VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER

K140465 · Ventana Medical Systems, Inc. · NQN · Mar 20, 2014 · Hematology

Device Facts

• Record ID: K140465
• Device Name: VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
• Applicant: Ventana Medical Systems, Inc.
• Product Code: NQN · Hematology
• Decision Date: Mar 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.1860
• Device Class: Class 2

Intended Use

The Virtuoso system provides automated digital slide creation, management, and viewing. It is intended for in vitro diamostic 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 IHC ER (SPI) 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 estrogen receptor (ER) protein in formalin-fixed, paraffin-embedded neoplastic tissue. This device is an accessory to the CONFIRM anti-Estrogen Receptor (ER) (SPI) Rabbit Monoclonal Primary Antibody Assay. The CONFIRM anti-Bstrogen Receptor (ER) (SPI) Rabbit Monoclonal Primary Antibody is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC BR (SP1) 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 ER protein. The pathologist should verify agreement with the Image Analysis sollware application score. The test results depends on the quality of the immunchistochemical 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- Estrogen Receptor (BR) (SP1) Rabbit Monoclonal Primary Antibody assay used to assure the validity of the Virtuoso System for IHC ER Digital Read and Image Analysis scores. The actual correlation of CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Antibody to clinical outcome has not been established. This device is intended for IHC slides stained on the BenchMark XT and BenchMark ULTRA stainers.

Device Story

Virtuoso System is an instrument-plus-software digital pathology solution for pathology labs. Input: digital images of IHC-stained histologic sections (formalin-fixed, paraffin-embedded) captured by iScan slide scanner. Operation: pathologist views digital images on monitor; selects fields of view (FOVs) for analysis; software provides quantitative data on ER protein expression. Output: quantitative scores for FOVs and aggregate slide scores. Pathologist reviews output, verifies agreement with image analysis, and may override scores. System requires human intervention for all analysis steps. Benefits: assists pathologist in consistent assessment of protein expression; provides adjunctive computer-assisted measurement to support clinical decision-making regarding endocrine treatment for breast cancer patients.

Clinical Evidence

Clinical concordance study evaluated 111 cases of formalin-fixed, paraffin-embedded neoplastic tissue. Comparison of Virtuoso digital read and image analysis against manual microscopic read (reference). Digital read OPA: 98.2% (95% CI: 93.7-99.5%), PPA: 98.6%, NPA: 97.6%. Image analysis OPA: 91.0% (95% CI: 84.2-95.0%), PPA: 91.4%, NPA: 90.2%. Acceptance criterion of 75% minimum total agreement met for both applications.

Technological Characteristics

System includes iScan slide scanner, computer, monitor, keyboard, mouse, and web-based software. Uses Ventana CONFIRM anti-ER (SP1) antibody and DAB chromogen. Staining performed on BenchMark ULTRA or XT stainers. Software performs image quality assessment and quantitative analysis of nuclear IHC staining. Connectivity: web-based interface. Operates on Windows platform.

Indications for Use

Indicated for use as an aid to pathologists in the detection and semi-quantitative measurement of estrogen receptor (ER) protein in formalin-fixed, paraffin-embedded neoplastic breast cancer tissue to assist in assessing patients for endocrine 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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: K140465

This 510(k) was reviewed under OIR’s Triage-Quick Review 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.