C DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Rockville MD 20857 Ms. Atonista Viahoulis WUL 16 2009 7647 N. Oconto Avenue Niles, IL 60714 Dear Ms. Vlahoulis: Thank you for your inquiry to then-Senator Barack Obama in October 2008, concerning the status with the Food and Drug Administration (FDA or the Agency) of the model 5100 McCarthy Myxo ETlogix Annuloplasty Ring for use in heart valve repair, manufactured by Edwards Lifesciences LLC (Edwards), You also made a similar inquiry with Senator Durbin of Illinois. Both inquiries asked the Agency to look into your situation. Since then-Senator Obama's Senate Office is no longer functioning, we are responding to his inquiry by sending our response directly to you. You will no doubt be hearing from Senator Durbin’s Office independently in the near future. Below we have repeated the two main questions highlighted in those inquiries, followed by the Agency's responses. At the end of the response to question 1, we also include the current status of activity at the Agency conceming this product. 1. Was the Myxo ETlogix Annuloplasty ring 5100 approved by the FDA at the time of surgery? Ina letter dated August 15, 2008, Edwards notified the Agency that they were marketing the Myxo ETlogix Annuloplasty Ring. The letter stated their belief that the Myxo ETlogix was substantially equivalent to the Edwards GeoForm, Model 4200, and Carpentier-Edwards Physio, Model 4450, Annuloplasty Rings, and that the Myxo Ring represented only a minor modification to the predicate rings. FDA has determined that the Myxo ETlogix Annuloplasty Ring was not originally covered under any premarket notification 510(k) clearance. A significant risk device such as the Myxo ETlogix Annuloplasty Ring that is not cleared or approved would be required to be studied under an investigational device exemption (IDE). On October 14, 2008, the sponsor came in to FDA for a regulatory meeting with the Office of Compliance of the Agency's Center for Devices and Radiological Health. At this meeting, the sponsor stated that the firm had discontinued distribution of the device. Edwards also stated publicly in October 2008 that the firm had discontinued distribution of the device On October 29, 2008, FDA received a 510(k) premarket notification submission from Edwards notifying the Agency of their intent to market the dETlogix (formerly called the Myxo ETlogix) Annuloplasty Ring. On April 10, 2009, FDA cleared a 510(k) forPage 2 —Ms. Atonista Viahoulis 4ETlogix Annuloplasty Ring. The dETlogix Annuloplasty Ring is indicated for the correction of mitral valvular insufficiency where the lesions are not severe enough to require total valve replacement. Clearance of this 510(k) submission demonstrates that the dETlogix device is substantially equivalent to the following legally marketed predicate devices: Edwards GeoForm, Model 4200; Carpenticr-Edwards Physio, Model 4450; and Edwards Classic, Model 4400. 2. What are the regulations related to FDA approval of a medical device? The following link will take you to the location on FDA’s Web site for an overview of the Agency’s medical device regulatory program: hutp://www fla. gov/edrh/devadvice/overview.him. These pages also link to more detailed descriptions of various regulatory procedures referenced below. Generally speaking, medical devices are divided into three categories, Class 1, Class Il and Class IIL depending upon the amount of regulatory control required by each product: This, in tum, depends on the intended use of the device and also on the indications for use. Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user and often are simpler in design than the other two classes of devices. Class I devices are subject to “General Controls.” Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments. Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness. In addition to complying with general controls, Class II devices also are subject to “Special Controls,” which may include special labeling requirements, mandatory performance standards, and postmarket surveillance. A few Class II devices are exempt from the premarket notification requirements. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes. Annuloplasty rings are Class II medical devices and require premarket clearance through the 510(k) premarket notification process. Class III is the most stringent regulatory category for devices. Class Ill devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or that present a potential, unreasonable risk of illness or injury. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. Premarket approval (PMA) is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Examples of Class III devices include replacement heart valves, silicone gel-filled breast implants, and implanted cerebella stimulators. More specific details of the Agency’s PMA procedures for Class III devices can be located at: http://www fila. gov/cdrh/devadvice/pma/. The 510(k) procedures are based on the concept of substantial equivalence to a legally marketed (predicate) device. All $10(K)s provide a comparison between the device to be marketed and the predicate device or devices. There is no premarket notification $10(k)Page 3 —Ms. Atonista Vlahoulis “form” to complete. A 510(k) is a document containing information required under 21 CFR 807 Subpart E. A 510(k) holder may make a modification to a device without filing a new 510(k) after concluding that the change does not significantly affect the safety or effectiveness of the device or constitute a major change in the intended use of the device. Sponsors may refer to FDA’s 510(k) memorandum (dated January 10, 1997), “Deciding When to Submit a 510(k) for a Change to an Existing Device,” for assistance in determining whether changes to a device require a new 510(k). This document at shutp:/rvww fda. gov/edrh/ode/S 1 Okmod. htm! includes a flowchart to help manufacturers through the logic scheme necessary to arrive at a decision on when to submit a 510(k) for a change to an existing device. The flowchart addresses labeling changes, technology ot performance specifications changes, and materials changes. This document recommends that, if a sponsor concludes that a new 510(k) is not required, the sponsor should document the analysis and file it for future reference, The following text is taken from the definitions section of the FDA memorandum: For the purpose of this guidance, documentation means recording the results of applying the model to proposed changes in a device. Consideration of each decision point should be recorded, as well asthe final conclusions reached. If testing or other engineering analysis is part of the process, the results ofthis activity should be recorded or referenced. A copy of this documentation should be maintained for future reference. It should be noted that no formal reporting by the 510(k) holder to the Agency is required if the sponsor concludes that a given change does not require a new 510(k), However, a 510(k) holder is required to maintain the documentation and make it available to FDA during an inspection. Thus, we can determine retroactively whether the sponsor has made the appropriate decision. As mentioned in the FDA memorandum, there are bound to be some changes that fit into a “gray area” as to whether a new 510(k) submission is required. In these cases, sponsors are encouraged to contact the Agency if they have questions regarding the appropriateness of a 510(k). Lastly, although a sponsor may conclude that a particular change does not require a 510(k), the sponsor may subsequently make additional changes to the same device that does require a new 510(k). When this occurs, sponsors are required to submit a $10(k) incorporating all the changes that have been made to the device since clearance of the most recent 510(k) for the device. ‘Thank you again for your interest in this matter. If we can be of further assistance, please let us know. Sincerely, ‘ UG fephen R. Mason /cting Assistant Commissioner for Legislation