(215 days)
Not Found
Not Found
No
The description mentions "computer-assisted image analysis" and "computer-assisted methodology" for detection, classification, and counting based on intensity, size, and shape. While this involves image processing, there is no mention of AI, ML, or any learning algorithms. The system appears to use pre-defined rules or algorithms for analysis rather than learning from data.
No
The device aids in analysis and assessment for diagnosis, but it does not directly treat or provide therapy to a patient.
Yes
The device is intended to aid a pathologist in the semi-quantitative detection of c-erbB-2 (HER2) antigen in tissue specimens, which is an aid in the assessment of breast cancer patients. This function directly contributes to the diagnostic process.
No
The device description explicitly states that the Ventana Image Analysis System (VIAS™) is "functionally connected to an interactive microscope," indicating a hardware component is involved in the system's operation.
Based on the provided text, the Ventana Image Analysis System (VIAS™) is likely considered an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the VIAS is an "adjunctive computer-assisted image analysis system functionally connected to an interactive microscope." It is intended to "aid a qualified pathologist for the semi-quantitative detection of c-erbB-2 (HER2) antigen in formalin-fixed, paraffin-embedded normal and neoplastic tissue specimens immunohistochemically stained for the presence of HER2 proteins." This describes a device used to analyze biological specimens (tissue) in vitro (outside the body) to provide information for diagnostic purposes (assessing breast cancer patients for Herceptin treatment).
- Analysis of Biological Specimens: The system analyzes images from microscope slides of "formalin-fixed, paraffin-embedded normal and neoplastic tissue specimens." This is a key characteristic of IVDs.
- Diagnostic Aid: The system is intended as an "aid to the pathologist" and an "aid in the assessment of breast cancer patients." While it's an adjunctive system and the final diagnosis rests with the pathologist, it provides crucial information derived from the analysis of biological samples that contributes to the diagnostic process.
- Used with an IVD Reagent: The VIAS is specifically intended for use with Ventana's PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody, which is itself indicated as an aid in the assessment of breast cancer patients. This close association with a known IVD reagent further supports the VIAS being considered an IVD.
While the text doesn't explicitly state "This device is an IVD," the description of its function, intended use, and the type of analysis it performs strongly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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 for the semi-quantitative detection of c-erbB-2 (HER2) antigen in formalin-fixed, paraffin-embedded normal and neoplastic tissue specimens immunohistochemically stained for the presence of HER2 proteins using Ventana® Medical Systems, Inc.'s (Ventana) PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody as well as Ventana's DAB copper chromogen and nuclear hematoxylin.
Ventana's PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2 (4B5)) is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® treatment is considered.
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 HER2 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 PATHWAY HER2 (4B5) to assure the validity of the VIAS-assisted HER2.
Product codes
NQN
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Microscope Slides
Anatomical Site
Formalin-fixed, paraffin-embedded normal and neoplastic tissue specimens (breast cancer specimens specified for the VIAS-assisted HER2)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified pathologist
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three wavy lines extending from its head.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
TriPath Imaging, Inc. c/o Bryan J. Tucker, Ph.D. Vice President, Clinical and Regulatory Affairs 4025 Stirrup creek Drive, Suite 400 Durham, NC 27703
JAN 1 0 2007
Re: K061613
Trade/Device Name: Ventana Image Analysis System - PATHWAY® HER (4B5) Regulation Number: 21 CFR 864.1860 Regulation Name: Immunohistochemistry reagents and kits Regulatory Class: Class II Product Code: NQN Dated: June 8, 2006 Received: June 9, 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 (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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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 Beckerf
Robert L. Becker, Jr., M.D., Ph.D. 4 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): K061613
Device Name: Ventana Image Analysis System - PATHWAY® HER2 (4B5)
Indications For Use:
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 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 for the semi-quantitative detection of c-erbB-2 (HER2) antigen in formalin-fixed, paraffin-embedded normal and neoplastic tissue specimens immunohistochemically stained for the presence of HER2 proteins using Ventana® Medical Systems, Inc.'s (Ventana) PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody as well as Ventana's DAB copper chromogen and nuclear hematoxylin.
Ventana's PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2 (4B5)) is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® treatment is considered.
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 HER2 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 PATHWAY HER2 (4B5) to assure the validity of the VIAS-assisted HER2.
Note: All of the patients in the Herceptin® clinical trials were selected using a clinical trial assay. None of the patients in those trials were selected using PATHWAY anti-HER-2/neu (4B5). PATHWAY anti-HER-2/neu (4B5) was compared to Ventana's PATHWAY HER2 (clone CB11) Primary Antibody on an independent sample and found to provide acceptably concordant results. The actual correlation of PATHWAY anti-HER-2/neu (4B5) to clinical outcome has not been established.
| Prescription Use | X |
|---|---|
| (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, Qffice of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of 1
510(K) K06/6/3