Inspections, Compliance, Enforcement, and Criminal Investigations
TZ Medical, Inc. 02-Feb-06
Department of Health and Human Services
Public Health Service
February 2, 2006
RETURN RECEIPT REQEUSTED
In reply, refer to Warning Letter SEA 06-18
Thomas R. Tribou, President
TZ Medical, Inc.
7272 SW Durham Road, Suite 800
Portland, Oregon 97224-7569
Dear Mr. Tribou:
During an inspection of your firm, TZ Medical, Inc., located at 7272 SW Durham Road, Suite 800, Portland, Oregon, from August 22-24, 2005, Mr. Dennis G. Kawabata, an investigator from the Seattle District Office of the Food and Drug Administration (FDA) determined that your establishment manufactures, markets, and distributes a device identified as the Booker Box System, which facilitates the connection between various products, including a defibrillator and EP catheters. Your firm also manufactures and distributes devices known as (1) PadTac Electrophysiology Recording Catheters, Junction Box Cable Connector, and Electrophysiology Connector Cable, K021421 (Junction Box Cable Connector), and, (2) Booker Box Defibrillation Cable Adaptor, K993205.
The products listed above are medical devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(h)), 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 to affect the structure or any function of the body.
Our review of information collected during the inspection revealed that, since being cleared for marketing, TZ Medical has combined the Junction Box Cable Connector and Booker Box Defibrillation Cable Adaptor into one new device, the Booker Box System.
In addition, a switch was added to the Booker Box Defibrillation Cable Adaptor in order to eliminate the need for connecting two defibrillators. The combination of the two devices as described, and the addition of a new switch, represents a significant change in the design or energy source of the device and requires the submission of a new 510(k) under 21 CFR 807.81(a)(3)(i). A review of our records reveals that no 510(k) submission has been received for the Booker Box System.
During the inspection, you provided our investigator with a Document Change Order and your justification for not submitting a new 510(k) for the new device. You justify not submitting a new 510(k) by stating that the combined devices have the same operating principles, technological characteristics, intended use, target population, and do not present any greater patient risk than the original 510(k) submissions. FDA disagrees with your conclusion. By combining the Junction Box Cable Connector with the Booker Box Defibrillation Cable Adaptor, a high voltage circuit and a low voltage circuit are being confined inside the same box, thereby increasing the risk of electromagnetic interference. Furthermore, the additional switch increases the risk in use of the device because there is a greater potential for the user to mistakenly connect the EP mapping catheters to the defibrillation parts installed on the box, possibly delivering a shock of up to 360 joules directly to the patient's heart. These changes represent significant changes in the design or energy source of the device.
The Booker Box System is misbranded under section 502(o) (21 U.S.C. § 352(o)), in that a notice or other information respecting the device was not provided to FDA as required by section 510(k), and as described under 21 CFR 807.81(a)(3)(i). The device is also adulterated within the meaning of section 501(f)(1)(B) of the Act (21 U.S.C. § 351(f)(1)(B)), in that it is a Class III device under section 513(f) and does not have an approved application in effect pursuant to Section 515(a) of an approved application for an investigational device exemption under section 520(g). For a device requiring premarket approval before marketing, the notification required by section 510(k) of the Act is deemed satisfied when a premarket approval application (PMA) is pending before the agency [21 C.F.R. 807.81(b)].
.This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure adherence to each requirement of the Act and regulations. The specific violations noted in this letter may be symptomatic of other serious underlying problems within your establishment . You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be system problems, you must promptly initiate permanent corrective and preventive. actions.
Federal agencies are advised of the issuance of all Warning Letters about devices so that they may consider this information when considering the award of contracts. In addition, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice to you. These actions include, but are not limited to, seizure, injunction and/or civil monetary penalties.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to all applicable FDA regulations and the Act.
Please notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violation, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 2rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483-4913.
Charles M. Breen