(170 days)
Not Found
No
The document describes an automated scanning microscope and image analysis system that uses image processing for cell detection and classification based on predefined criteria (color, intensity, size, pattern, shape). There is no mention of AI, ML, or any learning algorithms being used for this analysis. The system is described as an "adjunctive automated enumeration tool in conjunction with manual visualization," further suggesting a rule-based or traditional image processing approach rather than AI/ML.
No
The device is intended for in vitro diagnostic use as an aiding tool for pathologists or cytogeneticists in detecting, classifying, and enumerating cells of interest. It is not designed to directly treat, prevent, or diagnose disease, but rather to provide information to aid in diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for in vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist." It also details its use in detecting, classifying, and enumerating cells for various diagnostic purposes, such as assessing bone marrow transplantation effectiveness, aiding in the diagnosis of bladder carcinoma, and identifying patients eligible for specific cancer treatments.
No
The device description explicitly states that the system is constructed of an external microscope, motorized multi slide stage, camera, and a workstation, indicating it includes significant hardware components beyond just software.
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 system is "intended for in vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist".
- Accessory to FDA Cleared/Approved IVDs: The system is indicated as an accessory to several FDA cleared/approved devices, which are themselves IVDs (DNA Probe Kits for FISH). This further reinforces its role in the diagnostic process.
- Analysis of Biological Specimens: The system is used to analyze biological specimens (interphase nuclei, tissue specimens, urine specimens) for diagnostic purposes.
- Role in Diagnosis and Monitoring: The intended uses described for each accessory kit clearly outline the system's role in aiding in the diagnosis of conditions like bladder cancer and identifying patients eligible for specific treatments.
Therefore, based on the provided information, the GenASIs ScanView System is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GenASIs ScanView System is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern; and shape. The GenASIs ScanView System is indicated as an accessory to the following FDA cleared/approved devices to detect the following cell types:
- CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe Kit and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.
- Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, Paraffin embedded human breast cancer tissue specimens with Vysis® Path Vysion™ HER-2 DNA Probe kit. Results from the PathVysion™ Kit are intended for use as an adjunct to existing clinical and Pathologic information used as prognostic factors in stage II, node-positive breast cancer patients. The Path Vysion™ kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer, treated with adjuvant cyclophosphamide, doxorubicin, and 5fluorouracil (CAF) chemotherapy.
- Cells in urine specimens, stained by fluorescence in situ hybridization (FISH) using Vysis UroVysion™ Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus. from persons with hematuria suspected of having bladder cancer. The results are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
- Gene rearrangements involving the ALK gene (2p23) via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, using Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit. The Vysis ALK Break Apart FISH Probe Kit is indicated to aid in identifying those patients eligible for treatment with XALKORI® (crizotinib). The GenASIs ALK System is an accessory to Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit.
The GenASIs ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.
Product codes (comma separated list FDA assigned to the subject device)
NTH
Device Description
The GenASIs ScanView System is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Experts can view and scan cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, archived, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters.
The system is designed to work with a manual or automated microscope and includes a dedicated, high powered microscope camera combined with state-of-the-art image analysis software for clinical and research oriented image analysis.
The system's modular platform enables automation of a wide range of laboratory selected assays in pathology and cytogenetics applications. This flexible solution may be adapted to the advanced automation and workflow needs of any laboratory or research institution. The system includes a fully automated computer-controlled microscope, motorized 9-slide stage and high powered microscope-camera. This platform also comes with a variety of additional components such as oil dispenser, automated fluorescent illumination control and state-of-the-art image analysis software for clinical and research oriented image analysis and automatic robotic slide loading system, enabling high throughput automated slide analysis for a wide range of pathology applications that provides a true "walk-away" functionality, scanning up to 81 slides consecutively without human intervention. These scanning capabilities presented with the GenASIs High Throughput platform offer an efficient way to optimally use the scanning and analysis system for uninterrupted scanning.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence In Situ Hybridization (FISH)
Anatomical Site
Formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, Interphase nuclei from human breast cancer tissue specimens, Cells in urine specimens, Interphase nuclei (bone marrow transplantation)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pathologist or Cytogeneticist / Not Found
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
Slides containing formalin-fixed paraffin-embedded (FFPE) tissue specimens from patients with non-small cell lung cancer (NSCLC) were hybridized with the FDA approved Vysis ALK Break Apart FISH Probe Kit according to the manufacturer's instructions.
At each clinical site, archived slides from NSCLC tissue specimens, previously counted and analyzed manually in the last 6 months, were used for the test. Negative cases were selected sequentially from a known bank of negative samples. All positive and equivocal slides that were available during the period of the comparison studies were used for the analysis in order to have an adequate number of slides in each of the categories.
Patients with NSCLC that were negative for the EGFR test were included in the study. At four clinical sites, a total of 179 slides including 9 cases in the equivocal zone (10-50%) were analyzed. The GenASIs Scan View operator had no prior knowledge of the manual counting results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
a. Analytical Performance:
Method comparison study: Four clinical sites, 179 slides (including 9 equivocal cases 10-50%). Overall agreement: 100% (95% CI: 98%-100%), Negative percent agreement: 100% (95% CI: 97.5%-100%), Positive percent agreement: 100% (95% CI: 89.1%-100%).
b. Precision/Reproducibility:
A panel of 10 slides (4 negative, 3 equivocal, 6 positive) was evaluated.
Within-day/within system: each slide evaluated three times on the same system on the same day.
Between days: slides assessed on three separate days on the same system (interval at least five days).
Between systems: three GenASIs ScanView ALK Systems used at three different sites by three different operators.
Diagnoses over different days and systems were 100% concordant for positive vs. negative results, as were within-day results. Both repeatability and reproducibility in the study were 100%.
An additional panel of 5 equivocal specimens (10-25%) was tested for repeatability within-day/within-system. Results for Mean % Positive Cells, SD, and %CV are provided in Table 3.
c. Linearity: Not applicable
d. Carryover: Not applicable
e. Interfering Substances: Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall agreement: 100%% (95% CI: 98%-100%)
Negative percent agreement: 100% (95% CI: 97.5%-100%)
Positive percent agreement: 100% (95% CI: 89.1%-100%)
Repeatability and reproducibility in the study were 100% for positive/negative diagnosis.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.4700 Automated fluorescence
in situ hybridization (FISH) enumeration systems.(a)
Identification. An automated FISH enumeration system is a device that consists of an automated scanning microscope, image analysis system, and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays as an aid in the detection, counting and classification of cells based on recognition of cellular color, size, and shape, and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescencein situ Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image shows the logo for Applied Spectral Imaging. The logo consists of the letters "ASI" in a stylized font, with the "A" and "S" overlapping. To the right of the letters is a thick, vertical black bar. Below the logo are the words "Applied Spectral Imaging" in a bold font, followed by the tagline "Bringing Details to Light" in a smaller font.
510(k) Summary
As required by section 807.92(c). February 5, 2013
510(K) Number A.
B. Purpose for Submission
Addition of the GenASIs ALK System Application to the GenASIs ScanView System (former name Scan View System).
The GenASIs ALK System Application is to perform automated fluorescence in situ hvbridization (FISH) detection and enumerationfor the Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit (List No. 06N38-020). The ALK Break Apart FISH Probe is FDA approved (P11012) and is designed to detect rearrangements involving the ALK gene (2p23) via fluorescence in situ hybridization (FISH) in formalinfixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens to aid in identifying those patients eligible for treatment with XALKORI® (crizotinib).
Manufacturer and Instrument Name C.
C.1. Device Name
GenASIs ScanView System GenASI ALK System Application
Submitter's name C.2.
Name: Applied Spectral Imaging Ltd. 2 Ha Carmel St, New Industrial Zone, Yokneam 20691, Israel Tel: (972) 4 6547567, Fax: (972) 4 6547507
C.3. Submission contact person
Ilan Sharon P.O.B. 4414 (A-109), Caesarea 30889, Israel TEL: 972-52-8704904
Type of Test or Tests Performed D.
Performing automated fluorescence in situ hybridization (FISH) analysis for samples stained with Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020) to detect rearrangements involving the ALK gene (2p23) via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded tissue specimen (FFPE). The test is aimed for analysis of non-small cell lung cancer (NSCLC) tissue specimens, to aid in identifying those patients eligible for treatment with XALKORI® (crizotinib).
1
E. System Descriptions
Device description:
The GenASIs ScanView System is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Experts can view and scan cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, archived, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters.
The system is designed to work with a manual or automated microscope and includes a dedicated, high powered microscope camera combined with state-of-the-art image analysis software for clinical and research oriented image analysis.
The system's modular platform enables automation of a wide range of laboratory selected assays in pathology and cytogenetics applications. This flexible solution may be adapted to the advanced automation and workflow needs of any laboratory or research institution. The system includes a fully automated computer-controlled microscope, motorized 9-slide stage and high powered microscope-camera. This platform also comes with a variety of additional components such as oil dispenser, automated fluorescent illumination control and state-of-the-art image analysis software for clinical and research oriented image analysis and automatic robotic slide loading system, enabling high throughput automated slide analysis for a wide range of pathology applications that provides a true "walk-away" functionality, scanning up to 81 slides consecutively without human intervention. These scanning capabilities presented with the GenASIs High Throughput platform offer an efficient way to optimally use the scanning and analysis system for uninterrupted scanning.
F. Regulatory Information
Device Classification
Product Code: NTH 21 CFR 866.4700 CFR section: Immunology Regulation name: . Trade Name: GenASIs ALK System Automated fluorescence in situ hybridization (FISH) Common Name: enumeration system. Class II Classification:
G. Intended Use
The GenASIs ScanView System is an automated scanning microscope and image analysis system. It is intended for invitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on
2
color, intensity, size, pattern; and shape. The GenASIs ScanView System is indicated as an accessory to the following FDA cleared/approved devices to detect the following cell types: 1. CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe Kit and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.
-
Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed. Paraffin embedded human breast cancer tissue specimens with Vysis® Path Vysion™ HER-2 DNA Probe kit. Results from the Path Vysion " Kit are intended for use as an adjunct to existing clinical and Pathologic information used as prognostic factors in stage II, node-positive breast cancer patients. The Path Vysion™ kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer, treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy.
-
Cells in urine specimens, stained by fluorescence in situ hybridization (FISH) using Vysis UroVysion™ Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus, from persons with hematuria suspected of having bladder cancer. The results are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
-
Gene rearrangements involving the ALK gene (2p23) via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, using Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit. The Vysis ALK Break Apart FISH Probe Kit is indicated to aid in identifying those patients eligible for treatment with XALKORI® (crizotinib). The GenASIs ALK System is an accessory to Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit.
The GenASIs ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.
Substantial Equivalence Information H.
| # | Comparison
parameter | Proposed device:
GenASIs ScanView System | Predicate device:
ScanView System |
|---|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | 510(k) number | K122554 | K110345 |
| 2 | Owner | Applied Spectral Imaging Ltd. | Applied Spectral Imaging Ltd. |
| 3 | Intended use
and
indications
for use. | The GenASIs ScanView System is an
automated scanning microscope and image
analysis system. It is intended for in vitro
diagnostic use as an aiding tool to the
pathologist or cytogeneticist in the
detection, classification and enumeration
of cells of interest based on color. | The ScanView System is an automated scanning
microscope and image analysis system. It is
intended for in vitro diagnostic use as an aiding
tool to the pathologist or cytogeneticist in the
detection, classification and enumeration of cells
of interest based on color, intensity, size, pattern;
and shape. The ScanView is indicated as anl |
1. Comparison of Predicate devices:
3
| # | Comparison
parameter | Proposed device:
GenASIs ScanView System | Predicate device:
ScanView System | | | |
|---|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------|
| | | intensity, size, pattern; and shape. The
GenASIs ScanView System is indicated as
an accessory to the following FDA
cleared/approved devices to detect the
following cell types: | accessory to the following FDA cleared/approved
devices to detect the following cell types: | | | |
| | | 1. CEP® X Spectrum Orange™/CEP® Y
Spectrum Green™ DNA Probe Kit and is
limited to the analysis of CEP XY probes
via high magnification capture and
analysis of interphase nuclei. CEP XY is
indicated for use to assess the effectiveness
of bone marrow transplantation in.
opposite-sex transplants. | 1. CEP® X Spectrum Orange™/CEP® Y
Spectrum Green™ DNA Probe Kit and is limited
to the analysis of CEP XY probes via high
magnification capture and analysis of inrerphase
nuclei. CEP XY is indicated for use to assess the
effectiveness of bone marrow transplantation in
opposite-sex transplants. | | | |
| | | 2. Human breast cancer containing the
HER-2/neu gene labeled in Red and the
centromere of chromosome 17 labeled in
Green via fluorescence in situ
hybridization (FISH) in interphase nuclei
from formalin-fixed, Paraffin embedded
human breast cancer tissue specimens with
Vysis® Path Vysion™ HER-2 DNA Probe
kit. Results from the Path Vysion™ Kit are
intended for use as an adjunct to existing
clinical and Pathologic information used as.
prognostic factors in stage II, node-
positive breast cancer patients. The Path
Vysion™ kit is further indicated as an aid
to predict disease-free and overall survival
in patients with stage II, node positive
breast cancer, treated with adjuvant
cyclophosphamide, doxorubicin, and 5-
fluorouracil (CAF) chemotherapy. | 2. Human breast cancer containing the HER-
2/neu gene labeled in Red and the centromere of
chromosome 17 labeled in Green via fluorescence
in situ hybridization (FISH) in interphase nuclei
from formalin-fixed, paraffin embedded human
breast cancer tissue specimens with Vysis® Path
Vysion™ HER-2 DNA Probe kit. Results from
the PathVysionM Kit are intended for use as an
adjunct to existing clinical and pathologic
information used as prognostic factors in stage II,
node-positive breast cancer patients. The Path
VysionT" kit is further indicated as an aid to
predict disease-free and overall survival in
patients with stage II, node positive breast cancer,
treated with adjuvant cyclophosphamide,
doxorubicin, and 5- fluorouracil (CAF)
chemotherapy. | | | |
| | | 3. Cells in urine specimens, stained by
fluorescence in situ hybridization (FISH)
using Vysis UroVysion™ Bladder Cancer
Kit to detect aneuploidy for chromosomes
3, 7, 17, and loss of the 9p21 locus, from
persons with hematuria suspected of
having bladder cancer. The results are
intended for use, in conjunction with and
not in lieu of current standard diagnostic
procedures, as an aid for initial diagnosis
of bladder carcinoma in patients with
hematuria and subsequent monitoring for
tumor recurrence in patients previously
diagnosed with bladder cancer. | 3. Cells in urine specimens, stained by
fluorescence in situ hybridization (FISH) using
Vysis UroVysion™ Bladder Cancer Kit to detect
aneuploidy for chromosomes 3, 7, 17, and loss of
the 9p21.locus, from persons with hemnaturia
suspected of having bladder cancer. The results
are intended for use, in conjunction with and not
in licu of current standard diagnostic procedures,
as an aid for initial diagnosis of bladder
carcinoma in patients with hemnaturia and
subsequent monitoring for tumor recurrence in
patients previously diagnosed with bladder
cancer. | | | |
| | | | paraffin-embedded (FFPE) non-small cell
lung cancer (NSCLC) tissue specimens, . | 4. Gene rearrangements involving the
ALK gene (2p23) via fluorescence in situ
hybridization (FISH) in formalin-fixed | | The ScanView System is to be used as an
adjunctive automated enumeration tool in
conjunction with manual visualization. |
| | using Vysis® ALK (Anaplastic | | | | | |
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| # | Comparison
parameter | Proposed device:
GenASIs ScanView System | Predicate device:
ScanView System |
|----|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Lymphoma Kinase) Break Apart FISH
Probe kit. The Vysis ALK Break Apart
FISH Probe Kit is indicated to aid in
identifying those patients eligible for
treatment with XALKORI® (crizotinib).
The GenASIs ALK System is an accessory
to Vysis® ALK (Anaplastic Lymphoma
Kinase) Break Apart FISH Probe kit. | |
| | | The GenASIs ScanView System is to be
used as an adjunctive automated
enumeration tool in conjunction with
manual visualization. | |
| 4 | Probe Kit
(for GenASIs
ALK System) | Vysis® ALK Break Apart FISH Probe Kit
(List No. 06N38-020). | Vysis UroVysionTM Bladder Cancer Kit |
| 5 | Technical
Method | Fluorescence in situ hybridization FISH,
an adjunctive automated enumeration tool
in conjunction with manual visualization. | Fluorescence in situ hybridization FISH, an
adjunctive automated enumeration tool in
conjunction with manual visualization. |
| 6 | Target Area
(for GenASIs
ALK System) | Formalin-fixed, paraffin-embedded human
non-small cell lung cancer tissue specimen | Cells in urine specimens |
| 7 | Image
Special
Resolution | 1280 X 1024 pixels | 1280 X 1024 pixels |
| 8 | Device
Components | Automated microscope,
PC, keyboard and
control panel, color
monitor, CCD Camera,
and motorized stage | Automated microscope,
PC, keyboard and
control panel, color
monitor, CCD Camera,
and motorized stage |
| 9 | Software
Version | GenASIs ScanView Version 7.0 | ScanView Version 6.0 |
| 10 | Software
Applications | • Control of man-machine
Interface.
• Scan, Capture, Review
and images analysis
• Handling the images display, storage and
communication. | • Control of man-machine
Interface.
• Scan, Capture, Review
and images analysis
• Handling the images display, storage and
communication. |
2. Substantial Equivalence discussion
Similarities:
Both the proposed GenASIs ScanView system and legally cleared ScanView System (K110345) are platforms for IVD medical devices and laboratory test systems. Both systems use automated scanning microscope, CCD camera, image analysis software tools, storage media and display monitor as an aiding tool to the pathologist or cytogeneticist, in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern and shape.
The proposed GenASIs ScanView system and legally cleared ScanView System (K110345) predicate device are both adjunctive automated enumeration tools for FISH.
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Differencés:
The legally cleared Scan View System (K110345) is using software version 6.0 while proposed GenASIs ScanView system is using software version 7.0 that includes same applications and tools but has improved features, corrected bugs and is using improved SQL data base for storage (CDM). Additionally the proposed device includes ALK flow capability implemented by using the same FISH and spot counting tools. The legally cleared ScanView System is for use with Vysis UroVysion™ Bladder Cancer Kit, the proposed GenASIs ScanView system is additionally indicated for using Abbott's FDA approved (P110012) Vysis ALK Break Apart FISH Probe Kit (Vysis ALK Break Apart FISH Probe Kit (List No. 06N38-020)) to detect rearrangements involving the ALK gene (2p23) via fluorescence in situ hybridization (FISH) in formalin-fixed paraffinembedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, to aid in identifying those patients eligible for treatment with XALKORI® (crizotinib).
I. Special Control/ Guidance Document Referenced (if applicable)
The following Special Control and guidance documents are used in the preparation of the 510(K) submission:
-
"Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems" 23 May 2005.
-
Guidance for Industry and FDA Staff: "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests"; March 2007.
-
"Guidance for the Content of Premarket Submission for Software Contained in Medical Device", CDRH, May 2005.
J. Performance Characteristics
The following information of the device performance characteristics are based on ASI testing and experiments, using the Vysis® ALK™ FISH probe kit. The operators should be aware of the limitations derived from the following performance characteristics:
a. Analytical Performance:
Slides containing formalin-fixed paraffin-embedded (FFPE) tissue specimens from patients with non-small cell lung cancer (NSCLC) were hybridized with the FDA approved Vysis ALK Break Apart FISH Probe Kit according to the manufacturer's instructions.
At each clinical site, archived slides from NSCLC tissue specimens, previously counted and analyzed manually in the last 6 months, were used for the test. Negative cases were selected sequentially from a known bank of negative samples. All positive and equivocal slides that were available during the period of the comparison studies were used for the analysis in
6
order to have an adequate number of slides in each of the categories.
Patients with NSCLC that were negative for the EGFR test were included in the study. At four clinical sites, a total of 179 slides including 9 cases in the equivocal zone (10-50%) were analyzed. The GenASIs Scan View operator had no prior knowledge of the manual counting results. Method comparison results for all four sites combined are presented below in Table 1:
Table 1: Method Comparison of GenASIs ScanView vs. Manual Method – All sites combined
| Manual Method | |||||
|---|---|---|---|---|---|
| Negative | Positive | Total | |||
| GenASIs | Negative | ব | 147 | ||
| Scan View | Positive | ||||
| Method | l otal | c | 179 |
Overall agreement: 100%% (95% CI: 98%-100%) Negative percent agreement: 100% (95% CI: 97.5%-100%) Positive percent agreement: 100% (95% CI: 89.1%-100%)
b. Precision/Reproducibility:
A panel of 10 slides chosen by the manual counting results, 4 of which were negative (50%) were evaluated for repeatability and reproducibility of diagnosis (positive/negative) for the following:
- · Within-day/within system: each one of the slides was evaluated three times on the same system on the same day.
- · Between days: slides were assessed on three separate days on the same system (interval between assessments was at least five days).
- · Between systems: three GenASIs ScanView ALK Systems were used at three different sites by three different operators.
Diagnoses over different days and systems were 100% concordant for positive vs. negative results, as were within-day results. Both repeatability and reproducibility in the study were 100%.
Mean percent positive cells, standard deviation and % coefficient of variation for each study are presented in Table 2 below. For the negative specimens %CV values are not applicable as a higher degree of variance is to be expected in negative or low positive specimens due to the fewer signals.
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| Panel
Member | %
Positive
Cells
Counted
Manually | Within-day/Within-
System | | | Between-Day | | | Between-System | | |
|-----------------|-----------------------------------------------|------------------------------|-----|---------|-----------------------------|-----|---------|-----------------------------|-----|---------|
| | | Mean %
Positive
Cells | SD | %
CV | Mean %
Positive
Cells | SD | %
CV | Mean %
Positive
Cells | SD | %
CV |
| 1 | 61 | 56.9 | 4.6 | 8.0 | 56.4 | 3.7 | 6.7 | 56.2 | 3.1 | 5.5 |
| 2 | 52 | 46.9 | 5.9 | 12.6 | 47.5 | 4.3 | 9.1 | 46.1 | 4.4 | 9.5 |
| 3 | 85 | 79.6 | 5.2 | 6.5 | 80.0 | 3.8 | 4.8 | 79.4 | 3.5 | 4.5 |
| 4 | 0 | 0.9 | 1.0 | N/A | 1.2 | 0.8 | N/A | 1.1 | 0.7 | N/A |
| 5 | 0 | 1.3 | 1.3 | N/A | 0.8 | 1.1 | N/A | 1.1 | 1.1 | N/A |
| 6 | 0 | 0.6 | 0.7 | N/A | 0.5 | 0.5 | N/A | 0.7 | 0.7 | N/A |
| 7 | 0 | 0.6 | 1.0 | N/A | 0.9 | 0.8 | N/A | 0.8 | 0.8 | N/A |
| 8 | 18 | 22.2 | 2.9 | 13.2 | 25.2 | 4.8 | 19.1 | 24.4 | 5.0 | 20.5 |
| 9 | 27 | 26.7 | 4.2 | 15.9 | 27.8 | 3.8 | 13.6 | 28.3 | 4.1 | 14.4 |
| 10 | 31 | 29.6 | 5.7 | 19.2 | 32.6 | 6.4 | 19.6 | 32.2 | 5.9 | 18.2 |
Table 2: Repeatability and reproducibility analysis by panel member
An additional panel of 5 equivocal specimens around the cutoff (10-25%) were tested for repeatability within-day/within-system. Results are presented in Table 3 below:
| Panel Member | % Positive Cells
Counted Manually | Mean%
Positive Cells | SD | %CV |
|--------------|--------------------------------------|-------------------------|------|------|
| 1 | 12 | 11.6 | 1.62 | 13.9 |
| 2 | 19 | 18.6 | 1.13 | 6.0 |
| 3 | 22 | 19.7 | 0.6 | 3.1 |
| 4 | 18 | 17.6 | 0.98 | 5.6 |
| 5 | 19 | 19.6 | 1.32 | 6.7 |
Table 3: Within-day/Within Repeatability for specimens around the cutoff
c. Linearity
Not applicable
d. Carryover:
Not applicable
e. Interfering Substances:
Not applicable
3. Other Supportive Instrument Performance Data Not Covered Above:
Not applicable
8
K. Proposed Labeling
Labeling was prepared in accordance with the requirements of 21 CFR Part 809.10.
Conclusion L.
Based on the above, it is Applied Spectral Imaging's opinion that the proposed GenASIs System is substantially equivalent in terms of design, principles, and performance characteristics and is shown to be safe & effective for its intended use.
9
Image /page/9/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 7, 2013
Applied Spectral Imaging Ltd. Ilan Sharon P.O.B. 4414 (A-109) Caesarea 30889, Israel
Re: K122554
Trade/Device Name: GenASIs ScanView System, GenASI ALK System Regulation Number: 21 CFR 866.4700 Regulation Name: Automated fluorescence in situ hybridization (FISH) enumeration systems . Regulatory Class: Class II Product Code: NTH Dated: February 6, 2013 Received: February 7, 2013
Dear Mr. Sharon:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
10
Page 2 - Ilan Sharon
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go.to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Reena Pihilips-S
for
Maria M. Chan, Ph.D.
Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Enclosure
11
Indications for Use
510(k) Number (if known): K122554
Device Name: GenASIs ScanView System
Indications for Use:
The GenASIs ScanView System is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern; and shape. The GenASIs ScanView System is indicated as an accessory to the following FDA cleared/approved devices to detect the following cell types:
-
CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe Kit and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.
-
Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, Paraffin embedded human breast cancer tissue specimens with Vysis® Path Vysion™ HER-2 DNA Probe kit. Results from the PathVysion™ Kit are intended for use as an adjunct to existing clinical and Pathologic information used as prognostic factors in stage II, node-positive breast cancer patients. The Path Vysion™ kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer, treated with adjuvant cyclophosphamide, doxorubicin, and 5fluorouracil (CAF) chemotherapy.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Reena Philip
Division Sign-Off
Office of In Vitro Diagnostics and Radiological Health
510(k) K122554
Page 1 of 2
12
Indications for Use
510(k) Number (if known): K122554
Device Name: GenASIs ScanView System
Indications for Use: Continued from last page.
-
Cells in urine specimens, stained by fluorescence in situ hybridization (FISH) using Vysis UroVysion™ Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus. from persons with hematuria suspected of having bladder cancer. The results are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
-
Gene rearrangements involving the ALK gene (2p23) via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, using Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit. The Vysis ALK Break Apart FISH Probe Kit is indicated to aid in identifying those patients eligible for treatment with XALKORI® (crizotinib). The GenASIs ALK System is an accessory to Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit.
The GenASIs ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Reina Philip
Division Sign-Off
Office of In Vitro Diagnostics and Radiological Health
510(k) K122554
Page 2 of 2