IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM

K052577 · Ikonisys, Inc. · JOY · Jan 24, 2006 · Hematology

Device Facts

• Record ID: K052577
• Device Name: IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
• Applicant: Ikonisys, Inc.
• Product Code: JOY · Hematology
• Decision Date: Jan 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5260
• Device Class: Class 2

Indications for Use

The Ikoniscope™ fastFISH™ Amnio Test System is an automated scanning microscope coupled with image analysis, acquisition and display functions. It is intended for invitro diagnosis as an aide to the technologist or pathologist in the detection, classification and enumeration of cells of interest based on particular characteristics such as intensity, size, shape or fluorescence. The Ikoniscope™ fastFISH™ Amnio Test System is intended to detect amniotic cells stained by FISH using commercially available, FDA approved, direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21.

Device Story

Automated scanning microscope system for FISH-stained amniotic cells; utilizes automated slide loading/handling; performs low and high magnification scanning; captures digital images of cells exhibiting predetermined signal characteristics; stores image locations. System presents image gallery to operator/reader via workstation for diagnostic evaluation. Operates in clinical laboratory setting; used by cytotechnologists or pathologists. Pattern recognition algorithms identify signal characteristics; system provides pseudo-color images. Facilitates detection, classification, and enumeration of cells of interest; assists in diagnostic decision-making for chromosomal abnormalities.

Clinical Evidence

Clinical trial evaluated 62 amniotic fluid samples (124 slides) comparing Ikoniscope fastFISH to standard manual microscopy. Primary endpoint was diagnostic evaluation; results showed 100% concordance. Reproducibility study (80 slides, 76 processed) using normal and trisomic cell lines (10% and 70% concentrations) across four instrument runs showed 98.7% agreement between two independent cytotechnologists. No effect of instrument, operator, or run on reproducibility.

Technological Characteristics

Automated scanning microscope with integrated slide loader, digital camera, and image analysis workstation. Employs pattern recognition algorithms for automated cell locating/counting based on fluorescence signals. Connectivity via workstation display. System is an adjunct to manual FISH analysis.

Indications for Use

Indicated for use as an aid to technologists or pathologists in the detection, classification, and enumeration of amniotic cells stained by FISH (chromosomes X, Y, 13, 18, 21) in patients undergoing diagnostic amniocentesis.

Regulatory Classification

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.)

Predicate Devices

• Duet™ (K040591/S1)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
K052577

B. Purpose for Submission:
Original 510(k)

C. Manufacturer and Instrument Name:
Ikonisys, Inc., Ikoniscope™ fastFISH™ Amnio Test System

D. Type of Test or Tests Performed:
The Ikoniscope fastFISH Amnio Test System detects amniotic cells stained by FISH using commercially available direct labeled DNA probes or chromosomes X, Y, 13, 18, and 21.

E. System Descriptions:

1. Device Description:
The Ikoniscope fastFISH Amnio Test System is an automated scanning microscope system incorporating automated slide loading and handling, low and high magnification scanning to identify targets of interest and digital image acquisition, coupled with an image analysis workstation. Microscope slides, prepared according to the DNA probe manufacturers' specifications, are placed into a multiple slide cassette, and loaded into the Ikoniscope fastFISH Amnio test system. The system unloads each slide, scans each one, and returns it to the cassette automatically. During scanning, images of cells exhibiting the predetermined characteristics for FISH signals are digitally photographed and stored. After all the slides are scanned, the workstation provides an image gallery for each slide that displays the image of each cell meeting predetermined characteristics and quantity. The operator/reader can then evaluate the cell nuclei, and make the diagnostic determination accordingly.

2. Principles of Operation:
The Ikonisys fastFISH imaging system combines elements of existing technologies to perform its function. Fluorescence In-Situ Hybridization (FISH) uses commercially available DNA probes (not supplied with the test system) for marking chromosomes 13, 18, 12, X and Y. Automated cell locating/counting

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uses pattern recognition algorithms to identify the signal characteristics of interest. The Ikoniscope software automatically captures an image of each cell containing FISH signals and stores its location on the slide. These images are then presented to the operator, using a computer workstation for analysis.

3. Modes of Operation:
N/A

4. Specimen Identification:
Barcode

5. Specimen Sampling and Handling:
Amniotic fluid samples should be collected, handled, and prepared according to the protocols for each clinical laboratory. Ikonisys cassettes hold one standard microscope slide.

6. Calibration:
Calibration of the Ikoniscope is done at the time of installation by Ikonysis.

7. Quality Control:
ProbeChek® quality control slides provided by Abbott should be used with AneuVysion® probes as recommended by the probe manufacturer.

8. Software:
FDA has reviewed applicant's Hazard Analysis and Software Development processes for this line of product types:
Yes ☐ X ☐ or No ☐ Comprehensive software documentation at a moderate level of concern was provided.

F. Regulatory Information:

1. Regulation section:
21 CFR 864.5260, Automated cell-locating device

2. Classification:
Class II

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3 Product code:
JOY

4. Panel:
Hematology (81)

G. Intended Use:

1. Indication(s) for Use:
The Ikoniscope fastFISH Amnio Test System is an automated scanning microscope coupled with image analysis, acquisition and display functions. It is intended for in-vitro diagnosis as an aide to the technologist or pathologist in the detection, classification and enumeration of cells of interest based on particular characteristics, such as intensity, size, shape, or fluorescence. The Ikoniscope™ Amnio Test System is intended to detect amniotic cells stained by FISH using commercially available direct labeled DNA probes or chromosomes X, Y, 13, 18, and 21.

2. Special Conditions for Use Statement(s):
N/A

H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:
BioView Ltd., Duet™ System (K001420)

2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Illumination | Halogen Lamp | Same |
| Basic Components | Automated slide loading; automated microscope; camera; PC; keyboard and control panel; color monitor, color printer for reports | Same |
| Cells Targeted | Amniocytes | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Clinical Trial Comparison | Test device compared with standard FISH analysis. | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Method of Operation | Automated epi-fluorescent microscopy with monochrome digital image capture of wavelength specific fluorescent signals. | Automated microscopy in bright-field and fluorescent illumination with color digital image capture of color specific fluorescent signals. |
| Microscope Objectives | 10X, 100X (50X actual resolution) | 10X, 60X |
| Camera | Monochrome, Digital | Color, Digital |
| Image Presentation | Pseudo-color image | Color image |
| Clinical Trial Size | 124 slides for 62 patients | 133 slides for 68 patients |
| Indications for Use Matrix | Amniotic fluid stained by FISH using direct labeled DNA probes or chromosomes X, Y, 13, 18, and 21. | 1. Hematopoietic cells stained by Giemsa stain, immunochemistry or ISH (with brightfield or fluorescent) prepared from cell suspension. 2. Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18, and 21. |

I. Special Control/Guidance Document Referenced (if applicable):

N/A

J. Performance Characteristics:

1. Analytical Performance:

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a. Accuracy:

The accuracy study was a clinical trial that evaluated samples of amniotic fluid obtained from women undergoing diagnostic amniocentesis. A total of 62 samples (124 slides) were evaluated. Samples were split and prepared for FISH assay in the usual way, using the Vysis Aneu Vysion® probes and following the approved Aneu Vysion protocol. Two sets of slides were prepared from each sample. One set was analyzed using standard manual microscopy and the other using the Ikonisys™ fastFISH™ Amnio Imaging System. Trained cytotechnologists under blind conditions evaluated the samples. The study endpoint was the diagnostic evaluation. There was a 100% concordance of diagnostic results.

b. Precision/Reproducibility:

The reproducibility study evaluated possible effects of operator, instrument, or run on the reproducibility of results using the Ikonisys™ fastFISH Amnio Imaging System. Slides for evaluation were prepared by the Sponsor and shipped to the laboratory for testing. Slides for the study were produced using two cultured human amniocyte cell lines. One line has the normal human chromosome complement and the other is trisomic for chromosome 18. Mixtures containing a low (10%) or high (70%) concentration of trisomic cells were prepared from cultures of these lines. Slides containing fixed interphase nuclei were prepared from these specimens following a standard Carnoy fixation protocol. Hybridization of the slides was undertaken at the testing laboratory using the Aneu Vysion™ Kit according to the manufacturer's instructions.

Slide sets were assembled randomly with regard to high and low-concentration samples. Two sets of 10 slides were evaluated on each of four separate instrument runs on different days. Two independent cytotechnologists, who scored the slides in a blind fashion, evaluated the image gallery produced for each slide. Of the 80 slides, 76 were able to be processed. The trial endpoint was the detection of trisomic cells. In only one case was there disagreement between the two independent technologists, yielding an agreement rate of 98.7%. There was no affect of instrument, operator, or run on the reproducibility of the results.

c. Linearity:

N/A

d. Carryover:

N/A

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e. Interfering Substances:
N/A

2. Other Supportive Instrument Performance Data Not Covered Above:
N/A

K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

L. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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