(119 days)
Yes
The summary explicitly states "It is an AI (artificial intelligence) based feature."
No
The device is explicitly described as a "Diagnostic Ultrasound System" and its function is to "acquire and display ultrasound images" and "provide information based on which the competent health care professionals can make the diagnosis". It does not describe any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is a "Diagnostic Ultrasound System." The "Device Description" also mentions its function as an "ultrasonic diagnostic system" that provides information based on which "competent health care professionals can make the diagnosis."
No
The device is described as a "Diagnostic Ultrasound System" and a "general purpose, mobile, software controlled, ultrasonic diagnostic system." This implies the presence of hardware components necessary for generating and receiving ultrasound waves, in addition to the software that controls the system and processes the images.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (like blood, urine, or tissue). This device is a diagnostic ultrasound system that uses sound waves to create images of structures within the body.
- The intended use and device description clearly state it's for imaging and measuring anatomical structures and fluid flow within the body.
- There is no mention of analyzing biological samples.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
No
The letter explicitly states "Not Found" for "Control Plan Authorized (PCCP) and relevant text," meaning there is no indication that the FDA has reviewed or cleared a PCCP for this device.
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), ThoracicPleural (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 (comma separated list FDA assigned to the subject device)
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/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 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
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, fetal, abdominal, thoracic, vascular, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), Thoracic/Pleural, adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, urology, Intra-operative (abdominal, thoracic, and vascular), Laparoscopic, trans-rectal.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety. The device was evaluated under standards including NEMA UD 2-2004 (R2009), AAMI / ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2 Edition 4.0 2014-02, IEC 60601-1-6 Edition 3.1 2013-10, IEC 60601-2-37 Edition 2.1 2015, ISO 14971 Second edition 2007-03-01, ISO 10993-1 Fifth edition 2018-08, IEC 62304 Edition 1.1 2015-06, and IEC 62366-1 Edition 1.0 2015-02. The results demonstrated conformance to applicable medical safety standards and support substantial equivalence. Clinical studies were not required. The device's safety and effectiveness profile was found to be similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K210699, K200001, K210416, K202785
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Hao Yixuan Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong 518057 CHINA
November 16, 2021
Re: K212265
Trade/Device Name: TEX20/TEX20 Pro/TEX20S/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, 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: September 30, 2021 Received: October 12, 2021
Dear Hao Yixuan:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K212265
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), ThoracicPleural (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) | |
|---|---|
| X 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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
3
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: K212265
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 6129 Fax: +86 755 2658 2680
Contact Person
Hao Yixuan 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: July 15, 2021
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. TE7 is the main predicate devices.
4
| Device | Manufacturer | Model | Device
Class | Product
Code | 510K
Number |
|--------------------------------|--------------|-----------|-----------------|-----------------|----------------|
| 1. Primary
predicate device | Mindray | TE7 | II | IYN, IYO, ITX | K203391 |
| 2. Reference device | Mindray | Resona I9 | II | IYN, IYO, ITX, | K210699 |
| 3. Reference device | Mindray | MX7 | II | IYN, IYO, ITX | K200001 |
| 4. Reference device | Mindray | M9 | II | IYN, IYO, ITX | K210416 |
| 5. Reference device | Mindray | Resona 7 | II | IYN, IYO, ITX | K202785 |
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 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X TEX10 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, Intra-operative (abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, transtrans-vaginal, musculo-skeletal(conventional, rectal. superficial).
5
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, 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:
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 | Exp/TEX20 Subiect device 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 these predicate devices mentioned in 3. Predicate Devices with regards to intended use, imaging modes, features and functions and technological characteristics.
- . 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.
- . 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 has the same intended uses as the primary predicated device TE7 (K203391) except the mode of operation Strain Elastography, which has been cleared on predicate device Resona I9(K210699)
- . The patient contact materials of the transducers and needle-guided brackets of 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 are the same to the predicate devices or tested under ISO 10993-1.
- . The acoustic power levels of 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 TE7 (K203391).
6
- . 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 TE7 (K203391).
- . The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite has the equivalent features and functions as the predicated device. Among these features, the Auto DFR supported in proposed TEX20 series has been cleared in predicate device M9(K210416), the Smart Caliper and Smart Trace have been cleared in predicate device Resona I9(K210699).
For the differences compared to the 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 introduces new software and hardware options which in the below table that used as the enhancement based on the cleared functions to facilitate users or intended to support interconnecting information, no new intended use is added. Besides, the related verification/validation testing and risk analysis have been conducted and the results demonstrated the requirements for these new software and hardware options have been met.
| Printer bracket | It is used for holding the printer |
|---|---|
| Rear storage bin | It is used for keeping the cases, towelette, etc. |
| Air Charge | |
| Module | Configured with the air station to charge the main unit. |
| Air Probe Charging | |
| Holder | It is used to charge wireless probe. |
| Air station | Cover wired power into wireless to provide power for Air |
| Charge Module | |
| iVocal Plus | |
| Microphone Array | The iVocal Plus is an improvement of iVocal (cleared in |
| K210699), which both enables the system to perform | |
| operations through vocal commands and through tapping | |
| icons on the touch screen. The iVocal Plus Microphone | |
| array is a hardware used with iVocal Plus, it consists of | |
| microphone arrays (including wireless transceivers) and | |
| USB cables. | |
| X-Link | The Ultrasound System supports interconnecting |
| information with the bedside device through X-Link. The |
7
| interconnection function of X-Link mainly includes: | |
|---|---|
| Obtaining data: The data of the same patient are matched | |
| through network connection; | |
| Using data: Real-time data are obtained and displayed in | |
| combination with ultrasound image data; | |
| Storing and reviewing data: The data are stored in | |
| combination with the ultrasound image data and can be | |
| reviewed on the ultrasound device. | |
| ClamAV | It is an antivirus software |
| Smart Nerve | It is an AI (artificial intelligence) based feature. |
| It is used to recognize the interscalene and supraclavicular | |
| brachial plexus. It is intended for visualization purpose only | |
| and not intended for live guidance during interventional | |
| procedure. |
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 Diagnostic Ultrasound System has been evaluated for acoustic output, 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.
This 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 1
8
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 62304 Edition 1.1 2015-06, medical device software - software life cycle processes.
- . 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 / 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 medical device safety standards. Therefore, 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 substantially equivalent with respect to safety and effectiveness to its primary predicate device TE7.