DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel, intra-operative (abdominal, thoracic, and vascular) and urology exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D(Reape View, TDI, Color M. Strain Elastography, Contrast imaging (Contrast imaging (Contrast agent for LVO), STE,STQ.

Device Description

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. This system is a Track 3 device that employs an array of probes that include linear array. convex array, pencil phased and phased array.

AI/ML Overview

The provided text is a 510(k) Summary for a Diagnostic Ultrasound System, which is a general-purpose diagnostic imaging device. For such devices, the FDA typically relies on non-clinical performance data (e.g., electrical safety, acoustic output, electromagnetic compatibility, software validation) to demonstrate substantial equivalence to a predicate device, rather than clinical studies with specific acceptance criteria related to diagnostic performance metrics like sensitivity or specificity.

Therefore, the document explicitly states: "8. Clinical Tests: Not Applicable."

This means that the type of study for proving the device meets acceptance criteria, in the context of diagnostic performance metrics, was not performed for this submission. The "acceptance criteria" discussed in the document are primarily related to safety, electrical performance, and adherence to recognized standards, rather than clinical diagnostic efficacy.

Given the information in the provided document, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As clinical tests were "Not Applicable" and no specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this device's efficacy, a table of diagnostic acceptance criteria and performance cannot be generated from the provided text.

However, the document lists compliance with various regulatory and safety standards, which can be seen as the "acceptance criteria" the device met for its substantial equivalence determination. The "reported device performance" is its demonstration of compliance with these standards and its similarity to the predicate device.

Acceptance Criteria (Safety & Performance Standards)	Reported Device Performance
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod). - IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests. - IEC 60601-2-37 Edition 2.1 2015, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. - IEC 62304 Edition 1.1 2015-06, medical device software software life cycle processes. - ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices. - NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3. - AAMI / ANSI / ISO 10993-1: 2018, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process. - IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)] - IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability	- The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical and mechanical safety. - The device was found to conform with applicable medical safety standards (listed above). - The acoustic power levels are below FDA limits, similar to the predicate device. - The device is designed in compliance with FDA-recognized electrical and physical safety standards, similar to the predicate device. - The device's safety and effectiveness profile is found to be similar to the predicate device.

Acceptance Criteria (Safety & Performance Standards)

Reported Device Performance

- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod). - IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests. - IEC 60601-2-37 Edition 2.1 2015, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. - IEC 62304 Edition 1.1 2015-06, medical device software software life cycle processes. - ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices. - NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3. - AAMI / ANSI / ISO 10993-1: 2018, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process. - IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)] - IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

- The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical and mechanical safety. - The device was found to conform with applicable medical safety standards (listed above). - The acoustic power levels are below FDA limits, similar to the predicate device. - The device is designed in compliance with FDA-recognized electrical and physical safety standards, similar to the predicate device. - The device's safety and effectiveness profile is found to be similar to the predicate device.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable for diagnostic performance as no clinical tests were performed.
Data Provenance: Not applicable for diagnostic performance. For safety and performance evaluations, the data would typically come from internal engineering and lab testing conducted by the manufacturer (Shenzhen Mindray Bio-Medical Electronics Co., LTD in China).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as no clinical tests or diagnostic performance evaluations requiring expert ground truth were conducted or reported in this 510(k) summary.

4. Adjudication method for the test set

Not applicable as no clinical tests or diagnostic performance evaluations requiring adjudication were conducted or reported in this 510(k) summary.

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

No MRMC comparative effectiveness study was done or reported. This device is a general diagnostic ultrasound system, not an AI-assisted diagnostic tool that would typically undergo such a study for 510(k) clearance.

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

Not applicable. This is a diagnostic ultrasound system, not an standalone algorithm. The device has "Smart" features (e.g., Smart 3D, Smart Planes FH, Smart Pelvic, iClear+), but these are integrated functionalities of the ultrasound system itself, not standalone algorithms requiring separate "algorithm-only" performance evaluation in the context of this 510(k). The regulatory pathway for this device does not necessitate such a study as it's a general-purpose ultrasound.

7. The type of ground truth used

Not applicable for diagnostic performance metrics, as no clinical efficacy studies were conducted. For the non-clinical tests, the "ground truth" would be the established specifications and limits defined by the international and national standards to which the device was tested for compliance.

8. The sample size for the training set

Not applicable. This document describes a traditional diagnostic ultrasound system. While it has "Smart" features that likely involve internal algorithms some of which might be trained, the document does not provide details on algorithm training, or a "training set" in the context of a machine learning model submitted for software as a medical device (SaMD) clearance.

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

Not applicable, as a training set for a machine learning model is not discussed or required for this type of 510(k) submission for a general diagnostic ultrasound system.

Summary

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July 1, 2021

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: K211337

Trade/Device Name: DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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, LLZ Dated: April 28, 2021 Received: May 3, 2021

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 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

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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,

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)

K211337

Device Name

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System

Indications for Use (Describe)

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-78/DC-78/DC-70S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel, intra-operative (abdominal, thoracic, and vascular) and urology 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.

The assigned 510(k) number: K211337

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: Feb 28, 2021

2. Device Name:

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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)

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21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)

21 CFR 892.2050 Medical Image Management and Processing System (LLZ)

3. Device Description:

4. Intended Use:

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, Trans-esoph. (Cardiac), peripheral vessel, intra-operative (abdominal, thoracic, and vascular) and urology exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, PW+Color+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), STE,STQ.

5. Summary of Modifications

New Added Transducers:

DE10-3WE, DE11-3WE, ELC13-4s, V11-3HBE, L13-3WE, L14-3WE, CW2s, P7-3Ts, LAP13-4Cs;

New Added Needle-Guided Bracket:

NGB-047、NGB-048、NGB-051、NGB-054;

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Main Added Features:

1. STE/STQ to SC6-1E, L12-3E, L9-3E, C5-1E;
1. Strain Elastography to V11-3HBE、DE11-3WE;
1. Glazing Flow;
1. Smart Planes FH;
1. Smart Pelvic;
1. Ultrasound Fusion Imaging and Fusion RESP to SC6-1E, C5-1E, SP5-1E, L14-5WE;
1. Add the contrast imaging(Contrast imaging for Liver) function to C7-3E;
1. Add V-Mapping;
1. RIMT;
10.iClear+;

The hardware configuration

1. The battery can provide power supply when scanning (configurable);
1. Probe adapter PCM-SE01 for ELC13-4s, P7-3Ts, LAP13-4Cs;
1. iClear+Dongle.

The other New changes:

1. Add Transducer Element Check;
1. OS Upgrade from win7 to win10;
1. Add Macfee anti-virus software.
1. DICOM Abdomen SR
1. Add Respiratory Wave function.

6. Comparison with Predicate Devices:

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

PredicateDevice	Manufacturer	Device name	510(k)ControlNumber	DeviceClass	ProductCode
1.Primarypredicatedevice	Mindray	DC-80A DiagnosticUltrasound System	K201693	II	IYN, IYO,ITX, LLZ
2.Reference	Mindray	Resona R9 Diagnostic	K202785	II	IYN, IYO

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device		Ultrasound System		ITX
3.Referencedevice	Mindray	ZS3 and z.one proUltrasound Systems	K192410	II	IYN, IYO,ITX

PredicateDevice	Manufacturer	Device name	Regulation name
1.Primarypredicatedevice	Mindray	DC-80ADiagnosticUltrasoundSystem	21 CFR 892.1550 Ultrasonic Pulsed Doppler ImagingSystem (IYN)21 CFR 892.1560 Ultrasonic Pulsed Echo ImagingSystem (IYO)21 CFR 892.1570 Diagnostic Ultrasound Transducer(ITX)21 CFR 892.2050 Medical Image Management andProcessing System (LLZ)
2.Referencedevice	Mindray	ResonaR9DiagnosticUltrasoundSystem	21 CFR 892.1550 Ultrasonic Pulsed Doppler ImagingSystem (IYN)21 CFR 892.1560 Ultrasonic Pulsed Echo ImagingSystem (IYO)21 CFR 892.1570 Diagnostic Ultrasound Transducer(ITX)
3.Referencedevice	Mindray	ZS3andz.oneproUltrasoundSystems	21 CFR 892.1550 Ultrasonic Pulsed Doppler ImagingSystem (IYN)21 CFR 892.1560 Ultrasonic Pulsed Echo ImagingSystem (IYO)21 CFR 892.1570 Diagnostic Ultrasound Transducer(ITX)

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System employs the same technology as the predicate devices. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations. The subject device also has the same intended uses and basic operating modes as the predicate

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devices.

Subject device DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-78/DC-70S has the same probes and indication for use and modes of operation with the predicated device DC-80 A(K201693) , Reference device ZS3 ( K192410)

Subject DeviceDC-70	DC-80A(predicate device) (K201693)	Resona R9(predicate device) (K202785)	ZS3 (Reference device) (K192410)
DE10-3WE	/	DE10-3WU	/
DE11-3WE	/	DE10-3WU	/
ELC13-4s	/	ELC13-4U	/
V11-3HBE	V11-3HE	/	/
L13-3WE	L13-3WE	/	/
L14-3WE	L13-3WE	/	/
CW2s	CW2s	/	/
P7-3Ts	P7-3TE	/	/
LAP13-4Cs	/	/	C12-4lp

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S has the same

performance and functions with the predicated device DC-80A (K201693) .

Subject Device DC-70	Predicate device DC-80A (K201693)
Ultrasound Fusion Imaging	Ultrasound Fusion Imaging
Smart Pelvic	Smart Pelvic
STE/STQ	STE/STQ
Elastography	Elastography
Contrast imaging	Contrast imaging
Smart Planes FH	Smart Planes FH
Fusion RESP	Fusion RESP
Glazing Flow	Glazing Flow
RIMT	RIMT
V-Mapping	V-Mapping (Resona R9 K202785)
iClear+	iClear+ (Resona R9 K202785)

The materials of probes and Needle-guided brackets of DC-70/DC-70T /DC-70 ■

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Pro/DC-70 Exp/DC-75/DC-78/DC-70S are the same to the predicate device DC-80A (K201693).

The acoustic power levels of DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/ . DC-78/DC-70S are below the limits of FDA, which is the same as the predicated device DC-80A (K201693).
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S is designed in . compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DC-80A (K201693).

7. Non-clinical Tests:

DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S 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 found to conform with applicable medical safety standards.

Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
. IEC 60601-1-2 Edition 4.0 2014-02, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
. IEC 60601-2-37 Edition 2.1 2015, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
IEC 62304 Edition 1.1 2015-06, medical device software software life cycle . processes.
. ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic .

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ultrasound equipment revision 3.

. AAMI / ANSI / ISO 10993-1: 2018, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.
IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
. IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

8. Clinical Tests:

Not Applicable.

10. Summary

Based on the performance data as documented in the study, the DC-70 Diagnostic Ultrasound system was found to have a safety and effectiveness profile that is similar to the predicate device.

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 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to primary predicate device 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.