Resona I8W, Resona I8, Resona I8S, Resona I8S, Resona I8T, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa 18, Nuewa 18 Exp, Nuewa 18T, Imagyn 18, Imagyn 18T, Imagyn 18T, Imagyn 18 Exp, Nuewa 1Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal, Intra-operative (includes abdominal, Laparoscopic, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), Thoracic/Pleural, adult and pediatic cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology 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 imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).

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.

Device Description

The Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY 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(Realtime 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Important Note: The provided document is a 510(k) Premarket Notification from the FDA, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving direct performance against specific numerical acceptance criteria for a new, breakthrough device. Therefore, the "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence to the predicate device, primarily through non-clinical testing and comparison of features. The "study" refers to these non-clinical tests and comparisons.

Description of Acceptance Criteria and the Study that Proves the Device Meets Them

The Shenzhen Mindray Bio-medical Electronics Co., LTD's Resona I8W and associated systems (subject device) seek to prove substantial equivalence to predicate devices, primarily the Resona I9 (K210699). The acceptance criteria are largely focused on demonstrating that the subject device's intended use, technological characteristics, safety, and effectiveness are comparable to the legally marketed predicate devices.

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Implicitly Derived from 510(k) Content)	Reported Device Performance (Summary from 510(k))
Intended Use Equivalence	Intended uses are consistent with predicate devices.	The subject device has the same intended uses as the predicate device Resona I9 (K210699), applicable for adults, pregnant women, pediatric patients and neonates for various exams (fetal, abdominal, intra-operative, small organ, cardiac, etc.) and modes of operation (B, M, PWD, CWD, Color, etc.).
Technological Characteristics Equivalence	Device operates using the same fundamental scientific technology.	Both subject and predicate systems transmit ultrasonic energy, perform post-processing to generate onscreen display of anatomic structures and fluid flow. They both allow for specialized measurements and calculations.
Safety - Material Biocompatibility	Patient contact materials of transducers and needle-guided brackets are the same as predicate devices.	The patient contact materials of the transducers and needle-guided brackets of the subject device are the same as the predicate devices.
Safety - Acoustic Output	Acoustic power levels are below FDA limits and are the same as predicate devices.	Acoustic power levels of the subject device are below FDA limits and are the same as the predicate device Resona I9 (K210699).
Safety - Electrical, Thermal, Mechanical	Device complies with recognized electrical and physical safety standards.	The subject device is designed in compliance with FDA recognized electrical and physical safety standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62304, IEC 62366-1). This is stated to be the same as the predicate device Resona I9 (K210699).
Performance - Features and Functions	Equivalent features and functions, or new features cleared in other predicate/reference devices.	The subject device has equivalent features and functions to predicate devices. Specific advanced features (USAT, HRI+, HiFR CEUS, CEUS Chrono-Parametric Mode, TCMR, 3D-Print Format, Ultra-Micro Angiography, DICOM Pediatric SR, DICOM Urology SR, Biopsy Grid) were previously cleared in Resona R9 (K222928). Smart Bladder and ClamAV were cleared in Consona N9 (K221300). IOTA was cleared in Voluson E10 (K181985).
Non-clinical Tests	Device evaluated for acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, and mechanical safety.	Non-clinical tests were performed based on recognized international and national standards (NEMA UD 2-2004, ANSI AAMI ES60601-1, IEC 60601-1-2, IEC TR 60601-4-2, IEC 60601-1-6, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62304, IEC 62366-1). The results support substantial equivalence.
Clinical Studies	Not required to support substantial equivalence if non-clinical data is sufficient.	No clinical studies were deemed necessary or performed to support substantial equivalence for this submission.

2. Sample size used for the test set and the data provenance:

Not Applicable. The document explicitly states "Not applicable" for clinical studies. This submission relies on non-clinical performance data and comparison to predicate devices, rather than a clinical test set with patient data. The "test set" in this context refers to the device itself being tested for compliance with safety standards and functional equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. As no clinical "test set" with patient data was used to establish ground truth, this information is not relevant to this 510(k) submission. Ground truth, in the traditional sense of medical image interpretation, was not established for this device's comparison.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. No clinical test set requiring expert adjudication was conducted.

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. No MRMC study was conducted. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool. The submission does not describe any AI features that would necessitate an MRMC study to evaluate human reader improvement.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a diagnostic ultrasound system. While it has software controls and analysis packages, it does not represent a standalone "algorithm only" device that provides interpretations without human interaction. Its performance is demonstrated through its ability to acquire and display ultrasound images and facilitate measurements for human interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable (in the clinical sense). Ground truth, in this context, is established through compliance with recognized safety standards and functional equivalence to predicate devices, not through clinical diagnostic verification against pathology or outcomes data for new clinical claims. The "ground truth" for the device's acceptable performance is its adherence to industry standards and its comparability to existing, legally marketed ultrasound systems.

8. The sample size for the training set:

Not Applicable. This document does not describe a machine learning algorithm that underwent training with a specific dataset. It refers to a diagnostic ultrasound system.

9. How the ground truth for the training set was established:

Not Applicable. Since there is no described machine learning training set, the establishment of its ground truth is not relevant here.

Summary

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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" followed by the words "U.S. Food & Drug Administration".

April 22, 2024

Shenzhen Mindray Bio-medical Electronics Co., LTD. % Tang Jing Technical manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 CHINA

Re: K240115

Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona Trade/Device Name: I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8T, Imagyn I8T, Imagyn I8 Exp, Nuewa IY 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: March 21, 2024 Received: March 22, 2024

Dear Tang Jing:

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 hability 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.

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"

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(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 (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-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/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-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

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Indications for Use

510(k) Number (if known) K240115

Device Name

Resona I8W, Resona 18, Resona I8S, Resona I8T, Resona I8T, Resona I8 Easi, Eagus 18 Easi, Nuewa I8W, Nuewa I8W, Nuewa I8, Nuewa 18 Exp, Nuewa I8S, Nuewa 18T, Imagyn I8S, Imagyn I8T, Imagyn 18 Exp, Nuewa IY Diagnostic Ultrasound System

Indications for Use (Describe)

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: K240115

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

Tang Jing 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: January 8, 2024

2. Device Name

Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY 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 I8W series Diagnostic Ultrasound System is comparable with and substantially equivalent to the predicate devices listed below. Resona 19 is the main

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Device	Manufacturer	Model	DeviceClass	Product Code	510KNumber
1. Main predicate device	Mindray	Resona I9	II	IYN, IYO, ITX	K210699
2. Reference device	Mindray	Resona R9	II	IYN, IYO, ITX	K222928
3. Reference device	Mindray	MX7	II	IYN, IYO, ITX	K212900
4. Reference device	Mindray	TEX20	II	IYN, IYO, ITX	K220242
5. Reference device	Mindray	TE7	II	IYN, IYO, ITX	K203391
6. Reference device	Mindray	DC-80A	II	IYN, IYO, ITX	K201693
7. Reference device	Mindray	ZS3	II	IYN, IYO, ITX	K192410
8. Reference device	Mindray	Consona N9	II	IYN, IYO, ITX	K221300
9. Reference device	Mindray	Voluson E10	II	IYN, IYO, ITX	K181985

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:

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5. Indications for Use:

Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus 18 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn 18, Imagyn 18S, Imagyn 18T, Imagyn 18 Exp, Nuewa IY Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (includes abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), Thoracic/Pleural, adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology 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 I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8T, Imagyn I8T, Imagyn I8 Exp, Nuewa IY 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 I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8T, Imagyn I8T, Imagyn I8 Exp. Nuewa IY Diagnostic Ultrasound System has the same intended uses as the predicated device Resona I9 (K210699).

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The patient contact materials of the transducers and needle-guided brackets of subject device Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System are the same to the predicate devices.
The acoustic power levels of Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8S, Imagyn I8S, Imagyn 18T, Imagyn 18 Exp, Nuewa IY Diagnostic Ultrasound System are below the limits of FDA, which are the same as the predicated device Resona 19 (K210699).
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona 18 Easi, Eagus 18 Easi, Nuewa 18W, Nuewa 18, Nuewa 18 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY 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 I9 (K210699).
. Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona 18 Easi, Eagus 18 Easi, Nuewa 18W, Nuewa 18, Nuewa 18 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System has the equivalent features and functions as the predicated devices. Among these features, the USAT, HRI+, HiFR CEUS, CEUS Chrono-Parametric Mode, TCMR, 3D-Print Format, Ultra-Micro Angiography, DICOM Pediatric SR, DICOM Urology SR and Biopsy Grid supported in proposed Resona I8W series has been cleared in predicate device Resona R9(K222928).
. Resona I8W, Resona 18, Resona 18 Exp, Resona I8S, Resona I8T, Resona IY, Resona 18 Easi, Eagus 18 Easi, Nuewa 18W, Nuewa 18, Nuewa 18 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System has the equivalent features and functions as the predicated devices. Among these features, the Smart Bladder and ClamAV supported in proposed Resona I8W series has been cleared in predicate device Consona N9 (K221300).
Resona I8W, Resona 18, Resona 18 Exp, Resona I8S, Resona I8T, Resona IY, Resona 18 Easi, Eagus 18 Easi, Nuewa 18W, Nuewa 18, Nuewa 18 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System has the equivalent features and functions as the predicated devices. Among these features, the IOTA supported in proposed Resona I8W series has been cleared in predicate device Voluson E10 (K181985).

7. Non-clinical Tests:

Resona I8W, Resona I8, Resona I8 Exp, Resona I8T, Resona I8T, Resona IY, Resona

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I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8 Exp, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn 18T, Imagyn I8 Exp, Nuewa IY 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 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.
. 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 I8W, Resona I8, Resona I8 Exp,

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Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus 18 Easi, Nuewa 18W, Nuewa 18, Nuewa 18 Exp. Nuewa 18S, Nuewa 18T, Imagyn 18, Imagyn 18S, Imagyn 18T, Imagyn 18 Exp, Nuewa IY 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 I8W, Resona I8, Resona I8 Exp, Resona I8T, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8S, Imagyn 18T, Imagyn 18 Exp, Nuewa IY 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 I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa 18W, Nuewa 18, Nuewa 18 Exp, Nuewa I8S, Nuewa I8T, Imagyn 18, Imagyn 18S, Imagyn I8T, Imagyn 18 Exp, Nuewa IY Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to the predicate device Resona 19.

Regulation Number and Section

§ 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.