(1056 days)
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No
The summary describes an immunohistochemical stain and an automated staining system, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is used as an aid in diagnosing anaplastic tumors, not for treating them.
Yes
The intended use explicitly states the device is "an aid in the diagnosis of anaplastic tumors," indicating its role in the diagnostic process.
No
The device description explicitly states it is a "Primary Antibody for use on the Ventana ES automated immunohistochemistry system," indicating it is a reagent (a chemical substance) and 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 Ventana Anti-Vimentin is used "as an aid in the diagnosis of anaplastic tumors." This clearly indicates that the device is intended to be used in vitro (outside the body) to examine specimens (tissue samples) to provide information for diagnostic purposes.
- Device Description: It is a "Primary Antibody for use on the Ventana ES automated immunohistochemistry system." Antibodies used in immunohistochemistry are reagents that react with specific components in tissue samples to visualize them, which is a common in vitro diagnostic technique.
- Performance Studies: The description of the performance studies involves testing the antibody on "paraffin embedded preparations from normal and pathologic samples." This confirms that the device is used to analyze biological specimens in vitro.
The definition of an IVD is a medical device that is intended for use in the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of tissues or organs, or to monitor therapeutic measures. This device fits that definition.
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Intended Use / Indications for Use
Ventana Medical Systems, Inc. developed the Ventana Anti-Vimentin Primary Antibody for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-Vimentin (clone VIM 3B4) is substantially equivalent to other marketed immunohistochemical stains used in the identification of cells of normal and abnormal lineage as an aid in the diagnosis of anaplastic tumors.
Product codes
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Device Description
Ventana Anti-Vimentin Primary Antibody for use on the Ventana ES automated immunohistochemistry system.
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
Paraffin embedded preparations from normal and pathologic samples were tested using Ventana Anti-Vimentin. Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic tissues evaluated for staining included breast carcinomas, melanomas, squamous cell carcinomas and leiomyosarcomas. Slides were processed on the Ventana ES Automated Slide Stainer and prepared for examination, then evaluated on a blind basis for specific staining intensity and background staining.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Study:
Sensitivity of the antibodies was shown by appropriate staining of cells of mesenchymal origin and agreement with reported literature (Barwick, K.W. Intermediate Filaments and Keratin in Atlas of Diagnostic Immunohistopathology. Ed. L.D. True. 1990. J.B. Lippincott Co., Philadelphia. Azumi N. and H. Battifora Am J. Clin Pathol. 1987;Vol 88, pg 286-296.). In the Ventana study, 20 of 20 melanomas and 8 of 8 sarcomas stained positively compared to 16 of 18 melanomas and 17 of 20 sarcomas reported by Azumi and Battifora. Adenocarcioma (0/9), Squarnous cell carcinoma (0/10), and Carcinoid (0/9) compared favorably to positive test results reported by Azumi and Battifora, 15/147, 1/7, and 1/10, respectively.
Inter-run reproducibility: based on samples of the same tissue on 16 different instrument runs. Staining was equivalent for all slides.
Intra-run reproducibility: based on 10 samples of the same tissue within one run. Staining was equivalent for all slides.
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
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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).
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FEB | 0 |997 24159
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-Vimentin Primary Antibody for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-Vimentin (clone VIM 3B4) is substantially equivalent to other marketed immunohistochemical stains 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 Ventana Anti-Vimentin. Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic tissues evaluated for staining included breast carcinomas, melanomas, squamous cell carcinomas and leiomyosarcomas. Slides were processed on the Ventana ES Automated Slide Stainer and prepared for examination, then evaluated on a blind basis for specific staining intensity and background staining.
Results
Sensitivity of the antibodies was shown by appropriate staining of cells of mesenchymal origin and agreement with reported literature (Barwick, K.W. Intermediate Filaments and Keratin in Atlas of Diagnostic Immunohistopathology. Ed. L.D. True. 1990. J.B. Lippincott Co., Philadelphia. Azumi N. and H. Battifora Am J. Clin Pathol. 1987;Vol 88, pg 286-296.). In the Ventana study, 20 of 20 melanomas and 8 of 8 sarcomas stained positively compared to 16 of 18 melanomas and 17 of 20 sarcomas reported by Azumi and Battifora. Adenocarcioma (0/9), Squarnous cell carcinoma (0/10), and Carcinoid (0/9) compared favorably to positive test results reported by Azumi and Battifora, 15/147, 1/7, and 1/10, respectively.
Inter-run reproducibility, based on samples of the same tissue on 16 different instrument runs. Staining was equivalent for all slides. Intra-run reproducibility, based on 10 samples of the same tissue within one run. Staining was equivalent for all slides.