FISHVIEW

K050236 · Applied Spectral Imaging , Ltd. · LNJ · Jun 27, 2005 · Hematology

Device Facts

• Record ID: K050236
• Device Name: FISHVIEW
• Applicant: Applied Spectral Imaging , Ltd.
• Product Code: LNJ · Hematology
• Decision Date: Jun 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5260
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FISHView system is intended to be used for karyotyping with real-time microscope images from cultured and stained cell specimens in their metaphase. The system works with bright field and fluorescent samples. Specimens suitable for banding analysis are: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor. Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases (such as Down's syndrome), cancer, and for the follow up of cancer treatment. The FISHView system does not locate metaphase spreads; it does not rank the given cells according to quality; nor does it automatically classify chromosomes. In addition the FISHView is intended as an aiding tool to the pathologist or cytogeneticist for digital visualizing, processing, counting and classification of stained cells and for storage of FISH multi - dye images of the following specimens: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor. The FISHView system does require and relies on the operator to analyze the digitized microscope images.

Device Story

FISHView is a digital imaging platform modification of the BANDView system; integrates microscope, camera, frame grabber, and workstation. Inputs: bright field and fluorescent microscope images of cultured/stained cell specimens. Operation: operator manually scans cells; system captures, enhances, archives, retrieves, and prints images. Output: digitized images for pathologist/cytogeneticist review. Context: clinical laboratory setting; operator-dependent analysis. Benefit: facilitates digital visualization, counting, and classification of cells to aid in diagnosis of genetic conditions and cancer.

Clinical Evidence

Bench and clinical data provided. Device designed, verified, and validated in compliance with 21 CFR 820.30. No adverse effects detected. Specific performance metrics (sensitivity/specificity) not provided in summary.

Technological Characteristics

Integrated digital imaging platform consisting of a microscope, camera, frame grabber, and workstation. Supports bright field and fluorescent illumination. Software-based image enhancement, archiving, and retrieval. No automated metaphase location, ranking, or chromosome classification.

Indications for Use

Indicated for karyotyping and digital analysis of cultured/stained metaphase cell specimens (amniotic fluid, peripheral blood, chorionic villus, bone marrow, solid tumor) in patients requiring pre/postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases, or cancer follow-up. Used by pathologists/cytogeneticists. Does not automatically locate, rank, or classify chromosomes.

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

• BANDView system (K012103)
• Duet system (K040591)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))

#### Device Name

Proprietary Device Name: FISHView

### Establishment Name and Registration Number of Submitter

Name: Applied Spectral Imaging Ltd. Registration: 9615060 Submission contact: Dan Laor Sireni 6, Haifa

#### Device Classification

Device Code: CFR Section: Name: Classification: LNJ 864.5260 Automated cell-locating device. Class II Product

#### Reason for 510(k) Submission

Traditional 510(k) Submission

#### Identification of Legally Marketed Equivalent Devices

BANDView system K012103

Duet system K040591,

#### Device Description

The FISHView is a modification of the legally marketed (K012103) BANDView system. Digital visualizing, processing and storage of FISH multi dye images has been added to the BANDView original karyotyping features. The FISHVeiw System is a fully integrated digital imaging platform constructed of a microscope, camera, frame grabber and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Cytological analysis experts can view, manually scan cells and record the image, using both bright field and fluorescent illumination. The acquire images can be enhanced, archived, retrieved and printed.

#### Indications for use

The FISHView system is intended to be used for karyotyping with real-time microscope images from cultured and stained cell specimens in their metaphase.

The system works with bright field and fluorescent samples. Specimens suitable for banding analysis are: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor. Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases (such as Down's syndrome), cancer, and for the follow up of cancer treatment. The FISHView system does not locate metaphase spreads; it does not rank the given cells according to quality; nor does it automatically classify chromosomes.

{1}------------------------------------------------

In addition the FISHView is intended as an aiding tool to the pathologist or cytogeneticist for digital visualizing, processing, counting and classification of stained cells and for rol dignal Productions, provinces, "
storage of FISH multi - dye images of the following specimens: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor.

The FISHView system does require and relies on the operator to analyze the digitized microscope images.

#### Safety & Effectiveness

The device has been designed verified and validated complying to 21CFR 820.30 regulations. Bench and clinical data demonstrate that the FISHView meets the required specifications. No adverse affects have been detected.

#### Substantial Equivalency

It is Applied Spectral Imaging opinion that the FISHView is substantially equivalent in terms of safety and effectiveness to the predicate device.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

JUN 27 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Applied Spectral Imaging, Limited c/o Mr. Dan Laor Managing Director Quasar Quality Limited Sirni 6 Street Haifa 32972 Israel

k050236 Re: Trade/Device Name: FISHView Regulation Number: 21 CFR § 864.5260 Regulation Name: Automated cell-locating device Regulatory Class: II Product Code: LNJ Dated: May 16, 2005 Received: May 19, 2005

Dear Mr. Laor:

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.

{3}------------------------------------------------

Page 2 -

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 of quotions on career Device Evaluation and Safety at [phone]. Also, please note the vial Diagnostic De Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may obtain 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/industry/support/index.html

Sincerely yours,

loburt Beckerh

Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K050236

Device Name: FISHView

Indications For Use: The FISHView system is intended to be used for karyotyping with realtime microscope images from cultured and stained cell specimens in their metaphase. time microscope mages from cattered and fluorescent samples. Specimens suitable for banding The system works with bright freid and blood, chorionic villus, bone marrow and solid tumor. analysis are, annuotte fruit, perfeneral erre and postnatal diagnosis of birth defects, chromosome Karyotypling is normally applied for the pown's syndrome), cancer, and for the follow up of abliothianties, genette diseases (saen as 2 a 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 given cells according to quality; nor does it automatically classify chromosomes.

In addition the FISHView is intended as an aiding tool to the pathologist or cytogeneticist for If addition the PIST Viow is meeties and classification of stained cells and for storage of urgital Visualizing, processing, counting specimens: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor.

The FISHView system does require and relies on the operator to analyze the digitized microscope images.

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

| 510(k) | K050236 |
|----------------------------------------------|-------------------------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <b>X</b> AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)