(42 days)
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.
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The Ventura Image Analysis System (VIAS™) - p53 is intended to aid pathologists in detecting, classifying, and counting breast cancer cells based on marker intensity, size, and shape, specifically quantifying the percentage of positively stained nuclei for p53 proteins in formalin-fixed, paraffin-embedded breast cancer tissue specimens.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Description (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Reproducibility of p53 Analysis | The VIAS system demonstrates a high level of reproducibility for p53 assessments. |
Note: The document only explicitly mentions reproducibility as an outcome, not a specific quantitative acceptance criterion (e.g., minimum concordance, specific percentage agreement). The device's performance is stated as being an aid in "reproducibility."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or its data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of experts used or their qualifications to establish ground truth for the test set. It mentions the "responsibility of a qualified pathologist" but not in the context of ground truth establishment for a study.
4. Adjudication Method
The document does not describe any specific adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers' improvement with AI assistance. The system is described as an "adjunctive computer-assisted methodology" intended to "assist the reproducibility of a qualified pathologist," implying human-in-the-loop use, but a comparative study is not detailed.
6. Standalone (Algorithm Only) Performance Study
The document does not provide information about a standalone study of the algorithm's performance without human-in-the-loop. The system is consistently described as "adjunctive" and "computer-assisted" to aid pathologists.
7. Type of Ground Truth Used
The document implies that the ground truth for p53 assessment is established by a "qualified pathologist" who employs "appropriate morphological studies and controls as specified in the instructions for the Ventana p53 assay." It does not explicitly mention pathology reports or outcome data as the direct ground truth for the study.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set.
9. How Ground Truth for the Training Set Was Established
The document does not provide details on how the ground truth for the training set was established.
Summary of Study Information Provided:
The provided 510(k) clearance document focuses on the regulatory approval and indications for use of the Ventana Image Analysis System (VIAS) - p53. While it highlights the device's purpose as an aid to pathologists for reproducibility in p53 assessment, it lacks detailed information regarding specific acceptance criteria, study design parameters (like sample sizes for test or training sets, data provenance), ground truth establishment methodologies, expert qualifications, or specific performance metrics (beyond general reproducibility claims) that would typically be found in a comprehensive clinical study report. The document functions more as a regulatory notice than a scientific publication detailing a study's methodology and results.
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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.
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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 (240) 276-0484. 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 (800) 638-2041 or (240) 276-3150 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
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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
§ 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.