(53 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no description of training or test sets, which are typical for AI/ML devices.
No
Explanation: The device is explicitly described as a "Diagnostic Ultrasound System" and its intended use is for "ultrasound imaging, measurement, display and analysis of the human body and fluid," which indicates diagnostic rather than therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME77/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates." and "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...". The "Device Description" section also begins by naming the device as a "Diagnostic Ultrasound System".
No
The device description explicitly states it is a "Diagnostic Ultrasound System" and mentions employing "an array of probes," which are hardware components essential for ultrasound imaging. It also mentions evaluations for acoustic output, biocompatibility, thermal, electrical, and mechanical safety, all indicative of a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that this is a Diagnostic Ultrasound System. Ultrasound imaging works by sending sound waves into the body and interpreting the echoes to create images of internal structures and fluid flow. This is an in vivo (within the living body) diagnostic method, not an in vitro one.
- Intended Use: The intended use describes imaging of various anatomical sites within the body.
- Device Description: The description details the ultrasound technology and modes of operation, all of which are related to generating images from within the body.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME77/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , transesoph(Cardiac) 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, iScape, TDI, color M, Smart 3D, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
Product codes
IYN, IYO, ITX
Device Description
The MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 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, i iScape, TDI, color M, Smart 3D, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver) mode.
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
ophthalmic, fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel, urology
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates
Intended User / Care Setting
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.
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.
The MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 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.
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.
K210416, K203391, K202785, K172970
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes 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. % Shi Jufang Engineer of Technical Regulation Mindray Building, Keji 12th Road South, Hi-tech Industrial Park Nanshan, Shenzhen, 518057 P.R. CHINA
November 5, 2021
Re: K212900
Trade/Device Name: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus/ ME7T/MX8/MX8T/Vaus8/ME8 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: September 5, 2021 Received: September 13, 2021
Dear Shi Jufang:
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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)
K212900
Device Name
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME77/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System
Indications for Use (Describe)
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME77/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , transesoph(Cardiac) 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, iScape, TDI, color M, Smart 3D, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
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 8807.92(c).
The assigned 510(k) number is: K212900
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:
Shi Jufang 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 5, 2021
- Device Name: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 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)
4
Main Predicate Device: MX7 Diagnostic Ultrasound System
Classification
Regulatory Class: II
Review Category: Tier II
- 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN)
- 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)
- 21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
3. Device Description:
The MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 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, i iScape, TDI, color M, Smart 3D, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver) mode.
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:
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, 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, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , trans-esoph(Cardiac) exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement,
5
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, Smart 3D, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).
5. Summary of Modifications
- Newly Added Clinical Applications: Intra-operative(abdominal, thoracic, and vascular) , trans-esoph(Cardiac) exams;
- Newly Added Transducers:
L9-3s、L12-3VNs、L16-4Hs、C11-3s、P10-4s、P7-3Ts、P8-3Ts、C5-2s、L12-4s、 P8-2s、CW2s;
● Newly Added Needle-guided Brackets:
NGB-015、NGB-018、NGB-034;
● Main Added Features:
-
- Add Auto GA
-
- Add Smart FHR OB1
-
- Add Smart Bladder
-
- Add Auto DFR
● Other Changes:
-
- Add mobile trolley MT2
-
- Add CPP
6. Comparison with Predicate Devices:
The MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/
Vaus8/ME8 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
| Predicate Device | Manufacturer | Model | 510(k) Control
Number |
| ------------------ | -------------- | ------- | -------------------------- |
|---|
6
| 1. Primary predicate device | Mindray | MX7 | K200001 |
|---|---|---|---|
| 2. Reference device | Mindray | M9 | K210416 |
| 3. Reference device | Mindray | TE7 | K203391 |
| 4. Reference device | Mindray | Resona R9 | K202785 |
| 5. Reference device | Mindray | M7 | K172970 |
The MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/
MX8T/Vaus8/ME8 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 devices. All systems transmit ultrasonic energy into patients and perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.
- Subject device ●
The subject device and predicate MX7 (K200001) have similar clinical indications for use however the proposed subject device has the intra-operative (abdominal, thoracic, and vascular) and trans-esoph (Cardiac) applications which has been cleared on predicate TE7 (K203391)
7
| | MX7/MX7T/Vaus7/Zeus/ME7/Anesus
ME7/Anesus ME7T/MX8/
MX8T/Vaus8/ME8 Diagnostic
Ultrasound System is applicable for
adults, pregnant women, pediatric
patients and neonates. It is intended for
use in ophthalmic, fetal, abdominal,
pediatric, 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, peripheral vessel and urology,
intra-operative(abdominal, thoracic,
and vascular), trans-esoph(Cardiac)
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. | MX7/MX7T/Vaus7/Zeus/ME7/Anesus
ME7/Anesus ME7T/MX8/
MX8T/Vaus8/ME8 Diagnostic
Ultrasound System is applicable for
adults, pregnant women, pediatric
patients and neonates. It is intended for
use in ophthalmic, fetal, abdominal,
pediatric, 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, peripheral vessel and urology
exams.
TE7/TE5/TE7 Max/ TE5 Max/TE9
Diagnostic Ultrasound System is
applicable for adults, pregnant women,
pediatric patients and neonates. It is
intended for use in fetal, Laparoscopic,
abdominal,Intra-operative(abdominal,
thoracic, and vascular), Pediatric ,small
organ(breast, thyroid, testes), neonatal
and adult cephalic,trans-esoph.
(Cardiac), trans-rectal, trans-vaginal, | S |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|
| Intended
Use | | | |
8
| 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, Smart 3D, Strain
Elastography, Contrast imaging
(Contrast agent for LVO), Contrast
imaging (Contrast agent for Liver). | musculo-skeletal(conventional,
superficial), urology,Peripheral vessel,
Adult and Pediatric cardiac,
ophthalmic, Thoracic/Pleural exams.
This device is a general purpose
diagnostic ultrasound system intended
for use by qualified and trained
healthcare professionals for ultrasound
imaging, measurement, display and
analysis of the human body and fluid,
which is intended to be used in a
hospital or medical clinic.
Modes of operation include: B, M,
PWD, CWD, Color Doppler,
Amplitude Doppler, Combined
mode(B+M, PW+B, Color+B,
Power+B, PW+Color+B,
Power+PW+B), Tissue Harmonic
Imaging, Contrast imaging (Contrast
agent for LVO),TDI,Color M, Smart
3D,Contrast imaging (Contrast agent
for Liver) and iScape View. |
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
-
- The intended use of subject device is covered by predicate device MX7 (K200001)
Note:
- The intended use of subject device is covered by predicate device MX7 (K200001)
-
except intra-operative (abdominal, thoracic, and vascular) and trans-esoph (Cardiac) applications. But the predicate device TE7 (K203391) has intra-operative (abdominal, thoracic, and vascular) and trans-esoph (Cardiac) application.
-
- According to the requirements of FDA Guidance, "Marketing Clearance of Diagnostic
9
Ultrasound Systems and Transducers, June 27, 2019" (and following its numbering scheme), add modes of operation, operator qualification and device use settings in the Indications for use
- The subject device and predicate MX7 (K200001) have identical imaging modes, similar special functions, however the proposed subject device has the Auto GA、 Auto DFR functions which have been cleared in predicate M9 (K210416), and the Smart FHR OB1、Smart Bladder functions have been cleared in TE7(K203391).
- . The subject device has similar probes as the predicate MX7 (K200001) however the proposed subject device has the L9-3s、L12-3VNs、L16-4Hs、C11-3s、P10-4s、 P7-3Ts、P8-3Ts、C5-2s、L12-4s、P8-2s、CW2s, but they can be substantial equivalent with MX7 (K200001) , M9 (K210416), TE7(K203391), Resona R9 (K202785), and M7 (K172970).
- The acoustic power levels of subject device are below the limits of FDA, which is the same as the predicated device MX7 (K200001).
- The subject device is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device MX7 (K200001).
7. Non-clinical Tests:
The MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been designed to conform with applicable medical safety standards. This device has been tested and evaluated under the following standards:
- AAMI / ANSI ES60601-1:2005/(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:
10
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.
- . 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, MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 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 device safety standards. Therefore, the MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to device MX7
11
(K200001) .