CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS

K963065 · Shantou Institute of Ultrasonic Instuments · IYO · May 29, 1997 · Radiology

Device Facts

• Record ID: K963065
• Device Name: CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS
• 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, abdominal, and adult cardiac imaging as well as adult cardiac M-mode.

Device Story

CTS-285 is a portable diagnostic ultrasound system using electronic linear and convex scanning transducers. It processes ultrasonic pulsed echo signals via a built-in digital scan converter to produce B-mode and M-mode tomographic images on a video monitor. Operated by clinicians in clinical settings, the device allows for measurements of distance, area, circumference, time interval, velocity, depth, and heart rate. Output is visualized on a 5.5-inch monitor, assisting clinicians in diagnostic assessment of fetal, abdominal, and adult cardiac structures. The system is designed for portability, enabling use outside of traditional stationary imaging suites.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Portable ultrasound system; electronic linear/convex scanning; 64-element transducers (EZU-PL21, EZU-PC3B); 3.5MHz frequency; 4-step dynamic focusing with variable aperture; 512x512x4 bit memory; 16 grey levels; PAL/NTSC video output; Class I, Type B safety per IEC 801-1.

Indications for Use

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

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-310 (K862867)

Submission Summary (Full Text)

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K963065
SIUI
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS
MAY 29 1997

# Premarket Notification [510(k)] Summary

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

**Trade Name:** CTS-285 with EZU-PL21 and EZU-PC3B Transducers

**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-310, K862867

**Device Description:** Model CTS-285 is a compact-type linear/convex electronic scanning ultrasound system with a built-in digital scan converter (DSC). The unit allows adult heart, abdominal organ and fetal tomographic images to be observable 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, abdominal, and adult cardiac imaging as well as adult cardiac M-mode.

**Technological Characteristics:** See the attached "Comparison List" of the SIUI CTS-285 and the Hitachi EUB-310.

国家·中国国际电视学院
ADD: JINSHA ROAD, M., SHANTOU, CHINA
电话：[phone]

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COMPARISON LIST OF SIUI PRODUCT AND HITACHI PRODUCT

| Performance | | CTS-285 (portable) (SIUI) | EUB-210A (HITACHI) |
| --- | --- | --- | --- |
| main unit | scanning mode | electronic linear scanning (compatible 64 elements linear probe)
electronic convex sector (compatible convex probe of 64 elements) | electronic linear scanning (compatible 80 elements linear probe)
electronic convex sector (compatible convex probe of 80 elements) |
| | 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, depth and heart rate | in B mode display: distance, area and circumference
in M mode display: time interval, velocity, depth and heart rate |
| | calculation | area, circumference, volume, heart rate, pregnant weeks and heart function | area, circumference, volume, heart rate, pregnant weeks and heart function |
| | focusing mode | 4-steps dynamic focusing with variable aperture and lens focusing | 4-steps dynamic focusing with variable aperture and lens focusing |
| | scanning width | linear scanning: 3.5MHz probe 102mm, convex sector scanning probe: sector angle 60° | linear scanning: 3.5MHz probe 104mm, 5MHz probe 61mm
convex sector scanning probe: sector angle 60° |
| | transmitting voltage | pulse height 130V | pulse height 130V |
| | transmitting pulse width | 3.5MHz pulse width 160μs | 3.5MHz pulse width 140μs
5MHz pulse width 100μs |
| | detecting depth | 3.5MHz probe maximum depth: 210mm | 3.5MHz probe maximum depth: 210mm
5MHz probe maximum depth: 140mm |
| | zoom | 3.5MHz probe: x1.0, x1.2, x1.5, x2.0 selectable as well as depth shift | 3.5MHz probe: x1.0, x1.2, x1.5, x2.0 selectable as well as depth shift
5MHz probe: x1.0, x1.5, x2.0 selectable as well as depth shift |
| | frame rate | the maximum is 40 frame/second | the maximum is 40 frame/second |
| | grey scale | 16 | 16 |
| | memory | 512x512x4 bit | 512x512x4 bit |
| | coordinate transformation function | monitor can display electronic linear scanning image or convex sector scanning image | monitor can display electronic linear scanning image or convex sector scanning image |

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COMPARISON LIST OF SIUI PRODUCT AND HITACHI PRODUCT

| Performance | | CTS-285 (portable) (SIUI) | EUB-310A (HITACHI) |
| --- | --- | --- | --- |
| main unit | 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%, 50/80Hz, about 140W | 100V, 110V, 117V, 200V, 220V or
234V, ±10%, 50/80Hz, about 250W |
| | monitor | 5.5° black and white monitor | 5.5° and 9° black and white monitor |
| | volume and weight | 280(W)×235(H)×415(L)mm
approx. 13kg | 405(w)×710(1)×1310(h)mm
approx. 40kg |
| | cursor shift | by trackball on keyboard | by joystick on keyboard |
| | electric apparatus
safety standard | conform at requirement of I class
B type apparatus of IEC 801-1
isolate resistor testing: testing
voltage 1000V L-L, L-G>10MG
leakage current: U~G<500 μA
P-G<100 μA
voltage resistance testing: L-G,
P-G 1500V 2mA, no sparking or
arcing in I minute
work normally when voltage changes
±10% | conform at requirement of I class
B type apparatus of IEC 801-1
isolate resistor testing: testing
voltage 1000V L-L, L-G>10MG
leakage current: U~G<500 μA
P-G<100 μA
voltage resistance testing: L-G,
P-G, 1500V 2mA, no sparking or
arcing in I minute
work normally when voltage changes
±10% |
| probe ultrasound
transmitting
frequency | | linear probe:
EZU-PL21 64 elements, 3.5MHz,
scanning width 102mm
Convex sector probe:
EZU-PC3B 64 elements, 40R, 3.5MHz,
scanning width 60°
; | linear probe:
EZU-PL11 80 elements, 3.5MHz
scanning width 104mm
EZU-PL12 80 elements, 5MHz
scanning width 61mm
EUU-L11S 80 elements, 3.5MHz
scanning width 84mm
convex sector probe:
EZU-PC3A 80 elements, 40R, 3.5MHz,
scanning angle 60°
EZU-PC2A 80 elements, 40R, 5MHz,
scanning angle 60°
EUP-V12A 40 elements, 40R, 5MHz,
scanning angle 40° (transvergnal
probe) |
| operation
environment | | temperature 5-40° C, relative
humidity 30-50% (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 700-1060mB | temperature -10-60° C, relative
humidity 30-95% (no water drop)
air pressure 700-1060mB |
| note | | | |

*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

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

MAY 29 1997

Re: K963065
CTS-285 Diagnostic Ultrasound
System with Model EZU-PL 21
and EZU-PC3B Transducers
Dated: April 4, 1997
Received: April 7, 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-285 Diagnostic Ultrasound System, as described in your premarket notification:

**Transducer Model Number**

EZU-PL21 (3.5MHz)
EZU-PC3B (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 - Robert J. 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 “[e-mail]”.

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 2

510(k) Number (if known): K963065

Device Name: Transducer 3.5 MHz EZU-PL21 for CTS-285

Fill out one form for each ultrasound system or transducer.

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

Mode of Operation

| Clinical Application | A | B | N | PWD | CWD | 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 CNSR, Office of Device Evaluation (OPE)

David L. Seyman

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K963065

Prescription Use (Per 21 CFR 801.109)

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Ultrasound Device Indications Statement Page 2 of 2

510(k) Number (if known): K963065

Device Name: Transducer Model 3.5MHz EZU-PC3B for CTS-285

Fill out one form for each ultrasound system or transducer.

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

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | 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 | 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 CDRN, Office of Device Evaluation (CDE)

David G. Segerman

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K963065

Prescription Use (Per 21 CFR 801.109)