(60 days)
Not Found
No
The document describes standard ultrasound signal processing techniques (Doppler, autocorrelation, DSC) and does not mention any AI or ML algorithms or capabilities.
No
The device is described as a "clinical diagnostic imaging system" used for evaluating various anatomical sites, not for treating conditions.
Yes
The Device Description explicitly states: "This SonoScape X5 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications." and "This system is a portable, general purpose, software controlled, color diagnostic ultrasound system."
No
The device description explicitly states it is an "integrated preprogrammed color ultrasound imaging system" and lists hardware components such as probes, a keyboard control panel, power supply module, and color LCD monitor. It also describes the physical process of transmitting and receiving ultrasonic energy.
Based on the provided information, the SonoScape X5 system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The SonoScape X5 system, as described, is an ultrasound imaging system that uses sound waves to create images of internal organs and structures within the patient's body.
- The intended use and device description clearly state that it is a general-purpose ultrasonic system for evaluating various anatomical sites directly on the patient. It transmits ultrasonic energy into the patient and processes the reflected echoes.
- There is no mention of analyzing biological specimens.
Therefore, the SonoScape X5 system falls under the category of medical imaging devices, not IVD devices.
N/A
Intended Use / Indications for Use
The SonoScape X5 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology. Diagnostic ultrasound imaging or fluid flow analysis of the human body.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
This SonoScape X5 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The X5 system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and autocorrelation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical and acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a portable, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral 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 X5 Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output. Laboratory tests (including Phantom tests) were conducted to verify that the X5 system met all design specifications and the X5 system conformed to applicable medical device standards.
Clinical Test: No clinical testing was required.
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.
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/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
April 4, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SONOSCAPE MEDICAL CORP. % Ms. Toki Wu Regulatory Affairs Manager 4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building, Yuquan Road, Nanshan Shenzhen, GuangDong 518051 CHINA
Re: K160258
Trade/Device Name: X5 Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 22, 2016 Received: February 1, 2016
Dear Ms. Wu:
This letter corrects our substantially equivalent letter of April 1, 2016. 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 (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.
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 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. 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 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 yours,
Jeff Bollyea
FDA
For 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)
Device Name
X5 Digital Color Doppler Ultrasound System
Indications for Use (Describe)
The SonoScape X5 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral 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) |
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3
SonoScape X5 System:
Diagnostic Ultrasound Pulsed Echo System
Diagnostic Ultrasound Pulsed Doppler Imaging System
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 | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Other* | ||||||||
| Specify | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | Note 1 | Notes 2 | ||
| Abdominal | N | N | N | N | N | Note 1 | Notes 2 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | Note 1 | Notes 2 | ||
| Small Organ (specify) | N | N | N | N | N | Note 1 | Notes 2,6 | ||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 | |
| Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 | |
| Trans-rectal | N | N | N | N | N | Note 1 | Notes 2 | ||
| Fetal | |||||||||
| Imaging& | |||||||||
| Other | Trans-vaginal | N | N | N | N | N | Note 1 | Notes 2 | |
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | N | N | N | N | Note 1 | Notes 2 | ||
| Musculo-skeletal | |||||||||
| (Superficial) | N | N | N | N | N | Note 1 | Notes 2 | ||
| Intravascular | |||||||||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | Notes 2 | ||
| Other (Urology) | N | N | N | N | N | Note 1 | Notes 2 | ||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2 |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2 | |
| Intravascular(Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral vessel | N | N | N | N | N | Note 1 | Notes 2 | ||
| Peripheral | |||||||||
| Vessel | Cerebral vascular | N |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
4
Transducer: 3C-A Curved Array
Diagnostic Ultrasound 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 | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Other* | ||||||||
| Specify | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1 | Notes 2 | |
| Abdominal | N | N | N | N | N | N | Note 1 | Notes 2 | |
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| 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 | N | Note 1 | Notes 2 | |
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Cerebral vascular |
P = previously cleared by FDA; N = new indication; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 5: 4D
Note 4: 3D Note 3: TDI Note 6: Small Organ: breast, thyroid, testes
5
Transducer: C613 Micro-curved Array
Diagnostic Ultrasound 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 | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Other* | |||||||||
| Combined | Other* | |||||||||
| Specify | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | Note 1 | Notes 2 | |||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | Note 1 | Notes 2 | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 | ||
| Fetal | Adult Cephalic | |||||||||
| Imaging& | Trans-rectal | |||||||||
| Other | Trans-vaginal | |||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2 | ||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
6
Transducer: 3P-A Phased Array
Diagnostic Ultrasound 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 | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Other* | |||||||||
| Combined | Other* | |||||||||
| Specify | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N | Note 1 | Notes 2 | ||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 | ||
| Fetal | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 | |
| Imaging& | Trans-rectal | |||||||||
| Other | Trans-vaginal | |||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2 | ||
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2 | ||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
7
Transducer: 7P-B Phased Array
Diagnostic Ultrasound 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 | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Other* | |||||||||
| Combined | Other* | |||||||||
| Specify | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | Note 1 | Notes 2 | |||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 | ||
| Fetal | ||||||||||
| Imaging& | Adult Cephalic | |||||||||
| Other | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2 | ||
| Intravascular(Cardiac) | ||||||||||
| Cardiac | Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
8
Transducer: L741 Linear Array
Diagnostic Ultrasound 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 | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Other* | ||||||||
| Specify | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | N | N | N | N | N | N | Note 1 | Notes 2,6 | |
| Neonatal Cephalic | |||||||||
| Fetal | Adult Cephalic | ||||||||
| Imaging& | Trans-rectal | ||||||||
| Other | Trans-vaginal | ||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | N | N | N | N | N | Note 1 | Notes 2 | |
| Musculo-skeletal | |||||||||
| (Superficial) | N | N | N | N | N | N | Note 1 | Notes 2 | |
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | N | Note 1 | Notes 2 |
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
9
Transducer: 6V1 Micro-curved Array
Diagnostic Ultrasound 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 | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Other* | ||||||||
| Specify | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal | Adult Cephalic | ||||||||
| Imaging& | Trans-rectal | N | N | N | N | N | N | Note 1 | Notes 2 |
| Other | Trans-vaginal | N | N | N | N | N | N | Note 1 | Notes 2 |
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | N | N | N | N | N | N | Note 1 | Notes 2 | |
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
10
Transducer: EC9-5 Micro-curved Array
Diagnostic Ultrasound 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 | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Other* | ||||||||
| Specify | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal | Adult Cephalic | ||||||||
| Imaging& | Trans-rectal | N | N | N | N | N | Note 1 | Notes 2 | |
| Other | Trans-vaginal | N | N | N | N | N | Note 1 | Notes 2 | |
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | N | N | N | N | N | Note 1 | Notes 2 | ||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Cerebral vascular |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
11
Transducer: PWD2.0
Diagnostic Ultrasound 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 | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Other* | ||||||||
| Specify | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal | Adult Cephalic | N | |||||||
| Imaging& | Trans-rectal | ||||||||
| Other | Trans-vaginal | ||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Cerebral vascular | N |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
12
510(k) Summary
1. Submitter [21 CFR807.92 (a) (1)]
| Submitter: | SONOSCAPE MEDICAL CORP. |
|---|---|
| Address: | 4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building, Yuquan Road, |
| Nanshan, Shenzhen 518051, Guangdong, China | |
| Contact Person: | Toki Wu |
| Tel: | +86 755 26722890 |
| Fax: | +86 755 26722850 |
| Email: | ra@sonoscape.net |
| Date Prepared | March 30, 2016 |
2. Device [21 CFR807.92 (a) (2)]
| Trade Name: | X5 Digital Color Doppler Ultrasound System |
|---|---|
| Common Name: | Diagnostic Ultrasound System and Transducers |
Classification Regulatory:
| FR Number | Product Code | |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
Classification Panel: Radiology Device Class: ll
3. Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicate device within this submission is as follows: SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System K152164
4. Device Description [21 CFR 807.92(a) (4)]
This SonoScape X5 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The X5 system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the
13
delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and autocorrelation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical and acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.
This system consists of keyboard control panel, power supply module, color LCD monitor and optional probes.
This system is a portable, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes.
5. Intended Use [21 CFR 807.92(a) (5)]
The SonoScape X5 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), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
6. Comparison with the Predicate device [21 CFR 807.92(a) (6)]
X5 Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the predicate device:
SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System K152164
Intended Use Comparison:
Compared with the predicate device SonoScape S8 Exp (K152164), the Subject Device X5 has the same intended use.
14
| ID | Comparison
Items | Subject Device
SonoScape X5 | Predicate Device
SonoScape S8 Exp (K152164) |
|----|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended
Use | The device 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), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology. | The device 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), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic. OB/Gyn and Urology. |
Table 1 Intended Use Comparison
Note: According to Section D in the "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], issued on: July 28, 2014", the indications for use of the new device fall within the intended use of the predicate device, the two devices have the same intended use.
Regulation and Safety Standards Comparison:
Subject device X5 has the same classification as the predicate device. And subject device X5 is designed in compliance with the FDA recognized safety standards, which are the same as the predicate device.
| ID | Comparison
Items | Subject Device
SonoScape X5 | Predicate Device
SonoScape S8 Exp (K152164) | Remark |
|----|------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------|
| 2 | Classification
Name | Ultrasonic Pulsed Doppler
Imaging System
Ultrasonic Pulsed Echo
Imaging System
Diagnostic Ultrasound
Transducer | Ultrasonic Pulsed Doppler
Imaging System
Ultrasonic Pulsed Echo Imaging
System
Diagnostic Ultrasound
Transducer | Same |
| 3 | Product Code | 90-IYN/90-IYO/90-ITX | 90-IYN/90-IYO/90-ITX | Same |
| 4 | Regulation
Number | 892.1550/892.1560/892.1570 | 892.1550/892.1560/892.1570 | Same |
| 5 | Panel | Radiology | Radiology | Same |
| 6 | Class | II | II | Same |
| 7 | Acoustic Track | TRACK 3 | TRACK 3 | Same |
| 8 | Electrical Safety | IEC 60601-1 | IEC 60601-1 | Same |
Table 2 Regulation and Safety Standards Comparison
510(k) Summary
15
| ID | Comparison
Items | Subject Device
SonoScape X5 | Predicate Device
SonoScape S8 Exp (K152164) | Remark |
|----|--------------------------------|--------------------------------|------------------------------------------------|--------|
| | EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| | Performance | IEC 60601-2-37 | IEC 60601-2-37 | Same |
| | Biocompatibility | ISO 10993-5,
ISO 10993-10 | ISO 10993-5,
ISO 10993-10 | Same |
| | Acoustic Output
Display | AIUM/NEMA UD3-2004
(R2009) | AIUM/NEMA UD3-2004
(R2009) | Same |
| | Acoustic Output
Measurement | AIUM/NEMA UD2-2004
(R2009) | AIUM/NEMA UD2-2004
(R2009) | Same |
Acoustic Output Levels Comparison:
The acoustic output levels of the subject device X5 are below the limits of FDA, which are the same as the predicate device SonoScape S8 Exp (K152164).
| Table 3 Acoustic Output Levels Comparison | ||||||
|---|---|---|---|---|---|---|
| ------------------------------------------- | -- | -- | -- | -- | -- | -- |
| ID | Comparison Items | Subject Device
SonoScape X5 | Predicate Device
SonoScape S8 Exp (K152164) | Remark |
|----|------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------|
| 9 | Acoustic Output | Derated ISPTA: 720mW/cm2
maximum.
TIS/TIB/TIC: 6.0 maximum,
MI: 1.9 maximum,
Derated ISPPA: 190W/cm2
maximum | Derated ISPTA: 720mW/cm2
maximum.
TIS/TIB/TIC: 6.0 maximum,
MI: 1.9 maximum,
Derated ISPPA: 190W/cm2
maximum | Same |
Probes Comparison:
Subject device X5 has the similar probes as the predicate device SonoScape S8 Exp (K152164).
Table 4 Probes Comparison
| ID | Comparison
Items | Subject Device
SonoScape X5 | Predicate Device
SonoScape S8 Exp
(K152164) | Remark | |
|----|---------------------|--------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------|
| 10 | Probes | 3C-A Curved Array | C322 Micro-curved Array
C344 Curved Array
C353 Curved Array
C542 Curved Array
3C-A Curved Array | SE
Analysis 1 | |
| | | | C613 Micro-curved Array | | VC6-2 Curved Array
C613 Micro-curved Array |
| | | | 3P-A Phased Array
7P-B Phased Array | 2P1 Phased Array
2P2 Phased Array
3P1 Phased Array | |
16
| | L741 Linear Array | 5P1 Phased Array
5P2 Phased Array
8P1 Phased Array
4P-A Phased Array |
|--|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | L741 Linear Array | L741 Linear Array
L742 Linear Array
L743 Linear Array
L752 Linear Array
10L1 Linear Array
10I2 Linear Array |
| | 6V1 Micro-curved Array
EC9-5 Micro-curved Array | 6V1 Micro-curved Array
6V3 Micro-curved Array
EC9-5 Micro-curved Array
BCC9-5 Micro-curved Array
BCL10-5 Biplane (Curved +
Linear Array) |
| | PWD2.0 TCD | MPTEE Phased Array
(Multi-plane)
MPTEE mini Phased Array
(Multi-plane)
LAP7 Linear Array
CWD2.0 CW
CWD5.0 CW
PWD2.0 TCD |
SE Analysis 1:
Compared with the predicate device, most of the probes (3C-A, C613, L741, 6V1, EC9-5, PWD2.0) are the same as them cleared with predicate device SonoScape S8 Exp (K152164). Most of these probes with X5 system have wider frequency range, which is redefined based on the frequency range of excitation pulse of the X5 system.
SE Analysis 2:
Compared with the predicate device, there are two new probes (3P-A and 7P-B), which are similar with the probe 2P1 and 5P1 respectively cleared with predicate device SonoScape S8 Exp (K152164). The clinical application is the same, the performance or frequency is similar, and the difference of these doesn't affect the safety, effectiveness and clinical use.
Note: detailed description information about the new probe (including the engineering drawing) and the further comparison can be found in Substantial Equivalence Comparison of this submission.
17
Technical Characteristics Comparison:
Compared with the predicate device SonoScape S8 Exp (K152164), the Subject Device X5 has the similar technical characteristics, including Design, Operation Controls, Display Modes, Operation Modes, Measurement Items, Cine Loop, Operating and Storage Condition. And the differences will not raise new risk and different questions of safety and effectiveness and considered Substantially Equivalent in safety and effectiveness. The detailed analysis is shown as the following (shown in table 5).
| ID | Comparison
Items | Subject Device
SonoScape X5 | Predicate Device
SonoScape S8 Exp (K152164) | Remark |
|----|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| 11 | Design | Based on an embedded Linux
operating system. | Based on an embedded Linux
operating system. | Same |
| | | Autocorrelation for color
processing and FFT for pulse
and CW Doppler processing. | Autocorrelation for color
processing and FFT for pulse and
CW Doppler processing. | Same |
| | | Supporting Linear, Curve and
Phased Array probes | Supporting Linear, Curve and
Phase array probes | Same |
| | | Cine play back capability | Cine play back capability | Same |
| | | Image file archive | Image file archive | Same |
| | | Software upgraded with USB
flash drive. | Software upgraded with USB flash
drive. | Same |
| | | Digital Scan Converter
1130*820 | Digital Scan Converter
800x600 | SE
Analysis 3 |
| | | TGC 8 slider | TGC 8 slider | Same |
| 12 | Operation
Controls | Depth Range: 1.5 to 40cm | Depth Range: 3 to 24.8cm | SE
Analysis 4 |
| | | B Dynamic range control:
20-200 | B Dynamic range control:
20-280dB | SE
Analysis 4 |
| | | Gray map: 1-16 | Gray Scale Control: 1,2,3,4,5, 6,7
(7 optional) | SE
Analysis 4 |
| | | Focal Number: adjustable | Focal Number: adjustable | Same |
| | | B persistence: Off, low, mid,
high, max | B persistence: 0-95% | SE
Analysis 4 |
| | | PW sweeping speed: min,
slow, med, fast, max | PW sweeping speed 2,4,6,8 sec
over display | SE
Analysis 4 |
| | | PW Wall filter setting: min,
low, mid, high, max | PW Wall filter setting: 35 to 750 | SE
Analysis 4 |
| | | PW sample volume:0.5 to
24mm | PW sample volume:0.7 to 21mm | SE
Analysis 4 |
| | | PW angle correction:
adjustable -88 to 88 degree | PW angle correction: adjustable,
0 to 72 degree | SE
Analysis 4 |
| ID | Comparison
Items | Subject Device
SonoScape X5 | Predicate Device
SonoScape S8 Exp (K152164) | Remark |
| | | Spectrum baseline:
adjustable, such as shift and
invert | Spectrum baseline: adjustable,
such as shift and invert | Same |
| | | Color ROI setting: trackball
and set key to control size and
position | Color ROI setting: trackball and
set key to control size and position | Same |
| | | Color Wall Filter settings: min,
low, mid, high, max | Color Wall Filter settings: 35 to
750 | SE
Analysis 4 |
| | | Zoom adjustable | Zoom adjustable | Same |
| | | Freeze control: Toggling
freeze key | Freeze control: Toggling freeze
key | Same |
| | | Cine control: play/stop, loop
speed, the start, the end,
Frame by Frame | Cine control: play/stop, loop
speed, the start, the end, Frame
by Frame | Same |
| 13 | Operation
Mode | B, M, PW, CW, CFM, PDI,
THI, PHI, Compound Imaging | B, M, PW, CW, CFM, DPI, TDI,
Tissue Harmonic Image, Color M
Mode, PHI, Compound Imaging,
3D/4D Mode, Panoramic Imaging,
Trapezoid Imaging, Elastography | SE
Analysis 5 |
| 14 | Display
Modes | B,CFM, PDI, B+CFM, B+PDI,
M, PW,CW: V1/2,V1/1,V2/1,
H1/1,Full | B,CFM,DPI,TDI, 4D: Single, Dual,
Quad
B+CFM,B+DPI,B+TDI: Dual Live
B/M, CFM/M,TDI/M, Steer M:
V1/3,V1/2(Dual),V2/3,
H1/2,H1/4,1/4
PW,CW:V1/3,V1/2(Dual),V2/3,H1/
2,H1/4,1/4 | SE
Analysis 5 |
| 15 | Measurement
Items | B, CFM, DPI: Distance, Area,
Volume, Angle;
M: Distance,
Slope, %Sten(D), Ratio(D),
Time, HR;
CFM/PDI: Doppler Area,
Color Flow, Flow Velocity;
PW/CW: Velocity,
Acceleration, Auto Trace,
Time, HR, RI, PI, S/D | B, CFM, DPI, TDI: Distance, Area,
Volume, Angle, Doppler Area,
Color Flow, OB, SMP, GYN,
Vascular, Abdomen, Cardiac,
Urology, Pediatrics
M: Distance, Slope, %Sten(D),
Ratio(D), Time, HR, OB, SMP,
Vascular, GYN, Abdomen,
Cardiac, Urology
PW/CW: Velocity, Acceleration,
RI, PI, S/D, Auto Trace, Manual
Trace, Time, HR, OB, SMP,
Vascular, GYN, Abdomen,
Cardiac, Urology | SE
Analysis 5 |
| ID | Comparison
Items | Subject Device
SonoScape X5 | Predicate Device
SonoScape S8 Exp (K152164) | Remark |
| 16 | Power Supply | Voltage: 100-240V~ | Voltage: 110-240 VAC | SE
Analysis 6 |
| | | Frequency: 50/60Hz | Frequency: 50/60 Hz | Same |
| | | Power Consumption:
100-240V~, 1.5-0.75A | Power Consumption:
110-240V AC, 2.7-1.2A | SE
Analysis 6 |
| 17 | Screen Size | 15.6 inch LCD monitor | 15 inch LCD monitor | SE
Analysis 7 |
Table 5 Technical Features Comparison
510(k) Summary
18
19
SE Analysis 3:
Design, compared with the predicate device, the subject device employs the almost same design and has some differences in Digital Scan Converter. But both of them comply with the requirements of IEC60601-1 and meet clinical requirements. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
SE Analysis 4:
Operation Controls, compared with the predicate device, the subject device employs the same operation controls design and has some differences in value range or setting. But both of them comply with the requirements of IEC60601-1 & IEC60601-2-37 and meet clinical requirements. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
SE Analysis 5:
Compared with the predicate device, the subject device has some differences in Operation Mode, Display Modes and Measurement Items. But all of them for the subject device include the clinical basic items, and fall within these for the predicate device; all of them meet the clinical use and no new risk is raised.
SE Analysis 6:
Power Supply, compared with the predicate device, the subject device employs the same power type and has some differences in voltage range and power consumption. But both of them comply with the requirements of IEC60601-1. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
SE Analysis 7:
Screen Size, compared with the predicate device, the subject device employs the same screen type and has some differences in screen size. But both of them comply with the
20
requirements of IEC60601-1 & IEC60601-1-2 and meet clinical requirements. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
Therefore the Subject Device X5 can be considered Substantially Equivalent to the Predicate Devices in safety and effectiveness, and no new risk is raised, so the SE is not affected.
7. Non-Clinical Tests [21 CFR 807.92(b) (1)]
The X5 Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.
Laboratory tests (including Phantom tests) were conducted to verify that the X5 system met all design specifications and the X5 system conformed to applicable medical device standards.
The X5 system has been designed and manufactured to meet the following standards: IEC 60601-1:12005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance [08/20/2012];
IEC 60601-1-2:2007, Medical Electrical Equipment -Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests [03/30/2007];
IEC 60601-2-37:2007, Medical Electrical Equipment-Part 2-37: Particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment [08/09/2007];
ISO 10993-5:2009, Biological Evaluation of Medical Devices, Part 5-Tests for in vitro cytotoxicity [06/01/2009]:
ISO 10993-10:2010, Biological Evaluation of Medical Devices- Part 10: Tests for irritation and skin sensitization [08/01/2010]:
AIUM/NEMA UD 2:2004 (R2009), Acoustic output measurement standard for diagnostic ultrasound equipment [08/21/2009]; and
AIUM/NEMA UD 3:2004 (R2009), Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment [08/13/2010].
8. Clinical Test [21 CFR 807.92(b) (2)]
No clinical testing was required.
21
9. Substantially Equivalent Conclusions [21 CFR 807.92(b) (3)]
In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, SONOSCAPE MEDICAL CORP. concludes that X5 Digital Color Doppler Ultrasound System is substantially equivalent to the predicate device with regard to safety and effectiveness.