(24 days)
Virtuoso™ IHC ER (SP1) [Benchmark XT Stainer] K130515
Not Found
No
The document describes "image analysis algorithms" but explicitly states the software "makes no independent interpretations of the data and requires competent human intervention for all steps in the analysis process." There is no mention of AI, ML, or deep learning.
No.
The device is intended for in vitro diagnostic use, assisting pathologists in the analysis and classification of tissues and cells; it does not directly treat or prevent diseases. The information explicitly states it is "an aid to the pathologist" and "not the sole basis for treatment."
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "It is intended for in vitro diagnostic use as an aid to the pathologist..." and later, "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." These statements clearly indicate its role in diagnosis.
No
The device description explicitly states it is an "instrument-plus-software system" and lists hardware components including a slide scanner (iScan), computer, monitor, keyboard, and mouse.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is intended for in vitro diagnostic use as an aid to the pathologist..."
- Purpose: The device is designed to analyze biological specimens (formalin-fixed, paraffin-embedded tissue) outside of the body (in vitro) to provide information for the diagnosis and assessment of a disease (breast cancer).
- Clinical Context: It is used as an aid to the pathologist in the detection and measurement of a specific protein (ER) in tissue, which is a key factor in determining treatment for breast cancer patients.
- Accessory to an IVD: It is described as an accessory to the CONFIRM™ anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody assay, which is itself an IVD.
The description clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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 Ventana Medical Systems, Inc. CONFIRM™ anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody assay 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). For prescription use only.
Note: The IHC ER (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 software application score. The accuracy of the test results depends on the quality of the immunohistochemical staining. If 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 (ER) (SP1) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC ER Digital Read and Image Analysis scores.
Product codes
NOT, NQN, OEO, 21 CFR § 864.1860
Device Description
The Virtuoso™ System is an instrument-plus-software system designed to assist the qualified pathologist in the consistent assessment of protein expression in immunohistochemically stained histologic sections from formalin-fixed, paraffin-embedded normal and neoplastic tissues. The system consists of a slide scanner (iScan), computer, monitor, keyboard, mouse, image analysis algorithms for specific immunohistochemical markers, and software with a Windows web browser-based user interface. Virtuoso is a web-based, end-to-end, digital pathology software solution that allows pathology laboratories to acquire, manage, view, analyze, share, and report digital images of pathology specimens. Using the Virtuoso software, the pathologist can view digital images, add annotations, make measurements, perform image analysis, and generate reports.
The iScan slide scanning device captures digital images of formalin-fixed, Hardware: paraffin-embedded tissues that are suitable for storage and viewing. The device includes a digital slide scanner, racks for loading glass slides, computer, scanner software, keyboard, mouse and monitor.
The Virtuoso software is designed to complement the routine workflow of a Software: qualified pathologist in the review of immunohistochemically stained histologic slides. It allows the user to select fields of view (FOVs) in the digital image for analysis and provides quantitative data on these FOVs to assist with interpretation. The software makes no independent interpretations of the data and requires competent human intervention for all steps in the analysis process.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Histologic sections from formalin-fixed, paraffin-embedded tissues, immunohistochemically stained
Anatomical Site
Breast cancer specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified pathologist, pathology laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The objective of the clinical study was to establish agreement (concordance) of the Virtuoso System Digital Read and Image Analysis applications relative to the reference method of manual microscopy in the detection and semi-quantitative measurement of ER protein in formalin-fixed, paraffin-embedded neoplastic tissue using ER (SP1) reagents and immunohistochemically stained on the BenchMark ULTRA automated slide staining device and scanned on iScan Coreo.
125 cases were available from the original study and were evaluated per inclusion/exclusion criteria. 14 cases were ineligible for the study due to the following reasons: Run control slides and original tissue blocks unavailable (9 cases), Original cases stained on the BenchMark XT platform instead of BenchMark ULTRA platform (6 cases) and Broken or cracked slide (2 cases).
For the 111 evaluable cases, the overall percent agreement rate, defining negative and positive at the 1% positive staining cutoff, was 98.2%. The PPA and NPA rates were 98.6% and 97.6%, respectively.
For the 111 evaluable cases, the overall percent agreement rate, as defined above, was 91.0%. The PPA and NPA rates were 91.4% and 90.2%, respectively.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Concordance study; 111 evaluable cases.
The overall percent agreement rate between digital read and manual read was 98.2%. The Positive Percent Agreement (PPA) was 98.6% (69/70) and Negative Percent Agreement (NPA) was 97.6% (40/41).
The overall percent agreement rate between image analysis read and manual read was 91.0%. The Positive Percent Agreement (PPA) was 91.4% (64/70) and Negative Percent Agreement (NPA) was 90.2% (37/41).
The acceptance criterion of 75% minimum total agreement between the digital read and manual read was met.
The acceptance criterion of 75% minimum total agreement between the image analysis read and manual read was met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), Overall Percent Agreement (OPA).
Digital Read vs. Manual Read: PPA = 98.6%, NPA = 97.6%, OPA = 98.2%.
Image Analysis Read vs. Manual Read: PPA = 91.4%, NPA = 90.2%, OPA = 91.0%.
Predicate Device(s)
Virtuoso™ IHC ER (SP1) [Benchmark XT Stainer] K130515
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.1860 Immunohistochemistry reagents and kits.
(a)
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.(b)
Classification of immunohistochemistry devices. (1) Class I (general controls). Except as described in paragraphs (b)(2) and (b)(3) of this section, these devices are exempt from the premarket notification requirements in part 807, subpart E of this chapter. This exemption applies to IHC's that provide the pathologist with adjunctive diagnostic information that may be incorporated into the pathologist's report, but that is not ordinarily reported to the clinician as an independent finding. These IHC's are used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin. Examples of class I IHC's are differentiation markers that are used as adjunctive tests to subclassify tumors, such as keratin.(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.
(3) Class III (premarket approval). IHC's intended for any use not described in paragraphs (b)(1) or (b)(2) of this section.
(c)
Date of PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the Federal Food, Drug, and Cosmetic Act is required for any device described in paragraph (b)(3) of this section before this device may be commercially distributed. See § 864.3.
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Image /page/0/Picture/2 description: The image shows the word "VENTANA" in a sans-serif font. To the left of the word is a symbol that looks like a star made of arrows. To the right of the word is a symbol that looks like an A with a circle around it.
A Member of the Roche Group
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Name | Ventana Medical Systems, Inc. Digital Pathology | |
|---|---|---|
| Address | 203 Ravendale Drive | |
| Mountain View, CA 94043 | ||
| Contact | Mr. Mort Minaee | |
| Phone: (408) 207-4201 | ||
| FAX: (408) 207-4299 | ||
| Email: mort.minaee@ventana.roche.com | ||
| Date Prepared | February 21, 2014 | |
| Proprietary Name | Virtuoso™ System for IHC ER (SP1) | |
| Common Name | Digital pathology and image analysis system for immunochemistry-stained slides | |
| Classification Name | Immunohistochemistry reagents and kits | |
| Product Codes | NOT, NQN, OEO, 21 CFR § 864.1860 | |
| Predicate Devices | Virtuoso™ IHC ER (SP1) [Benchmark XT Stainer] K130515 | |
| Establishment Registration | Ventana Medical Systems Inc., Mountain View, California, #3007207919. |
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DEVICE DESCRIPTION 1.
General Description
The Virtuoso™ System is an instrument-plus-software system designed to assist the qualified pathologist in the consistent assessment of protein expression in immunohistochemically stained histologic sections from formalin-fixed, paraffin-embedded normal and neoplastic tissues. The system consists of a slide scanner (iScan), computer, monitor, keyboard, mouse, image analysis algorithms for specific immunohistochemical markers, and software with a Windows web browser-based user interface. Virtuoso is a web-based, end-to-end, digital pathology software solution that allows pathology laboratories to acquire, manage, view, analyze, share, and report digital images of pathology specimens. Using the Virtuoso software, the pathologist can view digital images, add annotations, make measurements, perform image analysis, and generate reports.
The iScan slide scanning device captures digital images of formalin-fixed, Hardware: paraffin-embedded tissues that are suitable for storage and viewing. The device includes a digital slide scanner, racks for loading glass slides, computer, scanner software, keyboard, mouse and monitor.
The Virtuoso software is designed to complement the routine workflow of a Software: qualified pathologist in the review of immunohistochemically stained histologic slides. It allows the user to select fields of view (FOVs) in the digital image for analysis and provides quantitative data on these FOVs to assist with interpretation. The software makes no independent interpretations of the data and requires competent human intervention for all steps in the analysis process.
Additional Materials Required:
- Ventana CONFIRM™ anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary . Antibody
- Ventana Benchmark ULTRA stainer .
- . Reagents for visualization, such as DAB chromogen
- Associated materials for completing immunohistochemical staining according to the . appropriate package insert
- . Color printer if user wishes to print color copies
Device Quality Control
The quality of results depends on the laboratory following the quality control instructions recommended in the labeling of the immunohistochemistry (IHC) reagents. The software also performs a quality check on the digital images to determine if they are suitable for further analysis using "Image Quality Assessment" algorithms.
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Modes of Operation
- Manual scoring of IHC ER stained slide images on a computer monitor (digital read). .
- Computer scoring of IHC ER stained slide images performed by ER Image Analysis . Application with manual verification by the pathologist.
Summary of Procedure
Samples are obtained as formalin-fixed, paraffin-embedded tissue blocks. Histologic sections are prepared and mounted onto glass slides. Slides are reacted with the ER (SP1) primary antibody, and are then visualized using DAB on the Benchmark ULTRA stainer. Prepared slides are loaded into the Virtuoso system scanner and scanned. Control slides should also be scanned and reviewed before scoring the slides. The resulting digital images are reviewed by the pathologist on a computer monitor, and appropriate fields of view (FOVs) are then selected for analysis by the Virtuoso software. The Virtuoso software produces a quantitative score for the FOV and an aggregate score over all the FOVs for the whole slide. The pathologist has the choice of accepting the result or overriding with his/her own score for some or all FOVs.
INDICATIONS FOR USE 2.
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 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, paraffinembedded neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody assay 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). For prescription use only.
Note: The IHC ER (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 software application score. The accuracy of the test results depends on the quality of the immunohistochemical staining. If 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 (ER) (SP1) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC ER Digital Read and Image Analysis scores.
Ventana Digital Pathology | 203 Ravendale Drive, Mountain View, CA 94043 |T: 408 207 4299 www.ventanadiqitalpathology.com
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3. TECHNOLOGICAL CHARACTERISTICS
The following chart describes similarities and differences between the two test systems.
| Characteristic | Virtuoso™ IHC ER (SP1)
[Benchmark ULTRA Stainer] | Virtuoso™ IHC ER (SP1)
[Benchmark XT Stainer] K130515 |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Intended
Use/Indications
for Use | This device is intended for in vitro diagnostic (IVD) use. | SAME |
| | The Virtuoso™ System provides automated digital slide
creation, management, analysis, and viewing. It is
intended for IVD 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, size, intensity, pattern and shape. | SAME |
| | The Virtuoso™ System for IHC ER (SP1) 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 Ventana Medical
Systems, Inc. CONFIRM™ anti-Estrogen Receptor
(ER) (SP1) Rabbit Monoclonal Primary Antibody assay.
The CONFIRM™ anti-Estrogen Receptor (ER) (SP1)
Rabbit Monoclonal Primary Antibody assay 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).
For Prescription Use Only. | SAME |
| Specimen Type | Formalin-fixed, paraffin-embedded tissue stained by
immunohistochemical technique | Same |
| System Operation
(Digital Read and
Image Analysis) | Histologic observation by a pathologist through the
viewer and image analysis systems | Same |
| Hardware and Software | Ventana iScan slide scanner, computer, color monitor,
proprietary software for ER (SP1) | Same |
| Platform Components | mouse, keyboard, windows web browser. | Same |
| Primary Antibody
(Assay) Reagent | Ventana CONFIRM™ anti-Estrogen Receptor (ER)
(SP1) Rabbit Monoclonal Primary Antibody | Same |
| Ancillary
Reagents/Stainers | DAB universal chromogen kits,
Slides stained with Benchmark ULTRA stainer | DAB universal chromogen kits,
Slides stained with Benchmark XT
stainer |
| Localization of
IHC positive stain | Nucleus | Same |
| Interpretation | Interpretation is performed by the pathologist. | Same |
Ventana Digital Pathology | 203 Ravendale Drive, Mountain View, CA 94043 |T: 408 207 4200|F: 408 207 4299 www.ventanadigitalpathology.com
:
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NON-CLINICAL PERFORMANCE EVALUATION 4.
See K130515
CLINICAL PERFORMANCE EVALUATION 5.
The objective of the clinical study was to establish agreement (concordance) of the Virtuoso System Digital Read and Image Analysis applications relative to the reference method of manual microscopy in the detection and semi-quantitative measurement of ER protein in formalin-fixed, paraffin-embedded neoplastic tissue using ER (SP1) reagents and immunohistochemically stained on the BenchMark ULTRA automated slide staining device and scanned on iScan Coreo.
125 cases were available from the original study and were evaluated per inclusion/exclusion criteria. 14 cases were ineligible for the study due to the following reasons: Run control slides and original tissue blocks unavailable (9 cases), Original cases stained on the BenchMark XT platform instead of BenchMark ULTRA platform (6 cases) and Broken or cracked slide (2 cases).
The Virtuoso System for IHC ER (SP1) with the Benchmark ULTRA stainer was clinically validated via a concordance study where 111 cases were evaluated three ways by one pathologist at one site in a blinded fashion. Each case was scored (1) manually with a routine microscope, (2) as a digital image, and (3) by way of the image analysis application using a different order of slide presentation for each round. The manual score (reference result) was compared to both the digital read result and the image analysis result.
For the 111 evaluable cases, the overall percent agreement rate, defining negative and positive at the 1% positive staining cutoff, was 98.2% The PPA and NPA rates were 98.6% and 97.6%, respectively. Table 1 below provides a summary of the results. This study objective was met, as the acceptance criterion of 75% minimum total agreement between the digital read and manual read was met.
| Manual Microscopic Read | ||||
|---|---|---|---|---|
| Digital Read | Positive | Negative | Total | |
| Positive | 69 | 1 | 70 | |
| Negative | 1 | 40 | 41 | |
| Total | 70 | 41 | 111 | |
| Positive Percent Agreement (PPA) n/N (%) (95% CI) | 69/70 (98.6) (92.3-99.7) | |||
| Negative Percent Agreement (NPA) n/N (%) (95% CI) | 40/41 (97.6) (87.4-99.6) | |||
| Overall Percent Agreement (OPA) n/N (%) (95% CI) | 109/111 (98.2) (93.7-99.5) |
| Table 1: 2X2 Agreement Table, ER Clinical Assessment Digital Read vs. Manual Read | |||
|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Positive=a clinical score of ≥1%; Negative= a clinical score of 0-0.99%.
All confidence intervals are 2-sided 95% confidence intervals calculated using the score method.
Ventana Digital Pathology | 203 Ravendale Drive, Mountain View, CA 94043 |T: 408 207 4299 www.ventanadigitalpathology.com
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For the 111 evaluable cases, the overall percent agreement rate, as defined above, was 91.0%. The PPA and NPA rates were 91.4% and 90.2%, respectively. Table 2 below provides a summary of the results. This study objective was also met as the acceptance criterion of 75% minimum total agreement between the image analysis read and manual read was met.
| Manual Microscopic Read | ||||
|---|---|---|---|---|
| Image Analysis Read | Positive | Negative | Total | |
| Positive | 64 | 4 | 68 | |
| Negative | 6 | 37 | 43 | |
| Total | 70 | 41 | 111 | |
| Positive Percent Agreement (PPA) n/N (%) (95% CI) | 64/70 (91.4) (82.5-96.0) | |||
| Negative Percent Agreement (NPA) n/N (%) (95% CI) | 37/41 (90.2) (77.5-96.1) | |||
| Overall Percent Agreement (OPA) n/N (%) (95% CI) | 101/111 (91.0) (84.2-95.0) |
| Table 2: 2X2 Agreement Table, ER Clinical Assessment Image Analysis vs. Manual Read
| A A A A A |
|---|
| ------------------------------------------------------------------------------------------------------ |
CONCLUSIONS 6.
Concordance studies were performed for the Virtuoso System for IHC ER (SP1) with the Benchmark ULTRA stainer. The overall concordance between the Virtuoso digital read and the manual method was 98.2%. Overall concordance between the Virtuosos image analysis and the manual method was 91.0%. The test system was shown to be safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66. G6(), Silver Spring, MD 20993-0002
March 20, 2014
VENTANA MEDICAL SYSTEMS, INC. MORTEZZA MINAEE SENIOR DIRECTOR, REGULATORY AFFAIRS 203 RAVENDALE DRIVE MOUNTAIN VIEW CA 94043
Re: K140465
Trade/Device Name: Virtuoso™ System for IHC (SP1) with Benchmark ULTRA stainer Regulation Number: 21 CFR 864.1860 Regulation Name: Immunohistochemistry reagents and kits Regulatory Class: II Product Code: NQN, OEO, NOT Dated: February 21, 2014 Received: February 24, 2014
Dear Mr. Minaee:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Mr. Minaee
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Reena-Philip-S
for
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Virtuoso System for IHC ER (SP1)
Indications for Use (Describe)
Intended Use and Indications for 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY Concurrence of Center for Devices and Radiclogical Health (CDRH) (Signalure)
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