(40 days)
Not Found
No
The description focuses on standard image processing techniques (assigning pixel values) and does not mention AI, ML, or related terms. There is no description of training or test sets, which are typical for AI/ML devices.
No
The device is described as storing, displaying, and enhancing ultrasound images for viewing, which are diagnostic functions, not therapeutic.
No
The device is intended for storage, display, and enhancement of ultrasound images, not for diagnosing medical conditions. It assists the physician in viewing images but does not provide diagnostic interpretations or identify specific diseases.
Yes
The device description explicitly states it is a "software package running on off-the-shelf hardware," indicating the medical device component is solely the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for the storage, display, enhancement, and viewing of ultrasound images. This is related to medical imaging, not the analysis of biological samples (like blood, urine, tissue, etc.) which is the hallmark of IVDs.
- Device Description: The description focuses on processing and displaying images, not on analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is centered around the manipulation and display of medical images.
N/A
Intended Use / Indications for Use
The CTC Workstation system is intended for use by a qualified physician to direct the storage, display, enhancement, and viewing of ultrasound images.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Under the direction of the physician the device stores, displays, and enhances ultrasound images. The image enhancement is performed by assigning pixels numeric values. The system is comprised of a software package running on off-the-shelf hardware.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The CTC Workstation has completed design verification and validation tests for conformance with specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K024028/K993802, K023772, K052411
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 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
1. 510K Summary:
| Submitted by: | Medical Diagnostic Technologies, Inc.
8960 W. Tropicana Ave.
Suite 700
Las Vegas, NV 89147 | SEP 11 2001 |
|-----------------|-----------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | James M. Benson
President & CEO
Tel: 702-933-0771
Fax: 702-933-0769 | |
| Product Name: | CTC Workstation | |
| Common Name: | Medical Image enhancement/processing system | |
| Classification: | LLZ; Class II; CFR 21 892.2050 | |
Predicate Devices:
| K # & Device Name | Manufacturer |
|---|---|
| K024028/K993802 SharpView/GOPView | ContextVision AB |
| K023772 KinetDx | Siemens |
| K052411 HIPAX | Steinhart Medizinsysteme |
Description of Device:
Under the direction of the physician the device stores, displays, and enhances ultrasound images. The image enhancement is performed by assigning pixels numeric values. The system is comprised of a software package running on off-the-shelf hardware.
Intended Use:
The CTC Workstation system is intended for use by a qualified physician to direct the storage, display, enhancement, and viewing of ultrasound images.
Comparison with Predicate Devices:
CTC Workstation system's technology and indication for use was the determining factor in selecting predicate devices for substantial equivalence. All of the devices selected as predicates share the same core functions as CTC Workstation: storage, display, viewing, enhancement/quantification of ultrasound images. All of the devices receive images via a computer. All three devices offer image enhancement/quantification on a user directed basis. All three devices require a qualified physician to direct the device.
Performance Studies:
The CTC Workstation has completed design verification and validation tests for conformance with specifications.
1
Summary of Safety and Effectiveness Data:
CTC Workstation provides functionality that is substantially equivalent to the cited predicate devices. The potential hazards have been studied and controlled as part of the design and development control processes, including risk analysis, test and design considerations, and planned verification and validation testing processes. CTC Workstation does not include any new indications for use, nor does the use of this device raise any new potential hazards or safety concerns. Like the named predicates, CTC Workstation provides qualified personnel the ability to direct the storage, retrieval, enhancement, and viewing of ultrasound images. All of the devices are completely user controlled and ensures a minimal impact on the standard of care.
As can be seen from the comparison tables, the subject device has the same basic technology provided by the predicates. It is primarily a software device that performs post-processing of images for the purposes of storage, retrieval, enhancement, and viewing of ultrasound images to yield information which supports a trained physician. The main technological difference is that the MDT device uses a different set of known algorithms to perform enhancement and assign numeric values to pixels.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The words "HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 1 1 2006
Mr. James Benson President and CEO Medical Diagnostic Technologies, Inc. 8960 W. Tropicana Ave,Suite 700 LAS VEGAS NV 89147
Re: K062229
Trade/Device Name: CTC Workstation Model 2200 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 1, 2006 Received: August 2, 2006
Dear Mr. Benson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the acronym "FDA" in large, bold letters. Underneath the acronym is the word "Centennial!" in a script font. There are three stars at the bottom of the logo. The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
3
Page 2 -
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: CTC Workstation Model 2200
Indications For Use: The CTC Workstation system is intended for use by a qualified physician to direct the storage, display, enhancement, and viewing of ultrasound images.
Prescription Use
(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 Device Evaluation (ODE)
David R. Seagram
(Division Sign-Off) Page 1 of 1 Division of Reproductive, Ab and Radiological Devices 510(k) Number _