DUET SYSTEM

K030192 · Bioview , Ltd. · JOY · Aug 20, 2003 · Hematology

Device Facts

• Record ID: K030192
• Device Name: DUET SYSTEM
• Applicant: Bioview , Ltd.
• Product Code: JOY · Hematology
• Decision Date: Aug 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5260
• Device Class: Class 2

Intended Use

The Duet™ system is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnosis use as an aiding tool to the pathologist in the detection, classification and counting of cells of interests based on particular color, intensity, size, pattern and shape. This particular application is intended to detect hematopoietic cells positively stained by Giemza stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension. The device can be used without limitation to specific diseases.

Device Story

Duet™ system is an automated scanning microscope and image analysis platform for laboratory slide screening. Input: cell samples on slides (Giemsa, IHC, or ISH stained). Operation: high-resolution, high-speed scanning in bright field and fluorescent illumination; automated image analysis identifies cells based on color, intensity, size, pattern, and shape. Output: suggested cell classification, combined morphological and staining data, and summary reports. Used in clinical laboratory settings by pathologists/technicians. Pathologist reviews, corrects, and validates system-suggested classifications to inform clinical decision-making. Benefits: reduces time and labor for manual slide screening; provides integrated morphological and specific staining information for individual cells.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Automated scanning microscope; brightfield and fluorescent illumination; image analysis software. Supports morphological staining, immunohistochemistry, and FISH. Calibration required every 6 months. System performs automated cell detection, classification, and counting based on color, intensity, size, pattern, and shape.

Indications for Use

Indicated for use by pathologists as an aid in the detection, classification, and counting of cells in peripheral blood and bone marrow specimens prepared on microscope slides using morphological staining, immunohistochemistry, or fluorescent in situ hybridization (FISH).

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

• SlideScan™ (K001420)
• ACIS (Automated Cellular Imaging System) (K984188)
• BandView (K012103)

Submission Summary (Full Text)

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AUG 2 0 2003

# 510(K) SUMMARY

Duet™ system

# 510(k) Number K_030192

## Applicant's Name:

Bioview Ltd. 12 Hamada Street, Rehovot 76703, Israel Tel: [phone] Fax: [phone]

# Contact Person:

Orly Maor Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: [phone] Fax: [phone] [e-mail]

# Date Prepared:

January, 2003

## Trade Name:

Duet™ system

# Classification Name:

Automated cell-location device

#### Classification:

The FDA has classified Automated cell-locating device as class II devices (product code 81 JOY, Regulation No. 864.5260) and they are reviewed by the Pathology Panel.

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#### Predicate Device:

- · SlideScan™, manufactured by Applied Imaging, Inc., cleared under K001420.
- · ACIS (Automated Cellular Imaging System), manufactured by CromaVision Medical Systems, Inc. cleared under K984188.
- · BandView, manufactured by Applied Spectral Imaging, cleared under K012103.
- · Human manual visualization by conventional microscope.

## 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 ●
- EN-1441: Medical devices Risk Analysis. ●
- 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 diagnosis use as an aiding tool to the pathologist in the detection, classification and counting of cells of interests based on particular color, intensity, size, pattern and shape.

This particular application is intended to detect hematopoietic cells positively stained by Giemza stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension. The device can be used without limitation to specific diseases.

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## 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:

Bioview Ltd. believes that the Duet™ system is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.

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Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is a stylized emblem consisting of three curved lines that resemble a human figure. The emblem is black and the background is white.

Bioview Limited c/o Mr. Orly Maor Push-Med Limited 117 Ahuzah Street Ra`ananna 43373 ISRAEL

AUG 2 0 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

k030192 Re:

> Trade/Device Name: Duet™ System Regulation Number: 21 CFR § 864.5260 Regulation Name: Automated cell-location device Regulatory Class: II Product Code: JOY Dated: July 7, 2003 Received: July 9, 2003

Dear Mr. 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 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE

510(k) Number (if known): K030192

Duet™ system Device Name:

Indications for Use: The Duet™ system is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnosis use as an aiding tool to the pathologist in the detection, classification and counting of cells of interests based on particular color, intensity, size, pattern and shape.

> This particular application is intended to detect hematopoietic cells positively stained by Giemza stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension. The device can be used without limitation to specific diseases.

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

510(k) Number

Prescription Use (Per 21 CFR 801.109) 1sion Sign-

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K030192

OR

Over the Counter Use