ViewMate Multi Ultrasound System VMM-ICE-01 is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Abdominal, thoracc, and vacular), Pediatric, Small Organ (Thyroid, Breast, Testes), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Intra-cardiac and Peripheral vessel 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, TDI, Color M.

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

ViewMate™ Multi 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, TDI, Color M.

ViewMate™ Multi 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.

AI/ML Overview

This document is a 510(k) summary for the ViewMate™ Multi Ultrasound System and does not contain detailed information about specific acceptance criteria or an explicit study proving performance against those criteria. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device, as required for FDA 510(k) clearance.

Therefore, many of the requested details about acceptance criteria, study specifics, sample sizes, expert qualifications, and ground truth are not present in this regulatory document.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, rather than presenting specific performance metrics against defined acceptance criteria for a new device's core functionality.

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

This information is not provided in the document. The document states "Non-clinical Tests" were performed, but does not detail a "test set" for performance evaluation in the context of clinical or diagnostic accuracy. It refers to testing against safety and performance standards.

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

This information is not provided in the document. As clinical studies were deemed "Not applicable," there's no mention of experts establishing ground truth for a test set.

4. Adjudication method for the test set

This information is not provided in the document.

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

This information is not provided and is not applicable. The ViewMate™ Multi Ultrasound System is described as a "general purpose diagnostic ultrasound system" and there is no indication it incorporates Artificial Intelligence (AI) or machine learning features that would necessitate an MRMC comparative effectiveness study to assess human reader improvement with AI assistance. Clinical studies are explicitly stated as "Not applicable."

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

This information is not provided and is not applicable. Based on the device description, it's a diagnostic ultrasound system intended for use by healthcare professionals, implying human-in-the-loop operation. There is no mention of a standalone algorithm for independent performance.

7. The type of ground truth used

This information is not provided and is not applicable as clinical studies were not performed. The testing mentioned (acoustic output, biocompatibility, safety standards) does not rely on a "ground truth" in the diagnostic sense (e.g., pathology, outcomes data).

8. The sample size for the training set

This information is not provided and is not applicable. Since clinical studies were not required, and there's no mention of AI/machine learning components that typically require training sets, this detail is absent.

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

This information is not provided and is not applicable for the same reasons as point 8.

Summary of what the document does provide regarding device evaluation:

The document indicates that the ViewMate™ Multi Ultrasound System underwent non-clinical tests to demonstrate its safety and effectiveness. These tests included:

Acoustic output evaluation (against NEMA UD 2-2004 (R2009))
Biocompatibility evaluation (against ISO 10993-1 Fifth edition 2018-08)
Cleaning and disinfection effectiveness
Thermal, electrical, and mechanical safety (against AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text), IEC 60601-1-2 Edition 4.0 2014-02, IEC 60601-2-37 Edition 2.1 2015)
Software life cycle processes (against IEC 62304 Edition 1.1 2015-06)
Usability engineering (against IEC 60601-1-6 Edition 3.1 2013-10 and IEC 62366-1 Edition 1.0 2015-02)
Risk management (against ISO 14971 Third Edition 2019-12)

The "study" or evaluation performed was primarily a comparison against recognized industry standards and a predicate device (Resona I9 K210699) to establish substantial equivalence, rather than a clinical performance study with specific diagnostic accuracy or efficacy endpoints. The acceptance criteria for these non-clinical tests would be compliance with the requirements of the listed standards. For example, for acoustic output, the acceptance criterion would be that the acoustic power levels are "below the limits of FDA."

Summary

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November 9, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Shenzhen Mindray Bio-Medical Electronics Co., LTD % Jin Jiahong Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong 518057 CHINA

Re: K222754

Trade/Device Name: ViewMate Multi 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: September 6, 2022 Received: September 12, 2022

Dear Jin Jiahong:

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 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

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801); 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,

Yanna S. Kang -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT 8C: 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) K222754

Device Name ViewMate Multi Ultrasound System

Indications for Use (Describe)

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, TDI, Color M.

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: K222754

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: September 6, 2022

2. Device Name

ViewMate™ Multi 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

ViewMate™ Multi Ultrasound System is comparable with and substantially equivalent to the predicate devices listed below. Resona I9 is the main predicate devices.

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Device	Manufacturer	Model	DeviceClass	Product Code	510KNumber
1. Main predicatedevice	Mindray	Resona I9	II	IYN, IYO, ITX	K210699
2. Reference device	Mindray	ZS3	II	IYN, IYO, ITX	K192410
3. Reference device	Mindray	TE7	II	IYN, IYO, ITX	K203391

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)

4. Device Description:

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5. Intended Use:

ViewMate™ Multi Ultrasound System VMM-ICE-01 is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Abdominal, Intra-operative (abdominal, thoracic, and vascular), Pediatric, Small Organ (Thyroid, Breast, Testes), Neonatal Cephalic, Adult Cephalic, Musculoskeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Transesoph. (Cardiac), Intra-cardiac and Peripheral vessel 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, TDI, Color M.

6. Comparison with Predicate Devices:

Subject device ViewMate™ Multi 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 1 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 ViewMate™ Multi Ultrasound System has the same intended . uses as the predicated device Resona I9 (K210699) except Intra-operative (abdominal, thoracic, and vascular) and Intra-cardiac application, which has been cleared on predicate device ZS3 (K192410).

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The patient contact materials of the transducers and needle-guided brackets of . subject device ViewMate™ Multi Ultrasound System are the same to the predicate devices or tested under ISO 10993-1.
The acoustic power levels of ViewMate™ Multi Ultrasound System are below ■ the limits of FDA, which are the same as the predicated device Resona I9 (K210699).
. ViewMate™ Multi 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).
. ViewMate"10 Multi Ultrasound System has the equivalent features and functions as the predicated devices.

7. Non-clinical Tests:

ViewMate™ Multi 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.
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: 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.

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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, ViewMate™ Multi Ultrasound System, does not require clinical studies to support substantial equivalence.

9. Summary

Based on the performance data as documented in the study, ViewMate™M Multi 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 ViewMate M Multi 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.