VIRTUSO SYSTEM FOR IHC (DO-7)

K121350 · Ventana Medical Systems, Inc. · NOT · Jun 1, 2012 · Hematology

Device Facts

• Record ID: K121350
• Device Name: VIRTUSO SYSTEM FOR IHC (DO-7)
• Applicant: Ventana Medical Systems, Inc.
• Product Code: NOT · Hematology
• Decision Date: Jun 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.1860
• Device Class: Class 2

Indications for Use

The Virtuoso system provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape. The Virtuoso™ System for p53 (DO-7) is for digital read and image analysis applications. This particular Virtuoso system is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of p53 (DO-7) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to the Ventana Medical Systems, Inc. CONFIRM™ anti-p53 (DO-7) Mouse Monoclonal Primary Antibody assay. The Ventana Medical Systems, Inc. CONFIRM™ anti-p53 assay is indicated for the assessment of p53 protein where mutations have been linked to tumor proliferation. When used with this assay, the Virtuoso™ System for p53 (DO-7) is indicated for use as an aid in the assessment of p53 status in breast cancer patients (but is not the sole basis for treatment). Note: The IHC p53 (DO-7) Digital Read and Image Analysis applications are adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and measurement of images from microscope glass slides of breast cancer specimens stained for the presence of p53 protein. The pathologist should verify agreement with the Image Analysis software application score. The accuracy of the test results depends on 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 CONFIRM™ anti-p53 (DO-7) Mouse Monoclonal Primary Antibody assay used to assure the validity of the Virtuoso System for IHC p53 Digital Read and Image Analysis scores. The actual correlation of CONFIRM™ anti-p53 (DO-7) Mouse Monoclonal Primary Antibody to clinical outcome has not been established.

Device Story

Virtuoso System is an instrument-plus-software digital pathology solution for pathology laboratories. It captures digital images of IHC-stained formalin-fixed, paraffin-embedded tissue slides using the iScan slide scanner. The system includes a computer, monitor, and web-based software. Pathologists use the software to view, annotate, measure, and analyze digital images. The system provides image analysis algorithms to assist in the semi-quantitative measurement of p53 protein expression. The pathologist selects fields of view (FOVs) for analysis; the software calculates quantitative scores for FOVs and an aggregate slide score. The pathologist reviews these outputs and may accept or override them. The system is an accessory to the Ventana CONFIRM p53 (DO-7) assay. It assists in clinical decision-making by providing quantitative data to support the pathologist's assessment of p53 status in breast cancer specimens.

Clinical Evidence

Clinical validation included concordance and reproducibility studies. Concordance studies compared digital read (DR) and image analysis (IA) results against manual microscopic reads across multiple sites. For the Benchmark XT stainer, overall agreement ranged from 82-95% (DR) and 90-97% (IA). Reproducibility studies (intra-pathologist and inter-pathologist) showed high agreement (90-99%). A separate concordance study for the Benchmark ULTRA stainer (n=120) showed 88.3% overall agreement for DR and 95.0% for IA compared to manual reads.

Technological Characteristics

System includes iScan slide scanner, computer, monitor, and web-based software. Uses immunohistochemistry (IHC) reagents (Ventana CONFIRM p53 DO-7) and DAB chromogen. Operates on formalin-fixed, paraffin-embedded tissue slides. Software provides image quality assessment and quantitative analysis of FOVs. Connectivity via Windows web browser-based interface.

Indications for Use

Indicated for use as an aid to pathologists in the detection and semi-quantitative measurement of p53 (DO-7) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue, specifically for assessing p53 status in breast cancer patients. Not for use as the sole basis for treatment.

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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# Decision Summary

Statement for the Record, k121350

This 510(k) was reviewed under OIVD’s Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.

OIVD, 4/2/12, v1.1