(59 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard ultrasound technology and image processing.
No.
The intended use explicitly states that this is a "general purpose diagnostic ultrasound system" for "ultrasound imaging, measurement, display and analysis," which indicates diagnostic rather than therapeutic function.
Yes
The device explicitly describes itself as a "Diagnostic Ultrasound System" in its intended use, device description, and throughout the document, stating it's for "ultrasound imaging, measurement, display and analysis of the human body and fluid."
No
The device description explicitly states it is a "software controlled, ultrasound diagnostic system" and employs "an array of probes that include linear array, convex array, pencil phased and phased array," indicating the presence of hardware components (probes) essential for its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Diagnostic Ultrasound System" used for "ultrasound imaging, measurement, display and analysis of the human body and fluid." This describes a device that uses physical principles (ultrasound waves) to create images and perform measurements within the body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
- Device Description: The description confirms it's an "ultrasound diagnostic system" that employs "probes" to interact with the body.
- Anatomical Site: The listed anatomical sites are all locations within the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or performing tests on specimens taken from the patient.
The device is a medical imaging device, specifically an ultrasound system, used for diagnostic purposes by visualizing internal structures. This falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for 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-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 imaging (Contrast agent for LVO), STE,STQ.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates
Intended User / Care Setting
qualified and trained healthcare professionals / hospital or medical clinic
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 performed.
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.
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.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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.
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 imaging (Contrast agent for LVO), STE,STQ.
| 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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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.
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)
4
21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
21 CFR 892.2050 Medical Image Management and Processing System (LLZ)
3. 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.
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.
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, 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;
5
Main Added Features:
-
- STE/STQ to SC6-1E, L12-3E, L9-3E, C5-1E;
-
- Strain Elastography to V11-3HBE、DE11-3WE;
-
- Glazing Flow;
-
- Smart Planes FH;
-
- Smart Pelvic;
-
- Ultrasound Fusion Imaging and Fusion RESP to SC6-1E, C5-1E, SP5-1E, L14-5WE;
-
- Add the contrast imaging(Contrast imaging for Liver) function to C7-3E;
-
- Add V-Mapping;
-
- RIMT;
- 10.iClear+;
The hardware configuration
-
- The battery can provide power supply when scanning (configurable);
-
- Probe adapter PCM-SE01 for ELC13-4s, P7-3Ts, LAP13-4Cs;
-
- iClear+Dongle.
The other New changes:
-
- Add Transducer Element Check;
-
- OS Upgrade from win7 to win10;
-
- Add Macfee anti-virus software.
-
- DICOM Abdomen SR
-
- 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:
| Predicate
Device | Manufacturer | Device name | 510(k)
Control
Number | Device
Class | Product
Code |
|----------------------------------|--------------|----------------------------------------|-----------------------------|-----------------|-----------------------|
| 1.Primary
predicate
device | Mindray | DC-80A Diagnostic
Ultrasound System | K201693 | II | IYN, IYO,
ITX, LLZ |
| 2.Reference | Mindray | Resona R9 Diagnostic | K202785 | II | IYN, IYO |
6
| device | Ultrasound System | ITX | |||
|---|---|---|---|---|---|
| 3.Reference | |||||
| device | Mindray | ZS3 and z.one pro | |||
| Ultrasound Systems | K192410 | II | IYN, IYO, | ||
| ITX |
| Predicate
| Device | Manufacturer | Device name | Regulation name |
|---|---|---|---|
| 1.Primary | |||
| predicate | |||
| device | Mindray | DC-80A | |
| Diagnostic | |||
| Ultrasound | |||
| System | 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) | |||
| 21 CFR 892.2050 Medical Image Management and | |||
| Processing System (LLZ) | |||
| 2.Reference | |||
| device | Mindray | Resona | |
| R9 | |||
| Diagnostic | |||
| Ultrasound | |||
| System | 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.Reference | |||
| device | Mindray | ZS3 | |
| and | |||
| z.one | |||
| pro | |||
| Ultrasound | |||
| Systems | 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) |
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
7
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 Device
| DC-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 ■
8
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 .
9
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.