(93 days)
No
The summary does not mention AI, ML, or related terms like deep learning or neural networks. The description focuses on standard ultrasound imaging modes and post-processing techniques.
No
The device is described as a "Diagnostic Ultrasound System" and its intended use is for various exams and to "acquire and display ultrasound images" and "measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis," which are all diagnostic functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "Diagnostic Ultrasound System" and is intended for use in various medical exams to generate images that medical professionals use for diagnosis. Additionally, the "Device Description" states its function is to "acquire and display ultrasound images" and "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" that transmits ultrasonic energy and performs post-processing of received echoes. This indicates the presence of hardware components (ultrasonic transducer, system for transmitting and receiving energy) in addition to the software control.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this is a "Diagnostic Ultrasound System." It transmits ultrasonic energy into patients and processes the received echoes to generate images of internal anatomical structures and fluid flow.
- Intended Use: The intended use describes imaging various parts of the body in different patient populations. This is consistent with an in-vivo (within the living body) diagnostic imaging device, not an in-vitro diagnostic device.
- Lack of Specimen Analysis: There is no mention of analyzing biological specimens or using reagents, which are hallmarks of IVD devices.
Therefore, the device described is an ultrasound system used for diagnostic imaging within the body, not an IVD.
N/A
Intended Use / Indications for Use
Resona 19/Resona 19 Exp/Resona I9T/Resona 19 Easi/Resona 19 Nasa/Resona IV/Imagyn 19/Imagyn 19/Imagyn 19S/ Imagyn 19 Easi/Nuewa 19/Nuewa 19T/Nuewa 19 Exp/Nuewa 19 Easi/Anesus 19/Anesus 19 Easi/Eagus 19 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, transvaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, urology and Thoracic/Pleural exams.
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, Smart3D, 4D(Reape View, TDI, Color M, Strain Elastography, Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).
Product codes
IYN, IYO, ITX
Device Description
The Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus 19 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, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STO, Contrast imaging (Contrast agent for Liver).
The Resona I9, Resona I9 Exp. Resona I9S, Resona I9T, Resona I9 Easi, Resona 19 Nasa, Resona IV, Imagyn 19, Imagyn 19S, Imagyn 19 Easi, Nuewa 19, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 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
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, urology and Thoracic/Pleural exams.
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates.
Intended User / Care Setting
Not Found
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 I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn 19 Easi, Nuewa 19, Nuewa 19S, Nuewa 19T, Nuewa 19 Exp, Nuewa 19 Easi, Anesus 19, Anesus 19 Easi, Eagus 19 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
Based on the performance data as documented in the study, the Resona 19, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn 19, Imagyn 19S, Imagyn 19 Easi, Nuewa I9S, Nuewa I9S, Nuewa I9T, Nuewa 19 Exp, Nuewa 19 Easi, Anesus 19, Anesus 19 Easi, Eagus 19 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)
K192152, K200001, K192410, K192903, K173021, K163077, K181985
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.
0
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" followed by the words "U.S. Food & Drug Administration".
June 10, 2021 Shenzhen Mindray Bio-medical Electronics Co., LTD % Hao Yixuan Engineer of Technical Regulation Mindray Building, Keji 12th Road South, Hi-tech Industrial Park Nanshan, Shenzhen 518057 P.R. CHINA Re: K210699 Trade/Device Name: Resona 19, Resona 19 Exp, Resona 19T, Resona 19T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus 19, Anesus I9 Easi, Eagus I9 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: May 24, 2021 Received: May 27, 2021
Dear Hao Yixuan:
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. 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 located 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 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
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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 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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210699
Device Name
Resona 19/Resona 19 Exp/Resona 19T/Resona 19 Easi/Resona IV/Imagyn 19/Imagyn 19/Imagyn 19S/Imagyn 19 Easi/ Nuewa 19/Nuewa I9S/ Nuewa I9T/Nuewa I9 Easi/Anesus I9/Anesus I9 Easi/Eagus I9 Diagnostic Ultrasound System
Indications for Use (Describe)
Resona 19/Resona 19 Exp/Resona I9T/Resona 19 Easi/Resona 19 Nasa/Resona IV/Imagyn 19/Imagyn 19/Imagyn 19S/ Imagyn 19 Easi/Nuewa 19/Nuewa 19T/Nuewa 19 Exp/Nuewa 19 Easi/Anesus 19/Anesus 19 Easi/Eagus 19 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, transvaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, urology and Thoracic/Pleural exams.
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, Smart3D, 4D(Reape View, TDI, Color M, Strain Elastography, Contrast agent for LVO), V Flow, STE, STQ, 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).
The assigned 510(k) number: K210699
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
Hao Yixuan 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: February 28, 2021
2. Device Name
Resona I9, Resona I9 Exp, Resona I9T, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp. Nuewa I9 Easi. Anesus I9, Anesus I9 Easi. Eagus I9 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 19 series Diagnostic Ultrasound System is comparable with and substantially equivalent to the predicate devices listed below. Resona 7 is the main predicate devices.
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| Device | Manufacturer | Model | Device | Product | 510K |
|---|---|---|---|---|---|
| Class | Code | Number | |||
| 1. Main predicate | |||||
| device | Mindray | Resona 7 | II | IYN, IYO, ITX | K171233 |
| 2. Reference device | Mindray | DC-80 | II | IYN, IYO, ITX, | |
| LLZ | K192152 | ||||
| 3. Reference device | Mindray | MX7 | II | IYN, IYO, ITX | K200001 |
| 4. Reference device | Mindray | ZS3 | II | IYN, IYO, ITX | K192410 |
| 5. Reference device | Samsung | RS85 | II | IYN, IYO, ITX | K192903 |
| 6. Reference device | SuperSonic | Aixplorer | II | IYN, IYO, ITX | K173021 |
| 7. Reference device | GE | LOGIQ E9 | II | IYN, IYO, ITX | K163077 |
| 8. Reference device | GE | VOLUS | |||
| ON E8 | II | IYN, IYO, ITX | K181985 |
The result shows the conformance of subject device to the predicate devices.
Regulation name and code
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)
21 CFR 892.2050 Picture Archiving and Communications System (LLZ)
4. Device Description:
The Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus 19 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, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STO, Contrast imaging (Contrast agent for Liver).
The Resona I9, Resona I9 Exp. Resona I9S, Resona I9T, Resona I9 Easi, Resona 19 Nasa, Resona IV, Imagyn 19, Imagyn 19S, Imagyn 19 Easi, Nuewa 19, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 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.
5
5. Intended Use:
Resona I9/Resona I9 Exp/Resona I9S/Resona I9 Easi/Resona I9 Nasa/ Resona IV/Imagyn 19/Imagyn I9S/Imagyn I9 Easi/Nuewa I9/Nuewa I9S/Nuewa 19T/Nuewa I9 Exp/Nuewa I9 Easi/Anesus I9/Anesus I9 Easi/Eagus I9 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, urology and Thoracic/Pleural exams.
Modes of operation include: B, M, PWD, CWD , Color Doppler, Amplitude Doppler. Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).
6. Comparison with Predicate Devices:
Subject device Resona I9, Resona I9 Exp, Resona I9T, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa 19 Exp, Nuewa I9 Easi, Anesus 19, Anesus 19 Easi, Eagus I9 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 19, Resona 19 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa 19, Nuewa 19S, Nuewa 19T, Nuewa I9 Exp, Nuewa 19 Easi, Anesus 19, Anesus 19 Easi, Eagus 19 Diagnostic Ultrasound System has the same intended uses as the predicated device Resona 7 (K171233) except the thoracic/pleural exam, which has been cleared on predicate device MX7(K200001) and the imaging modes as the predicated devices.
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- . The patient contact materials of the transducers and needle-guided brackets of subject device Resona 19, Resona 19 Exp, Resona I9S, Resona I9T, Resona 19 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa 19, Nuewa I9S, Nuewa 19T, Nuewa I9 Exp, Nuewa 19 Easi, Anesus 19, Anesus 19 Easi, Eagus 19 Diagnostic Ultrasound System are the same to the predicate devices or tested under ISO 10993-1.
- 1 The acoustic power levels of Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn 19 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus 19 are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233).
- . Resona 19, Resona 19 Exp, Resona 19S, Resona I9T, Resona 19 Easi, Resona 19 Nasa, Resona IV, Imagyn 19, Imagyn 19S, Imagyn 19 Easi, Nuewa 19, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa 19 Easi, Anesus 19, Anesus 19 Easi, Eagus 19 is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device Resona 7 (K171233).
- . The Resona 19, Resona 19 Exp, Resona 19S, Resona 19T, Resona 19 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus 19 has the equivalent features and functions as the predicated devices.
For the differences compared to the predicate devices:
- . The Resona 19, Resona 19 Exp, Resona 19S, Resona 19T, Resona 19 Easi, Resona 19 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn 19 Easi, Nuewa 19, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus 19 introduces new software and hardware options which in the below table that used as improvements or enhancement based on the cleared functions to facilitate users, no new intended use are added and all of them have passed the related tests, no clinical risks have been recognized nor introduced.
| High frame rate STE | High frame rate STE function is used to improve the frame rate (FR) for STE. High frame rate STE is a High frame rate mode of STE |
|---|---|
| Smart Scene 3D | In 3D/4D acquisition preparation status, this feature can adjust ROI size and position automatically and activate appropriate render modes according to the recognized anatomical structure of some organs. |
| CPP | Measures the pixel proportion of blood flow signal in the region of interest under Color or Power mode. The feature is not supported under TDI mode. |
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| DICOM basic unit installed first. | |
|---|---|
| DICOM Small | |
| Parts SR | Purpose: The ultrasound system transfers the |
| measurements obtained from Small Parts studies to | |
| storage devices. | |
| Battery assembly | There are two kinds of standby battery assemblies, 4 sets |
| and 8 sets of batteries. | |
| iClear+ Dongle | This optional hardware should be installed to realize the |
| iClear+ function | |
| Probe Adapter | |
| PCM-ES01 and | |
| PCM-US01 | The probe adapter is used for probe-unit interface |
| conversion. PCM-US01 Probe Adapter is used for probes | |
| with U-type socket to connect to the main unit with S-type | |
| socket accepted interface. The P7-3TU or SP5-1U probe | |
| should be configured. | |
| PCM-ES01 Probe Adapter is used for probes with E-type | |
| socket to connect to the main unit with S-type socket | |
| accepted interface. The SD8-1E, P7-3TE, SC6-1E, or | |
| SP5-1E probe should be configured. | |
| Magnetic | |
| navigation | |
| controller box | Used for carrying the magnetic navigation controller. |
7. Non-clinical Tests:
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa 19 Easi, Anesus 19, Anesus 19 Easi, Eagus 19 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.
- 1 AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
- IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment Part 1-2: . General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6 Edition 3.1 2013-10, medical electrical equipment part 1-6: 1
8
general requirements for basic safety and essential performance - collateral standard: usability.
- 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 Second edition 2007-03-01, 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 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)].
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 I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn 19 Easi, Nuewa 19, Nuewa 19S, Nuewa 19T, Nuewa 19 Exp, Nuewa 19 Easi, Anesus 19, Anesus 19 Easi, Eagus 19 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
9. Summary
Based on the performance data as documented in the study, the Resona 19, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn 19, Imagyn 19S, Imagyn 19 Easi, Nuewa I9S, Nuewa I9S, Nuewa I9T, Nuewa 19 Exp, Nuewa 19 Easi, Anesus 19, Anesus 19 Easi, Eagus 19 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 I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S,
9
Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus 19, Anesus 19 Easi, Eagus 19 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to its primary predicate device Resona 7.