Who is the manufacturer of AmCAD-UT?

Amcad Biomed Corporation filed the 510(k) submission for AmCAD-UT (K203555).

What is the FDA product code for AmCAD-UT?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for AmCAD-UT?

510(k) clearance (submission type: Traditional).

Does AmCAD-UT use AI or machine learning?

Yes. AmCAD-UT (K203555) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for AmCAD-UT?

AmCAD-UT Detection 2.2 (K180006).

Who can help prepare an FDA 510(k) submission like AmCAD-UT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like AmCAD-UT get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

AmCAD-UT

K203555 · Amcad Biomed Corporation · QIH · Sep 8, 2021 · Radiology

Device Facts

Record ID	K203555
Device Name	AmCAD-UT
Applicant	Amcad Biomed Corporation
Product Code	QIH · Radiology
Decision Date	Sep 8, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

AmCAD-UT is a Windows-based computer-aided detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA-cleared ultrasound systems. The region of interest (ROI) of a user-selected thyroid nodule is defined by users or suggested by an AI contouring algorithm. 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 ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.

Device Story

AmCAD-UT is a Windows-based CADe software for clinical use by physicians. It processes digital thyroid ultrasound images (DICOM, Bitmap, JPEG) from FDA-cleared systems. Users select a thyroid nodule; the device allows manual ROI definition or provides an AI-suggested contour. Once the ROI is confirmed, the device quantifies and visualizes sonographic characteristics (hyperechoic foci, echogenicity, texture, margin, orientation, anechoic areas). The software generates clinical reports based on user inputs and annotated findings, which can be printed or saved as PDFs on a PC or review station. By providing standardized quantification and visualization, the device assists physicians in interpreting thyroid nodules, potentially improving diagnostic consistency and supporting biopsy decision-making.

Clinical Evidence

Bench testing only. Standalone performance studies validated the AI-suggested ROI contouring function against ground truth labeled by a panel of specialists. Results demonstrated the device is effective in determining thyroid nodule contours on images from FDA-cleared ultrasound systems.

Technological Characteristics

Windows-based software for standard PC/review station. Inputs: DICOM, Bitmap, JPEG ultrasound images. Features AI-based contouring, statistical pattern recognition, and quantification algorithms. Connectivity: standalone PC/networked review station. Output: annotated images and automated reports (PDF/print).

Indications for Use

Indicated for medical professionals analyzing thyroid ultrasound images of discrete thyroid nodules >1cm requiring biopsy recommendation.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

AmCAD-UT Detection 2.2 (K180006)

Related Devices

K180006 — AmCAD-UT Detection 2.2 · Amcad Biomed Corporation · Aug 31, 2018
K122536 — AMCAD-UT DETECTION MODEL 2.0 · Lin & Associates, LLC · Oct 3, 2013
K240697 — See-Mode Augmented Reporting Tool, Thyroid (SMART-T) · See-Mode Technologies Pte, Ltd. · Sep 9, 2024
K203502 — MEDO-Thyroid · Medo DX Pte. , Ltd. · Apr 23, 2021
K242130 — Koios DS · Koios Medical, Inc. · Nov 15, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. AmCad BioMed Corporation % Nathan Liu Product Specialist FL.5-2, NO.167, Fu Hsing N. RD. Taipei 105 TAIWAN September 8, 2021 #### Re: K203555 Trade/Device Name: AmCAD-UT Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: July 30, 2021 Received: August 2, 2021 Dear Nathan Liu: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about 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. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203555 Device Name AmCAD-UT #### Indications for Use (Describe) AmCAD-UT is a Windows-based computer-aided detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA-cleared ultrasound systems. The region of interest (ROI) of a user-selected thyroid nodule is defined by users or suggested by an AI contouring algorithm. 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 ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. Type of Use (Select one or both, as applicable) | X Prescription Use (Part 21 CFR 801 Subpart D) | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 stylized blue "A" with a "C" inside. Next to 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. #### K203555 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: | Nathan Liu | | Title: | Product Specialist | | Phone: | 886-2-2713-6227 ext.2337 | | Fax: | 886-2-2514-0245 | | Email: | Nathan.liu@amcad.com.tw | | Manufacturer: | AmCad BioMed Corporation | | Date prepared: | November 27, 2020 | |----------------|--------------------| | Date revised: | September 02, 2021 | ## 5.2 Identification of Product | Submission Number: | K203555 | |------------------------------|------------------------------------------------| | Device Trade Name: | AmCAD-UT | | Device Classification Name: | Medical Image Management and Processing System | | Regulation Number: | 21 CFR 892.2050 | | Classification Product Code: | QIH | | Classification Panel: | Radiology | | Classification: | Class II | | Manufacturer: | AmCad BioMed Corporation | ## 5.3 Predicate Device This subject software medical device is substantially equivalent to the device listed below: {4}------------------------------------------------ Image /page/4/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 white circle inside. The text includes 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. Model: AmCAD-UT Detection 2.2 Manufacturer: AmCad BioMed Corporation 510(k) Number: K180006 ## 5.4 Device Description AmCAD-UT is a Windows-based computer-assisted detection (CADe) software application device designed to assist medical professionals in analyzing thyroid ultrasound images with the region of interest (ROI) of a selected nodule defined by users or suggested by an Al algorithm after the user specifies the location of the nodule. After the initial review of thyroid ultrasound images by the physician, he/she can use AmCAD-UT to analyze thyroid images for further interpretation. Once the ROI is confirmed, the physician may process the image for detection and quantification of sonographic characteristics (i.e., hyperechoic foci, echogenicity, texture, margin, orientation and anechoic areas) by AmCAD-UT. 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 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 is a Windows-based computer-aided detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA-cleared ultrasound systems. The region of interest (ROI) of a user-selected thyroid nodule is defined by users or suggested by an AI contouring algorithm. After the initial review of the ultrasound images by the physicians, the device further {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized letter "C" next to the company's name in both Chinese and English. Below the name is the company's 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. provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. # 5.6 Comparison with Predicate Devices AmCAD-UT is a computer-assisted detection (CADe) device which provides viewing and post-acquisition image processing and analysis of thyroid ultrasound images with regions of interest (ROI) and automatically generates reports from user inputs annotated during the image analysis process. This software medical device is substantially equivalent to the predicate device listed below: | Model: | AmCAD-UT® Detection, Version 2.2 | |----------------|----------------------------------| | Manufacturer: | AmCad BioMed Corporation | | 510(k) Number: | K180006 | The comparison as described in the following table: | | AmCAD-UT | AmCAD-UT® Detection 2.2 | |---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | AmCad BioMed Corp. | AmCad BioMed Corp. | | 510(k) Number | K203555 | K180006 | | Regulation Number | 21 CFR 892.2050 - Class II | 21 CFR 892.2050 - Class II | | Regulation Name | Medical Image Management and Processing System | Medical Image Management and Processing System | | Product Code | QIH | LLZ | | Intended Use | AmCAD-UT is intended to assist the medical professionals in analyzing thyroid ultrasound images by quantification and visualization of sonographic characteristics of thyroid nodules. | AmCAD-UT® Detection 2.2 is 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 | | | AmCAD-UT | AmCAD-UT® Detection 2.2 | | Indications for Use | AmCAD-UT is a Windows-based computer-aided detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA-cleared ultrasound systems. The region of interest (ROI) of a user-selected thyroid nodule is defined by users or suggested by an Al contouring algorithm. 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 ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD-UT® Detection 2.2 is a Windows-based computer-aided detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA-cleared ultrasound systems, with 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 ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | | Functional Capability of Image Processing | AmCAD-UT analyzes the user-defined or Al-suggested regions of interest (ROI) of a user-selected thyroid nodule for detection and quantification of sonographic characteristics (hyperechoic | AmCAD-UT® Detection 2.2 analyzes the user-selected regions of interest (ROI) of thyroid ultrasound image for the detection and quantification of sonographic characteristics (hyperechoic | | | AmCAD-UT | AmCAD-UT® Detection 2.2 | | | foci, echogenicity, texture, margin, orientation and anechoic areas). The device further provides detailed information with visualization of sonographic characteristics of thyroid nodules. | foci, echogenicity, texture, margin, orientation and anechoic areas). The device further provides detailed information with visualization of sonographic characteristics of thyroid nodules. | | Reading Paradigm | AmCAD-UT is to provide quantification and visualization of sonographic characteristics after physicians' initial review of the images. | AmCAD-UT® Detection 2.2 is to provide quantification and visualization of sonographic characteristics after physicians' initial review of the images. | | Output Generated by the CAD Device | The image can be annotated with the detected sonographic characteristics and be recorded by the device. The software also automatically generates reports given the user preference inputs in the analysis process. | The image can be annotated with the detected sonographic characteristics and be recorded by the device. The software also automatically generates reports given the user preference inputs in the analysis process. | | Type of Film to be Processed by the CAD Device | Digital ultrasound image | Digital ultrasound image | | Software Design | Based on Al, Statistical Pattern Recognition and Quantification method | Based on Statistical Pattern Recognition and Quantification method | | Ground Truth Establishment | The ground truth to be established for performance studies of the device is the ROI labeled by a panel of specialists. | The ground truth to be established for performance studies of the device includes the ROI, the presence of each sonographic characteristic, and the surgical pathology examination result. | | Platform | Window-based | Window-based | | Operating System | Standard PC or review station | Standard PC or review station | | Clinical Application | Thyroid cancers | Thyroid cancers | | | AmCAD-UT | AmCAD-UT® Detection 2.2 | | Image Type | Ultrasound Image | Ultrasound Image | | Image Format | DICOM3.0, Bitmap, JPEG | DICOM3.0, Bitmap, JPEG | | ROI Quantification | Yes | Yes | | Automatically Generating Report | Yes | Yes | | Report Storage | Paper printers, Local disk | Paper printers, Local disk | | Performance Testing Data to Support SE Determination | Results from standalone performance testing of the AI suggested ROI's of user-selected nodules | Results from standalone performance testing and clinical performance testing (MRMC study) | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo of Anke Bio Co., Ltd. The logo consists of a blue circle with a white "C" inside, followed by the company name in traditional Chinese characters. The characters are arranged horizontally and are black in color. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and other official documents. - TT - AmCad BioMed Corporation FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC Tel: +886-2-27136227 Fax: +886-2-25140245 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo and name of Anke Biotechnology Co., Ltd. The logo is a blue rounded square with a white "C" inside. The text is in traditional Chinese characters and is arranged in two lines. - TT - AmCad BioMed Corporation FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC Tel: +886-2-27136227 Fax: +886-2-25140245 FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC Tel: +886-2-27136227 Fax: +886-2-25140245 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo and name of "Anke Sheng Medical Co., Ltd." The logo is a blue rounded shape with a white "C" inside. The name of the company is written in Chinese characters to the right of the logo. The text is black and in a simple font. **AmCad Blomed Corporation** FL.5, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC Tel: +886-2-27136227 Fax: +886-2-25140245 AmCAD-UT is substantially equivalent to AmCAD-UT® Detection 2.2 that provides display and post-acquisition image analysis of ultrasound images assisting the physician in analyzing the ultrasound images of thyroid nodules. The standalone performance assessment results of AmCAD-UT are shown substantially equivalent to AmCAD-UT® Detection 2.2. The minor technological difference, i.e., the addition of the Al-suggested ROI of a user-selected nodule, do not raise any new questions of safety and effectiveness. Thus, AmCAD-UT is substantially equivalent to the predicate device as a Computer-Assisted Detection (CADe) device intended to assist the physicians in clinical practice. ## 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 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 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized letter "C" next to the company's name in both Chinese and English. Below the name is 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. 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 performance studies to validate and assess the performance of the AmCAD-UT for its added function of Al-suggested ROI contouring. The standalone studies evaluated the performance of the contours suggested by the AI algorithm of user-selected nodules on images acquired from FDA-cleared ultrasound systems and showed that the device was effective in determining the contour of thyroid nodules. # 5.10 Conclusions AmCAD-UT, being a computer assisted detection (CADe) software device, has the same intended use as the predicate device. The suggested ROI of a user-selected nodule is added in this proposed device and the performance data demonstrates that it performs effectively and the device is as safe and effective as the predicate device. AmCAD-UT is, therefore, substantially equivalent to the predicate devices as the new function of the device assists the medical professionals in identifying the contours of thyroid nodules without interfering with the analysis functions of the device.