(139 days)
No
The document describes standard ultrasound imaging modes and post-processing techniques, with no mention of AI, ML, or related concepts like deep learning or neural networks. The lack of sections on training/test sets and performance metrics further supports this.
No
The device is described as a "general purpose diagnostic ultrasound system" intended for "ultrasound imaging, measurement, display and analysis of the human body and fluid," which are diagnostic functions, not therapeutic ones.
Yes
The device is explicitly named "TE Air Diagnostic Ultrasound System" and its intended use is to "diagnose" via ultrasound imaging, measurement, display and analysis.
No
The device description explicitly states that the system consists of an app and probes which use wireless technology for communication. This indicates the presence of hardware components (the probes) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "general purpose diagnostic ultrasound system" for "ultrasound imaging, measurement, display and analysis of the human body and fluid". This describes a device used for imaging within the body, not for testing samples outside the body (which is the definition of an IVD).
- Device Description: The description focuses on acquiring and displaying ultrasound data from the body.
- Input Imaging Modality: The input modality is Ultrasound, which is an imaging technique applied to the body, not a method for analyzing biological samples.
- Anatomical Site: The listed anatomical sites are all locations within the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests on samples outside the body.
Therefore, the TE Air Diagnostic Ultrasound System is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, pediatric , thoracc/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.
Product codes
IYN, IYO, ITX
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 or Android devices, and probes which use wireless technology for communication.
This system is a Track 3 device that employs phased array probes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
abdominal, pediatric, thoracic/pleural, adult and pediatric cardiac, neonatal and adult cephalic, and urology
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates
Intended User / Care Setting
qualified and trained healthcare professionals; hospital or medical clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not applicable. The subject of this submission, TE Air Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
October 26, 2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Zhang Yuxi Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong 518057 P.R. CHINA
Re: K231685
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: September 12, 2023 Received: September 22, 2023
Dear Zhang Yuxi:
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" (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).
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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 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-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 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-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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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 abdominal, pediatric , thoracc/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.
| 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 is: K231685.
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:
Zhang Yuxi
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: June 31, 2023
2. Device Name: TE Air Diagnostic Ultrasound System(cleared in K220051) 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: TE Air 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:
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 or Android 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..
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.
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 predicate | |||
| device | Mindray | TE Air | K220051 |
| 2. Reference device | Mindray | TEX20 | K220242 |
As compared with the primary predicate device TE Air in K220051, the subject device has the modifications described as following.
| New added features | ||
|---|---|---|
| 1 | Add new feature AutoEF | |
| The other change | ||
| 2 | Add OS Android | |
| 3 | Update iOS 12 to iOS 13 |
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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 (K220051) have same clinical indications for use.
- The subject device and predicate TE Air (K220051) have identical imaging modes, same special functions, however the proposed subject device has the Auto EF functions which have been cleared in predicate TEX20 (K220242).
- The acoustic power levels of subject device are below the limits of FDA, which is the same as the predicated device TE Air (K220051).
- 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 (K220051).
- The OS changes of the subject device TE Air that have 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 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:
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- . 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 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.
Page 5 of 6
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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 demonstrates substantial equivalence to predicate device.