(415 days)
Not Found
No
The description focuses on automated scanning and image analysis based on predefined features (color, intensity, size, pattern, shape) and does not mention AI or ML. The performance studies also do not indicate the use of AI/ML training or validation methodologies.
No.
The device is an in-vitro diagnostic device intended to aid pathologists in detecting, classifying, and counting cells. It does not provide direct therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It is intended for in-vitro diagnostic use as an aid to the pathologist..." and then lists specific diagnostic applications such as detecting hematopoietic cells, amniotic cells, aneuploidy, and genetic rearrangements related to cancer.
No
The device description explicitly states that the Duet™ System is a "fully integrated imaging and scanning platform" that "integrates a microscope, CCD camera, motorized stage / slide-loader, computer, keyboard, mouse, joystick, monitor and a dedicated software program." This indicates it includes significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first sentence of the "Intended Use / Indications for Use" section explicitly states: "It is intended for in-vitro diagnostic use as an aid to the pathologist..." This is a clear declaration of its intended use as an IVD.
- Nature of the Device: The device analyzes biological samples (cells from various sources) in vitro (outside the living body) to provide information for diagnostic purposes. This aligns with the definition of an IVD.
- Specific Diagnostic Applications: The detailed list of intended uses (detecting specific cells, chromosomes, and genes using various staining and FISH techniques) further confirms its role in providing diagnostic information.
- Target User: The intended user is a pathologist, a medical professional involved in diagnosing diseases based on laboratory analysis.
- Performance Studies: The inclusion of performance studies like repeatability, reproducibility, and method comparison against manual methods demonstrates the evaluation of the device's analytical and clinical performance for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Duet™ System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aid to the pathologist in the detection, classification and counting of cells of interest based on color, intensity, size, pattern and shape.
The Duet™ System is intended to:
-
Detect Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with brightfield and fluorescent) prepared from cell suspension.
-
Detect Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X. Y. 13, 18 and 21).
-
Detect Aneuploidy for chromosomes 3,7. 17 and loss of the 9p21 locus via FISH in Urine specimens from subjects with transitional cell carcinoma of the bladder, probed by the Vysis Urovysion Bladder Cancer Kit.
-
Detect and quantify chromosome 17 and the HER-2/neu gene via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens, probed by the Vysis® Path Vysion™ HER-2 DNA Probe Kit. The Duet™ is to be used as an adjunctive automated enumeration tool, in conjunction with manual review of the digital image, to assist in determining HER-2/neu gene to chromosome 17 signal ratio.
-
Qualitatively detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, probed with the Vysis ® ALK Break Apart FISH Probe Kit. The Duer™ is to be used as an adjunctive autonated enumeration with manual review of the digital image. Note: The pathologist should verify the image analysis software application score.
Product codes (comma separated list FDA assigned to the subject device)
JOY, NTH
Device Description
The Duet™ System is a fully integrated imaging and scanning platform that automates time-consuming and difficult laboratory tasks of slide scanning.
The Duet™ System workstation integrates a microscope, CCD camera, motorized stage / slide-loader, computer, keyboard, mouse, joystick, monitor and a dedicated software program.
The Duet™ System is software controlled and includes features such as: acquisition of images, views, editing, relocation, enhancement capabilities, automatic/manual counting and classification, printing, export of images and backups.
The Duet™ System scans in high resolution cell samples at high speed both in bright light illumination and in fluorescent illumination.
The Duet™ System suggests classification of the cells according to their morphological features, their staining (Giemsa, IHC) and fluorescent signals, and allows the user to quickly examine the results, correct them as needed and generate a report summarizing the sample's data. The Duet™ system allows combined presentation of morphological and specific staining information of the same cell, for all the cells of the sample.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Brightfield illumination, Fluorescent illumination
Anatomical Site
Hematopoietic cells, Amniotic cells, Urine specimens from the bladder, human breast cancer tissue specimens, non-small cell lung cancer (NSCLC) tissue specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pathologist / In-vitro diagnostic use
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study 1 – Precision/Reproducibility Performance
Purpose: To evaluate the performance of the Duet™ System, for its performance with the ALK™ Kit, in terms of reproducibility and repeatability, within a system and across systems.
Sample Size: A panel of 16 archived clinical specimen slides (4 samples in each of 4 value ranges: 50%)
Study Design:
- Within-system and within-day: Three runs for each panel member on the same day.
- Within-system and between-day: Panel member performance assessed on three different days.
- Between-systems and sites: Each slide tested three times, each at a different site and Duet system.
Key Results: - Repeatability and Reproducibility on Binary Outcome Data (Positive/Negative final result) demonstrated 100% repeatability and reproducibility in all R&R studies.
- All overall %CVs derived from the Mixed Model were well below the performance goals specified.
- Of 48 slides, each measured three times, a single slide displayed a %CV above the 25% performance goal specified (27% for one positive slide in the "Day" study), with the next highest %CV being 17.1%.
- The acceptance criteria for repeatability and reproducibility (Positive samples: CV
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for "bioview". The logo consists of the letters "b", "i", "o", and "view" in a stylized font. The "b" and "i" are contained within a solid black circle, while the "o" is contained within a circle that is connected to two other circles. The word "view" is written in a simple, sans-serif font.
MAY 0 9 2014
Pre Market Notification Submission - 510(k)
510(K) SUMMARY Duet™ System 510(k) Number K130775
5.1 Company Name
Bioview Ltd. 3 Pekeris Street Rehovot 7670203, Israel Tel: +972-8-9366868 Fax: + 972-8-9366869
Contact Person 5.2
Orly Maor 25 A Sirkin Street Kfar-Saba 4442156, Israel Tel: 972-9-7453607 Fax: 972-153-9-7453607 Mail: oram.ma@gmail.com
5.3 Trade/Proprietary Name
Duet™ System
Classification Name 5.4
- Automated cell-location device and: .
- Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems. 트
Product Code/Regulation No. 5.5
- Automated cell-locating devices, product code: JOY, Regulation No. 864.5260. ■
- Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems, 트 product code: NTH, Regulation No. 866.4700.
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Image /page/1/Picture/0 description: The image shows the logo for Bioview. The logo consists of the word "bioview" in a sans-serif font. To the left of the word is a graphic of three circles connected by lines. The top circle is black, the middle circle is black with a white circle inside, and the bottom circle is gray.
Device Classification 5.6
Class II
5.7 Panel
Hematology and Immunology
Predicate Devices 5.8
- Duet™ System, manufactured by BioView Ltd., cleared under K030192, I K040591, K050840, and K061602.
- Human manual visualization of formalin-fixed paraffin-embedded human lung ■ cancer tissue specimens, probed by Vysis ALK Break Apart FISH Probe Kit (Hereinafter, ALK).
5.9 Intended Use
The Duet™ System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aid to the pathologist in the detection, classification and counting of cells of interest based on color, intensity, size, pattern and shape.
The Duet™ System is intended to:
- Detect Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or 1. ISH (with brightfield and fluorescent) prepared from cell suspension.
- Detect Amniotic cells stained by FISH (using direct labeled DNA probes for 2. chromosomes X,Y,13, 18 and 21).
- Detect Aneuploidy for chromosomes 3,7, 17 and loss of the 9p21 locus via 3. FISH in Urine specimens from subjects with transitional cell carcinoma of the bladder, probed by the Vysis Urovysion Bladder Cancer Kit.
- Detect and quantify chromosome 17 and the HER-2/neu gene via fluorescence 4. in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens, probed by the Vysis® Path Vysion™ HER-2 DNA Probe Kit. The Duet™ is to be used as an adjunctive automated enumeration tool, in conjunction with manual review of the digital image, to assist in determining HER-2/neu gene to chromosome 17 signal ratio.
- Qualitatively detect rearrangements involving the ALK gene via fluorescence in న. situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-
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Image /page/2/Picture/0 description: The image shows the logo for "bioview". The logo consists of the word "bioview" with the "bio" part stylized with three circles connected in a triangular shape. The "b" is inside a solid black circle, the "i" is inside a white circle with a black outline, and the third circle is below the other two and is white with a gray pattern inside.
small cell lung cancer (NSCLC) tissue specimens, probed with the Vysis ® ALK Break Apart FISH Probe Kit. The Duet™ is to be used as an adjunctive automated enumeration tool, in conjunction with manual review of the digital image.
Note: The pathologist should verify the image analysis software application score.
5.10 Device Description
The Duet™ System is a fully integrated imaging and scanning platform that automates time-consuming and difficult laboratory tasks of slide scanning.
The Duet™ System workstation integrates a microscope, CCD camera, motorized stage / slide-loader, computer, keyboard, mouse, joystick, monitor and a dedicated software program.
The Duet™ System is software controlled and includes features such as: acquisition of images, views, editing, relocation, enhancement capabilities, automatic/manual counting and classification, printing, export of images and backups.
The Duet™ System scans in high resolution cell samples at high speed both in bright light illumination and in fluorescent illumination.
The Duet™ System suggests classification of the cells according to their morphological features, their staining (Giemsa, IHC) and fluorescent signals, and allows the user to quickly examine the results, correct them as needed and generate a report summarizing the sample's data. The Duet™ system allows combined presentation of morphological and specific staining information of the same cell, for all the cells of the sample.
5.11 Performance Standards
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the Duet™ System complies with the following voluntary standards:
- IEC 60601-1-4 I
- . ISO 14971:2012
5.12 Guidance
- Guidance for Industry and FDA Staff Class II Special Controls Guidance ■ Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems, issued March 23, 2005.
- Guidance for the Content of Premarket Submissions for Software Contained in 미 Medical Devices, issued May 11, 2005.
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Image /page/3/Picture/0 description: The image shows the logo for Bioview. The logo consists of the word "bioview" in black font, with the "bio" portion of the word connected to a three-lobed shape. The "b" is lowercase, while the rest of the word is in lowercase. The three-lobed shape is made up of three circles, with the top circle filled in black, the middle circle containing three concentric circles, and the bottom circle filled with a dotted pattern.
5.13 Substantial Equivalence
The Duet™ System with detection of the Vysis® ALK Break Apart FISH Probe Kit is as safe and effective as the previously cleared Duet™ System with detection of the Vysis® HER-2 DNA Probe Kit. The systems have similar intended use, technological characteristics, and principles of operation as its predicate device. The technological differences between the current Duet™ System and its predicate device which are listed in the table below raise no new issues of safety or effectiveness.
Performance data demonstrate that the current Duet™ System is as safe and effective as previously cleared Duet™ System. Thus, the Duet™ System is substantially equivalent.
A substantial equivalence table, which summarizes the differences between the current Duet™ system, and its predicate device, is provided below.
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Image /page/4/Picture/0 description: The image shows the logo for "bioview". The logo consists of the word "bioview" in black font, with the "bio" portion of the word connected to a three-circle design. The three circles are arranged in a triangular shape, with the top circle filled with a black pattern, the middle circle containing a smaller circle inside, and the bottom circle filled with a light gray pattern.
| Characteristic | BioView Ltd.
Duet™ System (Current) | BioView Ltd.
Duet™ System (Predicate) |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k Number | K130775 | K061602 |
| Product Code | JOY 864.5260, NTH 866.4700 | JOY 864.5260, NTH 866.4700 |
| Intended use | The Duet™ 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 in the detection, classification and counting of cells of interest based on color, intensity, size, pattern, and shape. The Duet™ System is intended to detect:
• Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension.
• Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21).
• Cells in urine specimens, stained by FISH (using the Vysis UroVysion™ Bladder Cancer Recurrence Kit for chromosomes 3, 7, 17 and 9p21 locus), from subjects with transitional cell carcinoma of the bladder.
• Amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in human breast cancer tissue specimens, probed by the Vysis® PathVysion™ HER-2 DNA Probe Kit.
• Detect qualitatively rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, probed with the Vysis ALK Break Apart FISH Probe Kit. The Duet™ is to be used as an adjunctive automated enumeration tool, in conjunction with manual visualization. | The Duet™ 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 in the detection, classification and counting of cells of interest based on color, intensity, size, pattern, and shape. The Duet™ System is intended to detect:
• Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension.
• Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21).
• Cells in urine specimens, stained by FISH (using the Vysis UroVysion™ Bladder Cancer Recurrence Kit for chromosomes 3, 7, 17 and 9p21 locus), from subjects with transitional cell carcinoma of the bladder.
• Amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in human breast cancer tissue specimens, probed by the Vysis® PathVysion™ HER-2 DNA Probe Kit. |
| Software Version | DUET SW 3.5 | DUET SW 2.5 |
| Specimen Type | formalin-fixed paraffin-embedded (FFPE) non-small cell Lung Cancer (NSCLC) tissue specimens | formalin-fixed paraffin-embedded (FFPE) Breast cancer tissue specimens |
| Characteristic | BioView Ltd.
Duet™ System (Current) | BioView Ltd.
Duet™ System (Predicate) |
| Probe kit | Vysis® ALK Break Apart FISH Probe Kit | Vysis® PathVysion™ HER-2 DNA Probe Kit. |
| Slide Capacity | Up to 200 Slides | Up to 8 slides |
| Device components | Automated microscope | Automated microscope |
| | Motorized stage with up to 200 slides using slide-loader | Motorized stage with up to 8-slides |
| | Color or monochrome CCD camera | Color CCD camera |
| | PC | PC |
| | Display: 22" high resolution' monitor , optional 22" touch-screen with Pen pointing device | Display:17" high resolution LCD flat monitor |
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:
:
:
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Image /page/5/Picture/0 description: The image shows the logo for Bioview. The logo consists of the word "bioview" with the "b" and "i" in black circles. The "o" is a circle with a smaller circle inside, and the "view" is in plain text. The "b", "i", and "o" are connected by lines that form a shape resembling a molecule.
5.14 Performance Characteristics of the Duet™ System
A performance evaluation study was performed in order to evaluate the performance of the Duet™ System method to detect qualitatively rearrangements involving the ALK gene via fluorescence in situ hybridization in formalin-fixed paraffin-embedded non-small cell lung cancer tissue specimens, probed with the Vysis ALK Break Apart FISH Probe Kit, in terms of reproducibility and repeatability and its accuracy in comparison to the manual system.
A method comparison study was performed to provide evidence that all four previous indications cleared for the Duet™ system, can be used safely and effectively on the current system configuration that include different camera, optional slide loader and optional pen display.
Note: The performance of the Vysis ALK Break Apart Fish Probe Kit has been established with the Duet Version 3.5 configuration. Duet Version 2.5 was not validated for the ALK Break-apart test and it is not intended to perform this test.
The performance evaluation study report is comprised of the following studies, which are summarized below:
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Image /page/6/Picture/0 description: The image shows a logo for a company called "bioview". The logo consists of the word "bioview" with the "bio" part stylized. The "b" is inside a solid black circle, and the "io" is inside a circle with a white background and a black outline. To the left of the word is a graphic of three circles connected together.
Study 1 – Precision/Reproducibility Performance - an evaluation of the performance of the Duet™ System in terms of reproducibility and repeatability, within a system and across systems.
Study 2 - Analytical Performance/Methods Comparison - a comparison of the Duet™ System method to manual scoring method.
Study 3 - Configurations method comparison - to verify that the four indications previously cleared for use with Duet version 2.5 can be used safely and effectively on the current system configuration (3.5) that contains a different camera, slide loader, and pen display.
Repeatability and Reproducibility Study 5.14.1
The purpose of this study was to evaluate the precision of the Duet™ System, for its performance with the ALK™ Kit, in terms of reproducibility and repeatability. For this purpose, the Duet™ System was evaluated in three parts, as described below:
- Within-system and within-day I.
- Within-system and between-day II.
- Between-systems and sites. III.
Each of these studies were done using four (4) slides in each of the following categories of positive cells percentage : 50%) were chosen to establish device within-run, between-day, and between-site variability
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Image /page/7/Picture/0 description: The image shows the logo for "bioview". The logo consists of the letters "b", "i", "o", and the word "view". The letters "b", "i", and "o" are inside of circles that are connected to each other. The circles are arranged in a triangular shape, with the "b" at the top left, the "i" at the top right, and the "o" at the bottom.
Within-run: Three runs for each of the panel members were performed on the same day.
| Category | Slide ID | Mean | Standard
Deviation | Coefficient of
Variation (%) |
|----------|-----------|-------|-----------------------|---------------------------------|
| 50% | BV Val 09 | 74.7% | 4.2 | 5.6 |
| | BV Val 10 | 57.3% | 4.2 | 7.3 |
| | CYNK-36 | 69.3% | 5.8 | 8.3 |
| | CYNK-50 | 53.0% | 8.5 | 16.1 |
Between-day: Variability was assessed by assessing panel member performance of on three different days. The shortest between-day interval was five days.
| Category | Slide ID | Mean | Standard Deviation | Coefficient of Variation (%) |
|---|---|---|---|---|
| 50% | BV Val 03 | 64.7% | 3.1 | 4.7 |
| BV Val 06 | 55.3% | 3.1 | 5.5 | |
| BV Val 09 | 70.0% | 12.0 | 17.1 | |
| CYNK-50 | 52.3% | 7.5 | 14.3 |
:
・
Site-to-Site: Reproducibility was validated by testing each slide three times, each at a different site and Duet system.
| Category | Slide ID | Mean | Standard Deviation | Coefficient of Variation (%) |
|---|---|---|---|---|
| 50% | BV Val 06 | 58.7% | 3.1 | 5.2 |
| BV Val 09 | 76.7% | 8.3 | 10.9 | |
| BV Val 10 | 55.3% | 2.3 | 4.2 | |
| BV Val 02 | 79.3% | 12.9 | 16.2 |
Conclusions:
- Overall %CV's derived from the Mixed Model were all well below the . performance goals specified
- Of the 48 slides, each measured three (3) times, a single slide displayed a ● %CV above the 25% performance goal specified; %CV for the positive slide in the "Day" study was 27%, where the next highest %CV was 17.1%
- For binary outcomes: .
- Repeatability was 100% a.
- b. Reproducibility was 100%
We thus conclude that the acceptance criteria were met and the Duet™ system is repeatable and reproducible.
Analytical Performance (Method Comparison) Study 5.14.2
The purpose of this study was to demonstrate the accuracy of the Duet™ System method for detection of rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, probed with the Vysis ALK Break Apart FISH Probe Kit, in comparison to the manual scoring method.
The study consisted of a total of 113 specimen slides. Out of these 113 slides, 32 slides were positive and 11 were equivocal.
The slides were prepared and probed using the ALK Kit, according to the manufacturer, while each slide was screened both manually and using the Duet™ system.
Acceptance Criteria
The objective of this study is to demonstrate that the Duet™ System is concordant with manual counting.
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Image /page/10/Picture/0 description: The image shows the logo for Bioview. The logo consists of the word "bioview" in a sans-serif font, with the "bio" portion of the word stylized with a connected set of three circles. The first circle, which contains the letter "b", is shaded with a white letter on a black background. The second circle, which contains the letter "i", is shaded with a black letter on a white background. The third circle, which contains the letter "o", is shaded with concentric circles.
The statistical analysis performed for the pooled results included levels of agreement with the manual. The statistical analysis presented in the following tables below demonstrates the accuracy of the Duet™ system as indicated by its high level of agreement in comparison to the manual method.
| Manual scoring | ||||
|---|---|---|---|---|
| Final Result | - | + | Total | |
| With | ||||
| Duet | ||||
| Method | - | 81 | 1 | 82 |
| + | 0 | 31 | 31 | |
| Total | 81 | 32 | 113 |
Method comparison - Summary of Pooled Results
| Accuracy Parameter | Value | Lower 95%
CI | Upper 95%
CI |
|----------------------------------------|-------|-----------------|-----------------|
| Percent Agreement with Manual Negative | 100% | 95.5% | 100% |
| Percent Agreement with Manual Positive | 96.9% | 84.3% | 99.5% |
| Percent Overall Agreement | 99.1% | 95.2% | 99.8% |
Conclusion:
The test demonstrated that the acceptance criteria were met.
High correlation was found between the manual method and the results of the Duet™ System method, showing excellent accuracy in detecting positive and negative samples, as defined by the ALK Kit and the manual method. The overall agreement between both methods (the Duet™ and the manual) was 99.1% (95%, CI 95.2%-99.8%). No significant differences between the studies in the three sites were found, rendering the pooled analysis is valid.
Configurations Method Comparison Study 5.14.3
This study was intended to provide evidence that the changes in hardware configuration that includes different camera, optional slide loader and an optional pen display have not impacted performance with the indications cleared in previous 510(k) submissions.
The study was performed with the following guidelines:
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Image /page/11/Picture/0 description: The image shows the logo for "bioview". The logo consists of the word "bioview" with the "bio" part of the word stylized with circles. The "b" is inside a solid black circle, the "i" is inside a solid black circle, and the "o" is inside two concentric circles. The circles are connected by lines that form a three-way intersection, with the top circle being solid black and the bottom circle being gray.
- The study included comparison of patient slides from each of the four ● previously cleared indications: Hematopoietic cells, Amniotic cells, Bladdercancer cells probed by Urovysion and Breast-cancer cells probed by Her-2 Path Vysion probe.
- Same slides were evaluated on the cleared Duet™ configuration (version 2.5) . and by the current submission configuration (version 3.5).
- Each of the previously cleared indications was tested using patient slides . samples. Samples were selected to cover the intended use of both Normal, Abnormal and near the medical decision/cut-off (as applicable). Clinical specimen were selected from each relevant sample type and from each scoring category.
Results summary:
- The test sets included all required slides. .
- Final interpretation of results was identical in all slides between new . configuration and cleared configuration.
- The differences in numerical results between new configuration and cleared . configuration met the pre-defined acceptance criteria for each test, in all slides.
5.15 Final Conclusion
BioView Ltd. believes that the Duet™ System is substantially equivalent to the combination of its predicate devices in terms of Intended Use, Indications for Use, technological characteristics and mode of operation. Any differences between the Duet™ System and its predicate devices do not raise new safety or effectiveness issues, based on the performance results and the analysis of similarities and differences presented above.
12
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 9, 2014
BIOVIEW LTD. ORLY MAOR 25A SIRKIN ST. KFAR SABA 4442156 ISRAEL
Re: K130775 Trade/Device Name: Duet™ System Regulation Number: 21 CFR 866.4700 Regulation Name: Automated fluorescence in situ hybridization (FISH) enumeration systems Regulatory Class: II Product Code: NTH Dated: May 3, 2014 Received: May 6, 2014
Dear Ms. Maor:
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 10 as batter in the May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce provide thay 20, 2011 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmoties for (1 corp too) the device, subject to the general controls provisions of the Act. The I ou may, morelors, manus of the Act include requirements for annual registration, listing of general controls pro revering practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Themse note. One of 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 your device is classified nal controls. Existing major regulations affecting your device can be fromd in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may round in the Code of I casiants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please of advised hat I Dri 3 issuance or a cadesice complies with other requirements of the Act that FDA has made a determinations administered by other Federal agencies. You must of any rederal statutes and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements inental device-related auvellas ovense (QS) regulation (21 CFR Part 820); and if applicable, the as set 1011 in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
13
Page 2-Ms. Maor
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 Romin -S
Reena Philip, PhD Director Division of Molecular Genetics and Pathology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
14
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Expiration D
See PRA St
510(k) Number (if known) K130775
Device Name Duet™ System
Indications for Use (Describe)
The Duer™ System is an automated scanning microscope and imuge analysis system. It is intended for in-vitro diagnostic use as an aid to the pathologist in the detection, classification and counting of cells of interest based on color, intensity, size, pattern and shape.
The Duet™ System is intended to:
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Detect Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with brightfield and fluorescent) prepared from cell suspension.
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Detect Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X. Y. 13, 18 and 21).
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Detect Aneuploidy for chromosomes 3,7. 17 and loss of the 9p21 locus via FISH in Urine specimens from subjects with transitional cell carcinoma of the bladder, probed by the Vysis Urovysion Bladder Cancer Kit.
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Detect and quantify chromosome 17 and the HER-2/neu gene via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens, probed by the Vysis® Path Vysion™ HER-2 DNA Probe Kit. The Duet™ is to be used as an adjunctive automated enumeration tool, in conjunction with manual review of the digital image, to assist in determining HER-2/neu gene to chromosome 17 signal ratio.
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Qualitatively detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalinfixed paraffin-embedded (FFPE) non-
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small cell lung cancer (NSCLC) tissue specimens, probed with the Vysis ® ALK Break Apart FISH Probe Kit. The Duer™ is to be used as an adjunctive autonated enumeration with manual review of the digital image. Note: The pathologist should verify the image analysis software application score.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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