Department of Health and Human Services
Public Health Service
3310 Live Oak St
August 3, 2000
VIA FEDERAL EXPRESS
Phillip P. Janca, Chairman
Hyperbaric Technologies, Inc.
301 E. Main St
Olney, TX 76374
Ref. No. 2000 -DAL-WL-I 2
Dear Mr Janca:
During an inspection of your firm located in Olney, TX, on April 17 and 21, and May 18, 2000, our investigator determined that your firm manufacturers the HyperTec Oyster, HyperTec Hybrid, and HyperTec Monocoque hyperbaric chambers. Records and information collected during the inspection revealed serious regulatory problems involving your hyperbaric chambers.
Under a United States Federal Law, the Federal Food, Drug, and Cosmetic Act (the Act), these products are considered medical devices because they are used to diagnose or treat a medical condition or to affect the structure or function of the body. The law requires that manufacturers of medical devices obtain marketing clearance for their products from the Food and Drug Administration (FDA) before they may offer them for sale. This helps to 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 marketed in this country.
Our records show that you had submitted a premarket notification [510(k)] for some hyperbaric oxygen therapy devices, but that it was [redacted] from the 510(k) database on [redacted]. Further, our records do not show that you obtained marketing clearance for your HyperTec Oyster, HyperTec Hybrid, and HyperTec Monocoque devices before offering the products for sale.
During the inspection, your firm provided our investigator with a copy of a product brochure (an eleven-page description of Hyperbaric Oxygen Therapy (HBOT)) that is distributed to your customers and the "Specification & Capabilities Document". In reviewing the product brochure, we noted you identified future indications including: Acute Carbon Tetrachloride Poisoning, Cerebrovascular Accident, Head injury (cerebral edema), Fracture Healing or Bone Grafting, Hydrogen Sulfide Poisoning, Pyoderma Gangrenosum, Acute Retinal Arterial Occlusion, Selected Refractory Mycoses, Sickle Cell Anemia Crisis, and Acute Spinal Cord Injury. Your brochure further says that in the near future any hospital that does not provide these services will be falling behind. We also noted in your Specification & Capabilities Document that you included Sports Injury and Plastic/Cosmetic/Reconstructive claims, as current indications for your HyperTec Monocoque device. Please be advised that none of the above claims have been cleared through the 510(k) process and that these claims may require an approved premarket approval application (PMA). If you wish to reference any of the above claims in the labeling, promotion and advertising materials for your HBOT devices, your marketing application should include sufficient valid scientific evidence justifying each of the above claims.
Because you do not have marketing clearance from FDA, marketing your product is a violation of the law. In legal terms, the product is adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Act. Your product is adulterated under the Act because you did not obtain premarket approval based on information developed by you that shows your device is safe and effective. Your product is misbranded under the Act because you did not submit information that shows your device is substantially equivalent to other devices that are legally marketed.
You should know that this serious violation of the law might result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizing your product inventory, obtaining a court injunction against further marketing of the product, or assessing civil money penalties. Also, other Federal agencies are informed about the warning letters we issue, such as this one, so that they may consider this information when awarding government contracts. Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of medical devices. This letter pertains only to the issue of premarket clearance for your devices and does not necessarily address other obligations you have under the law. You may obtain general information about all of FDA's requirements for manufacturers of medical devices by contacting our Division of Small Manufacturers Assistance at 800-638-2041 or through the Internet at www.fda.gov.
Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed.
Your reply should be directed Reynaldo R. Rodriguez, Jr., Director, Compliance Branch, at the above letterhead address.
Michael A. Chappell
This page was posted on August 20, 2006.