(167 days)
NOT
Not Found
No
The description focuses on automated microscopy, image processing using "color spaces" and "color space conversion," and quantitative analysis based on color, size, and shape. There is no mention of AI, ML, training data, or complex algorithms typically associated with AI/ML for image analysis. The system appears to use traditional image processing techniques.
No
The device is an accessory to a diagnostic test (HercepTest™) used to aid in the detection and semi-quantitative measurement of HER2/neu, which helps in assessing breast cancer patients for potential treatment. It does not directly provide therapy.
Yes
The ACIS device is used as an aid in the detection and semi-quantitative measurement of Her2/neu, and specifically, to aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered, which are all diagnostic functions.
No
The device description explicitly states that the ACIS is a "highly automated microscope and software system," indicating it includes significant hardware components beyond just software.
Based on the provided information, the Automated Cellular Imaging System (ACIS) device, when used with the DakoCytomation HercepTest™, is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the ACIS is intended for laboratory use as an accessory to the DakoCytomation HercepTest™ to aid in the detection and semi-quantitative measurement of Her2/neu in tissue. It is also indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® treatment is being considered. This clearly describes a diagnostic purpose performed in vitro (outside the body) on biological specimens.
- Specimen Type: The device analyzes formalin-fixed, paraffin embedded normal and neoplastic tissue, which are biological specimens.
- Diagnostic Information: The device provides semi-quantitative measurement of Her2/neu, which is used to aid in the assessment of breast cancer patients for treatment consideration. This information is used for diagnostic purposes.
- Laboratory Use: The device is intended for laboratory use, which is a common setting for IVD devices.
- Accessory to an IVD: It is described as an accessory to the DakoCytomation HercepTest™, which is itself an IVD kit for immunohistochemical staining.
While the ACIS system is an "adjunctive computer-assisted methodology" and the pathologist is responsible for verifying the score, its role in providing quantitative data from in vitro stained tissue to aid in a diagnostic assessment firmly places it within the definition of an IVD device.
N/A
Intended Use / Indications for Use
The Automated Cellular Imaging System (ACIS) device is intended to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape.
In this software application the ACIS is intended for laboratory use as an accessory to the DakoCytomation HercepTest™ to aid in the detection and semi-quantitative measurement of Her 2/neu (c-erbB-2) in formalin-fixed, paraffin embedded normal and neoplastic tissue.
The ACIS is capable of detecting and quantifying regions of clinical interest in immunocytochemically stained material that would otherwise be appropriate for manual visualization by conventional microscopy.
When used with the DakoCytomation HercepTest™, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. The pathologist should verify agreement with the ACIS score.
The ACIS system is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscopic slides of breast cancer specimens stained for the presence of Her2 receptor protein. The accuracy of the test result depends upon the quality of immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in instructions for DakoCytomation HercepTest™ to assure the validity of the ACIS-assisted Her2 score.
NOTE: All of the patients in the HERCEPTIN® clinical trials were selected using an investigational immunohistochemical clinical trial assay (CTA). None of the patients in those trials were selected using the DakoCytomation HercepTest™. The DakoCytomation HercepTest™ was compared to the CTA on an independent set of samples and found to provide acceptably concordant results. The actual correlation of the DakoCytomation HercepTest™ to HERCEPTIN® clinical outcome has not been established.
Product codes
NOT
Device Description
The ACIS is a highly automated microscope and software system capable of operating continuously with limited human supervision and maintenance. By automating certain steps of the basic microscopic procedure (loading, positioning, focusing, scanning, and cell identification and quantification), the ACIS can significantly improve the consistency, speed, reproducibility, and accuracy of traditional manual or semi-manual laboratory results.
The ACIS can automatically scan and process up to 100 slides while operating unattended. As each slide is processed, the system automatically stores individual fields of view in order to map and integrate this into a single image, a histological reconstruction of the entire tissue section. The proprietary software-based digital color detection technology offers significant sensitivity and specificity to identify targeted cells using common laboratory stains. This technology utilizes advanced imaging concepts referred to as "color spaces" and "color space conversion."
During normal operation, a laboratory technician mounts prepared microscope slides onto a specially designed slide carrier which has the capacity to hold up to four slides. Up to 25 slide carriers can be loaded into the ACIS slide transport system, for a "run" throughput of 100 slides. The scanning process begins with the automatic loading of the first carrier of slides onto the microscope stage. During this stage of the process, the ACIS automatically reads bar codes affixed to the slides to facilitate participant data storage and access. During scanning, the ACIS automatically focuses each field of view, images the object using the CCD camera, and processes the resulting digital image through the image processor. Slides are then scanned at a low optical magnification (typically 4X objective) to find regions of interest based primarily on their color, along with size and shape characteristics. The locations of regions are stored until scanning is completed. Once the region of interest containing the specimen is found, a scan of the specimen commences to build a low power image of the specimen (histological reconstruction).
For the HER2 assay, the ACIS creates the histological reconstruction. The pathologist may then visit any area of the scanned tissue section at low or high magnification. The pathologist electronically selects regions of invasive carcinoma. The scoring is expressed as intensity of brown color within the stained cells in the selected area.
After scanning is completed, the operator is able to view the histological reconstruction of all stored images for interpretation of the detected objects, along with quantitative information, such as the number of objects detected and colorimetric value. Upon completion of this review, a report containing relevant images identified by the pathologist may be printed. Images may be saved on the hard drive or archived to removable media.
Complete details of the ACIS may be found in the ACIS Operator's Manual, available from Chroma Vision.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Microscope slides, digital image processed through image processor
Anatomical Site
Breast cancer specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laboratory technician, 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
The ACIS device was compared to the manual method of slide examination in the analysis of specimens immunohistochemically stained with the DakoCytomation HercepTest™ Kit for the detection of overexpression of the HER2/neu protein.
- Agreement between ACIS and Manual methods: Three pathologists scored 90 specimens on a Tissue Micro Array (TMA) slide. The specimens represented a range of HER2/neu staining intensities from 0 to 3+, previously selected by an independent pathologist. Approximately 1/3 of the selected specimens were 0 and 1+, 1/3 of the selected specimens were 2+ and 1/3 of the selected specimens were 3+ HER2 scoring intensities. The scores were determined manually according to DAKO's kit insert provided with the HercepTest kit. To assure blinding, a washout period of one-week occurred between readings, per pathologist.
- Within/between reproducibility of the ACIS device: Three pathologists analyzed 60 specimens on a standard light microscope and on a single ACIS device. Each pathologist analyzed each specimen three (3) times each, by both methodologies, at approximately the following representative HER2 staining intensity ranges (by DAKO guidelines): Negative (
§ 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
DEC 2 3 2003
*032/113/5/
510(k) Summary of Substantial Equivalence ChromaVision Medical Systems, Inc. (Automated Cellular Imaging System)
This summary of substantial equivalence information is furnished in accordance with 21 CFR 807.92 as follows:
21 CFR 807.92(a):
21 CFR 807.92(a)(1):
- Submitter's name and address:
ChromaVision Medical Systems, Inc. 33171 Pasco Cerveza San Juan Capistrano, California 92675
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- Submitter's telephone number: (949) 443-3355
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- Contact person:
Mr. David G Davis ChromaVision Medical Systems, Inc. 33171 Paseo Cerveza San Juan Capistrano, California 92675
- Date this 510(k) summary was prepared: June 30, 2003.
21 CFR 807.92(a)(2):
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- Trade/proprietary name of the device: ACIS (Automated Cellular Imaging System)
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- Classification name: Automated microscopy cell locating workstation
21 CFR 807.92(a)(3): Legally marketed predicate devices to which substantial equivalence is claimed:
510(k) summary.doc
000006
1
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ChromaVision Medical Systems, Inc. ACIS - ER/PR SW Application
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Human manual visualization by conventional microscopy
21 CFR 807.92(a)(4): Description of the device that is the subject of this premarket notification:
System Introduction
The ACIS is a highly automated microscope and software system capable of operating continuously with limited human supervision and maintenance. By automating certain steps of the basic microscopic procedure (loading, positioning, focusing, scanning, and cell identification and quantification), the ACIS can significantly improve the consistency, speed, reproducibility, and accuracy of traditional manual or semi-manual laboratory results.
The ACIS can automatically scan and process up to 100 slides while operating unattended. As each slide is processed, the system automatically stores individual fields of view in order to map and integrate this into a single image, a histological reconstruction of the entire tissue section. The proprietary software-based digital color detection technology offers significant sensitivity and specificity to identify targeted cells using common laboratory stains. This technology utilizes advanced imaging concepts referred to as "color spaces" and "color space conversion."
Overview of System Operation
During normal operation, a laboratory technician mounts prepared microscope slides onto a specially designed slide carrier which has the capacity to hold up to four slides. Up to 25 slide carriers can be loaded into the ACIS slide transport system, for a "run" throughput of 100 slides. The scanning process begins with the automatic loading of the first carrier of slides onto the microscope stage. During this stage of the process, the ACIS automatically reads bar codes affixed to the slides to facilitate participant data storage and access. During scanning, the ACIS automatically focuses each field of view, images the object using the CCD camera, and processes the resulting digital image through the image processor. Slides are then scanned at a low optical magnification (typically 4X objective) to find regions of interest based primarily on their color, along with size and shape characteristics. The locations of regions are stored until scanning is completed. Once the region of interest containing the specimen is found, a scan of the specimen commences to build a low power image of the specimen (histological reconstruction).
For the HER2 assay, the ACIS creates the histological reconstruction. The pathologist may then visit any area of the scanned tissue section at low or high magnification. The pathologist
510(k) summary.doc
Page 2
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electronically selects regions of invasive carcinoma. The scoring is expressed as intensity of brown color within the stained cells in the selected area.
After scanning is completed, the operator is able to view the histological reconstruction of all stored images for interpretation of the detected objects, along with quantitative information, such as the number of objects detected and colorimetric value. Upon completion of this review, a report containing relevant images identified by the pathologist may be printed. Images may be saved on the hard drive or archived to removable media.
Complete details of the ACIS may be found in the ACIS Operator's Manual, available from Chroma Vision.
21 CFR 807.92(a)(5): Intended use and labeled indications for use:
Intended Use:
The Automated Cellular Imaging System (ACIS) device is intended to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape.
In this software application the ACIS is intended for laboratory use as an accessory to the DakoCytomation HercepTest™ to aid in the detection and semi-quantitative measurement of Her 2/neu (c-erbB-2) in formalin-fixed, paraffin embedded normal and neoplastic tissue.
The ACIS is capable of detecting and quantifying regions of clinical interest in immunocytochemically stained material that would otherwise be appropriate for manual visualization by conventional microscopy.
When used with the DakoCytomation HercepTest™, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. The pathologist should verify agreement with the ACIS score.
The ACIS system is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscopic slides of hreast cancer specimens stained for the presence of Her2 receptor protein. The accuracy of the test result depends upon the quality of immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in instructions for DakoCytomation HercepTest™ to assure the validity of the ACIS-assisted Her2
510(k) summary.doc
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score.
NOTE: All of the patients in the HERCEPTIN® clinical trials were selected using an investigational immunohistochemical clinical trial assay (CTA). None of the patients in those trials were selected using the DakoCytomation HercepTest™. The DakoCytomation HercepTest™ was compared to the CTA on an independent set of samples and found to provide acceptably concordant results. The actual correlation of the DakoCytomation HercepTest™ to HERCEPTIN® clinical outcome has not been established.
21 CFR 807.92(a)(6): Technological characteristics:
The design, construction, energy source, and other characteristics of the ACIS candidate device are considered to be substantially equivalent to the relevant features of the predicate devices. A summary of the technological characteristics of the ACIS candidate device in comparison to those of the predicate devices follows:
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Method of cell detection: The same as the predicate devices; i.e., colorimetric pattern recognition by microscopic examination of prepared cells by size, shape, hue, and intensity as observed by an automated computer controlled microscope and/or by visual observation by a health care professional.
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System components: The system components comprising the candidate device are substantially equivalent to those in the predicate devices; i.e., computer, microscope, color monitor(s), keyboard, printer, automatic loading and positioning of prepared sample on microscope stage, automatic focusing of microscope, and automatic storage of acquired images.
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Energy source: The electrical service is 120 VAC 60 HZ, the same as the predicate devices.
21 CFR 807.92(b): 510(k) summaries for those premarket submissions in which a determination of substantial equivalence is also based on performance data shall contain the following information:
510(k) summary.doc
Image /page/3/Picture/11 description: The image shows a sequence of numbers, specifically six digits. The first five digits are zeros, and the last digit is a nine. The numbers are written in a simple, sans-serif font, and they appear to be slightly distorted or hand-drawn.
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21 CFR 807.92(b)(1): Brief discussion of the non-clinical tests submitted, referenced, or relied upon in this premarket notification submission:
There were no nonclinical tests submitted, referenced, or relied upon in this submission.
21 CFR 807.92(b)(2): Brief discussion of the clinical tests submitted in this premarket notification submission:
1. Agreement between ACIS and Manual methods of review:
Studies were conducted to demonstrate the performance of the ACIS device compared to the manual method of slide examination in the analysis of specimens immunohistochemically stained with the DakoCytomation HercepTest™ Kit for the detection of overexpression of the HER2/neu protein. Three pathologists scored 90 specimens on a Tissue Micro Array (TMA) slide. The specimens represented a range of HER2/neu staining intensities from 0 to 3+, previously selected by an independent pathologist. Approximately 1/3 of the selected specimens were 0 and 1+, 1/3 of the selected specimens were 2+ and 1/3 of the selected specimens were 3+ HER2 scoring intensities. The scores were determined manually according to DAKO's kit insert provided with the HercepTest kit. To assure blinding, a washout period of one-week occurred between readings, per pathologist. Data were analyzed to determine an estimate of agreement. Raw data was recorded, analyzed, and presented in 4 X 4 tables. There was an overall agreement of 75% between the two different methods of review using the 4category scale (0, 1+, 2+, 3+).
2. Within/between reproducibility of the ACIS device:
Three pathologists analyzed 60 specimens on a standard light microscope and on a single ACIS device. Each pathologist analyzed each specimen three (3) times each, by both methodologies, at approximately the following representative HER2 staining intensity ranges (by DAKO guidelines):
Negative (