VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS

K062428 · Tripath Imaging, Inc. · NQN · Sep 29, 2006 · Hematology

Device Facts

• Record ID: K062428
• Device Name: VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS
• Applicant: Tripath Imaging, Inc.
• Product Code: NQN · Hematology
• Decision Date: Sep 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.1860
• Device Class: Class 2

Intended Use

This antibody is intended for in vitro diagnostic (IVD) use. Ventana® Medical Systems' (Ventana) CONFIRM anti-p53 (DO-7) primary antibody is a mouse monoclonal antibody (IgG1, kappa) directed against human p53. The antibody is intended for laboratory use to qualitatively identify by light microscopy wild type and mutant p53 in sections of formalin fixed, paraffin embedded tissue on a Ventana automated slide stainer. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician

Device Story

Ventana Image Analysis System (VIAS) is an adjunctive, computer-assisted image analysis tool connected to an interactive microscope. It assists pathologists in quantifying p53 protein expression in breast cancer tissue. Input consists of microscopic images of formalin-fixed, paraffin-embedded tissue specimens stained immunohistochemically for p53 and hematoxylin. The system processes these images to detect, classify, and count cells based on marker intensity, size, and shape. Output is a quantitative measurement of the percentage of positively stained nuclei. Used in clinical laboratory settings by pathologists to improve reproducibility of p53 assessment. The pathologist remains responsible for validating results using morphological studies and controls. The system aids clinical decision-making by providing objective quantification of biomarker expression, potentially improving diagnostic consistency.

Clinical Evidence

No clinical studies performed. Analytical performance established via reproducibility studies (n=9 slides, 5 repeats, 3 systems) and a method comparison study (n=204 specimens). Method comparison evaluated concordance between three pathologists and three VIAS systems at 1%, 5%, and 10% cutoffs. Pathologist-System concordance ranged 86.0–98.0%; Pathologist-Pathologist concordance ranged 84.5–98.5%; System-System concordance ranged 96.5–100%.

Technological Characteristics

Workstation-based interactive histology imaging system. Components: microscope, motorized stage, digital color video camera, computer, monitor. Software: Windows XP, SQL Server. Analysis: 20x magnification, DAB/hematoxylin dye separation. Algorithm: threshold-based quantification with cytoplasmic noise correction. Connectivity: standalone, no LIS interface. Sterilization: N/A (reagents are separate).

Indications for Use

Indicated for use by qualified pathologists as an aid in the detection, classification, and quantification of p53 protein expression in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Used to quantify the percentage of positively stained nuclei in immunohistochemically stained slides.

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)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings.

## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## SEP 2 9 2006

TriPath Imaging, Inc. c/o Bryan J. Tucker, PhD Vice President, Clinical and Regulatory Affairs 4025 Stirrup Creek Drive Suite 400 Durham, NC 27703

Re:7k062428

Trade/Device Name: Ventana Image Analysis System (VIASTM) - p53 Regulation Number: 21 CFR 864.1860 Regulation Name: Microscope Automated Image Analyzers, Immunohistochemistry Regulatory Class: Class II Product Code: NQN Dated: August 17, 2006 Received: August 22, 2006

Dear Dr. Tucker:

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 stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior 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 (PMA), 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 agencies. You must comply with all the Act's requirements, including, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

Page 2 -

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert H. Becker

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: Ventana Image Analysis System - p53

Indications For Use:

The Ventana Image Analysis System (KAS™) 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 of interest based on marker intensity, size and shape 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 formalin-fixed, paraffin-embedded breast cancer tissue specimens immunohistochemically stained for the presence of p53 proteins using Ventana's reagents and nuclear hematoxylin. p53 over-expression is indicated for use as a marker of alterations of the p53 gene in breast tissue when used with in vitro diagnostic reagents marketed for these indications.

The VIAS is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of p53 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the Ventana p53 assay to assure the validity of the VIAS-assisted p53 assessment.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Maria Chan

Page 1 of 1

Office of In Vitro Diagnostic

510(k) Ko 62420