 2.0 standard. Representative Android devices (Samsung Galaxy A70s, Huawei MatePad Pro) configured as specified (CPU, RAM, ROM, resolution, WLAN, OS, Bluetooth). | Software Documentation for a Moderate Level of Concern included. Representative Android devices meet specified current, voltage, and USB 2.0 compliance. Samsung Galaxy A70s and Huawei MatePad Pro configurations are detailed. |
Note: The performance metrics provided relate to the operational specifications of the device (e.g., depth range, shades of gray, gain, focus, measurement types, transducer types, acoustic output limits, power requirements) and were deemed "Same" or had "SE (Substantial Equivalence) Analysis" where differences were addressed and determined not to affect safety or effectiveness.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of this 510(k) summary, as it explicitly states "No clinical testing was required." The "testing" referred to is non-clinical verification of compliance with standards and comparison to predicate devices, not a study on a human patient population or a dataset for AI.
- Data Provenance: Not applicable, as there was no clinical test set data. The device itself is manufactured in China (CHISON Medical Technologies Co., Ltd., Wuxi, Jiangsu, China).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as "No clinical testing was required" and therefore no human expert-established ground truth was part of the submission for clinical performance. The ground truth for engineering/safety testing would be derived from standard test equipment and protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical test set requiring adjudication was performed.
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
- No MRMC study was done. The document explicitly states "No clinical testing was required." This premarket notification is for a general diagnostic ultrasound system, not an AI-powered diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. This device is a hardware ultrasound system with integrated software, not an AI algorithm intended for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests conducted (electrical safety, EMC, biocompatibility, acoustic output), the "ground truth" would be the specifications and requirements defined by the international standards (IEC, ISO, ANSI/AAMI, CISPR) and FDA guidance documents. These are objective engineering and physical measurements. Clinical ground truth for diagnostic accuracy was not established or required for this 510(k) clearance.
8. The sample size for the training set
- Not applicable, as there is no mention of an AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of an AI/ML model requiring a training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CHISON Medical Technologies Co., Ltd. % 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: K201968
Trade/Device Name: SonoEye P3/ SonoEye V3/ Sono Eye G3 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 Qifei 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.
February 26, 2021
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201968
Device Name
SonoEye P3/ SonoEye V3/ SonoEye G3 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 Abdominal, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where 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, ShuofangIndustrial 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 :
SonoEye P3/ SonoEye V3/ SonoEye G3 Digital Color Doppler Palm Trade Name: 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 | LumifyDiagnosticUltrasound System | IYN,IYO,ITX | K192226 |
| 2.Reference device | Clarius Ultrasound System | IYN,ITX,IYO | K192107 |
| 3.Reference device | TE7 Diagnostic UltrasoundSystem | IYN,ITX,IYO | K 160381 |
4. Device Description:
The SonoEye P3/ SonoEye V3/ SonoEye G3 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 P3/ SonoEye V3/ SonoEye G3 Digital Color Doppler Palm
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Ultrasound System is a portable system facilitating point of care ultrasound applications. The SonoEye P3 Series 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 P3, SonoEye V3, SonoEye G3 Phase array USB 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
·RAM capacity 8GB
·ROM capacity 128GB
·Main screen resolution 2400x1080 pixels
•WLAN function Dual-band WIFI, IEEE 802.11 alb/g/n/ac (support 2.4G and 5GHz)
· Operating System: Android 9
- ·Support Bluetooth 5.0
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•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 Abdominal, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric.
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 reqards 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
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
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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 | DigitalColorDopplerPalmUltrasoundSystem | ||
| Indications for Use | Fetal/Obstetric,Abdominal,Pediatric,Cephalic,Urology,Gynecological,Cardiac FetalEcho,Small Organ,Musculoskeletal,PeripheralVessel,Carotid,Cardiac. | ophthalmic,fetal,abdominal,intraoperative(non-neurological), pediatric,small organ,cephalic(adult),trans-rectal,transvaginal,musculo-skeletal(conventional,superficial),urology,gynecology,cardiac (adult,pediatric),peripheralvessel,carotid, andproceduralguidance ofneedles intothe body | fetal,abdominal,intra-operative(abdominal, thoracic,and vascular),pediatrics,smallorgan(breast,thyroid, testes),neonatal and adultcephalic,trans-esoph.(Cardiac), trans-vaginal,musculo-skeletal(conventional, superficial),urology,peripheral vessel,adult and pediatriccardiac,ophthalmic exams | Abdominal,NeonatalCephalic,Adult Cephalic,Cardiac Adult,Cardiac,Pediatric | Same |
| Items | Main predicatedevice | Referencedevice | Reference device | SubmissionDevice | Remark |
| LumifyDiagnosticUltrasoundSystem | ClariusUltrasoundSystem | TE7 DiagnosticUltrasoundSystem | Digital ColorDoppler PalmUltrasoundSystem | ||
| Design | Autocorrelationfor colorprocessing andFFT for pulseDopplerprocessing.SupportingLinear, Curve,Phase arrayand Volumeprobes.Cine play backcapabilityImage filearchive | Autocorrelationfor colorprocessing andFFT for pulseDopplerprocessing.SupportingLinear, PhaseMicroconvex array,Endocavityprobe andVolumeprobes.Cine play backcapabilityImage filearchive | Autocorrelation forcolor processingand FFT for pulseDopplerprocessing.Supporting Linear,convex andphased array.Cine play backcapabilityImage file archive | Autocorrelationfor colorprocessingand FFT forpulseDopplerprocessing.SupportingPhased probe.Cine play backcapabilityImage filearchive | Same |
| OperatingControls | TGC | TGC | TGC | STC | Same |
| 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 22cm | SEAnalysis1 | |
| 256 shades ofgray | 256 in B-Mode | 30-240 in B mode | 256 shades ofgrayGain:0-255,1/step | Same | |
| Gain | Gain | Gain | Focus | Same | |
| Focus | Focus | Focus | Focus: adjustable | Same | |
| OperatingControls | 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,press or | Tap the cinecapture buttonto capture thecine as part ofthe exam. | Cine control | Cine control:step, playbackward, playcontinuously | Same | |
| Freeze control:Toggling freezekey | Freeze control:Toggling freezekey | Freeze control:Toggling freezekey | Freeze control:Toggling freezekey | Same | |
| SafetyCompliance | ANSI/AAMIES60601-1IEC60601-1IEC60601-2-37IEC60601-1-2ISO 10993-1 | ANSI/AAMIES60601-1IEC60601-1IEC 60601-2-37IEC 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 |
| Main predicatedevice | Referencedevice | Reference device | SubmissionDevice | ||
| Items | LumifyDiagnosticUltrasoundSystem | ClariusUltrasoundSystem | TE7 DiagnosticUltrasoundSystem | Digital ColorDoppler PalmUltrasoundSystem | Remark |
| 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 | |
| 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 | |
| Operation | N/A | M-Time | Time | B/M-Time | Same |
| Mode | 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 | |
| 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 | |
| BiopsyGuide | Biopsy Guide | Biopsy Guide | Biopsy Guide | Same | |
| Items | Main predicatedevice | Referencedevice | Reference device | SubmissionDevice | Remark |
| LumifyDiagnosticUltrasoundSystem | ClariusUltrasoundSystem | TE7 DiagnosticUltrasoundSystem | Digital ColorDoppler PalmUltrasoundSystem | ||
| Line | |||||
| 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 Gatehorizontal | Drag the SV gateto place the SV onthe target | Adjust size ofsample Gatehorizontal | Same | |
| 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 | |
| Items | Main predicate device | Reference device | Reference device | Submission Device | Remark |
| LumifyDiagnosticUltrasoundSystem | ClariusUltrasoundSystem | TE7 DiagnosticUltrasoundSystem | Digital ColorDoppler PalmUltrasoundSystem | ||
| DisplayAnnotations | Logo; HospitalName;Examdate;Examtime;MechanicalI index;Thermalindes;Probemodel;TGCCorve;Focusposition;Imagingparameters;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; Examdate; 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,CircumferenceDoppler mode: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 |
| Transducer Types &Connectors | Convex Array,Phased Array,Linear Array,USB interface | Micro convexarray,Endocavityprobe andVolume probes | Linear, convex andphased array. | Phased ArrayUSB interface | Same |
| UsersSites | 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 iscontinuouslydisplayed overthe range of0.0 tomaximumoutput, basedon thescanner andapplication, in | 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 | DigitalColorDopplerPalmUltrasoundSystem | ||
| 0.1 | |||||
| PowerRequirements | Powerrequirements:AC: 100V-240V,Frequency: 50-60HzOperatingtemperature: 5-40 ℃ ; 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-240VTemperature: 0°C(50°F) to 40°C(113°F)Humidity: 30% to85%sAtmospherepressure: 700 to1060 hPa | Powerrequirements:DC 5V,Operatingtemperature: 10-38 ℃ ; relativehumidity30-75%;Barometricpressure: 700 to1060 hPa | SEAnalysis2 |
Table 1 Substantial Equivalence Comparison
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510(k) Summary
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Comparison Analysis
SE Analysis 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 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
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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 P3/ SonoEye V3/ SonoEye G3 Digital Color Doppler Palm Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.
N/A