Inspections, Compliance, Enforcement, and Criminal Investigations
Replication Medical Inc
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
VIA UNITED PARCEL SERVICE
JULY 2, 2010
President and CEO
Replication Medical, Inc.
7 Clarke Drive
Cranbury, NJ 08512
RE: EnGuard™ Vessel Guard
Refer to GEN0901264 when replying to this letter.
Dear Ms. Prewett:
The Food and Drug Administration (FDA) has learned that your firm is marketing the EnGuard™ Vessel Guard in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, 21 U.S.C. 321(h), the EnGuard™ Vessel Guard is a device because it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. The Act requires that manufacturers of devices that are 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 medical 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.
FDA cleared with limitations your EnGuard™ Vessel Guard. The cleared indication for use for the EnGuard™ Vessel Guard is: "as a cover for vessels following anterior vertebral surgery." In accordance with section 513(i)(1)(E) of the Act, 21 U.S.C 360c(1)(E), FDA imposed the following limitation to appear in the Warnings section of the device's labeling and any promotional materials: "The safety and effectiveness of this device for reducing the incidence, severity, and extent of post-operative adhesion formation have not been established."
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed a White Paper available on your website (http://www.replicationmedical.com/docs/UseOfVesselProtectionWhitePaperDISCLAIMER.pdf) entitled "Use of Spinal Vessel Protection to Facilitate Anterior Revision Surgery," and your firm's product brochure for the EnGuard™ Vessel Guard entitled "We've got you covered."
The White Paper available on your website contains the following claims within its Conclusions section:
• "By preventing fibroblast penetration, vascular wall attachment to the membrane [of the device] is minimized and reoperation is thereby facilitated."
• "So if revision surgery is required, the vessel guard would be visible to the surgeon and mobilization of the necessary tissues, organs, and vessels would be facilitated."
Your promotional brochure contains the following claim about the EnGuard™ Vessel Guard:
• The Design Features of the EnGuard™ Vessel Guard "[f]orms a physical barrier to prevent penetration by fibroblasts"
We consider the above claims to be outside the scope of your 510(k) clearance and in violation of the limitation described above. We consider these claims to be consistent with adhesion barrier claims because prevention of fibroblast penetration and facilitation of mobilization of necessary tissues, organs, and vessels are equivalent to adhesion barrier functions. Adhesions can form after a surgery, including through fibroblast proliferation, and when a subsequent surgery is needed, adhesions make it more difficult for medical professionals to access the surgical area. Thus, revision surgery poses a different risk profile than an initial surgery. Because fibroblast proliferation can result in adhesion formation, and a device that prevents fibroblasts penetration would reduce the formation of adhesions at the surgical site, prevention of fibroblast penetration is equivalent to serving as an adhesion barrier. In addition, because mobilization of tissues, organs, and vessels during revision surgery can be hindered by the presence of adhesions, a reduction in adhesions would facilitate the mobilization of these structures. Thus, facilitating mobilization of tissues, organs, and vessels also is equivalent to serving as an adhesion barrier. The above claims represent a different intended use of the device. See 21 CFR 807.81(a)(3)(ii). Devices marketed for an intended use as a cardiovascular adhesion barrier are considered class III devices requiring a premarket approval application (PMA).
As a result, the EnGuard™ Vessel Guard as marketed for the new intended use is 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), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device, as promoted for the new intended use, is also misbranded under section 502(0) the Act, 21 U.S.C. 352(0), because you did not notify 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). 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 device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
The Office of Compliance requests that Replication Medical immediately cease the dissemination of promotional materials for EnGuard™ Vessel Guard the same as or similar to those described above. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties.
In addition, please note that FDA is concerned about claims in your promotional brochure and White Paper regarding the ability of the EnGuard™ Vessel Guard to act as a protective barrier against vessel damage in the event that revision surgery is required.1 FDA considers such claims to suggest minimization of adhesion formation for the purpose of serving as an adhesion barrier - an indication which is not within the scope of your cleared 510(k).
Please submit a written response lo this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for EnGuard™ Vessel Guard the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Michelle Noonan-Smith, Acting Branch Chief, Vascular and Circulatory Support Devices, at the letterhead address above, facsimile at (301) 847-8138. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for EnGuard™ Vessel Guard comply with each applicable requirement of the Act and FDA implementing regulations.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and