K Number

Device Name

CTS-310(B)

Manufacturer

SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS

Date Cleared

1999-05-05

(166 days)

Product Code

IYO

Regulation Number

892.1560

Intended Use

Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ, neonatal cephalic, adult cephalic, and heart.

Device Description

Model CTS-310B is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC). The unit allows heart, abdominal organic 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 9-inch video monitor and a special photographic unit.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K862867

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ultrasonic imaging device with a digital scan converter and video monitor. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the presence of such technology. The description focuses on the hardware and basic imaging capabilities.

Therapeutic

No
This device is for ultrasonic imaging and measurement, enabling visualization of anatomical structures. It does not mention any therapeutic function or intervention.

Diagnostic

No
Explanation: The device is described as an "ultrasonotomograph" for "imaging and measurement" of anatomical structures and for making "images to be observable on a video monitor." This suggests the device is used for capturing images or measurements of the body, which are then used by a healthcare professional to form a diagnosis. The device itself does not appear to provide a diagnosis or diagnostic output.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC)" and is a "portable" "main unit" that can be used with a "video monitor" and "special photographic unit." This indicates it is a hardware device that performs ultrasonic imaging.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
Device Function: The description clearly states that this device uses "Ultrasonic pulsed echo imaging" to create images of internal organs and structures. This is a form of in vivo imaging, meaning it is performed inside the body.
Intended Use: The intended use is for imaging and measurement of various anatomical sites within the body. This is consistent with an imaging device, not a diagnostic test performed on a sample.

Therefore, based on the provided information, this device is an ultrasound imaging system, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ, neonatal cephalic, adult cephalic, and heart.

Product codes (comma separated list FDA assigned to the subject device)

90 IYO

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic Pulsed Echo Imaging System

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (thyroid gland, breast, testes), Neonatal Cephalic, Adult Cephalic, Cardiac.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Hitachi Medical Corporation EUB-310, K862867

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
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.(b)
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.

Summary

KG84161

韶声仪器研究

5 1999 MAY

Tab 11

Premarket Notification [510(k)] Summary

September 7,1998

CTS-310B with EZU-PL12 and EZU-PC3A Transducers Trade Name:

Diagnostic Ultrasound System Common Name:

Ultrasonic Pulsed Echo Imaging System, 90 IYO Classification Name:

(per 21 CFR section 892.1560)

Shantou Institute of Ultrasonic Instruments

Manufacturer's Name:

Address:

Shantou Sez, 515041, China

#2, Jinsha Road, M.,

Corresponding Official: Mr. Jinzhong Yao

Title: President

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

Predicate: Hitachi Medical Corporation EUB-310, K862867

Device Description: Model CTS-310B is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC). The unit allows heart, abdominal organic 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 9-inch video monitor and a special photographic unit.

Intended Use: Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ, neonatal cephalic, adult cephalic, and heart.

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

COMPARIS ON LIST OF SIUI PRODUCT AND HITACHI PRODUCT

	Performance	CTS-310 (SIUI)	EUB-310A (HITACHI)
main
unit	scanning
mode	electronic linear scanning
(compatible 80 elements linear probe) electronic convex sector
(compatible convex probe of 80 elements)	electronic linear scanning
(compatible 80 elements linear probe) electronic convex sector
(compatible convex probe of 80 elements)
	display mode	B mode B/B ode, M mode, B/M mode
simultaneously	B mode, B/B mode, M mode, B/M
mode simultaneously
	measure-
ment	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
104mm, 5MHz probe 61mm
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 140 μs
5MHz pulse width 100 μs	3.5MHz pulse width 140 μs
5MHz pulse width 100 μs
	detecting
depth	3.5MHz probe maximum depth:
210mm
5MHz probe maximum depth:
140mm	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
5MHz probe: x1.0, 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	512 x 512 x 4 bit	512 x 512 x 4 bit
	coordinate
transforma-
tion 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
Performance		CTS-310 (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%, 50/60Hz, about
250W	100V, 110V, 117V, 200V, 220V or
234V, ±10%, 50/60Hz, about
250W
	monitor	9" black and white monitor	5.5" and 9" black and white monitor
	volume
and
weight	395 (W) x 1180 (H) x 728 (L)mm
approx. 65 kg	405(W) X 710(1) X 1310(h)mm
approx. 40kg
	cursor shift	by trackball on keyboard	by joystick on keyboard
	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	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≤500μA
P-G≤100μA	leakage current: U*-G≤500μA
P-G≤100µA
		voltage resistance testing: L-G, P-G
1500V 2mA, no sparking or arcing in
1 minute
work normally when voltage changes
± 10%	voltage resistance testing: L-G, P-G
1500V 2mA, no sparking or arcing in
1 minute
work normally when voltage changes
± 10%
	probe ultrasound	linear probe:	linear probe:
transmitting
frequency		EZU-PL12 80 elements,
5MHz
scanning width 61mm
EZU-PC3A 80 elements,
40R, 3.5MHz	EZU-PL11 80 elements, 3.5MHz
scanning width 104mm
EZU-PL12 80 elements, 5MHz
		3.5MHz scanning angle 60°	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° (transvaginal
probe)
operation		temperature 5-40°C, relative	temperature 5-40 °C, relative
environment		humidity 30-85% (no water drop)	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 drip) air
pressure 700-1060mB
note

COMPARIS ON LIST OF SIUI PRODUCT AND HITACHI PRODUCT

*U means main unit.

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

MAY 5 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shantou Institute of Ultrasonic Instruments C/O Robert J. Morton, M.S. President & Certified Radiological Physicist Quality & Regulatory Services 1106 Chiltern Drive Walnut Creek, California 94596

Re: K984161 SIUI CTS-310B Ultrasound Imaging System Dated: April 1, 1999 Received: April 5, 1999 Regulatory Class: II 21 CFR 892.1560/Procode: 90 IYO

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 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 SIUI CTS-310B Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

EZU-PL12 EZU-PC3A

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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS 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.

Page -2 - Mr. Morton

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 Perez at (301) 594-1212.

Sincerely yours,

Orind be. Seymon

for

CAPT Daniel B. Sch ltz, M.D. Acting Director Division of Reproductive,

Abdominal, Ear, Nose and Throat, And Radiological Devices Office of Device Evaluation Center for Devices and Radiological Devices

Enclosure(s)

Page 2 Re: K984161 SIUI CTS-310B Ultrasound Imaging System

Diagnostic Ultrasound Indications for Use Form Device Name: SIUI CTS-310B

Clinical Application	B	M	Combined (specify)
Ophthalmic
Fetal	N	N	N
Abdominal	N
Intraoperative (specify)
Intraoperative
Neurological
Pediatric	N	N	N
Small Organ (specify)	N
Neonatal Cephalic
Adult Cephalic
Cardiac	N	N	N
Transesophageal
Transrectal
Transvaginal
Transurethrat
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
superficial
Other (specify)

N=new indication

Additional Comments: thyroid gland, breast, testes____________________________________________________________________________________________________________________________

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

Concurrence of CDRH, office of Device Evaluation (ODE)

Yhrist A. Lezon

(Division Sign-Off)

Prescription Use (Per 21 CFR 801.109)

Division of Reproductive, Abdominal, ENT, and Radiological I

510(k) Number K984110

Scanhead Indications for Use Form Device Name: EZU-PL12

Clinical Application		Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal		N	N
Abdominal		N
Intraoperative (specify)
Intraoperative
Neurological
Pediatric		N
Small Organ (specify)		N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethrat
Intravascular
Perpheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
superficial
Other (specify)

N = new indication

Additional Comments: thyroid gland, breast, testes____________________________________________________________________________________________________________________________

..............................................................................................................................................................................

Concurrence of CDRH, office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K984161

Scanhead Indications for Use Form Device Name: EZU-PC3A

Clinical Application		Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal		N	N				N
Abdominal		N
Intraoperative (specify)
Intraoperative
Neurological
Pediatric		N	N				N
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N				N
Transesophageal
Transrectal
Transvaginal
Transurethrat
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
superficial
Other (specify)
N = new indication
Additional Comments:

Concurrence of CDRH, office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K984161
Devices