(228 days)
Not Found
No
The document describes a standard digital ultrasound system with various imaging modes and processing techniques (like gamma correction and harmonic imaging), but there is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies summary. The description of image processing focuses on conventional techniques.
No.
The device is described as a "diagnostic system" and its intended use is for "diagnostic" studies and to produce "cross-sectional images of the organ," not for treating conditions.
Yes
The product's name includes "Diagnostic System," and the intended use explicitly states it is a "digital ultrasound diagnostic system" for various applications, including examination of various anatomical sites to generate images for evaluation.
No
The device description explicitly states it includes hardware components such as a main unit, two probes, a lithium battery, and various functional modules (Power, Ultrasound front-end, Keyboard, Industrial control board, LCD screen, Interface board). It also describes the physical process of ultrasound wave generation and reception.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body.
- Device Function: The B-Ultrasound Diagnostic System uses ultrasound waves to create images of internal organs and structures within the human body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes imaging of various anatomical sites within the body for diagnostic purposes.
- Device Description: The description details the process of transmitting and receiving ultrasound waves and converting them into images, all of which occurs in vivo (within the living organism).
Therefore, this device falls under the category of an in vivo diagnostic imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application.
The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs (Thyroid, Galactophore, Testis), neonatal cephalic, peripheral vasculo-skeletal (both conventional and superficial), The device is intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional.
This device is not intended for home use.
Modes of operation include B, M, PWD(PW), B+M, 2B, 4B.
Product codes
IYO, ITX
Device Description
B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application.
The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, peripheral vascular, and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional.
This device is not intended for home use.
Modes of operation include B, M, PWD(PW), B+M, 2B, 4B.
Please refer to the acoustic output declaration for each transducer as following pages.
B-Ultrasound Diagnostic System is a Track 3, diagnostic ultrasound system, which has a main unit and two probes (Broadband convex array probe and Broadband convex array probe), powered by a 14.4V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2-12MHz.
The B-Ultrasound Diagnostic System of six functional modules: Power module, Ultrasound front-end module, Keyboard module, Industrial control board, LCD screen, and Interface board. When electrical pulses are applied to the piezoelectric wafer (transducer), it will produce ultrasound waves of a certain frequency, which will enter the human body. Due to the ultrasound waves traveling through different tissues in the human body with different acoustic impedances (caused by differences in density and ultrasound transmission speed), the reflected echoes generated by the surfaces of different organs in the human body will be different. The reflected echoes of different sizes will be received by the piezoelectric wafer, and then converted into electrical pulse signals. After digital beamforming and other processing, those signals are formed into standard video signals that can be displayed on the monitor screen as cross-sectional images of the organ.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic Pulsed Echo Imaging System
Anatomical Site
Fetal organ, abdominal, pediatric, small organs (Thyroid, Galactophore, Testis), neonatal cephalic, peripheral vascular, and musculo-skeletal.
Indicated Patient Age Range
Adult, pregnant woman, pediatric and neonate.
Intended User / Care Setting
Used by or on the order of a physician or similar qualified health care professional.
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 conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1: 2020, IEC 60601-1-2: 2020, IEC 60601-2-37: 2015, IEC 62133-2: 2017, ISO 10993-5: 2009, ISO 10993-10: 2010, IEC 62359: 2017, IEC TR 60601-4-2: 2016.
No clinical study is included in this submission.
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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 and Human Services (HHS) seal on the left and the FDA acronym and full name on the right. The HHS seal features an emblem with a staff and serpent, while the FDA part includes the acronym in a blue square and the words "U.S. Food & Drug Administration" in blue text.
May 3, 2024
Contec Medical Systems Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District, Beijing 102401 CHINA
Re: K232895
Trade/Device Name: B-Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, ITX Dated: March 26, 2024 Received: March 26, 2024
Dear Ray Wang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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
2
Indications for Use
510(k) Number (if known) K232895
Device Name B-Ultrasound Diagnostic System
B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application.
The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs (Thyroid, Galactophore, Testis), neonatal cephalic, peripheral vasculo-skeletal (both conventional and superficial), The device is intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional.
This device is not intended for home use.
Modes of operation include B, M, PWD(PW), B+M, 2B, 4B.
Please refer to the acoustic output declaration for each transducer in 510(K) Summary.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 PRAStaff(@fda.hhs.gov
"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 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number:
-
- Date of Preparation: 05/01/2024
-
- Sponsor
Contec Medical Systems Co., Ltd
No.112 Qinhuang West Street, Economic &Technical Development Zone, Qinhuangdao, Hebei Province, PEOPLE'S REPUBLIC OF CHINA 066004 Contact Person: Xueyong Li Position: Quality Manager Tel: +86-355-8015490 Fax: +86-355-8015490 Email: lxy1011@163.com
-
- Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China, 102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information(@believe-med.com
Proposed Device Identification 4.
Trade Name: B-Ultrasound Diagnostic System Common Name: System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic Model(s): CMS600P2PLUS Regulatory Information: Classification Name: System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic,
1
4
Diagnostic Classification: II Product Code: IYO; ITX Regulation Number: 21 CFR 892.1560; 21 CFR 892.1570 Regulation Name: Ultrasonic pulsed echo imaging system Review Panel: Radiology
Indication For Use Statement:
B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application.
The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs (Thyroid, Galactophore, Testis), neonatal cephalic, peripheral vascular, and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional.
This device is not intended for home use.
Modes of operation include B, M, PWD(PW), B+M, 2B, 4B.
Please refer to the acoustic output declaration for each transducer as following pages.
న. Device Description
B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application.
The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, peripheral vascular, and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional.
This device is not intended for home use.
Modes of operation include B, M, PWD(PW), B+M, 2B, 4B.
Please refer to the acoustic output declaration for each transducer as following pages.
B-Ultrasound Diagnostic System is a Track 3, diagnostic ultrasound system, which has a main unit and two probes (Broadband convex array probe and Broadband convex array probe), powered by a 14.4V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2-12MHz.
The B-Ultrasound Diagnostic System of six functional modules: Power module, Ultrasound front-end module, Keyboard module, Industrial control board, LCD screen, and Interface board. When electrical pulses are applied to the piezoelectric wafer (transducer), it will produce ultrasound waves of a certain frequency, which will enter the human body. Due to the ultrasound
5
waves traveling through different tissues in the human body with different acoustic impedances (caused by differences in density and ultrasound transmission speed), the reflected echoes generated by the surfaces of different organs in the human body will be different. The reflected echoes of different sizes will be received by the piezoelectric wafer, and then converted into electrical pulse signals. After digital beamforming and other processing, those signals are formed into standard video signals that can be displayed on the monitor screen as cross-sectional images of the organ.
Table 1 Output Range Summary
System: B-Ultrasound Diagnostic System Transducer: Broadband convex array probe
| Item | Mode of Operation | |||
|---|---|---|---|---|
| Global Maximum | ||||
| Output Levels (est.) | B | M | PW | Combined |
| B/M | ||||
| max ISPTA.3 | 73.47 | 101.22 | 604.77 | 163.47 |
| min ISPTA.3 | 18.37 | 25.31 | 151.19 | 40.87 |
| max MI | 1.67 | 1.67 | 1.20 | 1.67 |
| min MI | 0.42 | 0.42 | 0.30 | 0.42 |
| max TIS | 2.22 | 0.37 | 0.72 | 2.25 |
| min TIS | 0.56 | 0.09 | 0.18 | 0.56 |
| max TIB | 2.22 | 0.98 | 1.67 | 2.86 |
| min TIB | 0.56 | 0.25 | 0.42 | 0.72 |
Table 2 Output Range Summary
B-Ultrasound Diagnostic System System: Transducer: Broadband linear array probe
| Item | Mode of Operation | |||
|---|---|---|---|---|
| Global Maximum | ||||
| Output Levels (est.) | B | M | PW | Combined |
| B/M | ||||
| max ISPTA.3 | 94.10 | 152.58 | 232.97 | 497.48 |
| min ISPTA.3 | 23.53 | 38.15 | 58.24 | 124.37 |
| max MI | 1.86 | 1.86 | 1.86 | 1.22 |
| min MI | 0.46 | 0.46 | 0.46 | 0.30 |
| max TIS | 1.84 | 0.31 | 1.90 | 0.88 |
| min TIS | 0.46 | 0.08 | 0.48 | 0.22 |
| max TIB | 1.84 | 0.63 | 2.21 | 1.74 |
| min TIB | 0.46 | 0.16 | 0.55 | 0.43 |
Table 3 Transducer/Mode Combination Summary
6
System:
| Item | Mode of Operation | |||||
|---|---|---|---|---|---|---|
| Transducer Model | B | M | PWD | 2B | 4B | B/M |
| Broadband convex array probe | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Broadband line array probe | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Predicate Device Identification 6.
Predicate Device:
510(k) Number: K170856 Product Name: CMS600P2 B-Ultrasound Diagnostic System Manufacturer: Contec Medical Systems Co.,Ltd
7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A IEC 60601-1: 2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2: 2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
-
IEC 60601-2-37: 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- A IEC 62133-2: 2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
-
ISO 10993-5: 2009 Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity
- A ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: irritation and skin sensitization
- A IEC 62359: 2017 Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
-
IEC TR 60601-4-2: 2016 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and
7
medical electrical systems
- Clinical Test Conclusion 8.
No clinical study is included in this submission.
Substantially Equivalent (SE) Comparison 9.
| ITEM | Proposed Device | Predicate Device (K170856) | Remark |
|---|---|---|---|
| Product Code | IYO; ITX | IYO; ITX | SAME |
| Regulation No. | 21 CFR 892.1560; 21 CFR 892.1570 | 21 CFR 892.1560; 21 CFR 892.1570 | SAME |
| Class | 2 | 2 | SAME |
| Type of Use | Prescription Use | Prescription Use | SAME |
| Indication for | |||
| Use | B-Ultrasound Diagnostic System in a | ||
| general-purpose, digital ultrasound diagnostic | |||
| system for abdomen, gynecology, obstetric, | |||
| urology, and small-parts application. | |||
| The system is intended to use for the following | |||
| type of studies: fetal organ, abdominal, pediatric, | |||
| small organs (Thyroid, Galactophore, Testis), | |||
| neonatal cephalic, peripheral vascular, and | |||
| musculo-skeletal (both conventional and | |||
| superficial). The device is intended to adult, | |||
| pregnant woman, pediatric and neonate. | |||
| The system is a prescription device intended to be | |||
| used by or on the order of a physician or similar | |||
| qualified health care professional. | |||
| This device is not intended for home use. | |||
| Modes of operation include B, M, PWD(PW), | |||
| B+M, 2B, 4B. | |||
| Please refer to the acoustic output declaration for | |||
| each transducer as following pages. | CMS 600P2 B-Ultrasound Diagnostic System in a | ||
| general-purpose, digital ultrasound diagnostic | |||
| system for abdomen, gynecology, obstetric, | |||
| urology, and small-parts application. | |||
| The system is intended to use for the following type | |||
| of studies: fetal organ, abdominal, pediatric, small | |||
| organs, neonatal cephalic, peripheral vascular, and | |||
| musculo-skeletal (both conventional and | |||
| superficial). The device is intended to adult, | |||
| pregnant woman, pediatric and neonate. | |||
| The system is a prescription device intended to be | |||
| used by or on the order of a physician or similar | |||
| qualified health care professional. | |||
| This device is not intended for home use. | |||
| Please refer to the acoustic output declaration for | |||
| each transducer as following pages. | SAME |
Table 1 General Comparison
| ITEM | Proposed Device | Predicate Device (K170856) | Remark |
|---|---|---|---|
| Probe mode | C5~2-80R60- | ||
| BDC Convex array | |||
| probe | C3.5-80R60- | ||
| A16A | |||
| Convex probe | / | ||
| L12~5-80L40- | |||
| BDC Line array | |||
| probe | L7.5-80L40- | ||
| A16A | |||
| linear |
8
| Scan angle/width | 60° | 45mm | 110° | 6.3mm | Analyse 1 | |
|---|---|---|---|---|---|---|
| Maximum number of | ||||||
| Active elements for a | 40 | 40 | 5 | 5 | Analyse 1 | |
| single pulse | ||||||
| Frequency | 2~5MHz | 5~12MHz | 3.5MHz | 7.5MHz | Analyse 1 | |
| Number of Element | 80 | 80 | 80 | 80 | SAME | |
| Size of Element(mm) | 0.78*14 | 0.5*7.1 | 0.48×7.5 | 0.5×6.3 | Analyse 1 | |
| Spacing of element(mm) | 0.42 | 0.2 | 0.48 | 0.5 | Analyse 1 | |
| Array dimensions(mm) | 62.4*14 | 40*7.1 | 38.4×7.5 | 40×6.3 | Analyse 1 | |
| Detect Depth(mm) | ≥160 | ≥70 | ≥160 | ≥50 | Analyse 1 | |
| Resolution | Lateral | ≤2(depth≤130) | ||||
| ≤3(130 ≤1(depth≤60) ≤3(Depth≤80) | ||||||
| ≤4(80 ≤2(Depth≤40) Analyse 1 | ||||||
| (mm) | ≤1(depth≤130) | ≤0.5(depth≤50) | ≤2(Depth≤80) | |||
| ≤3(80 ≤1(Depth≤50) Analyse 1 | ||||||
| Blind Zone(mm) | ≤3 | ≤2 | ≤5 | ≤3 | Analyse 1 | |
| Focus Position | 4 focus, | |||||
| adjustable position | 4 focus, | |||||
| adjustable position | 4 focus, | |||||
| adjustable position | 4 focus, position is | |||||
| not adjustable | SAME | |||||
| Monitor Size | 15 inch | 10.1 inch | Analyse 2 | |||
| Display Mode | B, 2B, 4B, M, B/M, PW | B, 2B, BM, M, 4B | Analyse 3 | |||
| Image gray scale | 256 level | 256 level | SAME | |||
| Image Storage | 1086 frame | 2048 frame | Analyse 1 | |||
| Cine Loop | 1086 frame | 600 frame | Analyse 1 | |||
| Image Flip | Up/down, left/right, black/white | Up/down, left/right, black/white | SAME | |||
| Gamma (gray scale) correction, tissue harmonic | Gamma (gray scale) correction, tissue | |||||
| Image Process | imaging, histogram, local magnification | harmonic imaging, histogram, local | ||||
| magnification | SAME | |||||
| Measurement | Distance, circumference, area, volume, pregnant | Distance, circumference, area, volume, heart, | ||||
| pregnant age, fetal weight, expected date | SAME | |||||
| age, fetal weight, expected date | ||||||
| Notation | Date, time, name, No., sex, age, doctor, | Date, time, name, No., sex, age, doctor, | ||||
| hospital name, probe frequency, etc. | SAME | |||||
| hospital name, probe frequency, etc. | ||||||
| Net weight | 6.5 kg | 2.3 kg (include probe) | Analyse 2 | |||
| Power supply | DC 15V; Adapter: 100~240V, 50/60Hz | DC15V; Adapter:100 V~240 V, 50 Hz/60 Hz | SAME | |||
| Dimensions(mm) | 370mm×360mm×80mm | 292 mm(L) × 232 mm(W) × 45 mm(H) | Analyse 2 | |||
| Configuration | mainframe, transducer(probe) | mainframe, transducer(probe) | SAME | |||
| Acoustic | ISPTA.3 | |||||
| Output | ISPPA.3 | Meet the requirements of Track 3 | Meet the requirements of Track 3 | SAME | ||
| Parameter | MI | |||||
| Skin Contacted Material | Plastic housing of probe (ABS) | Probe Cover (ABS) | SAME | |||
| Acoustic Len (RTV) | Acoustic Lens (Silicone elastomer) | |||||
| Operation Environment | Temperature: +5°C~ +40°C | |||||
| Relative humidity: ≤80% | Relative humidity: 30%~ 75% | |||||
| Atmosphere pressure: 700 hPa ~ 1060 hPa | Atmosphere pressure: 700 hPa ~ 1060 hPa |
9
| Storage Environment | Temperature: -10°C ~ +55°C
Relative humidity: ≤93%, without condensation
Atmosphere pressure: 700 hPa ~ 1060 hPa | Temperature: -10°C ~ +55°C,
Relative Humidity: ≤93%, no condensation.
Atmosphere pressure: 700 hPa ~ 1060 hPa | SAME |
|---------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------|
| Sterile | No | No | SAME |
| Single Use | No | No | SAME |
Table 3 Applied Standards Comparison
| ITEM | Proposed Device | Predicate Device (K170856) | Remark |
|---|---|---|---|
| Biocompatibility | ISO10993-5 & ISO10993-10 | ISO10993-5 & ISO10993-10 | SAME |
| Electrical Safety | IEC60601-1 | IEC60601-1 | SAME |
| EMC | IEC60601-1-2 | IEC60601-1-2 | SAME |
| Performance | IEC 60601-2-37 | IEC 60601-2-37 | SAME |
The subject device has same classification information, same intended use, same indication for use, similar product design, similar specification, same safety elements, similar applied Standards as predicate device.
The differences are included as followings:
Analyse 1:
The device and predicate device have difference in performance specification, such as scan/angle/width, maximum number of active elements for a single pulse, frequency, size of element, spacing of element, array dimensions, detect depth, resolution, blind zone, image storage, cine loop. But the propose device have tested for measurement accuracy testing and software validation, so these difference can prove the effectiveness of propose device.
The proposed device has tested according with the safety standard IEC 60601-1-2 for the safety. The proposed device has tested according with the accuracy report, IEC 60601-2-37 report, IEC 62359 report for the effectiveness. The proposed device has tested according with the ISO 10993 series standard for the Biocompatibility.
Therefore, the differences above between the proposed device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety. No new technology is applied in the subject device. Most of the main aspects on effectiveness and safety between the proposed device and predicate device are same. The differences are slight so that no substantial influence on the effectiveness and safety.
Analyse 2:
The proposed device is different in monitor size, net weight, dimensions and operation environment from the predicate device. However, these differences are just in physical specification and will not raise any issues in safety and effectiveness. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted. Therefore, these differences will not affect safety and effectiveness of the proposed device.
10
Analyse 3:
The proposed device is different in display mode from the predicate device. The proposed device has tested according with the accuracy report, IEC 60601-2-37 report, IEC 62359 report for the effectiveness. So we believe that this difference will not raise any risks in safety and effectiveness, both the proposed device and predicate device are safe and effective.
10. Substantially Equivalent (SE) Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K170856).