CTS-415
Device Facts
| Record ID | K013327 |
|---|---|
| Device Name | CTS-415 |
| Applicant | Shantou Institute of Ultrasonic Instuments |
| Product Code | IYO · Radiology |
| Decision Date | Dec 14, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ cardiac.
Device Story
Portable electronic scanning ultrasonotomograph (linear/convex) for B, B/B, B/M, and M-mode imaging. Inputs: ultrasonic signals via C3I40 (curved) or L7I50 (linear) transducers (2.5-9.0 MHz). Processing: digital scan converter (DSC) and CPU module perform image reconstruction, gain adjustment, and measurement calculations. Outputs: tomographic images on 9-inch video monitor; quantitative measurements (distance, area, volume, HR, OB parameters). Used in clinical settings by healthcare professionals. Output facilitates diagnostic assessment of fetal, abdominal, cardiac, and small organ structures. Benefits: non-invasive visualization and biometric quantification for clinical decision-making.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing and technical comparison to the predicate device.
Technological Characteristics
Electronic convex/linear scanning; 256 grey levels; 2.5-9.0 MHz probe frequency; variable aperture electronic focusing; 512x512x8 bit DSC memory; B, B/B, B/M, M display modes; RS-232C connectivity; PAL/NTSC video output; portable form factor (~50kg).
Indications for Use
Indicated for fetal, abdominal, pediatric, small organ (thyroid, parathyroid, parotid, submaxillary gland, testes, breast), cardiac, and peripheral vascular imaging and measurement. For 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
- Hitachi Medical Corporation EUB-310 (K862867)
Submission Summary (Full Text)
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K013327
#### DEC 1 4 2001 Premarket Notification [510(k)] Summary
August 24,2001
| Trade Name: | CTS-415 with C3I40 and L7I50 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: | #77, Jinsha Road,<br>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-415 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 9inch 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 angle 82° (Convex)
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Depth 120mm 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)
- (11) Cineloop: up to 64 frames, continual/single
- (12) DSC memory capacity: 512 X 512 X 8 bit
- Monitor: 9-inch BMV monitor (13)
- (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, and various measured values.
- (15) Body marks: 25 types
- (16) Measuring functions:
- (a) Basic measurement: distance, circumference, area, volume, angle, HR
- (b) Obstetrics measurement: BPD, CRL, FL, AC, HC, GS, VOL, ANG
- (c) Other measurements:
- I/O port (17)
- (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)
- (19) Dimension 395(W) x 728(L) x 1180(H) mm
- (20) Net Weight: about 50kg
- (21) Power Consumption: ~220V±10%, 100VA
- 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2001
Shantou Institute of Ultrasonic Instruments % Mr. Bob Leiker Quality and Regulatory Services 1106 Chiltern Drive WALNUT CREEK CA 94596
Re: K013327
Trade Name: CTS-415 Ultrasound Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: 90 IYO Reagulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Product Code: 90 ITX Regulatory Class: II Dated: August 24, 2001 Received: October 5, 2001
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-415 Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
#### 3.5 MHz C3I40 Curved Array Probe 7.5 MHz L7150 Linear Array Probe
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
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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 (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 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 (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
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Page 3 - Mr. Leiker
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
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-415 Ultrasound Imaging System
: 上
K013327
### Indications for Use Form
Diagnostic Ultrasound System Indications for Use Form Device Name: CTS-415
| 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 | | 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_
..............................................................................................................................................................................
Concurrence of CDRH, office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Nancy C. Gordon
03
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# 3.1 SIUI CTS-415 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 | | N | N | | | | | | N | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | | | | | | N | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral 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
007
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## 3.2 SIUI CTS-415 Ultrasound Imaging System
#### Scanhead Indications for Use Form
Device Name: Linear Array L7I50
| 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 | | | | | | | | | | |
| Pediatric | | 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, parotid, submaxillary gland. __testes and breast Pediatric Intended Uses include: Peripheral Vasa Pediatric Comments:
... 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
510k) N
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