MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

K012138 · Chroma Vision Medical Systems, Inc. · MYA · Sep 30, 2002 · Hematology

Device Facts

• Record ID: K012138
• Device Name: MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
• Applicant: Chroma Vision Medical Systems, Inc.
• Product Code: MYA · Hematology
• Decision Date: Sep 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.1860
• Device Class: Class 2

Intended Use

The Automated Cellular Imaging System (ACIS) device is intended to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape. In this software application the ACIS device is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffinembedded tissue specimens immunohistochemically stained for Estrogen Receptors or Progesterone Receptors (ER/PR). It is indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer.

Device Story

ACIS is an automated cellular imaging system; inputs are formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for ER/PR. Device uses image analysis to detect, count, and classify cells based on color, size, and shape; quantitates percentage and intensity of positively stained nuclei. Used in clinical laboratory settings by trained personnel. Output provides quantitative data to clinicians; assists in breast cancer management, prognosis, and therapy outcome prediction. Benefits include standardized, objective quantification of staining compared to manual visual assessment.

Technological Characteristics

Automated cellular imaging system; utilizes image processing for cell detection, counting, and classification based on color, size, and shape. Designed for analysis of immunohistochemically stained tissue specimens. Software-based analysis of digital images.

Indications for Use

Indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes for patients with breast cancer. Used for measuring, counting, and quantitating percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for Estrogen Receptors (ER) or Progesterone Receptors (PR).

Regulatory Classification

Identification

Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.

Special Controls

(2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA,” Center for Devices and Radiologic Health, 1998). These IHC's are intended for the detection and/or measurement of certain target analytes in order to provide prognostic or predictive data that are not directly confirmed by routine histopathologic internal and external control specimens. These IHC's provide the pathologist with information that is ordinarily reported as independent diagnostic information to the ordering clinician, and the claims associated with these data are widely accepted and supported by valid scientific evidence. Examples of class II IHC's are those intended for semiquantitative measurement of an analyte, such as hormone receptors in breast cancer.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. David G. Davis SEP 3 0 2002 Manager of Regulatory Affairs ChromaVision Medical Systems, Inc. 33171 Paseo Cerveza San Juan Capistrano, California 92675-4824

Re: k012138

> Trade/Device Name: Automated Cellular Imaging System (ACIS) for detection of ER/PR Regulation Number: 21 CFR § 864.1860 Regulation Name: Immunohistochemistry Reagents and Kits Regulatory Class: II Product Code: MYA, MXZ Dated: June 29, 2002 Received: August 5, 2002

Dear Mr. Davis:

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 the Code of Federal Regulations, 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): K012138

Device Name: ACIS

Indications for Use:

The Automated Cellular Imaging System (ACIS) device is intended to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape.

In this software application the ACIS device is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffinembedded tissue specimens immunohistochemically stained for Estrogen Receptors or Progesterone Receptors (ER/PR).

It is indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer.

Deborah M. Moore

510(k) Number KO12/3

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

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