CADIMAS VERSION 1.0

K052023 · Alan Penn & Associates., Inc. · LNH · Dec 8, 2005 · Radiology

Device Facts

• Record ID: K052023
• Device Name: CADIMAS VERSION 1.0
• Applicant: Alan Penn & Associates., Inc.
• Product Code: LNH · Radiology
• Decision Date: Dec 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

CADimas™ V1.0 is indicated for processing of dynamic contrast enhanced MR images. CADimas™ V1.0 provides enhanced visualization for image interpretation.

Device Story

CADimas™ V1.0 is a post-processing software package for MRI studies; processes dynamic contrast-enhanced MR data. Device segments and labels tissue types using kinetic and margin characteristics of enhancement patterns; generates parametric image maps; performs image subtractions and multiplanar reformats. Used by radiologists to assist in discriminating tissue types and evaluating lesion morphology and kinetics. Operates on DICOM-compliant MRI data. Output provides enhanced visualization for image interpretation, assisting clinical decision-making regarding lesion characterization.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and functional comparison to predicate devices.

Technological Characteristics

Post-processing software for MRI; DICOM-compliant; performs tissue segmentation and classification based on kinetic and margin characteristics; generates parametric maps; supports multiplanar reformats and image subtraction.

Indications for Use

Indicated for processing dynamic contrast-enhanced MR images to provide enhanced visualization for image interpretation.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• CADstream™ Version 4.0 (K043216)
• B-CAD™ System Version 1.0 (K050846)
• 3TP Software Option (K031350)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] 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.

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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™<br>V1.0 | Predicate<br>Device<br>CADstream™ | Predicate<br>Device<br>B-CAD™ | Predicate<br>Device<br>3TP Software<br>Option |
|----------------------------------------------------------------------------|------------------|-----------------------------------|-------------------------------|-----------------------------------------------|
| Displays<br>parametric maps | Yes | Yes | No | Yes |
| Provides viewing<br>and post-<br>acquisition image<br>analysis | Yes | Yes | Yes | Yes |
| Performs tissue<br>segmentation and<br>classification. | Yes | Yes | Yes | ? |
| Allows the user to<br>interact with the<br>images and<br>overlays | Yes | Yes | Yes | Yes |
| Allows retrieval of<br>DICOM<br>data from any<br>DICOM-compliant<br>device | Yes | Yes | Yes | ? |
| Designed to assist<br>radiologists to<br>discriminate tissue<br>types. | Yes | Yes | Yes | ? |
| Evaluates Lesion<br>Morphology | Yes | No | Yes | No |
| Evaluates Lesion<br>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.

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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).

3

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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.

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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 [phone] or [phone] 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

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# 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