Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm413354
Timestamp: 2019-02-23 21:05:18
Document Index: 534674513

Matched Legal Cases: ['§ 321', '§ 352', '§ 360', 'art 803', 'art 803', '§ 351', '§ 360', '§ 360', '§ 352', '§ 360', '§ 360', '§ 360']

Advanced MicroVas II, LLC 6/30/14
Ref: 2014-DAL-WL-09
David M. Sitton, Managing Director
Advanced MicroVas II LLC.
3061 West Albany
Dear Mr. Sitton:
During an inspection of your firm located in Broken Arrow, Oklahomaon July 9, 2013 through November 18, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer for the Micro VAS8110 devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices 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.
For example, your firm is the specification developer for the Micro VAS8110 and has not established procedures for design inputs, design outputs, design verification, design validation, design changes, or design history files.
2. Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established as required by 21 CFR 820.198.
For example, your firm does not have any written procedures for receiving, reviewing, and evaluating complaints.
3. Failure to establish purchasing control procedures as required by 21 CFR 820.50.
For example, you are a specification developer for the Micro VAS8110, which you have contract manufactured. You do not have any procedures to control the evaluation of suppliers, define the type and extent of control to be exercised, or to maintain records of acceptable suppliers.
4. Quality audit procedures have not been established as required by 21 CFR 820.22.
For example, your firm has been in operation since July 2, 2012 and you have not written procedures for performing quality audits and you have not conducted any quality audits.
For example, your firm has distributed approximately (b)(4) Micro VAS8110 units and your firm does not have a device master record established for this device.
Our inspection also revealed that your firm’s Micro VAS8110 devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:
1. Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17.
A. SOP-1012, Rev. A does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
1. There are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and definitions for the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
B. SOP-1012, Rev. A does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
1. How your firm will submit all information reasonably known to it for each event.
2. The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.
C. SOP-1012, Rev. A does not describe how it will address documentation and record-keeping requirements, including:
Our inspection also revealed that the Micro VAS8110 devicesare 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the devices is described on the Internet at http://www.fda.gov /MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed.
In addition, FDA has reviewed your firm’s website (www.microvas.com) as well as the brochure entitled “Advanced MicroVas II diabetic & non-diabetic peripheral neuropathy” which is used to market your devices, and determined that several intended uses associated with Micro VAS8110 devices would require substantiation through clinical data. Examples include:
Your website states “Microvas Recommended Uses” and list intended uses not limited to:
Your website also states:
“Healthcare professionals who are familiar with MicroVas consider it an important new tool in the treatment of neuropathy, non-healing wounds, repetitive motion disorders, fibromyalgia, common sports injuries and many other conditions related to vascular insufficiency.”
“The following conditions have all responded decisively with excellent results: Peripheral Vascular Disease, Ischemic Rest Pain, Diabetic Neuropathy, Pressure Ulcers, Slow Non-Healing Wounds, Chronic Low Back Pain, Occupational Medicine (Carpal Tunnel Syndrome).”
“MicroVas has been used on diabetics with severe ischemic ulcers in the feet that were destined for amputation…MicroVas greatly improves the management of this condition.”
“The MicroVas team can report amazing success in reversing neuropathy in the feet of diabetics.”
“MicroVas proves to be of utmost efficacy in the treatment of diabetic peripheral neuropathy in the lower extremities.”
“…many cases of infection associated with non-healing wounds will resolve with MicroVas treatments where they would not otherwise.”
“After the patient began Micro Vas treatments, the effects were quickly apparent. Not only was the wound healing, but a fracture in the tibia was also healing.”
“MicroVas has been used to treat the following: Osteoporosis/Osteoarthritis/Degenerative Joint Disease.”
Your brochure states:
“Periphreal neuropathy is a condition of nerve impairment…MicroVas electrical stimulation is an advanced form of physical medicine that addresses the problem uniquely.”
“MicroVas stimulates the healing process so the body can heal itself.”
“MicroVas also helps to close stubborn, non-healing wounds quickly.”
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal years 2013 and 2014.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility, products or websites. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.