(135 days)
Not Found
No
The description focuses on standard image processing techniques like segmentation, labeling based on kinetic and margin characteristics, subtractions, and reformats, without mentioning AI or ML.
No
The device is described as post-processing software that provides enhanced visualization and analysis of medical images; it does not directly treat or diagnose a disease or condition.
Yes
The device is described as providing "enhanced visualization for image interpretation" and assisting in "evaluation of dynamic MRI data." While it does not explicitly state it provides a diagnosis, its function to process and analyze medical images for interpretation directly supports the diagnostic process by a radiologist, who uses these tools to make diagnostic decisions.
Yes
The device description explicitly states it is a "post-processing software package" and details its functions related to viewing and analyzing MRI studies. There is no mention of accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that CADimas™ V1.0 processes and analyzes MR images acquired from patients. It does not analyze biological samples like blood, urine, or tissue.
- The device is a post-processing software for medical images. Its function is to enhance visualization and aid in the interpretation of existing medical images, not to perform tests on biological specimens.
Therefore, based on the definition of an IVD, CADimas™ V1.0 does not fit that category. It is a medical image processing software.
N/A
Intended Use / Indications for Use
CADimas™ V1.0 is indicated for processing of dynamic contrast enhanced MR images. CADimas™ V1.0 provides enhanced visualization for image interpretation.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, LNH
Device Description
CADimas V1.0™ is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. CADimas™ supports evaluation of dynamic MRI data acquired during contrast administration. CADimas™ segments and labels tissue types based on kinetic and margin characteristics of enhancement patterns (parametric image maps), and performs other user-defined post-processing functions (image subtractions. multiplanar reformats).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
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): 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.
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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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APPENDIX 6: 510 {K} SUMMARY
DEC 8 2005
510(k) Summary As required by 807.92 For CADimas™ Prepared on September 27, 2005
Submitted by: Alan Penn & Associates, Inc. 14 Clemson Ct. Rockville, MI) 20850 Telephone: 301-279-5958 Fax: 301-858-0288 unow.alanpenn.com
Contact Person: Alan Penn, President
Device Trade Name: CADimas™
Common Name: Medical Image Processing System
Classification: Class H, Picture Archiving and Communication System Sec. 21 CFR 892.2050
Predicate Device: CADStream™ Version 4.0 (K043216) and B-CAD™ System Version 1.0 (K050846) and 3TP Software Option (K031350).
Manufactured by: Confirma. Inc. 821 Kirkland Avenue Kirkland. WA 98033 : The Medipattern Corporation 300 Sheppard Ave W Suite 204 Toronto. ON. Canada M9M: 3TP Imaging Sciences 245 Main Street. Suite 620. White Plains. New York 10601.
Description of the Device: CADimas V1.0™ is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. CADimas™ supports evaluation of dynamic MRI data acquired during contrast administration. CADimas™ segments and labels tissue types based on kinetic and margin characteristics of enhancement patterns (parametric image maps), and performs other user-defined post-processing functions (image subtractions. multiplanar reformats).
Intended Use for the Device: CADimas™ V1.0 is indicated for processing of dynamic contrast enhanced MR images. CADimas™ V1.0 provides enhanced visualization for image interpretation.
Alan Penn & Assoc.. Inc.
1
Substantial Equivalence to Predicate Devices: CADimas™ V1.0 is substantially
1.0 and Career Career TM Lismian 10 and R-C ADTN System Version 1.0 an Substantial Equivalence to Predicale DeVices. equivalent to CADstream' - Nersion 4.0 and D-CAD - Cystol.
Software Option. The following is a tabular comparison of the clinically significant
Software Option. The following features of each.
| Device Features | CADimas™
V1.0 | Predicate
Device
CADstream™ | Predicate
Device
B-CAD™ | Predicate
Device
3TP Software
Option |
|----------------------------------------------------------------------------|------------------|-----------------------------------|-------------------------------|-----------------------------------------------|
| Displays
parametric maps | Yes | Yes | No | Yes |
| Provides viewing
and post-
acquisition image
analysis | Yes | Yes | Yes | Yes |
| Performs tissue
segmentation and
classification. | Yes | Yes | Yes | ? |
| Allows the user to
interact with the
images and
overlays | Yes | Yes | Yes | Yes |
| Allows retrieval of
DICOM
data from any
DICOM-compliant
device | Yes | Yes | Yes | ? |
| Designed to assist
radiologists to
discriminate tissue
types. | Yes | Yes | Yes | ? |
| Evaluates Lesion
Morphology | Yes | No | Yes | No |
| Evaluates Lesion
Kinetics | Yes | Yes | No | Yes |
The intended use. design, and function and performance characteristics for I he intended use. designi and function and perceivate devices. It is the opinion of
C ADimas™ are substantially equivalent no the previews of safety, and C ADimas! * are substantially cqurvaient (6 the president of safety and Alan I Chi CC . sompared to the predicate devices.
2
Alan Penn & Associates., Inc. % Mr. Roger H. Schneider Consultant Medical & Radiation Technology Consulting 6319 Massachusetts Avenue BETHESDA MD 20816
Re: K052023
.
CADimas™ V1.0 Product Code: LLZ Dated: July 20, 2005 Received: July 26, 2005
Dear Mr. Schneider:
We have reviewed the above referenced premarket notification submission for CADimas™ W 1.0, which contains MR contrast agent as a drug component. This drug component is labeled . I . , whiles contains this contrast enhanced MR images of female breasts. We have discussed the use of this drug component for the indicated use with our Center for Drug Evaluation and Research (CDER) and have been advised that such use constitutes either a new or modified indicated use which has not been found to be safe and/or effective by CDER. Because of this determination, we are unable to complete our review of your section 510(k) notification.
You may resubmit your 510(k) submission after you have received clearance by CDER for the drug component(s) as indicated for use with this device (or when a NDA for the new drug crug component is expected to be approved within six months) or you may resubmit your 510(k) using (a) different drug component(s) which is (are) approved for the (these) indicated use(s) by CDER.
If the information is not received within 30 days, we will consider your premarket notification to be withdrawn and your submission will be deleted from our system. If you submit the requested information after 30 days it will be considered and processed as a new 510(k); therefore, all information previously submitted must be resubmitted so that your new 510(k) is complete.
You may not market this device until you have provided adequate information described above and required by 21 CFR 807.87, and you have received a letter from FDA allowing you to do so. If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug, and Cosmetic Act (Act).
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3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 8 2005
Alan Penn & Associates, Inc. % Mr. Roger H. Schneider Consultant Medical & Radiation Technology Consulting 6319 Massachusetts Avenue
Re: K052023
Trade/Device Name: CADimas™ V1.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Number: 21 CFR 892.2050 Regulatory Name: Picture archiving and communications system Regulatory Class: II Product Code: LNH and LLZ Dated: November 16, 2005
Received: November 16, 2005
Dear Mr. Schneider:
BETHESDA MD 20816
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levice is a creative is substantially equivalent (for the indications for use stated in above und have determinen arketed predicate devices marketed in interstate commerce prior to the cholosare) to regally mant date of the Medical Device Amendments, or to devices that have been May 20, 1770, the charantinents 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 do not require approval or a provisions of the Act. The general controls provisions of the Act de nee, subject to the general volusion, 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 n your de rooms which to such additional controls. Existing major regulations affecting your Apploral), It ifiel to subject 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 r rease of advasurement on that your device complies with other requirements of the Act or any Federal statues and regulations administered by other Federal agencies. You must comply with all the r cacrais skiller and regulating, 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.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms leter with anow you to organization of substantial equivalence of your device to a legally premarked notification: "The PDF missing proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you desire specific acree to: your in 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 Also, please note the regulation on your responsibilities under the Act from the 807.77). I ou may ooually careers, 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): KA52023
Device Name: CADimas™ V1.0
CADimas™ V1.0 is indicated for processing of dynamic contrast enhanced MR images. CADimas™ V1.0 provides enhanced visualization for image interpretation.
Prescription Use (Part 21 CFR 801 Subpart D)
D'OR Over-T
(21 CF
()ver-The-Counter Lise (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Edward G. Szymanski
(Division Sign-C Division of Reproductive, Abdomit and Radiological Devices 510(k) Number
Alan Penn & Assoc.. Inc.
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9/27/2005 Document Version 2.1