It is intended for use in fetal, abdominal, Intra-operative, small organ(breast, thyroid, testes), neonatal cephalic.adult cephalic.trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial), Thoracic Pleural, cardiac adult, cardiac pediatric, Trans-esoph., peripheral vessel and urology exams.

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, Smart 3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, STE, STQ, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

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.

Device Description

Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T 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, Smart 3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, STE, STQ, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver). Subject device can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or reported device performance metrics for the Consona N9/N8/N7 series Diagnostic Ultrasound System. The submission is a 510(k) premarket notification for substantial equivalence, not a performance study against specific acceptance criteria.

The document primarily focuses on demonstrating that the subject device is substantially equivalent to legally marketed predicate devices (primarily the Mindray MX7, K212900) in terms of intended use, imaging modes, features, functions, and technological characteristics.

Instead of a table of specific performance metrics, the document highlights:

Indications for Use: The subject device's indications are comparable to the predicate.
Patient Contact Materials: Same as predicate or tested under ISO 10993-1.
Acoustic Power Levels: Below FDA limits and same as the predicate (MX7).
Electrical and Physical Safety Standards: Complies with FDA recognized standards, same as the predicate (MX7).
Features and Functions: Same as predicate devices, with new options being either improvements or enhancements of cleared functions, with no new intended uses or clinical risks introduced.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."

Therefore, there is no test set, no sample size, and no data provenance (e.g., country of origin, retrospective/prospective) related to clinical performance for this submission. The evaluation is based on non-clinical tests and comparison to predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

As there were no clinical studies conducted and no test set, this information is not applicable. Ground truth for clinical performance was not established by experts for this particular submission.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for performance evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done, as the document states that clinical studies were not required and were not performed. Therefore, there's no reported effect size of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study of an algorithm was conducted or reported, as this is a general-purpose diagnostic ultrasound system, not an AI-driven diagnostic algorithm. The new features like "Smart Calc" are described as semi-automatic tools that assist the user, implying a human-in-the-loop design, but no performance study specific to this feature is detailed.

7. Type of Ground Truth Used

Given the absence of clinical studies, there is no mention of ground truth established through expert consensus, pathology, or outcomes data. The basis for substantial equivalence relies on technical specifications, compliance with safety standards, and functional comparison to predicate devices, rather than clinical performance data against a defined ground truth.

8. Sample Size for the Training Set

Not applicable. This submission concerns a diagnostic ultrasound system and does not involve an AI model with a distinct "training set" in the conventional sense of machine learning algorithms requiring large datasets for training. The "new options" like Smart Calc are described as improvements or enhancements but not as standalone AI algorithms whose performance requires training and validation datasets.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for an AI model.

Summary

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September 29, 2022

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K221300

Trade/Device Name: Consona N9, Consonance N9 Pro, Consona N9 Super, Consona Nova, Consona N9S. Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp. Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T 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: August 5, 2022 Received: August 25, 2022

Dear Zhang Wei:

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

{1}------------------------------------------------

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); 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 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,

Yanna Kang, Ph.D.

Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K221300

Device Name

Consona N9, Consona N9 Pro, Consona N9 Super, Consona N9S, Consona N1, Consona N1, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9, Consona N9, Consona N9, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Elite, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona N7S, Consona V1, Consona V1, Consona V7, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System

Indications for Use (Describe)

Consona N9, Consona N9 Pro, Consona Nova, Consona Nova, Consona NJ, Consona NJ, Consona NT, Nueva N9, Recho N9. Consona N9 Exp. Consona N9. Consona N9. Consona N8. Consona N8. Consona N8 Pro. Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Elite, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona N7S, Consona V1, Consona V1, Consona VT, Consona N7 Exp. Consona N7 Elite. Consona N7T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.

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: K221300

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 5655 Fax: +86 755 2658 2680

Contact Person

Zhang wei 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: September 19 2022

2. Device Name

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

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Consona N9 /N8/N7 series Diagnostic Ultrasound System is substantially equivalent in its technologies and functionality to MX7 Diagnostic Ultrasound System (predicate devices) that are already cleared by FDA, and they are listed below. MX7 is the main predicate devices.

Device	Manufacturer	Model	DeviceClass	ProductCode	510KNumber
1. Main predicatedevice	Mindray	MX7	II	IYN, IYO, ITX	K212900
2. Reference device	Mindray	Resona I9	II	IYN, IYO, ITX	K210699
3. Reference device	Mindray	DC-90	II	IYN, IYO, ITX,LLZ	K201693
4. Reference device	Mindray	DC-40	II	IYN, IYO, ITX	K183377
5. Reference device	Mindray	Resona R9	II	IYN, IYO, ITX	K202785
6. Reference device	Mindray	DC-7	II	IYN, IYO, ITX,LLZ	K103583

4. Device Description:

to provide information based on which the competent health care professionals can make the diagnosis.

5. Intended Use:

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neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal(conventional), musculo- skeletal(superficial), Thoracic/Pleural, cardiac adult, cardiac pediatric, Trans-esoph., 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, Smart 3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, STE, STQ, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

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.

6. Comparison with Predicate Devices:

Subject device Consona N9. Consona N9 Pro. Consona N9 Super, Consona Nova. Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T 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.

Items	Subject DeviceConsona N9/N8/N7 series	Predicate deviceMX7 (K212900)
Indicationsfor use	Diagnostic Ultrasound System is applicable foradults, pregnant women, pediatric patients andneonates.It is intended for use in fetal, abdominal, Intra-operative, pediatric, small organ(breast, thyroid,testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-	Diagnostic Ultrasound System is applicable foradults, pregnant women, pediatric patients andneonates.It is intended for use in ophthalmic, fetal,abdominal, pediatric, small organ (breast,thyroid, testes), neonatal cephalic, adultcephalic, transrectal, trans-vaginal, musculo-skeletal(conventional), musculo-

1 Indications for use

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skeletal(superficial), Thoracic/Pleural, cardiacadult, cardiac pediatric, Trans-esoph., peripheralvessel and urology exams.	skeletal(superficial), thoracic/pleural, cardiacadult, cardiac pediatric, peripheral vessel andurology, intra-operative(abdominal, thoracic,and vascular) , trans-esoph(Cardiac) exams
-------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The patient contact materials of the transducers and needle-guided brackets of subject device ■ are the same to the predicate devices or tested under ISO 10993-1.
The acoustic power levels of subject device are below the limits of FDA, which are the same as the predicated device MX7 (K212900).
The subject device is designed in compliance with the FDA recognized electrical and ■ physical safety standards, which are the same as the predicated device MX7 (K212900).
The subject device has the same features and functions as the predicated devices.

A technological comparison between your device and predicate devices ■

Items	Subject DeviceConsona N9/N8/N7series	Predicate deviceMX7 (K212900)	Predicate deviceResona I9(K210699)	Predicate deviceResona R9(K202785)
Transducers
Convex probe(C5-1, SC5-1N, C6-2,3C5A, C11-3, C6-1,DE11-3, SD8-1, D7-2,D6-2B)	√	√	√	√
Linear probe(L13-3N, L13-3,7L4B,L9-3, L14-3W,7LT4,L20-5s, L16-4Hs,ELC10-4,6LE7)	√	√	√	√
Phased array probe(P4-2, SP5-1N, P8-2,P10-4)	√	√	√	√
Intracavitary probe(V11-3HB, V11-3H,V11-3, V11-3B, V10-4,V10-4B,6CV1)	√	√	√	√
Pen probe(CW2s, CW5s)	√	√	√	√
TEE probe(P7-3Ts, P8-3Ts, P8-2Ts)	√	√	√	√
B	√	√	√	√
M	√	√	√	√
PWD	√	√	√	√
CWD	√	√	√	√
Color Doppler	√	√	√	√
Amplitude Doppler	√	√	√	√
Combined (specify)	√	√	√	√
Features
CW	√	√	√	√
4D	√	/	√	√
iScape View	√	√	√	√
Free Xros M	√	√	√	√
Free Xros CM	√	√	√	√
Tissue Doppler Imaging	√	√	√	√
TDI QA	√	√	√	√
Contrast imaging	√	√	√	√
Contrast Imaging QA	√	√	√	√
LVO	√	√	√	√
Strain Elastography	√	√	√	√
STE	√	/	√	√
STQ	√	/	√	√
Stress Echo	√	√	√	√
Tissue Tracking QA	√	√	√	√
Smart 3D	√	√	√	√
iPage+	√	/	√	√
SCV+	√	/	√	√
iLive	√	/	√	√
STIC	√	/	√	√
Color 3D	√	/	√	√
Niche	√	/	√	√
Smart Volume	√	/	√	√
Smart V Trace	√	/	√	√
Smart Planes CNS	√	/	√	√
Smart Face	√	/	√	√
Smart ICV	√	/	√	√
Smart Scene 3D	√	/	√	√
Ultra-MicroAngiography	√	/	√	√
Glazing Flow	√	/	√	√
iNeedle	√	√	√	√
Abdomen/GeneralPackage	√	√	√	√
Obstetrics Package	√	√	√	√
Gynecology Package	√	√	√	√
Cardiology Package	√	√	√	√
Small Parts Package	√	√	√	√
Urology Package	√	√	√	√
Vascular Package	√	√	√	√
Pediatrics Package	√	√	√	√
Nerve Package	√	√	√	√
Emergency&CriticalPackage	√	/	√	√
Smart Pelvic	√	/	√	√
Smart OB	√	√	√	√
Smart NT	√	√	√	√
Smart Fetal HR	√	/	√	√
Smart FLC	√	/	√	√
IVF	√	/	√	√
IMT	√	/	√	√
RIMT	√	√	√	√
AutoEF	√	√	√	√
R-VQS	√	√	√	√
Smart Hip	√	/	√	√
Smart HRI	√	/	√	√
Smart Bladder	√	√	/	/
Smart Trace	√	/	√	√
CPP	√	√	√	√
Smart B-line	√	√	√	/
V-Mapping	√	/	√	/
DICOM Basic	√	√	√	√
DICOM Worklist	√	√	√	√
DICOM MPPS	√	√	√	√
DICOM Query/Retrieve	√	√	√	√
DICOM OB/GYN SR	√	√	√	√
DICOM Vascular SR	√	√	√	√
DICOM Cardiac SR	√	√	√	√
DICOM Breast SR	√	√	√	√
DICOM Abdomen SR	√	√	√	√
DICOM Small Parts SR	√	/	√	√
iWorks	√	√	√	√
DVR Module	√	√	√	√
iVocal	√	√	√	/
New Features
Smart Calc	√	/	/	/
ClamAV	√	/	/	/
Hardware
Text printer	√	√	√	√
Video printer	√	√	√	√
Barcode reader	√	√	√	√
Footswitch	√	√	√	√
ECG	√	√	√	√
Battery	√	√	√	√

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For the differences compared to the predicate devices:

The subject device introduces new options, which in the below table that either the ■ improvements or enhancement based on the cleared functions to facilitate user, no intended uses are added and passed the related tests, no clinical risks introduced.

Subject Device	Function explanation	predicate device
Smart Calc	Semi-automatically recognizes the contour of the target area and measures the diameter, area and circumference of the target area. The user needs to identify the target area first. When the measures results are not	Resona R9 (K202785)

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	satisfactory, the user can use thetrackball to manually edit thecontour.
ClamAV	This is an anti-virus software	/

7. Non-clinical Tests:

Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9. Consona N9T. Consona N8. Consona N8 Pro. Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T 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:

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.
1 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.
. 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)].

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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, Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7, Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp. Consona N7 Elite, Consona N7T 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 Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T 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 Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9T, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to primary predicate device MX7.

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.