(409 days)
AmCAD-UT® Detection 2.0 is a Windows-based computer-assisted detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images of user-selected regions of interest (ROI). After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on Philips HDI5000 images of discrete thyroid nodules larger than 1cm, for which a biopsy has been recommended. The device performance has been validated on images collected from Philips HDI5000 with a 5-12MHz multi-frequency probe.
AmCAD-UT® Detection 2.0 is a Windows-based computer-assisted detection (CADe) software application device designed to assist medical professionals in analyzing thyroid ultrasound images of user selected regions of interest (ROI). The device uses statistical pattern recognition and quantification methods to perform analytical function of images. For thyroid ultrasound, these pattern recognition and quantification methods are used by a medical professional to analyze DICOM/JPEG/Bitmap compliant thyroid ultrasound images. The software application consists of proprietary software developed by AmCad BioMed Corporation. The software is a Windows-based that may be installed on a standalone PC or review station. AmCAD-UT® Detection 2.0 user interface is designed to follow typical clinical workflow patterns to process, review, and analyze digital images. After the initial review of thyroid ultrasound images by the physician, he/she can use AmCAD-UT® Detection 2.0 to analyze the thyroid images for further interpretation. The physician selects an ROI (Region of Interest) to define the initial boundary of the ROI. Once the ROI is confirmed, the physician may process the image for detection and quantification of sonographic characteristics (i.e., hyperechoic foci, echo-pattern, echo-texture, and anechoic areas) by AmCAD-UT® Detection 2.0. The device provides more detailed information with quantification and visualization of the sonographic characteristics of thyroid nodule that may assist physician in his/her complete interpretation. The software application also automatically generates reports given the user preference inputs (e.g., the nodule size, nodule location and shape, and the presence or absence of the sonographic characteristics) annotated during the image analysis process. A report form has been designed by AmCad to be consistent with the conventional clinical thyroid report form. An output of the report may be viewed and sent to paper printers or saved on the standalone PC or review station as PDF file.
Here's a breakdown of the acceptance criteria and the study details for the AmCAD-UT® Detection 2.0 device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria or provide a table of performance metrics (e.g., sensitivity, specificity) for the AmCAD-UT® Detection 2.0 device. Instead, it broadly states that the clinical reader performance studies demonstrated that physician reading with the assistance of AmCAD-UT® Detection 2.0 enhanced their ability in analyzing sonographic characteristics and led to a significant increase in the effectiveness of clinical judgment.
Here's the summary of reported performance:
| Acceptance Criteria Category | Reported Device Performance (AmCAD-UT® Detection 2.0) |
|---|---|
| Detection Accuracy | Validated through standalone studies. |
| Reproducibility Testing | Validated through standalone studies. |
| Algorithm Stability | Validated through standalone studies. |
| Clinical Effectiveness | Enhanced physicians' ability in analyzing sonographic characteristics and led to a significant increase in effectiveness of making clinical judgment when assisting physicians in reading thyroid nodule sonography images. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated in the document. The document mentions "clinical reader performance studies" but does not provide the number of cases/images used in these studies.
- Data Provenance: The images were collected from a Philips HDI5000 with a 5-12MHz multi-frequency probe. The country of origin for the data is not specified in the provided text, but the manufacturer is based in Taiwan. It is a retrospective study (as implied by collected images used for validation).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not explicitly stated. The document mentions "the surgical pathology examination result" as part of the ground truth, which implies expert pathology review.
- Qualifications of Experts: The document explicitly mentions "surgical pathology examination result" as part of the ground truth. This indicates that pathologists, likely with relevant experience, were involved. However, specific qualifications (e.g., years of experience, board certification) are not provided.
4. Adjudication Method for the Test Set:
- The document does not explicitly describe an adjudication method (such as 2+1 or 3+1) for the test set. It mentions "surgical pathology examination result" as part of the ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- Yes, an MRMC comparative effectiveness study was done. The document states: "The intended use of the AmCAD-UT® Detection 2.0 was validated in a clinical (MRMC) study."
- Effect Size: The document states that the study "demonstrated that the physician reading thyroid nodule sonography images with the assistance of AmCAD-UT® Detection 2.0 can enhance their ability in analyzing the sonographic characteristics and has led to a significant increase in effectiveness of making clinical judgment." However, it does not provide a specific quantitative effect size (e.g., percentage improvement in AUC, sensitivity, or specificity) of how much human readers improve with AI vs. without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, standalone performance testing was done. The document states: "AmCad BioMed Corporation has conducted standalone and clinical reader performance studies to validate and assess the performance of the AmCAD-UT® Detection 2.0 for its intended use. The standalone studies include the detection accuracy testing, reproducibility testing, and algorithm stability testing."
7. The Type of Ground Truth Used:
- The ground truth used for performance studies included:
- Region of Interest (ROI) definition.
- Presence of each sonographic characteristic (hyperechoic foci, echo-pattern, echo-texture, and anechoic areas).
- Surgical pathology examination result.
8. The Sample Size for the Training Set:
- The document does not provide information regarding the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established:
- The document does not explicitly describe how the ground truth for the training set was established. However, given that the "surgical pathology examination result" and evaluation of sonographic characteristics are used for performance studies, it is reasonable to infer a similar process would be used for training data, likely involving expert review and pathology confirmation.
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K122536
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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
5.1 Identification of Submitter:
| Submitter: | AmCad BioMed Corporation |
|---|---|
| Address: | FL.5-2, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, R.O.C. |
| Phone: | 886-2-2713-6227 |
| Fax: | 886-2-2514-0245 |
| Contact: | Jack Yang |
| Title: | Vice President |
| Phone: | 886-2-2713-6227 ext.358 |
| Fax: | 886-2-2514-0245 |
| Email: | jack.yang@amcad.com.tw |
| Manufacturer: | AmCad BioMed Corporation |
| US Agent and Contact: | Chiu S. Lin, Ph.D.Lin & Associates, LLC |
|---|---|
| Address: | 9223 Cambridge Manor CourtPotomac, MD 20854 |
| Phone: | (O) 301-591-3895 |
| E-mail: | cslin@lin-associates.com |
Date prepared: August 17, 2012
5.2 Identification of Product
AmCAD-UT® Detection 2.0 Device Trade Name: Common and Usual Name: Computer-Assisted Detection (CAD) Device Device Classification Name: Picture Archiving and Communications System
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Image /page/1/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized image of an elephant. Below the logo is the company name in both Chinese and English. The address is listed as FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-25140245.
Regulation Number: 21 CFR 892.205 Classification Product Code: 90 LLZ Classification: Class II Classification Panel: Radiology Devices Manufacturer: AmCad BioMed Corporation
5.3 Predicate Device
This subject software medical device is substantially equivalent to the devices listed below:
| Model: | Q LAB Software |
|---|---|
| Manufacturer: | Philips Medical System Company |
| 510(k) Number: | K021966, cleared on July 2, 2002 |
Model: B-CAD System, Version 1.0 Manufacturer: Medipattem Corporation K050846, cleared on May 26, 2005 510(k) Number:
Model: ColonCAD API Manufacturer: Medicsight PLC 510(k) Number: K083423, cleared on May 17, 2011
5.4 Device Description
AmCAD-UT® Detection 2.0 is a Windows-based computer-assisted detection (CADe) software application device designed to assist medical professionals in analyzing thyroid ultrasound images of user selected regions of interest (ROI).
The device uses statistical pattern recognition and quantification methods to perform analytical function of images. For thyroid ultrasound, these pattern recognition and quantification methods are used by a medical professional to analyze DICOM/JPEG/Bitmap compliant thyroid ultrasound images.
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Image /page/2/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized image of an elephant. Below the logo is the company name in both Chinese and English. The address is listed as FL.S, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-25140245.
The software application consists of proprietary software developed by AmCad BioMed Corporation. The software is a Windows-based that may be installed on a standalone PC or review station. AmCAD-UT® Detection 2.0 user interface is designed to follow typical clinical workflow patterns to process, review, and analyze digital images.
After the initial review of thyroid ultrasound images by the physician, he/she can use AmCAD-UT® Detection 2.0 to analyze the thyroid images for further interpretation. The physician selects an ROI (Region of Interest) to define the initial boundary of the ROI. Once the ROI is confirmed, the physician may process the image for detection and quantification of sonographic characteristics (i.e., hyperechoic foci, echo-pattern, echo-texture, and anechoic areas) by AmCAD-UT® Detection 2.0. The device provides more detailed information with quantification and visualization of the sonographic characteristics of thyroid nodule that may assist physician in his/her complete interpretation.
The software application also automatically generates reports given the user preference inputs (e.g., the nodule size, nodule location and shape, and the presence or absence of the sonographic characteristics) annotated during the image analysis process. A report form has been designed by AmCad to be consistent with the conventional clinical thyroid report form. An output of the report may be viewed and sent to paper printers or saved on the standalone PC or review station as PDF file.
5.5 Indications for Use
AmCAD-UT® Detection 2.0 is a Windows-based computer-assisted detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images of user-selected regions of interest (ROI). After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on Philips HDI5000 images of discrete thyroid nodules larger than 1cm, for which a biopsy has been recommended. The device performance has been validated on images collected from Philips HDI5000 with a 5-12MHz multi-frequency probe.
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Image /page/3/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized elephant-like figure with the letters 'C' and 'A' incorporated into its design. Below the logo is the company name in both Chinese and English, followed by the address: FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is +886-2-27136227 and the fax number is +886-2-25140245.
5.6 Comparison with Predicate Devices
AmCAD-UT® Detection 2.0 is substantially equivalent to Q LAB Software with a general intended use for viewing and quantifying ultrasound image data. AmCAD-UT® Detection 2.0 is also substantially equivalent to B-CAD, version 1.0 and ColonCAD API as being Computer-Assisted Detection software device to assist the physicians in clinical practice. The standalone and clinical reader performance assessment of AmCAD-UT® Detection 2.0 are substantially equivalent to the standalone performance assessment and clinical MRMC reader study of ColonCAD API. Minor technological characteristics differences do not raise any new questions of safety and effectiveness. Thus, AmCAD-UT® Detection 2.0 is substantially equivalent to the Q LAB Software generally intended for viewing and quantifying ultrasound image data and substantially equivalent to the B-CAD System and ColonCAD API as the Computer-Assisted Detection device intended to assist the physicians in clinical practice.
The comparison table between our device and the predicate devices is provided below:
| AmCAD-UT®Detection 2.0 | B-CAD SystemVersion 1.0 | ColonCAD API | Q LAB Software | |
|---|---|---|---|---|
| Manufacturer | AmCad BioMedCorp. | MedipattemCorp. | Medicsight PLC | Philips MedicalSystem Company |
| 510(k) Number | K122536 | K050846 | K083423 | K021966 |
| DeviceCommon Name | Computer-AssistedDetection (CADe) | Same | Same | Picture ArchivingandCommunicationsSystemsWorkstation |
| RegulationNumber | 21 CFR 892.2050 -Class II | Same | Same | Same |
| RegulationName | Picture archivingandcommunicationssystem | Same | Same | Same |
| Product Code | LLZ | LLZ | NWE | LLZ |
| AmCAD-UT®Detection 2.0 | B-CAD SystemVersion 1.0 | ColonCAD API | Q LAB Software | |
| Intended Use | AmCAD-UT®Detection 2.0 isintended to assistthe medicalprofessionals inanalyzing thyroidultrasound imagesof user-selectedregions of interest(ROI). After theinitial review ofthe ultrasoundimages by thephysicians, thedevice furtherprovides detailedinformation withquantification andvisualization ofsonographiccharacteristics ofthyroid nodules. | The B-CADSystem providesviewing andpost-acquisitionimage analysis ofuser-selectedregions of intereston breastultrasoundimages. | The MedicsightColonCAD API isintended to beused on patientsreferred for a CTcolonography(CTC)examination, asan overlay tool toprompt theradiologist tocolonic findingsthat have beenidentified by thedevice. The CADcan assistradiologists afterthey have madean initial reviewof all thecolonography.image data,supporting theirevaluation( | |
| AmCAD-UT® | B-CAD System | ColonCAD API | Q LAB Software | |
| Detection 2.0 | Version 1.0 | |||
| The device is | software | |||
| intended for use | automatically | |||
| on Philips HDI5000 | generates reports | |||
| images of discrete | from user inputs | |||
| thyroid nodules | annotated during | |||
| larger than 1cm, | the image | |||
| for which a biopsy | analysis process. | |||
| has been | An output may be | |||
| recommended. | viewed and sent | |||
| The device | to standard film | |||
| performance has | or paper printers | |||
| been validated on | or sent | |||
| images collected | electronically to | |||
| from Philips | an intranet web | |||
| HD15000 with a | server or other | |||
| 5-12MHz | DICOM device. | |||
| multi-frequency | The software may | |||
| probe. | retrieve archived | |||
| reports from a | ||||
| web server or | ||||
| other DICOM | ||||
| device. | ||||
| B-CAD includes | ||||
| the option to add | ||||
| annotations | ||||
| based on the | ||||
| ACR-BI-RADS® | ||||
| Breast Imaging | ||||
| Atlas. In addition, | ||||
| the report form | ||||
| has been | ||||
| designed to | ||||
| support | ||||
| compliance with | ||||
| the ACR-BI-RADS®UltrasoundLexiconClassificationForm. | ||||
| When interpreted | ||||
| by a skilled | ||||
| physician, this | ||||
| device provides | ||||
| information that | ||||
| may be useful in | ||||
| screening and | ||||
| diagnosis. Patient | ||||
| management | ||||
| decisions should | ||||
| not be made | ||||
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Image /page/4/Picture/0 description: The image shows the logo of Anke BioMedical Co., Ltd. The logo consists of a circled "C" symbol followed by the company name in traditional Chinese characters. The characters are arranged horizontally, with "Anke" followed by "BioMedical" and then "Co., Ltd."
J AmCad BioMed Corporation
.
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Image /page/5/Picture/0 description: The image contains the logo and name of a company. The logo is a stylized letter C. Next to the logo is the company name in Chinese characters, which translates to "Anke Sheng Medical Co., Ltd." Below the Chinese name is the company name in English, "AmCad BioMed Corporation."
FLS, NO.167, Fo Hsing N. RD., Taipei 105, Taiwan, ROC
FL.S, NO.167, Fo Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: +886-2-27136227 Fax: +886-2-25140245
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Image /page/6/Picture/0 description: The image shows the logo for Anke Bio Co., Ltd. The logo consists of a stylized letter "C" with a small circle inside, followed by the company name in traditional Chinese characters. The text reads "安克生醫股份有限公司", which translates to Anke Bio Co., Ltd.
FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: +886-2-27136227 - Fax: +886-2-25140245
| AmCAD-UT®Detection 2.0 | B-CAD SystemVersion 1.0 | ColonCAD API | Q LAB Software | |
|---|---|---|---|---|
| FunctionalCapability ofImageProcessing | AmCAD-UT®.Detection 2.0analyzes theuser-selectedregions of interest(ROI) of thyroidultrasound imagefor the detectionand quantificationof sonographiccharacteristics(hyperechoic foci,echo-pattern,echo-texture andanechoic areas).The device furtherprovides detailedinformation withvisualization ofsonographiccharacteristics ofthyroid nodules. | B-CAD SystemVersion 1.0solely on theresults of B-CADanalysis. Theultrasoundimages displayedon B-CAD mustnot be used forprimarydiagnosticinterpretation.B-CADautomaticallysegments andclassifies shapeand orientationcharacteristics ofuser-selectedregions of interest(ROI) of breastultrasoundimages. | The devicehighlights thepotential polyps(of the colon) in2D and 3 D imageviews. The resultsare displayed inthe form of "CADmarks" on or nearthe potentialpolyps | The Q LABsoftware providesa means ofopening anddisplaying(ultrasonic) imagefiles, creating AVIand BMP filesfrom the imagedata displayed bythe software,quantifying theimage data usinga plugin moduledesigned tooperate with thecore engine of thesoftware,performing anautomaticdistancemeasurement ofthe intima mediathickness of anarteryrepresented inthe image filedata, creatingregion of interestfigures overlaidon the image datadisplayed by thesoftware,analyzing thecontent of theimage datacontained withinthe ROI figure,presenting theROI data in an XY |
| AmCAD-UT® | B-CAD System | ColonCAD API | Q LAB Software | |
| Detection 2.0 | Version 1.0 | |||
| graphic format,performing acurve fitoperation on adata setgenerated by theROI analysissoftware, andexporting thedata generated bythe pluginmodules in a formaccessible to theend user. | ||||
| ReadingParadigm | For use as "seconddetector" meaningthat the functionof AmCAD-UT®Detection 2.0 is toprovidequantification andvisualization ofsonographiccharacteristicsafter physicians'initial review ofthe images. | Same | Same | The deviceprovides thefunctions ofviewing andquantifying imagedata as a"QuantificationSoftware" to thephysician inanalyzing theultrasound image. |
| OutputGenerated bythe CAD Device | The image can beannotated withthe detectedsonographic.characteristics andbe recorded bythe device. Thesoftware alsoautomaticallygenerates reportsgiven the userpreference inputsin the analysisprocess. | The user mayselect any viewfor furtheranalysis ofanatomy andpathology. Thesoftware allowsthe user toannotate, tag,measure, andautomaticallyrecord selectedview. Results ofthe analysis aredisplayed on themonitor and maybe selected by theuser forautomatedreporting. | Not known | The software canexport the datagenerated by theplugin modules ina form accessibleto the end user. |
| Type of Film tobe Processedby the device | Digital ultrasoundimage | Digital ultrasoundimage | Digital CTcolonography | Digital ultrasoundImage |
:
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Image /page/7/Picture/0 description: The image contains a logo with a circled "C" and the text "安克生醫股份有限公司". The text is in a traditional Chinese font and is arranged horizontally. The logo and text appear to be a company name or trademark.
L.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: +886-2-27136227 Fax: +886-2-25140245
న-8
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Image /page/8/Picture/0 description: The image contains the logo of Anke Bio Co., Ltd. The logo consists of a circular symbol on the left, followed by the company's name in traditional Chinese characters. The characters are arranged horizontally, with each character clearly visible.
TT AmCad BioMed Corporation
FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: +886-2-27136227 Fax: +886-2-25140245
Tel: +886-2-2713622/ Fax: +886-2-25140245
| AmCAD-UT®Detection 2.0 | B-CAD SystemVersion 1.0 | ColonCAD API | Q LAB Software | |
|---|---|---|---|---|
| SoftwareDesign | Based onStatistical PatternRecognition andQuantificationmethod | Based onMutivariatePatternRecognitionmethod | Based onMathematicalImage ProcessingTechniques | Not known |
| Ground TruthEstablishment | The ground truthto be establishedfor performancestudies of thedevice includesthe ROI, thepresence of eachsonographiccharacteristic, andthe surgicalpathologyexaminationresult. | Not known | Not known | Not known |
| Platform | Window-based | Window 2000/XP,DICOMcompatible | Not known | Windows2000/XP |
| OperatingSystem | Standard PC orreview station | Same | Not known | Same |
| ClinicalApplication | Thyroid cancers | Breast cancers | Colon cancers | Not specified; forgeneral intendeduse |
| Image Type | Ultrasound Image | Same | CT image | Ultrasound Image |
| Image Format | DICOM3.0,Bitmap, JPEG | DICOM3.0 | DICOM 3.0 | Image dataacquired onPhilips MedicalSystemsultrasoundproducts |
| ROIQuantification | Yes | Yes | No | Yes |
| AutomaticallyGeneratingReport | Yes | Yes | Not known | Not known |
| Report Storage | Paper printers,Local disk | Standard film,paper printers,web server, otherDICOM device | Not known | Not known |
| PerformanceTesting Data toSupport SEDetermination | Results fromstandaloneperformancetesting and clinicalperformancetesting MRMC | From the 510(k)Summary that isavailable on theFDA database, itappears that nodata from | Standaloneperformanceassessment, andclinical MRMCstudy | From the 510(k)Summary that isavailable on theFDA database, itappears that nodata from |
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Image /page/9/Picture/0 description: The image shows a logo with Chinese and English text. The Chinese text reads "安克生醫股份有限公司", and the English text reads "AnCac BioMed Corp.". The logo also includes a stylized graphic to the left of the text.
FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC
Tel: +886-2-27136227 Fax: +886-2-25140245
| AmCAD-UT®Detection 2.0 | B-CAD SystemVersion 1.0 | ColonCAD API | Q LAB Software |
|---|---|---|---|
| study) | standalone | standalone | |
| performancetesting and | performancetesting and | ||
| reader | reader | ||
| performance | performance | ||
| testing were | testing were | ||
| submitted. | submitted. |
5.7 Performance Standards
No applicable FDA performance standards have been issued under the authority of Section 514.
5.8 Software
Software development for the AmCAD-UT® Detection 2.0 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.
5.9 Summary of Performance Data to Support Substantial Equivalence
AmCad BioMed Corporation has conducted standalone and clinical reader performance studies to validate and assess the performance of the AmCAD-UT® Detection 2.0 for its intended use. The standalone studies include the detection accuracy testing, reproducibility testing, and algorithm stability testing.
The intended use of the AmCAD-UT® Detection 2.0 was validated in a clinical (MRMC) study. The results of the MRMC study demonstrated that the physician reading thyroid nodule sonography images with the assistance of AmCAD-UT® Detection 2.0
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Image /page/10/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized image of an elephant. Below the logo is the company name in both Chinese and English. The address is listed as FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-25140245.
can enhance their ability in analyzing the sonographic characteristics and has led to a significant increase in effectiveness of making clinical judgment.
5.10 Conclusions
The intended use of AmCAD-UT® Detection 2.0 as a CAD device is equivalent to the predicate devices in that it views, analyzes, quantifies, and visualizes the user selected radiologic images that may reveal abnormalities during analysis of patient radiologic images by the intended user. Minor technological characteristics differences do not raise any new questions of safety and effectiveness. Thus, AmCAD-UT® Detection 2.0 is substantially equivalent to the predicate devices as the Computer-Assisted Detection (CAD) device intended to provide viewing and post-acquisition analysis functions for assisting the physicians in clinical practice.
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Public Health Service
Image /page/11/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3. 2013
AmCad BioMed Corporation % Chiu S. Lin, Ph.D. President Lin & Associates, LLC 9223 Cambridge Manor Court POTOMAC MD 20854
Re: K122536
Trade/Device Name: AmCAD-UT® Detection Model 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 15, 2013 Received: August 16, 2013
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. Iisting 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 11 (Special Controls) or class 111 (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
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Page 2 - Chiu Lin. Ph.D.
forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K122536
AmCad-UT Detection 2.0 Device Name:
Indications for Use:
AmCAD - UT® Detection 2.0 is a Windows - based computer - assisted detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images of user - selected regions of interest (ROI). After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on Philips HDI5000 images of discrete thyroid nodules larger than Icm, for which a biopsy has been recommended. The device performance has been validated on images collected from Philips HDI5000 with a 5 - 12MHz multi - frequency probe.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(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)
$(m.7)$
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K122536 510(k)
Page 1 of 1
§ 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).