(107 days)
No
The description focuses on image processing and classification based on color intensity and periodic pulsatile waveforms, without mentioning AI, ML, or related concepts like training or testing datasets for model development.
No.
The device is a medical image processing tool for vascular pulsatility analysis and information display, not for providing therapy.
No
The "Intended Use / Indications for Use" states that the device "must not be used alone for primary diagnostic interpretation." This indicates it is not a standalone diagnostic device.
Yes
The device description explicitly states "AmCAD-UV (model number 1.0) is a software device" and describes its function as processing existing ultrasound image data. It does not mention any accompanying hardware components or hardware-specific functions beyond processing images from FDA-cleared ultrasound systems.
Based on the provided information, AmCAD-UV is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AmCAD-UV's Function: AmCAD-UV processes and analyzes images (flow Doppler ultrasound images) acquired from an external medical device (ultrasound system). It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's a "general-purpose medical image processing tool for vascular pulsatility analysis" and "must not be used alone for primary diagnostic interpretation." This aligns with image processing software, not an IVD.
- Device Description: The description reinforces that it works with existing ultrasound images and provides "pulsatile information of existing information from flow Doppler ultrasound images."
Therefore, AmCAD-UV falls under the category of medical image processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AmCAD-UV is a software device designed for classifying the ultrasonic color intensity data and allowing users to view classified color-coded signals, namely, primary pulsatile, and unidentified signals of flow Doppler ultrasound images. It is intended as a general-purpose medical image processing tool for vascular pulsatility analysis but must not be used alone for primary diagnostic interpretation.
Product codes
LLZ
Device Description
AmCAD-UV (model number 1.0) is a software device designed for classifying the ultrasonic color intensity data and allowing users to view classified color-coded signals, namely, primary pulsatile, secondary pulsatile, and unidentified signals of flow Doppler ultrasound images. The ultrasonic color intensity data here means the flow Doppler ultrasound images (i.e. color and power Doppler ultrasound images) acquired from FDA-cleared ultrasound systems. The device quantifies those color pixels within the quadrilateral scanning area on a sequence of flow Doppler ultrasound images based on their color intensities and groups the color pixels with similar periodic pulsatile waveforms. The image with classified color-coded pulsatile signals will then be generated by the proposed device for users to evaluate the vascular pulsatility, such as pulsatile flow velocity and flow energy, dependent on the type of flow Doppler ultrasound image analyzed. As a PACS (Picture Archiving and Communication System) software device, AmCAD-UV does not generate new quantities but provide pulsatile information of existing information from flow Doppler ultrasound images. The device is intended as a general-purpose medical image processing tool for vascular pulsatility analysis but must not be used alone for primary diagnostic interpretation. AmCAD-UV provides dual images for viewing original flow Doppler ultrasound images and the image with classified color-coded pulsatile signals. The user can delineate a specific region of interest (ROI) on the image for analysis. The device also provides a trend chart for displaying pulsatile waveforms with summarized statistics. The device can export the quantified values of the classified pulsatile signals in text format and export the sequence of color-coded pulsatile images and the waveform trend chart in Bitmap (.bmp) and JPEG (.jpg or *.jpeg) formats.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
flow Doppler ultrasound images (i.e. color and power Doppler ultrasound images)
Anatomical Site
Not Found
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
The software verification testing, including software unit test, software integration test, and software system test, was performed to ensure that AmCAD-UV meets all functional and specifications for its indications for use. The intended use of the AmCAD-UV was validated in the performance validation testing. The results of performance validation testing (i.e. human validation study) demonstrated that AmCAD-UV can be used to visualize and quantify the primary pulsatile, secondary pulsatile, and unidentified signals of flow Doppler ultrasound images. The images with classified color-coded signals displayed on AmCAD-UV must not be used alone for primary diagnostic interpretation.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, arranged in a cascading manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2017
AmCad BioMed Corporation % Chiu S. Lin. Ph.D. President Lin & Associates, LLC 9223 Cambridge Manor Court POTOMAC MD 20854
Re: K170069 Trade/Device Name: AmCAD-UV Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 24, 2017 Received: March 27, 2017
Dear Dr. Lin:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2- Chiu S. Lin, Ph.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Robert Oolo
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170069
Device Name AmCAD-UV
Indications for Use (Describe)
AmCAD-UV is a software device designed for classifying the ultrasonic color intensity data and allowing users to view classified color-coded signals, namely, primary pulsatile, and unidentified signals of flow Doppler ultrasound images. It is intended as a general-purpose medical image processing tool for vascular pulsatility analysis but must not be used alone for primary diagnostic interpretation.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized letter "A" with a circle inside. The text includes the company name in both Chinese and English, followed by the address: FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is +886-2-27136227 and the fax number is +886-2-27152181.
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92
1.1 Identification of Submitter:
| Submitter: | AmCad BioMed Corporation |
|---|---|
| Address: | FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, R.O.C. |
| Phone: | 886-2-2713-6227 |
| Fax: | 886-2-2715-2181 |
| Contact: | Jack Yang |
| Title: | Vice President |
| Phone: | 886-2-2713-6227 ext.2358 |
| Fax: | 886-2-2715-2181 |
| Email: | jack.yang@amcad.com.tw |
| Manufacturer: | AmCad BioMed Corporation |
| US Agent and Contact: | Chiu S. Lin, Ph.D. |
| Lin & Associates, LLC | |
| Address: | 5614 Johnson Avenue |
| Bethesda, MD 20817 | |
| Phone: | (0) 301-591-3895 |
| E-mail: | cslin@lin-associates.com |
| Date prepared: | April 25, 2017 |
- 1.2 Identification of Product
| Device Trade Name: | AmCAD-UV |
|---|---|
| Model number: | 1.0 |
| Common and Usual Name: | Medical Image Processing and Analysis Software |
| Device Classification Name: | Picture Archiving and Communications System |
4
Image /page/4/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "A" with a circle in the upper right corner. Below the logo is the company name in both Chinese and English. The address is listed as FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is +886-2-27136227 and the fax number is +886-2-27152181.
| Regulation Number: | 21 CFR 892.2050 |
|---|---|
| Classification Product Code: | LLZ |
| Classification: | Class II |
| Classification Panel: | Radiology Devices |
| Manufacturer: | AmCad BioMed Corporation |
1.3 Predicate Device
This subject software medical device is substantially equivalent to the devices listed below:
| Primary Predicate Device | |
|---|---|
| Model: | QLAB Quantification Software |
| Manufacturer: | Philips Ultrasound, Inc. |
| 510(k) Number: | K132165, cleared on August 09, 2013. |
In terms of technology, the reference device is listed below.
| Model: | ClearViewHD |
|---|---|
| Manufacturer: | ClearView Diagnostics Inc. |
| 510(k) Number: | K140139, cleared on May 28, 2014 |
1.4 Device Description
AmCAD-UV (model number 1.0) is a software device designed for classifying the ultrasonic color intensity data and allowing users to view classified color-coded signals, namely, primary pulsatile, secondary pulsatile, and unidentified signals of flow Doppler ultrasound images. The ultrasonic color intensity data here means the flow Doppler ultrasound images (i.e. color and power Doppler ultrasound images) acquired from FDA-cleared ultrasound systems. The device quantifies those color pixels within the quadrilateral scanning area on a sequence of flow Doppler ultrasound images based on their color intensities and groups the color pixels with similar periodic pulsatile waveforms. The image with classified color-coded pulsatile signals will then be generated by the proposed device for users to evaluate the vascular pulsatility,
5
Image /page/5/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "A" with a "C" inside, next to the company's name in both Chinese and English. Below the name is the address: FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is Tel: +886-2-27136227 and the fax number is Fax: +886-2-27152181.
such as pulsatile flow velocity and flow energy, dependent on the type of flow Doppler ultrasound image analyzed. As a PACS (Picture Archiving and Communication System) software device, AmCAD-UV does not generate new quantities but provide pulsatile information of existing information from flow Doppler ultrasound images. The device is intended as a general-purpose medical image processing tool for vascular pulsatility analysis but must not be used alone for primary diagnostic interpretation. AmCAD-UV provides dual images for viewing original flow Doppler ultrasound images and the image with classified color-coded pulsatile signals. The user can delineate a specific region of interest (ROI) on the image for analysis. The device also provides a trend chart for displaying pulsatile waveforms with summarized statistics. The device can export the quantified values of the classified pulsatile signals in text format and export the sequence of color-coded pulsatile images and the waveform trend chart in Bitmap (.bmp) and JPEG (.jpg or *.jpeg) formats.
1.5 Indications for Use
AmCAD-UV is a software device designed for classifying the ultrasonic color intensity data and allowing users to view classified color-coded signals, namely, primary pulsatile, secondary pulsatile, and unidentified signals of flow Doppler ultrasound images. It is intended as a general-purpose medical image processing tool for vascular pulsatility analysis but must not be used alone for primary diagnostic interpretation.
1.6 Comparison with Predicate Devices
The proposed device is specifically intended for use as a PACS software device for viewing and quantifying the flow Doppler ultrasound image data and is substantially equivalent to the predicate, QLAB Quantification Software, K132165, with the same intended use for viewing and quantifying Doppler ultrasound image data. They both provide statistical analysis of the intensity data or the image content obtained from the ultrasound machine. Both devices are classified as Picture Archiving and Communication System, 21 CFR 892.2050. Minor technological characteristics differences do not raise any new questions of safety and effectiveness. In terms of technology, the reference device is the software used on the ClearViewHD device.
6
Image /page/6/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized "A" with a circle around the top portion. Below the logo is the company name in both Chinese and English. The address is listed as FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-27152181.
The comparison table 1.6.1 between our device and the predicate devices and reference device is provided below:
| Device | Proposed Device | Primary Predicate Device | Reference Device |
|---|---|---|---|
| AmCAD-UV | QLAB Quantification Software | ClearViewHD | |
| Manufacturer | AmCad BioMed Corp. | Philips Ultrasound, Inc. | ClearView Diagnostics Inc. |
| 510(k) Number | K170069 | K132165 | K140139 |
| Device Common Name | Picture archiving and communications systems | Same | Image Enhancement System |
| Regulation Number | 21 CFR 892.2050 - Class II | Same | Same |
| Regulation Name | Picture archiving and communications system | Picture archiving and communications system, workstation | Picture archiving and communication system |
| Product Code | LLZ | Same | Same |
| Indications for Use/Intended Use | AmCAD-UV is a software device designed for classifying the ultrasonic color intensity data and allowing users to view classified color-coded signals, namely, primary pulsatile, secondary pulsatile, and unidentified signals of flow Doppler ultrasound images. It is intended as a general-purpose medical image processing tool for vascular pulsatility analysis but must not | QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips Healthcare ultrasound products. The software allows users to examine tissue Doppler imaging and provides a tool for drawing regions of interest that measure the myocardial velocity, strain, strain rate, and displacement along those regions in the myocardium | The ClearView Image Enhancement System is intended for use by a qualified technician or diagnostician to reduce speckle noise, enhance contrast and transfer ultrasound images. The software provides a DICOM-compliant ClearViewHD-enhanced image along with the original ultrasound image to assist in image interpretation by the trained physician. ClearViewHD is |
| Device | Proposed Device | Primary Predicate | |
| Device | Reference Device | ||
| AmCAD-UV | QLAB Quantification | ||
| Software | ClearViewHD | ||
| be used alone for | |||
| primary diagnostic | |||
| interpretation. | (excerpted from | ||
| QLAB User Manual). | intended for use by a | ||
| qualified | |||
| technologist for | |||
| transfer and | |||
| enhancement of | |||
| ultrasound images | |||
| from a variety of | |||
| diagnostic systems. | |||
| Functional | |||
| Capability of | |||
| Image | |||
| Processing | The device provides | ||
| dual images for | |||
| viewing original | |||
| dynamic f and | |||
| classified color-coded | |||
| signals of flow | |||
| Doppler ultrasound | |||
| images. The device | |||
| also provides a trend | |||
| chart for displaying | |||
| waveforms of | |||
| pulsatile intensity | |||
| changes with | |||
| summarized | |||
| statistics. It is | |||
| intended as a | |||
| general-purpose | |||
| medical image | |||
| processing tool for | |||
| vascular pulsatility | |||
| analysis, such as flow | |||
| velocity and flow | |||
| energy, over a | |||
| number of cardiac | |||
| cycles. AmCAD-UV | |||
| can export the | |||
| quantified values of | |||
| the classified | |||
| pulsatile signals in | |||
| text format and | |||
| export the sequence | The software can | ||
| display the dynamic | |||
| intensity information | |||
| as color-coded image | |||
| and provide a chart | |||
| for displaying the | |||
| intensity changes | |||
| over time on a | |||
| waveform, which is | |||
| able to evaluate the | |||
| periodic strain | |||
| fluctuation in | |||
| myocardial tissue | |||
| motion over a | |||
| number of cardiac | |||
| cycles. | The software | ||
| generates an | |||
| enhanced image | |||
| with reduced speckle | |||
| noise and improved | |||
| contrast | |||
| enhancement for | |||
| viewing and | |||
| diagnosing. | |||
| Device | Proposed Device | Primary Predicate Device | Reference Device |
| AmCAD-UV | QLAB Quantification Software | ClearViewHD | |
| of color-coded pulsatile images and the waveform trend chart in Bitmap (.bmp) and JPEG (.jpg or *.jpeg)formats. | |||
| Software Design/ Example | Based on classification method of ultrasonic color intensity data contained in the dynamic flow Doppler ultrasound images (i.e. color and power Doppler ultrasound images). | ||
| Image: Ultrasound image with color Doppler | Based on the strain rate method of velocity of myocardial tissue motion contained in the dynamic tissue Doppler images. | ||
| Image: Ultrasound image with color Doppler | Based on a core noise reduction and contrast enhancement algorithm in gray-scale ultrasound images. | ||
| Image: Gray-scale ultrasound image | |||
| Output Generated by the Device/ Example | AmCAD-UV allows users to view classified color-coded signals, namely, primary pulsatile, secondary pulsatile, and unidentified signals of flow Doppler ultrasound images and trend chart of intensity changes over time on a waveform. The device exports the quantified values of the classified | The software can display the dynamic intensity information as color-coded image and export the intensity changes over time on a waveform. | |
| Image: Color-coded intensity image | |||
| Image: Waveform | The software can display an image with enhanced contrast and reduced noise. | ||
| Image: Enhanced gray-scale ultrasound image | |||
| Device | Proposed Device | Primary Predicate | |
| Device | Reference Device | ||
| AmCAD-UV | QLAB Quantification | ||
| Software | ClearViewHD | ||
| pulsatile signals in | |||
| text format and | |||
| exports the | |||
| sequence of | |||
| color-coded pulsatile | |||
| images and the | |||
| waveform trend | |||
| chart in Bitmap | |||
| (*.bmp) and JPEG | |||
| (*.jpg or | |||
| *.jpeg)formats. |
Image: Ultrasound images and waveform chart and table | | |
| Meaning of
Color Pixels in
the Output | The classified
color-coded signals
of flow Doppler
ultrasound images
indicate different
intensity values
defined by the scale
of the color bar. | The color pixels in
the virtual trace
image indicate
different values of
myocardial tissue
motion information
defined by the scale
of the color bar. | Not available. |
| Meaning of
Fluctuation in
the Waveform | The trends of
intensity changes
over a sequence of
frames is used for
evaluation of the
periodic fluctuation
in vascular pulsatility | The trends of
myocardial
information at the
user-selected specific
points for evaluation
of the periodic
fluctuation in | Not available. |
| Device | Proposed Device | Primary Predicate
Device | Reference Device |
| | AmCAD-UV | QLAB Quantification
Software | ClearViewHD |
| | cardiac cycles. | motion over a
number of cardiac
cycles. | |
| Measurement | Average, maximum,
and minimum values
for the trends of
pulsatile intensity
changes. | Mean values for the
trends of dynamic
intensity
information. | Not available. |
| Type of File to
be Processed
by the device | Dynamic flow
Doppler ultrasound
images in DICOM,
Bitmap, or JPEG
formats (Vendor
independent). | Dynamic tissue
Doppler image data
acquired on Philips
Healthcare
ultrasound products. | DICOM node that
accepts DICOM3.0
digital medical files
from an ultrasound
device or another
DICOM source. |
| Platform/
Operating
System | Standard PC,
workstation, and
on-board
FDA-cleared
ultrasound systems. | Standard PC,
workstation, and
on-board Philips'
ultrasound systems. | Windows XP or
higher, Windows
Embedded and
DICOM-compliant
medical devices. |
| Clinical
Application | Not specified; for
general intended use | Same | Same |
Table 1.6.1 – The substantial equivalence comparison table
7
Image /page/7/Picture/0 description: The image shows the logo of Anke BioMedical Co., Ltd. The logo consists of a blue circular shape with a white "C" inside, followed by the company's name in traditional Chinese characters. The text reads "安克生醫股份有限公司", which translates to Anke BioMedical Co., Ltd.
Tel: +886-2-27136227 Fax: +886-2-27152181
8
Image /page/8/Picture/0 description: The image shows the logo of Anke BioMedical Co., Ltd. The logo consists of a blue circular shape with a white "C" inside, followed by the company's name in traditional Chinese characters. The text reads "安克生醫股份有限公司", which translates to Anke BioMedical Co., Ltd.
Tel: +886-2-27136227 Fax: +886-2-27152181
9
Image /page/9/Picture/0 description: The image contains the logo and name of AnC Bio Medical Co., Ltd. The logo is a blue circle with a white "C" inside. The name of the company is written in traditional Chinese characters. The English translation of the company name is also included.
Tel: +886-2-27136227 Fax: +886-2-27152181
10
Image /page/10/Picture/0 description: The image shows the logo of Anke Sheng Medical Co., Ltd. The logo consists of a blue circle with a white "C" inside, followed by the company name in Chinese characters. The characters are written in black and are arranged horizontally.
- AmCad BioMed Corporation
L.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: +886-2-27136227 Fax: +886-2-27152181
1.7 Performance Standards
No performance standards for PACS systems or components have been issued under the authority of Section 514.
1.8 General Safety and Effectiveness Concerns
Software development for the AmCAD-UV follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for this type of image viewing and quantification device.
11
Image /page/11/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "A" with a circle around it. The text includes the company name in both Chinese and English, followed by the address: FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is +886-2-27136227 and the fax number is +886-2-27152181.
The device labeling contains operating instructions for use and necessary warnings and notes to provide the safe and effective use of the AmCAD-UV.
1.9 Summary of Performance Data to Support Substantial Equivalence
AmCad BioMed Corporation has conducted the software verification testing and performance validation testing to evaluate the safety and effectiveness of AmCAD-UV and to validate the performance of the AmCAD-UV for its intended use. The software verification testing, including software unit test, software integration test, and software system test, was performed to ensure that AmCAD-UV meets all functional and specifications for its indications for use. The intended use of the AmCAD-UV was validated in the performance validation testing. The results of performance validation testing (i.e. human validation study) demonstrated that AmCAD-UV can be used to visualize and quantify the primary pulsatile, secondary pulsatile, and unidentified signals of flow Doppler ultrasound images. The images with classified color-coded signals displayed on AmCAD-UV must not be used alone for primary diagnostic interpretation.
1.10 Conclusions
The software development for AmCAD-UV followed documented processes for software design, verification and validation testing, and performance testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for the device. There is no known direct safety or health risk caused by, or related to, the use of the device. The safety and effectiveness of the device has been described in the verification and validation document.
The data presented in this 510(k) application demonstrates that the proposed device, AmCAD-UV, is as safe and effective as the primary predicate device. The intended use of AmCAD-UV is similar to the primary predicate device. The technological differences do not raise any new questions regarding the safety and effectiveness of the device
12
Image /page/12/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized letter "A" with a circle inside. Below the logo is the company name in both Chinese and English. The address is listed as FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-27152181.
and the secondary referenced device is listed to reference the similar technological characteristics as that of the proposed device. Thus, AmCAD-UV is substantially equivalent to the predicate device as a software device intended to view and quantifying the ultrasonic image data. Both devices are classified as Picture Archiving and Communication Systems, 21 CFR 892.2050.