(1049 days)
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No
The summary describes an antibody and an automated staining system, with performance evaluated by a pathologist. There is no mention of AI, ML, or image processing that would indicate the use of such technologies.
No
The device is described as an immunohistochemical stain used as an aid in diagnosing anaplastic tumors, not for treating conditions.
Yes
The "Intended Use / Indications for Use" states that the antibody is used "as an aid in the diagnosis of anaplastic tumors," indicating its role in the diagnostic process.
No
The device is an antibody (a biological reagent) used in conjunction with an automated immunohistochemistry system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the antibody is used "as an aid in the diagnosis of anaplastic tumors." This clearly indicates a diagnostic purpose.
- Device Description: It's a primary antibody used on an automated immunohistochemistry system, which is a common method for in vitro diagnostic testing on tissue samples.
- Performance Studies: The performance studies involve testing the antibody on tissue samples and evaluating its staining characteristics to determine its specificity and sensitivity in identifying certain cell types, which is a key aspect of validating an IVD.
- Key Metrics: The key metrics reported (Sensitivity, Specificity, Reproducibility) are standard performance indicators for IVD devices.
The device is used to analyze biological samples (tissue) outside of the body to provide information that aids in a medical diagnosis. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
Ventana Anti-Desmin Primary Antibody for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-Desmin Primary Antibody (clone DE-R-11) is substantially equivalent to other marketed immunohistochemical stians used in the identification of cells of normal and abnormal lineage as an aid in the diagnosis of anaplastic tumors.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
Inter-run reproducibility was determined based on samples of the same intesting tissue block on 11 different instrument runs. Staining was equivalent between all slides. Intra-run reproducibility was based on 10 samples of the same tissue within one run. The staining was equivalent between the ten slides.
Key Metrics
Specificity of the antibody was shown by appropriate staining of cells of myocytic origin and no staining of cells of non-muscle origin. Staining occurred in the muscle cells of normal skin, small intestine, stomach, prostate, tonsil, esophagus, testes, pancreas, cardiac muscle, and kidney tissues. In addition, the specificity seen in this study agrees with the data published by Jones et al, 1990. The sensitivity of this antibody was shown by consistent staining of normal smooth and striated muscle and appropriate staining of myocytic sarcomas.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).
0
C941516
FEB 1 0 1997
510 (k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Ventana Medical Systems, Inc. developed the Ventana Anti-Desmin Primary Antibody for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-Desmin Primary Antibody (clone DE-R-11) is substantially equivalent to other marketed immunohistochemical stians used in the identification of cells of normal and abnormal lineage as an aid in the diagnosis of anaplastic tumors.
Comparative Study
Supporting data for the equivalence statement is shown by the following study. Paraffin embedded preparations from normal and pathologic samples were tested using the Ventana Anti-Desmin Primary Antibody and compared to published results (Jones et al, 1990, Journal of Pathology, 162:29-Samples were obtained from excess tissues obtained 33) . . for reasons other than the present study. Slides were processed on the Ventana ES Automated Slide Stainer, prepared for examination, and evaluated by a qualified pathologist for specific staining intensity and background staining.
Results
Specificity of the antibody was shown by appropriate staining of cells of myocytic origin and no staining of cells of non-muscle origin. Staining occurred in the muscle cells of normal skin, small intestine, stomach, prostate, tonsil, esophagus, testes, pancreas, cardiac
muscle, and kidney tissues. In addition, the specificity seen in this study agrees with the data published by Jones et al, 1990.
The sensitivity of this antibody was shown by consistent staining of normal smooth and striated muscle and appropriate staining of myocytic sarcomas. As with any immunohistochemical reagent, the sensitivity is dependent on fixation, tissue processing, and slide preparation The negative control which was run with each parameters. tissue gave negative results. When compared with literature results, Ventana Anti-Desmin Primary Antibody consistently stained the same type of line cancers.
Inter-run reproducibility was determined based on samples of the same intesting tissue block on 11 different instrument runs. Staining was equivalent between all slides. Intra-run reproducibility was based on 10 samples of the same tissue within one run. The staining was
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equivalent between the ten slides.