Inspections, Compliance, Enforcement, and Criminal Investigations
Medtronic Incorporated 01-Oct-07
Department of Health and Human Services
Public Health Service
Center for Devices and Radiological Health
OCT 1 2007
Senior Vice President and President, Spinal and Biologics
1800 Pyramid Place
Memphis, Tennessee 38132
Re: SATELLITE™s Spinal System and ARCUATE™ Vertebral Augmentation System
Dear Mr. Wehrly:
The Office of Compliance(OC) in the Center for Devices and Radiological Health (CDRH) has reviewed various portions of the Surgical Technique Manual for the SATELLITE™ Spinal System, which was provided by Medtronic Sofamor Danek, Memphis, TN to the OC via email on Friday, July 20, 2007. The SATELLITE™ Spinal System is a device within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 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 to affect the structure or any function of the body. The device was cleared for marketing under premarket notification (510(k)) submission numbers K051320 (cobalt chrome spheres) and K060415 (PEEK Optima LT1 spheres). As discussed below, the manual reveals that the device is being distributed for intended uses and indications that represent major changes or modifications in the intended use and design of the device requiring submission of either a new premarket notification submission (510(k)),or an application for premarket approval(PMA)(21 C.F.R. 807.81(a)(3)(i)&(ii)).
The cleared SATELLITE™ Spinal System consists of spheres manufactured from either cobalt chrome or PEEK OPTIMA LT1, which are available in sizes between 9.5 mm and 19 mm. The letters clearing the device for marketing include the following Indications for Use Statement:
The SATELLITE™ Spinal System is intended to be inserted between the vertebral bodies into the disc space from L3 to SI to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal.
The SATELLITE™ Spinal System is intended to be used with bone graft.
The clearance letters state, in accordance with Section 513(i)(1)(E) of the Act, that the following limitation must be prominently displayed, in close proximity to the trade name, in all labeling for the device, including pouch, box and carton labels, instructions for use, and other promotional materials:
The safety and effectiveness of this device for use in motion sparing, non-fusion procedures has not been established.
The intended uses for the SATELLITE™ Spinal System described in the Surgical Technique Manual provided by your firm represent major changes or modifications to the cleared intended uses for this device that could significantly affect its safety or effectiveness. Specifically:
-Step 1 in the Manual states that "The patient is placed on the operating table in the prone position," indicating that a posterior approach is intended. However, Step 1 in Exhibit 14 of K051320 states: "The patient is placed on the operating table in a supine position," indicating that an anterior approach is intended.
-The Surgical Technique Manual does not include a step for the implantation of bone graft, contrary to the cleared intended use of the device.
-The Surgical Technique Manual describes a non-fusion procedure, in that there is no specific mention of either bone graft insertion or bony fusion, contrary to the statement required to be displayed, as described above.
-The instruments described by the Surgical Technique Manual provided by your firm include an 8 mm Trial and an 8 mm Sphere Curette, suggesting implantation of an 8 mm sphere. The cleared device includes spheres between the 9.5 and 19 mm.
As described above, your device 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 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 may be legally marketed.
The Office of Compliance requests that Medtronic Sofamor Danek immediately cease the dissemination of promotional materials for SATELLITE™ Spinal System which 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 SATELLITE™ Spinal System the same as or similar to those described above, and explaining your plan for discontinuing use of such materials.
The Office of Compliance acknowledges that, on July 30 and 31, 2007, Medtronic Sofamor Danek emailed the Office of Compliance to indicate that Medtronic Sofamor Danek would initiate a corrective and preventive action (CAPA) item to address the inappropriate distribution of the SATELLITE™ Spinal System Surgical Technique Manual, and provided additional labeling material for the device, including a draft package insert and a draft package label. On September 14, 2007, Medtronic Sofamor Danek emailed the Office of Compliance to indicate that the firm is in the process of initiating a recall of the SATELLITE™ Spinal System Surgical Technique Manual. The information provided, however, does not completely address the concerns described in this letter. To address the concerns described in this letter, a CAPA which includes, but is not limited to the following is needed:
1. The cause of nonconformities relating to the SATELLITE™ Spinal System's Surgical Technique Manual;
2. The actions needed to correct and prevent recurrence of the nonconformities relating to the SATELLITE™ Spinal System's Surgical Technique Manual(i.e., removing product from the market, notification that the information disseminated by the product is not cleared via 510(k), assessment of the potential hazard to health caused by the dissemination of the product, recall strategy); and
3. The corrective and preventive action to ensure that above actions are effective (verification or validation).
Please provide this information in your response to this letter.
For your information, the FDA has located a press release dated September 27, 2006, on your website www.medtronic.com, that announces the availability of the ARCUATE™ Vertebral Augmentation System in the United States. However, a review of our records indicates that your firm's 510(k), K063248, for the ARCUATE™ Vertebral Augmentation System was not cleared until March 13, 2007. In addition, the press release made the following claims, for which you have not obtained marketing clearance or approval:
". . .controlled cement delivery system;"
"The proprietary ARC™ Osteotome creates arcs within the existing bone structure, allowing a preferential flow of cement into arcs and cancellous bone openings . . .may allow for a better distribution of cement across the vertebral body minimizing the number of incisions and steps necessary to create a biomechanically stable support for the spine;"
" . . . may reduce procedure time and limit radiation exposure by taking the surgeons'
hands out of the radiation field;" and
" . . . may mean abbreviated procedure time, potentially shorter recovery times and the
possibility of less pain. "
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials comply with each applicable requirement of the Act and FDA implementing regulations.
Failure to correct the promotional violations discussed above may result in FDA regulatory action, including seizure, injunction, or civil money penalties without further notice.
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. We remind you that only written communications are considered official.
We request a meeting with your firm to discuss your strategy to bring your medical devices into compliance with the Act. Please contact Mr. MacFarland to arrange this meeting. Please be prepared to discuss your corrective action plan for compliance and your efforts to prevent the recurrence of these deficiencies.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and
Cc: Mr. William A. Hawkins, President and Chief Operating Officer Medtronic Incorporated 710 Medtronic Parkway Minneapolis, MN 55432-5604
Susan Alpert, Ph.D., M.D., Senior Vice President - Chief Quality and Regulatory Officer Medtronic Incorporated 710 Medtronic Parkway Minneapolis, MN 55432-5604