CTS-200 WITH EZU-PL21 TRANSDUCER

K963068 · Shantou Institute of Ultrasonic Instuments · IYO · May 29, 1997 · Radiology

Device Facts

• Record ID: K963068
• Device Name: CTS-200 WITH EZU-PL21 TRANSDUCER
• Applicant: Shantou Institute of Ultrasonic Instuments
• Product Code: IYO · Radiology
• Decision Date: May 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

Ultrasonic pulsed echo imaging and measurement for fetal and abdominal imaging and adult cardiac M-mode.

Device Story

CTS-200 is a portable, compact linear electronic scanning ultrasound system with a digital scan converter (DSC). It utilizes a 64-element linear transducer (EZU-PL21) to acquire ultrasound signals; processes these via 4-step focusing with variable aperture and lens focusing; and displays B-mode, B/B, M-mode, and B/M-mode images on a 9-inch video monitor. Operated by clinicians in clinical settings, the device performs measurements (distance, area, circumference, time interval, velocity, heart rate) and calculations (volume, pregnant weeks). Output is viewed on a monitor to assist in diagnostic assessment of fetal and abdominal structures and adult cardiac function. The system is designed for portability, allowing use in various clinical locations.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Portable ultrasound system; 64-element linear transducer (3.5MHz); electronic linear scanning; 4-step focusing with variable aperture and lens focusing; 16 grey levels; 256x512x4 bit memory; 120V pulse height; 25 fps max frame rate; PAL/NTSC video output; 9-inch B&W monitor; IEC 601-1 Class I Type B safety compliance.

Indications for Use

Indicated for diagnostic ultrasound imaging of the human body, specifically fetal and abdominal (B-mode) and adult cardiac (M-mode).

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Hitachi Medical Corporation EUB-240 (K862164)

Submission Summary (Full Text)

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SIUI
K963068
SHANTOU INSTITUTE OF ULTRASOUND INSTRUMENTS
AIU ZH 1
MAY 29 1997

# Premarket Notification [510(k)] Summary

July 30, 1996 (revised 5/6/97)

**Trade Name:** CTS-200 with EZU-PL21 Transducer

**Common Name:** Diagnostic Ultrasound System

**Classification Name:** Ultrasonic Pulsed Echo Imaging System, 90 IYO (per 21 CFR section 892.1560)

**Manufacturer's Name:** Shantou Institute of Ultrasonic Instruments
**Address:** #2, Jinsha Road, M., Shantou Sez, 515041, China

**Corresponding Official:** Mr. Jinzhong Yao
**Title:** President

**Telephone:** (86) 754-8250150
**Fax:** (86) 754-8251499

**Predicate:** Hitachi Medical Corporation EUB-240, K862164

**Device Description:** Model CTS-200 is a compact-type linear electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows abdominal organ and fetal images to be observed on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a full keyboard, 9-inch video monitor and a special photographic unit.

**Intended Use:** Ultrasonic pulsed echo imaging and measurement for fetal and abdominal imaging and adult cardiac M-mode.

**Technological Characteristics:** See the attached "Comparison List" of the SIUI CTS-200 and the Hitachi EUB-240.

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COMPARISON LIST OF SIUI PRODUCT AND HITACHI PRODUCT

| Performance | | CTS-200 (portable) (SIUI) | EUB-240 (HITACHI) |
| --- | --- | --- | --- |
| main unit | scanning mode | electronic linear scanning (compatible 64 elements linear probe) | electronic linear scanning (compatible 64 elements linear probe) |
| | display mode | B mode, B/B mode, M mode, B/M mode simultaneously | B mode, B/B mode, M mode, B/M mode simultaneously |
| | measurement | in B mode display: distance, area and circumference
in M mode display: time interval, velocity and heart rate. | in B mode display: distance, area and circumference
in M mode display: time interval, velocity and heart rate |
| | calculation | area, circumference, volume, heart rate and pregnant weeks | area, circumference, volume, heart rate and pregnant weeks |
| | focusing mode | 4-steps focusing with variable aperture and lens focusing | 4-steps focusing with variable aperture and lens focusing |
| | scanning width | 3.5MHz probe: 102mm | 3.5MHz probe: 102mm
5 MHz probe: 56mm |
| | transmitting voltage | pulse height 120V | pulse height 120V |
| | transmitting pulse width | 3.5MHz pulse width 190μs | 3.5MHz pulse width 190μs
5MHz pulse width 144μs |
| | detecting depth | 3.5MHz maximum depth: 200mm | 3.5MHz maximum depth: 200mm
5MHz maximum depth: 180mm |
| | zoom magnification | x1.0, x1.5, x2.0 selectable as well as depth shift | x1.0, x1.5, x2.0 selectable as well as depth shift |
| | frame rate | the maximum is 25 frame/second | the maximum is 25 frame/second |
| | grey scale | 16 | 16 |
| | memory | 256x512x4 bit | 256x512x4 bit |
| | video output | PAL or NTSC system TV signal (confirmed in order) | PAL or NTSC system TV signal (confirmed in order) |
| | power supply | 100V, 110V, 117V, 200V, 220V or 234V, ±10%, 50/60Hz, about 140W | 100V, 110V, 117V, 200V, 220V or 234V, ±10%, 50/60Hz, about 140W |
| | monitor | 9" black and white monitor | 9" black and white monitor |
| | volume and weight | 280 (w) x235 (l) x415 (h) mm
approx. 13kg | 400 (w) x720 (l) x1290 (h) mm
approx. 65kg |
| cursor shift | by 9 cursor shift keys ↑, ↓, →, ←, /, \,, /, and FAST | by 9 cursor shift keys ↑, ↓, →, ←, /, \,, /, and FAST | |

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COMPARISON LIST OF SIUI PRODUCT AND HITACHI PRODUCT

| Performance | | CTS-200 (portable) (SIUI) | EUB-240 (HITACHI) |
| --- | --- | --- | --- |
| main unit | electric apparatus
safty standard | conform to requirement of I class B type apparatus of IEC 601-1
isolate resistor testing: testing voltage 1000V L-L, L-G>10MΩ
leakage current: U°-G<500 μA, P-G<100 μA
voltage resistance testing: L-G, P-G, 1500V 2mA, no sparking or arcing in 1 minute
work normally when voltage changes ±10% | conform to requirement of I class B type apparatus of IEC 601-1
isolate resistor testing: testing voltage 1000V L-L, L-G>10MΩ
leakage current: U°-G<500 μA P-G<100 μA
voltage resistance testing: L-G, P-G, 1500V 2mA, no sparking or arcing in 1 minute
work normally when voltage changes ±10% |
| probe (compatible) | | EZU-PL21: 64 elements 3.5MHz linear probe | EZU-PL21: 64 elements 3.5MHz linear probe
EZU-PL22: 64 elements 3.5MHz linear probe |
| operation environment | | temperature 5-40° C, relative humidity 30-85% (no water drop) | temperature 5-40° C, relative humidity 30-85% (no water drop) |
| storage environment | | temperature -10-60° C, relative humidity 30-95% (no water drop)
air pressure 700-1060 mB | temperature -10-60° C, relative humidity 30-95% (no water drop)
air pressure 700-1060mB |

* U means main unit.

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DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 29 1997

Shantou Institute of Ultrasonic Instruments
c/o Robert J. Morton, President
Quality and Regulatory Services
1106 Chiltern Drive
Walnut Creek, CA 94596

Re: K963068
CTS-200 Diagnostic Ultrasound
System with Model EZU-PL21
Dated: May 9, 1997
Received: May 12, 1997
Regulatory Class: II
21 CFR 892.1560/Procode: 90 IYO
21 CFR 892.1570/Procode: 90 ITX

Dear Mr. Morton:

We have reviewed your section 510(k) 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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the CTS-200 Diagnostic Ultrasound System as described in your premarket notification:

**Transducer Model Number**

EZU-PL21 (3.5MHz)

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the *Federal Register*. *Please note*: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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.

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Page 2 - Mr. Robert Morton

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone] or at its Internet address “http://www.fda.gov/cdrh/dsmamain.html”.

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

Sincerely yours,


Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure(s)

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Ultrasound Device Indications Statement Page 1 of 1

510(k) Number (if known): K963068

Device Name: Transducer Model 3.5MHz EZU-PL21 for CTS-200

Fill out one form for each ultrasound system or transducer.

Indications For Use: Diagnostic ultrasound imaging (Specify) of the human body as follows:

| Clinical Application | A | B | M | PMD | CVD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined. (Specify) | Other (Specify) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ophthalmic | | | | | | | | | | |
| Fetal | | X | | | | | | | | |
| Abdominal | | X | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac Adult | | | X | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |

Other Indications or Modes:

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

Concurrence of CDRR, Office of Device Evaluation (ODR)

Prescription Use (Per 21 CFR 801.109)

David A. Sejorn

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K963068

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