TE Air Diagnostic Ultrasound System

{0} FDA U.S. FOOD & DRUG ADMINISTRATION Shenzhen Mindray Bio-Medical Electronics Co., Ltd May 30, 2025 Jufang Shi Engineer of Technical Regulation Mindray Building, Keji12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, GuangDong 518057 CHINA Re: K250024 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: April 29, 2025 Received: April 29, 2025 Dear Jufang Shi: 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 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. 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250024 - Jufang Shi Page 2 (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/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-report-medical-device-problems. {2} K250024 - Jufang Shi Page 3 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/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-devices/device-advice-comprehensive-regulatory-assistance/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, Digitally signed by Michael D. O'hara -S Date: 2025.05.30 15:40:44 -04'00' For 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 Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K250024 | | | Device Name TE Air Diagnostic Ultrasound System | | | Indications for Use (Describe) TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetalabdominal, pediatric, small organneonatal and adult cephalic, musculo-skeletal(Conventional and Superficial)thoracic/pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric 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, Power 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) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | | | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | {4} K250024 # 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: K250024 ## 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, 2024 ## 2. Device Name: TE Air Diagnostic Ultrasound System Classification Regulatory Class: II Review Category: Tier II Page 1 of 6 {5} 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: TE Air Diagnostic Ultrasound System (cleared in K240906) ## 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: 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, Power 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 or Android devices, and probes which use wireless technology for communication. The iOS or Android devices could be mobile platform available from the market, or the Mindray's customized Android platform called AirSight. ## 4. Intended Use: TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, Page 2 of 6 {6} pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, musculo-skeletal(Conventional and Superficial), thoracic/pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric 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, Power 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 below predicate device: | Device | Manufacturer | Model | 510(k) Number | | --- | --- | --- | --- | | 1. Primary predicate device | Mindray | TE Air | K240906 | As compared with the primary predicate device TE Air in K240906, the subject device has the modifications described as following. | New added options | | | --- | --- | | 1 | Add AirSight. The TE Air consists of an app which can be installed on iOS or Android devices, and probes which use wireless technology for communication. The iOS or Android devices could be mobile platform available from the market, or the Mindray’s Customized Android platform called AirSight. The AirSight is introduced in this application. | {7} The AirSight is a device composed of the processor, memory, display screen, audio module, wireless module, battery, Android software operating system, sheet metal, and housing. The final form of AirSight is similar to a mobile phone. The AirSight, ultrasound probe and TE Air APP form a complete Ultrasonic imaging system for ultrasound imaging, measurement, and display. 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 allow for specialized measurements of structures and flow, and calculations. - The subject device and predicate TE Air (K240906) have same clinical indications for use. - The subject device and predicate TE Air (K240906) have identical imaging modes, same special functions - The acoustic power levels of subject device are below the limits of FDA, which is the same as the predicated device TE Air (K240906). - 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 TE Air (K240906). The AirSight is newly introduced in the proposed TE Air, and this change has passed the related bench tests, no safety risk is introduced. ## 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 Page 4 of 6 {8} 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 TR 60601-4-2 Edition 1.0 2024-03 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems - 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 62366-1:2015+AMD1:2020 Medical devices - Part 1: Application of usability engineering to medical devices. - IEC 60601-1-6 Edition 3.2 2020-07 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability. Page 5 of 6 {9} 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: 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 the predicate device. Page 6 of 6