(220 days)
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Not Found
No
The description focuses on automated scanning, image analysis based on predefined parameters (color, intensity, size, pattern, shape), and semi-quantitative results, without mentioning AI or ML algorithms.
No
The device is an in vitro diagnostic (IVD) device that aids pathologists in the detection and analysis of cells, specifically for HER2/neu overexpression in breast cancer. It does not directly treat or alleviate a disease, but rather provides information for diagnostic purposes.
Yes
The device is explicitly stated to be "intended for in vitro diagnostic use as an aid to the pathologist" and to provide "semi-quantitative immunohistochemical (IHC) results to aid in the determination of HER-2/neu (HER2) over-expression in breast cancer tissues." It also states it is "indicated for use as an aid in the assessment of breast cancer patients."
No
The device description explicitly states it is an "automated scanning microscope and image analysis system," indicating it includes hardware components (the microscope and scanning mechanism) in addition to the image analysis software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is intended for in vitro diagnostic use as an aid to the pathologist..."
- Purpose: The device is used to analyze biological samples (breast cancer tissues) in vitro (outside of the living body) to provide information for the diagnosis and treatment of a disease (breast cancer and potential Herceptin treatment).
- Accessory to an IVD: It is intended for use as an accessory to the HercepTest, which is also an IVD. This further reinforces its role in the diagnostic process.
- Aid to Pathologist: It is designed to assist a qualified pathologist in making diagnostic assessments based on the analysis of stained tissue samples.
Therefore, based on the provided text, the Applied Imaging Ariol™ system, when used with the Hersight application and DAKO HercepTest, clearly falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Applied Imaging 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 Hersight application is intended for use as an accessory to the HercepTest™ (DAKO USA, Carpinteria, CA) and is intended to provide semi-quantitative immunohistochemical (IHC) results to aid in the determination of HER-2/neu (HER2) over-expression in breast cancer tissues routinely processed for histological evaluation.
When used with DAKO HercepTest, it is indicated for use as an aid in the assessment of breast cancer patients for whom Herceptin® (Trastuzumab) treatment is being considered. Note: The actual correlation of the DAKO HercepTest to Herceptin clinical outcome has not been cstablished.
The Ariol system is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the DakoCytomation HercepTest to assure the validity of the Ariol-assisted HER2 score.
Product codes
NOT
Device Description
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Mentions image processing
The Applied Imaging 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.
The Ariol system is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER2 receptor protein.
Mentions AI, DNN, or ML
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Input Imaging Modality
Microscope slides
Anatomical Site
Breast cancer tissues
Indicated Patient Age Range
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Intended User / Care Setting
Pathologist / In vitro diagnostic use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.1860 Immunohistochemistry reagents and kits.
(a)
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.(b)
Classification of immunohistochemistry devices. (1) Class I (general controls). Except as described in paragraphs (b)(2) and (b)(3) of this section, these devices are exempt from the premarket notification requirements in part 807, subpart E of this chapter. This exemption applies to IHC's that provide the pathologist with adjunctive diagnostic information that may be incorporated into the pathologist's report, but that is not ordinarily reported to the clinician as an independent finding. These IHC's are used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin. Examples of class I IHC's are differentiation markers that are used as adjunctive tests to subclassify tumors, such as keratin.(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.
(3) Class III (premarket approval). IHC's intended for any use not described in paragraphs (b)(1) or (b)(2) of this section.
(c)
Date of PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the Federal Food, Drug, and Cosmetic Act is required for any device described in paragraph (b)(3) of this section before this device may be commercially distributed. See § 864.3.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
JAN - 8 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Diane C. Oates Applied Imaging Corp. 2380 Walsh Avenue - Bldg. B Santa Clara, GA 95051
K031715 Trade/Device Name: Ariol™ HER-2/neu IHC Regulation Number: 21 CFR 864.1860 Regulation Name: Immunohistochemistry reagents and kits Regulatory Class: Class II Product Code: NOT Dated: October 24, 2003 Received: October 27, 2003
Dear Ms. Oates:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your been wind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the entribute) is 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 r ou may, therefere, mains of the Act include requirements for annual registration, listing of general controll proficturing 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 n may or subject to back and 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 r rease be actives and i 1975 that I DT has Intact and regulations administered by other Federal agencies. You must or any I citizates as a s requirements, including, but not limited to: registration and listing (21 Comply with and 1100 (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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.
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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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 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): ____K031715
Device Name: Ariol™ HER-2/neu IHC
Indications for Use:
The Applied Imaging 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 Hersight application is intended for use as an accessory to the HercepTest™ (DAKO USA, Carpinteria, CA) and is intended to provide semi-quantitative immunohistochemical (IHC) results to aid in the determination of HER-2/neu (HER2) over-expression in breast cancer tissues routinely processed for histological evaluation.
When used with DAKO HercepTest, it is indicated for use as an aid in the assessment of breast cancer patients for whom Herceptin® (Trastuzumab) treatment is being considered. Note: The actual correlation of the DAKO HercepTest to Herceptin clinical outcome has not been cstablished.
The Ariol system is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the DakoCytomation HercepTest to assure the validity of the Ariol-assisted HER2 score.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ OR | Over--the-Counter Use ______ |
|---|---|---|
| ------------------------------------------ | ------------------------------------------------------------------------------------------------------------- | ------------------------------ |
| marie m chan | |
|---|---|
| Division Sign-Off |
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K031715 |
|---|---|
| -------- | --------- |
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