CTS-485 ULTRASOUND IMAGING SYSTEM

K012772 · Shantou Institute of Ultrasonic Instuments · IYO · Oct 1, 2001 · Radiology

Device Facts

• Record ID: K012772
• Device Name: CTS-485 ULTRASOUND IMAGING SYSTEM
• Applicant: Shantou Institute of Ultrasonic Instuments
• Product Code: IYO · Radiology
• Decision Date: Oct 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ cardiac.

Device Story

CTS-485 is a portable electronic scanning ultrasonotomograph; utilizes linear/convex transducers to acquire ultrasonic pulsed echo signals; digital scan converter (DSC) and CPU process signals into B, B/B, B/M, and M-mode images; output displayed on 9-inch video monitor. Used in clinical settings by healthcare professionals for diagnostic imaging and measurements (distance, area, volume, HR, etc.). Features include cineloop, body marks, and character display for patient/hospital data. RS-232C port allows image transmission to PC. Benefits include non-invasive visualization of internal structures for clinical assessment and decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and bench testing of the ultrasound system.

Technological Characteristics

Electronic convex/linear scanning; B, B/B, B/M, M display modes; 256 grey scale; 2.5-9.0 MHz probe frequency; variable aperture 1-4 focal zone electronic focusing; 512x512x8 bit DSC memory; 9-inch B/W monitor; RS-232C connectivity; 11kg weight; 100VA power consumption; operating range 0-40°C, 30-85% RH.

Indications for Use

Indicated for fetal, abdominal, pediatric, small organ (thyroid, parathyroid, parotid, submaxillary gland, testes, breast), and cardiac imaging. Patient population includes pediatric and adult patients requiring diagnostic ultrasound. Prescription use only.

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

• MEDISON Co. SONOACE 600 (K000030)

Submission Summary (Full Text)

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K0/2772
p.1/2

#### Tab 9

## Premarket Notification [510(k)] Summary

- August 10, 2001

| Trade Name: | CTS-485 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: | Mr. Jinzhong Yao | |
| Title: | President | |
| Telephone: | (86) 754-8250150 | Fax: [phone] |

- Predicate: MEDISON Co. SONOACE 600, K000030
Device Description: Model CTS-485 is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC) and main CPU module. 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 cardiac.

#### Technological Characteristics:

(1) Scanning method: Electronic convex sector scanning, linear scanning

- (2) Display mode: B, B/B, B/M, M
- (3) Grey scale: 256

.

- (4) Frequency of probe: 2.5MHz to 9.0MHz
- (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 220mm angel 82° (Convex)

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K0/2772
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Depth 140mm width 50mm (Linear 5.0MHz)

- (8) Image adjustment

| Gain: | 0 to 99 (digital) |
|--------------------|--------------------|
| Near Gain: | 0 to -60 (digital) |
| Far Gain: | 0 to 6.0 (digital) |
| Grey map curve: | 8 types |
| Frame Correlation: | 4 steps |
| Edge Enhance: | 4 steps |

(9) Sweep Speed in M Mode: 1, 2, 4, 8sec/frame

- Image Display: left/right, positive/negative (10)
- Cineloop: up to 64 frames, continual/single (11)
- DSC memory capacity: 512 X 512 X 8 bit (12)
- Monitor: 9-inch B/W monitor (13)
- Character display (14)
- (a) Patient's ID
- (b) Hospital Name
- (c) Comment
- (d) Automatically Display Items: Date & time, probe frequency, gain and other operating parameters, and various measured values.
- Body marks: 25 types (15)
- Measuring functions: (16)
- (a) Basic measurement: distance, circumference, area, volume, angle, HR
- (b) Obstetrics measurement: BPD, CRL, FL, AC, HC, GS, VOL, ANG
- (c) Other measurements:
- (17) I/O port
- (a) RS-232C port for transmitting image to PC
- (b) One active convex or linear array ports
- Video system: 625lines/frame, 50fields/second (PAL) (18) or 525lines/frame, 60fields/second (NTSC)
- Dimension 290(W) x 728(L) x 250(H) mm
- (19) Net Weight: about 11kg (20)
- ~220V±10%, 100VA Power Consumption: (21)
- Or ~110V±10%, 100VA
- (22) Environmental Requirements:
- (a) Operating Temperature & Humidity: 0°C to 40°C, 30% to 85%RH
- (b) Atmospheric Pressure: 70 to 106 KPa (700 to 1060 mbars)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 1 2001

Shantou Institute of Ultrasonic Instruments % Mr. Bob Leiker Ouality & Regulatory Services 1106 Chiltern Drive WALNUT CREEK CA 94596

Re: K012772

Trade Name: CTS-485 Ultrasound Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: II Product Code: 90 IYO Dated: August 10, 2001 Received: August 17, 2001

Dear Mr. Leiker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your beenon broke 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 ready 20, 1770, the enavance 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 may, divisions of the Act include requirements for annual registration, listing of devices, good controls provibions or anabeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the CTS-485 Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

C3140 (3.5 MHz, 40mm Curved Array) L7150 (7.5 MHz, 50mm Linear Array)

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be 11 your additional controls. Existing major regulations affecting your device can be found in the Such 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 I DIT has made a advertising 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 Atter Part 801); good manufacturing practice requirements as set forth in the quality systems (QS)

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Page 2 - Mr. Leiker

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]. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours.

Nancy C. Brogdon

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

Enclosure(s)

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# 3.3 SIUI CTS-485 Ultrasound Imaging System

#### Indications for Use Form

Diagnostic Ultrasound System Indications for Use Form Device Name: CTS-485

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

N=new indication

Additional Comments: _Small organs includes: thyroid, parathyroid, parotid, submaxillary gland, testes and breast___ Pediatric Comments: Pediatric Intended Uses include: Cardiology, Abdomen, Peripheral Vasa

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 GFR 801.109)

Nancy C. Boydon

productive. Abdominal. cal Devices

ਹੈ ਉ

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# 3.1 SIUI CTS-485 Ultrasound Imaging System

### Scanhead Indications for Use Form

Device Name: Convex Array C3I40

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

N=new indication

Additional Comments: __Pediatric Comments: Pediatric Intended Uses include: Cardiology, Abdomen

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)

Nancy C brogdon

ਨੂੰ ਉ

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# 3.2 SIUI CTS-485 Ultrasound Imaging System

# Scanhead Indications for Use Form

Device Name: Linear Array L7150

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

N=new indication

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

Pediatric Comments: Pediatric Intended Uses include: Peripheral Vasa

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)

Nancy C Brogdon

510(k) Num

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