(122 days)
The SonoAir Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CFM + D (PW),B+CPA(PD) + D (PW), Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic intended for use by an appropriatelytrained qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ), Adult Cephalic, Cardiac Adult. Musculo-skeletal(Conventional, Superficial).Peripheral Vascular, Trans-vaginal and Urology,which is intended to be used in a hospital or medical clinic.
The SonoAir Series Digital Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (2D), Fusion Harmonic Imaging, M-Mode, Pulsed Doppler (PW) Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode or a combination of these mode.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SonoAir Series Digital Color Doppler Ultrasound System, structured to answer your questions:
Important Note: The provided document is a 510(k) Summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission generally relies on demonstrating that the new device is as safe and effective as existing devices, often without requiring new large-scale clinical trials measuring specific performance metrics against pre-defined acceptance criteria in the way a novel AI algorithm might.
1. A table of acceptance criteria and the reported device performance
The document does not provide explicit acceptance criteria and corresponding performance metrics for the SonoAir Series Digital Color Doppler Ultrasound System in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications, safety standards, and intended uses.
The "acceptance criteria" in this context are broadly related to meeting established medical device safety and performance standards, and having comparable features and indications for use as the predicate device. The "reported device performance" is essentially that it complies with these standards and operates similarly to the predicate.
Here's a table based on the provided information, focusing on the comparisons made for substantial equivalence, rather than specific performance metrics against diagnostic acceptance criteria:
| Acceptance Criterion (Implicit) | Reported Device Performance (SonoAir Series) |
|---|---|
| Indications for Use (Substantially Equivalent to Predicate) | Comparable to predicate devices (EBit 90 & XBit 90) with minor differences. Differences analyzed and deemed not to raise new safety/effectiveness concerns. |
| Design | Same autocorrelation for color processing, FFT for pulse/CW Doppler, supporting linear, curve, phase array probes, Cine playback, image archive. |
| Operational Controls | Same design as predicate. Minor differences in setting ranges (e.g., depth range, color wall filter, color baseline, PW sweeping speed, PW sample volume, PW angle correction, baseline) exist but comply with standards and meet clinical requirements. |
| Safety Compliance | Complies with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993 (various parts). |
| Operational Modes | Comparable operational modes (B mode, M mode, CFM, PW, CPA(PD), DPD, Triplex, HPRF, FHI, etc.) to predicate devices. |
| Measurements | Similar 2D, M-mode, and Doppler measurements to predicate devices. |
| Transducer Types & Connectors | Convex Array, Phased Array, Linear Array, 4 ports. Considered similar to predicate (differing slightly in volume probe and number of ports). |
| Users / Sites | Hospitals, clinics usage (same as predicate). |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB (Derated Ispta: 720mW/cm² max, TIS/TIB/TIC: 0.1-4.0 Range, Mechanical Index: 1.9 Max, Derated Isppa: 190 W/cm² max) - same as predicate. |
| Power Requirements | Power requirements: AC: 100V-240V, Freq: 50-60Hz; Operating temp: 10-38°C; relative humidity 30-75%; Barometric pressure: 700 to 1060hPa. Operating temperature is within the scope of the predicate. |
| Software Documentation (Moderate Level of Concern) | Included and reviewed per FDA guidance. |
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 means there was no specific clinical test set used to evaluate the device against diagnostic performance metrics. The evaluation was based on non-clinical tests demonstrating compliance with recognized standards and a comparison of technical specifications with predicate devices.
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 required, there were no "experts" in the context of establishing ground truth for a diagnostic test set. The evaluation relied on regulatory compliance and engineering comparisons.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was 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. This is a general diagnostic ultrasound system, not an AI-assisted diagnostic device, and no clinical studies of this nature were conducted or required for this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a general diagnostic ultrasound system, not an AI-driven algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this 510(k), the "ground truth" for demonstrating substantial equivalence was adherence to recognized medical device standards and the technical specifications and operational characteristics of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is a general diagnostic ultrasound system; there is no mention of an AI component or a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set was identified.
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March 31, 2023
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CHISON Medical Technologies Co., Ltd. % Yingying Chen RA Specialist No.3 Changjiang South Road, Xinwu District Wuxi, Jiangsu 214028 CHINA
Re: K223570
Trade/Device Name: SonoAir Series Digital Color Doppler 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: February 24, 2023 Received: February 27, 2023
Dear Yingying Chen:
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 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,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of 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) K223570
Device Name
SonoAir Series Digital Color Doppler Ultrasound System
Indications for Use (Describe)
The SonoAir Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CFM + D (PW),B+CPA(PD) + D (PW), Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic intended for use by an appropriatelytrained qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ), Adult Cephalic,
Cardiac Adult. Musculo-skeletal(Conventional, Superficial).Peripheral Vascular, Trans-vaginal and Urology,which is intended to be used in a hospital or medical clinic.
| 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.3 Changjiang South Road, Xinwu District, Wuxi, 214028 Jiangsu,P.R. China |
| Contact : | Mrs. Chen Yingying |
| Tel: | +86-510-8531-0019 |
| Fax: | +86-510-8531-0021 |
| Date Prepared: | October 14th, 2022 |
2. Device :
Trade Name: SonoAir Series Digital Color Doppler Ultrasound System
Common Name: Diagnostic Ultrasound System with Transducers
Classfication: Regulatory Class: II Review Category: Tier II
| Classfication Name | 21 CFRSection | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
3. Predicate Device(s):
| Device | Model | Product Code | 510(k)Number |
|---|---|---|---|
| Main predicate device | EBit 90 Digital ColorDoppler Ultrasound System | IYN, IYO, ITX | K162172 |
| Reference device | XBit 90 Digital ColorDoppler Ultrasound System | IYN, IYO, ITX | K200780 |
4. Device Description:
The SonoAir Series Digital Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (2D), Fusion Harmonic Imaging, M-Mode, Pulsed
510(k) Summary
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CHISON Medical Technologies Co., Ltd.
Doppler (PW) Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode or a combination of these mode.
5. Indications for Use:
The SonoAir Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D),B/M,M,B+CFM,B+CPA (PD), B+DPD,B+PW, B+ CFM + D (PW), B+ CPA(PD) + D (PW), Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by an appropriately-trained qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ),Adult Cephalic,Cardiac Adult, Musculoskeletal(Conventional, Superficial),Peripheral Vascular, Trans-vaginal and Urology, which is intended to be used in a hospital or medical clinic.
6. Summary of Non-Clinical Tests:
The SonoAir Series Digital Color Doppler 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.
ANSI AAMI ES60601-1:2015 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
IEC 60601-1-2: 2014 Medical Electrical Equipment - Part 1-2: General Requirements For Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
IEC 60601-2-37:2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
Output Indices on Diagnostic Ultrasound Equipment
ISO 10993-1:2018 Biological Evaluation of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process
The following quality assurance measures are applied to the development of the system:
Risk Management
Requirement review and Design reviews
Testing on unit level (Module verification)
Integration testing (system verification)
Performance testing (Verification)
Safety testing (Verification)
The biocompatibility was evaluated and meets the ISO10993 series standard and FDA guidance.
7. Clinical Test:
No clinical testing was required.
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CHISON Medical Technologies Co., Ltd.
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.
8. Determination of Substantially Equivalent:
| Items | Main PredicateDevice | Reference Device | Submission Device | Remark |
|---|---|---|---|---|
| Items | EBit 90 Digital ColorDoppler UltrasoundSystem(K162172) | XBit 90 Digital ColorDoppler UltrasoundSystem(K200780) | SonoAir SeriesDigital Color DopplerUltrasound System | |
| Indications forUse | FetalAbdominalPediatricSmall Organ (breast,thyroid ,testes)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalMusculo-skeletal( ConventionaI, Superficial)Cardiac(adult ,pediatric)Peripheral VascularUrologyTrans-esophageal | FetalAbdominalPediatricSmall Organ (breast,thyroid ,testes)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalMusculo-skeletal( ConventionaI, Superficial)Cardiac(adult ,pediatric)Peripheral VascularOB/GYN,UrologyTrans-esophageal | FetalAbdominalPediatricSmall Organ (breast,thyroid ,testes)Adult CephalicTrans-vaginalMusculo-skeletal( ConventionaI, Superficial)Cardiac AdultPeripheral VascularUrology | SEAnalysis1 |
| Design | Autocorrelation forcolor processing andFFT for pulse andCW Dopplerprocessing.Supporting Linear,Curve , Phase arrayand Volume probes .Cine play backcapabilityImage file archive | Autocorrelation forcolor processing andFFT for pulse andCW Dopplerprocessing.Supporting Linear,Curve , Phase arrayand Volume probes .Cine play backcapabilityImage file archive | Autocorrelation forcolor processing andFFT for pulse andCW Dopplerprocessing.Supporting Linear,Curve and Phasearray probes.Cine play backcapabilityImage file archive | Same |
| Operati | TGC 8 slider | TGC 8 slider | TGC 8 slider | Same |
| Depth Range:0-30.8cm | Depth Range: 0-45cm | Depth Range:0- 22.7cm | SEAnalysis2 | |
| ngControls | 256 shades of gray | 256 shades of gray | 256 shades of gray | Same |
| ltems | B Dynamic rangecontrol: 30-180dB | B Dynamic rangecontrol: 20-180dB | B Dynamic rangecontrol: 30-180dB | Same |
| Gain:0-255, 1/step | Gain:0-255, 1/step | Gain:0-255, 1/step | Same | |
| Focal Number:adjustable | Focal Number:adjustable | Focal Number:adjustable | Same | |
| Focus position:adjustable | Focus position:adjustable | Focus position:adjustable | Same | |
| B steer: available onlinear transducers | B steer: available onlinear transducers | B steer: available onlinear transducers | Same | |
| B Persistence: 7steps | B Persistence: 7steps | B Persistence: 7steps | Same | |
| ROI size/position:adjustable | ROI size/position:adjustable | ROI size/position:adjustable | Same | |
| Color Wall Filtersettings:8 steps | Color Wall Filtersettings:8 steps | Color Wall Filtersettings:4 steps | ||
| Color Baseline:16steps | Color Baseline:16steps | Color Baseline: 7steps | SEAnalysis2 | |
| Color Maps: 21 maps | Color Maps: 21 maps | Color Maps: 9 maps | ||
| PW sweeping speed:6 steps | PW sweeping speed:6 steps | PW sweeping speed:3 steps | ||
| Color Invert: on/off | Color Invert: on/off | Color Invert: on/off | Same | |
| PW Wall Filter: 7steps | PW Wall Filter: 7steps | PW Wall Filter: 7steps | Same | |
| PW sample volume:0.5-30mm (PWonly), 13 steps | PW sample volume:0.5-30mm (PW only) | PW sample volume:1-8mm (PW only) | SE | |
| PW angle correction:-89~89degrees, 1/step | PW angle correction:-89~89degrees, 1/ste | PW angle correction:-70-70degrees, 1/step | Analysis2 | |
| Baseline: 8steps | Baseline: 8steps | Baseline: 6steps | ||
| Cine control:step,play backward, playcontinuously | Cine control:step,play backward, playcontinuously | Cine control:step,play backward, playcontinuously | Same | |
| Doppler Auto Trace | Doppler Auto Trace | Doppler Auto Trace | Same | |
| Freezecontrol: Togglingfreeze key | Freezecontrol: Togglingfreeze key | Freezecontrol: Togglingfreeze key | Same | |
| SafetyCompliance | ANSI AAMIES60601-1IEC 60601-1-2ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-23IEC 60601-2-37 | ANSI AAMIES60601-1IEC 60601-1-2ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-23IEC 60601-2-37 | ANSI AAMIES60601-1IEC 60601-1-2ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-23IEC 60601-2-37 | Same |
| Operation | B mode | B mode | B Mode | Same |
| Dual mode | B/M Mode | B/B Mode | Same |
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SonoAir Series Digital Color Doppler Ultrasound System
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| CHISON Medical Technologies Co., Ltd. | ||||||
|---|---|---|---|---|---|---|
| -- | -- | --------------------------------------- | -- | -- | -- | -- |
SonoAir Series Digital Color Doppler Ultrasound System
| Mode | Quad mode | M mode | 4B Mode | Same |
|---|---|---|---|---|
| B/M Mode | Dual mode | B/M Mode | Same | |
| M mode | Quad mode | M Mode | Same | |
| CFM mode | CFM mode | CFM Mode | Same | |
| PW mode | CPA Mode | PW Mode | Same | |
| CPA(PD) Mode | DPD Mode | CPA(PD) Mode | Same | |
| DPD Mode | PW mode | DPD Mode | Same | |
| 2D Steer | 2D Steer | 2D Steer | Same | |
| Triplex Mode | Triplex Mode | Triplex Mode | Same | |
| Quadplex Mode | Quadplex Mode | Quadplex Mode | Same | |
| / | HD 3D Mode | HD 3D Mode | Same | |
| Free Steer M | Free Steering M | Free Steer M | Same | |
| HPRF Mode | HPRF Mode | HPRF Mode | Same | |
| FHI | FHI | FHI | Same | |
| Color M Mode | Color M Mode | Color M Mode | Same | |
| Trapezoidal Mode | Trapezoidal Mode | Trapezoidal Mode | Same | |
| Elastography Mode | Elastography Mode | Elastography Mode | Same | |
| / | Sono Contrast | Sono Contrast | Same | |
| Super Needle | Super Needle | Super Needle | Same | |
| Biopsy | / | Biopsy | Same | |
| Curved Panoramic | Curved Panoramic | Curved Panoramic | Same | |
| TGC | / | TGC | Same | |
| / | LGC | LGC | Same | |
| Chroma | Chroma | Chroma | Same | |
| / | X-contrast | X-contrast | Same | |
| Q-beam | Q-beam | Q-beam | Same | |
| Compound | Compound | Compound | Same | |
| AIO | AIO | AIO | Same | |
| SRA | SRA | SRA | Same | |
| Q-image | Q-image | Q-image | Same | |
| general measurementpackage | general measurementpackage | general measurementpackage | Same | |
| OB measurementpackage | OB measurementpackage | OB measurementpackage | Same | |
| GYN measurementpackage | GYN measurementpackage | GYN measurementpackage | Same | |
| URO measurementpackage | URO measurementpackage | URO measurementpackage | Same | |
| cardiac measurementpackage | cardiac measurementpackage | cardiac measurementpackage | Same |
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| CHISON Medical Technologies Co., Ltd. | SonoAir Series Digital Color Doppler Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| vascularmeasurementpackage | vascularmeasurementpackage | Same | |||||
| small partsmeasurementpackage | small partsmeasurementpackage | Same | |||||
| Pediatricmeasurementpackage | Pediatricmeasurementpackage | Same | |||||
| TCD measurementpackage | TCD measurementpackage | Same | |||||
| / | Free OB | Same | |||||
| Bodymark | Bodymark | Same | |||||
| Auto IMT | Auto IMT | Same | |||||
| / | SonoColor | Same | |||||
| Stress Echo | Stress Echo | Same | |||||
| / | Strain and StrainRate | Same | |||||
| DisplayAnnotations | Logo; Hospital Name;Exam date;Examtime; AcousticPower;Mechanical index;Tissue thermal indes;ID,Last name,FirstName,Middleinitial,Gender, Age;Probe model;ECGico;Operator;TGC Corve;Focusposition;Thumbnail;Imagingparameters;Dynamic | Logo; Hospital Name;Exam date;Examtime; AcousticPower ;Mechanicalindex;Thermalindes;Probemodel;ECG ico;TGCCorve;Focusposition;Imagingparameters;DynamicTrackball indices;Systemstatus;Gray/Color bar | Logo; Hospital Name;Exam date;Examtime; AcousticPower ;Mechanicalindex;Thermalindes;Probe model;TGC Corve;Focusposition;Imagingparameters;TTouchpad; Systemstatus;Gray/Color bar | Same |
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SonoAir Series Digital Color Doppler Ultrasound System
| Measurements | 2D mode: Depth ,Distance ,Area:Ellipse, Trace, Spline,Cross, Trace Length,Double Distance,Parallel, Volume:Distance, Ellipse,Ellipse + Distance,Length Ratio, AreaRatio, IMT, BHistogram, B Profile,Volume Flow, ColorVelocity;M mode: Distance,Time, Slope, HeartRate, Velocity;Doppler mode: DVelocity, Time, HeartRate, Acceleration, DTrace, PS/ED,Volume Flow; | 2D mode: Depth ,Distance ,Area:Ellipse, Trace, Spline,Trace Length ,Double DistanceParallel ,Volume :Distance, Ellipse, Ellipse+ Distance, DistanceRatio ,Area Ratio ,IMT, Volume Flow,Color Velocity;M mode:Distance,Time,Slope, HeartRate,Velocity;Doppler mode: DVelocity ,Time ,HeartRate,Acceleration ,DTrace,PS/EDVolume Flow; | 2D mode: Depth ,Distance ,Area:Ellipse, Trace, Spline,Trace,Length ,Volume : Distance, Ellipse, Ellipse+ Distance, DistanceRatio, Area Ratio ,IMT, Volume Flow;M mode:Distance,Time,Slope,HeartRate,Velocity;Doppler mode: DVelocity ,Time ,Heart Rate,Acceleration ,DTrace,ED/PS,Volume Flow; | Same |
|---|---|---|---|---|
| TransducerTypes &Connectors | Convex Array,Phased Array, LinearArray, Volume probe2 ports | Convex Array,Phased Array, LinearArray,Volume probe4ports | Convex Array,Phased Array, LinearArray,4ports | Same |
| Users /Sites | Hospitals, clinicsusage | Hospitals, clinicsusage | Hospitals, clinicsusage | Same |
| AcousticOutput | Track 3; MI, TIS,TIC, TIBDerated Ispta:720mW/cm²maximum,TIS/TIB/TIC:0.1-4.0Range, MechanicalIndex: 1.9 Maximum,or Derated Isppa: 190W/cm² max | Track 3; MI, TIS,TIC, TIBDerated Ispta:720mW/cm²maximum,TIS/TIB/TIC:0.1-4.0Range, MechanicalIndex: 1.9 Maximum,or Derated Isppa: 190W/cm² max | Track 3; MI, TIS,TIC, TIBDerated Ispta:720mW/cm²maximum,TIS/TIB/TIC:0.1-4.0 Range,Mechanical Index: 1.9Maximum, or DeratedIsppa: 190 W/cm²max | Same |
| PowerRequirements | Power requirements:AC :100V- 240V,Frequenzy:50-60HzOperatingtemperature: 10-40°C; relative humidity30-75%;Barometric pressure:700 to 1060hPa | Power requirements:AC :100V- 240V,Frequenzy:50-60HzOperatingtemperature:0-40°C; relativehumidity 30-75%;Barometric pressure:700 to 1060 hPa | Power requirements:AC :100V- 240V,Frequenzy:50-60HzOperatingtemperature:10-38°C; relativehumidity 30-75%;Barometric pressure:700 to 1060 hPa | SEAnalysis3 |
SE Analysis 1:
Compared with the predicate device, the submission device has some differences in
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CHISON Medical Technologies Co., Ltd.
indications for use. Principles of operation transducer configuration is the same, the only difference is the number of probe. Both of the predicate and submission device comply with the requirements of ANSI AAMI ES60601-1& IEC 60601-2-37 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 submission device employs the same operation controls design ,but has some differences in setting range. But both of them comply with the requirements of ANSI AAMI ES60601-1 & 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 3:
Compared with the predicate device, the submission device has some differences in operating temperature. But the operating temperature of the device is contained within the scope of the predicate device. Both them comply with the requirements of ANSI AAMI ES60601-1. Therefore they can be considered Substantially Equivalent in safety, and no new risk is raised, so the SE is not affected.
9. 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 SonoAir Series Digital Color Doppler Ultrasound System is substantially equivalent to the predicate device with regard to safety and effectiveness.
N/A