SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000

K042369 · Sonoscape Company Limited · IYN · Oct 20, 2004 · Radiology

Device Facts

• Record ID: K042369
• Device Name: SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000
• Applicant: Sonoscape Company Limited
• Product Code: IYN · Radiology
• Decision Date: Oct 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen; Pediatric; Small Organ (breast, tests, thyroid); heart soft tissue; Peripheral Vascular, Musculo-skeletal (conventional) and Urology.

Device Story

SonoScape SSI-1000/SSI-5000 is a diagnostic ultrasound system; available as portable (SSI-1000) or roll-around (SSI-5000) units. System uses phased, linear, and curved linear array transducers to acquire ultrasound data via piezoelectric effect. Operates in B-Mode, M-Mode, Color-Flow, Pulsed, Power, and CW Doppler modes. Features 64-channel digital beam former, progressive dynamic receive focusing, and native frequency digital scan converter. Operated by physicians in clinical settings. Output displayed on LCD (SSI-1000) or CRT (SSI-5000) monitors. Provides real-time imaging and measurements (distance, area, velocity, etc.) to assist in clinical diagnosis of abdominal, cardiac, vascular, and musculoskeletal conditions. Includes LAN port for image management and USB 2.0 for data transport.

Clinical Evidence

Bench testing only. No clinical data provided. System performance validated through acoustic output measurements, safety compliance testing (IEC601-1, IEC60601-2), and comparison of imaging capabilities to predicate devices.

Technological Characteristics

All-digital architecture; 64-channel beam former; progressive dynamic receive focusing. Supports phased, linear, and curved linear array probes. Modes: B, M, Color/Power/PW/CW Doppler, Tissue Harmonic Imaging. Connectivity: LAN, USB 2.0. Operating system: Linux. Safety: IEC601-1, IEC60601-2. Acoustic output: Track 3, MI max 1.9, Ispta max 720mW/cm2.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients for applications including Abdominal, Ob/GYN, Small Organ (breast, thyroid, testes), Cardiac, Peripheral Vascular, and Musculo-skeletal (conventional).

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

• GE Logiq 500 (K970901, K991611, K010329)

Submission Summary (Full Text)

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### OCT 2 0 2004 PREMARKET NOTIFICATION [510(k)] Summary

| Trade Name: | SonoScape Ultrasound System, SSI-1000/SSI-5000TM<br>with PA2.5 MHz Phased Array, LA7.5 MHz Linear Array, and<br>CLA3.5 MHz Curved Linear Array. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Diagnostic Ultrasound System |
| Classification Name: | Ultrasonic Pulsed Echo Imaging System, 90 IYO |
| Manufacturer's Name: | SonoScape Company Limited<br>4/F., Yizhe Building, Yuquan Road,<br>Nanshan, 518051, Shenzhen, China |
| Contact: | Mr. Jinzhong Yao, President<br>Telephone: [phone]<br>Fax: [phone] |
| U.S. Agent: | Bob Leiker<br>Quality & Regulatory Services, Inc.<br>Dublin, CA 94568 |

GE Logiq 500 - K970901, K991611, and K010329 Predicate Device:

The SonoScape SSI-1000/SSI-5000 ultrasound system is an Device Description: 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

Image /page/0/Picture/7 description: The image shows a portable computer with a screen and keyboard. The computer is labeled "SSI-1000" at the bottom left of the image. The computer has a handle on top, suggesting it is designed to be carried around. The screen is dark, and the keyboard is visible below it.

for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.

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The SonoScape System can be configured either as a portable (SSI-1000) model, or as a roll-around model on wheels (SSI-5000). These systems are designed with

the latest technology, using the same quality procedures as ultrasound systems which have been available in the market for vears.

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, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes.

The major features of the SonoScape SSI-1000/SSI-5000:

- 64 Channel all digital beam former .
- Progressive dynamic receive focusing .
- Wide band all digital demodulation .
- Native frequency digital scan converter .
- SSI-1000 can be hand carried for portable use .
- Remote access image management through LAN port .
- USB2.0 flash drive for image transport and software upgrade .
- Support for Phase array, Linear array, and Curve Linear array probes .
- Based on Linux operating system .
- Supports 2D B-mode, M-mode, Harmonic Image, Color, Power Doppler, Pulse . wave Doppler, and CW.

The SSI-1000 utilizes an LCD viewing monitor, and the SSI-5000 uses a CRT monitor. The following drawings are provided for illustration;

Image /page/1/Figure/17 description: The image shows three different models of medical equipment, labeled as SSI-1000 and SSI-5000. The SSI-1000 model is a boxy unit with horizontal ventilation slats. The SSI-5000 model has a monitor on top and an articulated arm extending from the side, and it is mounted on a wheeled base. The middle model has a monitor on top and is mounted on a wheeled base.

Premarket Notification 510(k) Summary

Image /page/1/Picture/21 description: The image shows a black and white picture of an SSI-5000 ultrasound machine. The machine has a monitor on top, a keyboard, and a control panel. The machine is on wheels, and there are cables hanging from the side. The image is a close-up of the machine, and the background is blurred.

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Intended Use: The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen; Pediatric; Small Organ (breast, tests, thyroid); heart soft tissue; Peripheral Vascular, Musculo-skeletal (conventional) and Urology.

## Technological Characteristics

| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode; 2-D/Pulsed Doppler and<br>Triplex 2-D/CD/Pulsed Doppler image formats; Dual B and Color in real time |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurements | Distance; area; circumference; calipers; velocity, PI, RI. Cardiac. OB and Vascular<br>package |
| Principle of<br>Operation | Applying high voltage burst to the Piezoelectric material in the transducer and<br>detect the reflected echo to construct the 2-D B-mode, Doppler color, and Doppler<br>spectrum image for diagnostic purpose. |
| Operating<br>Controls | TGC 8 slider, +/- 24dB Depth Range: 3 to 24 cm Image sector size: 32 lines to full B (256 lines) Image Sector position: Steering within full maximum B orientation flip: L/R key with marking on the screen B Dynamic range control: preset 5 curves over 50-90 dB Gray Scale Control: 8 Settings Focal Number: 16 focal zone setting B persistence: 30-90% recursive Image Processing: Smoothing, edge enhancement PW sweeping speed 2,4,8 sec over display. PW Wall filter setting: 16 settings, 0.25 to 20% of PRF PW sample volume: 0.5 to 10mm with 0.5mm step size. PW/B update: with UPDATE key PW cursor steering: Steer soft key PW angle correction: 0 to 70 degree user control PW trace: Peak, Mean PW spectrum dynamic range: 5 preset curve over 15-48 dB Spectrum baseline shift and invert Color ROI setting: trackball and set key to control size and position Color steering on flat probe: +, 0, - Color Wall Filter: Color wall filter with 16 selection, 0.25-20% of PRF Color & B priority: C-B priority soft menu Color Packet size: preset per Exam range from 8 to 12 Color spatial filter: preset per Exam, horizontal, vertical, off Zoom factor: 1 to 10 continuously Freeze control: Toggling freeze key Cine control: step, play backward, play continuously |
| Acoustic<br>Output | Track 3; MI, TIS, TIC, TIB<br>Derated Ispta: 720mW/cm2 maximum, TIS/TIB/TIC:0.1-4.0 Range, Mechanical<br>Index: 1.9 Maximum, or Derated Isppa: 190 W/cm² max |
| Safety<br>Compliance | IEC601-1 International Electrotechnical Comission; Medical Electrical Equipment<br>IEC60601-2 International Electrotechnical Comission; Electromagnetic<br>Compatibility |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2004

SonoScape Company, Ltd. % Mr. Bob Leiker Quality & Regulatory Services 7263 Cronin Circle DUBLIN CA 94568-2330

Re: K042369

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Trade Name: SonoScape SSI-1000/SSI-5000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: October 11, 2004 Received: October 12, 2004

Dear Mr. Leiker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the SonoScape SSI-1000/SSI-5000 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

2P1, PA2.5 MHz Phased Array L741, LA7.5 MHz Linear Array C344, CLA3.5 MHz Curved Linear Array

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Page 2 - Mr. Leiker - - - -

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), W it may be subject to such 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); 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.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and . prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to · proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address {"http://www.fda.gov/cdrh/dsmamain.html".

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Page 3 - Mr. Leiker

Ìf you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone]. .

:

· Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices : Office of Device Evaluation Center for Devices and Radiological Health .

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510(k) Number:________________________________________________________________________________________________________________________________________________________________

Device Name: SonoScape SSI-1000/SSI-5000

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: Mode of Oneration

| Mode of Operation | | | | | | | | | | |
|------------------------------------------|---|---|---|-----|-----|---------------|---------------------------|------------------------|----------|-------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined | Tissue Harmonic Imaging |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | Note 1 | N |
| Ob/GYN | | N | N | N | | N | N | | Note 1 | N |
| IntraOperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (breast,<br>thyroid, testes) | | N | N | N | | N | N | | Note 1 | N |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | N | | Note 1 | N |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | Note 1 | N |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | N | N | N | | N | N | | Note 1 | N |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |

P = previously cleared by FDA E = added under Appendix E N = new indication

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Additional Comments:

Concurrence of CDRH, Office of Device

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive. Abdominal,
and Radiological Devices
Page 2 of 5 Uno

Prescription Use (Per 21 CFR 801.109)

Indications For Use 510(k) Number ____________________________________________________________________________________________________________________________________________

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510(k) Number:________________________________________________________________________________________________________________________________________________________________

Device Name: 2P1, PA2.5 MHz Phased Array Diagnostic Ultrasound Transducer

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

| Mode of Operation | | | | | | | | | | |
|------------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|----------|-------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined | Tissue<br>Harmonic<br>Imaging |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Ob/GYN | | | | | | | | | | |
| IntraOperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (breast,<br>thyroid, testes) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | N | N | N | | Note 1 | N |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |

P = previously cleared by FDA E = added under Appendix E N = new indication

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Additional Comments:

Concurrence of CDRH, Office of D

Nancy C. Bergdon

(Division S Division of Reproductive and Radiological Device 510(k) Number _

Prescription Use (Per 21 CFR 801.109)

Indications For Use

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.

510(k) Number:________________________________________________________________________________________________________________________________________________________________

Device Name: L741, LA7.5 MHz Linear Array Diagnostic Ultrasound Transducer

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

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined | Tissue<br>Harmonic<br>Imaging |
|------------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|----------|-------------------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Ob/GYN | | | | | | | | | | |
| IntraOperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (breast,<br>thyroid, testes) | N | N | N | | N | N | N | | Note 1 | N |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral Vascular | N | N | N | | N | N | N | | Note 1 | N |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | N | N | N | | N | N | N | | Note 1 | N |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |

P = previously cleared by FDA E = added under Appendix E N = new indication

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Additional Comments:

Concurrence of CDRH, Office of Device Evaluation (ODE

Nancy C. hogdon
(Division Sign-Off)

Prescription Use (Per 21 CFR 801.109)

Division of Reproductive, Abdominal, and Radiological Dovices

Indications For Use I - Indications For Use

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510(k) Number:________________________________________________________________________________________________________________________________________________________________

Device Name: C344, CLA3.5 MHz Curved Linear Array Diagnostic Ultrasound Transducer

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

| Mode of Operation | | | | | | | | | | |
|------------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|----------|-------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined | Tissue<br>Harmonic<br>Imaging |
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | Note 1 | N |
| Ob/GYN | | N | N | N | | N | N | | Note 1 | N |
| IntraOperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (breast,<br>thyroid, testes) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |

P = previously cleared by FDA E = added under Appendix E N = new indication

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD

Additional Comments:

Concurrence of CDRH, Office of Device Evaluation (OD

Nancy C brondon

(Division Sign-Off Division of Reproductive, Abdo and Radiological Devices 510/k) Number _________

Prescription Use (Per 21 CFR 801.109)

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