(123 days)
The Ventana Image Analysis System (VIAS) 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 in tissue 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 paraffin embedded breast cancer tissue immunohistochemically stained for estrogen receptor (ER) or progesterone receptor (PR) proteins using Ventana's DAB copper chromogen and Ventana's ER and PR reagents and nuclear hematoxylin. It is not intended for use as an aid in the management, prognosis, or outcomes of breast cancer when used with in vitro diagnostic reagents marketed for these indications.
The Ventana Image Analysis System (VIAS) is an adjunctive computer-assisted image analysis system functionally connected to an interactive microscope.
The provided text describes the 510(k) clearance for the Ventana Image Analysis System (VIAS). While it mentions that the device is "substantially equivalent" to legally marketed predicate devices and is intended to "aid a qualified pathologist," it does not contain a detailed study proving the device meets specific acceptance criteria.
The document is a regulatory approval letter and outlines the "Indications for Use" but does not include the detailed performance data or study design that would demonstrate the device's accuracy or efficacy. Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or human reader improvement with AI assistance from this document.
To answer your specific questions, I would need a different type of document, such as a detailed clinical study report or a summary of safety and effectiveness data submitted to the FDA for the device.
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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" around the perimeter. Inside the circle is a stylized graphic of what appears to be three wavy lines, possibly representing a human form or abstract design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 6 2005
Bryan J. Tucker, Ph.D. Vice President, Clinical and Regulatory Affairs TriPath Imaging, Inc. 780 Plantation Drive Burlington, NC 27215
K050012 Re:
Trade/Device Name: Ventana Image Analysis System Regulation Number: 21 CFR 864.1860 Regulation Name: Immunohistological Reagents and Kits Regulatory Class: Class II Product Code: NQN Dated: March 22, 2005 Received: March 23, 2005
Dear Dr. Tucker:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becaren on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfod in the encreated of the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1779) in accordance with the provisions of the Federal Food, Drug, devices that have been roomed in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, mercere, mance of the Act include requirements for annual registration, listing of gencial controls provisions 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 it may be subject to sater as a same as a Regulations (CFR), Parts 800 to 895. In addition, FDA can or tound in Ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that FDA issualite or our device complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must of any I carated and the Act's requirements, including, but not limited to: registration and listing (21 comply with an the 110 to 120 pm Parts 801 and 809); and good manufacturing practice CFR Part 807), labornish in the quality systems (QS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to ogin manieting of substantial equivalence of your device to a legally premarket notification: "The PDF in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In of quotions on the promie Evaluation and Safety at (240) 276-0484. Also, please note the vitto Diagnouted "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu may ocain ours. getain of Schanional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology 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
Indications For Use:
The Ventana Image Analysis System (VIAS) is an adjanctive computer-assisted image The Ventaina finage Analysis Cysterted to an interactive microscope. It is intended for analysis system fanotionally connection, classification and counting of cells of use as an all to the pathologic in thepe 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 in this application, the virte is internatify the percentage of positively stained nuclei in and measurement of inaged to quinning immunohistochemically stained for paramir embedded broad. Sanson (ER) or progesterone receptor (PR) proteins using the presence of estrogen roospiel (1) as Ventana's DAB copper chromogen and ventana s ER and I N reagents ed for use as an aid in the management, prognosis, muclear nomatoxyin. It is nutcomes of breast cancer when used with in vitro diagnostic reagents marketed for these indications.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of SBTHA
Division Sign-Off
Office of In ***** " " " " "nostic Device valuation ساعت التحت ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
(k) K050012
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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.