Source: https://www.federalregister.gov/documents/2005/03/23/05-5643/medical-devices-immunology-and-microbiology-devices-classification-of-the-automated-fluorescence-in
Timestamp: 2018-09-25 17:21:00
Document Index: 316078802

Matched Legal Cases: ['art 807', 'art 807', '§\u2009866', '§\u2009807', '§\u2009866', '§\u2009866']

Federal Register :: Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Fluorescence in situ Hybridization Enumeration Systems
Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Fluorescence in situ Hybridization Enumeration Systems
A Rule by the Food and Drug Administration on 03/23/2005
This rule becomes effective April 22, 2005. The classification was effective December 13, 2004.
70 FR 14532
14532-14534 (3 pages)
Docket No. 2005N-0081
05-5643
https://www.federalregister.gov/d/05-5643 https://www.federalregister.gov/d/05-5643
The Food and Drug Administration (FDA) is classifying automated fluorescence in situ hybridization (FISH) enumeration systems into class II (special controls). The special control that will apply to the device is the guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems.” The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety Start Printed Page 14533and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.
Maria Chan, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0493, ext. 130.
In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976, generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously marketed devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's regulations.
In accordance with section 513(f)(1) of the act, FDA issued an order on October 1, 2004, classifying the VYSIS AUTOVYSION SYSTEM in class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On October 13, 2004, Vysis, Inc. submitted a petition requesting classification of the VYSIS AUTOVYSION SYSTEM under section 513(f)(2) of the act. The manufacturer recommended that the device be classified into class II.
In accordance with section 513(f)(2) of the act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the act. Devices are to be classified into class II if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA determined that the VYSIS AUTOVYSION SYSTEM can be classified in class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of safety and effectiveness of the device.
The device is assigned the generic name automated FISH enumeration system. It is identified as 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.
FDA has identified the risks to health associated with this type of device as inaccurate results that could lead to improper patient management. Improper patient management, which includes misdiagnosis and improper treatment, could result from failure of the test to perform as indicated or error in interpretation of results. A falsely low fluorescence signal count, or false negative, could contribute to a delay in detecting the disease, disease recurrence, disease prognosis, or a false indication of response to therapy. A falsely high fluorescence signal count, or false positive, could contribute to unnecessary monitoring, inappropriate treatment decisions, or failure to treat adequately. In addition, use of assay results to adjust a treatment regimen without consideration of other clinical factors could pose a risk.
The class II special controls guidance document aids in mitigating potential risks by providing recommendations on validation of performance characteristics, including software validation; control methods; reproducibility; and clinical studies. The guidance document also provides information on how to meet premarket (510(k)) submission requirements for the device. FDA believes that following the class II special controls guidance document generally addresses the risks to health identified in the previous paragraph. Therefore, on December 13, 2004, FDA issued an order to the petitioner classifying the device into class II. FDA is codifying this classification by adding § 866.4700.
Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for an automated FISH enumeration system will need to address the issues covered in the special controls guidance. However, the firm need only show that its device meets the recommendations of the guidance, or in some other way provides equivalent assurance of safety and effectiveness.
Section 510(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, however, FDA has determined that premarket notification is necessary because FDA's review of the system's key performance characteristics, test methodology and labeling to satisfy requirements of § 807.87(e), will provide reasonable assurance that acceptable levels of performance for both safety and effectiveness will be addressed before marketing clearance. Thus, persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the automated FISH enumeration system they intend to market.
1. Petition from Vysis, Inc., dated October 13, 2004.
2. Section 866.4700 is added to subpart E to read as follows:
§ 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 Fluorescence in situ Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the availability of this guidance document.
[FR Doc. 05-5643 Filed 3-22-05; 8:45 am]