(81 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ultrasound imaging modes and features without mentioning any AI/ML capabilities.
No
The device is clearly indicated as a "Diagnostic Ultrasound System" in its intended use and device description, and its function is to acquire and display ultrasound data for imaging, measurement, display, and analysis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state multiple times that it is a "Diagnostic Ultrasound System" and a "general purpose diagnostic ultrasound system".
No
The device is described as a "Diagnostic Ultrasound System" which is a hardware device that uses probes to acquire ultrasound data. While it is "software controlled," it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device description: The provided text describes a diagnostic ultrasound system. Ultrasound systems use sound waves to create images of internal body structures. They do not analyze specimens taken from the body.
- Intended Use: The intended use clearly states that the device is for "ultrasound imaging, measurement, display and analysis of the human body and fluid." This involves imaging the body directly, not analyzing samples.
Therefore, based on the provided information, this device falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/M9 Premium Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.
It is intended for use in fetal, abdominal, Intra-operative, Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-raginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended tc 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, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast agent for Liver).
Product codes
IYN, IYO, ITX
Device Description
The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in 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, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).
This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array probe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
fetal, abdominal, Intra-operative, Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-raginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel and urology exams.
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates.
Intended User / Care Setting
qualified and trained healtheare 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)
Not applicable. The subject of this submission, M9/M9CV/M9T/M8 Elite/M10 /M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.
June 9, 2023
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Tang Jing Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong 518057 CHINA
Re: K230768
Trade/Device Name: M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium 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: March 9, 2023 Received: March 20, 2023
Dear Tang Jing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K230768
Device Name
M9M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/M9 Premium Diagnostic Ultrasound System
Indications for Use (Describe)
The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/M9 Premium Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.
It is intended for use in fetal, abdominal, Intra-operative, Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-raginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph.(Cardiac), peripheral vessel and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended tc 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, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast agent for Liver).
| 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: K230768
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 6293 Fax: +86 755 2658 2680
Contact Person:
Tang Jing 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: May 26, 2023
2. Device Name: M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/
Crius M11/Operus M11/M9 Premium 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)
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002-1
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Main Predicate Device: M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius
M10/M11/M11CV/ Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System (cleared in K210416).
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:
The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in 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, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).
This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array probe.
4. Intended Use:
The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, Laparoscopic, 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 and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by
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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, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).
5. Summary of Modifications
Newly Added Transducers: P8-2s
- 5.1 An overall description of the transducer P8-2s design
- 5.1.1 Illustration of the P8-2s
Image /page/5/Picture/6 description: The image shows an ultrasonic transducer on a blue background. The transducer is white and has a long, coiled cable. The transducer head is rectangular and has the words "Ultrasonic Transducer" printed on it. The cable is coiled in a circular pattern and is connected to the transducer head at one end and a smaller probe at the other end. The probe has the marking "PB-2s".
Fig.1 Transducer picture
002-3
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Image /page/6/Picture/0 description: The image shows a diagram of a medical device with several labeled parts. The device has a probe head labeled as '1' and '2', connected by a cable labeled '3' to a handheld unit labeled '4'. The diagram appears to be a technical illustration, possibly from a user manual or product specification sheet.
Fig.2 Overview
| No. | Item | Description |
|---|---|---|
| 1. | Probe head | Converts the electrical signal into an ultrasonic signal, |
| focusing the sound beams in a given direction; meanwhile, | ||
| it receives the reflected ultrasonic signal and converts it | ||
| into an electrical signal for transmission over the cable. | ||
| The lens on the surface is the acoustic lens. Apply | ||
| ultrasound gel on the acoustic lens for correct operation. | ||
| 2. | Probe shell | Fix the probe head and provide the gripping position. |
| 3. | Probe cable | Transmits electrical signals between the probe body and |
| connector. | ||
| 4. | Probe connector | Connects the probe and cable to the ultrasonic diagnostic |
| system. |
5.1.2 Major parameters of the P8-2s is listed in the table below
| Transducer | Nominal
frequency
(MHz) | Geometrical
shape | Array
elements | Radius
/Width
(mm) | Distance
between
adjacent
elements
(mm) | Axis
size
(mm) | Maximum
number of
active
elements |
|------------|-------------------------------|----------------------|-------------------|--------------------------|-----------------------------------------------------|----------------------|--------------------------------------------|
| P8-2s | 5MHz | Phased | 96 | / | 0.16 | 8 | 96 |
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5.1.3 Indication(s) for use and Mode of operation of the P8-2s
| Transducer | P8-2s | |
|---|---|---|
| Indication(s) for use | Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Musculo- | |
| skeletal (Conventional), Cardiac Adult, Cardiac Pediatric | ||
| Modes of | ||
| operation | B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined | |
| Modes, Tissue Harmonic Imaging, iScape, Color M, Smart 3D, TDI |
5.2 Materials of the P8-2s
| Transducer | Materials | Contact type | |
|---|---|---|---|
| P8-2s | Probe shell | Valox 3706 (colour | |
| number: MR-DS193-S) | |||
| Acoustic lens | MLG-34-G/MLG-34-N | Contact the normal skin, | |
| short-term contact | |||
| Mucilage glue | RTV162 | ||
| RTV167 |
5.3 Energy sources of the P8-2s
| Energy source | acoustic output power |
|---|---|
| Is the acoustic output below Ispta.3 = | |
| 720mW/cm2 and either MI=1.9 or Isppa.3 | |
| =190W/cm2? | yes |
| Acoustic output is measured and recorded | |
| according to the procedures in 510(k) | |
| guidance? | yes |
6. Comparison with Predicate Devices:
The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11 /Operus M11/M9 Premium Diagnostic Ultrasound System is comparable with and substantially equivalent to the predicate device:
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| Predicate Device | Manufacturer | Model | 510(k) Control Number |
|---|---|---|---|
| 1. Primary predicate device | Mindray | M9 | K210416 |
The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System 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 device. 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.
- The subject device and predicate M9 (K210416) have identical imaging modes.
- The subject device has similar probes as the predicate M9 (K210416) however the proposed subject device has the P8-2s, but it can be substantial equivalent with P7-3s(K210416).
- The acoustic power levels of subject device are below the limits of FDA, which is the same as the predicated device M9 (K210416)
- The subject device is designed in compliance with the FDA recognized electrical and . physical safety standard, which is the same as the predicated device M9 (K210416).
7. Non-clinical Tests:
The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11 /Operus M11/M9 Premium Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning, disinfection and sterilization 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 ES60601-1:2005/(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).
9
- 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 Third Edition 2019-12, 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 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.
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, M9/M9CV/M9T/M8 Elite/M10 /M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
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
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device safety standards. Therefore, the M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.