TE7/TE5/TE7 Max/TE9 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, Laparoscopic, abdominal,Intra-operative(abdominal, thoracic, and vascular), Pediatric ,small organ(breast, thyroid, testes), neonatal and adult cephalic,trans-esoph. (Cardiac), transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic, Thoracic/Pleural 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(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging (Contrast agent for LVO),TDI,Color M, Smart 3D,Contrast imaging (Contrast agent for Liver) and iScape View.

Device Description

TE7/TE5/TE7 Max/ TE5 Max/TE9 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode , Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Contrast imaging (Contrast agent for LVO),TDI, Color M, Smart 3D,Contrast imaging (Contrast agent for Liver) and iScape View. This system is a Track 3 device that employs an array of probes that include Linear array, Convex array, Phased array and Volume probe.

AI/ML Overview

This document is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD. TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System. It largely focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance rather than detailed performance studies against specific acceptance criteria for novel AI features.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes for test and training sets, and expert involvement for ground truth is not explicitly provided in this type of regulatory submission. The submission primarily relies on showing that the new features or modifications are "similar to" or "have been cleared with" existing features in predicate devices. There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or a standalone algorithm-only study.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or detailed performance metrics for the added features like Smart IVC, Smart VTI, Smart B-Line, EPSS, Smart Trace, Auto GA, Smart Bladder, or Smart FHR OB1. Instead, it states that these features are "similar to" or "have been cleared on" predicate devices, implying that their performance is considered equivalent and therefore acceptable.

Feature	Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
New Applications	Performance of new applications (e.g., ophthalmic, CW to fetal, abdominal, fetal to specific transducers) is comparable to that of predicate devices where these applications were already cleared.	The ophthalmic application has already been cleared with L12-4s in the predicate device TE7/TE5 (K180912). The fetal application with CW has already been cleared with SP5-1s in the predicate device TE7/TE5 (K180912). The abdominal application has already been cleared with L13-3s in the predicate device MX7 (K200001). The fetal application has already been cleared with L9-3U in the predicate device Resona 7 (K171233).
Smart 3D	Performance comparable to existing Smart 3D inpredicate devices.	This feature has been cleared with L16-4Hs in the predicate device M9 (K171034). Functionality described: operator moves probe for scanning, system reconstructs and displays a single frame of 3D image.
LVO mode	Performance comparable to existing LVO mode in predicate devices.	This feature has been cleared with L10-5 in predicate device ZS3 (K192410).
iScape View	Performance comparable to existing iScape View in predicate devices.	The feature has been cleared on the predicate device M9 (K171034). Functionality described: extends field of view by piecing together multiple B images into a single, extended B image.
Smart IVC	Automated measurement of IVC inner diameter and calculation of change rate in B mode image is accurate and reliable.	The feature has been cleared on the predicate device MX7 (K200001). Functionality described: automatically measure the IVC inner diameter and calculate the change rate in the B mode image.
Smart VTI	Calculation of CO of LVOT to evaluate cardiac function is accurate and reliable.	The feature has been cleared on the predicate device MX7 (K200001). Functionality described: used to calculate the CO (cardiac output) of the LVOT (left ventricular output tract), so as to quickly evaluate the cardiac function.
Smart B-Line	Detection of B-line of the lung in B mode (real-time and freeze) is accurate and reliable.	The feature has been cleared on the predicate device MX7 (K200001). Functionality described: used to detect the B line of the lung in B mode; supports B-line detecting in both real-time and freeze modes.
EPSS	Accurate measurement of the distance between point E and Interventricular Septum when mitral valve is fully open.	The feature has been cleared on the predicate device MX7 (K200001). Functionality described: measures the distance between point E and Interventricular Septum when mitral valve is fully open.
Smart Trace	Accurate tracing of contours of normal anatomical regions, automatic recognition of margins, and measurement of lengths, area, and circumference.	This feature is similar to the cleared feature Trace on the predicate device Resona 7 (K171233). Functionality described: helps the operator to trace the contour of the normal anatomical regions by automatically recognizing the margin of the target and measures the lengths of major axis, area and circumference of the closed region.
Auto GA	Accurate identification of gastric antrum boundary and calculation of its area.	This feature is similar to the feature Area trace on the predicate device TE7/TE5 (K180912). Functionality described: After acquired image(s) of gastric antrum, by freezing image and tapping the Auto GA button, the feature shows boundary of gastric antrum and calculates the area of gastric antrum.
Smart Bladder	Accurate measurement of urine volume in the bladder.	The feature has been cleared on the predicate device DC-40 (K183377). Functionality described: used to measure the volume of the urine in the bladder.
Smart FHR OB1	Automatic measurement of fetal heart rate is accurate and reliable.	It is similar to the cleared feature OB FHR (M) on the predicate device Resona 7 (K171233). Functionality described: to measure the fetal heart rate automatically.
Acoustic Power	Below FDA limits.	The acoustic power levels of TE7/TE5/TE7 Max/TE5 Max/TE9 are below the limits of FDA, which is the same as the predicated device TE7/TE5 (K180912).
Safety (electrical, physical)	Compliance with FDA recognized electrical and physical safety standards.	TE7/TE5/TE7 Max/TE5 Max/TE9 is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device TE7/TE5 (K180912). Compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO14971.
Biocompatibility	Materials of probes and needle-guided brackets are tested under ISO 10993-1 or are the same as predicate.	The materials of probes and needle-guided brackets of TE7/TE5/TE7 Max/TE5 Max/TE9 are the same to the predicate device or tested under ISO 10993-1.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission relies on "similarity" to predicate devices, implying that testing data from those predicate devices supports the current submission, or that specific testing for these features was performed internally without detailing the datasets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The document makes no mention of expert involvement for ground truth establishment related to the new features. Given the approach of "similarity to cleared features," it's likely that established methods of performance evaluation for ultrasound systems were followed, but the specifics are not disclosed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The submission does not claim to include AI assistance to human readers that would necessitate such a study; rather, it describes automated measurement and image processing features that are presumably integrated into the device's functionality.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

While the new features (e.g., Smart IVC, Smart VTI, Smart B-Line, Smart Bladder, Smart FHR OB1) imply automated algorithms perform measurements or detections, the document does not explicitly describe a standalone algorithm-only performance study. The context is the overall ultrasound system, and these features are presented as integrated capabilities of the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not explicitly stated. Given the nature of ultrasound imaging and a 510(k) submission primarily focused on substantial equivalence for a diagnostic ultrasound system:

For quantitative measurements (e.g., Smart IVC, Smart VTI, Auto GA, Smart Bladder, Smart FHR OB1), the ground truth would likely be established through manual measurements by trained Sonographers/Physicians using validated techniques, or comparison against other gold standard measurement methods if available.
For image processing and detection features (e.g., Smart 3D, iScape View, Smart B-Line, Smart Trace), the ground truth would likely involve expert visual assessment and consensus by radiologists/cardiologists/specialists interpreting the images and verifying the function's output.
However, this is inferred, not stated.

8. The sample size for the training set

This information is not provided. The document is a 510(k) summary for an ultrasound system, not a detailed technical report for an AI algorithm. In submissions of this type for devices primarily relying on substantial equivalence, detailed training set information is often not required or included unless the AI component is a truly novel aspect requiring extensive de novo review. The features described are framed as similar to those already cleared.

9. How the ground truth for the training set was established

This information is not provided.

Summary

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March 23, 2021

Image /page/0/Picture/1 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 and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a square and the name in a sans-serif font.

Shenzhen Mindray Bio-Medical Electronics Co., LTD. % Ma Chao Engineer of Technical Regulation Keji 12th Road South, Hi-Tech Industrial Park Shenzhen, Guangdong 518057 CHINA

Re: K203391

Trade/Device Name: TE7/TE5/TE7 Max/TE5 Max/TE9 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 22, 2021 Received: January 28, 2021

Dear Ma Chao:

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 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

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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,

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K203391

Device Name

TE7/TE5/TE7 Max/ TE5 Max/TE9 Diagnostic Ultrasound System

Indications for Use (Describe)

TE7/TE5/TE7 Max/TE9_Diagnostic_Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, Laparoscopic, abdominal,Intra-operative(abdominal, thoracic, and vascular), Pediatric ,small organ(breast, thyroid, testes), neonatal and adult cephalic,trans-esoph. (Cardiac), transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic, Thoracic/Pleural exams.

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: K203391 - .

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: March 22, 2021

2. Device Name: TE7/TE5/TE7 Max/ TE5 Max/TE9 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:

4. Intended Use:

The TE7/TE5/TE7 Max/TE9 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, Laparoscopic, abdominal, Intra-operative (abdominal, thoracic, and vascular), Pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculoskeletal (conventional, superficial), urology, Peripheral vessel, Adult and Pediatric

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cardiac, ophthalmic, Thoracic/Pleural exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Contrast imaging (Contrast agent for LVO), TDI, Color M, Smart 3D, Contrast imaging (Contrast agent for Liver) and iScape View.

ട്. Summary of Modifications

New Added Transducers and Needle-guided bracket: Transducers: L12-3VNs, LAP13-4Cs, C9-3Ts, SP5-1Ns, SC5-1Ns, P8-2Ts and P8- 3Ts;
Needle-guided bracket: NGB-043, NGB-044;
New added Clinical Application Thoracic/Pleural, Laparoscopic

● Modification

Textual modification of the probe model-"L12-3RC" modified to "L12-3RCs"

Main Added Features:

> New applications are added to the transducers:

1. Add ophthalmic application to L11-3VNs, L12-3RCs and L12-3VNs;

The ophthalmic application has already been cleared with L12-4s in the predicate device TE7/TE5(K180912).

2. Add the CW to the fetal Application for P4-2s;

The fetal application has already been cleared with SP5-1s in the predicate device TE7/TE5(K180912).

3. Add Abdominal application to L20-5s;

The abdominal application has already been cleared with L13-3s in the predicate device MX7 (K200001)

4. Add Fetal application to L9-3s;

The fetal application has already been cleared with L9-3U in the predicate device Resona 7 (K171233).

5. Add Smart 3D function to L7-3s、L14-6s、7LT4s、L14-5sp、L20-5s、7L4s、 L9-3s、L11-3VNs、L12-3RCs、L14-5Ws、L12-3VNs;

By using the Smart 3D function, the operator moves the probe to change its position/angle when performing the scanning. After the scanning, the system carries out image

reconstruction, and then displays a single frame of 3D image. This feature has been cleared with L16-4Hs in the predicate device M9 (K171034).

6. Add LVO mode to 7LT4s;

LVO is an exam mode for Left Ventricular Contrast Imaging. This feature has been cleared with L10-5 in predicate device ZS3 (K192410).

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> New Features:

7.Add iScape View;

It extends your field of view by piecing together multiple B images into a single, extended B image. The feature has been cleared on the predicate device M9 (K171034).

8. Add Smart IVC;

Smart IVC is used to automatically measure the IVC inner diameter and calculate the change rate in the B mode image.The feature has been cleared on the predicate device MX7 (K200001).

9. Add Smart VTI;

Smart VTI is used to calculate the CO (cardiac output) of the LVOT (left ventricular output tract), so as to quickly evaluate the cardiac function. The feature has been cleared on the predicate device MX7 (K200001).

10. Add Smart B-Line;

Smart B-line is used to detect the B line of the lung in B mode. It supports B-line detecting in both real-time and freeze modes. The feature has been cleared on the predicate device MX7 (K200001).

11. Add EPSS:

It measures the distance between point E and Interventricular Septum when mitral valve is fully open. The feature has been cleared on the predicate device MX7 (K200001).

12. Add Smart trace;

It helps the operator to trace the contour of the normal anatomical regions by automatically recognizing the margin of the target and measures the lengths of major axis, area and circumference of the closed region. This feature is similar to the cleared feature Trace on the predicate device Resona 7 (K171233) .

13. Add Auto GA;

After acquired image(s) of gastric antrum, by freezing image and tapping the Auto GA button, the feature shows boundary of gastric antrum and calculates the area of gastric antrum. This feature is similar to the feature Area trace on the predicate device TE7/TE5 (K180912);

14. Add Smart Bladder;

Smart Bladder is used to measure the volume of the urine in the bladder, which has been cleared on the predicate device DC-40(K183377).

15. Add Smart FHR OB1:

Smart FHR OB1 is to measure the fetal heart rate automatically. It is similar to the cleared feature OB FHR (M) on the predicate device Resona 7 (K171233).

16. Add transducer element check

This function is used to check the condition of transducer elements to evaluate the probe performance.

New accessories A

17. Add UMT-400plus trolley

This trolley is used for supporting the main unit of ultrasound system.

● Operating svstem upgrade

Win 7 upgrade to win 10.

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6. Comparison with Predicate Devices:

TE7/TE5/TE7 Max/ TE5 Max/TE9 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

Predicate Device	Manufacturer	Model	510(k)Number
1. Primarypredicate device	Mindray	TE7	K180912
2. Reference device	Mindray	ZS3, z.one pro	K192410
3. Reference device	Mindray	MX7	K200001
4. Reference device	Mindray	M9	K171034
5. Reference device	Mindray	Resona 7	K171233
6. Reference device	Mindray	DC-40	K183377

TE7/TE5/TE7 Max/ TE5 Max/TE9 has the same 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.

● Subject device

TE7/TE5/TE7 Max/ TE5 Max/TE9 has the similar intended uses as the predicated device TE7/TE5 (K180912)

Subject Device TE7/TE5/TE7 Max/ TE5Max/TE9	Predicate device TE7/TE5 (K180912)
Diagnostic Ultrasound System isapplicable for adults, pregnant women,pediatric patients and neonates. It isintended for use in fetal, Laparoscopic,abdominal, Intra-operative (abdominal,thoracic, and vascular), Pediatric, smallorgan (breast, thyroid, testes), neonataland adult cephalic, trans-esoph.(Cardiac), trans-rectal, trans-vaginal,musculoskeletal (conventional,superficial), urology, Peripheral vessel,Adult and Pediatric cardiac, ophthalmic,Thoracic/Pleural exams	The TE7/TE5 Diagnostic UltrasoundSystem is applicable for adults, pregnantwomen, pediatric patients and neonates.It is intended for use in fetal, abdominal,intra-operative (abdominal, thoracic, andvascular), Pediatric, small organ (breast,thyroid, testes), neonatal and adultcephalic, trans-esoph. (cardiac),trans-rectal, trans-vaginal,musculoskeletal (conventional,superficial), urology, peripheral vessel,adult and pediatric cardiac, ophthalmic,exams.

Subject Device TE7/TE5/TE7 Max/ TE5Max/TE9

Predicate device TE7/TE5 (K180912)

Diagnostic Ultrasound System isapplicable for adults, pregnant women,pediatric patients and neonates. It isintended for use in fetal, Laparoscopic,abdominal, Intra-operative (abdominal,thoracic, and vascular), Pediatric, smallorgan (breast, thyroid, testes), neonataland adult cephalic, trans-esoph.(Cardiac), trans-rectal, trans-vaginal,musculoskeletal (conventional,superficial), urology, Peripheral vessel,Adult and Pediatric cardiac, ophthalmic,Thoracic/Pleural exams

The TE7/TE5 Diagnostic UltrasoundSystem is applicable for adults, pregnantwomen, pediatric patients and neonates.It is intended for use in fetal, abdominal,intra-operative (abdominal, thoracic, andvascular), Pediatric, small organ (breast,thyroid, testes), neonatal and adultcephalic, trans-esoph. (cardiac),trans-rectal, trans-vaginal,musculoskeletal (conventional,superficial), urology, peripheral vessel,adult and pediatric cardiac, ophthalmic,exams.

The acoustic power levels of TE7/TE5/TE7 Max/ TE5 Max/TE9 are below the limits of FDA, which is the same as the predicated device TE7/TE5 (K180912).
TE7/TE5/TE7 Max/ TE5 Max/TE9 is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device TE7/TE5 (K180912)

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The materials of probes and needle-guided brackets of TE7/TE5/TE7 Max/ TE5 Max/TE9 are the same to the predicate device or tested under ISO 10993-1.

7. Non-clinical Tests:

TE7/TE5/TE7 Max/ TE5 Max/TE9 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: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic ● safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests (Edition 3)
IEC 60601-2-37: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 62304: Medical device software - Software life cycle processes
IEC 62366: Medical devices - application of usability engineering to medical devices
IEC 60601-1-6: medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability
ISO14971: Medical devices - Application of risk management to medical devices
. ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.

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, TE7/TE5/TE7 Max/ TE5 Max/TE9 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

9. 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 TE7/TES/TE7 Max/ TE5 Max/TE9 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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.