CDRH UNTITLED LETTERS.

The following untitled letters are the first in a series issued by the Promotion and Advertising Staff of the Center for Devices, Office of Compliance (CDRH-OC). Companies whose names begin with the letters C through L are summarized in this issue. Copies of these letters are available to subscribers from our RECORD-RETRIEVE Service for $7 plus retrieval.

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CryoGen, San Diego, CA, Oct. 5, 1999 (CDRH-OC). FDA cited the company for promoting its First Option cyrogenic ablation device for use in removal of endometrial and uterine fibroid tissues. The letter commented that "we are aware of your appeal pending before the agency regarding the appropriate approval or clearance route for this device," but the agency nonetheless insisted that the firm must file a PMA or a 510(k) before making claims not already cleared. The letter addressed CryoGen's Web site which described a clinical study of "a new, minimally-invasive procedure" for treatment of abnormal uterine bleeding as an alternative to hysterectomy and claimed the device "will reduce or eliminate menstrual bleeding, providing relief to women who suffer from this condition." FDA deemed such statements violative because "CryoGen has not established that the appropriate treatment for abnormal uterine bleeding is ablation of the endometrium nor has CryoGen established that its First Option system is safe and effective in ablating endometrial tissues." PMA, Web

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Damor America, Melrose Park, IL, Oct. 19, 1999 (CDRH-OC). The letter stated that Damor's Web site promotion of its wound dressing and "creme" included claims not cleared by FDA, including arterial ulcers and radiotherapy-induced wounds. The agency insisted that such claims constituted a new intended use and called for a 510(k). 510(k), Web

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Dynamika, Novosibirsk, Russia, March 22 (CDRH-OC). The letter cited the firm for claims at its Web site for the Frolov respiratory trainer, including treatment for chronic bronchitis, emphysema, osteochondrosis, pathological climax and atherosclerosis. FDA pointed out that "the only claims for this device when sold in the U.S. are for use as a positive expiratory pressure device and inspiratory muscle trainer for single-patient use." The agency advised Dynamika that "one way to come into compliance with United States law would be to have a completely inde-pendent Web site targeted only at the Russian (and/or international) population and remove all links to U.S. Web sites." Web

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Dynatronics, Salt Lake City, UT, Nov. 3, 1999 (CDRH-OC). FDA requested copies of all promotional materials promulgated in connection with the firm's DynaPak iontophoresis electrode kit, the Iontophor R-PM/DX delivery device and the Microphor iontophoresis device, all manufactured by LifeTech.

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Ears-Rite, Tucker, GA, Feb. 18 (CDRH-OC). The letter referred to a telephone conversation in which an Ears-Rite representative indicated that, while the firm preferred that customers obtain a hearing exam prior to purchasing its EZ Hear, it would nonetheless ship the hearing aid based solely on a "purchase with a credit card or personal check." FDA stated that regulations require that, if the purchaser had not undergone an evaluation of hearing within the previous six months, the customer be informed that waiving the requirement was not in their own best interest. FDA also stated that the company could not "in any way actively encourage the prospective user to waive such a medical evaluation," and had to allow the prospective customer an opportunity to sign a waiver of medical evaluation. The letter commented that FDA had received complaints that personnel with the firm had described the hearing aid as an "assistive listening" or "amplification" device and the agency noted that "there is currently no formal definition for these terms in the regulations."

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ESC Medical Systems, Bothell, WA, April 19 (CDRH-OC). The firm's Web site promoting the Derma 20 laser system included claims of wrinkle removal, which the letter stated the firm "made a written commitment to remove." The letter stated that the agency "would have no objection" if the firm promoted such uses to potential customers in other nations so long as "you have a separate Web site for that purpose." Web

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Exogen, Piscataway, NJ, Sept. 7, 1999 (CDRH-OC). FDA cited the firm's promotion for its Sonic Accelerated Fracture healing system in a journal ad that stated "by routinely prescribing SAFHS for fresh fractures, you are circumventing what may become a nonunion." The agency stated that the device was approved for accelerated healing of fresh, closed, posteriorly-displaced distal radius fractures and fresh, closed or Grade 1 open tibial diaphysis fractures in skeletally-mature individuals" when orthopedically managed by closed reduction and cast immobilization. The letter stated that the claim regarding a nonunion was misleading because the device "was not specifically approved to circumvent/prevent a nonunion" and FDA felt that "the promotional material needs to be qualified by noting the device's intended use so that the reader will not be misled."

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Fidia, Padua, Italy, April 7 (CDRH-OC). FDA informed the company that distributors for Hyalgan (sodium hyaluronate) in the U.S. "continue to make inappropriate claims," including relief of pain for up to 12 months. The letter noted that Fidia had a pending PMA supplement for the term, but that the application had not yet cleared. The distributors, Sanofi-Synthelabo of New York and Orthologic of Tempe, AZ, were also said to have promoted the device for a course of therapy involving three injections "instead of the approved five-injection course of therapy." FDA commented that both firms committed to make claims of effectiveness for no longer than six months, and noted that the device was cleared for claims of treatment of pain in patients with osteoarthritis of the knee who did not "respond adequately to conservative non-pharmacologic therapy and to simple analgesics." The letter also made note of promotional materials which stated that Hylagan contained a natural, highly purified hyaluronate which was "not chemically cross-linked with formaldehyde, like Synvisc." The agency insisted that the statement implied that the competitor product was "unsafe because of the presence of formaldehyde" and that "no such determination" had been made by FDA.

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W.L. Gore & Associates, Flagstaff, AZ, Oct. 26, 1999 (CDRH-OC). FDA referred to a letter dated June 1998 that made the claim that the firm's Preclude dura substitute and dura gel can "resist adhesions against the dura following spinal surgery." FDA stated that Gore had promised to eliminate the claim in future marketing materials, but that "two of your promotional materials...continue to imply that" the product may reduce adhesions. The letter pointed out that claims which the agency cleared included "temporary or permanent prosthesis for repair of dura mater during neurosurgery." FDA also asked the company to forward information clarifying "the regulatory status" of the Preclude Spinal Membrane, which the letter stated was not the subject of an existing 510(k). 510(k)

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W.L. Gore & Associates, Newark, DE, Dec. 1, 1999 (CDRH-OC). FDA indicated that it had received "a complaint that the Seamguard is being used and promoted in the United States for indications in bariatric surgery" and had reviewed a copy of the device's instructions for use which indicated that the device "can be used to reinforce staple lines during lung and/or gastric resection." The agency commented that the device "is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using linear surgical staplers" and that among its uses is the reinforcement of staple lines during gastric banding. FDA insisted that the Seamguard had not been cleared for use in conjunction with gastric resection and that the new intended uses called for submission of a 510(k). 510(k)

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W.L. Gore & Associates, Flagstaff, AZ, Jan. 12 (CDRH-OC). FDA referred to the company's response to the request for information on the Preclude Spinal Membrane which the firm stated was a renamed version of its Gore-Tex dual mesh biomaterial. The agency stated it disagreed with the firm's conclusion that a 510(k) was not called for because of claims that the device provided a "physical barrier in the spine, limiting scar tissue migration into the spinal canal." The letter added that the claims constituted a new intended use and detailed that regulations required submission of a 510(k) when a promotion "creates an implied new indication for use." 510(k)

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Guidant, Santa Clara, CA, Oct. 5 (CDRH-OC). The agency stated that claims for Guidant's ACS Multilink coronary stent system should be accompanied by contraindications including patients judged to have a lesion that prevents complete inflation of an angioplasty balloon and patients in whom anti-platelet and/or anti-coagulant therapy is contraindicated. FDA suggested that warnings and precautions should include risk of subacute thrombosis and vascular complications and allergic reactions for those allergic to 316LS stainless steel. The letter also stated that subsequent restenosis may require repeated dilation of the arterial segment, which involved an unknown outcome over the long term. Adverse events detailed in the letter included "death, Q wave MI, non-Q wave MI and bleeding, while potential adverse events were to include myocardial ischemia and arrhythmia.

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Healthier You, Lake Worth, FL, Aug. 31 (CDRH-OC). FDA stated that the firm had indicated it would require only a credit card number to ship its MaxiSound hearing aid and that the sales representative did not ask whether the caller had consulted with a physician about hearing loss. The letter stated that regulations required sellers of hearing aids to have obtained evaluation within six months prior to placing the order or that the buyer sign a waiver of medical evaluation. The letter also noted that the firm could not encourage the waiver of evaluation and that the customer must be afforded an opportunity to sign a statement that waiving the exam was not in his/her best interest.

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Heareasy Hearing Aids, Moreno Valley, CA, Feb. 18 (CDRH-OC). The agency stated that it had a telephone conversation in which a company representative indicated that the EZ Hear device may be used for mild to moderate hearing loss of less than 55 decibels and that the firm would ship the hearing aid based solely on a "purchase with a credit card or personal check." FDA stated that regulations require that, if the purchaser had not undergone an evaluation of hearing within the previous six months, the customer be informed that waiving the requirement was not in their own best interest. FDA also stated that the company could not "in any way actively encourage the prospective user to waive such a medical evaluation," and had to allow the prospective customer an opportunity to sign a waiver of medical evaluation. The letter commented that FDA had received complaints that personnel with the firm had described the hearing aid as an "assistive listening" or "amplification" device and the agency noted that "there is currently no formal definition for these terms in the regulations."

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IGIA Direct, New York, NY, Oct. 4, 1999 (CDRH-OC). FDA stated that the firm's Touch 'N Go tweezer epilator had not been cleared for claims of permanent hair removal, as indicated in an ad in a catalog as well as on the company's Web site. The agency noted that such devices were exempt from premarket notification requirements, the modification of the intended use voided the exemption. 510(k), Web

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Intercontinental New Technologies, Northbrook, IL, March 10 (CDRH-OC). The letter requested copies of promotional materials in connection with the Frolov respiratory trainer device.

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International Hair Removal Systems, Southern Pines, NC, July 20, 1999 (CDRH-OC). The letter stated that the firm had promoted its TD-829 hair removal machine as "offering 4 methods of permanent hair removal in one machine

tweezer, transdermal, continuous and the new Hands Free" and that the firm had filed no 510(k) for the transdermal, continuous or Hands Free modes of hair removal. 510(k)

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International Medical Electronics, Kansas City, MO, March 31 (CDRH-OC). The agency stated that the company's Magnatherm 2000 and 1000 SS devices had been cleared for therapeutic deep heat in an adjunctive role, but that IME's Web site included claims regarding the treatment of edema, which had not been included in device clearance, and "other musculoskeletal conditions." The agency observed that the latter claim was "too broad and changes the intended use." The letter commented that the Web site also included a reference to "a 1926 textbook by Sampson" that identified a series of claims in vogue at that time, including treatment of acute cystitis, prostatitis and herpes zoster, and FDA insisted that the inclusion of this material "implies that these conditions can be treated with" the firm's devices. 510(k), Web

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Indiana LASIK Center, Marion, IN, Sept. 24, 1999 (CDRH-OC). FDA stated that the clinic's newsletter, which discusses the NIDEK EC-5000 scanning laser, inferred the use of the device for LASIK procedures "through the fact that the laser is being used at LASIK centers and the LASIK procedure and LASIK patients are discussed." The letter noted that continued claims would cause the device to be misbranded and adulterated because NIDEK EC-5000 had not been cleared for use in LASIK. 510(k)

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IOMED, Salt Lake City, UT, Nov. 3, 1999 (CDRH-OC). The agency requested copies of all promotional materials promulgated in connection with the firm's iontophoretic drug delivery systems and electrodes.

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The Johnston Center for Sight, Leesburg, VA, Jan. 25 (CDRH-OC). FDA cited the clinic's promotion of LASIK using the VISX Star 2 excimer laser because the device had not been approved for LASIK treatment. 510(k)

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KeraVision, Fremont, CA, Aug. 31 (CDRH-OC). FDA stated that the firm's Web site made claims regarding the effectiveness of its Intac device that have not been cleared with the agency. The letter stated that approved claims included "74% of patients achieved 20/20 vision" and 16% achieved vision of 20/16. The letter accused the firm of posting claims at its Web site of 82% at 20/20 and 63% at 20/16. The letter also blasted the firm for making comparisons to LASIK treatment and noted that a press release using the same numbers as the Web site were based on "patients at a single site" whereas the claims for safety and efficacy were based on "an entire study." The agency complained that the data had not been submitted to FDA to back the claims. Web

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Kinetic Concepts, San Antonio, TX, July 28, 1999 (CDRH-OC). The agency acknowledged Kinetic's "commitment to remove the claim for BiaFine regarding the recruitment of macrophages to the wound site and impacting all three phases of the wound healing process from both your promotional materials and your Web site." However, FDA commented that the firm's claims of "faster migration" of macrophages, fibroblasts and epithelial cells across the wound bed, which appeared in an unnamed volume of the "Plastic Surgical Nurse" were unclear "because we do not know to what you are comparing the speed." The letter also noted that the claim of accelerated migration "would significantly modify the intended use" of the device and hence require the submission of a 510(k). FDA made a similar observation regarding a claim of "helping to reduce bacterial colonization" and commented that study results reported in the "Annals of Plastic Surgery" in 1997 were inconclusive with regard to "growth and inhibitory factors in wound effluent treatment during subatmospheric pressure treatment."

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LPG USA, Fort Lauderdale, FL, Jan. 6 (CDRH-OC). FDA cited the firm for promotional materials that mention the Synergie therapeutic massager manufactured by Dynatronics. The agency stated that the claim "no FDA approval" implied that Dynatronics was marketing the device illegally. The letter stated that the flyer also commented that the rival company was the subject of an FDA investigation in connection with a letter by LPG registering a complaint against Dynatronics. FDA insisted that the agency had received LPG's letter and that to extrapolate "the letter to imply that Dynatronics has done something to violate FDA regulations or that there is an ongoing investigation of this device is false and misleading." The agency stated that a representative of LPG had made "disparaging remarks" regarding Dynatronics' equipment at a trade show and a convention of the Colorado Chiropractic Association. The letter from FDA stated that "a manufacturer who makes a false and/or misleading representation in the labeling with respect to another device causes his own device to be misbranded."

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Lakeside Products, Pompano Beach, FL, Oct. 4, 1999 (CDRH-OC). The letter advised Lakeside that a representative of the firm "was asked what would be required" to receive the firm's Bio Ear hearing aid and that the representative replied that only a credit card number would be required. FDA informed the firm that regulations mandated that the firm not sell a hearing aid to a customer who had not received an evaluation in the preceding six months unless the customer was at least 18 years of age and had signed a waiver of medical evaluation. The agency noted that regulations also called for the seller to avoid actively encouraging the prospective buyer to waive the evaluation and that the customer had to be offered an opportunity to sign a statement indicating that s/he was aware that medical evaluation was in his/her best interest.

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Laser Eye Center of Silicon Valley, Santa Clara, CA, Sept. 28, 1999 (CDRH-OC). The agency notified Laser Eye Center that its Web site and its ad in the Pacific Bell Smart yellow pages were out of compliance with regard to references to the VISX Star S2 excimer laser and the NIDEK laser because references to LASIK inferred "that these lasers are used to perform LASIK" when the agency had not approved them for the procedure.