ARIOL HER-2/NEU FISH

K043519 · Applied Imaging Corp. · NTH · Apr 25, 2005 · Immunology

Device Facts

• Record ID: K043519
• Device Name: ARIOL HER-2/NEU FISH
• Applicant: Applied Imaging Corp.
• Product Code: NTH · Immunology
• Decision Date: Apr 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.4700
• Device Class: Class 2

Intended Use

Ariol™ is an automated scanning microscope and image analysis system. It is 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. This particular Ariol application is an accessory to the PathVysion® HER-2/neu DNA Probe kit (PathVysion, Vysis, Inc., Downers Grove, IL). PathVysion is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffinembedded human breast cancer tissue specimens. Results from the PathVysion kit are intended for use as an adjunct to existing clinical and pathologic information used as prognostic factors in stage II, node-positive breast cancer patients. The PathVysion kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer, treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy. The PathVysion kit is also indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. While the PathVysion kit provides the probes that offer direct visualization and manual enumeration of the HER2 and Chromosome 17 genes with a fluorescent microscope, the Ariol may be used as an accessory that provides automated enumeration.

Device Story

Ariol™ system is an automated scanning microscope and image analysis platform; functions as an accessory to the PathVysion® HER-2/neu DNA Probe kit. Input: fluorescently labeled tissue slides (formalin-fixed, paraffin-embedded breast cancer). Operation: system scans slides using motorized stage and monochrome CCD camera; utilizes two-pass or region-cam methods to capture DAPI-counterstained nuclei and fluorescent probe signals (Spectrum Orange/Green). Software processes images to enumerate signals and compute HER2/Chr17 ratios. Output: data grid displaying probe counts, ratios, and cell images; pathologist reviews automated results to finalize diagnostic score on report. Used in clinical laboratory settings by pathologists/technicians. Benefits: provides automated enumeration to assist in HER-2/neu gene amplification assessment, supporting prognostic and therapeutic decision-making.

Clinical Evidence

No clinical data provided in the document; the device is cleared as an accessory to an existing diagnostic kit.

Technological Characteristics

System includes automated microscope, monochrome CCD camera, PC, monitor, and printer. Objectives: 1.25x, 5x, 10x, 20x, 40x. Light source: Mercury lamp. Connectivity: Barcode reader for specimen ID. Software performs automated signal enumeration and ratio calculation. Calibration: Spatial (stage steps/pixels) and illumination (lamp/filter settings).

Indications for Use

Indicated for use as an aid to pathologists in the detection, classification, and counting of cells in formalin-fixed, paraffin-embedded human breast cancer tissue specimens to detect HER-2/neu gene amplification via FISH. Used as an adjunct to clinical/pathologic information for stage II, node-positive breast cancer patients to predict disease-free and overall survival following CAF chemotherapy, and to assess patients for HERCEPTIN® (Trastuzumab) treatment.

Regulatory Classification

Identification

An automated FISH enumeration system is a device that consists of an automated scanning microscope, image analysis system, and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays as an aid in the detection, counting and classification of cells based on recognition of cellular color, size, and shape, and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens.

Special Controls

The device is classified as Class II under regulation 21 CFR 866.4700 with special controls. The special control guidance document " Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems" is available at www.fda.gov/cdrh/oivd/guidance/1550.pdf.

*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescence*in situ* Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the availability of this guidance document.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

APR 2 5 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Applied Imaging Corp. c/o Ms. Diane C. Day Vice President, Regulatory, Clinical and Quality 120 Baytech Drive San Jose, CA 95134-2302

Re: k043519

Trade/Device Name: ArioI™ HER-2/neu FISH Regulation Number: 21 CFR 866.4700 Regulation Name: Automated Fluorescent in situ Hybridization (FISH) Enumeration Systems Regulatory Class: Class II Product Code: NTH Dated: December 17, 2004 Received: December 20, 2004

Dear Ms. Day:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & hare reviewe 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 ass batted in are 1876, the enactment date of the Medical Device Amendments, or to devices that provision in that 20, 1978, are cordance 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 therefore, maintons 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 n your as hise to such additional controls. Existing major regulations affecting your device can be may of subjoct to sach additions, Title 21, Parts 800 to 898. 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 that I Dri has mude a actesmulations 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); an the Act 3 requirements) increases of the requirements as set forth in the quality labeling (21 OF RT art 801), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Diane C. Day

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and it you to organial equivalence of your device of your device to legally prematice noutheating a results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you attire of Compliance 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 general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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Sincerely yours,
Robert L. Becker Jr.

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

Enclosure

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## STATEMENT OF INTENDED USE

| 510(K) Number (if known): | K043519 |
|-------------------------------------------------|-------------------------------------------------------------|
| | <div> maria m chan </div> <div>Division Sign-Off</div> |
| Device Name: Ariol ^TM HER-2/neu FISH | Office of In Vitro Diagnostic Device Evaluation and Safety |
| | 510(k) K043519 |

## Indications for Use:

Ariol™ is an automated scanning microscope and image analysis system. It is 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.

This particular Ariol application is an accessory to the PathVysion® HER-2/neu DNA Probe kit (PathVysion, Vysis, Inc., Downers Grove, IL). PathVysion is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffinembedded human breast cancer tissue specimens. Results from the PathVysion kit are intended for use as an adjunct to existing clinical and pathologic information used as prognostic factors in stage II, node-positive breast cancer patients. The PathVysion kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer, treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy. The PathVysion kit is also indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. While the PathVysion kit provides the probes that offer direct visualization and manual enumeration of the HER2 and Chromosome 17 genes with a fluorescent microscope, the Ariol may be used as an accessory that provides automated enumeration.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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OR

Over-the-Counter Use