VENTANA IMAGE ANALYSIS SYSTEM

K050012 · Tripath Imaging, Inc. · NQN · May 6, 2005 · Hematology

Device Facts

• Record ID: K050012
• Device Name: VENTANA IMAGE ANALYSIS SYSTEM
• Applicant: Tripath Imaging, Inc.
• Product Code: NQN · Hematology
• Decision Date: May 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.1860
• Device Class: Class 2

Intended Use

The Ventana Image Analysis System (VIAS) is an adjunctive computer-assisted image analysis system functionally connected to an interactive microscope. It is intended for use as an aid to the pathologist in the detection, classification and counting of cells using appropriate controls to assure the validity of the VIAS scores. In this application, the VIAS is intended to aid a qualified pathologist in the acquisition and measurement of images to quantify the percentage of positively stained nuclei in immunohistochemically stained formalin-fixed paraffin embedded breast cancer tissue sections for the presence of estrogen receptor (ER) or progesterone receptor (PR) proteins using Ventana's DAB copper chromogen and Ventana's ER and PR reagents and nuclear hematoxylin. It is intended for use as an aid in the management, prognosis, and treatment outcomes of breast cancer when used with in vitro diagnostic reagents marketed for these indications.

Device Story

VIAS is an interactive, computer-supported bright-field microscopy system assisting pathologists in quantitative assessment of immunohistochemically stained histological sections. Input: color images of tumor areas acquired via digital camera mounted on a Zeiss Axioskop 2 Mot plus microscope. Operation: pathologist manually screens slide, selects tumor fields, and may refine regions of interest using interactive drawing tools. System software performs color deconvolution to separate DAB (brown) and hematoxylin (blue) components; detects nuclei; calculates percent positive nuclei using a formula that corrects for cytoplasmic foreground staining noise. Output: quantitative percent positive score displayed to the pathologist. Used in clinical laboratory settings by pathologists to complement routine screening workflows. Benefits: provides quantitative data to assist in reproducibility of slide interpretation for ER/PR status in breast cancer.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on the intended use and technological characteristics of the system as an adjunctive tool for pathologists.

Technological Characteristics

System includes PC, flat panel LCD, keyboard, mouse, barcode reader, printer, Zeiss Axioskop 2 Mot plus microscope (20X magnification), 3CCD color camera, and motorized stage. Operates via bright-field microscopy. Software performs color deconvolution (DAB/hematoxylin) and automated nuclear counting. Standalone system; no LIS connectivity. Moderate hazard level software.

Indications for Use

Indicated for use as an aid to qualified pathologists in the quantification of ER and PR protein expression in immunohistochemically stained formalin-fixed paraffin-embedded breast cancer tissue sections. Used for management, prognosis, and treatment outcomes of breast cancer patients.

Regulatory Classification

Identification

Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.

Special Controls

(2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA,” Center for Devices and Radiologic Health, 1998). These IHC's are intended for the detection and/or measurement of certain target analytes in order to provide prognostic or predictive data that are not directly confirmed by routine histopathologic internal and external control specimens. These IHC's provide the pathologist with information that is ordinarily reported as independent diagnostic information to the ordering clinician, and the claims associated with these data are widely accepted and supported by valid scientific evidence. Examples of class II IHC's are those intended for semiquantitative measurement of an analyte, such as hormone receptors in breast cancer.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of what appears to be three wavy lines, possibly representing a human form or abstract design.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY - 6 2005

Bryan J. Tucker, Ph.D. Vice President, Clinical and Regulatory Affairs TriPath Imaging, Inc. 780 Plantation Drive Burlington, NC 27215

k050012 Re:

Trade/Device Name: Ventana Image Analysis System Regulation Number: 21 CFR 864.1860 Regulation Name: Immunohistological Reagents and Kits Regulatory Class: Class II Product Code: NQN Dated: March 22, 2005 Received: March 23, 2005

Dear Dr. Tucker:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becaren on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfod in the encreated of the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1779) in accordance with the provisions of the Federal Food, Drug, devices that have been roomed in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, mercere, mance of the Act include requirements for annual registration, listing of gencial controls provisions practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device it may be subject to sater as a same as a Regulations (CFR), Parts 800 to 895. In addition, FDA can or tound in Ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that FDA issualite or our device complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must of any I carated and the Act's requirements, including, but not limited to: registration and listing (21 comply with an the 110 to 120 pm Parts 801 and 809); and good manufacturing practice CFR Part 807), labornish in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to ogin manieting of substantial equivalence of your device to a legally premarket notification: "The PDF in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In of quotions on the promie Evaluation and Safety at [phone]. Also, please note the vitto Diagnouted "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu may ocain ours. getain of Schanional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Robert Beckerh

Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __ Ventana Image Analysis System

Indications For Use:

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× 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)

Concurrence of SBTHA

Division Sign-Off

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