DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

K130801 · Sonoscape Company Limited · IYN · Jun 14, 2013 · Radiology

Device Facts

• Record ID: K130801
• Device Name: DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
• Applicant: Sonoscape Company Limited
• Product Code: IYN · Radiology
• Decision Date: Jun 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SonoScape S11 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Device Story

The SonoScape S11 is a general-purpose, software-controlled, digital color Doppler ultrasound system. It acquires ultrasound data via various transducers (linear, curved, phased array) and displays images in B-Mode (including Tissue Harmonic Imaging), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler, Power Doppler, and 4D. Used in clinical settings by qualified physicians, the system features a 64-channel digital beamformer and progressive dynamic receive focusing. The device provides diagnostic images and measurements (distance, area, volume, velocity, HR, PI, RI) to assist in clinical evaluation. It includes cine playback, image archiving, and USB-based software updates. The system benefits patients by providing non-invasive diagnostic imaging across multiple clinical specialties.

Clinical Evidence

No clinical testing was required. Substantial equivalence was established through bench testing, including verification of design specifications, acoustic output measurements per NEMA UD 2-2004 and NEMA UD 3-2004, and compliance with electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards.

Technological Characteristics

Digital color Doppler ultrasound system; 64-channel full digital beamformer; 15-inch widescreen LCD; 100-240 VAC power; embedded Linux OS; supports linear, curved, and phased array probes (2-15 MHz). Connectivity via USB for software updates. Biocompatibility per ISO 10993-5/10. Acoustic output per NEMA UD 2/UD 3.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), cephalic (neonatal/adult), trans-rectal, trans-vaginal, peripheral vascular, musculoskeletal (conventional/superficial), cardiac (neonatal/adult), OB/Gyn, and urology applications.

Regulatory Classification

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.

Predicate Devices

• SonoScape S6 (K112602)

Submission Summary (Full Text)

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510(k) Summary

## JUN 1 4 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number: __________________________________________________________________________________________________________________________________________________

- 1. Date of submission: March 13, 2013
## 2. Submitter

SonoScape Company Limited

Address: Yizhe Building, Yuquan Road, Nanshan, Shenzhen 518051, P.R. China

Tel: [phone]

Fax: [phone]

Contact Person: Toki Wu

E-mail:[e-mail]/[e-mail]

## 3. Proposed Device Identification

Trade/Proprietary Name: S11 Digital Color Doppler Ultrasound System Common Name: Diagnostic Ultrasound System and Transducers Classification:

21 FR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN)

21 FR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

Classification Panel: Radiology

Device Class: II

## 4. Legally Marketed Predicate Device

SonoScape Company Limited, Diagnostic Ultrasound System, Model S6 has been cleared by FDA through 510(k) No.K112602 (Decision Date - November 07, 2011).

510(k) Summary

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#### 5. Device Description

The SonoScape S11 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.

The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.

This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.

#### 6. Intended Use Statement

The SonoScape S11 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

#### 7. Testing

Laboratory testing was conducted to verify that the S11 system with added transducer met all design specification and was substantially equivalent to the Predicate Device. 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 acoustic output is measured and calculated per "NEMA UID 2: 2004 Acoustic Output

510(k) Summary

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Measurement Standard for Diagnostic Ultrasound Equipment" and "NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment".

IEC 60601-1: 1988+A1:1991+A2:1995 Medical Electrical Equipment - Part 1: General Requirements for Safety

IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests. IEC 60601-2-37: 2008 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3.

NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment

#### 8. Clinical Test:

No clinical testing was required.

#### 9. Comparison Table

The differences between the S11 and the predicate device S6 in almost every part are listed in the tables below.

| ID | Comparison<br>Items | Proposed Device<br>Sonoscape S11 | Predicate Device<br>Sonoscape S6 | Remark |
|----|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| 2 | Classification<br>Name | Ultrasonic Pulsed Doppler<br>Imaging System<br>Ultrasonic Pulsed Echo<br>Imaging System<br>Diagnostic Ultrasound<br>Transducer | Ultrasonic Pulsed Doppler<br>Imaging System<br>Ultrasonic Pulsed Echo<br>Imaging System<br>Diagnostic Ultrasound<br>Transducer | SE |
| 3 | Product<br>Code | 90-IYN/90-IYO/90-ITX | 90-IYN/90-IYO/90-ITX | SE |
| ID | Comparison<br>Items | Proposed Device<br>Sonoscape S11 | Predicate Device<br>Sonoscape S6 | Remark |
| 4 | Regulation<br>Number | 892.1550/892.1560/892.1570 | 892.1550/892.1560/892.1570 | SE |
| 5 | Panel | Radiology | Radiology | SE |
| 6 | Class | II | II | SE |
| 1 | Intended<br>Use | The device is a<br>general-purpose ultrasonic<br>imaging instrument intended for<br>use by a qualified physician for<br>evaluation of Fetal, Abdominal,<br>Pediatric, Small Organ (breast,<br>testes, thyroid), Cephalic<br>(neonatal and adult),<br>Trans-rectal, Trans-vaginal,<br>Peripheral Vascular,<br>Musculo-skeletal (Conventional<br>and Superficial), Cardiac<br>(neonatal and adult), Urology<br>and OB/Gyn. | The device is a<br>general-purpose ultrasonic<br>imaging instrument intended for<br>use by a qualified physician for<br>evaluation of Fetal, Abdominal,<br>Pediatric, Small Organ (breast,<br>testes, thyroid),<br>Cephalic(neonatal and adult),<br>Trans-rectal, Trans-vaginal,<br>Peripheral Vascular,<br>Musculo-skeletal (Conventional<br>and Superficial), Cardiac<br>(neonatal and adult), OB/Gyn<br>and Urology. | SE |
| 7 | Probe Type<br>&<br>Connectors | L741 Linear Array, 5.0-10.0<br>MHz<br>L742 Linear Array, 5.0-12.0<br>MHz<br>L743 Linear Array, 5.0-10.0<br>MHz<br>C344 Curved Array, 2.0-5.0<br>MHz<br>C362 Curved Array, 2.0-6.0<br>MHz<br>C354 Curved Array, 2.0-5.0<br>MHz<br>C611 Micro-curved Array,<br>4.0-8.0 MHz<br>VC6-2 Curved Array, 2.0-6.0<br>MHz<br>6V1 Micro-curved Array,<br>4.0-8.0 MHz<br>6V3 Micro-curved Array,<br>5.0-9.0 MHz<br>EC9-5 Micro-curved Array,<br>5.0-9.0 MHz | L741 Linear Array, 5.0-10.0<br>MHz<br>L742 Linear Array, 5.0-12.0<br>MHz<br>L743 Linear Array, 5.0-10.0<br>MHz<br>C344 Curved Array, 2.0-5.0<br>MHz<br>C362 Curved Array, 2.0-6.0<br>MHz<br>C611 Micro-curved Array,<br>4.0-8.0 MHz<br>VC6-2 Curved Array, 2.0-6.0<br>MHz<br>6V1 Micro-curved Array,<br>4.0-8.0 MHz<br>6V3 Micro-curved Array,<br>5.0-9.0 MHz<br>EC9-5 Micro-curved Array,<br>5.0-9.0 MHz | SE<br>Analysis<br>1<br>SE<br>SE<br>SE |
| | | 2P1 Phased Array, 2.0-4.0 MHz | 2P1 Phased Array, 2.0-4.0 MHz | SE |
| ID | Comparison Items | Proposed Device<br>Sonoscape S11 | Predicate Device<br>Sonoscape S6 | Remark |
| | | 5P1 Phased Array, 4.0-7.0 MHz | 5P1 Phased Array, 4.0-7.0 MHz | |
| | | Multi-port connector connects 3 transducers | Multi-port connector connects 2 transducers | SE<br>Analysis<br>2 |
| 8 | Acoustic Track | TRACK 3 | TRACK 3 | SE |

#### Table 1 General Comparison

510(k) Summary

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## SonoScape Company Limited

510(k) Submission

510(k) Summary

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## SonoScape Company Limited

## 510(k) Submission

## Table 2 Functions Comparison

| ID | Comparison<br>Items | Proposed Device<br>SonoScape S11 | Predicate Device<br>SonoScape S6 | Remark |
|----|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| 9 | Design | Based on an embedded Linux<br>operating system.<br>Based on a 64 channel full<br>digital beam former.<br>Autocorrelation for color<br>processing and FFT for pulse<br>and CW Doppler processing.<br>Supporting Linear, Curve linear<br>and Phase array probes from 2<br>to 15 MHz.<br>Cine play back capability<br>Image file archive<br>Software upgrades with USB<br>flash drive.<br>Digital Scan Converter<br>800×600<br>TGC 8 slider<br>Depth Range: 3 to 32 cm<br>Image sector size: 32 lines to<br>full B (256 lines)<br>Image Sector position: Steering<br>within full maximum | Based on an embedded Linux<br>operating system.<br>Based on a 64 channel full<br>digital beam former.<br>Autocorrelation for color<br>processing and FFT for pulse<br>and CW Doppler processing.<br>Supporting Linear, Curve linear<br>and Phase array probes from 2<br>to 15 MHz.<br>Cine play back capability<br>Image file archive<br>Software upgrades with USB<br>flash drive.<br>Digital Scan Converter<br>800×600<br>TGC 8 slider<br>Depth Range: 3 to 32 cm<br>Image sector size: 32 lines to<br>full B (256 lines)<br>Image Sector position: Steering<br>within full maximum | SE |
| 10 | Operation<br>Controls | B orientation flip :L/R key with<br>marking on the screen<br>B Dynamic range control:<br>preset 14 curves over 140 dB<br>Gray Scale Control: 7 Settings<br>Focal Number: 12 focal zone<br>setting<br>B persistence: 0-95%<br>Image Processing: Smoothing | B orientation flip :L/R key with<br>marking on the screen<br>B Dynamic range control:<br>preset 14 curves over 140 dB<br>Gray Scale Control: 7 Settings<br>Focal Number: 12 focal zone<br>setting<br>B persistence: 0-95%<br>Image Processing: Smoothing | SE |
| | Comparison | Proposed Device | Predicate Device | |
| ID | Items | SonoScape S11 | SonoScape S6 | Remark |
| | | edge enhancement | edge enhancement | |
| | | PW sweeping speed 2,4,6,8 | PW sweeping speed 2,4,6,8 | SE |
| | | sec over display | sec over display | |
| | | PW Wall filter setting: 16 | PW Wall filter setting: 16 | SE |
| | | settings,25 to 750 HZ | settings,25 to 750 HZ | |
| | | PW sample volume:0.5 to | PW sample volume:0.5 to | SE |
| | | 20mm | 20mm | |
| | | PW/B update: with UPDATE | PW/B update: with UPDATE | SE |
| | | key | key | |
| | | PW cursor steering: Steer soft | PW cursor steering: Steer soft | SE |
| | | key | key | |
| | | PW angle correction:0 to 80 | PW angle correction:0 to 80 | SE |
| | | degree user control | degree user control | |
| | | PW spectrum dynamic | PW spectrum dynamic | SE |
| | | range: 10 preset curve over | range:10 preset curve over | |
| | | 15-48 dB | 15-48 dB | |
| | | Spectrum baseline shift and | Spectrum baseline shift and | SE |
| | | invert | invert | |
| | | Color ROI setting: trackball and | Color ROI setting: trackball and | SE |
| | | set key to control size and | set key to control size and | |
| | | position | position | |
| | | Color steering on flat probe:±20 | Color steering on flat probe:±20 | SE |
| | | ±160 | ±160 | |
| | | Color Wall Filter: Color wall | Color Wall Filter: Color wall | SE |
| | | filter with 16 selection, 25-750 | filter with 16 selection, 25-750 | |
| | | of PRF | of PRF | |
| | | Color priority-B priority soft | Color priority-B priority soft | SE |
| | | menu | menu | |
| | | Color Packet size: preset per | Color Packet size: preset per | SE |
| | | Exam, horizontal, vertical, off | Exam, horizontal, vertical, off | |
| | | Zoom adjustable | Zoom adjustable | SE |
| | | Freeze control: Toggling freeze | Freeze control: Toggling freeze | SE |
| | | key | key | |
| | | Cine control: step, play | Cine control: step, play | SE |
| | | backward, play continuously | backward, play continuously | |
| 11 | Operation | B, M, PW, CW, CFM, DPI, TDI, | B, M, PW, CW, CFM, DPI, TDI, | SE |
| | Mode | Tissue Harmonic Image | Tissue Harmonic Image | Analysis |
| | | 4D Mode | 3D/4D Mode | 3 |
| | | Color M Mode | Color M Mode | |
| 12 | Display | Dual B, Quad Display, | Dual B, Quad Display, | SE |
| | Modes | B and M, B and Doppler | B and M, B and Doppler | |
| ID | Comparison<br>Items | Proposed Device<br>SonoScape S11 | Predicate Device<br>SonoScape S6 | Remark |
| | | B + Color, Dual B(Flow) | B + Color, Dual B(Flow) | |
| | | Triplex mode: B,CFM, and | Triplex mode: B,CFM, and | |
| | | PW/CW; B,DPI, and | PW/CW; B,DPI, and | |
| | | PW/CW;B,THI and Color M,<br>steer M | PW/CW;B,THI and Color M,<br>steer M | |
| | | Dual B and Color in real time…