Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound functionalities.

Therapeutic

No
The device is described as a "digital diagnostic ultrasound system" with "intended use / indications for use" for "ultrasonic pulsed echo imaging and measurement". This indicates its purpose is for diagnosis, not therapy.

Diagnostic

Yes
The device is described as a "digital diagnostic ultrasound system" and its "Intended Use / Indications for Use" explicitly state "imaging and measurement for... applications," which implies diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of probes, a main unit, a control panel, and a monitor, indicating it is a hardware-based ultrasound system with integrated software, not a standalone software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes the device as an "Ultrasonic pulsed echo imaging and measurement" system for various anatomical sites. This is a description of a medical imaging device used for visualizing internal structures, not for testing samples of human origin (like blood, urine, or tissue) outside the body.
Device Description: The description details the components and functionalities of an ultrasound system, which is a non-invasive imaging modality.
Input Imaging Modality: "Ultrasonic pulsed echo imaging" is a method of generating images of the body, not a method for analyzing biological samples.
Anatomical Site: The listed anatomical sites are parts of the human body being imaged, not samples being tested.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device is clearly an imaging system used for diagnostic purposes through visualization, not through laboratory testing of samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular and muscular-skeletal applications.

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

IYO, ITX

Device Description

The SIUI CTS-900 is a digital diagnostic ultrasound system capable of the following operating modes: 2D (B mode) and B/M. The system is designed for use in linear and convex scanning modes and supports linear, and convex transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities. The system consists of probes, main unit, control panel and monitor.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic pulsed echo imaging

Anatomical Site

Abdominal, pediatric, small organ (thyroid, testes, breast), cardiac, peripheral vascular, muscular-skeletal, fetal, uterus, ovary, prostate

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.

SIUI CTS-7700 , K061083 and K070982

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

0

K081110

SIUI CTS-900 Digital Ultrasound Imaging System

MAY 1 6 2008

Section 7 510(k) Summary of Safety and Effectiveness

Trade Name:	CTS-900 with C3L60B and L7L38B Transducers
Common Name:	Digital Ultrasound Imaging System
Classification Name:	Ultrasonic Pulsed Echo Imaging System, IYO
(Per 21 CFR section 892.1560)
Diagnostic Ultrasonic Transducer, ITX
(Per 21 CFR section 892.1570)
Manufacturer's Name:	Shantou Institute of Ultrasonic Instruments
Address:	#77, Jinsha Road,
Shantou, Guangdong 515041, China
Corresponding Official:	Flower Cai
Title:	Overseas Cooperation Supervisor
Telephone:	(86) 754- 8250150 Fax: (86) 754-8251499
US Agent:	Bob Leiker/ Consultant /QRS
Dublin, CA 94568
Telephone: 1-925-556-1302 Fax: 1-866-718-3819
Predicate Device:	SIUI CTS-7700 , K061083 and K070982

Device Description: The SIUI CTS-900 is a digital diagnostic ultrasound system capable of the following operating modes: 2D (B mode) and B/M. The system is designed for use in linear and convex scanning modes and supports linear, and convex transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities. The system consists of probes, main unit, control panel and monitor.

Intended Use: Ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organ, cardiac, peripheral vascular and muscular-skeletal applications.

Technological Characteristics:

1. Scanning modes: convex and linear scanning
1. Display modes:
- a) B-Mode (B, 2B)
- b) B/M-Mode

1

1. Supporting transducers:
- a) C3L60B: 2.5-5.0 MHz 60R 128e convex transducer
- b) L7L38B: 5.0-9.0 MHz 38mm 128e linear transducer
1. Focus mode:
- a) Transmit focus mode:
  - 1-4 selectable, focus depth: variable
- b) Receive focus mode: dynamic focus
1. Grey scale: 256
1. Pre-processing:
- 32-channel digital beam-former: a)
- Receive gain (include TGC): 70dB b)
- Dynamic range: 35-66dB c)
- Edge enhancement: 4 steps d)
- Image persistence: 7 steps e)
- Line density: normal, high f)
1. Post-processing

10 types of gray maps, among which 4 types are user-definable

1. Image manipulation:
- a) Real-time zoom in x4.0 max.
- b) Frozen image
1. B/M-mode speed:

Time for full screen scroll: 1.2, 2.5, 5.0, 10.0 sec

10)Cine: Max. 256 frames
11)Image store and recall: 32 frames
12)Image orientation:
- c) Left/right flip
- d) Up/down flip
- e) 90-degree rotation (selectable steps: 0, 90, 180. 270 degrees)

13)Documentation and storage:

a) 60GB HDD, images stored in BMP file format;
b) USB interface memory, images stored in BMP file format
c) Documentation devices:
d) B&W video printer

14)Measurements and calculations

a) General measurements and calculations 2D: Distance, Area, Circumference, and Angle M-Mode: Distance, Time, Slope, Heart rate
b) Specific measurements and calculations Abdomen, Obstetrics, Gynecology, Cardiology, Small parts, Peripheral Vascular.
510(k) Summary of Safety and Effectiveness
Page 2 of 2

2

Public Health Service

Image /page/2/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" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shantou Institute of Ultrasonic Instruments (SIUI) % Mr. Bob Leiker Consultant Quality & Regulatory Services 7263 Cronin Circle DUBLIN CA 94568

Re: K081110

Trade/Device Name: SIUI CTS-900 Digital Ultrasound Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: April 15, 2008 Received: April 18, 2008

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.

MAY 1 6 2008

This determination of substantial equivalence applies to the following transducers intended for use with the SISU CTS-900 Digital Ultrasound Imaging System as described in your premarket notification:

Transducer Model Number

Convex Array C3L60B Linear Array L7L38B

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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

3

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, (cnclosed) 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Sundar Rajan at (240) 276-3666.

Sincerely yours.

Vorui M. Whag

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

Enclosure(s)

4

SIUI CTS-900 Digital Ultrasound Imaging System Diagnostic Ultrasound Indications for Use Form

1. System Indications for Use Form

Device Name: CTS-900

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color	Power	Color	Combined	Other
						Doppler	(Amplitude)	Velocity	(Specify)	(Specify)
							Doppler	Imaging
Opthalmic
Fetal		P1							P1
Abdominal		P1							P1
IntraOperative
(Cardiac)
IntraOperative
Neurological
Pediatric		P1							P1
Small Organ		P1							P1
(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P1							P1
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Vascular
Peripheral Vascular		P1							P1
Laparascopic
Muscular-Skeletal		P2							P2
Conventional
Muscular-Skeletal		P2							P2
Superficial
Others (Specify)		P1							P1

N=new indication

:

E=added under Appendix E

P1=previously cleared by FDA (K061083)

E=added under Appendix E

P2=previously cleared by FDA (K070982)

Additional Comments: Small organs include: thyroid, testes, breast Combined: B/M Mode

Other uses include: Uterus, Ovary, and Prostate

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

Concurrence of CDRH, office of Device Evaluation(((Division Sign-Off)

y

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _______________________________________________________________________________________________________________________________________________________________ KO81110

:ription Use (Per 21 CFR 801.109)

ગા 8

Indications For Use

5

SIUI CTS-900 Digital Ultrasound Imaging System

Diagnostic Ultrasound Indications for Use Form

2. Transducer Indications for Use Form

Device Name: Convex Array C3L60B

Mode of Operation

Clinical Application	B	Color	Power	Color	Combined	Other
		Doppler	(Amplitude)	Velocity	(Specify)	(Specify)
			Doppler	Imaging
Opthalmic
Fetal	P1				P1
Abdominal	P1				P1
IntraOperative
(Cardiac)
IntraOperative
Neurological
Pediatric
Small Organ
(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P1				P1
Transesophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethrai
Intra-Vascular
Peripheral Vascular
Laparascopic
Muscular-Skeletal
Conventional
Muscular-Skeletal
Superficial
Others (Specify)	P1				P1

N=new indication

E=added under Appendix E

P1=previously cleared by FDA (K061083) P2=previously cleared by FDA (K070982)

Additional Comments: other uses include: Uterus, Ovary and Prostate Combined: BIM Mode

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

Concurrence of CDRH, office of Device Evaluation (ODE)

Jorge M. Ortiz

Division of Reproductive, Abdominal and Radiological Devices Kog 1110 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109) Section 8

Indications For Use

Page 3 of 4

6

SIUI CTS-900 Digital Ultrasound Imaging System

Diagnostic Ultrasound Indications for Use Form

3. Transducer Indications for Use Form

Device Name: Linear Array L7L38B

| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|-----------------------------------|---|----|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| IntraOperative
(Cardiac) | | | | | | | | | | |
| IntraOperative
Neurological | | | | | | | | | | |
| Pediatric | | P1 | | | | | | | P1 | |
| Small Organ
(Specify) | | P1 | | | | | | | P1 | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral Vascular | | P1 | | | | | | | P1 | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | P2 | | | | | | | P2 | |
| Muscular-Skeletal
Superficial | | P2 | | | | | | | P2 | |
| Others (Specify) | | | | | | | | | | |

Mode of Operation

N=new indication

E=added under Appendix E

P1=previously cleared by FDA (K061083) P2=previously cleared by FDA (K070982) Additional Comments: Small organs include: thyroid, testes, breast Combined: B/M Mode

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

Concurrence of CDRH, office of Device Evaluation (ODE)

Ibrú Mthz

(Division Sian-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number Page 4 of 4

Prescription Use (Per 21 CFR 801.109) Section 8

Indications For Use