(1123 days)
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No
The summary describes an immunohistochemistry stain and an automated staining system, with no mention of AI or ML for image analysis or interpretation.
No
The device is an antibody used for immunohistochemistry to aid in the diagnosis of tumors, not to treat them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "used in the identification of cells of normal and abnormal lineage as an aid in diagnosis of anaplastic tumors." The phrase "aid in diagnosis" directly indicates a diagnostic purpose.
No
The device is an antibody used in immunohistochemistry, which is a biological reagent and not a software-only medical device. It is used on an automated system, but the device itself is the antibody.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Ventana Anti-S100 antibody is used "as an aid in diagnosis of anaplastic tumors." This clearly indicates its use in a diagnostic process.
- Device Description: The description details a reagent (antibody) used to identify specific proteins (S100) in biological samples. This is a common characteristic of IVD devices.
- Performance Studies: The "Summary of Performance Studies" describes testing on "paraffin embedded preparations from normal and pathologic samples" and evaluating "staining intensity and pattern of staining." This type of testing is performed on biological samples in vitro (outside the body) to provide information for diagnosis.
The entire context of the document describes a reagent used to analyze biological samples to aid in a medical diagnosis, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Ventana Medical Systems, Inc. developed the Ventana Anti-S100 antibody for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-S100 is substantially equivalent to other marketed immunohistochemical stains used in the identification of cells of normal and abnormal lineage as an aid in diagnosis of anaplastic tumors.
Product codes
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Device Description
Ventana Medical Systems' Anti-S100 (rabbit polyclonal) contains rabbit antiserum directed against an epitope found on S100 protein. S100 used for immunization was purified by ammonium sulphate fractionation, DEAE-Sephadex chromatography and gel filtration on Sephadex G100. The antiserum was obtained from rabbits after repeated injections of S100 protein complexed to methylated bovine serum albumin in complete Freund's adjuvant.
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 the Ventana Anti-S100. Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic tissues evaluated for staining included leiomyosarcomas, squamous cell carcinomas, breast carcinomas, carcinoid tumors and melanomas. Slides were processed on the Ventana ES Automated Slide Stainer and prepared for examination, then evaluated for specific staining intensity and background staining.
Summary of Performance Studies
Inter-run reproducibility was determined based on samples of the same tissue on 16 different instrument runs. Staining intensity and pattern of staining was similar in all tissue slides evaluated. Intra-run reproducibility was determined based on ten samples of the same tissue within one run. The staining intensity and pattern of staining in the ten slides was similar in all slides.
Key Metrics
Sensitivity of Ventana Anti-S100 was shown by the appropriate staining of nerve cells in normal tissues tested and staining of 80% of the melanoma tissues tested. This data compares favorably to published literature.
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
K9415K4
R 25 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-S100 antibody for use on the Ventana ES automated immunohistochemistry system. Ventana Anti-S100 is substantially equivalent to other marketed immunohistochemical stains used in the identification of cells of normal and abnormal lineage as an aid in diagnosis of anaplastic tumors. Epithelial Membrane Antigen (EMA) is such a stain.
Antibody
Ventana Medical Systems' Anti-S100 (rabbit polyclonal) contains rabbit antiserum directed against an epitope found on S100 protein. S100 used for immunization was purified by ammonium sulphate fractionation, DEAE-Sephadex chromatography and gel filtration on Sephadex G100. The antiserum was obtained from rabbits after repeated injections of S100 protein complexed to methylated bovine serum albumin in complete Freund's adjuvant. To determine if positive staining was a consequence of the S100 antiserum-S100 antigen interaction, 50ug of S100 protein was mixed with a 1/200 dilution of S100 antiserum prior to immunostaining. Pre-absorption resulted in complete loss of staining of tissue sections.
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-S100. Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic tissues evaluated for staining included leiomyosarcomas, squamous cell carcinomas, breast carcinomas, carcinoid tumors and melanomas. Slides were processed on the Ventana ES Automated Slide Stainer and prepared for examination, then evaluated for specific staining intensity and background staining.
Results
Sensitivity of Ventana Anti-S100 was shown by the appropriate staining of nerve cells in normal tissues tested and staining of 80% of the melanoma tissues tested. This data compares favorably to published literature.
Inter-run reproducibility was determined based on samples of the same tissue on 16 different instrument runs. Staining intensity and pattern of staining was similar in all tissue slides evaluated. Intra-run reproducibility was determined based on ten samples of the same tissue within one run. The staining intensity and pattern of staining in the ten slides was similar in all slides.