(122 days)
Not Found
No
The description focuses on standard ultrasound imaging modes and post-processing of echoes, with no mention of AI, ML, or related concepts.
No.
The device is described as a "Diagnostic Ultrasound System" intended for "clinical diagnostic imaging applications" and does not mention any therapeutic capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states "C5 Diagnostic Ultrasound System is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ...". The "Device Description" also refers to it as capable of "clinical diagnostic imaging applications" and a "color diagnostic ultrasound system."
No
The device description explicitly states it consists of a mobile console with keyboard control panel, power supply module, color LCD monitor, and optional probes, which are all hardware components. While it is software-controlled, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The C5 Diagnostic Ultrasound System uses ultrasonic energy transmitted into the patient's body to create images of internal structures and fluid flow. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
- Intended Use: The intended use describes the evaluation of various anatomical sites within the patient's body.
- Device Description: The description clearly states the system transmits energy into the patient's body and processes received echoes.
Therefore, the C5 Diagnostic Ultrasound System is a diagnostic imaging device that operates in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
C5 Diagnostic Ultrasound System is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The C5 Diagnostic Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.
This system is a Track 3 device that employs a series of probes that include linear array (frequency: 7.5 MHz), convex array (frequency: 3.5 MHz), trans-vaginal (also belong to the category of "linear array") (frequency: 6.5 MHz), micro-convex array (frequency: 5.0 MHz). This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.
This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode , M-Mode, Color-Flow Doppler, Pulsed Wave Doppler and Power Doppler, or the combination of these modes (i.e. "B-Mode + Color-Flow Doppler", "B-Mode + Color-Flow Doppler + Pulsed Wave Doppler" and "B-Mode + M-Mode").
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
Indicated Patient Age Range
neonatal and adult
Intended User / Care Setting
qualified physician
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)
Non-Clinical Tests: The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:
- Biocompatibility according to ISO 10993-5 and ISO 10993-10;
- Electrical Safety according to AAMI / ANSI ES60601-1;
- Electromagnetic Compatibility according to IEC 60601-1-2;
- Performance Safety and Effectiveness according to IEC 60601-2-37.
Key Results: The safety and effectiveness of subject device have been tests according to the same FDA recongized standards as the predicate device - IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5 and ISO 10993-10, the result of which displays that subject device fully meets the standards requirement, that subject device will be as safe and effective for usage as the predicate device.
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.
S12 Digital Color Doppler Ultrasound System K142474
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
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Guangzhou Sonostar Technologies Co., Ltd. % Ms. Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room302, NO.21 Building, Kaiyu Garden, Xishan South Road Wenzhou, Zhejiang 325000 CHINA
Re: K171926
Trade/Device Name: C5 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 1, 2017 Received: August 14, 2017
Dear Ms. Nan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
October 27, 2017
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Robert Oaks
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K171926
Device Name C5 Diagnostic Ultrasound System
Indications for Use (Describe)
C5 Diagnostic Ultrasound System is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Image /page/3/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a lightning bolt shape cut out of the top left corner. To the right of the star is the text "SonoStar" in a bold, green font.
| System: | C5 Diagnostic Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | ||||||||
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Track 1&3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (PDI) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N - Note 1 | |||||
| N - Note 2 | ||||||||
| N - Note 3 | N | |||||||
| Abdominal | N | N | N - Note 3 | N | ||||
| Intra-operative (Specify) | ||||||||
| Intra-Operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N - Note 1 | N | ||||
| Small Organ | ||||||||
| (breast, testes, thyroid) | N | N | N - Note 1 | N | ||||
| Fetal | ||||||||
| Imaging | ||||||||
| &Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | N | N | N - Note 1 | N | ||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | N | N | ||||||
| Musculo-skeletal | ||||||||
| (Superficial) | N | N | ||||||
| Intravascular | ||||||||
| Other (OB/Gyn) | N | N | N | N | N - Note 1 | |||
| N - Note 2 | ||||||||
| N - Note 3 | N | |||||||
| Other (Urology) | N | N | N - Note 1 | N | ||||
| Cardiac Adult | N | N | N | N | N - Note 3 | |||
| N - Note 1 | ||||||||
| N - Note 2 | N | |||||||
| Cardiac | Cardiac Pediatric | N | N | N | N | N - Note 3 | ||
| N - Note 1 | ||||||||
| N - Note 2 | N | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-epoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral Vessel | N | N | N | N - Note 1 | |||
| N - Note 2 | N | |||||||
| Other (Specify) | ||||||||
| System: | C5 Diagnostic Ultrasound System | |||||||
| Transducer: | Convex Array Transducer (3C6C) | |||||||
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Track 1&3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (PDI) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| &Other | Fetal | N | N | N | N | N - Note 1 | N | |
| N - Note 2 | ||||||||
| N - Note 3 | ||||||||
| Abdominal | N | N | N - Note 1 | N | ||||
| Intra-operative (Specify) | ||||||||
| Intra-Operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ | ||||||||
| (breast, testes, thyroid) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (OB/Gyn) | N | N | N | N | N - Note 1 | N | ||
| N - Note 2 | ||||||||
| N - Note 3 | ||||||||
| Other (Urology) | N | N | N - Note 1 | N | ||||
| Cardiac | Cardiac Adult | N | N | N | N | N - Note 3 | N | |
| N - Note 1 | ||||||||
| N - Note 2 | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-epoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral Vessel | |||||||
| Other (Specify) |
N=new indication; P=previously cleared by FDA; E=added under this appendix
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Note 1: B and Color Doppler Combined;
Note 2: B, Color Doppler and PWD Combined;
4
Image /page/4/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a green arrow pointing from the bottom left to the top right. To the right of the star is the text "SonoStar" in a green, bold, sans-serif font.
Diagnostic Ultrasound Indications For Use Format
N=new indication; P=previously cleared by FDA; E=added under this appendix
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Note 1: B and Color Doppler Combined;
Note 2: B, Color Doppler and PWD Combined;
5
Image /page/5/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a lightning bolt shape in the upper left corner. To the right of the star is the word "SonoStar" in a stylized, green font.
| System: | C5 Diagnostic Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | Linear Array Transducer (7L4C) | ||||||||
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | Specific | B | M | PWD | CWD | Color | |||
| Doppler | Combined | ||||||||
| (Specify) | Other* | ||||||||
| (PDI) | |||||||||
| (Track 1 Only) | (Track 1&3) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-Operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N - Note 1 | N | |||||
| Small Organ | N | N | N - Note 1 | N | |||||
| (breast, testes, thyroid) | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| &Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | ||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | N | ||||||||
| Intravascular | |||||||||
| Other (OB/Gyn) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-epoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral Vessel | N | N | N - Note 1 | N | ||||
| Other (Specify) |
Diagnostic Ultrasound Indications For Use Format
N=new indication; P=previously cleared by FDA; E=added under this appendix
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Note 1: B and Color Doppler Combined;
Note 2: B, Color Doppler and PWD Combined;
6
Image /page/6/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a green arrow pointing from the bottom left to the top right. To the right of the star is the text "SonoStar" in a green, bold, sans-serif font.
| Diagnostic Ultrasound Indications For Use Format | ||||||||
|---|---|---|---|---|---|---|---|---|
| System: | C5 Diagnostic Ultrasound System | |||||||
| Transducer: | Trans-vaginal Transducer (6E1C) | |||||||
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Track 1&3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (PDI) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N - Note 3 | N | ||
| N - Note 1 | ||||||||
| N - Note 2 | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-Operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ | ||||||||
| (breast, testes, thyroid) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| &Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | N | N | N - Note 1 | N | ||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (OB/Gyn) | N | N | N | N | N - Note 1 | N | ||
| N - Note 2 | ||||||||
| N - Note 3 | ||||||||
| Other (Urology) | N | N | N - Note 1 | N | ||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Cardiac | Intravascular (Cardiac) | |||||||
| Trans-epoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral Vessel | |||||||
| Other (Specify) | ||||||||
| System: | C5 Diagnostic Ultrasound System | |||||||
| Transducer: | Micro-Convex Array Transducer (6C15C) | |||||||
| Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Track 1&3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (PDI) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | N | N | N - Note 1 | N | ||||
| Intra-operative (Specify) | ||||||||
| Intra-Operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N - Note 1 | ||||
| N - Note 2 | N | |||||||
| Small Organ | ||||||||
| (breast, testes, thyroid) | ||||||||
| Neonatal Cephalic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| &Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (OB/Gyn) | N | N | N | N | N - Note 1 | |||
| N - Note 2 | ||||||||
| N - Note 3 | N | |||||||
| Other (Urology) | N | N | N - Note 1 | N | ||||
| Cardiac Adult | N | N | N | N | N - Note 3 | |||
| N - Note 1 | ||||||||
| N - Note 2 | N | |||||||
| Cardiac | Cardiac Pediatric | N | N | N | N | N - Note 3 | ||
| N - Note 1 | ||||||||
| N - Note 2 | N | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-epoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral Vessel | |||||||
| Other (Specify) |
N=new indication; P=previously cleared by FDA; E=added under this appendix
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Note 1: B and Color Doppler Combined;
Note 2: B, Color Doppler and PWD Combined;
7
Diagnostic Ultrasound Indications For Use Format
N=new indication; P=previously cleared by FDA; E=added under this appendix
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
Note 1: B and Color Doppler Combined;
Note 2: B, Color Doppler and PWD Combined;
8
Image /page/8/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star with a green outline on the left side of the image. To the right of the star is the text "SonoStar" in a green, sans-serif font. The text is slightly bolded and the letters are evenly spaced.
007 510(k) Summary
(As required by 21 CFR 807.92(a))
7.1 Submitter Information
- · Company: Guangzhou Sonostar Technologies Co., Ltd.
- · Address: 504#, C Building, #27 Yayingshi Road, Science Town,
Guangzhou, Guangdong, 510665, P.R.China
- ・ Phone: 086-20-32382095
- ・ Fax: 086-20-62614030
- · Contact: Weizhong Cai, General Manager
- · Date: May 01, 2017
7.2 Device Information
- · Trade/Device Name: Diagnostic Ultrasound System
- Model: C5
- · Common Name: Diagnostic Ultrasound System and Transducer
- · Classification: 1) Device: System, Imaging, Pulsed Doppler, Ultrasonic
Regulation Description: Ultrasonic pulsed doppler
imaging system
Review Panel: Radiology
Product Code: IYN
Submission Type: 510(k)
Regulation Number: 21 CFR 892.1550
Device Class: 2
-
- Device: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Description: Ultrasonic pulsed echo imaging
- Device: System, Imaging, Pulsed Echo, Ultrasonic
system
Review Panel: Radiology
Product Code: IYO
9
Regulation Number: 21 CFR 892.1560 Device Class: 2 3) Device: Transducer, Ultrasonic, Diagnostic Regulation Description: Diagnostic ultrasonic transducer Review Panel: Radiology Product Code: ITX Regulation Number: 21 CFR 892.1570 Device Class: 2
7.3 Predicate Device Information
S12 Digital Color Doppler Ultrasound System submitted by SonoScape Company Limited 510K Number: K142474
7.4 Device Description
The C5 Diagnostic Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.
This system is a Track 3 device that employs a series of probes that include linear array (frequency: 7.5 MHz), convex array (frequency: 3.5 MHz), trans-vaginal (also belong to the category of "linear array") (frequency: 6.5 MHz), micro-convex array (frequency: 5.0 MHz). This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes.
10
This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode , M-Mode, Color-Flow Doppler, Pulsed Wave Doppler and Power Doppler, or the combination of these modes (i.e. "B-Mode + Color-Flow Doppler", "B-Mode + Color-Flow Doppler + Pulsed Wave Doppler" and "B-Mode + M-Mode").
7.5 Indications for Use
C5 Diagnostic Ultrasound System is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
7.6 Comparison of Technological Characteristics with the Predicate Device
| 7.6.1 Comparison Table of Technological Characteristic with the | ||
|---|---|---|
| Predicate Device | ||
| Comparison Items | Subject Device: | |
| Diagnostic Ultrasound | ||
| System | ||
| (Model: C5) | Predicate Device: | |
| S12 Digital Color | ||
| Doppler Ultrasound | ||
| System | ||
| (K142474) | ||
| Classification & Intended Use | ||
| Classification | Product Codes: | |
| IYN & IYO & ITX | ||
| Class: 2 | Product Codes: | |
| IYN & IYO & ITX | ||
| Class: 2 | ||
| Intended Use | A general-purpose | |
| ultrasonic imaging | A general-purpose | |
| ultrasonic imaging | ||
| instrument intended for | ||
| use by a qualified | ||
| physician for | ||
| evaluation of Fetal, | ||
| Abdominal, Pediatric, | ||
| Small Organ (breast, | ||
| testes, thyroid), | ||
| Trans-vaginal, | ||
| Peripheral Vascular, | ||
| Musculo-skeletal | ||
| (Conventional and | ||
| Superficial), Cardiac | ||
| (neonatal and adult), | ||
| OB/Gyn and Urology. | instrument intended for | |
| use by a qualified | ||
| physician for | ||
| evaluation of Fetal, | ||
| Abdominal, Pediatric, | ||
| Small Organ (breast, | ||
| testes, thyroid), | ||
| Cephalic(neonatal and | ||
| adult), Trans-rectal, | ||
| Trans-vaginal, | ||
| Peripheral Vascular, | ||
| Musculo-skeletal | ||
| (Conventional and | ||
| Superficial), Cardiac | ||
| (neonatal and adult), | ||
| OB/Gyn and Urology. | ||
| Technological Characteristics | Based on an embedded | |
| Linux Operating | ||
| System | Based on an embedded | |
| Linux Operating | ||
| System | ||
| Autocorrelation for | ||
| color processing and | ||
| FFT for pulse. | Autocorrelation for | |
| color processing and | ||
| FFT for pulse and CW | ||
| Doppler processing. | ||
| Design | Supporting Linear | |
| probes (7.5MHz & 6.5 | ||
| MHz) and Convex | ||
| array probes (3.5MHz | Supporting Linear, | |
| Curve linear and Phase | ||
| array probes from 2 to | ||
| 15MHz | ||
| Cine play back | Cine play back | |
| capability | capability | |
| Image file archive | Image file archive | |
| Software upgrade with | Software upgrade with | |
| USB flash drive | USB flash drive | |
| Digital Scan Converter | ||
| 1024×768 | 800×600 | |
| With full keyboard | With full keyboard | |
| panel | panel | |
| TGC 8 slider | TGC 8 slider | |
| Depth Range: 3.6 to | Depth Range: 3 to | |
| 35.1cm | 24.8cm | |
| B Dynamic range | B Dynamic range | |
| control: 30-165dB | control: 20-280dB | |
| Gray Scale Control: | Gray Scale Control: | |
| 0,1,2,3,4,5,6,7 | ||
| 8,9,10,11,12,13,14(14 | ||
| Optional) | 1,2,3,4,5,6,7 (7 | |
| Optional) | ||
| Operation Controls | Focal Number: | Focal Number: |
| adjustable, max 4 | adjustable, max 12 | |
| B persistance: 0-95% | B persistance: 0-95% | |
| PW sweeping speed | PW sweeping speed | |
| 0,1,2,3,4 sec over | ||
| display | 2,4,6,8 sec over display | |
| PW Wall filter setting: | PW Wall filter setting: | |
| 0 to 3 | 35 to 750 | |
| PW sample volume: 0 | ||
| to 7mm | PW sample volume: 0.7 | |
| to 21mm | ||
| PW angle correction: | PW angle correction: | |
| adjustable, 0 to 85 | adjustable, 0 to 72 | |
| degree | degree | |
| Spectrum baseline: | Spectrum baseline: | |
| adjustable | adjustable, such as shift | |
| and invert | ||
| Color ROI setting: | Color ROI setting: | |
| trackball to control size | trackball and set key to | |
| and position | control size and | |
| position | ||
| Color Wall Filter | Color Wall Filter | |
| settings: 0 to 7 | settings: 35 to 750 | |
| Zoom adjustable | Zoom adjustable | |
| Freeze control: | Freeze control: | |
| Toggling freeze key | Toggling freeze key | |
| Cine control: play/stop, | Cine control: play/stop, | |
| loop speed, the start, | loop speed, the start, | |
| the end, Frame by | the end, Frame by | |
| Frame | Frame | |
| Operation Mode | B, M, PW, Color, PDI, | B, M, PW, CW, CFM, |
| Compound Imaging | DPI, TDI, Tissue | |
| (i.e. B+Color, | ||
| B+Color+PW, B+M). | Harmonic Image, Color | |
| M Mode, PIH, | ||
| Compound Imaging, | ||
| 3D/4D Mode | ||
| Panoramic Imaging, | ||
| Trapezoid Imaging. | ||
| Display Modes | B, PDI: Single, Dual, | B, CFM, DPI, TDI, |
| Quad | 4D: Single, Dual, Quad | |
| M: V1/3, V1/2(Dual), | B+CFM, B+DPI, | |
| V2/3, H1/2, H1/4, 01/4 | B+TDI: Dual Live | |
| PW: V1/3, V1/2(Dual), | B/M, CFM/M, TDI/M, | |
| V2/3, H1/2, H1/4, 01/4 | Steer M: V1/3, | |
| V1/2(Dual), V2/3, | ||
| H1/2, H1/4, 01/4 | ||
| PW, CW: V1/3, | ||
| V1/2(Dual), V2/3, | ||
| H1/2, H1/4, 01/4 | ||
| B, PDI, Color | B, CFM, DPI, TDI: | |
| Doppler: Distance, | Area Ratio, Angle, | |
| Area, Circumference, | Volume, Volume | |
| Volume, Area Ratio, | L×W×H, Doppler Area, | |
| Distance Ratio, Angle, | Vascular, Small Part, | |
| Abdomen, Kidney, | Ortho, OB/GYN, | |
| Gynecology, Uterus, | Cardiac, URO, VHE; | |
| Ovary, Follicles, | M: Distance, Time, | |
| Obstetrics, AFI, Fetal | Slope, HR, Left | |
| Measurement Items | Cardiology, Small | Ventricle, Mitral Valve, |
| Parts, Urology, | Aortic Valve; | |
| Pediatric | PW/CW: Flow | |
| M: Distance, Time, | Velocity, Acceleration, | |
| Heart Rate, Slope Rate, | Time, Trace, Auto | |
| Fetal Cardiology | Trace, HR, Vascular, | |
| PW: Flow Speed Ratio, | OB/GYN, Cardiac, VE | |
| Speed, Time, Heart | ||
| Rate, Acceleration, | ||
| Spectral Trace, | ||
| Obstetrics, Vascular | ||
| Cine Loop | Automatic | Automatic |
| review/manual review | review/manual review | |
| Review speed can be | Review speed can be | |
| adjusted | adjusted | |
| Operating Condition | Temperature:5~+40°C | Temperature: 10~40°C |
| Relative humidity: | Relative humidity: | |
| 25~80% | 30~75% | |
| Air pressure: | Air pressure: | |
| 700hPa~1060hPa | 700hPa~1060hPa | |
| Storage Condition | Temperature: | Temperature: -20~55°C |
| -20~+55°C | ||
| Relative humidity: | Relative humidity: | |
| 25~93% | 20~90% | |
| Air pressure: | Air pressure: | |
| 700hPa~1060hPa | 700hPa~1060hPa | |
| Power Supply | Voltage: 100-240V AC | Voltage: 100-240V AC |
| Frequency: 50/60 Hz | Frequency: 50/60 Hz | |
| Power Consumption: | Power Consumption: | |
| 100-240V AC, 2.4-1A | 100-240V AC, | |
| 2.7-1.1A | ||
| Screen Size | 15 inch LCD monitor | 15 inch LCD monitor |
| Safety & Effectiveness | ||
| Electrical Safety | Evaluated according to | Evaluated according to |
| IEC 60601-1 | IEC 60601-1 | |
| EMC | Evaluated according to | Evaluated according to |
| IEC 60601-1-2 | IEC 60601-1-2 | |
| Bio-compatibility | Evaluated according to | Evaluated according to |
| ISO 10993-5 & ISO | ||
| 10993-10 | ISO 10993-5 & ISO | |
| 10993-10 | ||
| Performance Safety | Evaluated according to | |
| IEC 60601-2-37 | Evaluated according to | |
| IEC 60601-2-37 |
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Guangzhou Sonostar Technologies Co., Ltd.
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Image /page/12/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star on the left side of the image. To the right of the star is the name of the company, "SonoStar", in green font.
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Image /page/13/Picture/0 description: The image contains the logo for SonoStar. The logo features a green star outline on the left side of the image. To the right of the star is the text "SonoStar" in a green, sans-serif font.
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Image /page/14/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star with a green outline on the left side of the image. To the right of the star is the word "SonoStar" in green, with the "S" in "SonoStar" being larger than the rest of the letters.
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Image /page/15/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star with a green wordmark to the right of the star. The wordmark reads "SonoStar" in a sans-serif font.
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7.6.2 Brief Summary
First, the subject device enjoys identical classification and similar intended use with the predicate device, which forms the foundation of substantial equivalence between the two devices. Though their intended use are not identical, the intended use of subject device is covered by that of predicate device which has a larger usage scope, thus will not affecting the substantial equivalence comparison between the two devices.
Secondly, the subject device boasts similar technological characteristics with the predicate device: 1) they have identical cine loop setting and screen size; 2) though their operation mode, display modes and measurement items are not identical, the operation mode, display modes and measurement items of subject device are covered by those of predicate device; 3) they share similar design which is almost the same, and the slight difference in digital scan converter will not affect the core usage of devices, thus will not affecting their substantial equivalence comparison; 4) though they are not identical in operating condition and storage condition, their slight difference in operating condition and storage condition will not affect the core usage of subject device as long as users operate according to instruction, thus will not influencing the substantial equivalence comparison between them; 5) although their power supply are slightly different, the electrical safety and EMC of subject device have been tested according to FDA recognized standards - IEC 60601-1 and IEC 60601-1-2, thus will not bringing in new safety concerns; 6) though the two devices are quite different in operation controls, the basic safety and essential performance of subject device has
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been evaluated according to FDA recognized standard - IEC 60601-2-37, thus will not bringing new safety and effectiveness concerns. All of the above facts further support that the two devices are substantially equivalent.
Last but not least, the safety and effectiveness of subject device have been tests according to the same FDA recongized standards as the predicate device - IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5 and ISO 10993-10, the result of which displays that subject device fully meets the standards requirement, that subject device will be as safe and effective for usage as the predicate device.
Accordingly, it is reasonable to conclude that two devices are substantially equivalent.
7.7 Discussion of Tests Performed
7.7.1 Clinical Tests
Clinical testing was not performed for C5 Diagnostic Ultrasound System as part of the submission.
7.7.2 Non-Clinical Tests
The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:
-
- Biocompatibility according to ISO 10993-5 and ISO 10993-10;
-
- Electrical Safety according to AAMI / ANSI ES60601-1;
-
- Electromagnetic Compatibility according to IEC 60601-1-2;
-
- Performance Safety and Effectiveness according to IEC 60601-2-37.
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Image /page/18/Picture/0 description: The image shows the logo for SonoStar. The logo features a green star with a green outline on the left side of the image. To the right of the star is the word "SonoStar" in green, with the "S" in SonoStar being the same green as the star outline and the rest of the word being a darker green.
7.8 Conclusion
From the above analysis, it is reasonable for us to conclude that the subject device - C5 Diagnostic Ultrasound System is substantially equivalent to the predicate device - S12 Digital Color Doppler Ultrasound System (K142474).