(60 days)
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.
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.
The SonoScape X5 Digital Color Doppler Ultrasound System is compared to the predicate device, SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System (K152164), to establish substantial equivalence. The information provided outlines the comparison and the tests conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not explicitly state quantitative clinical acceptance criteria for the device's performance (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, the substantial equivalence is based on the device conforming to applicable medical device standards and having similar performance characteristics to a legally marketed predicate device. The "reported device performance" is primarily demonstrated through compliance with various safety and performance standards, and comparison of technical specifications to the predicate.
| Acceptance Criteria Category | Specific Criteria (Implicit from testing/comparison) | SonoScape X5 Reported Performance (based on comparison and testing) |
|---|---|---|
| Intended Use | Same as predicate device | Same as predicate (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). Minor differences in specific application modes (e.g., no Trans-esoph. Cardiac, Laparoscopic on X5) are deemed not to affect safety/effectiveness. |
| Pulsed Doppler Imaging | Compliance with 21 CFR 892.1550 | Compliant (Class II, Product Code 90-IYN) |
| Pulsed Echo Imaging | Compliance with 21 CFR 892.1560 | Compliant (Class II, Product Code 90-IYO) |
| Diagnostic Transducer | Compliance with 21 CFR 892.1570 | Compliant (Class II, Product Code 90-ITX) |
| Electrical Safety | Compliance with IEC 60601-1 | Compliant with IEC 60601-1 |
| EMC | Compliance with IEC 60601-1-2 | Compliant with IEC 60601-1-2 |
| Performance (Ultrasound) | Compliance with IEC 60601-2-37 | Compliant with IEC 60601-2-37 |
| Biocompatibility | Compliance with ISO 10993-5, ISO 10993-10 | Compliant with ISO 10993-5, ISO 10993-10 |
| Acoustic Output Display | Compliance with AIUM/NEMA UD3-2004 | Compliant with AIUM/NEMA UD3-2004 |
| Acoustic Output Measurement | Compliance with AIUM/NEMA UD2-2004 | Compliant with AIUM/NEMA UD2-2004 |
| Acoustic Output Levels | Below FDA limits; similar to predicate | Derated ISPTA: 720mW/cm2 max; TIS/TIB/TIC: 6.0 max; MI: 1.9 max; Derated ISPPA: 190W/cm2 max (Same as predicate) |
| Design (General) | Embedded Linux OS, autocorrelation/FFT, probe support, cine playback, image archive, USB upgrade | Same as predicate; minor difference in Digital Scan Converter resolution (1130*820 vs 800x600) deemed not to affect safety/effectiveness. |
| Operation Controls | Similar functionality and ranges to predicate | Generally similar; some differences in value range or setting (e.g., Depth Range: 1.5-40cm vs 3-24.8cm; B Dynamic range: 20-200 vs 20-280dB; Gray map: 1-16 vs 7 options) deemed not to affect safety/effectiveness. |
| Operation Modes | Includes clinical basic items, within predicate's capabilities | B, M, PW, CW, CFM, PDI, THI, PHI, Compound Imaging (Subset of predicate's broader modes which also include TDI, Color M Mode, 3D/4D, Panoramic, Trapezoid, Elastography) deemed not to affect safety/effectiveness. |
| Display Modes | Includes clinical basic items, within predicate's capabilities | B, CFM, PDI, B+CFM, B+PDI, M, PW,CW: V1/2,V1/1,V2/1,H1/1,Full (Subset of predicate's broader modes like Dual, Quad, Dual Live, Steer M) deemed not to affect safety/effectiveness. |
| Measurement Items | Includes clinical basic items, within predicate's capabilities | 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 (Subset of predicate's broader list, but covers basic items) deemed not to affect safety/effectiveness. |
| Power Supply | Same type as predicate, compliant with standards | Voltage: 100-240V~; Frequency: 50/60Hz; Power Consumption: 100-240V~, 1.5-0.75A (Similar to predicate's voltage range and power consumption, compliant with IEC60601-1) |
| Screen Size | Same type as predicate, compliant with standards | 15.6 inch LCD monitor (Similar to predicate's 15 inch LCD monitor, compliant with IEC60601-1 & IEC60601-1-2) |
| Probes Compatibility | Similar to predicate, new probes comparable to existing | Most probes (3C-A, C613, L741, 6V1, EC9-5, PWD2.0) are same or slightly adjusted frequency range; Two new probes (3P-A and 7P-B) are similar to predicate probes (2P1 and 5P1) with same clinical application and similar performance/frequency, deemed not to affect safety/effectiveness. |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "No clinical testing was required." Therefore, there is no test set in the sense of clinical data from patients. The "tests" conducted were primarily non-clinical laboratory tests to verify design specifications and compliance with recognized safety and performance standards. The data provenance for these non-clinical tests would be internal laboratory testing by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Given that no clinical testing was referenced, there were no "experts" involved in establishing ground truth for a clinical test set. The assessment relied on expert judgment of engineering, quality, and regulatory personnel to confirm compliance with standards and equivalence to the predicate device.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was performed or referenced.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The submission is for a diagnostic ultrasound system and does not mention any AI components or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The submission is for a diagnostic ultrasound system, not an algorithm.
7. The type of Ground Truth Used
As per the document, "No clinical testing was required." Therefore, no specific type of "ground truth" (e.g., expert consensus, pathology, outcomes data) derived from clinical cases was used to validate the device's diagnostic performance for this 510(k) submission. The "truth" in this context is the device's adherence to regulatory standards and its demonstrated equivalence in technical characteristics and safety to an already cleared device.
8. The Sample Size for the Training Set
Not applicable, as this is not a submission for a machine learning or AI-based device requiring a training set in that context.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set was used or referenced for a machine learning or AI-based device.
{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 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | 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 | ||
| FetalImaging&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 | ||
| PeripheralVessel | 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 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | 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 | |||||||||
| FetalImaging&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) | |||||||||
| PeripheralVessel | 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 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | 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 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | 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 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | 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 | ||
| FetalImaging& | 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 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | 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 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | 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 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | 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 1ONLY) | Specific(TRACKS 1 & 3) | B | M | PWD | CWD | ColorDoppler | 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 | ComparisonItems | Subject DeviceSonoScape X5 | Predicate DeviceSonoScape S8 Exp (K152164) |
|---|---|---|---|
| 1 | IntendedUse | 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 | ComparisonItems | Subject DeviceSonoScape X5 | Predicate DeviceSonoScape S8 Exp (K152164) | Remark |
|---|---|---|---|---|
| 2 | ClassificationName | Ultrasonic Pulsed DopplerImaging SystemUltrasonic Pulsed EchoImaging SystemDiagnostic UltrasoundTransducer | Ultrasonic Pulsed DopplerImaging SystemUltrasonic Pulsed Echo ImagingSystemDiagnostic UltrasoundTransducer | Same |
| 3 | Product Code | 90-IYN/90-IYO/90-ITX | 90-IYN/90-IYO/90-ITX | Same |
| 4 | RegulationNumber | 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
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| ID | ComparisonItems | Subject DeviceSonoScape X5 | Predicate DeviceSonoScape 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 OutputDisplay | AIUM/NEMA UD3-2004(R2009) | AIUM/NEMA UD3-2004(R2009) | Same | |
| Acoustic OutputMeasurement | 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 DeviceSonoScape X5 | Predicate DeviceSonoScape S8 Exp (K152164) | Remark |
|---|---|---|---|---|
| 9 | Acoustic Output | Derated ISPTA: 720mW/cm2maximum.TIS/TIB/TIC: 6.0 maximum,MI: 1.9 maximum,Derated ISPPA: 190W/cm2maximum | Derated ISPTA: 720mW/cm2maximum.TIS/TIB/TIC: 6.0 maximum,MI: 1.9 maximum,Derated ISPPA: 190W/cm2maximum | Same |
Probes Comparison:
Subject device X5 has the similar probes as the predicate device SonoScape S8 Exp (K152164).
Table 4 Probes Comparison
| ID | ComparisonItems | Subject DeviceSonoScape X5 | Predicate DeviceSonoScape S8 Exp(K152164) | Remark | |
|---|---|---|---|---|---|
| 10 | Probes | 3C-A Curved Array | C322 Micro-curved ArrayC344 Curved ArrayC353 Curved ArrayC542 Curved Array3C-A Curved Array | SEAnalysis 1 | |
| C613 Micro-curved Array | VC6-2 Curved ArrayC613 Micro-curved Array | ||||
| 3P-A Phased Array7P-B Phased Array | 2P1 Phased Array2P2 Phased Array3P1 Phased Array |
{16}------------------------------------------------
| L741 Linear Array | 5P1 Phased Array5P2 Phased Array8P1 Phased Array4P-A Phased Array | |
|---|---|---|
| L741 Linear Array | L741 Linear ArrayL742 Linear ArrayL743 Linear ArrayL752 Linear Array10L1 Linear Array10I2 Linear Array | |
| 6V1 Micro-curved ArrayEC9-5 Micro-curved Array | 6V1 Micro-curved Array6V3 Micro-curved ArrayEC9-5 Micro-curved ArrayBCC9-5 Micro-curved ArrayBCL10-5 Biplane (Curved +Linear Array) | |
| PWD2.0 TCD | MPTEE Phased Array(Multi-plane)MPTEE mini Phased Array(Multi-plane)LAP7 Linear ArrayCWD2.0 CWCWD5.0 CWPWD2.0 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 | ComparisonItems | Subject DeviceSonoScape X5 | Predicate DeviceSonoScape S8 Exp (K152164) | Remark |
|---|---|---|---|---|
| 11 | Design | Based on an embedded Linuxoperating system. | Based on an embedded Linuxoperating system. | Same |
| Autocorrelation for colorprocessing and FFT for pulseand CW Doppler processing. | Autocorrelation for colorprocessing and FFT for pulse andCW Doppler processing. | Same | ||
| Supporting Linear, Curve andPhased Array probes | Supporting Linear, Curve andPhase array probes | Same | ||
| Cine play back capability | Cine play back capability | Same | ||
| Image file archive | Image file archive | Same | ||
| Software upgraded with USBflash drive. | Software upgraded with USB flashdrive. | Same | ||
| Digital Scan Converter1130*820 | Digital Scan Converter800x600 | SEAnalysis 3 | ||
| TGC 8 slider | TGC 8 slider | Same | ||
| 12 | OperationControls | Depth Range: 1.5 to 40cm | Depth Range: 3 to 24.8cm | SEAnalysis 4 |
| B Dynamic range control:20-200 | B Dynamic range control:20-280dB | SEAnalysis 4 | ||
| Gray map: 1-16 | Gray Scale Control: 1,2,3,4,5, 6,7(7 optional) | SEAnalysis 4 | ||
| Focal Number: adjustable | Focal Number: adjustable | Same | ||
| B persistence: Off, low, mid,high, max | B persistence: 0-95% | SEAnalysis 4 | ||
| PW sweeping speed: min,slow, med, fast, max | PW sweeping speed 2,4,6,8 secover display | SEAnalysis 4 | ||
| PW Wall filter setting: min,low, mid, high, max | PW Wall filter setting: 35 to 750 | SEAnalysis 4 | ||
| PW sample volume:0.5 to24mm | PW sample volume:0.7 to 21mm | SEAnalysis 4 | ||
| PW angle correction:adjustable -88 to 88 degree | PW angle correction: adjustable,0 to 72 degree | SEAnalysis 4 | ||
| ID | ComparisonItems | Subject DeviceSonoScape X5 | Predicate DeviceSonoScape S8 Exp (K152164) | Remark |
| Spectrum baseline:adjustable, such as shift andinvert | Spectrum baseline: adjustable,such as shift and invert | Same | ||
| Color ROI setting: trackballand set key to control size andposition | Color ROI setting: trackball andset key to control size and position | Same | ||
| Color Wall Filter settings: min,low, mid, high, max | Color Wall Filter settings: 35 to750 | SEAnalysis 4 | ||
| Zoom adjustable | Zoom adjustable | Same | ||
| Freeze control: Togglingfreeze key | Freeze control: Toggling freezekey | Same | ||
| Cine control: play/stop, loopspeed, the start, the end,Frame by Frame | Cine control: play/stop, loopspeed, the start, the end, Frameby Frame | Same | ||
| 13 | OperationMode | B, M, PW, CW, CFM, PDI,THI, PHI, Compound Imaging | B, M, PW, CW, CFM, DPI, TDI,Tissue Harmonic Image, Color MMode, PHI, Compound Imaging,3D/4D Mode, Panoramic Imaging,Trapezoid Imaging, Elastography | SEAnalysis 5 |
| 14 | DisplayModes | 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,QuadB+CFM,B+DPI,B+TDI: Dual LiveB/M, CFM/M,TDI/M, Steer M:V1/3,V1/2(Dual),V2/3,H1/2,H1/4,1/4PW,CW:V1/3,V1/2(Dual),V2/3,H1/2,H1/4,1/4 | SEAnalysis 5 |
| 15 | MeasurementItems | 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, PediatricsM: Distance, Slope, %Sten(D),Ratio(D), Time, HR, OB, SMP,Vascular, GYN, Abdomen,Cardiac, UrologyPW/CW: Velocity, Acceleration,RI, PI, S/D, Auto Trace, ManualTrace, Time, HR, OB, SMP,Vascular, GYN, Abdomen,Cardiac, Urology | SEAnalysis 5 |
| ID | ComparisonItems | Subject DeviceSonoScape X5 | Predicate DeviceSonoScape S8 Exp (K152164) | Remark |
| 16 | Power Supply | Voltage: 100-240V~ | Voltage: 110-240 VAC | SEAnalysis 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 | SEAnalysis 6 | ||
| 17 | Screen Size | 15.6 inch LCD monitor | 15 inch LCD monitor | SEAnalysis 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.
§ 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.