DIGITAL COLOR DOPPLER ULTASOUND SYSTEM

K132527 · Sonoscape Company Limited · IYN · Nov 14, 2013 · Radiology

Device Facts

• Record ID: K132527
• Device Name: DIGITAL COLOR DOPPLER ULTASOUND SYSTEM
• Applicant: Sonoscape Company Limited
• Product Code: IYN · Radiology
• Decision Date: Nov 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SonoScape S30 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, Trans-esoph (Cardiac), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Urology and OB/Gyn.

Device Story

S30 Digital Color Doppler Ultrasound System; integrated preprogrammed color ultrasound imaging system. Inputs: ultrasound data from various transducers (linear, curved, phased, multi-plane arrays). Processing: all-digital architecture; progressive dynamic receive focusing; exam-dependent default settings; soft-menu controls. Outputs: B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler, Power Doppler, 3D/4D. Used in clinical settings by qualified physicians. Output displayed on 19-inch widescreen LCD; used for diagnostic evaluation and clinical decision-making. Benefits: high detail resolution; enhanced diagnostic utility and confidence.

Clinical Evidence

No clinical testing was required. Bench testing only, including thermal, mechanical, electrical safety, and biocompatibility. Acoustic output measured per NEMA UD 2-2004 and NEMA UD 3-2004.

Technological Characteristics

Digital architecture; 64-channel full digital beam former; 19-inch widescreen LCD; touch panel interface; 8-slider TGC; connectivity via USB; embedded Linux OS. Transducers: linear, curved, phased, multi-plane arrays (2-15 MHz). Acoustic output per NEMA UD 2/UD 3. Safety per IEC 60601-1, 60601-1-2, 60601-2-37.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, pediatric, small organ (breast, testes, thyroid), cephalic (neonatal/adult), trans-rectal, trans-vaginal, trans-esophageal (cardiac), peripheral vascular, musculoskeletal (conventional/superficial), cardiac (neonatal/adult), urology, and OB/Gyn 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 SSI-8000 (K102642)

Submission Summary (Full Text)

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K132527
Page 1 of 10

510(k) Submission

# 510(k) Summary

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: August 07, 2013
# NOV 1 4 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: S30 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 SSI-8000 has been cleared by FDA through 510(k) No.K102642 (Decision Date - March 04, 2011).

510(k) Summary

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#### 5. Device Description

The SonoScape S30 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. 3D/4D.

#### 6. Intended Use Statement

The SonoScape S30 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, Trans-esoph (Cardiac), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Urology and OB/Gyn.

#### 7. Testing

Laboratory testing was conducted to verify that the \$30 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: 2005 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 S30 and the predicate device SSI-8000 in almost every part are listed in the tables below.

| ID | Items | Proposed Device<br>SonoScape S30 | Predicate Device<br>SonoScape SSI-8000 | Remark |
|----|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 1 | Intended<br>Use | The SonoScape S30 device is<br>a general-purpose ultrasonic<br>imaging instrument intended<br>for use by a qualified physician<br>for evaluation of Fetal,<br>Abdominal, Pediatric, Small<br>Organ (breast, testes, thyroid),<br>Cephalic (neonatal and adult),<br>Trans-rectal, Trans-vaginal, | The device is a<br>general-purpose ultrasonic<br>imaging instrument intended<br>for use by a qualified physician<br>for evaluation of Fetal,<br>Abdominal, Pediatric, Small<br>Organ (breast, testes, thyroid),<br>Cephalic (neonatal and adult),<br>Trans-rectal, Trans-vaginal, | Same |

#### Table 1 Intended Use Comparison

510(k) Summary

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510(k) Submission

| Trans-esoph (Cardiac),<br>Peripheral Vascular,<br>Musculo-skeletal<br>(Conventional and Superficial),<br>Cardiac (neonatal and adult),<br>Urology and OB/Gyn. | Trans-esoph (Cardiac),<br>Peripheral Vascular,<br>Musculo-skeletal<br>(Conventional and Superficial),<br>Cardiac (neonatal and adult),<br>Urology and OB/Gyn. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|

# Table 2 General Comparison

| ID | Comparison<br>Items | Proposed Device<br>SonoScape S30 | Predicate Device<br>SonoScape SSI-8000 | 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 | Same |
| 3 | Product<br>Code | 90-IYN/90-IYO/90-ITX | 90-IYN/90-IYO/90-ITX | Same |
| 4 | Regulation<br>Number | 892.1550/892.1560/892.1570 | 892.1550/892.1560/892.1570 | Same |
| 5 | Panel | Radiology | Radiology | Same |
| 6 | Class | II | II | Same |
| 7 | Probe Type &<br>Connectors | L741 Linear Array, 5.0-10.0 MHz<br>L742 Linear Array, 5.0-12.0 MHz<br>L743 Linear Array, 5.0-10.0 MHz<br>L752 Linear Array, 5.0-12.0 MHz<br>10L1 Linear Array, 6.0-12.0 MHz<br>C362 Curved Array, 2.0-6.0 MHz<br>C344 Curved Array, 2.0-5.0 MHz<br>C353 Curved Array, 2.0-6.0 MHz<br>C542 Curved Array, 2.0-7.0 MHz<br>C322 Curved Array, 2.0-6.0 MHz<br>C353 Curved Array, 2.0-6.0 | L741 Linear Array, 5.0-10.0 MHz<br>L742 Linear Array, 5.0-12.0 MHz<br>L743 Linear Array, 5.0-10.0 MHz<br>C362 Curved Array, 2.0-6.0 MHz<br>C344 Curved Array, 2.0-5.0 MHz | SE<br>Analysis<br>1 |

510(k) Summary

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510(k) Submission

| ID | Comparison<br>ltems | Proposed Device<br>SonoScape S30 | Predicate Device<br>SonoScape SSI-8000 | Remark |
|----|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| | | MHz | | |
| | | C611 Micro-curved Array,<br>4.0-8.0 MHz<br>C311 Micro-curved Array,<br>2.0-4.0 MHz | C611 Micro-curved Array.<br>4.0-8.0 MHz | |
| | | VC6-2 Curved Array, 2.0-6.0<br>MHz | VC6-2 Curved Array, 2.0-6.0<br>MHz | |
| | | 6V1 Micro-curved Array,<br>4.0-8.0 MHz | 6V1 Micro-curved Array,<br>4.0-8.0 MHz | |
| | | 6V3 Micro-curved Array,<br>5.0-9.0 MHz | 6V3 Micro-curved Array,<br>5.0-9.0 MHz | |
| | | EC9-5 Micro-curved Array,<br>5.0-9.0 MHz<br>BCC9-5 Micro-convex Array | EC9-5 Micro-curved Array,<br>5.0-9.0 MHz | |
| | | 5.0-9.0MHz<br>BCL10-5 Micro-convex Array | | |
| | | 5.0-10.0MHz | | |
| | | 2P1 Phased Array, 2.0-4.0<br>MHz | 2P1 Phased Array, 2.0-4.0<br>MHz | |
| | | 5P1 Phased Array, 4.0-7.0<br>MHz | 5P1 Phased Array, 4.0-7.0<br>MHz | |
| | | MPTEE Multi-plane Array,<br>4.0-7.0 MHz | MPTEE Multi-plane Array,<br>4.0-7.0 MHz | |
| | | MPTEE mini Multi-plane<br>Array, 4.0-7.0 MHz | MPTEE mini Multi-plane<br>Array, 4.0-7.0 MHz | |
| | | Multi-port connector connects<br>4 transducers | Multi-port connector connects<br>4 transducers | Same |
| 8 | Acoustic<br>Track | TRACK 3 | TRACK 3 | Same |
| | Comparison | Proposed Device | Predicate Device | |
| ID | ltems | SonoScape S30 | SonoScape SSI-8000 | Remark |
| | | Based on an embedded Linux | | |
| | | operating system. | Based on an embedded Linux<br>operating system. | Same |
| | | Based on a 64 channel full | Based on a 64 channel full | |
| | | digital beam former. | digital beam former. | SE |
| | | Autocorrelation for color | Autocorrelation for color | |
| | | processing and FFT for pulse | processing and FFT for pulse | Same |
| | | and CW Doppler processing. | and CW Doppler processing. | |
| | | Supporting Linear, Curve linear | Supporting Linear, Curve linear | |
| | | and Phase array probes from 2 | and Phase array probes from 2 | Same |
| 9 | Design | to 15 MHz. | to 15 MHz. | |
| | | Cine play back capability | Cine play back capability | Same |
| | | Image file archive | Image file archive | Same |
| | | Software upgrade with USB | Software upgrade with USB | Same |
| | | flash drive. | flash drive. | |
| | | Digital Scan Converter | Digital Scan Converter | Same |
| | | 800×600 | 800×600 | |
| | | | | SE |
| | | With touch panel | With full keyboard | Analysis<br>2 |
| | | TGC 8 slider | TGC 8 slider | Same |
| | | Depth Range: 3 to 32 cm | Depth Range: 3 to 32 cm | Same |
| | | Image sector size: 32 lines to | Image sector size: 32 lines to | SE |
| | | full B (512 lines) | full B (256 lines) | Analysis |
| | | Image Sector position: Steering | Image Sector position: Steering | 3 |
| | | within full maximum | within full maximum | Same |
| | | B orientation flip :L/R key with | B orientation flip :L/R key with | |
| | | marking on the screen | marking on the screen | Same |
| | | B Dynamic range control: | B Dynamic range control: | |
| | Operation | preset 14 curves over 140 dB | preset 14 curves over 140 dB | Same |
| 10 | Controls | Gray Scale Control: 7 Settings | Gray Scale Control: 7 Settings | Same |
| | | Focal Number: 12 focal zone | Focal Number: 9 focal zone | SE |
| | | setting | setting | Analysis |
| | | | | 3 |
| | | B persistence: 0-95% | B persistence: 0-95% | Same |
| | | Image Processing: Smoothing,<br>edge enhancement | Image Processing: Smoothing,<br>edge enhancement | Same |
| | | PW sweeping speed 2,4,6,8 | PW sweeping speed 2,4,6,8 | |
| | | sec over display | sec over display | Same |
| | | PW Wall filter setting: 16 | PW Wall filter setting: 16 | |
| | | settings,25 to 750 HZ | settings 25 to 750 HZ | Same |
| | | | | |
| ID | Comparison<br>Items | Proposed Device<br>SonoScape S30 | Predicate Device<br>SonoScape SSI-8000 | Remark |
| | | PW sample volume:0.5 to<br>20mm | PW sample volume:0.5 to<br>20mm | Same |
| | | PW/B update: with UPDATE<br>key | PW/B update: with UPDATE<br>key | Same |
| | | PW cursor steering: Steer soft<br>key | PW cursor steering: Steer soft<br>key | Same |
| | | PW angle correction:0 to 80<br>degree user control | PW angle correction:0 to 72<br>degree user control | SE<br>Analysis<br>3 |
| | | PW trace: Peak, Mean | PW trace: Peak, Mean | Same |
| | | PW spectrum dynamic<br>range:10 preset curve over<br>15-48 dB | PW spectrum dynamic<br>range:10 preset curve over<br>15-48 dB | Same |
| | | Spectrum baseline shift and<br>invert | Spectrum baseline shift and<br>invert | Same |
| | | Color ROI setting: trackball and<br>set key to control size and<br>position | Color ROI setting: trackball and<br>set key to control size and<br>position | Same |
| | | Color steering on flat<br>probe:±20, ±16,0 | Color steering on flat<br>probe:±20, ±16,0 | Same |
| | | Color Wall Filter: Color wall<br>filter with 16 selection, 25-750<br>of PRF | Color Wall Filter: Color wall<br>filter with 16 selection,25-750<br>of PRF | Same |
| | | Color priority-B priority soft<br>menu | Color priority-B priority soft<br>menu | Same |
| | | Color Packet size: preset per<br>Exam, horizontal, vertical, off | Color Packet size: preset per<br>Exam, horizontal, vertical, off | Same |
| | | Zoom adjustable | Zoom adjustable | Same |
| | | Freeze control: Toggling freeze<br>key | Freeze control: Toggling freeze<br>key | Same |
| | | Cine control: step, play<br>backward, play continuously | Cine control: step, play<br>backward, play continuously | Same |
| 11 | Operation<br>Mode | B, M, PW, CW, CFM, DPI, TDI,<br>Tissue Harmonic Image<br>3D/4D Mode<br>Color M Mode | B, M, PW, CW, CFM, DPI, TDI,<br>Tissue Harmonic Image<br>3D/4D Mode<br>Color M Mode | Same |
| 12 | Display<br>Modes | Dual B, Quad Display,<br>B and M, B and Doppler<br>B + Color, Dual B(Flow)<br>Triplex mode: B,CFM, and<br>PW/CW, B,DPI, and | Dual B, Quad Display,<br>B and M, B and Doppler<br>B + Color, Dual B(Flow)<br>Triplex mode: B,CFM, and<br>PW/CW, B,DPI, and | Same |
| ID | Comparison<br>Items | Proposed Device<br>SonoScape S30 | Predicate Device<br>SonoScape SSI-8000 | Remark |
| | | PW/CW,B,THI and Color M,<br>steer M<br>Dual B and Color in real time<br>Compound Imaging,<br>Panoramic Imaging.<br>Trapezoid Imaging. | PW/CW,B,THI and Color M<br>Dual B and Color in real time<br>Compound Imaging,<br>Panoramic Imaging,<br>Trapezoid Imaging. | |
| 13 | Measurement<br>Items | Distance; area; circumference;<br>calipers; volume, velocity, HR,<br>PI, RI. Cardiac. OB/GYN,<br>Urology, Vascular and small<br>part package | Distance; area; circumference;<br>calipers; volume, velocity, HR,<br>PI, RI. Cardiac. OB/GYN,<br>Urology, Vascular and small<br>part package | Same |
| 14 | Cine Loop | Automatic review/ manual<br>review | Automatic review/ manual<br>review | Same |
| | | Review speed can be adjusted | Review speed can be adjust | Same |

510(k) Summary

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# Table 3 Functions Comparison

510(k) Summary

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510(k) Submission

510(k) Summary

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510(k) Submission

## Table 4 Specifications Comparison

| ID | Comparison<br>Items | Proposed Device<br>SonoScape S30 | Predicate Device<br>SonoScape SSI-8000 | Remark | | | | |
|----|-------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------|------------------|-------------------------------------|----------------|------|
| 15 | Power<br>Supply | Voltage: 110-127/220-240 VAC<br>Frequency: 50/60 Hz<br>Power Consumption: 450VA | Voltage: 100/220VAC<br>Frequency: 50/60 Hz<br>Power Consumption: 330 VA | SE<br>Analysis<br>4 | | | | |
| 16 | Operating<br>Condition | Temperature: 10~40°C<br>Relative humidity: 30~75%<br>Air pressure: 700hPa ~1060hPa | Temperature: 10~40°C<br>Relative humidity: 30~75%<br>Air pressure: 700hPa ~1060hPa | Same | | | | |
| 17 | Storage<br>Condition | Temperature: -20~55°C<br>Relative humidity: 20~90%<br>Air pressure: 700hPa ~1060hPa | Temperature: -20~55°C<br>Relative humidity: 20~90%<br>Air pressure: 700hPa ~1060hPa | Same | | | | |
| 18 | Screen Size | 19 inch Widescreen LCD monitor | 17 inch LCD color monitor | SE<br>Analysis<br>5 | | | | |
| 19 | Measurement<br>Accuracy | Parameter | Value range | Error<br>range | Parameter | Value<br>range | Error<br>range | |
| | | Display<br>depth | Max 32.9<br>cm; (Probe<br>depend) | $\pm$ 3% | Display<br>depth | Max<br>32.9cm;<br>(Probe<br>depend) | $\pm$ 3% | Same |
| | | Distance | 0~31.0 cm | $\pm$ 3% | Distance | 0~31.0cm | $\pm$ 3% | Same |
| | | Area | Max. ≥855<br>cm² | $\pm$ 7% | Area(Tra<br>ce) | Max.<br>≥855cm² | $\pm$ 7% | Same |
| | | Angle | 10~193° | $\pm$ 3% | Angle | 10~193°<br>(Probe<br>depend) | $\pm$ 3% | Same |

510(k) Summary

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510(k) Submission

| ID | Comparison<br>Items | | Proposed Device<br>SonoScape S30 | | Predicate Device<br>SonoScape SSI-8000 | Remark | | |
|----|---------------------|---------------------|-----------------------------------------------------------------------------------------------|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|----------------|----------------|
| | | Circumference | 200 cm | ±3% | Circumference | 200 cm | ±3% | Same |
| | | Volume | Max.<br>25000 cm³ | ±10% | Volume | Max.<br>25000 cm³ | ±10% | Same |
| | | M-Mode time | 2,4,6,8 S | ±1% | M-Mode time | 2, 4, 6, 8S | ±1% | Same |
| | | Heart Rate | 8 - 1000<br>beats/sec | ±3% | Heart Rate | 8 - 1000<br>beats/sec | ±3% | Same |
| | | Slope | 1300 cm/s | ±3% | Slope | 1300 cm/s | ±3% | Same |
| | | Velocity<br>(PW) | 0.04-2940<br>cm/s | Angle ≤60°,<br>≤5% | Velocity(pw) | 0.04-2940<br>cm/s | Angles 60°,≤5% | Same |
| | | Velocity<br>(CW) | 0.12-3795<br>cm/s | Angle ≤60°,<br>≤5% | Velocity(cw) | 0.13-3529<br>cm/s | Angles 60°,≤5% | SE<br>Analysis |
| | | Velocity<br>(Color) | 1-298 cm/s | Angle ≤60°,<br>≤5% | Velocity<br>(color) | 2-226cm/s | Angles 60°,≤5% | 6 |
| 20 | Acoustic<br>Output | | Track 3:MI,TIS,TIC,TIB<br>Derated ispta: 720Mw/cm²<br>maximum. | | Track 3:MI,TIS,TIC,TIB<br>Derated ispta: 720Mw/cm²<br>maximum.<br>TIS/TIB/TIC: 6.0 Maximum,<br>Mechanical Index: 1.9 Maximum,<br>or<br>Derated Isppa: 190W/cm² max | Same | | |
| | | | TIS/TIB/TIC: 6.0 Maximum,<br>Mechanical Index: 1.9 Maximum,<br>or Derated Isppa: 190W/cm² max | | | | | |

#### SE Analysis 1:

Probe Type. Compare to the predicate device, the proposed device is with different probe type or frequency, such as L752, 10L1, C353 etc. But no new intended use is added and all of them comply with IEC 60601-2-37. 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:

The proposed device is with touch panel and the predicate device is with the full keyboard, but both of them comply with IEC 60601-1 and IEC 60601-1-2. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.

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K132527
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510(k) Submission

#### SE Analysis 3:

The proposed device and the predicate device are with different Image sector size/ Focal number/ PW angle correction, but the proposed device is better. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.

#### SE Analysis 4

The Power Supply of the proposed device and the predicate device are 110-127/220-240 VAC, 450VA and 100/220VAC. 330 VA respectively, but both of them comply with IEC60601-1 and IEC 60601-1-2. Therefore, power supply can be considered Substantially Equivalent in safety and effectiveness.

#### SE Analysis 5

The screen size of the proposed is larger than that of the SSI-8000. This difference is considered to have no effect on effectiveness and safety.

#### SE Analysis 6:

The proposed device and the predicate device are with different measurement accuracy in Velocity (CW/ Color), but the proposed device is better. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.

#### Discussion of Substantially Equivalent

The subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device. The differences above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.

#### 10. Substantially Equivalent Conclusion .

In accordance with the Federal Food. Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, SonoScape Company Limited concludes that S30 Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.

#### 510(k) Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/10/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 14, 2013

SonoScape Company Limited % Ms Toki Wu Regulatory Affairs Manager Yizhe Building, Yuquan Road, Nanshan Shenzhen, Guangdong CHINA 518051

Re: K132527

Trade/Device Name: S30 Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: August 7, 2013 Received: August 19, 2013

Dear Ms. Wu:

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 eoniners 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. 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.

This determination of substantial equivalence applies to the following transducers. intended for use with the S30 Digital Color Doppler Ultrasound System, as described in your premarket notification:

### Transducer Model Number

2P1 Phase Array C311 Micro-curved Array EC9-5 Micro-curved Array C344 Curved Array C362 Curved Array L741 Linear Array L752 Linear Array MPTEE mini Multi-plane Array

5P1 Phase Array 6VI Micro-curved Array BCC9-5 Micro-curved Array C353 Curved Array C322 Curved Array L742 Linear Array 10L1 Linear Array

C611 Micro-curved Array 6V3 Micro-curved Array BCL10-5 Biplane Array C542 Curved Array VC6-2 Curved Array L743 Linear Array MPTEE Multi-plane Array

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Page 2-Ms. Wu

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note

the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/McdjcalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sm.h.7)

ிர

Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number: K132527

S30 Digital Color Doppler Ultrasound System Device Name:

- Indications for Use: The SonoScape S30 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. Trans-esoph (Cardiac), Peripheral Vascular, Cardiac Musculo-skeletal (Conventional and Superficial), (neonatal and adult), Urology and OB/Gyn.
. Over-The-Counter Use _ AND/OR Prescription Use ____________X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

\$\sin^{-1}(x)\$

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) __ K132527

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SonoScape S30 System:

Diagnostic Ultrasound Pulsed Echo System

Diagnostic Ultrasound Pulsed Doppler Imaging System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | N | N | | N | N | Note 1 | Notes 2,4,5 |
| | Abdominal | N | N | N | | N | N | Note 1 | Notes 2,4,5 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Small Organ (specify) | N | N | N | | N | N | Note 1 | Notes 2.4.6 |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| Fetal<br>Imaging&<br>Other | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Trans-rectal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Trans-vaginal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | Note 1 | Notes 2.4 |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | Notes 2,4,5 |
| | Other (Urology) | N | N | N | | N | N | Note 1 | Notes 2, 4 |
| | Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2.3.4 |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Intravascular(Cardiac) | | | | | | | | |
| Cardiac | Trans-esoph. (Cardiac) | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Other (specify) | | | | | | | | |

P = previously cleared by FDA; E = added under this appendix N = new indication;

Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging Note 3: TDI Note 4: 3D

Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) _

Indications for Use

7-2 .

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Transducer: 2P1 Phase Array

Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|---|-------------------|-----|---------|------------------|---------------------------------|--------------------|-------------------|--|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CW<br>D | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | Note 1 | Notes 2,4 | |
| | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (specify) | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (specify) | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: B/M; B/PWD; B/THI (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

Note 3: TDI Note 4: 3D Note 5: 4D

Note 6: Small Organ: breast, thyroid, testes

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) _______________________________________________________________________________________________________________________________________________________________________

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### Transducer: 5P1 Phase Array

### Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|---|-------------------|-----|-----|------------------|----------------------------------|--------------------|-------------------|--|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude<br>) Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1 | Notes 2,4 | |
| | Small Organ (specify) | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3.4 | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph(non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| | Intravascular(Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (specify) | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1: Other Combined includes: BIM; B/PWD; B/THI (The feature does not use contrast agents); M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD

Note 2: Tissue Harmonic Imaging

Note 5: 4D Note 3: TDI Note 4: 3D

Note 6: Small Organ: breast, thyroid, testes

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

.

510(k) __ .

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#### Transducer: C611 Micro-curved Array

Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation | | | | | | Other* | |
|------------------------------|------------------------------------|---|-------------------|-----|-----|------------------|----------------------------------|----------|-------------|--|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude<br>) Doppler | Combined | Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | Note 1 | Notes 2.4 | |
| | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | Note 1 | Notes 2,4 | |
| | Small Organ (specify) | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2,3,4 | |
| | Adult Cephalic | | | | |…