Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/neomedix-corp-02262014
Timestamp: 2020-07-10 13:49:56
Document Index: 777621740

Matched Legal Cases: ['§ 321', '§ 807', '§ 351', '§ 360', '§ 360', '§ 352', '§ 360']

Neomedix Corp - 02/26/2014 | FDA
Neomedix Corp - 02/26/2014
Neomedix Corp February 26, 2014
Dr. Michael Mittelstein
15042 Parkway Loop
Tustin, California 92780-6528
Re: Trabectome High Frequency Generator/LP
K061258
Refer to CPT1400130
Dear Dr. Mittelstein:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Trabectome High Frequency Generator/LP (Trabectome) in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device 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 Trabectome was cleared under K061258 for “use with compatible electrosurgical instruments in low power microsurgical applications for the removal, destruction and coagulation of tissue.” The K061258 submission did not include data regarding the treatment of glaucoma, and the device was not cleared for the treatment of glaucoma. FDA has reviewed your website (www.neomedix.net, most recently on February 25, 2014), including the invite/agenda for an external training on the Trabectome to be given on February 27, 2014, in Washington, DC, available at http://www.trabectome.com/Learning/TrabectomeTraining/Register. These materials provide evidence of a major change or modification in the intended use of your device under 21 CFR § 807.81(a)(3)(ii). For example, these materials promote the Trabectome for the “minimally invasive surgical management of glaucoma,” “for minimally invasive treatment of glaucoma,” and “33% IOP [intraocular pressure] Reduction on Average.”
Therefore, the Trabectomeis adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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), for the device as described and marketed. The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
Our office requests that NeoMedix Corporation immediately cease activities that result in the misbranding or adulteration of the Trabectome, such as the commercial distribution of the device for the uses discussed above.
Refer to the identification number CPT1400130 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Mrs. Debra E. Demeritt at 301-796-5770 or by facsimile at
301-847-8137.
Neomedix Corp - Close Out Letter 5/21/14