(101 days)
No
The summary does not mention AI, ML, or related terms, nor does it describe any features or performance studies indicative of AI/ML functionality.
No.
The device is described as a "general purpose diagnostic ultrasound system" intended for "ultrasound imaging, measurement, display and analysis of the human body and fluid," which is used to "make the diagnosis." It is not intended for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This device is a general purpose diagnostic ultrasound system." Additionally, the "Device Description" section repeatedly refers to the system as a "Diagnostic Ultrasound System" and mentions its ability to "measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis."
No
The device is described as a "general purpose, mobile, software controlled, ultrasonic diagnostic system," indicating it includes hardware components for acquiring and displaying ultrasound images, not just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid". This describes a device used for imaging and analysis within the body, not for testing samples outside the body.
- Device Description: The description reinforces that it's an "ultrasonic diagnostic system" that "acquire and display ultrasound images".
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples in vitro (outside the living organism).
Ultrasound systems are considered medical devices, but they fall under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Resona A10S, Resona A20 Pro, Resona A20S, Resona A20W, Resona A20, Resona A20, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A MV, Eagus A20W, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), GYN/Pelvic, urology, adult and pediatric cardiac, and peripheral vessel exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STQ, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
Product codes
IYN, IYO, ITX
Device Description
The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, mode(B+M, PW+B, Color+B, Power+B, Combined PW+Color+B. Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STO, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp. Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
Ophthalmic, fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), GYN/Pelvic, urology, adult and pediatric cardiac, and peripheral vessel exams.
Indicated Patient Age Range
Adults, pregnant women, pediatric patients and neonates.
Intended User / Care Setting
Qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
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)
Not applicable. The subject of this submission, Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
Based on the performance data as documented in the study, Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System was found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
November 8, 2024
Shenzhen Mindray Bio-medical Electronics Co., LTD. Jiahong Jin Technical Manager, Technical Regulation Department Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 CHINA
Re: K242231
Trade/Device Name: Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 8, 2024 Received: October 8, 2024
Dear Jiahong Jin:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
YANNA S. KANG-S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242231
Device Name
Resona A10S, Resona A20 Pro, Resona A20S, Resona A20S, Resona A20, Resona A20, Resona A20 Exp. Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20 Diagnostic Ultrasound System
Indications for Use (Describe)
Resona A10S, Resona A20 Pro, Resona A20S, Resona A20W, Resona A20, Resona A20, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A MV, Eagus A20W, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), GYN/Pelvic, urology, adult and pediatric cardiac, and peripheral vessel exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STQ, Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
| 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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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).
K242231 The assigned 510(k) number:
1. Submitter
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Tel: +86 755 8188 6129 Fax: +86 755 2658 2680
Contact Person
Jin Jiahong Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Date Prepared: July 29, 2024
2. Device Name
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System Classification Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
3. Predicate devices
Resona A10S series Diagnostic Ultrasound System is comparable with and substantially equivalent to the predicate devices listed below. Resona R9 is the main
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| Device | Manufacturer | Model | Device
Class | Product Code | 510K
Number |
|--------------------------|--------------|------------|-----------------|---------------|----------------|
| 1. Main predicate device | Mindray | Resona R9 | II | IYN, IYO, ITX | K222928 |
| 2. Reference device | Mindray | Consona N9 | II | IYN, IYO, ITX | K221300 |
| 3. Reference device | Mindray | ZS3 | II | IYN, IYO, ITX | K192410 |
| 4. Reference device | GE | LOGIQ E9 | II | IYN, IYO, ITX | K163077 |
predicate devices.
The result shows the conformance of subject device to the predicate devices.
Regulation name and code
21 CFR 892.1550 Ultrasonic Pulsed Dopple Imaging System
(IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
4. Device Description:
The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, mode(B+M, PW+B, Color+B, Power+B, Combined PW+Color+B. Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STO, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp. Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.
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5. Indications for Use:
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), GYN/Pelvic, urology, adult and pediatric cardiac, and peripheral vessel exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B. M. PWD, CWD, Color Doppler, Power Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STQ, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
6. Comparison with Predicate Devices:
Subject device Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices mentioned in 3. Predicate Devices with regards to intended use, imaging modes, features and functions and technological characteristics.
- . All systems transmit ultrasonic energy into patients, perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, as well as calculations.
- . Subject device Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System has the same intended uses as the predicated device Resona R9 (K222928) except Ophthalmic and GYN/Pelvic applications. At the same time, Ophthalmic and GYN/Pelvic applications have been cleared in predicate device ZS3 (K192410).
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- . The patient contact materials of the transducers and needle-guided brackets of subject device Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System are the same to the predicate devices or tested under ISO 10993-1.
- 1 The acoustic power levels of Resona A10S. Resona A20 Pro. Resona A20T. Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System are below the limits of FDA, which are the same as the predicated devices Resona R9 (K222928) and ZS3(K192410).
- . Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device Resona R9 (K222928).
- . Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System has the equivalent features and functions as the predicated devices. Among these features, the Smart Calc and ClamAV supported in proposed Resona A10S series have been cleared in predicate device Consona N9 (K221300).
For the differences compared to the predicate devices:
- The subject device introduces new options, which in the below table that either . the improvements or enhancement based on the cleared functions to facilitate user. no intended uses are added and passed the related tests, no clinical risks introduced.
| Subject Device | Function explanation |
|---|---|
| Super Resolution | |
| CEUS and Super | |
| Resolution CEUS QA | Super Resolution CEUS is used to acquire more contrast image data |
| of microbubbles in a period of time within a closed area, and then | |
| calculate and output the calculation results, based on Contrast | |
| imaging. Super Resolution CEUS displays more image details than | |
| Contrast imaging, and it dynamically display the vascular structure | |
| and perfusion characteristics of the microbubbles. | |
| Super Resolution CEUS QA is used to calculate the pixel distance | |
| and pixel ratio of the vessel within the ROI to obtain the | |
| quantitative information of vessel distance, vessel density, and | |
| vessel density ratio. based on the results of certain image frames | |
| acquired by the “Super Resolution CEUS” mode. |
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| Smart Scene | It is used to initialize the imaging or measurement parameters related to the current scanning through customized automatic workflow, so as to simplify the operation procedure. |
|---|---|
| STVi (Sound Touch | |
| Viscoelastography) | This function is used to calculate and display viscosity and frequency dispersion parameters by the velocities of shear waves at different frequencies. |
| Image Info | |
| Synchronization | This function is used to transfer the real-time ultrasound image to the PC device, and provide more information for scientific research for users. |
| Volume Data Export | This function is used to save and output the reconstructed volume data and provide more information for scientific research for users. |
| TSSI (Target Sound | |
| Speed Index) | It is used to measure the sound velocity change in the liver according to the echo signal of liver parenchyma. |
| Arterial PWV Analysis | Pulse wave is a transverse wave generated by the human body spontaneously and transmitted along the vessel wall. This function calculates PWV by analyzing the motion status of the artery. |
| HD Scope+ | For B and color mode, the image inside the ROI is clearer than these outside when the function is enabled. |
7. Non-clinical Tests:
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and this device has been designed to conform with applicable medical safety standards.
This device has been tested and evaluated under the following standards:
- . NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
- . ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)].
- . IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
- IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
- IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
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- IEC 60601-2-37 Edition 2.1 2015, Medical electrical equipment Part 2-37: . Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
- ISO 14971 Third Edition 2019-12, Medical devices Application of risk ■ management to medical devices.
- ISO 10993-1 Fifth edition 2018-08, biological evaluation of medical devices part 1: evaluation and testing within a risk management process.
- IEC 62304 Edition 1.1 2015-06, medical device software - software life cycle processes.
- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, Medical devices -Part 1: Application of usability engineering to medical devices.
These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.
8. Clinical Studies
Not applicable. The subject of this submission, Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
9. Summary
Based on the performance data as documented in the study, Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System was found to have a safety and effectiveness profile that is similar to the predicate device.
10.Conclusion:
Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design. development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to the predicate device.