(42 days)
No
The description focuses on standard image archiving, review, measurement, and reporting functionalities without mentioning AI or ML algorithms.
No.
The device is described as an integrated cardiovascular information system and a picture archiving and communications system, focused on acquiring, storing, processing, and displaying clinical information and images. It does not exert any direct therapeutic action on a patient.
No
Explanation: The device is described as a system for acquiring, storing, printing, transferring, and archiving clinical information, including images and hemodynamic studies. It allows users to review, annotate, perform measurements, and generate reports. While it processes diagnostic-quality images and assists in report generation, it does not explicitly state that it performs diagnosis itself. It primarily functions as an information management and review system rather than an automated diagnostic tool.
Yes
The device is described as "software comprised of modules that perform under standard 'off-the-shelf' personal computers and servers" and "combines modular software applications and third party 'off-the-shell' software on standard computer workstations and servers". While it requires standard computer hardware to run, the medical device itself is the software.
Based on the provided information, the VERICIS device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- VERICIS Function: The description of VERICIS clearly states its purpose is to acquire, store, process, and display clinical information, primarily images and related data, from various medical imaging modalities. It focuses on managing and analyzing data already generated by other diagnostic devices.
- Lack of Biological Sample Analysis: There is no mention of VERICIS interacting with or analyzing biological specimens. Its inputs are digital data from imaging systems and other clinical information systems.
Therefore, VERICIS falls under the category of a medical imaging information system or PACS (Picture Archiving and Communications System), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data. VERICIS is intended to allow users to review diagnostic and non-diagnostic quality images, annotate studies, perform digital subtraction on images, to perform quantitative measurements on images (including but not limited to quantitative coronary analysis, left ventricular analysis, time, area, length, velocity, angle, volume, and velocity-time integrals), to generate physician-generated clinical reports (via structure reporting and template based tools), and to store this information in a database.
Product codes
LZZ, LLZ
Device Description
The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system. The VERICIS is a modification of the Camtronics Analytical Review Station (K955519) and the Echocardiography System (K992259) to accept multiple modalities. The VERICIS combines modular software applications and third party "off-the-shell" software on standard computer workstations and servers running the specified Microsoft Windows operating systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM (Digital Imaging and Communications in Medicine) image data files from multiple modalities.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 Camtronics Medical Systems. The logo consists of a stylized "C" shape on the left, followed by the word "Camtronics" in a larger, bold font. Below "Camtronics" is the phrase "MEDICAL SYSTEMS" in a smaller font. The logo is simple and professional, and it is likely used to represent the company in its marketing and branding materials.
AUG 2 - 2005
Summary of Safety and Effectiveness for VERICIS Cardiovascular Image and Information System
Submitter A.
Camtronics Medical Systems 900 Walnut Ridge Drive Hartland, Wisconsin 53029 262-367-0700 Telephone: Contact person: Steve Krueger Date prepared: June 1, 2005
Device B.
| Trade Name: | VERICIS Cardiovascular Image and Information System |
|---|---|
| Common Name: | Picture Archiving and Communications Systems and Workstations |
| Regulation Number: | 21CFR 892.2050 |
| Regulation Name: | System, Image Processing, Radiological |
| Regulation Class: | II |
| Product Code: | LZZ |
C. Predicate Devices
McKesson Horizon Medical Imaging (K043146)
D. Device Description
The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system. The VERICIS is a modification of the Camtronics Analytical Review Station (K955519) and the Echocardiography System (K992259) to accept multiple modalities. The VERICIS combines modular software applications and third party "off-the-shell" software on standard computer workstations and servers running the specified Microsoft Windows operating systems.
E. Intended Use
VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import
1
from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data. VERICIS is intended to allow users to review diagnostic and non-diagnostic quality images, annotate studies, perform digital subtraction on images, to perform quantitative measurements on images (including but not limited to quantitative coronary analysis, left ventricular analysis, time, area, length, velocity, angle, volume, and velocity-time integrals), to generate physiciangenerated clinical reports (via structure reporting and template based tools), and to store this information in a database.
· VERICIS is software comprised of modules that perform under standard "offthe-shelf" personal computers and servers running the Microsoft Windows 2000/2003/XP operating systems.
• VERICIS is image data storage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) image data files from multiple modalities. It accepts text data using other standards-based formats including but not limited to HL7 and XML.
• VERICIS is an Internet/Intranet network system that is designed for small and large, multi-user environments. The VERICIS network structure (including server and workstations) provides for the system's database management, storage, printing, and all DICOM/HL-7 interface services.
ட். Substantial Equivalence
The VERICIS Cardiovascular Image and Information system employs the same fundamental scientific technology as the McKesson Medical Imaging Company, Horizon Medical Imaging (K043146), the predicate device.
Technological Characteristics G.
The VERICIS combines modular software applications and third party off-theshelf software on standard computer workstations and servers running the Microsoft Windows 2000/2003 and XP operating systems. When the VERICIS software is loaded on the specified IBM PC compatible computers, hardware and peripherals the resulting system will act and perform similar to the McKesson Horizon Imaging system to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
Conclusions H.
Camtronics Medical Systems has demonstrated through its comparison of performance with the predicate devices that the VERICIS is equivalent to the Horizon Medical Imaging system.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged one behind the other.
AUG 2 - 2005
Received: June 21, 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Krueger Director of Regulatory Affairs/Quality Assurance Camtronics Medical System 900 Walnut Ridge Drive HARTLAND WI 53029
Re: K051649
Trade/Device Name: VERICIS Cardiovascular Image and Information System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 20, 2005
Dear Mr. Krueger:
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 stied in the enclosure) to legally marketed predicate devices marketed in interstate commons on use 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.
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 requirements of the Accoln and Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); abeling (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.
3
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
×05 16 49
Indications for Use
510(k) Number (if known):
- Camtronics Medical Systems VERICIS Cardiovascular Image and Information Device Name: System
VERICIS is a system intended to be used to acquire, store, print, transfer, and Indications For Use: archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data. VERICIS is intended to allow users to review diagnostic and non-diagnostic quality images, annotate studies, perform digital subtraction on images, to perform quantitative measurements on images (including but not limited to quantitative coronary analysis, left ventricular analysis, time, area, length, velocity, angle, volume, and velocity-time integrals), to generate physiciangenerated clinical reports (via structure reporting and template based tools), and to store this information in a database.
· VERICIS is software comprised of modules that perform under standard "offthe-shelf' personal computers and servers running the Microsoft Windows 2000/2003/XP operating systems.
• VERICIS is image data storage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) image data files from multiple modalities. It accepts text data using other standards-based formats including but not limited to HL7 and XML.
• VERICIS is an Internet/Intranet network system that is designed for small and large, multi-user environments. The VERICIS network structure (including server and workstations) provides for the system's database management, storage, printing, and all DICOM/HL-7 interface services.
X Prescription Use (Part 21 CFR 801 Subpart D)
Radiological Devic
()(k) Number
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
r →