S22 Digital Color Doppler Ultrasound System

K142815 · Sonoscape Company Limited · IYN · Jan 28, 2015 · Radiology

Device Facts

• Record ID: K142815
• Device Name: S22 Digital Color Doppler Ultrasound System
• Applicant: Sonoscape Company Limited
• Product Code: IYN · Radiology
• Decision Date: Jan 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SonoScape S22 system 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), Trans-esoph.(Cardiac), OB/Gyn and Urology.

Device Story

Mobile, software-controlled, color diagnostic ultrasound system; used in clinical settings by physicians. Inputs: ultrasonic energy transmitted into patient body via linear, convex, or phased array probes (2.0–15.0 MHz). Processing: system receives echoes, performs post-processing, and generates images of anatomic structures and fluid flow. Outputs: B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler, Power Doppler, Elastography, and 3D/4D imaging displayed on integrated color LCD monitor. Healthcare providers use visual output for clinical diagnostic imaging; aids in evaluation of various organ systems and pathologies. Benefits: provides non-invasive diagnostic visualization of internal anatomy and hemodynamics.

Clinical Evidence

No clinical testing was required. Bench testing only, including electrical, mechanical, thermal, and electromagnetic compatibility safety, biocompatibility, and acoustic output. Phantom testing verified Elastography function accuracy and repeatability.

Technological Characteristics

Mobile console with keyboard, power supply, and color LCD. Probes: linear, convex, phased arrays (2.0–15.0 MHz). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO 10993-10, NEMA UD2, NEMA UD3. Software-controlled imaging system.

Indications for Use

Indicated for use by qualified physicians for diagnostic ultrasound imaging of fetal, abdominal, pediatric, small organ (breast, testes, thyroid), cephalic (neonatal/adult), transrectal, transvaginal, peripheral vascular, musculoskeletal (conventional/superficial), cardiac (neonatal/adult), transesophageal, OB/Gyn, and urological 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 S30 Digital Color Doppler Ultrasound System (K132527)
• Philips EPIQ Diagnostic Ultrasound System (K132304)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid with three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

January 28, 2015

Sonoscape Company Limited % Mrs. Toki Wu Regulatory Affairs Manager Yizhe Building, Yuquan Road, Nanshan Shenzhen Guandong 518051 P.R. CHINA

Re: K142815

Trade/Device Name: S22 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 29, 2014 Received: January 09, 2015

Dear Mrs. 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 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.

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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K142815

Device Name

S22 Digital Color Doppler Ultrasound System

Indications for Use (Describe)

The SonoScape S22 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), OB/Gyn and Urology.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

# 1. Submitter [21 CFR807.92 (a) (1)]

| Submitter: | SonoScape Company Limited |
|-----------------|---------------------------------------------------------------------|
| Address: | Yizhe Building, Yuquan Road, Nanshan, Shenzhen<br>518051, P.R.China |
| Contact Person: | Toki Wu |
| Tel: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| Date Prepared | August 29, 2014 |

## 2. Device [21 CFR807.92 (a)(2)]

| Trade Name: | S22 Digital Color Doppler Ultrasound System |
|--------------|----------------------------------------------|
| Common Name: | Diagnostic Ultrasound System and Transducers |

Classification Regulatory:

| | FR Number | Product Code |
|------------------------------------------|-----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |

Classification Panel: Radiology Device Class: ll

# 3. Predicate Device(s) [21 CFR 807.92(a) (3)]

| The identified predicate devices within this submission are as follows: | |
|-------------------------------------------------------------------------|---------|
| SonoScape S30 Digital Color Doppler Ultrasound System | K132527 |
| Philips EPIQ Diagnostic Ultrasound System | K132304 |

## 4. Device Description [21 CFR 807.92(a) (4)]

This SonoScape S22 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 basic principle is that system transmits ultrasonic energy into patient body and

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implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.

This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 2.0 MHz to 15.0 MHz. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.

This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D.

#### 5. Intended Use [21 CFR 807.92(a)(5)]

The SonoScape S22 system 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), Trans-esoph.(Cardiac), OB/Gyn and Urology.

## 6. Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]

S22 Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the predicate devices:

| SonoScape S30 Digital Color Doppler Ultrasound System | K132527 |
|-------------------------------------------------------|---------|
| Philips EPIQ Diagnostic Ultrasound System | K132304 |

#### Intended Use Comparison:

Compared with SonoScape S30 (K132527), the Subject Device S22 has the same intended uses.

#### Technical Characteristics Comparison:

The basic and main technical features of the subject device S22 are the same as the predicated device S30 (K132527), including Design, Operation Controls, Display Modes, Measurement Items, Cine Loop and Operating and Storage Condition.

For Operation Modes, Elastography is a special Operation Mode for the Subject Device S22, but already employed by many marketed devices and considered Substantially Equivalent to the Predicate Device Philips EPIQ (K132304) and detailed comparison analysis can be found in Substantial Equivalence Comparison.

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The detailed technical features comparison and analysis can be found in Substantial Equivalence Comparison and the detailed technical features can be found in General Device Descriptions of the submission.

Probes Comparison:

Subject device S22 has the similar probes as the predicated device SonoScape S30 (K132527).

| Subject device<br>SonoScape S22 | Predicate Device<br>SonoScape S30 | Remark |
|-----------------------------------------------|----------------------------------------------------|------------------|
| C322 Micro-curved Array | C322 Micro-curved Array | |
| C344 Curved Array | C344 Curved Array | |
| C353 Curved Array | C353 Curved Array | SE<br>Analysis 1 |
| C354 Curved Array | C362 Curved Array | |
| C542 Curved Array | C542 Curved Array | |
| VC6-2 Curved Array | VC6-2 Curved Array | Same |
| C613 Micro-curved Array | C611 Micro-curved Array<br>C311 Micro-curved Array | SE<br>Analysis 1 |
| 2P1 Phased Array | 2P1 Phased Array | Same |
| 5P1 Phased Array | 5P1 Phased Array | |
| L741 Linear Array | L741 Linear Array | |
| L742 Linear Array | L742 Linear Array | |
| L752 Linear Array | L743 Linear Array<br>L752 Linear Array | Same |
| 10L1 Linear Array | 10L1 Linear Array | |
| 6V1 Micro-curved Array | 6V1 Micro-curved Array | |
| 6V3 Micro-curved Array | 6V3 Micro-curved Array | |
| EC9-5 Micro-curved Array | EC9-5 Micro-curved Array | Same |
| BCC9-5 Micro-curved Array | BCC9-5 Micro-curved Array | |
| BCL10-5 Biplane (Micro-curved + Linear Array) | BCL10-5 Biplane (Micro-curved +<br>Linear Array) | |
| MPTEE Phased Array<br>(Multi-plane) | MPTEE Phased Array<br>(Multi-plane) | Same |
| MPTEE mini Phased Array<br>(Multi-plane) | MPTEE mini Phased Array<br>(Multi-plane) | |

# Table 1 Probes Comparison

#### SE Analysis 1:

Compared with the predicate device, there are only two new probes (C354 and C613) for the subject device, but no new intended use. And the frequency and performance of C354 and C613 probes is the same as C353 and C611 respectively for predicate device.

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Moreover, compared with predicated devices, the subject device (S22) complies with the same regulation and safety standards and has the consistent acoustic output levels. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.

# 7. Non-Clinical Tests [21 CFR 807.92(b) (1)]

The S22 Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.

Laboratory tests were conducted to verify that the S22 system met all design specifications and the S22 system conformed to applicable medical device standards. Phantom test was conducted to verify that the strain Elastography function was effective and Elastography performance met design specifications, including accuracy and repeatability of strainratio measurement and etc.

The S22 system has been designed and manufactured to meet the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, ISO10993-10, UD2, and UD3.

### 8. Clinical Test [21 CFR 807.92(b) (2)]

No clinical testing was required.

## 9. Substantially Equivalent Conclusions [21 CFR 807.92(b) (3)]

In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, SonoScape Company Limited concludes that S22 Digital Color Doppler Ultrasound System is substantially equivalent to the predicate devices with regard to safety and effectiveness.