(126 days)
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.
Ariol™ is an automated scanning microscope and image analysis system.
This looks like a medical device submission, specifically a 510(k) for an automated HER-2/neu FISH enumeration system called Ariol™. The provided text is a letter from the FDA acknowledging the substantial equivalence of the device and an "Indications for Use" statement.
Unfortunately, the provided text does not contain the acceptance criteria or a detailed study description with reported device performance. The FDA letter is an approval document, not the study results or the criteria themselves. The "Statement of Intended Use" only describes the device's purpose and its accessory nature to the PathVysion® HER-2/neu DNA Probe kit.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Stand-alone performance results
- Type of ground truth used
- Training set sample size
- How ground truth for the training set was established
This information would typically be found in the scientific study report(s) submitted as part of the 510(k) application, which are not included in the provided document. The provided text only states that the device is "substantially equivalent" to predicate devices, implying that its performance has been demonstrated to be comparable, but it doesn't detail how that demonstration was done or the specific metrics achieved.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
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 (240) 276-0131. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address
(2017年45 0577 01 at 18 mm/cdrh/dsma/dsmamain.html
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 |
|---|---|
| maria m chan Division Sign-Off | |
| 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.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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OR
Over-the-Counter Use
§ 866.4700 Automated fluorescence
in situ hybridization (FISH) enumeration systems.(a)
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.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescencein situ Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the availability of this guidance document.