Inspections, Compliance, Enforcement, and Criminal Investigations

Caliber Imaging & Diagnostics, Inc. 1/8/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993

 

WARNING LETTER
 JAN 8, 2015
 
Via United Parcel Services
 
L. Michael Hone
Chief Executive Officer
Caliber Imaging and Diagnostics, Inc.
50 Methodist Hill Drive
Suite 1000
Rochester, New York 14623
 
Re: Vivascope 1500, Vivascope 1500 Multilaser, Vivascope 3000
Refer to CMS # 431658
 
 
Dear Mr. Hone:
 
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Vivascope 1500, the Vivascope 1500 Multilaser, and the Vivascope 3000 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), 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 are intended to affect the structure or any function of the body.
 
Vivascope 1500
 
The FDA has reviewed your firm’s website (www.caliberid.com) and determined that the Vivascope 1500is 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 Vivascope 1500is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered 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). 
 
Specifically, the Vivascope 1500 was cleared under K080788[1]with the following indications:
 
The Vivascope System is intended to acquire, store, retrieve, display and transfer in vivo images of tissue, including blood, collagen and pigment, in exposed unstained epithelium and the supporting stroma for review by physicians to assist in forming a clinical judgment.
 
However, your firm’s promotion of the Vivascope 1500 device provides evidence that the device is intended for diagnosing skin cancers and monitoring therapeutic outcomes of skin cancer treatments, which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval. Examples from your website include:
 
  • “Diagnosing skin cancers with high sensitivity and specificity”
  • “Differentiating benign lesions from lesions requiring surgery”
  • “Monitoring therapeutic outcomes of noninvasive treatments”
  • “The VivaScope 1500…has become an integral part of many skin cancer centers world-wide for the diagnosis of melanoma, basal cell carcinoma and squamous cell carcinoma…”
  • “It is also used to evaluate healing processes and for monitoring therapeutic outcomes of skin cancer treatments and pharmaceuticals.”
 
Promotion of the Vivascope 1500 for use in the diagnosis of skin cancers, a high-risk and common disease, and monitoring of therapeutic outcomes of skin cancer treatments and pharmaceuticals fall outside of the device’s cleared indications and constitute major changes or modifications to the device’s intended use because the device is only indicated for the in vivo imaging of tissue that is reviewed by physicians to assist in forming a clinical judgment, not to diagnose skin cancers or monitor therapeutic outcomes of skin cancer treatments.
 
Vivascope 1500 Multilaser
 
The FDA has reviewed your firm’s website (www.caliberid.com) and learned that your firm is marketing the Vivascope 1500 Multilaser for the following intended use: “The VivaScope 1500 Multilaser images the in vivo morphology of exposed unstained epithelium and the supporting stroma to help assist in forming a clinical judgment. The Vivascope 1500 Multilaser is not intended as a primary means of diagnosis.” In addition, the website claims that the device has a wide variety of applications including:
  • “Determining the efficacy of therapeutic regimens”
  • “Assessing dermal-epidermal junction architecture and pigment density”
  • “Quantifying changes in skin layers and measuring individual cell sizes”
  • “Assessing changes in collagen structure”
  • “Evaluating transdermal drug delivery system”
 
Based on the FDA’s review of the Vivascope 1500 Multilaser’s intended use statement, including the applications as referenced above, the Vivascope 1500 Multilaser meets the definition of a medical device under the Act.  The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from FDA before they may offer them for sale.
 
A review of our records reveals that your firm has not obtained marketing clearance or approval to market the Vivascope 1500 Multilaser, which is a violation of the law.  Specifically, the Vivascope 1500 Multilaseris 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).  The Vivascope 1500Multilaser is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 360(k). 
 
Vivascope 3000
 
The FDA has reviewed your firm’s website (www.caliberid.com) and determined that the Vivascope 3000is 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 Vivascope 3000is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered 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). 
 
Specifically, the Vivascope 3000 was cleared under K080788with the following indications:
 
The Vivascope System is intended to acquire, store, retrieve, display and transfer in vivo images of tissue, including blood, collagen and pigment, in exposed unstained epithelium and the supporting stroma for review by physicians to assist in forming a clinical judgment.
 
However, your firm’s promotion of the Vivascope 3000 provides evidence that the device is intended for diagnosing skin cancers and therapeutic monitoring, which would constitute a major change or modification to its intended use, for which your firm lack clearance or approval. Examples from your website include:
 
  • “Diagnosing skin cancers, especially around the nose, eyes and behind the ears, with high sensitivity and specificity”
  • “VivaScope 3000…an integral part of many dermatology clinics and medical institutions for the diagnosis of skin cancers and diseases…”
  • “Differentiating benign lesions from lesions requiring surgery”
  • “Delineating skin tumor margins pre-operatively”
  • “Therapeutic monitoring”
 
Promotion of the Vivascope 3000 for use in the diagnosis of skin cancers, a high-risk and common disease, and for therapeutic monitoring, falls outside of the device’s cleared indications and constitutes a major change or modification to the device’s intended use.
 
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. See 21 CFR 807.81(b).  The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. Do we also want to refer them to ODE or OIR for discussion of an IDE and/or data needed for clearance or approval? The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
 
We also note that 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. It appears that your firm has not fulfilled annual registration and listing requirements for fiscal year 2014. For example, it does not appear that your firm has updated its registration information to reflect the change in the name of your company from “Lucid, Inc.” to “Caliber Imaging and Diagnostics, Inc.” within 30 days of the change as required by 21 CFR 807.22(b)(2) and in accordance with 21 CFR 807.25(b), and failed to list the Vivascope 1500 Multilaser as required by 21 CFR 807.22(b)(3). Therefore, your firm’s devices may also be misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360. In addition, the Vivascope 1500 Multilaser also appears to be misbranded for not being listed with FDA as required by section 510(j) of the Act, 21 U.S.C. § 360(j).
 
Our Office requests that Caliber Imaging and Diagnostics, Inc. immediately cease activities that result in the misbranding or adulteration of the Vivascope 1500, the Vivascope 1500 Multilaser, and the Vivascope 3000, such as the commercial distribution of the device for the uses discussed above.
 
Your firm should take prompt action to correct the violations addressed in this letter.  Failure to do so may result in regulatory action being initiated by the FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties.  Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. 
 
Please notify this Office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.  Your firm’s response should be sent to:
 
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Inspections Support Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
 
Refer to the identification number CMS # 431658when 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: LaShanda M. Long, Chief, Surveillance and Enforcement Branch I at (301) 796-5465 or via fax at (301) 847-8137.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm.  It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.  
 
Sincerely yours,
/S/ 
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
      Radiological Health


[1] The Vivascope system, which may include either an arm mounted imaging head (Vivascope 1500) or a handheld imaging head (Vivascope 3000), was cleared under K080788.

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