(137 days)
Unknown
The document describes an "image analysis system" that "suggests classification of the cells according to their morphological features, their staining... and fluorescent signals". While this functionality could potentially be implemented using AI/ML, the document does not explicitly mention AI, ML, deep learning, or any related terms. The description of the studies focuses on agreement with manual methods and reproducibility, not on the training or validation of an AI/ML model. Without explicit mention or further detail on the "image analysis" methods used, it's impossible to definitively confirm the presence of AI/ML.
No
The device is an in-vitro diagnostic tool intended to assist pathologists in analyzing cells, not to provide therapy or directly treat patients.
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 in the detection, classification and counting of cells of interest".
No
The device description explicitly states it is a "fully integrated imaging and scanning platform" and mentions "bright light illumination and fluorescent illumination," indicating it includes hardware components beyond just software.
Yes, the Duet™ System is an IVD (In Vitro Diagnostic) device.
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".
- Device Description: The description details how the system is used to analyze biological samples (cell samples, urine specimens) prepared from patients, which is a core characteristic of IVD devices.
- Performance Studies: The provided performance studies evaluate the system's ability to detect and enumerate cells in patient samples (bladder cancer recurrence kit, amniotic cells, hematopoietic cells) and compare its performance to manual methods and other systems, which are typical evaluations for IVD devices.
- Predicate Devices: The listed predicate devices include other Duet™ Systems and the Vysis UroVysion™ Bladder Cancer Recurrence Kit and AutoVysion™ System, all of which are IVD devices.
The system analyzes biological samples in vitro (outside the body) to provide information for diagnostic purposes, fitting the definition of 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.
- 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.
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™ scans in high resolution and in full color cell samples at high speed both in bright light illumination and in fluorescent illumination.
Duet™ 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 presents 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 illumination, Fluorescent illumination
Anatomical Site
Hematopoietic cells, Amniotic cells, Cells in urine specimens (from subjects with transitional cell carcinoma of the bladder)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pathologist, Clinical Laboratory, Cytogeneticist (for manual comparison)
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
Study 1 - Comparison of the Duet™ System method to manual scoring method
Total of 135 slides were probed using the Vysis UroVysion™ Bladder Cancer Recurrence Kit according to the manufacturer instructions (Vysis Inc., Downers Grove, IL). The slides were screened both manually and using the Duet™ system, while the slides at one of the laboratories were screened twice for each method.
Study 2 - Evaluation the performance of the Duet™ System in terms of reproducibility and repeatability, within a system and across systems.
The experiment included four (4) slides. The slides were selected to cover the range of the intended use, namely, to include two (2) negative slides, one (1) positive and one (1) near the medical decision cutoff. The experiment was performed by two (2) operators at Bio View Lab, in cooperation with Meir Hospital, Kfar Saba, Israel.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study 1 - Comparison of the Duet™ System method to manual scoring method
Study Type: Comparative performance study
Sample Size: 135 slides (total of 178 slides for pooled results as some slides screened twice for each method)
Key Results: High correlation was found between the results of the manual method and the Duet™ Method, showing excellent accuracy in detecting both normal and abnormal samples, as defined by the manual method. The overall agreement level between both methods (described by Kappa agreement level index) was calculated to be 0.918 (P-value
§ 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).
0
510(K) SUMMARY
Duet™ system
510(k) Number K_050840
Applicant's Name:
Bioview Ltd. 3 Pekeris St. Rehovot P.O.B. 4051, Nes Ziona 70400, Israel Tel: 972-8-9366868 Fax: 972-8-9366869
Contact Person:
Dorit Winitz, Ph.D. Biomedical Strategy Ltd. 11 Menachem Begin Street. Ramat Gan 52521, Israel Tel: +972-3-6123281 Fax: +972-3-6123282 Mail: dorit@ebms.co.il
Date Prepared:
March, 2005
Trade Name:
Duet™ System
Classification Name:
Automated cell-location device and: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems
Classification:
FDA has classified Automated cell-locating devices (product code JOY, I'DA Tias Chassillor No. 864.5260) and Automated Fluorescence In situ Hybridization
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(FISH) Enumeration Systems (product code NTH, Regulation No. 866.4700) as class II devices and they are reviewed by the Pathology and Immunology Panels, respectively.
Predicate Devices:
- · Duet™ System, cleared under K030192, and K040591 (Product code JOY)
- · Vysis UroVysion™ Bladder Cancer Recurrence Kit, cleared under K011031 and K033982 (Product code NOT)
- · Human manual visualization of urine specimens cells from subjects with transitional cell carcinoma of the bladder, probed by the UroVysion™ Kit by conventional microscope.
- · Vysis@ AutoVysion™ System, K041875 (product code NTH)
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:
- . EN 61010-1
-
EN 61326-1
- IEC 60601-1-4 용
- EN-1441: Medical devices Risk Analysis. す
- ISO 14971 Medical Devices-Risk Management .
Indications:
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 labelcd 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.
7-4
2
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™ scans in high resolution and in full color cell samples at high speed both in bright light illumination and in fluorescent illumination.
Duet™ 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 presents combined presentation of morphological and specific staining information of the same cell, for all the cells of the sample.
Substantial Equivalence:
Intended use
The intended use of the Duet™ System is expanded to include the indication of an aiding tool in the detection of 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 Recurrence Kit
Detection, classification and counting of urine specimens from subjects with traditional cell carcinoma of the bladder, stained using the cleared Vysis UroVysion™ Bladder Cancer Recurrence Kit are routinely performed manually by cytogeneticist using conventional microscopes, according to the kit instructions.
The claim of an automated aiding tool for detection and enumeration of FISH signals is also claimed by the 510(k)-cleared Vysis AutoVysion™ System and the previously cleared Duet™ System.
The Duet™ System employs the same procedures as employed by human manual visualization using conventional microscopes. Additionally, the new intended use was supported by a comparative performance study demonstrating that the operation of the Duet™ System is safe and effective as an aiding tool in the detection of 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 Recurrence Kit, in comparison to manual microscopy.
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Technological characteristics
The current Duet™ System is the same system as the 510(k)-cleared Duet™ System. No changes were incorporated to the system's hardware or software to support the new indication.
Mode of Operation
Exactely as the cleared Duet™ System, the current Duet™ System provides two modes of operation:
- · Automatic scanning: provides a gallery of targets that the system captures for all identified cells.
- Manual scanning: provides interactive control over the microscope. . This enables a user-controlled scan of any slide under either bright field or fluorescent illumination.
The user of the current Duet™ Systems, enters the scan parameters, slide number, comments, and annotates the results in the same manner as done using the predicate devices and during standard human visualization of cytology slides. Similarly, final classification is performed by the operator.
A special task was designed for the use of the Duet™ System with the UroVysion™ Kit, defining filters, classes and stop criteria in accordance with the UroVysion™ Kit. In addition, specific instructions for scanning and analysis of the UroVysion™ Kit were added to the Duet™ User's manual. The performance studies described below confirms that any minor differences between the manual and the automated Duet™ System do not raise any issue of safety or efficacy.
Performance characteristics of the Duet System:
Performance characteristics of the Duet System were verified by the following studies:
내 Study 1 - Comparison of the Duet™ System method to manual scoring method
This study was performed to demonstrate the equivalency of the Duet™ method to the manual scoring method for detection and enumeration of slides probed by the Vysis Urovysion™ Bladder Cancer Recurrence Kit.
Total of 135 slides were probed using the Vysis UroVysion™ Bladder Cancer Recurrence Kit according to the manufacturer instructions (Vysis Inc., Downers Grove, IL). The slides were screened both manually and using the Duet™ system, while the slides at one of the laboratories were screened
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twice for each method. Statistical analysis was performed for each study separately and for the pooled results (178 slides).
The statistical analysis performed included acceptable accuracy analysis with calculation of positive/negative predictive values, combined with Kappa value for agreement level.
High correlation was found between the results of the manual method and the Duet™ Method, showing excellent accuracy in detecting both normal and abnormal samples, as defined by the manual method. The overall agreement level between both methods (described by Kappa agreement level index) was calculated to be 0.918 (P-value