(42 days)
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Not Found
No
The description uses terms like "computer-assisted image analysis" and "adjunctive computer-assisted methodology," which are common for traditional image processing but do not explicitly mention or imply the use of AI/ML techniques like deep learning or machine learning algorithms for classification or detection. The focus is on aiding the pathologist in measurement and quantification based on predefined criteria (marker intensity, size, shape), rather than learning patterns from data.
No
This device is an aid for pathologists to detect, classify, and count cells, which is a diagnostic function, not a therapeutic one.
Yes
The device aids pathologists in detecting, classifying, and counting cells of interest "based on marker intensity, size and shape," and "to quantify the percentage of positively stained nuclei in formalin-fixed, paraffin-embedded breast cancer tissue specimens." This directly relates to diagnosing conditions or diseases.
No
The device description is not provided, but the intended use explicitly states it is "functionally connected to an interactive microscope." This indicates a hardware component is involved in the system, even if the core analysis is software-based.
Based on the provided information, the Ventana Image Analysis System (KAS™) is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it is "intended for use as an aid to the pathologist in the detection, classification and counting of cells of interest..." and specifically mentions its use with "in vitro diagnostic reagents marketed for these indications." This directly aligns with the definition of an IVD, which are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Use with IVD Reagents: The system is designed to be used with "Ventana's reagents and nuclear hematoxylin" and "in vitro diagnostic reagents marketed for these indications." This further confirms its role in an in vitro diagnostic process.
- Adjunctive Aid to Pathologist: While it's an "adjunctive computer-assisted image analysis system," its purpose is to assist the pathologist in interpreting results from in vitro diagnostic tests (immunohistochemical staining).
Therefore, the Ventana Image Analysis System (KAS™) is clearly intended to be used as part of an in vitro diagnostic procedure.
N/A
Intended Use / 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.
Product codes
NQN
Device Description
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Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
pathologist
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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.
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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
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