(56 days)
Not Found
No
The document describes a standard diagnostic ultrasound system with various imaging modes and analysis packages, but there is no mention of AI or ML capabilities. The sections related to training/test sets and performance studies, which are typically included for AI/ML devices, are marked as "Not Applicable".
No.
The device is a "Diagnostic Ultrasound System" intended to acquire and display ultrasound images and measure anatomical structures to aid healthcare professionals in making a diagnosis, not to provide therapy.
Yes
The text explicitly states "TEX...Diagnostic Ultrasound System" in multiple sections, and its "Intended Use" clearly lists a wide range of exams for diagnostic purposes, and it "can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis."
No
The device is described as a "Diagnostic Ultrasound System," which inherently includes hardware components (transducer, processing unit, display, etc.) to acquire and display ultrasound images. While it is "software controlled," it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this is a "Diagnostic Ultrasound System." Ultrasound systems use sound waves to create images of internal body structures. They do not analyze samples taken from the body.
- Intended Use: The intended use describes imaging various anatomical sites within the body, not analyzing biological samples.
- Device Description: The description focuses on the system's ability to acquire and display ultrasound images and measure anatomical structures.
- Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TEX20/TEX20 Pro/TEX20S/TEX20 Exp/TEX20 Elite/TEX10 Pro/TEX10S/TEX10S/TEX10T/TEX10 Exp/ TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), Thoracic/Pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology 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, Smart3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).
Product codes
IYN, IYO, ITX
Device Description
The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic 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, Smart3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).
The TEX20/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic 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.
Mentions image processing
All systems transmit ultrasonic energy into patients, perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, fetal, abdominal, Intraoperative (abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, transvaginal, musculo-skeletal(conventional, superficial), Thoracic/ Pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, transesoph. (Cardiac), peripheral vessel, and urology exams.
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates.
Intended User / Care Setting
Not Found
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, TEX20/TEX20 Pro/TEX20S/ TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10 / TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 % Jiang Xiaoyong Engineer of Technical Regulation Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057 P.R. CHINA
March 25, 2022
Re: K220242
Trade/Device Name: TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite 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: January 20, 2022 Received: January 28, 2022
Dear Jiang Xiaoyong:
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
1
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 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,
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)
K220242
Device Name
TEX20/TEX20 Pro/TEX20S/TEX20 Exp/TEX20 Elite/TEX10/TEX10S/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
Indications for Use (Describe)
TEX20/TEX20 Pro/TEX20S/TEX20 Exp/TEX20 Elite/TEX10 Pro/TEX10S/TEX10S/TEX10T/TEX10 Exp/ TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), Thoracic/Pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology 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, Smart3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).
| 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: K220242
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 6238 Fax: +86 755 2658 2680
Contact Person
Jiang Xiaoyong 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: Jan 20, 2022
2. Device Name
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite 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. Predicate devices
TEX20 series Diagnostic Ultrasound System is comparable with and substantially equivalent to the predicate devices listed below. TEX20 is the primary predicate device.
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| Device | Manufacturer | Model | Device | Product | 510K |
|---|---|---|---|---|---|
| Class | Code | Number | |||
| Primary Predicate | |||||
| device | Mindray | TEX20 | II | IYN, IYO, | |
| ITX | K212265 | ||||
| Secondary | |||||
| Predicate device | Mindray | Resona I9 | II | IYN, IYO, | |
| ITX | K210699 |
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:
The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic 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, Smart3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ The TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic 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.
5. Intended Use:
The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, Intraoperative (abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, transvaginal, musculo-skeletal(conventional, superficial), Thoracic/ Pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, transesoph. (Cardiac), peripheral vessel, and urology exams.
5
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, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).
6. Comparison with Predicate Devices:
The TEX20/TEX20 Pro/ TEX20S/ TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/ TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System is comparable with and substantially equivalent to the predicate devices with regards to intended use, imaging modes, features and functions and technological characteristics.
As compared with the primary predicate device TEX20 in K212265, the subject device has the modifications described as following.
| Material change | |
|---|---|
| 1 | Material change of the probe shells of the transducers i3P and i3PA |
| New added features | |
| 1 | Add new feature AutoEF |
| 2 | Add new feature AutoEF Plus |
- 1 The modified patient contact materials of the subject device TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Elite/TEX10/TEX10 Pro/ TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System are tested under ISO 10993-1.
- The features and functions supported in subject device TEX20/TEX20 . Pro/TEX20S/TEX20T/TEX20 | Exp/TEX20 Elite/TEX10/TEX10 Pro/ TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System and primary predicated device TEX20 (K212265) are identical except:
-
The subject device has introduced two new features (AutoEF, AutoEF Plus). The feature AutoEF has been previously cleared in Resona I9 (K210699) and the AutoEF Plus is an improved feature of the AutoEF (cleared in K210699), which could be used to automatically measure the systole or diastole views in real time.
-
- All systems transmit ultrasonic energy into patients, 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, as well as calculations.
- 1 The subject device TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20
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Elite/TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System has the same intended uses as the primary predicated device TEX20 (K212265).
- . The acoustic power levels of the subject device TEX20/TEX20 Pro/TEX20S/ TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/ TEX10 Exp/TEX10 Elite/TE X/TE X Lite are below the limits of FDA, which are the same as the primary predicated device TEX20 (K212265).
- 1 The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the primary predicated device TEX20 (K212265).
7. Non-clinical Tests:
The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Ultrasound System has been evaluated for acoustic output, Diagnostic 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.
The subject 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 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.
7
- IEC 62304 Edition 1.1 2015-06, medical device software software life cycle . processes.
- 1 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, TEX20/TEX20 Pro/TEX20S/ TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10 / TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
9. Summary
Based on the performance data as documented in the study, the TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/ TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic 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 device safety standards. Therefore, the medical TEX20/TEX20 Exp/TEX20 Pro/TEX20S/TEX20T/ TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/ TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared (K212265/K210699) for market