(213 days)
Not Found
No
The document describes standard ultrasound and elastography techniques and mentions "signal and image processing," which are common in medical imaging but do not inherently indicate AI/ML. There is no mention of AI, ML, deep learning, or related terms.
No
The device is described as a "Diagnostic System" for "quantificational ultrasound" and "imaging." Its stated "Intended Use" is to "measure the speed of 50Hz shear wave" and to be "an aid to clinical management," as well as for "general purpose pulse echo ultrasound imaging and Doppler flow analysis." These functions are diagnostic in nature, providing information about a condition rather than treating it.
Yes
The device is explicitly named "Shear Wave Quantificational Ultrasound Diagnostic System" and its intended use states it is an "aid to clinical management of patients with liver disease," which clearly indicates a diagnostic purpose.
No
The device description explicitly states it is a "software-controlled, diagnostic ultrasound system" and is "equipped with two probes," which are hardware components essential to its function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is an ultrasound system that uses mechanical vibration and ultrasound waves to measure shear wave speed within the liver in vivo (in the living body). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's a "Diagnostic System" that measures shear wave speed in the liver and is used for "general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body." This is consistent with an in vivo diagnostic imaging device.
While the device provides diagnostic information, it does so by interacting directly with the patient's body, not by analyzing samples in vitro.
N/A
Intended Use / Indications for Use
Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is intended to measure the speed of 50Hz shear wave with 2.5MHz ultrasound wave in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease.
Shear Wave Quantificational Ultrasound Diagnostic System, Model 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.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX, IYN
Device Description
The Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. The system 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.
Under elastography mode, the system uses transient elastography to measure shear wave speed non-invasively and estimate tissue stiffness in liver. 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
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
- IEC 60601-1-2:2007, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
- NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3. (Radiology)
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
- ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Stiffness Bias: (-16.7%) – (8.6%)
Precision: (0.9%) – (2.0%)
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.
Not Found
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
§ 892.1560 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Wuxi Hisky Medical Technologies Co., Ltd. % Mr. Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. 5-402, Building #27, No. 56, LiangXiang East Rd., FangShan District Beijing, 102401 CHINA
Re: K173595
Trade/Device Name: Shear Wave Quantificational Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX, IYN Dated: May 23, 2018 Received: May 29, 2018
Dear Mr. Wang:
We have reviewed vour 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. 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.
June 22nd, 2018
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Bargas
for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 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) K173595
Device Name
Shear Wave Quantificational Ultrasound Diagnostic System
Indications for Use (Describe)
Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is intended to measure the speed of 50Hz shear wave with 2.5MHz ultrasound wave in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease.
Shear Wave Quantificational Ultrasound Diagnostic System, Model 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.
Details please refer to the attached pages.
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.
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PSC Publishing Services (301) 443-6740
3
Diagnostic Ultrasound Indications For Use
System: Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Combined | ||||||||
| (Specify) | Other* | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Other | Fetal | ||||||||
| Abdominal | N | N | N | N | N | Note 1, 2 | |||
| Intra-operative | |||||||||
| (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non- | |||||||||
| Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Urology) | |||||||||
| Other (OB/GYN) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: A mode
Note 2: Vibration Controlled Transient Elastography at 50Hz
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||
|---|---|---|
| Prescription Use: ✓ | OR | Over-the Counter Use: __ |
| (Per 21 CFR 801.109) | (Per 21 CFR 807) |
4
Diagnostic Ultrasound Indications For Use
System: Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000
Transducer: FT-2.5D9
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| Doppler | |||||||||
| (Amplitude) | Combined | ||||||||
| (Specify) | Other* | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Other | Fetal | ||||||||
| Abdominal | N | Note 1, 2 | |||||||
| Intra-operative | |||||||||
| (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non- | |||||||||
| Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: A mode
Note 2: Vibration Controlled Transient Elastography at 50Hz
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||
|---|---|---|
| Prescription Use: √ | OR | Over-the Counter Use: __ |
| (Per 21 CFR 801.109) | (Per 21 CFR 807) |
5
Diagnostic Ultrasound Indications For Use
System: Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000 Transducer: FT-3.5R65, Convex
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Vibration Controlled Transient Elastography at 50Hz
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (Track 1 Only) | Specific | |||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| Doppler | ||||||||||
| (Amplitude) | Combined | |||||||||
| (Specify) | Other* | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | |||||||||
| Abdominal | N | N | N | |||||||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non- | ||||||||||
| Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (OB/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | |||||||||
| Other (Specify) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use: √ OR Over-the Counter Use: (Per 21 CFR 801.109) (Per 21 CFR 807)
6
Tab #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 Title 21, CFR Section 807.92.
The assigned 510(k) Number: K173595
-
- Date of Preparation: 5/23/2018
-
- Sponsor Identification
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 Establishment Registration Number: not registered
Contact Person: Jinhua Shao Position: General Manager Tel: 86-10-82151572 Fax: 86-10-82151571 Email: shaojh@fibrotouch.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd. 5-402, Building #27, No. 56, LiangXiang East Rd.,
FangShan District, BeiJing, China 102401
Tel: +86-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com
7
4. Identification of Proposed Device
Trade Name: Shear Wave Quantificational Ultrasound Diagnostic System Common Name: Diagnostic Ultrasound System with Accessories Model(s): FT9000
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:
Intended Use Statement:
Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is intended to measure the speed of 50Hz shear wave with 2.5MHz ultrasound wave in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease.
Shear Wave Quantificational Ultrasound Diagnostic System, Model 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.
Device Description
The Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. The system 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.
Under elastography mode, the system uses transient elastography to measure shear wave speed non-invasively and estimate tissue stiffness in liver. 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.
8
| Transducer Model | Type | Frequency | Application |
|---|---|---|---|
| FT-2.5D9 | Round probe | 2.5MHz(deviation≤±15%) | Liver, elasticity measurement |
| 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 |
Table 7-1 Transducer List
Fig 7-1 Working Frame of FT9000
Image /page/8/Figure/4 description: The image shows a block diagram of an ultrasound and elastography system. The system consists of two main parts: the elastography system and the ultrasound imaging system. Both systems are connected to a system control CPU, which also connects to a keyboard, monitor, and power supply. The elastography system includes modules for transmitting/receiving, signal excitation, pre-amplification, signal processing, and numerical calculation, while the ultrasound imaging system includes modules for real-time control, signal and image processing, digital beam synthesis, high-speed A/D conversion, and pre-amplification.
- Identification of Predicate Device(s) ર.
Predicate Device 1 : 510(k) Number: K123806 Product Name: FibroScan® Manufacturer: Echosens
Predicate Device 2 :
510(k) Number: K072164 Product Name: Diagnostic Ultrasound System Model Name: DC-6 Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
9
6. 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:
- IEC 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic a. safety and essential performance
- IEC 60601-1-2:2007, Medical Electrical Equipment-Part 1-2: General Requirements For Basic b. Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
- NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard For Diagnostic Ultrasound c. Equipment Revision 3. (Radiology)
- d. ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
- ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation e. and delay-type hypersensitivity
-
- Clinical Test Conclusion
No clinical study is included in this submission.
10
8. Substantially Equivalent (SE) Comparison
Table 7-1 Comparison of Technology Characteristics to K123806
| Item | Proposed Device(s) | Predicate Device 1
(K123806) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | FT9000 Shear Wave Quantificational Ultrasound Diagnostic System | FibroScan® |
| 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 Ultrasonic Transducer |
| Product Code | IYO
ITX
IYN | IYO
ITX |
| Regulation Number | 892.1550;
892.1560;
892.1570; | 892.1560;
892.1570; |
| Intended Use | Shear Wave Quantificational Ultrasound Diagnostic System, Model
FT9000, is intended to measure the speed of 50Hz shear wave with
2.5MHz ultrasound wave in the liver. The shear wave speed may be
used as an aid to clinical management of patients with liver disease.
Shear Wave Quantificational Ultrasound Diagnostic System, Model
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. | The FibroScan® system is intended to provide 50Hz shear wave speed
measurements through internal structures of the body.
FibroScan® is indicated for noninvasive measurement of shear wave
speed at 50 Hz in the liver. The shear wave speed may be used as an
aid to clinical management of patients with liver disease. |
11
510(k) Summary
| Probe Types | Fibrosis scanning probe FT-2.5D9 | M+ probe
XL+ probe |
|--------------------|-----------------------------------------------|-----------------------------------------|
| Probe frequency | Fibrosis scanning probe (FT-2.5D9):
2.5MHz | M+ probe: 3.5 MHz
XL+ probe: 2.5 MHz |
| Modes of Operation | M-mode
A-mode | M-mode
A-mode |
| Applied Standards: | | |
| Biocompatibility | ISO10993-5&ISO10993-10 | ISO10993-5&ISO10993-10 |
| Electrical Safety | IEC60601-1 | IEC60601-1 |
| EMC | IEC60601-1-2 | IEC60601-1-2 |
| Performance | UD2 | UD2 |
The subject device is similar to the predicate devices:
- Has the same intended use and indications for use >
- Utilizes the same operating principle A
- Incorporates the same basic design A
- Incorporates the same technological characteristics A
- Tested to the same electrical and electromagnetic safety standards for medical electrical equipment >
- A Manufactured under a quality system
12
| Item | Proposed Device(s) | Predicate Device 2 (K072164) |
|---|---|---|
| Device name | FT9000 Shear Wave Quantificational Ultrasound Diagnostic System | DC-6 Diagnostic Ultrasound System |
| Classification Name | Ultrasonic Pulsed Echo Imaging System; | |
| Diagnostic Ultrasound Transducer; | ||
| Ultrasonic Pulsed Doppler Imaging System; | Ultrasonic pulsed echo imaging system | |
| Product Code | IYO | |
| ITX | ||
| IYN | IYO | |
| ITX | ||
| IYN | ||
| Regulation Number | 892.1550; | |
| 892.1560; | ||
| 892.1570; | 892.1550; | |
| 892.1560; | ||
| 892.1570; | ||
| Intended Use | Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is intended to measure the speed of 50Hz shear wave with 2.5MHz ultrasound wave in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease. | |
| Shear Wave Quantificational Ultrasound Diagnostic System, Model 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. | The device is intended for use by a qualified physician for ultrasound evaluation of abdominal, cardiac, small parts (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal, transvaginal, pediatric,neonatal cephalic, musculoskeletal (general and superficial), Urology/Prostate and intraoperative (liver, gallbladder, pancreas) | |
| Probe Types | Convex probe | Convex probe |
| Linear probe | ||
| Micro-Convex Probe | ||
| Modes of Operation | B Mode, | B-Mode |
| N/A | M-Mode | |
| Pulsed (PW) Doppler Mode | Pulsed (PW) Doppler mode | |
| N/A | Continuous wave (CW) Doppler mode | |
| Color Doppler Mode | Color Doppler Mode | |
| N/A | Amplitude Doppler Mode | |
| N/A | 3D Imaging or Harmonic Imaging | |
| N/A | 4D Imaging | |
| Applied Standards: | ||
| Biocompatibility | ISO10993-5&ISO10993-10 | ISO10993-5&ISO10993-10 |
| Electrical Safety | IEC60601-1 | IEC60601-1 |
| EMC | IEC60601-1-2 | IEC60601-1-2 |
| Performance | UD2 | IEC60601-2-37 |
| UD2 | ||
| Acoustic Output | Track 1 & Track 3 | Track 3 |
Table 7-2 Comparison of Technology Characteristics to K072164
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510(k) Summary
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- Substantially Equivalent (SE) Conclusion
SE Analysis :
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:
- Difference between Fibroscan® (K123806) and FT9000
FT9000 has one additional imaging probe, FT-3.5R65, which is a convex Ultrasonic Imaging Probe for image guiding.
Instead of FibroScan's two elasticity probes(M*, XL*), FT9000 come with one fibrosis scanning probe (FT-2.5D9).
- Difference between Mindray DC-6 (K072164) and FT9000
No Continuous Wave (CW) Doppler Mode, Amplitude Doppler Mode, 3D/4D Imaging or Harmonic Imaging Mode for FT9000, due to the less variety of ultrasound probes for FT9000, one convex probe, other than Mindray's DC-6 multiple ultrasound probes.
FT9000 follows Track 1 and Track 3 of FDA ultrasound submission, and Mindray DC-6 follows Track 3, but this difference does not raise issues in safety since FT9000 follows UD2 acoustic output standard and FDA guidance: Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Issued on 9/9/2008).
| FibroScan® | K123806 | FT9000 | Conclusion / Discussion |
|---|---|---|---|
| Transient elastography | Transient elastography | Same | |
| Vibration control elastography imaging | Vibration control elastography imaging | Same | |
| Frequency range(2.5MHz,3.5MHz) | Frequency: 2.5MHz | Similar | |
| M-mode, A-mode | M-mode, A-mode | Same | |
| N/A | Ultrasound-B imaging | Additional 2D imaging. | |
| Stiffness | |||
| Bias: (-13.9%) – (1.3%) | |||
| Precision: (0%) – (3.1%) | Stiffness | ||
| Bias: (-16.7%) – (8.6%) | |||
| Precision: (0.9%) – (2.0%) | Similar |
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510(k) Summary
Analyse 1: The device and predicate device have difference in performance specification, But the propose device have tested for measurement accuracy by accuracy testing and software validation, so these difference can prove the effectiveness of propose device.
Analyse 2: FT9000 follows Track 1 of FDA ultrasound submission, and Mindray DC-6 follows Track 3, but this difference does not raise issues in safety since FT9000 follows UD2 acoustic output standard.
Conclusion: The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness.