Inspections, Compliance, Enforcement, and Criminal Investigations
St. Jude Medical Atrial Fibrillation Division Inc. 4/23/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|10903 New Hampshire Avenue
Silver Spring, MD 20993
APR 23 2010
VIA UPS EXPRESS
Jane J. Song
St. Jude Medical, Inc.
Atrial Fibrillation Division
240 Santa Ana Court
Sunnyvale, California 94085
Dear Ms. Song:
During an inspection of your firm located in Sunnyvale, California, on July 9 through July 29, 2009, and after reviewing your firm's website, www.sjmprofessional.com. the Food and Drug Administration (FDA) has learned that your firm is promoting and marketing the Epicor™ LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device in the United States (U.S.) in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, the Epicor™ LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body, 21 U.S.C. 321(h).
FDA cleared the Epicor™ LP Cardiac Ablation System under premarket notification, K080292 (which includes the UltraWand LP and UltraCinch LP Ablation Devices, the Ablation Control System, connecting cable, and accessories), for the intended use of ablation of cardiac tissue during cardiac surgery.
FDA also approved your investigational device exemption (IDE) application for the Epicor™ LP Cardiac Ablation System (which includes the UltraWand LP and UltraCinch LP Ablation Devices, the Ablation Control System, connecting cable, and LP Positioning and Sizing Accessory) for the clinical study of a new indication for the treatment of atrial fibrillation, IDE #G060036.
On your website, www.sjmprofessional.com/Products/US/Ablation-Therapy/Epicor-LP-Cardiac-Ablation-System.aspx, you claim:
• "The Epicor LP system is designed specifically to create the critical Cox Maze III lesions entirely epicardially, which helps mitigate risks associated with other cardiac ablation technologies."
• "The Epicor UltraCinch LP Ablation Device ... is designed to safely, effectively and reproducibly create a classic box lesion in a single step."
FDA considers these claims on your website to be promotion of these devices for the treatment of atrial fibrillation. Although the box lesion and Maze lesions are ablation lesions performed on cardiac tissue during cardiac surgery, they are specifically intended to disrupt abnormal electrical conduction to isolate the pulmonary veins in an attempt to terminate a patient's atrial fibrillation. Therefore, FDA considers references to the classic box or Maze cardiac lesions to be synonymous with the treatment of atrial fibrillation.
FDA has determined that your activities as the (b)(4) of the clinical study for the Epicor™ LP Cardiac Ablation System, including its component devices, failed to comply with applicable federal regulations. Our review revealed several violations of Title 21, Code of Federal Regulations (21 C.F.R.) Part 812 .- Investigational Device Exemptions and Section 520(g) (21 U.S.C. 360j(g)) of the Act.
FDA considers the above statements on your website to he promotion of your Epicor™ L.P Cardiac Ablation System and your Epicor UltraCinch LP Ablation Device that are (b)(4) for the treatment of atrial fibrillation, which is the (b)(4). As a result. you are in violation of FDA's prohibition against promoting an (b)(4) before FDA has approved the device for commercial distribution under 21 CFR XI2.7(a). In addition, you are representing that the Epicor UltraCinch LP Ablation Device is safe or effective for the purposes for which it is (b)(4) in violation of 21 CFR 812.7(d).
The Epicor™ LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device that are under IDE are adulterated under section 501(i) of the Act 21 USC 351(i), because they are devices for which an exemption has been granted under section 520(g) of the Act for (b)(4), and you have failed to comply with requirements prescribed by or under such section. Failing or refusing to comply with any requirement prescribed under section 520(g) of the Act is a prohibited act. Section 301(q) of the Act, 21 USC 331(q).
FDA also has learned that your firm is marketing the Epicor™ LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device in the U.S. without marketing clearance or approval, in violation or the Act. The Act requires that manufacturers of devices that arc not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
Your firm's website, www.sjmprofessional.com/Product/US/Ablation-Therapy/Epicor-LP-Cardiac-Ablation-System.aspx. states that the Epicor™ LP Cardiac Ablation System "is commercially available for use in the United States ...... A review or our records reveals that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law.
Marketing the commercially available Epicor™ L.P Cardiac Ablation System and Epicor UltraCinch LP Ablation Device for the treatment of atrial fibrillation, represents a major change or modification in the intended use of the devices. 21 CFR 807.81(a)(3)(ii). The commercially available Epicor™ LP Cardiac Ablation System and Epicor UltraCinch LP Ablation Device are adulterated under section 501(f)(1)(B) of the Act. 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant In section 515(a) of the Act, 21 U.S.C. 360e(a). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b), The kind of information you need to submit in order to obtain approval or clearance for your devices is described on the Internet at www.fda.gov/cdrh/devadvise/3122.html. The FDA will evaluate the information you submit and decide whether your products may he legally marketed.
In addition, FDA reviewed your promotional materials collected during our inspection. Included in the launch kit materials intended to be distributed to St Jude Medical Field Representatives are an Epicor LP Sales Representative Resources CD, an Epicor LP Brochure, and an Epicor LP Spec Sheet.
The Epicor LP Sales Representative Resources CD, intended for the audience of St. Jude Medical field representatives." contains a PowerPoint presentation entitled "Epicor™ LP Cardiac Ablation System: Positioning: opening new accounts and driving increased utilization," The following slides are included in the presentation:
• Slide 12 of the PowerPoint
o "Give the surgeon a compelling reason to try Epicor"
o "Allows for the creation of it classic box lesion epicardially. on a beating heart and in a single step"
• Slide 13
o The Epicor has the "Ability to complete a full left atrial maze epicardially"
• Slide 16
o "Only Epicor allows surgeons to safely and reliably create the critical left atrial Cox-Maze III lesions without requiring that an atriotomy be performed"
The Epicor LP Brochure and the Epicor LP Spec Sheet, intended for the audience of "physicians and allied healthcare professionals" and "hospital purchasing departments and OR managers," respectively, include claims regarding the Epicor UltraCinch LP Ablation Device, The Brochure claims: "The Epicor UltraCinch LP Ablation Device. . . is designed to safely, effectively and reproducibly create a classic box lesion in a single step," The Spec Sheet claims: "The Epicor UltraCinch LP Abation Device is designed to replicate the classic box lesion, isolating all four pulmonary veins by creating a contiguous lesion."
Please be advised that FDA considers these to be an indication for which the Epicor™ LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device are being (b)(4) and outside of the cleared intended use of your 510(k). If these promotional materials are distributed, as intended, to "physicians. "allied healthcare professionals," "hospital purchasing departments," or "managers," then such promotions and representations of these devices (b)(4) would cause the devices to be adulterated under section 501(i) of the Act and constitute a prohibited act under section 301(q) of the Act. Such claims would also represent a major change or modification in the intended use of these devices that are commercially available pursuant to 21 CFR 807.81(a)(3)(ii). With a significantly modified intended use, these devices that are commercially available would be adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351 (f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act 21 U.S.C. 360e(a). The devices would also he misbranded under section 502(o) the Act. 21 U.S.C. 352(0) because you have not notified the agency of your intent to introduce the device into commercial distribution as required by section 510(k) of the Act. 21 U.S.C. 360(k).
The Office of Compliance requests that St. Jude Medical immediately cease the dissemination of promotional materials the same as or similar to that described above for these devices.
You should take prompt action to correct these violations. Failure to respond to this letter and promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice to you. These actions include but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Epicor™ LP Cardiac Ablation System and its components comply with each applicable requirement of the Act and FDA implementing regulations. Also, it is your responsibility as a study sponsor to ensure compliance with the Act and applicable regulations.
Within fifteen (15) working days of receiving this letter. please provide written documentation of the actions you have taken or will take to correct these violations and what actions you have taken or will take to prevent the recurrence of similar violations in current or future studies for which you are the study sponsor. Please also list all promotional materials for these devices the same as or similar to that described above, and explain your plan for discontinuing use of such materials. Any submitted corrective action plan must include projected completion dales for each action to be accomplished. If you need more time, let us know why and when you expect to complete your correction. Please direct your response or any questions you may have to:
Melissa Torres, Acting Branch Chief
Cardiac Rhythm and Electrophysiology Devices Branch
Office of Compliance
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO-66, Room 2040
Silver Spring, MD 20993
Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter does not necessarily address other obligations you have under the law.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and