TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, pediatric , thoracic/pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, neonatal and adult cephalic, 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(Color+B, Power+B), Tissue Harmonic Imaging, and TDI.

Device Description

The TE Air Diagnostic Ultrasound System is a general purpose, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode (Color+B, Power+B), Tissue Harmonic Imaging, and TDI mode.

TE Air consists of an app which can be installed on iOS devices, and probes which use wireless technology for communication.

This system is a Track 3 device that employs phased array probes.

AI/ML Overview

The provided FDA 510(k) summary for the TE Air Diagnostic Ultrasound System explicitly states "Not applicable. The subject of this submission, TE Air Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." Therefore, no clinical study was conducted to prove the device meets acceptance criteria.

The submission relies on non-clinical tests to demonstrate substantial equivalence to predicate devices. These non-clinical tests include acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, conforming to applicable medical safety standards.

Below is a table summarizing what would typically be included if clinical performance data were available, based on the information provided, or indicating its absence.

Acceptance Criteria and Device Performance (Based on Non-Clinical Assessment):

Acceptance Criterion Type	Reported Device Performance
Acoustic Output Safety	Below the limits of FDA.
Biocompatibility	Evaluated to conform with ISO 10993-1.
Cleaning and Disinfection Effective.	Evaluated for effectiveness.
Thermal Safety	Evaluated to conform with AAMI / ANSI ES60601-1 and IEC 60601-2-37.
Electrical Safety	Evaluated to conform with AAMI / ANSI ES60601-1 and IEC 60601-2-37.
Mechanical Safety	Evaluated to conform with AAMI / ANSI ES60601-1 and IEC 60601-2-37.
Electromagnetic Compatibility (EMC)	Evaluated to conform with IEC 60601-1-2.
Software Life Cycle Processes	Evaluated to conform with IEC 62304.
Risk Management	Evaluated to conform with ISO 14971.
Usability Engineering	Evaluated to conform with IEC 62366-1 and IEC 60601-1-6.
Clinical Performance (Accuracy, Sensitivity, Specificity, etc.)	Not evaluated through clinical studies for substantial equivalence.

Absence of Clinical Study Information:

Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used to assess performance for substantial equivalence.
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 was used to establish ground truth for performance assessment.
Adjudication method for the test set: Not applicable, as no clinical test set was used.
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, as no MRMC study or AI assistance performance evaluation was described. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of clinical decision support.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as no standalone algorithm performance was assessed for clinical endpoints.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth was established for performance assessment.
The sample size for the training set: Not applicable, as no clinical training set was described for performance assessment.
How the ground truth for the training set was established: Not applicable, as no clinical training set was described.

Summary of the FDA's Stance:
The FDA determined that the TE Air Diagnostic Ultrasound System is "substantially equivalent" to legally marketed predicate devices based on its similar technological characteristics, comparable key safety and effectiveness features (as demonstrated by non-clinical tests), and identical intended uses and basic operating modes. This determination did not require clinical studies to support substantial equivalence in this specific case.

Summary

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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: K220051

Trade/Device Name: TE Air 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: December 31, 2021 Received: January 6, 2022

March 4, 2022

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); 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the 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,

Jessica Lamb, Ph.D. Assistant 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)

K220051

Device Name

TE Air Diagnostic Ultrasound System

Indications for Use (Describe)

Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(Color+B, Power+B), Tissue Harmonic Imaging, and TDI.

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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ 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 is: _K220051

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: December 31, 2021

2. Device Name: TE Air Diagnostic Ultrasound System

Classification

Regulatory Class: II

Review Category: Tier II

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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)

Main Predicate Device: TEX20 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:

TE Air consists of an app which can be installed on iOS devices, and probes which use wireless technology for communication.

This system is a Track 3 device that employs phased array probes.

4. Intended Use:

TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, pediatric ,

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thoracic/pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, neonatal and adult cephalic, and urology exams..

Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode (Color+B, Power+B), Tissue Harmonic Imaging, and TDI.

5. Comparison with Predicate Devices:

The TE Air Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

Device	Manufacturer	Model	510(k)Number
1. Primary predicatedevice	Mindray	TEX20	K212265
2. Reference device	Mindray	MX7	K212900
3. Reference device	Butterfly Network	Butterfly iQ	K202406

The TE Air Diagnostic Ultrasound System has the similar 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

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	Subject Device	Predicate device
Items	TE Air	TEX20(K212265)	S/D
Indicationsfor use	Diagnostic Ultrasound System isapplicable for adults, pregnantwomen, pediatric patients andneonates.It is intended for use in abdominal,pediatric , thoracic/pleural (Fordetection of fluid and pleuralmotion/sliding.), adult and pediatriccardiac, neonatal and adult cephalic,and urology exams.	Diagnostic Ultrasound System isapplicable for adults, pregnant women,pediatric patients and neonates.It is intended for use in Ophthalmic, fetal,abdominal, Intra-operative (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 (Fordetection of fluid and pleuralmotion/sliding.), adult and pediatriccardiac, trans-esoph. (Cardiac), peripheralvessel, and urology exams	S
Modes ofoperation	Modes of operation include: B, M,PWD, Color Doppler, AmplitudeDoppler, Combined mode(Color+B, Power+B), TissueHarmonic Imaging, and TDI.	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,	S
	iScape View, TDI, Color M, StrainElastography, Contrast imaging (Contrastagent for LVO), and Contrast imaging(Contrast agent for Liver).

allow for specialized measurements of structures and flow, and calculations.

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Subject device
The subject device and predicate TEX20 (K212265) have same clinical indications for use.
The subject device and predicate TEX20 (K212265) have identical imaging modes, same special functions, however the proposed subject device has the Auto EF、Smart Bladder functions which have been cleared in predicate MX7 (K212900) .
The acoustic power levels of subject device are below the limits of FDA, which is the same as the predicated device TEX20 (K212265).
The proposed TE Air has a software app which can be installed on user's mobile device that provides some of the processing and uses the screen of the mobile device as the display like is done for cleared Butterfly iQ (K202406).

6. Non-clinical Tests:

The TE Air 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

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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 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 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.

7. Clinical Studies

Not applicable. The subject of this submission, TE Air Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

Conclusion:

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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 TE Air Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to predicate device.

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.