S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
Device Facts
| Record ID | K132768 |
|---|---|
| Device Name | S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM |
| Applicant | Sonoscape Company Limited |
| Product Code | IYN · Radiology |
| Decision Date | Oct 4, 2013 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The SonoScape S8 Exp 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
Portable digital color Doppler ultrasound system; utilizes digital architecture with progressive dynamic receive focusing. Inputs: ultrasound data from various transducers (linear, curved, phased arrays). Processing: B-Mode (including Tissue Harmonic Imaging), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler, Power Doppler, 3D/4D. Output: diagnostic images displayed on 15-inch LCD monitor. Used in clinical settings by physicians; exam-dependent default settings minimize user adjustment; soft-menu controls allow advanced customization. Benefits: provides high-detail resolution for diagnostic confidence; supports diverse clinical applications via multiple transducer options.
Clinical Evidence
Bench testing only. No clinical testing was required. Device conforms to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasonic performance), and NEMA UD 2/UD 3 (acoustic output). Biocompatibility verified per ISO 10993-5 and ISO 10993-10.
Technological Characteristics
Embedded Linux OS; 128-channel digital beamformer. Supports linear, curved, and phased array probes (2-15 MHz). 15-inch LCD monitor. Connectivity: USB for software upgrades. Acoustic output per NEMA UD 2/UD 3. Biocompatible materials per ISO 10993. Software level of concern: Moderate.
Indications for Use
Indicated for fetal, abdominal, pediatric, small organ (breast, testes, thyroid), cephalic (neonatal/adult), trans-rectal, trans-vaginal, peripheral vascular, musculoskeletal (conventional/superficial), cardiac (neonatal/adult), OB/Gyn, and urology imaging. Contraindications: none stated.
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 Portable Digital Color Doppler Ultrasound System, Model S9 (K131088)
Related Devices
- K130119 — PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM · Sonoscape Company Limited · Apr 12, 2013
- K152164 — S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Aug 28, 2015
- K233697 — SonoMax Series Digital Color Doppler Ultrasound System · CHISON Medical Technologies Co., Ltd. · Aug 9, 2024
- K132527 — DIGITAL COLOR DOPPLER ULTASOUND SYSTEM · Sonoscape Company Limited · Nov 14, 2013
- K063500 — DC-6 DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 6, 2006
Submission Summary (Full Text)
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510(k) Submission
# 510(k) Summary
### 1. Date Prepared {21 CFR807.92 (a) (1)]
August 30, 2013
### 2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | SonoScape Company Limited |
|------------------|---------------------------------------------------------------------|
| Address: | Yizhe Building, Yuquan Road, Nanshan, Shenzhen<br>518051, P.R.China |
| Contact Name: | Toki Wu |
| Telephone No.: | +86 755 26722890 |
| Fax No.: | +86 755 26722850 |
| Email Address: | Faith@sonoscape.net/wusq@sonoscape.net |
#### 3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]
| Trade Name: | S8 Exp Portable Digital Color Doppler Ultrasound System | | |
|-----------------------|---------------------------------------------------------|-------------------|--|
| Common Name: | Diagnostic Ultrasound System and Transducers | | |
| Classification: | - | | |
| | 21 CFR892.1550 Ultrasonic Pulsed Doppler Imaging System | Product code: IYN | |
| | 21 CFR892.1560 Ultrasonic Pulsed Echo Imaging System | Product code: IYO | |
| | 21 CFR892.1570 Diagnostic Ultrasonic Transducer | Product code: ITX | |
| Classification Panel: | Radiology | | |
| Device Class: | II | | |
#### 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicates within this submission are as follows: SonoScape Company Limited, Portable Digital Color Doppler Ultrasound System, Model S9 has been cleared by FDA through 510(k) No.K131088 (May 24, 2013).
#### 5. Description of the Device [21 CFR 807.92(a)(4)]
The SonoScape S8 Exp Portable 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
#### 510(k) Summary
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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 [21 CFR 807.92(a)(5)]
The SonoScape S8 Exp 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 S8 Exp 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 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.
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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 S8 Exp and the predicate device S9 in almost every part are listed in the tables below.
| ID | Items | Proposed Device<br>SonoScape S8 Exp | Predicate Device<br>SonoScape S9 | Remark |
|----|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 1 | Intended<br>Use | The SonoScape S8 Exp device<br>is a 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. | The SonoScape S9 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. | Same |
### Table 1 Intended Use Comparison
### Table 2 General Comparison
| ID | Comparison<br>Items | Proposed Device<br>SonoScape S8 Exp | Predicate Device<br>SonoScape S9 | 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 |
| ID | Comparison Items | Proposed Device SonoScape S8 Exp | Predicate Device SonoScape S9 | Remark |
| 5 | Panel | Radiology | Radiology | Same |
| 6 | Class | II | II | Same |
| 7 | Probe Type & Connectors | L741 Linear Array, 5.0-10.0 MHz<br>L742 Linear Array, 5.0-12.0 MHz<br>L752 Linear Array, 5.0-12.0 MHz<br>L743 Linear Array, 5.0-10.0 MHz<br>10L1 Linear Array, 6.0-12.0 MHz<br>C611 Micro-curved Array,<br>4.0-8.0 MHz<br>C311 Micro-curved Array,<br>2.0-4.0 MHz<br>C344 Curved Array, 2.0-5.0 MHz<br>C322 Curved Array, 2.0-6.0 MHz<br>C353 Curved Array, 2.0-6.0 MHz<br>C362 Curved Array, 2.0-6.0 MHz<br>C354 Curved Array, 2.0-6.0 MHz<br>C542 Curved Array, 4.0-7.0 MHz<br>VC6-2 Curved Array,<br>2.0-6.0 MHz | L741 Linear Array, 5.0-10.0 MHz<br>L742 Linear Array, 5.0-12.0 MHz<br>L752 Linear Array, 5.0-12.0 MHz<br>/ | SE<br>Analysis<br>1 |
| | | C344 Curved Array, 2.0-5.0 MHz | | |
| | | C322 Curved Array, 2.0-6.0 MHz | | |
| | | C353 Curved Array, 2.0-6.0 MHz | | |
| | | VC6-2 Curved Array,<br>2.0-6.0 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 | | |
| | | BCC9-5 Micro-convex Array.<br>5.0-9.0MHz | | |
| | | BCL10-5 Micro-convex Array,<br>5.0-10.0MHz | | |
| | | 2P2 Phased Array, 1.0-5.0 MHz | 2P2 Phased Array, 1.0-5.0 MHz | |
| | | 3P1 Phased Array, 1.0-5.0 MHz | 3P1 Phased Array, 1.0-5.0 MHz | |
| | | 5P2 Phased Array, 3.0-8.0 MHz | 5P2 Phased Array, 3.0-8.0 MHz | |
| | | 8P1 Phased Array, 4.0-12.0 MHz | 8P1 Phased Array, 4.0-12.0 MHz | |
| | | 2P1 Phased Array, 2.0-4.0 MHz<br>5P1 Phased Array, 4.0-7.0 MHz | | |
| | | Multi-port connector connects 2 transducers | Multi-port connector connects 2 transducers | |
| 8 | Acoustic Track | TRACK 3 | TRACK 3 | Same |
| ID | Comparison<br>Items | Proposed Device<br>SonoScape S8 Exp | Predicate Device<br>SonoScape S9 | Remark |
| | | Based on an embedded Linux<br>operating system. | Based on an embedded<br>Linux operating system. | Same |
| | | Based on a 128 channel full<br>digital beam former. | Based on a 128 channel full<br>digital beam former. | Same |
| | | Autocorrelation for color<br>processing and FFT for pulse<br>and CW Doppler processing. | Autocorrelation for color<br>processing and FFT for<br>pulse and CW Doppler<br>processing. | Same |
| 9 | Design | Supporting Linear, Curve<br>linear and Phase array probes<br>from 2 to 15 MHz. | Supporting Linear, Curve<br>linear and Phase array<br>probes from 2 to 15 MHz. | Same |
| | | Cine play back capability | Cine play back capability | Same |
| | | Image file archive | Image file archive | Same |
| | | Software upgrade with USB<br>flash drive. | Software upgrade with USB<br>flash drive. | Same |
| | | Digital Scan Converter<br>800×600 | Digital Scan Converter<br>800×600 | Same |
| | | With full keyboard panel | With touch-screen panel | SE<br>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<br>full B (256 lines) | Image sector size: 32 lines<br>to full B (256 lines) | Same |
| | | Image Sector position:<br>Steering within full maximum | Image Sector position:<br>Steering within full maximum | Same |
| | Operation<br>Controls | B orientation flip :L/R key with<br>marking on the screen | B orientation flip :L/R key<br>with marking on the screen | Same |
| 10 | | B Dynamic range control:<br>preset 14 curves over 140 dB | B Dynamic range control:<br>preset 14 curves over 140 dB | Same |
| | | Gray Scale Control: 7 Settings | Gray Scale Control: 7<br>Settings | Same |
| | | Focal Number: 12 focal zone<br>setting | Focal Number: 12 focal zone<br>setting | Same |
| | | B persistence: 0-95% | B persistence: 0-95% | Same |
| | | Image Processing: Smoothing,<br>edge enhancement | Image Processing:<br>Smoothing, edge<br>enhancement | Same |
| | | PW sweeping speed 2 4 6 8 | PW sweeping speed 2 4 6 8 | Same |
510(k) Summary
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510(k) Summary
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# Table 3 Functions Comparison
510(k) Summary
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| ID | Comparison | Proposed Device | Predicate Device | Remark | | | |
|----|-------------------|----------------------------------|--------------------------------|--------|--|--|--|
| | ltems | SonoScape S8 Exp | SonoScape S9 | | | | |
| | | sec over display | sec over display | | | | |
| | | PW Wall filter setting:16 | PW Wall filter setting: 16 | Same | | | |
| | | settings,25 to 750 HZ | settings,25 to 750 HZ | | | | |
| | | PW sample volume:0.5 to | PW sample volume:0.5 to | Same | | | |
| | | 20mm | 20mm | | | | |
| | | PW/B update: with UPDATE | PW/B update: with UPDATE | Same | | | |
| | | key | key | | | | |
| | | PW cursor steering: Steer soft | PW cursor steering: Steer | | | | |
| | | key | soft key | Same | | | |
| | | PW angle correction:0 to 80 | PW angle correction:0 to 80 | | | | |
| | | degree user control | degree user control | Same | | | |
| | | PW spectrum dynamic | PW spectrum dynamic | | | | |
| | | range:10 preset curve over | range:10 preset curve over | Same | | | |
| | | 15-48 dB | 15-48 dB | | | | |
| | | Spectrum baseline shift and | Spectrum baseline shift and | | | | |
| | | invert | invert | Same | | | |
| | | Color ROI setting: trackball | Color ROI setting: trackball | | | | |
| | | and set key to control size and | and set key to control size | Same | | | |
| | | position | and position | | | | |
| | | Color steering on flat | Color steering on flat | Same | | | |
| | | probe:±20 ±160 | probe: ±20 ± 160 | | | | |
| | | Color Wall Filter: Color wall | Color Wall Filter: Color wall | | | | |
| | | filter with 16 selection, 25-750 | filter with 16 selection, | Same | | | |
| | | of PRF | 25-750 of PRF | | | | |
| | | Color priority-B priority soft | Color priority-B priority soft | | | | |
| | | menu | menu | Same | | | |
| | | | Color Packet size: preset | | | | |
| | | Color Packet size: preset per | per Exam, horizontal, | Same | | | |
| | | Exam, horizontal, vertical, off | vertical, off | | | | |
| | | Zoom adjustable | Zoom adjustable | Same | | | |
| | | Freeze control: Toggling | Freeze control: Toggling | Same | | | |
| | | freeze kev | freeze key | | | | |
| | | Cine control: step, play | Cine control: step, play | Same | | | |
| | | backward, play continuously | backward, play continuously | | | | |
| | Operation<br>Mode | B, M, PW, CW, CFM, DPI, TDI, | B, M, PW, CW, CFM, DPI, | | | | |
| | | Tissue Harmonic Image | TDI, | | | | |
| 11 | | 3D/4D Mode | Tissue Harmonic Image | Same | | | |
| | | Color M Mode | 3D/4D Mode | | | | |
| | | | Color M Mode | | | | |
| 12 | Display | Dual B, Quad Display. | Dual B, Quad Display, | | | | |
| | Modes | B and M. B and Doppler | B and M. B and Doppler | Same | | | |
510(k) Summary
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| ID | Comparison<br>Items | Proposed Device<br>SonoScape S8 Exp | Predicate Device<br>SonoScape S9 | Remark |
|----|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | | B + Color, Dual B(Flow)<br>Triplex mode: B,CFM, and<br>PW/CW; B,DPI, and<br>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. | B + Color, Dual B(Flow)<br>Triplex mode: B,CFM, and<br>PW/CW; B,DPI, and<br>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. | |
| 13 | Measurement 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;<br>circumference; calipers;<br>volume, velocity, HR, PI, RI.<br>Cardiac: OB/GYN, Urology.<br>Vascular and small part<br>package | Same |
| 14 | Cine Loop | Automatic review/ manual<br>review<br>Review speed can be adjusted | Automatic review/ manual<br>review<br>Review speed can be<br>adjusted | Same |
# Table 4 Specifications Comparison
| ID | Comparison<br>Items | Proposed Device<br>SonoScape S8 Exp | Predicate Device<br>SonoScape S9 | Remark | | |
|----|-------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------|
| 15 | Power<br>Supply | Voltage: 110-240 VAC<br>Frequency: 50/60 Hz<br>Power Consumption: 110-240V AC, 2.7-1.2A | Voltage: 110-240 VAC<br>Frequency: 50/60 Hz<br>Power Consumption: 110-240V AC, 2.7-1.2A | Same | | |
| | | 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 | 15 inch Widescreen LCD monitor | 15 inch Widescreen LCD monitor | Same | | |
| 19 | Measurement<br>Accuracy | Parameter: Display depth<br>Value range: Max 32.9 cm; (Probe depend)<br>Error range: ±3% | Parameter: Display depth<br>Value range: Max 32.9 cm; (Probe depend)<br>Error range: ±3% | Same | | |
510(k) Summary
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### SonoScape Company Limited
510(k) Submission
| ID | Comparison<br>Items | | Proposed Device<br>SonoScape S8 Exp | | Predicate Device<br>SonoScape S9 | Remark | | |
|----|---------------------|----------------------------------------------------------------------------------|-------------------------------------|-----------------|----------------------------------------------------------------------------------|------------------|-----------------|------|
| | | Distance | 0~31.0 cm | ±3% | Distance | 0~31.0 cm | ±3% | Same |
| | | Area | Max. ≥855 cm² | ±7% | Area | Max. ≥855 cm² | ±7% | Same |
| | | Angle | 10~193° | ±3% | Angle | 10~193° | ±3% | Same |
| | | Circumference | 200 cm | ±3% | Circumference | 200 cm | ±3% | Same |
| | | Volume | Max. 25000 cm³ | ±10% | Volume | Max. 25000 cm³ | ±10% | Same |
| | | M-Mode time | 2,4,6,8 S | ±1% | M-Mode time | 2,4,6,8 S | ±1% | Same |
| | | Heart Rate | 8~1000 beats/sec | ±3% | Heart Rate | 8~1000 beats/sec | ±3% | Same |
| | | Slope | 1300 cm/s | ±3% | Slope | 1300 cm/s | ±3% | Same |
| | | Velocity (PW) | 0.04-2940 cm/s | Angle ≤60°, ≤5% | Velocity (PW) | 0.04-2940 cm/s | Angle ≤60°, ≤5% | Same |
| | | Velocity (CW) | 0.12-3795 cm/s | Angle ≤60°, ≤5% | Velocity (CW) | 0.12-3795 cm/s | Angle ≤60°, ≤5% | Same |
| | | Velocity (Color) | 1-298 cm/s | Angle ≤60°, ≤5% | Velocity (Color) | 1-298 cm/s | Angle ≤60°, ≤5% | Same |
| 20 | Acoustic Output | Track 3:MI, TIS, TIC, TIB<br>Derated ispta: 720Mw/cm² maximum. | | | Track 3: MI, TIS, TIC, TIB<br>Derated ispta: 720Mw/cm² maximum. | | | Same |
| | | TIS/TIB/TIC: 6.0 Maximum,<br>Mechanical Index: 1.9<br>Maximum, or Derated Isppa: | | | TIS/TIB/TIC: 6.0 Maximum,<br>Mechanical Index: 1.9<br>Maximum, or Derated Isppa: | | | |
| | | 190W/cm² max | | | 190W/cm² max | | | |
# Table 5 Safety Comparison
| ID | Comparison Items | Proposed Device<br>SonoScape S8 Exp | Predicate Device<br>SonoScape S9 | Remark |
|----|---------------------------------|-------------------------------------|-------------------------------------|--------|
| 21 | Electrical Safety | -IEC 60601-1 | -IEC 60601-1 | Same |
| 22 | EMC | -IEC 60601-1-2 | -IEC 60601-1-2 | Same |
| 23 | Performance | -IEC 60601-2-37 | -IEC 60601-2-37 | Same |
| 24 | Biocompatibility | -ISO 10993-5,<br>-ISO 10993-10 | -ISO 10993-5,<br>-ISO 10993-10 | Same |
| 25 | Level of Concern Of<br>Software | Moderate level of<br>concern system | Moderate level of<br>concern system | Same |
510(k) Summary
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K132768
Page 9 of 9
510(k) Submission
#### SE Analysis 1:
Probe Type, Compare to the predicate device, the proposed device is with different probe type or frequency, such as L743, 10L1, C611, C311 etc. But no new intended use is added and all of them comply with IEC 60601-2-37, NEMA UD 2-2004 and NEMA UD3: 2004, 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 full keyboard panel and the predicate device is not, 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.
### Discussion of Substantially Equivalent
It is reasonable that there are some differences between our new system and its predicate. All of parameters comply with 21CFR1020.33 and related IEC standards. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE).
The proposed 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 Conclusions
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 S8 Exp Portable Digital Color Doppler Ultrasound System is substantially equivalent to predicate devices with regard to safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the figure. The figure is black, and the text is also black.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002
October 4, 2013
SonoScape Company Limited % Ms. Toki Wu Regulatory Affairs Manager Yizhe Building, Yuquan Road Shenzhen, Guangdong 518051 P.R. CHINA
Re: K132768
Trade/Device Name: S8 Exp Portable 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, ITX Dated: August 30, 2013 Received: September 4, 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 10 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. 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 "S8 Exp Portable Digital Color.Doppler Ultrasound System," as described in your premarket notification:
#### Transducer Model Number
2P1 Phase Array 5P1 Phase Array C611 Micro-curved Array 6V3 Micro-curved Array BCL10-5 Biplane Array C354 Curved Array C322 Curved Array L742 Linear Array
2P2 Phase Array 5P2 Phase Array C311 Micro-curved Array EC9-5 Micro-curved Array C344 Curved Array C542 Curved Array VC6-2 Curved Array L743 Linear Array 10L1 Linear Array
3P1 Phase Array 8P1 Phase Array 6V1 Micro-curved Array BCC9-5 Micro-curved Array C353 Curved Array C362 Curved Array L741 Linear Array L752 Linear 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 (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/or You/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/MedicalDevices/Safety/ReportaProblem/dgfault.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 (800) 638-2041 or (301) 796-7100 or at its Internet address > http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
for
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
K132768 510(k) Number: S8 Exp Portable Digital Color Doppler Ultrasound System Device Name:
Indications for Use: The SonoScape S8 Exp 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, Transvaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
Prescription Use _ _ X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
\$m.h.7).
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K132768 510(k) _
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System: SonoScape S8 Exp
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 |
| | 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) | | | | | | | | |
| | 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; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 4: 3D Note 5: 4D Note 3: TDI
Note 6: Small Organ: breast, thyroid, testes
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) __
{13}------------------------------------------------
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 | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Adult Cephalic | N | N | N | N | N | N | 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) | | | | | | | | |
| Cardiac | 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) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | 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; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
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
{14}------------------------------------------------
### Transducer: 2P2 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 | 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…
