(42 days)
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.
· 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.
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.
The provided text is a 510(k) premarket notification for the "VERICIS Cardiovascular Image and Information System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a detailed clinical study with acceptance criteria and performance metrics against a ground truth.
Therefore, the document does not contain the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the submission states:
"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."
This indicates that the "study" proving the device meets its "acceptance criteria" (which in this context would be the requirement of substantial equivalence) was a comparison to a predicate device (McKesson Horizon Medical Imaging, K043146) based on technological characteristics and intended use, rather than a clinical performance study with predefined metrics. The submission asserts that the VERICIS "employs the same fundamental scientific technology" and will "act and perform similar" to the predicate.
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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
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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.
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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.
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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
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×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 →
§ 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).