(91 days)
Not Found
Not Found
No
The summary describes a "computer-assisted image analysis system" that aids in detection and counting based on predefined criteria (intensity, size, shape). It does not mention AI, ML, training sets, or performance metrics typically associated with AI/ML models.
No.
The device is an image analysis system intended to aid pathologists in diagnosis, not to directly treat patients.
Yes
The device aids pathologists in the detection and counting of cells of interest and in the semi-quantitative detection of c-erbB-2 (HER-2/neu) in tissue specimens, which are functions related to making a diagnosis or assessing a patient's condition.
No
The device description explicitly states that the system is "functionally connected to an interactive microscope," indicating a hardware component beyond just software.
Based on the provided text, the Ventana Image Analysis System (VIAS) is likely an IVD (In Vitro Diagnostic). Here's why:
- Intended Use: The intended use clearly states that the VIAS is used as an aid to the pathologist in the detection and counting of cells of interest in tissue specimens. It specifically mentions its use with immunohistochemically stained specimens for the presence of HER-2/neu proteins, which are biomarkers. This aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Accessory to an IVD: The text states that this particular application is an accessory to the Ventana PATHWAY™ Her2, which is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® treatment is considered. This further supports the IVD nature of the system, as it is used in conjunction with another IVD for a diagnostic purpose.
- Analysis of Biological Specimens: The system analyzes images from microscope slides of formalin-fixed, paraffin embedded normal and neoplastic tissue specimens, which are biological specimens from the human body.
- Provides Information for Clinical Decisions: The information provided by the VIAS (semi-quantitative detection of HER-2/neu) is intended to aid a qualified pathologist in making assessments that can influence treatment decisions (Herceptin® treatment).
While the text doesn't explicitly state "In Vitro Diagnostic," the intended use, the type of specimens analyzed, and its role in providing information for clinical assessment strongly indicate that the Ventana Image Analysis System falls under the category of an IVD.
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 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 (HER-2/neu) in formalin-fixed, paraffin embedded normal and neoplastic tissue specimens immunohistochemically stained for the presence of HER-2/neu proteins using Ventana's HER-2/neu reagents as well as Ventana's DAB copper chromogen and nuclear hematoxylin.
This particular application is an accessory to the Ventana PATHWAY™ Her2 (clone CB11) (Ventana Medical Systems, Inc., Tucson, Arizona) and the Ventana PATHWAY™ Her2 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 to assure the validity of the VIAS-assisted HER2 score.
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™ Her2. The PATHWAY™ Her2 was compared to the DAKO HercepTest™ on an independent sample and found to provide acceptably concordant results. The actual correlation of PATHWAY™ Her2 to clinical outcome has not been established.
Product codes
NOT
Device Description
The Ventana Image Analysis System (VIAS) is an adjunctive computer-assisted image analysis system functionally connected to an interactive microscope.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
microscope slides
Anatomical Site
breast cancer specimens
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)
The PATHWAY™ Her2 was compared to the DAKO HercepTest™ on an independent sample and found to provide acceptably concordant results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
TriPath Imaging, Inc. c/o Mr. Bryan J. Tucker Vice President, Clinical and Regulatory Affairs 4025 Stirrup Creek Drive Ste. 400 Durham, NC 27703
AUG 1 6 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K051282
Trade/Device Name: Ventana Image Analysis System – Her2/neu Regulation Number: 21 CFR 864.1860 Regulation Name: Immunohistochemistry reagents and kits Regulatory Class: Class II Product Code: NOT Dated: May 16, 2005 Received: May 17, 2005
Dear Mr. 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.
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 legally marketed predicate device results 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 Vitro Diagnostic Device Evaluation and Safety 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 (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, Ph Director Division of Immunology and Hematology 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): K051282
Device Name: Ventana Image Analysis System - Her2/neu
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 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 (HER-2/neu) in formalin-fixed, paraffin embedded normal and neoplastic tissue specimens immunohistochemically stained for the presence of HER-2/neu proteins using Ventana's HER-2/neu reagents as well as Ventana's DAB copper chromogen and nuclear hematoxylin.
This particular application is an accessory to the Ventana PATHWAY™ Her2 (clone CB11) (Ventana Medical Systems, Inc., Tucson, Arizona) and the Ventana PATHWAY™ Her2 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 to assure the validity of the VIAS-assisted HER2 score.
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™ Her2. The PATHWAY™ Her2 was compared to the DAKO HercepTest™ on an independent sample and found to provide acceptably concordant results. The actual correlation of PATHWAY™ Her2 to clinical outcome has not been established.
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)
Marie Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051282
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