(229 days)
Not Applicable
Unknown
The description mentions "image analysis" and "suggests classification of the cells according to their morphological features, their staining... and fluorescent signals," which could potentially involve AI/ML techniques for pattern recognition and classification. However, the document does not explicitly mention AI, ML, deep learning, or any related terms, nor does it provide details about training or test sets that are typical for AI/ML models. The description of the system components (microscope, camera, computer, software) is generic and doesn't specifically point to AI hardware or software.
No.
The device is an in vitro diagnostic (IVD) tool designed to assist pathologists in analyzing microscopy slides by detecting, classifying, and counting cells. It does not provide any direct treatment or therapy to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Duet™ System is "intended for in vitro diagnostic use as an aiding tool to the pathologist." It also lists several specific diagnostic applications, such as detecting hematopoietic cells, amniotic cells, cells in urine specimens, and quantifying HER-2/neu gene in breast cancer tissue specimens.
No
The device description explicitly states that the Duet™ System integrates a microscope, CCD camera, motorized stage, computer, keyboard, mouse, joystick, monitor, and dedicated software. This indicates it is a system with significant hardware components, not a software-only device.
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 Duet™ System is "intended for in vitro diagnostic use as an aiding tool to the pathologist". It also lists specific diagnostic applications involving the analysis of biological samples (cells from various sources) using staining and imaging techniques.
- Device Description: The description details a system designed to analyze biological samples on slides, which is a core function of IVD devices.
- Performance Studies: The document includes summaries of performance studies (Methods Comparison, Precision/Reproducibility) that evaluate the device's accuracy and reliability in a diagnostic context.
- Key Metrics: The inclusion of metrics like NPA, PPA, Overall Agreement, and Kappa are standard measures used to evaluate the performance of diagnostic devices.
- Predicate Devices: The listing of predicate devices with K numbers indicates that this device is being compared to other legally marketed IVD devices.
All of these elements strongly support the classification of the Duet™ System as an In Vitro Diagnostic device.
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 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.
- Detect amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21).
- Detect 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.
- 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® PathVysion™ HER-2 DNA Probe Kit. The Duet™ is to be used as an adjunctive automated enumeration tool, in conjunction with manual visualization, to assist in determining HER-2/neu gene to chromosome 17 signal ratio.
Product codes
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 screening by making a significant reduction in time and labor currently required.
The Duet™ System workstation integrates a microscope, CCD camera, motorized stage, computer, keyboard, mouse, joystick, monitor and a dedicated software program.
The Duet™ System scans in high resolution and in full color cell samples at high speed both in bright 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 unique feature of the Duet™ System allows the combined presentation of morphological and specific staining information of the same cell, for all the cells of the sample.
Mentions image processing
The Duet™ System is an automated scanning microscope and image analysis system.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Bright field and fluorescent illumination
Anatomical Site
Human breast cancer tissue specimens; Hematopoietic cells; Amniotic cells; Cells in urine specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
In vitro diagnostic use as an aiding tool to the 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
A total of 56 specimen slides, prepared from human breast cancer tissue specimens in various stages of the disease, representing the entire intended use population, were probed by the PathVysion™ Kit according to the manufacturer instructions. Each slide was screened both manually and using the Duet™ system.
For the purpose of the agreement analysis between the manual and the Duet™ System, 'Amplification' scoring ("FISH positive") was defined as a ratio of ≥ 2.0 and 'No-Amplification' scoring (FISH negative'') was defined as a ratio of
§ 864.5260 Automated cell-locating device.
(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).
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510(K) SUMMARY
510(K) Number K061602
Applicant's Name: 5.1
Bioview Ltd. 3 Pekeris St. Rehovot P.O.B. 4051, Ness Ziona 70400, Israel Tel: 972-8-9366868 Fax: 972-8-9366869
JAN 2 3 2007
5.2 Contact Person:
Dorit Winitz, Ph.D. Biomedical Strategy (2004) Ltd. 7 Jabotinsky Street. Ramat Gan 52520, Israel Tel: +972-3- 6123281 Fax: +972-3-6123282 Mail: dorit@ebms.co.il
Date Prepared: 5.3 June 2006
5.4 Trade Name:
Duet™ System
Classification Name: 5.5
- Automated cell-location device and: .
- Automated Fluorescence in situ Hybridization (FISH) Enumeration . Systems
Medical Specialty: 5.6
Hematology and Immunology
Product Code: 5.7
- Automated cell-locating devices, product code: JOY .
- . Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems, product code: NTH
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5.8 Device Class:
- II
5.9 Regulation Number:
- Automated cell-locating devices (product code JOY, Regulation No. ■ 864.5260)
- . Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems (product code NTH, Regulation No. 866.4700)
5.10 Panel:
Hematology and Immunology
5.11 Predicate Devices:
BioView Ltd. is relying on the combination of the following predicate devices and a standard procedure for the current Duet™ System substantial equivalence discussion:
- Duet™ System, manufactured by BioView Ltd., cleared under K030192, K040591 and K050840 (Product codes JOY and NTH)
- Ariol® HER-2/neu FISH, manufactured by Applied Imaging Corp., . cleared under K043519 (product code NTH)
- Vysis® AutoVysion™ System, manufactured by Vysis Inc., cleared . under K041875 (product code NTH)
- Human manual visualization of human breast cancer tissue . specimens, probed by Vysis® PathVysion™ HER-2 DNA Probe Kit (Hereinafter, the Manual Method).
5.12 Performance Standards and Guidance:
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, and Guidance:
- EN 61010-1 미
- 트 EN 61326-1
- 파 IEC 60601-1-4
- ISO 14971-1
- FDA Guidance for Industry and FDA Staff Class II Special Controls I Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems (March 2005).
- . General Principles of Software Validation; Final Guidance for Industry and FDA Staff, FDA, CDRH (January 2002).
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5.13 Intended Use / Indication for 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:
- Giemsa stain, Hematopoietic cells stained by . Detect Immunohistochemistry or ISH (with bright field 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 cells in urine specimens, stained by FISH (using the Vysis t UroVysion™ Bladder Cancer Recurrence Kit for chromosomes 3, 7, 17 and 9p21 locus), from subjects with transitional cell carcinoma of the bladder.
- · 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® PathVysion™ HER-2 DNA Probe Kit. The Duet™ is to be used as an adjunctive automated enumeration tool, in conjunction with manual visualization, to assist in determining HER-2/neu gene to chromosome 17 signal ratio.
5.14 Device Description:
The Duet™ System is a fully integrated imaging and scanning platform that automates time-consuming and difficult laboratory tasks of slide screening by making a significant reduction in time and labor currently required.
The Duet™ System workstation integrates a microscope, CCD camera, motorized stage, computer, keyboard, mouse, joystick, monitor and a dedicated software program.
The Duet™ System scans in high resolution and in full color cell samples at high speed both in bright 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 unique feature of the Duet™ System allows the combined presentation of morphological and specific staining information of the same cell, for all the cells of the sample.
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5.15 Substantial Equivale
Intended Use
The intended use of the Duet™ System is expanded to include the detection and quantification of chromosome 17 and 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 (the PathVysion™ Kit). The Duet™ is to be used as an adjunctive automated enumeration tool, in conjunction with manual visualization, to assist in determining HER-2/neu gene to chromosome 17 signal ratio. Besides the additional indication, the Intended Use and Indication for Use statement of the Duet™ System were not changed.
Detection, classification and counting of HER-2/neu gene amplification via fluorescence in situ hybridization (FISH) in human breast cancer tissue specimens, probed by the PathVysion™ Kit, are routinely performed manually at the specialized laboratories using conventional microscopes, according to the instructions provided with the approved kit. The claim of an automated aiding tool for the detection and enumeration of FISH signals is also claimed by the 510(k)-cleared automatic enumeration predicate devices, the Vysis® AutoVysion™ System, the Ariol® HER-2/neu FISH and the previously cleared Duet™ System. Both the Vysis AutoVysion™ System and the Ariol® HER-2/neu FISH, similar to the Duet™ System, are intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. In particular, the specific indication of HER-2/neu gene amplification detection via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens, probed by the PathVysion™ Kit, is common to the Duet™ System and to both these predicates.
The new intended use was supported by a comparative performance study demonstrating that the operation of the Duet™ System is safe and effective for this application in comparison to manual microscopy. This study, which is summarized below, further confirms that any minor differences between the manual and the automated Duet™ System do not raise any issue of safety or efficacy.
Technological Characteristics and Mode of Operation
The current Duet™ System is the same system as the 510(k)-cleared Duet™ System. No change was required to be incorporated to the system's hardware to support the new indication, and only minor software changes, including new algorithm for the automatic calculation of the overall amplification ratio of HER-2/neu gene, were made. All these changes were fully verified and validated through software verification and validation. The performance study described below
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further confirms that any minor differences between the manual and the automated Duet™ System do not raise any issue of safety or efficacy.
5.16 Performance Characteristics of the Duet™ System:
A performance evaluation study was performed in order to evaluate the performance of the Duet™ System for the detection of amplification of the HER-2/neu gene via FISH in human breast cancer tissue specimens, probed by the PathVysion™ Kit, in terms of its accuracy in comparison to the manual system, and its reproducibility and repeatability.
The performance evaluation study report is comprised of the following four studies, which are summarized below:
Study 1 - Methods Comparison - a comparison of the Duet™ System method to manual scoring method.
Study 2 - 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 3 - The Optimal Number of Fields of View - a determination of the optimal number of Fields of View required to be captured by the system for accurate sampling of the specimen.
Study 4 - Methods Comparison at the Borderline Range. A comparison of the Duet™ System method to manual scoring method at the borderline range.
5.16.1 Methods Comparison with Predicate Device
The purpose of this study was to demonstrate the accuracy of the Duet™ System method for detection of amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in human breast cancer tissue specimens, probed by the PathVysion™ Kit, in comparison to the manual scoring method.
The study was conducted in four (4) sites, which followed the same study protocol. A total of 56 specimen slides, prepared from human breast cancer tissue specimens in various stages of the disease, representing the entire intended use population, were probed by the PathVysion™ Kit according to the manufacturer instructions. Each slide was screened both manually and using the Duet™ system.
For the purpose of the agreement analysis between the manual and the Duet™ System, 'Amplification' scoring ("FISH positive") was defined as a ratio of ≥ 2.0 and 'No-Amplification' scoring (FISH negative'') was
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d as a ratio of 2.3). All slides were prepared according to the probe manufacturer's instructions.
The statistical analyses performed include estimating the average value, standard deviation and percent coefficient of variation (CV) for each slide separately for repeatability, lab reproducibility and day reproducibility.
Test results obtained for three (3) FOVs analysis demonstrated that CV values were usually low and ranged between 0.56 and 12.90 % for all cases. Only one exception was seen is laboratory reproducibility for one of the sample with a CV of 31.92%, resulted from very high amplification, which avoided accurate spot counting. Considering this objective problem of accuracy, good repeatability and reproducibility for the Duet™ System was demonstrated.
Therefore it can be concluded that the Duet™ System was proven to have high values of repeatability within run, between days and between sites, for three (3) FOVs analyses.
5.16.3 The Optimal Number of Fields of View
Method comparison studies and reproducibility and repeatability studies were conducted using both 3 and 6 FOVs to evaluate the optimal performance of the Duet System using a minimal number of FOVs. The correlation between results obtained from the Duet System 3 and 6 FOV analyses revealed a correlation of .996, with R-square = .993. In addition, the constant was near 0 (0.0084) and non-significant (t = 0.207, p = 0.836). Therefore, 3 FOV provides results that are sufficient for the effective performance of the Duet System.
5.16.4 Methods Comparison at the Borderline Range
The purpose of this study was to further demonstrate the accuracy of the Duet™ System method for detection of amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in human oreast cancer tissue specimens, probed by the PathVysion™ Kit, in comparison to the manual scoring method, in the borderline range.
For this purpose, a total of 21 human breast cancer tissue specimen slides, representing a borderline range [1.5-2.5], were selected,
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including the seven (7) borderline samples of this range from Study-1 and additional new fourteen (14) borderline samples collected from additional site.
A combined analysis of these results with the results of the seven (7) borderline samples from Study-1 was performed. All slides used for the analysis were human clinical specimens prepared from breast cancer tissues, probed by the PathVysion™ Kit according to the manufacturer instructions and which were found to be in the predefined borderline range [1.5-2.5].
For the purpose of the analysis of the agreement between the manual and the Duet™ System, the same criteria used in Study-1 (Method Comparison) were used. Thus, 'Amplification' scoring ("FISH positive") was defined as a ratio of ≥ 2.0 and 'No-Amplification' scoring ("FISH negative") was defined as a ratio of