DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR

K092907 · Shantou Institute of Ultrasonic Instuments · IYN · Mar 5, 2010 · Radiology

Device Facts

• Record ID: K092907
• Device Name: DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR
• Applicant: Shantou Institute of Ultrasonic Instuments
• Product Code: IYN · Radiology
• Decision Date: Mar 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac and peripheral vascular applications.

Device Story

Digital ultrasound imaging system; supports linear, convex, phased array, and 3D transducers. Inputs: ultrasonic echoes from patient anatomy. Processing: system performs signal processing to generate 2D (B-mode), M-mode, PWD, Color Doppler, and 3D images. Features include cine review, image zoom, measurements, calculations, storage, and printing. Used in clinical settings by healthcare professionals for diagnostic imaging. Output: visual ultrasound images and quantitative measurements displayed on-screen for clinician review. Clinical utility: assists in diagnosis and assessment of abdominal, pediatric, small organ, musculo-skeletal, cardiac, and peripheral vascular conditions.

Clinical Evidence

Bench testing only. The device was tested per FDA guidance 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' (2008). Acoustic output measured per NEMA UD 2:2004. Conformance to safety standards IEC 60601-1, ISO 10993-5, and ISO 10993-10 verified.

Technological Characteristics

Digital ultrasound imaging system; supports linear, convex, phased array, and 3D transducers. Operating modes: B, M, PWD, Color Doppler, 3D. Safety standards: IEC 60601-1, ISO 10993-5, ISO 10993-10. Acoustic output per NEMA UD 2:2004.

Indications for Use

Indicated for diagnostic ultrasonic imaging in abdominal, pediatric, small organ, musculo-skeletal, cardiac, and peripheral vascular applications using B, M, PWD, Color Doppler, and 3D imaging modes. Contraindications not specified.

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

• Ultrasonix Ergosonix 500 Ultrasound Scanner (K042326)

Submission Summary (Full Text)

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# 510(k) Summary

MAR - 5 2010

This summary of 510(k) safety and effectiveness information is provided in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).

The assigned 510(k) number is: K092907

1. 510(k) Owner:

Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road, Shantou, Guangdong 515041, China Tel: [phone] Fax: [phone]

#### Contact Person:

Flower Cai

Shantou Institute of Ultrasonic Instruments Co., Ltd. 77 Jinsha Road, Shantou, Guangdong 515041, China

Date Prepared: February 4, 2010

#### 2. Device/Trade Name:

CTS-8800 Digital Ultrasound Imaging System

#### Classification Name:

Regulatory Class: II

| Ultrasonic Pulsed Doppler Imaging System | 90-IYN (per 21 CFR 892.1550) |
|------------------------------------------|------------------------------|
| Ultrasonic Pulsed Echo Imaging System | 90-IYO (per 21 CFR 892.1560) |
| Diagnostic Ultrasound Transducer | 90-ITX (per 21 CFR 892.1570) |

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#### 3. Predicate Device:

The subject device is substantially equivalent to the device currently having FDA 510(k) clearance Ultrasonix Ergosonix 500 Ultrasound Scanner (K042326) with respect to intended use, principles of operation and technological characteristics.

#### 4. Device Description:

The SIUI CTS-8800 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.

#### 5. Intended Use:

The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac and peripheral vascular applications.

#### 6. Safety Considerations:

The CTS-8800 Digital Ultrasound Imaging System has been tested per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in September 2008. The acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004. The device conforms to applicable medical device safety standards, such as IEC 60601-1, ISO10993-5 and ISO 10993-10.

#### 7. Conclusion:

The conclusions drawn from testing of the CTS-8800 Digital Ultrasound Imaging System demonstrates that the device is as safe and effective as the legally marketed predicate device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

# APR - 1 2010

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) % Mr. Bob Leiker ORS Representative Quality and Regulatory Services, Inc. 7263 Cronin Circle DUBLIN CA 94568

Re: K092907

Trade/Device Name: CTS-8800 Digital Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: February 4, 2010 Received: February 16, 2010

Dear Mr. Leiker:

This letter corrects our substantially equivalent letter of March 5, 2010.

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-8800 Digital Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

Convex Array C3L60G Linear Array L7L38G Convex Array 4DL40G Phased Array P3F14G

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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 895. 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at [phone].

Sincerely yours

Donald JAB

Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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(

SIUI CTS-8800 Digital Ultrasound Imaging System

### Indications for Use Statement

Device Name:

CTS-8800 Digital Ultrasound Imaging System with

Convex Array Transducer C3L60G

Linear Array Transducer L7L38G

Convex Array Transducer 4DL40G

Phased Array Transducer P3F14G

Indications for Use:

Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardi ;

peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.

Prescription Use (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IP NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K092907

: 让

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## Diagnostic Ultrasound Indications for Use Form

## 3.1 System Indications for Usc Form System: CTS-8800

| Clinical Application | Mode of Operation | | | | | | | | |
|-----------------------------|------------------------------------|---|---|-----|-----|------------------|-----------------------|--|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | | O: er*<br>(S ecify) |
| Ophthalmic | Ophthalmic | | | | | | | | N |
| Fetal<br>Imaging<br>& Other | Fetal | N | N | | | | | | |
| | Abdominal | N | N | N | | N | | | N |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | | | |
| | Small Organ (Specify) | N | N | N | | N | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeleral<br>(Conventional) | N | N | N | | N | | | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | | | |
| | Intravascular | | | | | | | | |
| | Other (Specify) | N | N | N | | N | | | N |
| Cardiac | Cardiac Adult | N | N | N | | N | | | |
| | Cardiac Pediatric | N | N | N | | N | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | | | |
| | Other (Specify) | | | | | | | | |

N = new indication: P = previously cleared by FDA: E = added under this appendix

* Other modes of oneration include: 3-D Imaging:

· Other modes of Oncranon a lines include: Prosuste, Kidney, Uterus, Ovary Small organs include: Thyroid, Testes, Breast

Prescription Usc (Per 2) CFR 801.109)

9)

Division of Radiolo Offica of In

510K K692907

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## Diagnostic Ultrasound Indications for Use Form

# 3.2 Transducer Indications for Use Form Transducer: Convex Array C3L60G

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Ot er*<br>(S cify) |
| Ophthalmic | Ophthalmic | | | | | | | - |
| Fetal<br>Imaging<br>& Other | Fetal | N | N | | | | | - |
| | Abdominal | N | N | N | . | N | | - |
| | Intra-operative (Specify) | | | | | | | - |
| | Intra-operative (Neuro) | | | | | | | - |
| | Laparoscopic | | | | | | | - |
| | Pediatric | | | | | | | - |
| | Small Organ (Specify) | | | | | | | - |
| | Neonatal Cephalic | | | | | | | - |
| | Adult Cephalic | | | | | | | - |
| | Trans-rectal | | | | | | | - |
| | Trans-vaginal | | | | | | | - |
| | Trans-urethral | | | | | | | - |
| | Trans-esoph. (non-Card.) | | | | | | | - |
| | Musculo-skeletal<br>(Conventional) | | | | | | | - |
| | Musculo-skeletal<br>(Superficial) | | | | | | | - |
| | Intravascular | | | | | | | - |
| | Other (Specify) | N | N | N | | N | | - |
| Cardiac | Cardiac Adult | | | | | | | - |
| | Cardiac Pediatric | | | | | | | - |
| | Intravascular (Cardiac) | | | | | | | - |
| | Trans-esoph. (Cardiac) | | | | | | | - |
| | Intra-cardiac | | | | | | | - |
| | Other (Specify) | | | | | | | - |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | - |
| | Other (Specify) | | | | | | | - |

Other (Specity)
N = new indication; P = previously cleared by FDA: E = addch under this annendix Additional Comments: Other uses include: Prostate, Kidney, Utcrus, Qvary

Prescription Use (Per 21 CFR 801.109)

DAPO
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

S10K. K092907

Indications For Use

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## Diagnostic Ultrasound Indications for Use Form

# 3.3 Transducer Indications for Use Form Transduccr: Lincar Array L7L38G

| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|--|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | | | |
| | Small Organ (Specify) | N | N | N | | N | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-csoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | | | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | | | |
| | Intravascular | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | | | |
| | Other (Specify) | | | | | | | | |

N = new indication: P = previously cleared by FDA: E = added under this appeadix N = new indication: P = previously cleared by 12711 = 1211 = 1211 = 161

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safet

S10K 6042461

Indications l'or Use

{8}------------------------------------------------

## Diagnostic Ultrasound Indications for Use Form

# 3.4 Transducer Indications for Use Form Transducer: Conyex Array 4DL40G

| Clinical Application | | Mode of Operation | | | | | | | Ot er*<br>(Specify) |
|-----------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|--|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | N |
| Fetal<br>Imaging<br>& Other | Fetal | | N | | | | | | |
| | Abdominal | | N | | | | | | N |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Ncuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skelctal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | N |
| | Other (Specify) | N | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |

N = new indication: P = previously cleared by FDA: E = added under this apnendix

· Other modes include: 3-D Imaging;

· Other mouts include: 5-2 millions Prostate. Kidney, Uterus, Ovary

Prescription Use (Per 21 CFR 801.109)

Division of Rediological Office of in Vitro Diagn

610K K692907

Indications For Use

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#### ടുപ്പു പോട്-8800 Digital Ultrasound Imaging System

## Diagnostic Ultrasound Indications for Use Form

# 3.5 Transducer Indications for Use Form Transducer: Phased Array P3F14G

| Clinical Application | | | Mode of Operation | | | | | | |
|-----------------------------|------------------------------------|---|-------------------|-----|-----|------------------|-----------------------|-------|-----------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Otl * | (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | |
| | Small Organ (Specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-csoph. (non-Card.) | | | | | | | | |
| | Musculo-skolctal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| | Cardiac Adult | N | N | N | | N | | | |
| Cardiac | Cardiac Pediatric | N | N | N | | N | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | |

Outer (Specify)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Sefaty
610K. K092907