M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel and urology 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, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

Device Description

The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, CW-Mode, CW-Mode, Color-Mode , Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array probe.

AI/ML Overview

The provided document is a 510(k) Summary for a diagnostic ultrasound system. It outlines the device's features, intended use, and comparison to predicate devices, but it explicitly states that no clinical studies were performed.

Therefore, I cannot provide information on:

Acceptance criteria and reported device performance based on clinical studies.
Sample size, data provenance, ground truth establishment, or expert details for a test set.
Adjudication method or MRMC comparative effectiveness studies.
Standalone algorithm performance.
Training set details (sample size, ground truth establishment).

The document explicitly states:

8. Clinical Studies

Not applicable. The subject of this submission, M9/M9CV/M9T/M8 Elite/M10 /M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

This indicates that the substantial equivalence determination for this ultrasound system was based on non-clinical tests (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety, and compliance with recognized standards) and a comparison of technical characteristics and intended uses with legally marketed predicate devices, rather than a study proving the device meets specific acceptance criteria for AI-assisted performance or human-in-the-loop improvements.

The "acceptance criteria" for this device, as implied by the document, are primarily related to safety and effectiveness being substantially equivalent to predicate devices through engineering and design validation, and adherence to relevant industry standards. There are no performance metrics provided that would typically be seen for an AI/ML-driven device requiring clinical validation against specific performance targets.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Shenzhen Mindray Bio-Medical Electronics Co., LTD % Shi Jufang Engineer of Technical Regulation Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057 P.R. CHINA

Re: K210416

Trade/Device Name: M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium 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 8, 2021 Received: March 14, 2021

June 10, 2021

Dear Shi Jufang:

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 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)

K210416

Device Name M9/M9CV/M9TM8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crus M11/M9 Premium Diagnostic Ultrasound System

Indications for Use (Describe)

M9/M9CV/M9T/M8 Elite/M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, transesoph.(Cardiac), peripheral vessel and urology exams.

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).

K210416 The assigned 510(k) number is: _

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 6293 Fax: +86 755 2658 2680

Contact Person:

Shi Jufang 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 7, 2021

2. Device Name: M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/

Crius M11/Operus M11/M9 Premium 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)

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Main Predicate Device: M9 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. Device Description:

This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array probe.

4. Intended Use:

This device is a general purpose diagnostic ultrasound system intended for use by

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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, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

5. Summary of Modifications

Newly Added Models:
M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium;
Newly Added Transducers: SC6-1s, L9-3s, P8-2Ts, LAP13-4Cs, ELC13-4s;
Newly Added Needle-guided Brackets: NGB-034, NGB-051;
Main Added Features and Modifications:
- 1. Add Smart VTI
- 1. Add Smart IVC
- 1. Add Smart B-line
- 1. Add Smart Hip
- 1. Add Auto GA
- 1. Add Auto DFR
- 1. Add function of transducer element check
- 1. Add mobile trolley MT5
- 1. Add iVocal
- 1. Upgrade the operating system
- 1. Add actions to strengthen the cybersecurity:
  - (1) add anti-virus software McAfee, support domain server and VPN
  - (2) support for WiFi enterprise-level security authentication
  - (3) encrypt data to prevent the risk of information leakage
- 1. Enhance TTQA function

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1. Enhance Stress Echo
1. Enhance iNeedle function
1. Optimize blood flow of heart
1. Optimize PW measurement and workflow

6. Comparison with Predicate Devices:

The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11 /Operus M11/M9 Premium Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

Predicate Device	Manufacturer	Model	510(k) Number
1. Primary predicate device	Mindray	M9	K171034
2. Reference device	Mindray	MX7	K200001
3. Reference device	Mindray	DC-80A	K201693
4. Reference device	Mindray	ZS3	K192410
5. Reference device	Mindray	DC-80	K192152
6. Reference device	Mindray	TE7	K203391

The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius

M11/Operus M11/M9 Premium Diagnostic Ultrasound System has the same technological characteristics, is comparable in key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices. All systems transmit ultrasonic energy into patients and 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, and calculations.

Subject device
The subject device and predicate M9 (K171034) have similar clinical indications for use however the proposed subject device has the Laparoscopic applications which has been cleared on predicate ZS3(K192410).

Items	Subject Device	Predicate device	S/D

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	M9/M9CV/M9T/M8Elite/M10/M10CV/CriusM10/M11/M11CV/Crius M11/Operus M11/M9 Premium	M9 (K171034) &ZS3(K192410)
Indications for Use	M9/M9CV/M9T/M8Elite/M10/M10CV/CriusM10/M11/M11CV/Crius M11/OperusM11/M9 Premium Diagnostic UltrasoundSystem is applicable for adults, pregnantwomen, pediatric patients and neonates. It isintended for use in fetal, abdominal,Intra-operative, Laparoscopic, pediatric,small organ(breast, thyroid, testes), neonataland adult cephalic, trans-rectal,trans-vaginal, musculo-skeletal(conventional, superficial), adult andpediatric cardiac, trans-esoph.(Cardiac),peripheral vessel and urology exams.	The M9 Diagnostic Ultrasound System isapplicable for adults, pregnant women,pediatric patients and neonates. It is intendedfor use in fetal, abdominal, Intra-operative,pediatric, small organ(breast, thyroid, testes),neonatal and adult cephalic, trans-rectal,trans-vaginal, musculo-skeletal(conventional,superficial), adult and pediatric cardiac,trans-esoph.(Cardiac), peripheral vessel ,urology exams.	S

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This device is a general purpose diagnostic
ultrasound system intended for use byqualified and trained healthcareprofessionals for ultrasound imaging,measurement, display and analysis of thebe used in a hospital or medical clinic.	The ZS3 Ultrasound Systems are intended foruse by a qualified physician for ultrasoundevaluation of Ophthalmic; Fetal; Abdominal(renal, GYN/Pelvic); Intra-operative(abdominal, thoracic(cardiac), and vascular);
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, iScape, TDI,Color M, Elastography, Contrast imaging(Contrast agent for LVO), Smart 3D,4D(Real-time 3D), Contrast imaging(Contrast agent for Liver).	Intra-operative (Neuro); Laparoscopic;Pediatric; Small organ (thyroid, breast, testes,etc); Neonatal cephalic; AdultCephalic/Transcranial; Trans-rectal;Trans-vaginal; Trans-esoph.(non-Card);Musculoskeletal (Conventional);Musculoskeletal (Superficial);Cardiac Adult;Cardiac Pediatric; Trans-esoph. (Cardiac);Intra-cardiac; Peripheral vessel.

Note:

The intended use of subject device is covered by predicate device M9 (K171034) except Laparoscopic applications. But the predicate device ZS3(K192410) has Laparoscopic application.

1. According to the requirements of FDA Guidance, "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, June 27, 2019 " (and following its numbering scheme), add descriptions of modes of operation, operator qualification and device use settings in the Indications for use.
The subject device and predicate M9 (K171034) have identical imaging modes, ● similar special functions however the proposed subject device has the Smart VTI, Smart IVC, Smart B-line functions which has been cleared on predicate MX7(K200001), and the Auto GA function has been cleared in TE7(K203391).

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The subject device has similar probes as the predicate M9 (K171034) however the proposed subject device has the SC6-1s, L9-3s, LAP13-4Cs, and ELC13-4s, but they can be substantial equivalent with DC-80A(K201693), DC-80 (K192152) and ZS3(K192410).
The acoustic power levels of subject device are below the limits of FDA, which is . the same as the predicated device M9 (K171034)
The subject device is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device M9 (K171034).

7. Non-clinical Tests:

The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11 /Operus M11/M9 Premium Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been designed to conform with applicable medical safety standards. This device has been tested and evaluated under the following standards:

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 compatibility - requirements and tests.
. 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.
. IEC 62304 Edition 1.1 2015-06, medical device software - software life cycle processes.
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.

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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)].
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.

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, M9/M9CV/M9T/M8 Elite/M10 /M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

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 M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to device M9(K171034) .

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.