CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM

K061488 · Shantou Institute of Ultrasonic Instruments (Siui · IYN · Jun 30, 2006 · Radiology

Device Facts

• Record ID: K061488
• Device Name: CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM
• Applicant: Shantou Institute of Ultrasonic Instruments (Siui
• Product Code: IYN · Radiology
• Decision Date: Jun 30, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

Portable diagnostic ultrasound system; utilizes convex and linear transducers to acquire acoustic echo data; processes signals for 2D (B-mode), M-mode, and B/M-mode imaging. Features include cine review, image zoom, and automated measurements (distance, area, circumference, angle, time, slope, heart rate, and obstetric parameters). Operated by clinicians in clinical settings; system includes main unit, control panel, and monitor. Output displayed on 10-inch B/W monitor; supports image transmission to PC via RS-232C. Assists clinicians in visualizing anatomy and performing quantitative assessments to support diagnostic decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through acoustic output measurements and functional testing of imaging modes, measurement accuracy, and system specifications.

Technological Characteristics

Portable ultrasound system; 256 grey levels; 2.5MHz to 9.0MHz probe frequency range; convex and linear scanning; B, M, and B/M display modes. Features variable aperture 1-4 focal zone electronic focusing. Includes 10-inch B/W monitor, RS-232C connectivity, and 512x512x8 bit DSC memory. Power: 220V/110V. Dimensions: 320x415x310 mm; weight ~10-11kg.

Indications for Use

Indicated for diagnostic ultrasound imaging and measurement in abdominal, pediatric, small organ (thyroid, parathyroid, parotid, submaxillary gland, testes, breast), cardiac, and peripheral vascular applications. For use by clinicians in B-mode, M-mode, and B/M-mode.

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

• SIUI CTS-485 (K012772)

Submission Summary (Full Text)

{0}------------------------------------------------

JUN 3 0 2006

SIUI CTS-5500/6600 Ultrasound Imaging System

# Section 7 Summary of Safety and Effectiveness

| Trade Name: | CTS-5500/CTS-6600 with C3I40 and L7I50 Transducers |
|-------------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | Diagnostic Ultrasound System |
| Classification Name: | Ultrasonic Pulsed Echo Imaging System, 90 IYO<br>(Per 21 CFR section 892.1560) |
| Manufacturer's Name: | Shantou Institute of Ultrasonic Instruments |
| Address: | #77, Jinsha Road,<br>Shantou SEZ, 515041, China |
| Corresponding Official: | Li Delai |
| Title: | President |
| Telephone: | (86) 754-8250150 Fax: [phone] |
| US Agent: | Bob Leiker/ Consultant /QRS<br>Dublin, CA 94568<br>Telephone: [phone] Fax: [phone] |

SIUI CTS-485 , K012772 Predicate Device:

Device Description: The SIUI CTS-5500/CTS-6600 is a portable diagnostic ultrasound system capable of the following operating modes: 2D (B mode), M 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, 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 applications

Technological Characteristics:

1) Scanning modes: convex and linear scanning

2) Display modes: a) B-Mode (B, 2B) b) M-Mode c) B/M-Mode

3) Grey scale: 256

4) Frequency of probe: 2.5MHz to 9.0MHz

Section 7

Summary of Safety and Effectiveness

Page 1 of 2

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#### SIUI CTS-5500/6600 Ultrasound Imaging System

- 5) Image Display multiple: x1.0, x1.5, x2.0; Shift 2mm step
- 6) Focusing method: Variable aperture 1-4 focal zone electronic focusing
- 7) Display range (max):

Depth 210mm angle 82°(Convex probe)

Depth 140mm width 50mm (Linear probe)

- 8) Image adjustment:
- a) Gain: 0 to 99 (digital) c) Grey map curve: 8 b) TGC: 6 steps

types

- d) Frame correlation: 4 steps e) Edge enhance: 4 steps
- 9) M-mode speed:

Time for full screen scroll: 1, 2, 4, 8 sec

- 10) Cineloop: 64 frames.continual/single
- 11) DSC memory capacity: 512x512x8 bit
- 12) Image display: Left/right, positive/negative
- 13) Monitor: 10-inch B/W monitor
- 14) Character display
- a) Patient's ID b) Hospital Name c) Comment

d) Automatically display items: Date & time, probe frequency, gain and other operating parameters

- 15) Body marks: 25 types
- 16) Measurements and calculations
- (a) General measurements and calculations

2D: Distance, Area, Circumference, and Angle

M-Mode: Distance, Time, Slope, Heart rate

- (b) Obstetrics measurements: BPD, CRL, FL, AC, HC, GS, VOL, ANG
- (c) Other measurements
- 17) I/O port

RS-232C port for transmitting images to PC

- 18) Dimension: 320(w) x415 (I) x310 (h) mm
- 19) Net Weight: approx. 11kg for CTS-5500, 10kg for CTS-6600
- 20) Power Consumption:

220V±10, 110VA or 110V±10, 110VA

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2006

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

Re: K061488

Trade Name: CTS-5500/CTS-6600 Diagnostic Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Number: 21 CFR 892.1560 Regulatory Name: Ultrasonic pulsed echo imaging Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 26, 2006 Received: May 31, 2006

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.

This determination of substantial equivalence applies to the following transducers intended for use with the CTS-5500/CTS-6600 Diagnostic Ultrasound Imaging System, as described in your premarket notification:

Image /page/2/Picture/11 description: The image is a circular seal with the letters "FDA" in the center. The text "The New FDA Centennial" is arranged around the top and bottom of the circle. The seal is surrounded by a dotted border.

: Protecting and Promoting Public Health

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#### Transducer Model Number

### Convex Array C3140 Linear Array L7150

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 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, (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), please contact the Office of Compliance at [phone]. 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 Act from the Division of Small

![Image of a blurred text block]

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Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/odrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D. at [phone].

Sincerely yours,

Nancy C. Brogdon

Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

-

{5}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form

| 1. System Indications for Use Form |
|------------------------------------|
|------------------------------------|

Device Name: CTS-5500/CTS-6600

K061488

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

N = new indication P = previously cleared by FDA E = added under Appendix E

Additional Comments: Small organs includes: thyroid, parathyroid, parotid, submaxillary gland, testes and breast

Combined: B/M Mode

Pediatric Comments: Pediatric Intended Uses include: Cardiology, Abdomen, Peripheral Vascular

Pediatic Comments: Pediatic Intended Uses include: Cardiology, Abdomen, Peripheral Vascular

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Offi
Division of Reprod
and Radiological Devi
510(k) Number***_***_

Section 8

Indications For Use

{6}------------------------------------------------

SIUI CTS-5500/6600 Ultrasound Imaging System

Diagnostic Ultrasound Indications for Use Form

Mode of Op

| 2. Transducer Indications for Use Form |
|----------------------------------------|
|----------------------------------------|

| Device Name: | Convex Array C3I40 |
|--------------|--------------------|
|--------------|--------------------|

K061488

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

N = new indication P = previously cleared by FDA E = added under Appendix E
Additional Comments: Pediatric Comments: Pediatric Intended Uses include: Cardiology AbdomenAdditional Comments: Pediatric Comments: Pediatric Intended Uses include: Cardiology, Abdomen

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)

J. Horace Borden

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Section 8

Indications For Use

{7}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form

Device Name: Linear Array L7150

KOBIG

Mode of Operation

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

P = previously cleared by FDA E = added under Appendix E N = new indication

Additional Comments: Small organs includes: thyroid, parotid, submaxillary gland, testes and breast

Combined: B/M Mode

Pediatric Comments: Pediatric Intended Uses include: Peripheral Vascular

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

Concurrence of CDRH, office of Device Evaluation (ODE)

Lila Carter

Division Sign-Off Presion of Reproductive, Abdominal. na Qadiologic

Prescription Use (Per 21 CFR 801.109)

-- •

Section 8

Indications For US