Department of Health and Human Services
Public Health Service
2098 Gaither Rd
September 17, 1997
VIA FEDERAL EXPRESS
George Hamilton, President
Miramar Industries, Ltd.
5410 Redding Rd
San Diego, CA 92115
Ref. No. K915230
Dear Mr Hamilton:
The Food and Drug Administration (FDA) has reviewed promotional materials for the H-Wave Powered Muscle Stimulator (H-Wave). The H-Wave is distributed by Miramar Industries, LTD. (Miramar) and is a device as defined within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The H-Wave muscle stimulator has been cleared under section 510(k) of the Act and is intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. Additionally, muscle stimulators may make the following additional claims:
- relaxation of muscle spasm;
- prevention or retardation of disuse atrophy;
- increasing local blood circulation;
- muscle re-education;
- immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and,
- maintaining or increasing range of motion.
Our review of promotional materials for the H-Wave which we received at our Los Angeles District Office, indicates that Miramar is promoting the H-Wave device for intended uses that have not been cleared by the Agency. Claims listed in the brochures . include:
- HIV/Aids (peripheral neuropathy)
- reflex sympathetic dystrophy (RSD)
- diabetic neuropathy
- herniated nucleus pulposus
- migraine headache
- avascular necrosis
- reduction of acute and chronic edema
- wound healing claims (accelerated tissue repair, cellulitis, decubitis ulcers)
- prevention of adhesions/scar tissue
- failed back surgeries
- vascular insufficiency
- bells palsy
- faciaI nerve disorder
- peripheral vascular disease.
Promotional cIaims for a given device are limited to the indications for use that were cleared as part of the 510(k) premarket notification submission. The six intended uses for muscle stimulators listed above (relaxation of muscle spasms…), are the only intended uses cleared for the H-Wave. Manufacturers or distributors may not narrow the intended use of a device to a specific body site, tissue, specific patient population, or disease state without the submission and prior clearance of a new 510(k) premarket notification.
The H-Wave is adulterated within the meaning of section 501(f)(1)(B) of the Act in that it is a Class III device under section 513(f), and does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a), or an approved application for investigational device exemption (IDE) under section 520(g).
The H-Wave is also misbranded within the meaning of section 502(o) of the Act, in that a notice or other information respecting the modification in the intended use of the device was not provided to FDA as required by 21 CFR 807.81(a)(3)(ii), and the device were not found to be substantially equivalent to a predicate device.
Additionally, we note that Miramar's promotional materials make reference to the FDA name, registration, 510(k) numbers, and FDA clearance. Examples are: "H-Wave is registered with the US Food and Drug Administration for safety and efficacy. The FDA has issued 510(k) numbers to H-Wave for the following applications…" Reference to FDA, in advertisements or other promotional materials for medical devices is prohibited by the Act and represents misbranding under section 502(a). The reference for this may be found under 21 CFR 807.39 and 807.97, "Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding," and, "any representation that creates an impression of official approval because of complying with the premarket notification regdations is misleading and constitutes misbranding." Miramar Industries may not make any reference to FDA clearance/approval, use of 510(k) numbers and/or reference registration and listing of your devices. These references in your promotional materials should therefore cease immediately.
This letter is not intended to be an all-inclusive list of deficiencies associated with your H-Wave device. It is your responsibility to ensure adherence to each requirement of the Act and Federal regulations. The specific violations noted in this letter may represent practices used in other promotion or advertising materials used by your firm. You are responsible for investigating and reviewing these materials to assure compliance with applicable regulations.
You should take prompt action to correct these violations. Failure to promptIy correct these deviations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not Iimited to, seizure, injunction, and/or civil penalties.
Please notify this office, in writing, within 15 working days of receipt of this letter, outlining the specific steps you have taken to correct the cited violations. Your response shouId also include all steps being taken to address misleading information currently in the market place and actions to prevent similar violations in the future. The Agency is concerned that Miramar, by its promotions, has made a direct connection between the name "H-Wave" and these serious off-label conditions. Miramar's proposal should address how the name "H-Wave" can remain in the marketplace without continuing to imply that it is effective in treating the above conditions and/or disease states. If corrective action cannot be completed within 15 working days, state the reason for the deIay and the time within which the corrections will be completed. Your response should be sent to Mr Steven E. Budabin, Consumer Safety Officer, Promotion and Advertising Policy Staff (HFZ-302), Office of Compliance, Center for Devices and Radiological Health, 2098 Gaither Rd, Rockville, MD 20850.
A copy of this letter is being sent to FDA's Los Angeles District Office. Please send a copy of your response to the District Director, Food and Drug Administration, Los Angeles District Office, 19900 MacArthur Blvd #300, Irvine, CA 92612-2445.
Byron Tart for
LilIian J. Gill
Director, Office of Compliance
This page was posted on August 20, 2006.