(56 days)
Not Found
No
The document describes standard ultrasound and elastography techniques and signal/image processing, but there is no mention of AI or ML.
No.
The device is described as a 'Shear Wave Quantificational Ultrasound Diagnostic System' intended for diagnostic purposes (e.g., aid to diagnosis and monitoring of patients with liver disease) and not for treating conditions.
Yes
The Intended Use / Indications for Use section explicitly states, "Shear Wave Quantificational Ultrasound Diagnostic System" and later, "The shear wave speed and stiffness, and UAP may be used as an aid to diagnosis and monitoring of patients with liver disease." The Device Description also refers to it as a "general purpose, mobile, software-controlled, diagnostic ultrasound system."
No
The device description explicitly states that the system is equipped with probes (fibrosis scanning probe and imaging probe) which are hardware components. While it is software-controlled, it is not a software-only medical device.
Based on the provided information, 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: This device uses ultrasound technology to measure shear wave speed and estimate tissue stiffness and Ultrasound Attenuation Parameter (UAP) within the body, specifically in the liver. It is a non-invasive method.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the internal structures.
Therefore, while it is a diagnostic device used to aid in the diagnosis and monitoring of liver disease, it falls under the category of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000, FT100 and Mini800), Transient Elastography based device, is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP ) in internal structures of the body.
Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000, FT100 and Mini800), is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as Ultrasound Attenuation Parameter ( UAP ).
The shear wave speed and stiffness, and UAP may be used as an aid to diagnosis and monitoring of patients with liver disease, as part of an overall assessment of the liver.
Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000), is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. It can be used in the following applications: Abdominal, including location of the liver.
Product codes
IYO, ITX, IYN
Device Description
The Shear Wave Quantificational Ultrasound Diagnostic System, Models: FT9000, FT100 and Mini800, iLivTouch brand, is a general purpose, mobile, software-controlled, diagnostic ultrasound system. FT9000 is equipped with two probes, a fibrosis scanning probe used in elastography mode and an imaging probe used in imaging mode. The fibrosis scanning probe is used for elasticity measurement while the imaging probe is a convex probe used for ultrasound imaging. But the model FT100 and Mini800 is equipped with only one fibrosis scanning probe.FT100 and Mini800 have the same appearance structure and hardware, but the software is different.
Under elastography mode, the system uses transient elastography to measure shear wave speed non-invasively and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body. A mechanical vibrator produces low-amplitude shear waves at 50 Hz that travel through the skin and intercostal space into the liver. The propagation speed of the shear wave is measured using ultrasound at 2.5 MHz.
Under imaging mode, the system acquires and displays ultrasound images in B, B/B, B/C (CFM), B/C/D (CPWD) modes. The system uses convex array probe with a frequency range of 2.1MHz to 5 MHz on abdomen for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. The ultrasonic imaging also helps to find a proper location for the transient elastography examination.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Internal structures of the body, Liver, Abdominal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance;
- NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3. (Radiology).
- IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
- ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
No clinical study is included in this submission.
For UAP function, the proposed devices has passed the related performance test (eg UD2 test ). The Proposed Device Mini800 use the different probe frequency is same with the Predicate Devices has passed the related performance test and safety test (eg UD2 test ,IEC60601-1 test ,IEC60601-1-2 test) ; So the safety and performance of the product can be ensured to be substantially equivalency with predicate device.
The proposed device has passed the rest and safety test (eg UD2 test ,JEC6060 - 1 est , JEC6060 - 1-2 test, measurement accuracy by acunacy testing and software validation).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Shear wave speed (0.8-5.2 m/s)
Stiffness (2.0-80 kPa)
UAP (90-450 dB/m)
Bias: (-4.7%) - (2.4%) for FT9000, (-2.1%) - (3.5%) for FT100, (-5.3%) - (1.2%) for Mini800 (for Shear Wave Speed/Stiffness)
Precision: (0.0%) - (1.6%) for FT9000, (0.0%) – (3.8%) for FT100, (0.0%) - (1.8%) for Mini800 (for Shear Wave Speed/Stiffness)
Bias: (-3.3%) - (2.0%) for FT9000, (-1.6%) – (6.5%) for FT100, (-6.9%) - (4.8%) for Mini800 (for CAP/UAP)
Precision: (0.2%) - (1.5%) for FT9000, (0.3%) - (2.0%) for FT100, (0.2%) – (2.0%) for Mini800 (for CAP/UAP)
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). 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.
Wuxi Hisky Medical Technologies Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. 5-402, Building #27, No. 56, LiangXiang East Rd. FangShan District Beijing, Beijing 102401 CHINA
March 17, 2020
Re: K200136
Trade/Device Name: Shear Wave Quantificational Ultrasound Diagnostic System Model(s): FT9000, FT100, Mini800 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX, IYN Dated: January 17, 2020 Received: January 21, 2020
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 (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
1
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 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 medical devices and radiation-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
Indications for Use
510(k) Number (if known) K200136
Device Name
Shear Wave Quantificational Ultrasound Diagnostic System Model(s): FT9000, FT100, Mini800
Indications for Use (Describe)
Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000, FT100 and Mini800), Transient Elastography based device, is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP ) in internal structures of the body.
Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000, FT100 and Mini800), is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as Ultrasound Attenuation Parameter ( UAP ).
The shear wave speed and stiffness, and UAP may be used as an aid to diagnosis and monitoring of patients with liver disease, as part of an overall assessment of the liver.
Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000), is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. It can be used in the following applications: Abdominal, including location of the 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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3
Tab #7 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K200136
-
- Date of Preparation: 03/09/2020
-
- Sponsor
Wuxi Hisky Medical Technologies Co., Ltd.
Room B401, 530 Plaza, University Science Park, Taihu International Science & Technology Park, 214135 Wuxi, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA
Contact Person: Jinhua Shao Position: General Manager Tel: 86-10-82151572 Fax: 86-10-82151571 Email: shaojh@fibrotouch.com
3. Submission Correspondent
Ray Wang General Manager
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401
Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
4
Identification of Proposed Device
Trade Name: Shear Wave Quantificational Ultrasound Diagnostic System Common Name: Diagnostic Ultrasound System with Accessories Model(s): FT9000, Mini800, FT100
Regulatory Information
Classification Name: 1) Ultrasonic Pulsed Echo Imaging System; 2) Diagnostic Ultrasound Transducer; 3) Ultrasonic Pulsed Doppler Imaging System; Classification:II Product Code: IYO & ITX & IYN Regulation Number:21 CFR 892.1550 & 21 CFR 892.1560 & 21 CFR 892.1570 Review Panel: Radiology:
Indication For Use Statement:
Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000, FT100 and Mini800), Transient Elastography based device, is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body.
Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000, FT100 and Mini800), is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as Ultrasound Attenuation Parameter (UAP).
The shear wave speed and stiffness, and UAP may be used as an aid to diagnosis and monitoring of patients with liver disease, as part of an overall assessment of the liver.
Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000), is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. It can be used in the following applications: Abdominal, including location of the liver.
4. Device Description
The Shear Wave Quantificational Ultrasound Diagnostic System, Models: FT9000, FT100 and Mini800, iLivTouch brand, is a general purpose, mobile, software-controlled, diagnostic ultrasound system. FT9000 is equipped with two probes, a fibrosis scanning probe used in elastography mode and an imaging probe used in imaging mode. The fibrosis scanning probe is used for elasticity measurement while the imaging probe is a convex probe used for ultrasound imaging. But the model FT100 and Mini800 is equipped with only one fibrosis scanning probe.FT100 and Mini800 have the same appearance structure and hardware, but the software is different.
5
Under elastography mode, the system uses transient elastography to measure shear wave speed non-invasively and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body. A mechanical vibrator produces low-amplitude shear waves at 50 Hz that travel through the skin and intercostal space into the liver. The propagation speed of the shear wave is measured using ultrasound at 2.5 MHz.
Under imaging mode, the system acquires and displays ultrasound images in B, B/B, B/C (CFM), B/C/D (CPWD) modes. The system uses convex array probe with a frequency range of 2.1MHz to 5 MHz on abdomen for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. The ultrasonic imaging also helps to find a proper location for the transient elastography examination.
| Name | Qty. | Usage |
|---|---|---|
| Imaging probe | 1 | To determine the test zone |
| Fibrosis Scanning probe | 1 | To test the liver stiffness and UAP |
| Main unit | 1 | To calculate the liver stiffness with acquired data |
| Power Cord | 1 | To energize the main unit |
| Footswitch | 1 | To start the examination |
| Fuse T3.15 AH250V | 2 | Overcurrent protection |
| Protective earth wire | 1 | To connect the system with the ground |
Table 7-1 Accessories List of FT9000
| Table 7-2 Accessories List of FT100 and Mini800 | |
|---|---|
| ------------------------------------------------- | -- |
| Name | Qty. | Usage |
|---|---|---|
| Fibrosis scanning probe | 1 | To test the liver stiffness and UAP |
| Main unit | 1 | To calculate the liver stiffness with acquired data |
| Probe holder | 1 | To hold the probe |
| AC/DC adapter | 1 | To energize the main unit |
| Foot switch | 1 | To start the examination |
| Keyboard (optional) | 1 | For ease of operate |
| Mouse (optional) | 1 | For ease of operate |
6
| Product
model | Transducer
Model | Type | Frequency | Application |
|----------------------------------------------------------------------------------------------------|---------------------|--------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| FT9000 | FT-2.5D9 | Round probe | 2.5MHz(deviation≤±15%) | Liver, elasticity measurement |
| FT9000 | FT-3.5R65 | convex probe | 3.5MHz(nominal),
2.1, 2.5, 3.1, 5.0
(broadband frequency) | Abdomen, general purpose
Pulse echo ultrasound
imaging and
Doppler flow analysis |
| FT100 | FT-2.5D9 | Round probe | 2.5MHz(deviation≤±15%) | Liver, elasticity
measurement |
| Mini800 | XW-01 | Round probe | 2.5MHz(deviation≤±15%) | Liver, elasticity
measurement |
| Note: The XW-01 probe for Mini800 is exactly the same as the FT- 2.5D9 probe for FT9000/FT100. And | | | | |
| all materials and manufacturing processes to produce final finished form of XW-01 are identical to | | | | |
| FT-2.5D9. . | | | | |
Fig 7-1 Working Frame of (Models: FT9000)
Image /page/6/Figure/3 description: The image shows a block diagram of an elastography system and an ultrasound imaging system. The elastography system includes transmitting/receiving, signal excitation device, pre-amplification, signal processing & numerical calculation, and signal processing blocks. The ultrasound imaging system includes real-time control, transmitting/receiving, signal & image processing, pre-amplification, digital beam synthesis, and high-speed A/D conversion blocks. Both systems are connected to a system control CPU and a power supply, as well as a keyboard and monitor.
7
Image /page/7/Figure/1 description: This image is a block diagram of a device with several components. The main unit is connected to an AC/DC adapter, a probe holder, a fibrosis scanning probe, and a footswitch. The main unit contains a power board, a Li-ion battery, an interface board, a CPU and display, a USB port, a mini DP port, and an E ultrasonic board.
Fig 7-2 Working Frame of (Models: FT100 and Mini800)
న్. Identification of Predicate Device
Primary Predicate Device: 510(k) Number: K173595 Product Name: Shear Wave Quantificational Ultrasound Diagnostic System Manufacturer: Wuxi Hisky Medical Technologies Co., Ltd.
Secondary Predicate Device:
510(k) Number: K181547 Product Name: FibroScan® Family Of Products Model Name: FibroScan® 502 Touch Manufacturer: Echosens
The reason we selected the secondary device is that the Indication For Use of subject device covered both primary and secondary predicate device.
-
- 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:
- Non-Clinical Test Conclusion
8
-
IEC 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance;
-
NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3. (Radiology).
-
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
-
ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
-
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
-
- Clinical Test Conclusion
No clinical study is included in this submission.
9
8. Substantially Equivalent (SE) Comparison
Table 7-4 Comparison of Technology Characteristics to Primary Predicate Device
| Item | Proposed Device(s) | Primary Predicate Device
(K173595) | remark |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------|
| Device name | Models: FT9000, FT100 and Mini800
Shear Wave Quantificational Ultrasound Diagnostic System | FT9000 Shear Wave Quantificational
Ultrasound Diagnostic System | / |
| | | | |
| Classification
Name | 1) Ultrasonic Pulsed Echo Imaging System; | 1) Ultrasonic Pulsed Echo Imaging System; | |
| | 2) Diagnostic Ultrasound Transducer; | 2) Diagnostic Ultrasound Transducer; | Same |
| | 3) Ultrasonic Pulsed Doppler Imaging System; | 3) Ultrasonic Pulsed Doppler Imaging System; | |
| Product Code | IYO | IYO | |
| | ITX | ITX | Same |
| | IYN | IYN | |
| Regulation
Number | 892.1550; | 892.1550; | |
| | 892.1560; | 892.1560; | Same |
| | 892.1570; | 892.1570; | |
| Intended Use | Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000,
FT100 and Mini800), Transient Elastography based device, is intended to provide | Shear Wave Quantificational Ultrasound
Diagnostic System, Model FT9000, is intended | |
| | 50Hz shear wave speed measurements and estimates of tissue stiffness as well as | to measure the speed of 50Hz shear wave with | |
| | Ultrasound Attenuation Parameter (UAP) in internal structures of the body. | 2.5MHz ultrasound wave in the liver. The shear | |
| | Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000, | wave speed may be used as an aid to clinical | Analysis 1 |
| | FT100 and Mini800), is indicated for noninvasive measurement in the liver of 50 | management of patients with liver disease. | |
| | Hz shear wave speed and estimates of stiffness as well as Ultrasound Attenuation | Shear Wave Quantificational Ultrasound | |
| | Parameter ( UAP ). | Diagnostic System, Model FT9000, is intended | |
| | The shear wave speed and stiffness, and UAP may be used as an aid to diagnosis | for general purpose pulse echo ultrasound | |
10
| | | and monitoring of patients with liver disease, as part of an overall assessment of the
liver.
Shear Wave Quantificational Ultrasound Diagnostic System (Models: FT9000 ), is
intended for general purpose pulse echo ultrasound imaging and Doppler flow
analysis of the human body. It can be used in the following applications:
Abdominal, including location of the liver. | imaging and Doppler flow analysis of the
human body. It can be used in the following
applications: Abdominal. | |
|-----------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------|
| Probe Types | FT9000 | Fibrosis scanning probe FT-2.5D9
an imaging probe FT-3.5R65 | | Same |
| | FT100 | Fibrosis scanning probe FT-2.5D9 | Fibrosis scanning probe FT-2.5D9
an imaging probe FT-3.5R65 | |
| | Mini800 | Fibrosis scanning probe XW-01 | | Analysis 1 |
| Probe frequency | | Fibrosis scanning probe (FT-2.5D9):2.5MHz
an imaging probe FT-3.5R65: 3.5 MHz
Fibrosis scanning probe XW-01 Probe (2.5 MHz) | Fibrosis scanning probe (FT-2.5D9):2.5MHz
an imaging probe FT-3.5R65: 3.5 MHz | Same |
| | | | | |
| Modes of
Operation | M-mode | | M-mode | Same |
| | A-mode | | A-mode | |
| Applied Standards: | | | | |
| 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 | UD2 | | UD2 | Same |
Analysis 1:
The Proposed Device(s) is similar to the predicate devels sight, and only in the indications for use (adding UAP finctions) and probe models,
a、for the added UAP function, the proposed devices has passed the related performance test (eg UD2 test );
b . The Proposed Device Mini800 use the different probe frequency is same with the Predicate Devices has passed the related
11
performance test and safety test (eg UD2 test ,IEC60601-1 test ,IEC60601-1-2 test) ;
So the safety and performance of the product can be ensured to be substantially equivalency with predicate device.
Table 7-5 Comparison of Technology Characteristics to Secondary Predicate Device
| Item | Proposed Device(s) | | | Secondary Predicate Device
(K181547) | remark |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | FT9000 | FT100 | Mini800 | | |
| Device name | Models: FT9000, FT100 and Mini800
Shear Wave Quantificational Ultrasound Diagnostic System | | | FibroScan® 502 Touch
(Predicate) | / |
| Classification
Name | 1) Ultrasonic Pulsed Echo Imaging System;
2) Diagnostic Ultrasound Transducer;
3) Ultrasonic Pulsed Doppler Imaging System; | | | 1) Ultrasonic Pulsed Echo Imaging System;
2) Diagnostic Ultrasound Transducer; | Same |
| Product Code | IYO
ITX
IYN | | | IYO
ITX | Same |
| Regulation
Number | 892.1550;
892.1560;
892.1570; | | | 892.1560;
892.1570; | Same |
| Intended Use | Shear Wave Quantificational Ultrasound Diagnostic System
(Models: FT9000, FT100 and Mini800), Transient Elastography
based device, is intended to provide 50Hz shear wave speed
measurements and estimates of tissue stiffness as well as Ultrasound
Attenuation Parameter ( UAP ) in internal structures of the body.
Shear Wave Quantificational Ultrasound Diagnostic System | | | The FibroScan® Family of Products (Models: 502 Touch) is
intended to provide 50Hz shear wave speed measurements and
estimates of tissue stiffness as well as 3.5 MHz ultrasound
coefficient of attenuation (CAP: Controlled Attenuation
Parameter) in internal structures of the body.
FibroScan® Family of Products (Models: 502 Touch) is | Same |
| | | | | | |
| | (Models: FT9000, FT100 and Mini800), is indicated for noninvasive
measurement in the liver of 50 Hz shear wave speed and estimates
of stiffness as well as Ultrasound Attenuation Parameter (UAP).
The shear wave speed and stiffness, and UAP may be used as an aid
to diagnosis and monitoring of patients with liver disease, as part of
an overall assessment of the liver.
Shear Wave Quantificational Ultrasound Diagnostic System
(Models: FT9000), is intended for general purpose pulse echo
ultrasound imaging and Doppler flow analysis of the human body. It
can be used in the following applications: Abdominal, including
location of the liver. | | | indicated for noninvasive measurement in the liver of 50 Hz
shear wave speed and estimates of stiffness as well as 3.5 MHz
ultrasound coefficient of attenuation (CAP: Controlled
Attenuation Parameter).
The shear wave speed and stiffness, and CAP may be used as
an aid to diagnosis and monitoring of adult patients with liver
disease, as part of an overall assessment of the liver.
Shear wave speed and stiffness may be used as an aid to
clinical management of pediatric patients with liver disease. | |
| Imaging modes | | A-mode
M-mode
Transient Elastography /
Shear Wave | | A-mode
M-mode
Transient Elastography /
Shear Wave | Same |
| Ultrasound
Source | Piezoelectric ultrasound source | | | Piezoelectric ultrasound source | Same E |
| Probe | FT-2.5D9 Probe (2.5 MHz)
FT-3.5R65(3.5 MHz) | FT-2.5D9 Probe
(2.5 MHz) | XW-01 Probe
(2.5 MHz) | S+ Probe (5 MHz)
(single element ultrasound transducer) | Analysis 2 |
| Elastography
mode | Transient
Elastography | | | Vibration-controlled Transient
ElastographyTM | Same E |
| Source of
Mechanical
Vibration | External electromechanical
Vibrator | | | External electromechanical
Vibrator | Same |
| Shear Wave
Speed | Post-processing | | | Post-processing | Same |
| Determination | | | | | |
| TE mode | Shear wave speed measurements and tissue stiffness | | | Shear wave speed measurements and tissue stiffness | Same |
| TE display | Shear wave speed (0.8-5.2 m/s)
Stiffness (2.0-80 kPa)
Interquartile range (IQR) and IQR/median ratio | | | Shear wave speed (0.8-5.0 m/s)
Stiffness (2.0-75 kPa)
Interquartile range (IQR) and IQR/median ratio | Analysis 2 |
| Bias | (-4.7%) - (2.4%) | (-2.1%) - (3.5%) | (-5.3%) - (1.2%) | (-14.3%) - (3.6%) | Analysis 2 |
| Precision | (0.0%) - (1.6%) | (0.0%) – (3.8%) | (0.0%) - (1.8%) | (0.2%) - (1.9%) | Analysis 2 |
| CAP/UAP
display | UAP (90-450 dB/m)
Interquartile range (IQR) and IQR/median ratio | | | CAP (100-400 dB/m)
Interquartile range (IQR) and IQR/median ratio | Analysis 2 |
| Bias | (-3.3%) - (2.0%) | (-1.6%) – (6.5%) | (-6.9%) - (4.8%) | (0.0%) - (10.0%) | Analysis 2 |
| Precision | (0.2%) - (1.5%) | (0.3%) - (2.0%) | (0.2%) – (2.0%) | (0.0%) - (1.0%) | Analysis 2 |
| Applied Standards: | | | | | |
| 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
UD2 | | | IEC60601-2-37
UD2 | Same |
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510(k) Summary
Analysis 2:
The Proposed Device(s) is similar to the predicate devices, the difference is very slight, and only in the probe frequency, the mode and CAPUAP display, but the proposed devices has passed the rest and safety test (eg UD2 test ,JEC6060 - 1 est , JEC6060 - 1-2 test, measurement accuracy by acunacy testing and software validation) - the safety and be ensured - so the safety and performance of the product can be ensured, so the
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proposed device is determined to be substantially equivalency with predicate device.
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.
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.