Inspections, Compliance, Enforcement, and Criminal Investigations
Spineology, Inc. 15-Aug-07
Department of Health and Human Services
Public Health Service
9200 Corporate Boulevard
AUG 15 2007
TRANSMITTED BY FACSIMILE
Ms. Karen Roche
Vice President, Operations and Technology
7200 Hudson Blvd. N., Suite 205
St. Paul, Minnesota 55128
Re: OptiMesh® Deployable Grafting System
Dear Ms. Roche:
The Food and Drug Administration (FDA) has learned that your firm is marketing OptiMesh® in the United States (U.S.) for use in procedures requiring structural support, such as kyphoplasty, vertebroplasty, or spineoplasty, or for the surgical treatment of vertebral compression fractures, 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 OptiMesh® 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 clearance for their products from 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.
FDA has reviewed various portions of your website, www.spineology.com, as well as a promotional DVD, "OptiMesh® 1500E Surgical Video with QuikTrak™," which you distributed at the North American Spine Society annual meeting in Seattle, Washington in September 2006. Both the website and the DVD promote the OptiMesh® device for an intended use that requires submission of either a new premarket notification submission (510(k)), or an application for premarket approval (PMA) (21 U.S.C. 807.81 (a)(3)(ii)).
A review of our records reveals that you did not obtained marketing clearance before you began offering the OptiMesh® for use in procedures requiring structural support, such as kyphoplasty, vertebroplasty, or spineoplasty, or for the surgical treatment of vertebral compression fractures. Your 510(k), K014200 (cleared November 26, 2003), was cleared for use in maintaining the relative position of bone graft material (such as autograft or allograft) within a vertebral body defect (e.g. tumor) that does not impact the stability of the relative position and does not include the vertebral endplates. The device was required to bear a contraindication not to use the device in patients with instability (e.g. resected or collapsed vertebral bodies or fracture of the anterior column) and to state that the device does not provide structural support. The device was also required to bear a black box warning stating that the safety and effectiveness of the device for use in fusion of the interbody space has not been established.
Your promotion and introduction into interstate commerce of the OptiMesh® for these uncleared indications renders it 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 is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), 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, U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act is deemed satisfied when a PMA is pending before the agency (21 U.S.C. 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 maybe legally marketed.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for OptiMesh® comply with each applicable requirement of the Act and FDA implementing regulations.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by FDA without further notice. 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 Office of Compliance requests that Spineology immediately cease the dissemination of promotional materials for OptiMesh® that include the intended uses described above. Please submit a written response to this letter within fifteen (15) working days of receipt of this letter, describing your intent to comply with this request, listing all promotional materials for OptiMesh® the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Mr. William MacFarland at the Food and Drug Administration, 2094 Gaither Road, HFZ-343, Rockville, Maryland 20850, facsimile at (240) 276-0129.
Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only to the issue of premarket review for your device and does not necessarily address other obligations you have under the law.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and