(230 days)
The Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, Color Doppler, Combined(B+Color), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid.
The Digital Color Doppler Palm Ultrasound System is intended for use in environments where is provided by healthcare professionals.
The SonoEye P1/ SonoEye P1-G/ SonoEye V1-G/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The Digital Color Doppler Palm Ultrasound System 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 P1, SonoEye V1, SonoEye G1, SonoEye P1-G, SonoEye V1-G, SonoEye G1-G Linear array USB transducer.
The provided text is a 510(k) Summary for the CHISON Medical Technologies Co., Ltd. SonoEye P1/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study (or lack thereof) to prove the device meets these criteria, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the format of specific performance metrics with target values. Instead, it demonstrates compliance by comparing the subject device's features and safety adherence to those of legally marketed predicate devices. The "acceptance criteria" are implied to be the standards and functionalities met by the predicate devices and general medical device regulations.
The provided comparison table shows similarities in various aspects between the subject device and the predicate devices. Below is a summarized table reflecting the reported device performance as per the comparison table, where "Same" indicates alignment with predicate devices, and specific values are given where differences are noted.
Table 1: Reported Device Performance vs. Implied Acceptance Criteria (via Predicate Comparison)
| Acceptance Criteria Category (Implied by Predicate Features & Standards) | Reported Device Performance (SonoEye Digital Color Doppler Palm Ultrasound System) |
|---|---|
| Indications for Use | Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid (Same as some predicate indications, subset of others) |
| Design Fundamentals | Autocorrelation for color processing, FFT for pulse Doppler processing, Supporting Linear probe, Cine play back capability, Image file archive (Same as predicates) |
| TGC Functionality | STC (Same as predicates' TGC) |
| Depth Range | 1.0 to 9.9cm (Different from predicate ranges, but "meets clinical requirements") |
| Shades of Gray | 256 (Same as predicates) |
| Gain Control | Gain: 0-255, 1/step (Same as predicates) |
| Focus Control | Adjustable (Same as predicates) |
| ROI Adjustment | Adjustable (Same as predicates) |
| Baseline | Present (Same as predicates) |
| Cine Control | Step, play backward, play continuously (Same as predicates) |
| Freeze Control | Toggling freeze key (Same as predicates) |
| Safety Compliance | ANSI/AAMI ES60601-1, IEC60601-1, IEC60601-2-37, IEC60601-1-2, ISO 10993-1 (Same as predicates) |
| Operation Modes | B mode, PW mode, B/M mode, CFM mode, FHI (Same as predicates, FHI corresponds to predicate's IQ) |
| Image Controls | Gain, Depth, STC, Compound, Frequency Scaling, Freeze/Unfreeze, Zoom (Same as predicates) |
| Measurements (2D mode) | Depth, Distance, Area, Volume (Same as predicates, volume mentioned which some predicates have) |
| Measurements (Doppler mode) | Velocity, Time, B/M mode: Distance, Time, HR (Same as predicates) |
| Specialized Measurement Packages | Vessel measure package, Small Organ measure package (Same as predicates) |
| Reporting | General report, Vessel report, Small Organ report (Same as predicates) |
| User Interface Features | Multi-language Interface, Clipboard (Thumbnail), Instant AIO (iTouch), Biopsy Guide, SonoRemote (Reacts Session Views), SonoNeedle (iNeedle), SuperNeedle (NeedleEnhance), Save Cine, Save Image, Cine Loop, Annotation, Bodymark, Arrow Mark, Patient management, Voice/Angle/Baseline on PW, Physical key, Setting, Archives (Patient database), Tutorials, Easyview (Review), Demo, About, Sample Gate adjustments (Same as predicates, with some naming differences) |
| Display Annotations | Logo; Hospital Name; Exam date; Exam time; Mechanical index; Thermal index; Probe model; STC; Focus position; Imaging parameters; System status; Gray/Color bar (Same as predicates, STC vs TGC) |
| Transducer Types & Connectors | Linear Array, USB interface (Subset of predicate types) |
| Users / Sites | Hospitals, clinics usage (Same as predicates) |
| Acoustic Output | Track 3, Ispta.3 ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0 (Same as predicates) |
| Power Requirements | DC 5V, Operating temperature: 10-38°C, Relative humidity: 30-75%, Barometric pressure: 700 to 1060 hPa (Different from predicate, but verified compliant with standards) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical testing was required." This indicates that there was no test set involving human subjects or clinical data for performance evaluation in the usual sense of a clinical study. The evaluation focused on non-clinical tests and comparisons to predicate devices. Therefore, information on sample size, data provenance, or retrospective/prospective nature of a clinical test set is not applicable.
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)
Since no clinical testing was performed, there was no "test set" in the context of clinical images requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing and no clinical test set were used.
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. The device is a "Digital Color Doppler Palm Ultrasound System," which is a diagnostic imaging system, not an AI-assisted diagnostic tool for interpretation. The document does not mention any AI capabilities or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an ultrasound system with human-in-the-loop operation for image acquisition and interpretation. There's no "algorithm only" performance reported in the context of a diagnostic interpretation task. The non-clinical tests indicate standalone performance of the device in terms of safety and technical specifications, but not diagnostic accuracy of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical testing was performed for diagnostic accuracy. The ground truth for the non-clinical tests would be the established engineering and safety standards (e.g., IEC 60601-1, ISO 10993-1) against which the device's technical performance was measured.
8. The sample size for the training set
Not applicable. The document does not indicate the use of machine learning or AI models requiring a training set for diagnostic purposes. The software mentioned is a "CHISON Ultrasound software" running as an Android app, which enables the device's functionalities, not a learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set for AI/ML was mentioned or implied.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 2, 2021 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: K201965
Trade/Device Name: SonoEye P1/ SonoEye V1/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G 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.
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); 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) K201965
Device Name
SonoEye P1-G/ SonoEye V1 /SonoEye V1-G/ SonoEye G1/ SonoEye G1-G 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, Color Doppler, Combined(B+Color), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid.
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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K201965
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 :
Trade Name: SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System
Common Name: Diagnostic Ultrasound System
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 | K160381 |
4. Device Description:
The SonoEye P1/ SonoEye P1-G/ SonoEye V1-G/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System is a mobile, general purpose, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data in various modes of operation. The Digital Color Doppler Palm Ultrasound System is a portable system facilitating point of care ultrasound
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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 P1, SonoEye V1, SonoEye G1, SonoEye P1-G, SonoEye V1-G, SonoEye G1-G Linear 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 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 USB 2.0 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 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
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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,Color Doppler,Combined(B+Color), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid.
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 -Part1:General Requirements for Safetv
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 issued on: June 16, 2016)
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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:
| Main predicatedevice | Referencedevice | Reference device | SubmissionDevice | ||
|---|---|---|---|---|---|
| Items | LumifyDiagnosticUltrasoundSystem | ClariusUltrasoundSystem | TE7 DiagnosticUltrasoundSystem | DigitalColorDopplerPalmUltrasoundSystem | Remark |
| Indications for Use | Fetal/Obstetric,Abdominal,Pediatric,Cephalic,Urology,Gynecological,Cardiac FetalEcho, SmallOrgan,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,and proceduralguidance ofneedles intothe body. | fetal, abdominal,Intra-operative(abdominal, thoracic,and vascular),Pediatric ,smallorgan(breast,thyroid, testes),neonatal and adultcephalic,trans-esoph.(Cardiac),trans-rectal,trans-vaginal,musculo-skeletal(conventional,superficial),urology, Peripheralvessel, Adult andPediatric cardiac | Pediatrics, SmallOrgan,Musculoskeletal,PeripheralVessel, Carotid | Same |
| Design | Autocorrelationfor colorprocessing andFFT for pulseDopplerprocessing.SupportingLinear, Curve,Phase arrayand Volumeprobes. | Autocorrelation for colorprocessingand FFT forpulse Dopplerprocessing.SupportingLinear, Phasearray, Microconvex array,Endocavity | Autocorrelation forcolor processingand FFT for pulseDopplerprocessing.Supporting Linear,convex andphased array.Cine play backcapabilityImage file archive | Autocorrelationfor colorprocessing andFFT for pulseDopplerprocessing.SupportingLinear probe.Cine play backcapabilityImage file | Same |
| Items | Main predicatedevice | Referencedevice | Reference device | SubmissionDevice | Remark |
| LumifyDiagnosticUltrasoundSystem | ClariusUltrasoundSystem | TE7 DiagnosticUltrasoundSystem | Digital ColorDoppler PalmUltrasoundSystem | ||
| Cine play backcapabilityImagefilearchive | probe andVolume probesCine play backcapabilityImagefilearchive | archive | |||
| TGC | TGC | TGC | STC | Same | |
| OperatingControls | DepthRange:0.003 to >30 cm | Depth Range:5.0 to 10.0cm(Depth dependon probe type) | Depth depend onprobe type | DepthRange:1.0 to 9.9cm | SEAnalysis1 |
| 256 shades ofgray | 256 in B-Mode | 30-240 in B mode | 256 shadesof gray | 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,pressor | Tap the cinecapture buttonto capture thecine as part ofthe exam. | Cine control | Cine control:step, playbackward, playcontinuously | Same | |
| Freeze control:Toggling freezekey | Freeze control:Togglingfreeze key | Freeze control:Toggling freezekey | 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 | |
| OperationMode | 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 | |
| Main predicatedevice | Referencedevice | Reference device | SubmissionDevice | ||
| Items | LumifyDiagnosticUltrasoundSystem | ClariusUltrasoundSystem | TE7 DiagnosticUltrasoundSystem | Digital ColorDoppler PalmUltrasoundSystem | Remark |
| 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 | |
| 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 | Small part | Small Organmeasurepackage | Same | |
| N/A | Report | Report | General report | Same | |
| N/A | N/A | Vascular ExamReport | Vessel report | Same | |
| N/A | N/A | Small Parts ExamReport | Small Organreport | 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/Baseline | Angle/Baseline on | Voice/Angle/Bas | Same | |
| Main predicatedevice | Referencedevice | Reference device | SubmissionDevice | ||
| Items | LumifyDiagnosticUltrasoundSystem | ClariusUltrasoundSystem | TE7 DiagnosticUltrasoundSystem | Digital ColorDoppler PalmUltrasoundSystem | Remark |
| on PW | PW | eline on PW | |||
| N/A | N/A | Physical key | Physical key | Same | |
| Setting | Setting | Setup | Setting | Same | |
| Patient | Patientinformation | Patient datamanagement | Archives | Same | |
| Database | |||||
| 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 | AdjustPWsample gate | Drag the SV gateto place the SV onthe target | AdjustPWsample gate | Same | |
| DisplayAnnotations | Logo; HospitalName;Examdate;Examtime;Mechanicalindex;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,iNeedle,frequency,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:Depth,Distance ,Area,Circumference | B mode:Depth,Distance,Area,CircumferenceDopplermode:Volume,Velocity, Time | 2D mode: Depth,Distance,Area,CircumferenceB/C mode:VolumeDopplermode:Velocity, Time,M mode: Distance,Time, HR | 2D mode:Depth, Distance,Area, VolumeDoppler mode:Velocity, Time,B/M mode:Distance, Time,HR | Same |
| Items | Main predicatedevice | Referencedevice | Reference device | SubmissionDevice | Remark |
| LumifyDiagnosticUltrasoundSystem | ClariusUltrasoundSystem | TE7 DiagnosticUltrasoundSystem | DigitalColorDopplerPalmUltrasoundSystem | ||
| M mode:Distance,Time, HR | |||||
| Transducer Types &Connectors | Convex Array,Phased Array,Linear Array,USB interface | Micro convexarray,Endocavityprobe andVolume probes | Linear, convex andphased array. | Linear ArrayUSB interface | Same |
| Users /Sites | Hospitals,clinics usage | Hospitals,clinics usage | Hospitals, clinicsusage | Hospitals, clinicsusage | Same |
| AcousticOutput | Track 3Ispta.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, inincrements of0.1 | Track 3Ispta.3 ≤ 720mW/cm²MI ≤ 1.9 | Track 3Ispta.3 ≤ 720mW/cm²MI ≤ 1.9TI ≤ 6.0 | Same |
| 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: 700to1060 hPa | Powerrequirements:DC 5V,Operatingtemperature:10-38 °C ; relativehumidity30-75%;Barometricpressure:700to1060 hPa | SEAnalysis2 |
Table 1 Substantial Equivalence Comparison
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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
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 P1, SonoEye V1, SonoEye G1, SonoEye P1-G, SonoEye V1-G, SonoEye G1-G 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.