(131 days)
Not Found
No
The summary describes a device that performs measurements of shear wave speed, stiffness, and ultrasound attenuation. It does not mention any AI or ML algorithms used for data processing, interpretation, or diagnosis. The performance studies focus on bench testing and substantial equivalence to a predicate device, without mentioning any AI/ML-specific validation.
No
The device provides measurements that aid in diagnosis and monitoring, but it does not directly treat or cure the disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device's measurements "may be used as an aid to diagnosis and monitoring of adult patients with liver disease." This indicates its role in the diagnostic process.
No
The device description and performance studies mention electrical safety, electromagnetic compatibility, basic safety and essential performance, and biocompatibility testing, which are typically associated with hardware components, not software-only devices. The input imaging modality is ultrasound, which requires hardware.
Based on the provided information, the Liverscan Mobile is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The Liverscan Mobile is described as a non-invasive device that uses ultrasound to measure properties within the liver. It does not involve the collection or analysis of biological samples like blood, urine, or tissue.
- The intended use and device description clearly state it performs measurements in the liver. This is an in-vivo measurement, not an in-vitro analysis.
- The device description focuses on physical measurements (shear wave speed, stiffness, attenuation) within the organ. This is characteristic of imaging or measurement devices, not IVDs.
Therefore, the Liverscan Mobile falls under the category of a medical device that performs non-invasive measurements, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Liverscan Mobile is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter) in internal structures of the body. The shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease.
The Liverscan Mobile is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5MHz ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter).
The shear wave speed and stiffness, and MAP 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.
Product codes
IYO, ITX
Device Description
The Liverscan Mobile is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter) in internal structures of the body. The shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease.
The Liverscan Mobile is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5MHz ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter).
The shear wave speed and stiffness, and MAP 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
liver
internal structures of the body
Indicated Patient Age Range
adult patients
Intended User / Care Setting
doctor's office
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
Bench 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:
- Electrical safety: IEC6060-1:2005+A1:2012+A2:2020
- Electromagnetic compatibility(EMC): IEC 60601-1-2:2014 /AMD1:2020
- Basic Safety And Essential Performance: IEC 60601-2-37:2015, IEC 62359: 2017, IEC 61161: 2013-01, IEC 60601-1-6:2010+A1:2013+A2:2020, IEC 62366-1 Edition 1.0 2015-02
- Software Verification and Validating Testing: Documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "Moderate" level of concern.
- Biocompatibility testing: ISO 10993-1:2009, ISO 10993-10:2021, ISO 10993-23:2021
A series of safety and performance tests were conducted on the subject device: Biocompatibility, Software Validation, Electromagnetic compatibility and electrical safety, Function test. All the test results demonstrate the Liverscan Mobile meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices. No clinical test data was used to support the decision of substantial equivalence.
Key Metrics
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
February 12, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
Eieling Technology Limited % Salon Chen System Engineer IMD Medical & Drug Technology Service Institutions Room 308, Building 11, No. 23 Jinqu Road, Wanjiang District, Dongguan City Dongguan, Guangdong 523000 CHINA
Re: K233401
Trade/Device Name: Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, ITX Dated: December 22, 2023 Received: January 10, 2024
Dear Salon Chen:
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.
1
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" (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 QS 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.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
Indications for Use (Describe)
The Liverscan Mobile is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter) in internal structures of the body. The shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease.
The Liverscan Mobile is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5MHz ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter).
The shear wave speed and stiffness, and MAP 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.
This device is designed to be used in a doctor's office to measure the stiffness and ultrasonic attenuation of the liver in patients with liver disease. It does so in a painless and completely noninvasive manner.
To ensure safe and effective operation,the operator shall meet the following requirements:
-
- Receive training as required by local state and national regulations if applicable
-
- Receive additional training as required by the authorized distributor or EIELING
-
- Has a thorough knowledge and understanding of the material presented in this manual
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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4
510(k) Summary
1. Submitter's Identification:
-
Company Name: Eieling Technology Limited
-
Address: RM 529, 5/F, Core Building 5W Hong Kong Science Park, NT Hong Kong.
-
Phone: +852 6103 2309/13148822309
-
Fax: +852 6103 2309
-
Contact Person (Title): Lin Yangmin (General Manager)
-
E-mail: alyssalin@eieling.com
-
Date of Preparation: Dec. 22, 2023
2. Name of the Device:
-
Portable Liver Elastography Ultrasound Diagnostic System
-
Model: Liverscan Mobile
3. Common Name and Classification:
-
Device Classification Name: system, imaging, pulsed echo, ultrasonic
- Classification Product Code: IYO >
-
Subsequent Product Code: ITX
-
Regulation Number:21 CFR 892.1560
-
Class:2
- Review Panel: Radiology A
Predicate Device Information: 4.
-
510(k) Number: K212035
-
Device Classification Name: system, imaging, pulsed echo, ultrasonic
-
Sponsor: Echosens
-
Classification Product Code: IYO
-
Subsequent Product Code: ITX
5
- Regulation Number:21 CFR 892.1560 >
-
Class:2
-
Review Panel: Radiology
- A Trade/Proprietary Name: FibroScan® 230
- Common Name: Diagnostic Ultrasound System and Accessories A
-
- Application Correspondent
- A Company Name: IMD Medical & Drug technology service institutions
-
Phone: +86-18613190779
-
Fax: +86-755-62809168
-
Contact Person (Title): Salon Chen (System engineer)
-
E-mail: 33999439@qq.com
- Address: Room 308, Building 11, No. 23 Jinqu Road, Wanijang District, Dongguan City, A Guangdong Province, China
6. Device Description
The Liverscan Mobile is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter) in internal structures of the body. The shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease.
The Liverscan Mobile is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5MHz ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter).
The shear wave speed and stiffness, and MAP 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.
7. Indications for Use
The Liverscan Mobile is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter) in internal structures of the body. The shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease.
6
The Liverscan Mobile is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5MHz ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter).
The shear wave speed and stiffness, and MAP 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.
This device is designed to be used in a doctor's office to measure the stiffness and ultrasonic attenuation of the liver in patients with liver disease. It does so in a painless and completely non-invasive manner.
To ensure safe and effective operation, the operator shall meet the following requirements:
- Receive training as required by local, state and national regulations, if applicable 1)
- Receive additional training as required by the authorized distributor or EIELING 2)
- Has a thorough knowledge and understanding of the material presented in this user manual 3)
8. Comparison to the predicate device
Table 1 General Comparison
| Elements of
| Comparison | Proposed Device | Predicate Device | Judgment |
|---|---|---|---|
| Company | |||
| Name | Eieling Technology Limited | Echosens | / |
| Device Name | Portable Liver Elastography | ||
| Ultrasound Diagnostic System | Diagnostic Ultrasound System and | ||
| Accessories | / | ||
| Classification | |||
| Product | |||
| Code | IYO | IYO | SE |
| Subsequent | |||
| Product | |||
| Codes | ITX | ITX | SE |
| Regulation | 21 CFR 892.1560 | 21 CFR 892.1560 | SE |
| Classification | |||
| Name | system, imaging, pulsed echo, | ||
| ultrasonic | system, imaging, pulsed echo, ultrasonic | SE |
7
| Class | 2 | 2 | SE |
|---|---|---|---|
| Prescription | |||
| or OTC | Prescription Use | Prescription Use | SE |
| Application | Abdominal | Abdominal | SE |
| Ultrasound | Piezoelectric ultrasound source | Piezoelectric ultrasound source | SE |
| Intended Use | The Liverscan Mobile is intende | ||
| d to provide shear wave speed m | |||
| easurements and estimates of tiss | |||
| ue stiffness as well as ultrasound |
| The FibroScan® is intended to provide shear
wave speed measurements and estimates of
tissue stiffness as well as ultrasound
coefficient of attenuation (CAP: Controlled
Attenuation Parameter) in
internal structures of the body. The Shear
wave speed and stiffness measurements may
be used as an aid to clinical management of
adult patients with liver disease. | Note 1 |
| | The Liverscan Mobile is indicate
d for non-invasive measurement
in the liver of 50 Hz shear wave
speed and estimates of stiffness a
s well as determining a 3.5MHz
ultrasound coefficient of attenuat
ion (MAP: Mobile Attenuation
Parameter). | The FibroScan® is indicated for non-invasive
measurement in the liver of 50 Hz shear wave
speed and estimates of stiffness as well as
determining a 3.5 MHz ultrasound coefficient
of attenuation (CAP: Controlled Attenuation
Parameter). | |
| | The shear wave speed and stiffne
ss, and MAP may be used as an
aid to diagnosis and monitoring
of adult patients with liver diseas
e, as part of an overall assessmen
t of the liver. | 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, and CAP may
be used as an aid in the clinical management
of pediatric patients with liver disease. | |
8
Table 2 Safety factor & Performance Comparison
9
| Safety factor &
| Performance | Proposed Device | Predicate Device | Judgment |
|---|---|---|---|
| Electrical Safety | Compliance with IEC | ||
| 60601-1 | Compliance with IEC 60601-1 | SE | |
| EMC | Compliance with IEC | ||
| 60601-1-2 | Compliance with IEC 60601-1-2 | SE | |
| Usability | Compliance with IEC | ||
| 60601-1-6: | Compliance with IEC 60601-1-6: | SE | |
| Usability | |||
| Engineering | Compliance with IEC | ||
| 62366-1 | Compliance with IEC 62366-1 | SE | |
| Software | Compliance with IEC | ||
| 62304 | Compliance with IEC 62304 | SE | |
| Biocompatiblity | Compliance with ISO | ||
| 10993-1 | Compliance with ISO 10993-1 | SE | |
| Performance | Compliance with IEC | ||
| 60601-2-37/ IEC 62359: | |||
| 2017/ IEC 61161 | Compliance with IEC | ||
| 60601-2-37/ IEC 62127-1/ IEC | |||
| 62127-03/ IEC 61161 | similar | ||
| Imaging Modes | B-mode | ||
| Transient Elastography | |||
| (TE) | A-mode / M-mode | ||
| Transient Elastography/ | |||
| Shear | |||
| Wave / (CAPTM) | Note 2 | ||
| Probes | LS01 probe (3.5 MHz) | M+-probe (3.5 MHz) | |
| XL+ probe (2.5 MHz) | |||
| S+ probe (5 MHz) | |||
| (single element ultrasound | |||
| transducer) | Note 3 | ||
| Depth Analysis | |||
| Method | 25-65 / 35-75 mm | Fixed Depth: | |
| S1 exam : 15-40 mm | |||
| S2 exam : 20-50 mm | |||
| Adaptive Depth (SmartDepth): | |||
| M exam: 25-65 / 30-70 mm | |||
| XL exam: 35-75 mm/ 40-80 mm/ | |||
| 45-85 mm | Note 4 | ||
| Safety factor & | |||
| Performance | Proposed Device | Predicate Device | Judgment |
| VCTETM Mode | Shear wave speed | ||
| measurements and tissue | |||
| stiffness | Shear wave speed measurements | ||
| and tissue | |||
| stiffness | SE | ||
| VCTET™ Range | Shear wave speed (0.7-5.0 m/s) | ||
| Stiffness (1.5-75 kPa) | Shear wave speed (0.8-5.0 m/s) | ||
| Stiffness (2.0-75 kPa) | Note 5 | ||
| VCTETM | |||
| Display | Shear wave speed and | ||
| stiffness medians and | |||
| IQR/median ratio | Shear wave speed and stiffness | ||
| medians and IQR/median ratio | SE | ||
| Attenuation | |||
| Mode | Mobile Attenuation | ||
| Parameter(MAP ) | Controlled Attenuation | ||
| Parameter (CAP) | Note 6 | ||
| Attenuation | |||
| Range | MAP value (100-400 dB/m) | CAP value (100-400 dB/m) | SE |
| Attenuation | |||
| Display | MAP median and IQR | CAP mean and standard | |
| deviation | Note 7 | ||
| Attenuation | |||
| Display - Probes | |||
| compatibility | LS01 Probe | S+ Probe | |
| M+ Probe | |||
| XL Probe | Note 8 | ||
| Size and Weight | 525mmX175mmX315mm | ||
| (Lx W x H) | |||
| 4.15kg with accessories | 265.5mm x 157mm x 200mm | ||
| (H x W x D) | |||
| 4.4kg with accessories | Note 9 | ||
| Power supply | 100-240 V ~ 50-60 Hz | 100-240 V ~ 50-60 Hz | SE |
| Safety factor & | |||
| Performance | Proposed Device | Predicate Device | Judgment |
| Core | |||
| Component | Elastography engine | ||
| Analog front end High | |||
| frequency (US): Transducer | |||
| 3.5L3213A-001 | |||
| Elastography engine | |||
| Analog front end High frequency | |||
| (US): PV3 | |||
| Analog front end Low frequency | |||
| (servo control): | |||
| PV3 | Note 10 | ||
| Operating | |||
| system | Windows 10 Embedded | Windows 10 Embedded | SE |
| Screen | Size: Minimum 13 inches or User's computer (Screen | ||
| above | |||
| Resolution: 1920 X 1080 | resolution req: 1024 x |
-
| Note 11 |
| Internet | / | An Internet connection is
required prior to first usage | Note 12 |
| Battery | Rechargeable Li-ion battery
pack (Model:18650) | N/A | N/A |
| Accessories | N/A | N/A | N/A |
10
11
As shown in the above comparison Table, Portable Liver Elastography Ultrasound Diagnostic System in similarity to the predicate device. Accordingly, we are substantially equivalent to the predicate device FibroScan® 230 (K212035).
Design and Technology – The basic design and technology of providing Portable Liver
Elastography Ultrasound Diagnostic System is the same or similar.
Performance and Specifications – The subject device has similar Portable Liver Elastography
Ultrasound Diagnostic System and specifications to the predicate device.
Indications – The indications include in. the predicate device scope.
Review of Differences:
Note 1:
12
The predicate device has 3 probes, of which S+ head is for children, M+, XL+ probe is for adult, and the proposed device' probe is for adult.
Note 2:
A mode in the predicate device is waveform signal: variable. M mode in the predicate device is the signal change of A mode in different time periods: one-dimensional graph.
The proposed device is an ultrasonic transducer with a linear array of 32 elements, and the 2D imaging is in two-dimensional mode and the B-mode is the liver ultrasonic contour morphogram (2D image).
Note 3:
The proposed device is the same as the predicate device' M+ probe, the proposed device has no S+, XL+ probe, and this difference does not affect the safety and effectiveness of the product.
Note 4:
The measurement depth of the proposed device is the same as that of the predicate device' M+ probe. Compared with the measurement depth greater than 5mm of the predicate device, it is more convenient to sample during the measurement process.
Note 5:
Stiffness scope in the proposed device is a little wider than the predicate device and the performance test report in the proposed device verifies that 1.5kPa can be measured.
Note 6:
Only terminology difference. CAP & MAP is the abbreviations of each other.
Note 7:
Only statistical parameter selection difference between the predicate device and the proposed device. IQR and standard deviation are both used to measure the degree of dispersion of data, and this difference does not affect the safety and effectiveness of the product.
Note 8:
The intended use of LS01 Probe in the proposed device is the same as M+ Probe in the predicate device.
Note 9:
13
Differences in weight and size between the predicate device and the proposed device do not affect safety and effectiveness of the product.
Note 10:
The predicate device is a single array ultrasonic transducer with one-dimensional imaging mode.
The proposed device is an ultrasonic transducer with a linear array of 32 elements, and the 2D imaging is in two-dimensional mode.
Note 11:
The proposed device is higher resolution than predicate device.
Note 12:
The proposed device does not connect to the Internet.
Bench 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:
1) Electrical safety
IEC6060-1:2005+A1:2012+A2:2020 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
2) Electromagnetic compatibility(EMC)
IEC 60601-1-2:2014 /AMD1:2020 Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests.
3) Basic Safety And Essential Performance _
IEC 60601-2-37: Medical Electrical Equipment - Part 2-37: Particular Requirements for The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment; Edition 2.1 2015.
IEC 62359: 2017 Ultrasonics - Field characterization - Test methods for the determination of
14
thermal and mechanical indices related to medical diagnostic ultrasonic field IEC 61161: Ultrasonics -- Power Measurement -- Radiation Force Balances and Performance Requirements; Edition 3.0 2013-01.
IEC 60601-1-6 :2010+A1:2013+A2:2020 Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability. IEC 62366-1 Edition 1.0 2015-02: Medical Devices - Application of Usability Engineering To Medical Devices.
4) Software Verification and Validating Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.
5) Biocompatibility testing
ISO 10993-1:2009 Biological evaluation of medical devices-Parts 1: Evaluation and testing. ISO 10993-10:2021 Biological evaluation of medical devices-Parts 10: Tests for skin
sensitization
ISO 10993-23:2021 Biological evaluation of medical devices-Parts 10: Tests for irritation
9. Discussion of Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The proposed device is the same as the predicate device but the two devices are different. A series of safety and performance tests were conducted on the subject device:
Biocompatibility
Software Validation
15
Electromagnetic compatibility and electrical safety
Function test
All the test results demonstrate the Liverscan Mobile meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.
10. Clinical Tests Performed
No clinical test data was used to support the decision of substantial equivalence.
11. Conclusion
The subject devices have all features of the predicate devices. The few differences do not affect the safety and effectiveness of the subject devices.
Thus, the subject devices are substantially equivalent to the predicate devices.