(133 days)
The XBit Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B (2D/3D/4D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CW,B+CFM +D (PW)/CW, B+ CPA(PD) + D (PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified clinician for evaluation of Fetal ,Abdominal,Pediatric,Small Organ (breast, thyroid,testes ), Neonatal Cephalic , Adult Cephalic, Cardiac (adult , pediatric), Musculo-skeletal (Conventional , Superficial) , Peripheral Vascular, Transesophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology.
The XBit Series Digital Color 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 LED 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 (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, contrast imaging, 3D/4D. Auto Follicle, SonoBeam, SonoColor, and SonoFusion, these four features are all semi-automated functions, they need to be modified during processing.
The provided text is a 510(k) Summary for the CHISON XBit Series Digital Color Doppler Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results designed to prove device performance against specific acceptance criteria.
Therefore, the document does not contain the acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a novel AI/ML device. The focus here is on the similarity of the new device to existing, already cleared ultrasound systems.
Specifically, the document states:
- "7. Clinical Test: No clinical testing was required." This explicitly indicates that no clinical study was conducted for this submission.
Given this, I cannot extract the information required for accepting a device, particularly regarding a study that proves the device meets specific performance acceptance criteria related to AI/ML features. The "Acceptance Criteria" in this context would likely refer to the FDA's requirements for demonstrating substantial equivalence (e.g., similar indications for use, technological characteristics, and safety/performance as a legally marketed predicate device).
However, I can extract information related to the device's assessment of its substantially equivalent nature, which includes functional comparisons. The "SE Analysis" sections do describe what the device's "semi-automated functions" do and compare them to predicate features. These comparisons serve as the basis for the declaration of substantial equivalence, which is the "acceptance" in a 510(k) context.
Let's break down what can and cannot be answered based on the provided text, assuming the "AI" features refer to the "semi-automated functions" mentioned in section 4 and detailed in the SE Analyses (e.g., Auto Follicle, SonoBeam, SonoColor, SonoFusion).
Summary of what can be extracted from the document:
The document describes the XBit Series Digital Color Doppler Ultrasound System, which includes "semi-automated functions" like Auto Follicle, SonoBeam, SonoColor, and SonoFusion. For a 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against novel, quantitatively defined acceptance metrics. Indeed, the document explicitly states: "No clinical testing was required."
However, the "SE Analysis" sections serve as the basis for demonstrating that these "semi-automated functions" are substantially equivalent to features found in predicate devices. This is the closest the document comes to describing how the device "meets acceptance criteria" for these features.
1. A table of acceptance criteria and the reported device performance:
Since "No clinical testing was required," there are no explicit quantitative acceptance criteria or reported device performance metrics in the traditional sense (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is claimed based on functional similarity.
Here's how the document frames the comparison for the "semi-automated functions":
| Feature (Subject Device) | Claimed Functionality (Subject Device) | Predicate Device Analogue(s) | Predicate Functionality | Basis for Equivalence (Implicit Acceptance Criteria) |
|---|---|---|---|---|
| Auto Follicle | Automatically identifies, traces, and calculates area and circumference of follicles after user positions ROI. Output values can be modified (semi-automated). | Acuson x700 Diagnostic Ultrasound System (synqo® Auto Follicle measurement option) | Automated measurement technique for fast, accurate assessment of multiple follicles. Measurement methods supported: Distance, 2Dist + Avg, 3Dist + Avg, 2Dist Avg, 3Dist Avg, Area, Volume, Circumference. | Both can get area and circumference of follicles. The semi-automated nature of the subject device is noted but doesn't affect substantial equivalence. |
| SonoFusion | (Implied: Makes real-time ultrasound image match with CT/MR image.) | Resona 7 Diagnostic Ultrasound System (Fusion Imaging) | (Implied: Makes real-time ultrasound image match with CT/MR image.) | Both improve diagnostic efficiency by matching images (despite differences in "navigation device and navigation bracket"). |
| SonoColor | Recognizes vessel angle automatically. | Resona 7 Diagnostic Ultrasound System (Color Vol) | (Implied: Requires user control for vessel angle recognition.) | Both can get point velocity and meet clinical requirements, despite differences in automation level for angle acquisition. |
| SonoBeam | Improved version of Q-beam, multi-beam blood flow high frame rate function based on traditional dual beamformer principle. Improves processing speed, increases frame rate, reduces noise. | CBit 9 Digital Color Doppler Ultrasound System (Q-beam) | Q-beam is implied to be a less advanced multi-beam technology for blood flow. | Both improve image quality. The subject device's improvement is noted but does not invalidate substantial equivalence. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document states "No clinical testing was required." The "test set" for demonstrating substantial equivalence is the comparison of functional specifications and safety data to predicate devices.
- Data Provenance: Not applicable for a clinical test set. The regulatory submission data provenance is CHISON Medical Technologies Co., Ltd. from China. The comparison is based on the declared specifications and previously cleared status of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical testing with ground truth establishment was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical testing was performed for which adjudication would be relevant.
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. The document explicitly states "No clinical testing was required." Therefore, no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No standalone performance evaluation for these "semi-automated functions" is mentioned or appears to have been required. The functions are described as "semi-automated," implying a human-in-the-loop is always present.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. As no clinical testing was performed, no ground truth needed to be established for performance evaluation. Ground truth for the predicate devices' original clearances would have been established, but this document does not detail that.
8. The sample size for the training set:
- Not applicable. The document does not provide information on the training set for the "semi-automated functions" (AI/ML components). This level of detail is typically not required for a 510(k) submission unless the AI/ML algorithm represents a significant change in technology or indications from the predicate.
9. How the ground truth for the training set was established:
- Not applicable. As no information on the training set is provided, how its ground truth was established is also not detailed.
In conclusion, this 510(k) summary for an ultrasound system relies on demonstrating substantial equivalence to predicate devices, and explicitly states that no clinical testing was required. Therefore, the detailed and quantitative information typically sought for AI/ML device acceptance criteria and performance studies (sample sizes, expert ground truth, MRMC studies, etc.) is not present in this document. The "acceptance" of this device is based on its similarity to already cleared devices in terms of indications, technology, and safety/performance characteristics.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CHISON Medical Technologies Co., Ltd. % Liu Qifei Regulatory Affairs Manager No. 228, Changjiang East Road, Block 51 and 53 Phase 5, Shuofang Industrial Park Xinwu District, Wuxi, Jiangsu 214142 CHINA
August 5, 2020
Re: K200780
Trade/Device Name: XBit 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: June 6, 2020 Received: June 6, 2020
Dear Liu Qifei:
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 (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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200780
Device Name
XBit Series Digital Color Doppler Ultrasound System
Indications for Use (Describe)
The XBit Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B (2D/3D/4D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CW,B+CFM +D (PW)/CW, B+ CPA(PD) + D (PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified clinician for evaluation of Fetal ,Abdominal,Pediatric,Small Organ (breast, thyroid,testes ), Neonatal Cephalic , Adult Cephalic, Cardiac (adult , pediatric), Musculo-skeletal (Conventional , Superficial) , Peripheral Vascular, Transesophageal, Trans-rectal, Trans-vaginal, OB/GYN and Urology.
| Type of Use (Select one or both, as applicable) | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary
K200780
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: | March 12th, 2020 |
2. Device :
Trade Name: XBit Series Digital Color Doppler 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 | CBit 9 Digital Color Doppler Ultrasound System | IYN, IYO, ITX | K180974 |
| 2.Reference device | Resona 7 Diagnostic Ultrasound System | IYN, IYO, ITX | K171233 |
| 3.Reference device | Acuson x700 Diagnostic Ultrasound System | IYN, IYO, ITX, OBJ | K141846 |
4. Device Description:
The XBit Series Digital Color 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 LED monitor and optional probes.
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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 (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, contrast imaging, 3D/4D.
Auto Follicle, SonoBeam, SonoColor, and SonoFusion, these four features are all semi-automated functions, they need to be modified during processing.
5. Indications for Use:
The XBit Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D/3D/4D), B/M, M, B+CFM,B+CPA (PD),B+DPD,B+PW,B+CW, B+ CFM + D (PW)/CW, B+ CPA(PD) + D (PW)/CW, TDI and Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified clinician for evaluation of Fetal,Abdominal,Pediatric,Small Organ (breast, thyroid,testes ), Neonatal Cephalic ,Adult Cephalic,Cardiac (adult , pediatric),Musculoskeletal (Conventional, Superficial), Peripheral Vascular,Transesophageal,Trans-rectal, Trans-vaginal, OB/GYN and Urology.
6. Summary of Non-Clinical Tests:
The XBit 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.
IEC 60601-1: 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 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)
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- 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)
7. 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.
8. Comparison to Predicate Device:
Table 1 Substantial Equivalence Comparison
| Main predicatedevice | Referencedevice | Referencedevice | SubmissionDevice | ||
|---|---|---|---|---|---|
| Items | CBit 9 DigitalColor DopplerUltrasoundSystemK180974 | Resona 7DiagnosticUltrasoundSystemK171233 | Acuson x700DiagnosticUltrasoundSystemK141846 | XBit SeriesDigital ColorDopplerUltrasoundSystem | Remark |
| Indications forUse | FetalAbdominalPediatricSmall Organ(breast,thyroid ,testes)NeonatalCephalic ,AdultCephalicTrans-rectalTrans-vaginalMusculo-skeletal( Conventional,Superficial)Cardiac(adult ,pediatric)PeripheralVascularOB/GYN,UrologyTrans-esophageal | FetalAbdominalIntra-operative(abdominal,thoracic, andvascular)PediatricSmallorgan(breast,thyroid ,testes)NeonatalCephalicAdult CephalicTrans-rectalTrans-vaginalMusculo-skeletaI(conventional,superficial),Cardiac adultCardiacpediatricTrans-esoph.(cardiac),Peripheralvesselurology | Cardiac (Adult,Pediatric)Transesphageal(Cardiac)IntracardiacCerebrovascularPeripheralVesselAbdominalRenalFetalAbdominalIntra-operativePediatricSmall OrganNeonatalCepahalicAdult CephalicOrthopedicsMusculo-skeleta ConventionalMusculo-skeletaI SuperficialPelvicObstetricalGynecologicalUrological | FetalAbdominalPediatricSmall Organ(breast,thyroid ,testes)NeonatalCephalic ,AdultCephalicTrans-rectalTrans-vaginalMusculo-skeletaI( Conventional,Superficial)Cardiac(adult ,pediatric)PeripheralVascularOB/GYN,UrologyTrans-esophageal | Same |
| Items | Main predicate device | Reference device | Reference device | Submission Device | Remark |
| CBit 9 Digital Color Doppler Ultrasound System K180974 | Resona 7 Diagnostic Ultrasound System K171233 | Acuson x700 Diagnostic Ultrasound System K141846 | XBit Series Digital Color Doppler Ultrasound System | ||
| Design | Autocorrelation for color processing and FFT for pulse and CW Doppler processing. Supporting Linear, Curve, Phase array and Volume probes . Cine play back capability Image file archive | Transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. | The ACUSON X700 ultrasound system features a sophisticated imaging engine migrated from our premium imaging products as well as technology to bolster compatibility across systems. | Autocorrelation for color processing and FFT for pulse and CW Doppler processing. Supporting Linear, Curve, Phase array and Volume probes . Cine play back capability Image file archive | Same |
| TGC 8 slider | TGC 8 slider | TGO: 8 controls | TGC 8 slider | Same | |
| Depth Range: 0 to 45 cm | Depth Range: 1.5 to 40 cm | Depth Range: 1 to 30 cm | Depth Range: 0 to 45 cm | Same | |
| 256 shades of gray | NA | NA | 256 shades of gray | Same | |
| B Dynamic range control: 20-280dB | B Dynamic range control: 30-260dB | B Dynamic range selection: 30-90dB | B Dynamic range control: 20-280dB | Same | |
| Gain:0-255,1/step | Gain:0-100,1/step | Gain:-30-+30,1/step | Gain:0-255,1/step | Same | |
| Focal Number: adjustable | No physical focus to adjust | Focal Number: adjustable | Focal Number: adjustable | Same | |
| Focus position: adjustable | No physical focus to adjust | Focus position: adjustable | Focus position: adjustable | Same | |
| Operating Controls | B steer: available on linear transducers | B steer: available on linear transducers | B steer: available on linear transducers | B steer: available on linear transducers | Same |
| B Persistence: 7 steps | B Persistence: 7 steps | B Persistence:5 levels | B Persistence: 7 steps | Same | |
| ROI size/position: adjustable | ROI size/position: adjustable | ROI size/position: adjustable | ROI size/position: adjustable | Same | |
| Color Wall Filter settings:8 steps | Color Wall Filter settings:8 steps | Wall filter : 4 selections | Color Wall Filter settings:8 steps | Same | |
| Color Baseline: 16 steps Color Maps: 21 maps Color Invert: | Color Baseline: 16 steps Color Maps: 21 maps Color Invert: | Color Baseline: 9 steps Color maps: 16 maps Color | Color Baseline: 16 steps Color Maps: 21 maps Color Invert: | Same | |
| Main predicate device | Reference device | Reference device | Submission Device | Remark | |
| Items | CBit 9 Digital Color Doppler Ultrasound System K180974 | Resona 7 Diagnostic Ultrasound System K171233 | Acuson x700 Diagnostic Ultrasound System K141846 | XBit Series Digital Color Doppler Ultrasound System | |
| on/off | on/off | invert :on/off | on/off | ||
| PW sweeping speed: 6 steps | PW sweeping speed: 6 steps | Sweep speed: 8 selections | PW sweeping speed: 6 steps | Same | |
| PW Wall Filter: 7 steps | PW Wall Filter: 8 or 9 steps | Wall filter: 25 – 3906 Hz, 8 steps | PW Wall Filter: 7 steps | Same | |
| PW sample volume:0.5-30mm (PW only) | PW sample volume:0.5-30mm (PW only) | Gate size: 0.2 - 20 mm | PW sample volume:0.5-30mm (PW only) | Same | |
| PW angle correction:-89~8 9degrees, 1/step | PW angle correction:-89~8 9degrees, 1/step | Angle correction: 0 – 89° in 1° increments | PW angle correction:-89~8 9degrees, 1/step | Same | |
| Baseline: 8steps | Baseline: 9steps | Baseline shift: 17 levels | Baseline: 8steps | Same | |
| Cine control: step, play backward, play continuously | Cine control: step, play backward, play continuously | Cine control: step, play backward, play continuously | Cine control: step, play backward, play continuously | Same | |
| Doppler Auto Trace | Doppler Auto Trace | Autotrace Function | Doppler Auto Trace | Same | |
| Freeze control:Toggling freeze key | Freeze control:Toggling freeze key | Freeze control:Toggling freeze key | Freeze control:Toggling freeze key | Same | |
| Safety Compliance | IEC60601-1IEC60601-1-2ISO 10993-1ISO 10993-5ISO 10993-10IEC 60601-2-37 | IEC60601-1IEC60601-1-2ISO 10993-1ISO 9001ISO 13485IEC 60601-2-37 | EN/IEC 60601-1EN/IEC 60601-1-1EN/IEC 60601-1-2EN/IEC 62304EN/IEC 62366EN/IEC 60601-2-18EN/IEC 60601-2-25 | IEC60601-1IEC60601-1-2ISO 10993-1ISO 10993-5ISO 10993-10IEC 60601-2-37 | Same |
| Operation Mode | B mode | B mode | B mode | B mode | Same |
| B/M mode | B/M mode | B/M mode | B/M mode | Same | |
| M mode | M mode | M mode | M mode | Same | |
| Dual mode | Dual mode | Dual mode | Dual mode | Same | |
| Quad mode | Quad mode | Quad mode | Quad mode | Same | |
| CFM mode | CFM mode | CFM mode | CFM mode | Same | |
| CPA mode | CPA mode | PD mode | CPA mode | Same | |
| DPD mode | DPD mode | DPD mode | DPD mode | Same | |
| Items | Main predicatedevice | Referencedevice | Referencedevice | SubmissionDevice | Remark |
| CBit 9 DigitalColor DopplerUltrasoundSystemK180974 | Resona 7DiagnosticUltrasoundSystemK171233 | Acuson x700DiagnosticUltrasoundSystemK141846 | XBit SeriesDigital ColorDopplerUltrasoundSystem | ||
| B/BC mode | B/BC mode | B/BC mode | B/BC mode | Same | |
| 2D Steer | 2D Steer | NA | 2D Steer | Same | |
| Triplex mode | Triplex mode | Triplex mode | Triplex mode | Same | |
| Quadplex | Quadplex | NA | Quadplex | Same | |
| HD 3D | NA | Freehand 3D | HD 3D | Same | |
| CW mode | CW mode | CW mode | CW mode | Same | |
| Free Steering Mmode | Free Xros M | Anatomical Mmode | Free Steering Mmode | Same | |
| HPRF | NA | NA | HPRF | Same | |
| S-flow | NA | NA | S-flow | Same | |
| Auto TGC | NA | TGO | Auto TGC | Same | |
| Stress echo | Stress echo | Stress echo | Stress echo | Same | |
| TDI | TDI | TDI | TDI | Same | |
| Color M mode | Color M mode | Color M mode | Color M mode | Same | |
| CurvedPanoramic | iScape view | SieScape | CurvedPanoramic | Same | |
| Trapezoidalimage | ExFov | TrapezoidalMode | Trapezoidalimage | Same | |
| compound | NA | SieClear | compound | Same | |
| SRA | iClear | SpeckleReduction(SRI) | SRA | Same | |
| Chroma | NA | NA | Chroma | Same | |
| Elastography | Elastography | Strain-basedElastography | Elastography | Same | |
| ECG | ECG | ECG | ECG | Same | |
| LV trackingStrain and StrainRatio | TT QA(TissueTracking) | Auto LHStrain and StrainRate | LV trackingStrain and StrainRatio | Same | |
| LGC | LGC | NA | LGC | Same | |
| Auto IMT | Auto IMT | Auto IMT | Auto IMT | Same | |
| Free NT | Smart NT | NA | Free NT | Same | |
| Super Needle | iNeedle | NA | Super Needle | Same | |
| NA | TSI | NA | TSS | Same | |
| NA | ContrastImaging | Contrast AgentImage | SonoContrast | Same | |
| S-Flow | NA | NA | SoundFlow | Same | |
| NA | V Flow | NA | SonoVector | Same | |
| NA | NA | Syno AutoFollicle | Auto Follicle | SEAnalysis 1 | |
| NA | Smart OB | Syno Auto OB | Free OB | same | |
| NA | Fusion Imaging | NA | SonoFusion | SEAnalysis 2 | |
| NA | Color Vol | NA | SonoColor | SEAnalysis 3 | |
| Items | Main predicate device | Reference device | Reference device | Submission Device | Remark |
| CBit 9 DigitalColorUltrasoundSystemK180974 | Resona 7DiagnosticUltrasoundSystemK171233 | Acuson x700DiagnosticUltrasoundSystemK141846 | XBit SeriesDigital ColorDopplerUltrasoundSystem | Analysis 3 | |
| generalmeasurementpackage | generalmeasurementpackage | NA | generalmeasurementpackage | Same | |
| OBmeasurementpackage | OBmeasurementpackage | Obstetricsmeasurementpackage | OBmeasurementpackage | Same | |
| GYNmeasurementpackage | GYNmeasurementpackage | Gynecologymeasurementpackage | GYNmeasurementpackage | Same | |
| UROmeasurementpackage | UROmeasurementpackage | Urologymeasurementpackage | UROmeasurementpackage | Same | |
| cardiacmeasurementpackage | cardiacmeasurementpackage | cardiacmeasurementpackage | cardiacmeasurementpackage | Same | |
| vascularmeasurementpackage | vascularmeasurementpackage | VenousmeasurementpackageCerebrovascularmeasurementpackagePeripheralVascularmeasurementpackage | vascularmeasurementpackage | Same | |
| small partsmeasurementpackage | small partsmeasurementpackage | NA | small partsmeasurementpackage | Same | |
| Pediatricmeasurementpackage | Pediatricmeasurementpackage | Orthopedicmeasurementpackage | Pediatricmeasurementpackage | Same | |
| TCDmeasurementpackage | TCDmeasurementpackage | Cerebrovascularmeasurementpackage | TCDmeasurementpackage | Same | |
| 4D softwarepackage | 4D softwarepackage | 4D softwarepackage | 4D softwarepackage | Same | |
| Breastmeasurementpackage | Breastmeasurementpackage | Breastmeasurementpackage | Breastmeasurementpackage | Same | |
| Virtual HD | iLive | NA | Virtual HD | Same | |
| X-Contrast | iBeam | NA | X-Contrast | Same | |
| FHI | THI | THI | FHI | Same | |
| Q image | NA | NA | Q image | Same | |
| Main predicatedevice | Referencedevice | Referencedevice | SubmissionDevice | Remark | |
| Items | CBit 9 DigitalColor DopplerUltrasoundSystemK180974 | Resona 7DiagnosticUltrasoundSystemK171233 | Acuson x700DiagnosticUltrasoundSystemK141846 | XBit SeriesDigital ColorDopplerUltrasoundSystem | |
| Q-flow | NA | NA | Q-flow | Same | |
| Q-beam | NA | NA | Q-beamSonoBeam | SEAnalysis 4 | |
| AIO | iTouch | NA | AIO | Same | |
| DisplayAnnotations | Logo; HospitalName;Examdate;Exam time;AcousticPower ;Mechanicalindex;Thermalindes;Probemodel;ECGico;TGCCorve;Focusposition;Imagingparameters;Dynamic Trackballindices; Systemstatus;Gray/Color bar | Logo; HospitalName;Examdate;Exam time;AcousticPower ;Mechanicalindex;Thermalindes;Probemodel;ECGico;TGC Corve;Imagingparameters;Dynamic Trackballindices; Systemstatus;Gray/Color bar | Logo; HospitalName;Examdate;Exam time;AcousticPower ;Mechanicalindex;Thermalindes;Probemodel; ECGico;TGOCorve;Focusposition;Imagingparameters;Dynamic Trackballindices; Systemstatus;Gray/Color bar | Logo; HospitalName;Examdate;Exam time;AcousticPower ;Mechanicalindex;Thermalindes;Probemodel;ECGico;TGCCorve;Focusposition;Imagingparameters;Dynamic Trackballindices; Systemstatus;Gray/Color bar | Same |
| Measurements | 2D mode:DepthDistance ,Area:Ellipse, Trace,Spline, TraceLength , DoubleDistance ,Parallel ,Volume:Distance,Ellipse, Ellipse +Distance,DistanceRatio ,AreaRatio , IMT,Volume Flow,Color Velocity;M mode:Distance,Time,Slope, HeartRate,Velocity;Doppler mode:DVelocity ,Time ,H | 2D mode:DepthDistance ,Area:Ellipse, Trace,Spline, TraceLength , DoubleDistance ,Parallel ,Volume:Distance,Ellipse, Ellipse +Distance,DistanceRatio ,AreaRatio , IMT,Volume Flow,Color Velocity:M mode:Distance,Time,Slope, HeartRate,Velocity:Doppler mode:DVelocity ,Time ,Heart | 2D mode:Depth, Distance,Angle, Area andcircumference:ellipse, trace,Volume:1distance,2distance,3distance,ellipse anddistance Flowvolume:velocity anddistance,velocity and1ellipse,Stenosis:ellipse,distance;M mode:Distance, Time,Slope, HeartRate; | 2D mode:DepthDistance ,Area:Ellipse, Trace,Spline, TraceLength , DoubleDistance ,Parallel ,Volume:Distance,Ellipse, Ellipse +Distance,DistanceRatio ,AreaRatio , IMT,Volume Flow,Color Velocity;M mode:Distance,Time,Slope, HeartRate,Velocity;Doppler mode:DVelocity ,Time ,Heart | |
| Main predicatedevice | Referencedevice | Referencedevice | SubmissionDevice | ||
| Items | CBit 9 DigitalColor DopplerUltrasoundSystemK180974 | Resona 7DiagnosticUltrasoundSystemK171233 | Acuson x700DiagnosticUltrasoundSystemK141846 | XBit SeriesDigital ColorDopplerUltrasoundSystem | Remark |
| Rate,Acceleration ,DTrace,PS/ED ,Volume Flow; | Rate,Acceleration ,DTrace,PS/ED ,Volume Flow; | Velocity/Frequency/PressureGradient, Heartrate/Heartcycle/Time, PS,ED, TAMx,TAMn, PI, RI,S/D, TAV, VTI,Acceleration/Deceleration, Flowvolume | Rate,Acceleration ,DTrace,PS/ED ,Volume Flow; | ||
| TransducerTypes &Connectors | Convex Array,Phased Array,LinearArray,Volumeprobe4ports | Convex Array,Phased Array,LinearArray,Volumeprobe4ports | Convex Array,Phased Array,LinearArray,Volumeprobe3ports | Convex Array,Phased Array,LinearArray,Volumeprobe4ports | Same |
| Users / Sites | Hospitals, clinicsusage | Hospitals, clinicsusage | Hospitals, clinicsusage | Hospitals, clinicsusage | Same |
| AcousticOutput | Track 3; MI, TIS,TIC, TIBDerated Ispta:720mW/cm²maximum,TIS/TIB/TIC:0.1-4.0 Range,MechanicalIndex: 1.9Maximum, orDerated Isppa:190 W/cm² max | Track 3; MI,TIS, TIC, TIBDerated Ispta:720mW/cm²maximum,TIS/TIB/TIC:0.1-4.0 Range,MechanicalIndex: 1.9Maximum, orDerated Isppa:190 W/cm² max | Track 3; MI,TIS, TIC, TIBDerated Ispta:720mW/cm²maximum,TIS/TIB/TIC:0.1-4.0 Range,MechanicalIndex: 1.9Maximum, orDerated Isppa:190 W/cm² max | Track 3; MI,TIS, TIC, TIBDerated Ispta:720mW/cm²maximum,TIS/TIB/TIC:0.1-4.0 Range,MechanicalIndex: 1.9Maximum, orDerated Isppa:190 W/cm² max | Same |
| PowerRequirements | Powerrequirements:AC :100V- 240V,Frequenzy:50-60HzOperatingtemperature:10-40 °C ; relativehumidity30-75%;Barometricpressure:700 to1060 hPa | Powerrequirements:AC :100V- 240V,Frequenzy:50-60HzOperatingtemperature:0-40 ℃ ; relativehumidity20-85%;Barometricpressure:700 to1060 hPa | Powerrequirements:AC :100V- 240V,Frequenzy:50-60HzOperatingtemperature:10-40 °C ; relativehumidity30-75%;Barometricpressure:700 to1060 hPa | Powerrequirements:AC :100V- 240V,Frequenzy:50-60HzOperatingtemperature:10-40 °C ; relativehumidity30-75%;Barometricpressure:700 to1060 hPa | Same |
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Comparison Analysis
SE Analysis 1:
Operation Controls, compared with the predicate device--Acuson x700 Diagnostic Ultrasound System, the subject device employs the same operation controls design and has some differences in analyzed object.
The synqo® Auto Follicle measurement option of predicate device is an automated measurement tecnique that enables fast and acurate assessment of multiple follicles. Follicles measurement methods supported Distance, 2Dist + Avg, -- 3Dist + Avg, -- 2Dist Avg,-- 3Dist Avg,-- Area,-- Volume,-- Circumference.
Auto Follicle Detection of subject device can automatically identify, trace, and calculate the area and circumference of the follicle after the user moves the square ROI to the follicle area. It is operated in a semi-automated fashion since the output value of area and circumference can be modified.
But both of them can get area and circumference of follicle. 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 navigation device and navigation bracket. But both of them can make real-time ultrasound image match with CT/MR image. Both of them can improve the diagnostic efficiency. so the SE is not affected.
SE Analysis 3:
Operation Controls, compared with the predicate device, the subject device employs the same operation controls design and has some differences in angle acquisition. subject device recognizes the vessel angle automatically. The predicate reference device recognizes the vessel angle by user control. But both of them can get point velocity and meet clinical requirements. so the SE is not affected.
SE Analysis 4:
Operation Controls, the sonobeam function is a type of image optimization technology. SonoBeam is an improved version of Q-beam as a multi-beam blood flow high frame rate function which is based on traditional dual beamformer principle. Compared with Q-beam, SonoBeam multi-beamformer can improve the processing speed, and then increase the frame rate of image display and reduce noise. But both of them can improve image quality. so the SE is not affected.
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9. 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 XBit Series Digital Color Doppler Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.
N/A