Inspections, Compliance, Enforcement, and Criminal Investigations
Mectra Labs, Inc. 11/14/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
NOV 14, 2013
Mectra Labs Inc.
Highway 231 South
2 Quality Way
Bloomfield, Indiana 47424
Re: Electro-Lube, Magnified Insufflation Needle
A Light Insufflation Endoscopic Needle
Refer to CPT1300223
Dear Mr. Clement:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing Electro-Lube anti-stick solution, Magnified Insufflation Needle (MAGI), and A Lighted Insufflation Endoscopic Needle (ALIEN) devices 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 to affect the structure or any function of the body.
The FDA has reviewed your website, www.mectralabs.com, and determined that the MAGI and ALIEN devices are 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 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 in that a notice or other information respecting the modification to the devices was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR. 807.81(a)(3)(i). Specifically, your firm modified the Pneumoperitoneum Insufflation Needle, cleared under K021247 and distributed by your firm as the MAGI and ALIEN devices, by the addition of a 75mm needle, which is outside of the cleared specifications of 120 mm and 150 mm. For example, your firm’s website includes electronic brochures that state the following:
“MAGI . . . . Magnified Insufflation Needle . . . . Available in 75 mm, 120 mm and 150 mm”
“ALIEN . . . . Available in 75 mm, 120 mm and 150 mm.”
Additionally, the user interface for the MAGI and ALIEN devices has been changed from an indicator band on the needle to LED lights (green and red) that indicate the placement of the needle. This is outside the cleared design specification. For example, your firm’s website states:
“ALIEN – A Lighted Insufflation Endoscopic Needle. . . . Our new lighted double indicator LED needle. Red indicates that the needle is not correctly placed; green indicates the tip is free from blockage.”
Compared to the cleared device, the use of the new, indirect indicator of needle placement within the peritoneal cavity includes additional elements in the signal transition chain and, therefore, poses the risk of indicating the wrong signal to the user. These modifications raise safety and effectiveness questions; therefore, they need to be reviewed in a new premarket submission.
In addition, we have found that the Electro-Lube is 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 Electro-Lube is 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 device into commercial distribution in that a notice or other information respecting the new intended use of the device was not provided to the FDA as required by section 510(k), 21 U.S.C. § 360(k), and 21 CFR. 807.81(a)(3)(ii). Specifically, the Electro-Lube was cleared under K033880 as a single patient use device intended to be used on electrodes to reduce sticking. However, your firm’s promotion of the device indicates that the device is intended for indications, including, but not limited to:
- robotic instrument,
- gynecology (kleppingers, cutting forceps, endo coagulators),
- general surgery ( L-Hook Electrodes, Spatula Electrodes, Maryland Dissectors, Metz Curved Scissors),
- ENT (Bovine tips for tonsils, adenoid and thyroid procedures),
- suction coagulator,
- Neuro (Bipolar Jewelers Forceps),
- latex free and non-allergenic and
- HUNDREDS of OTHER applications
These are specific new indicationsthat would constitute a major change or modification to the product’s intended use and would require a new premarket submission.
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. 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. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Our office requests that Mectra Labs immediately cease activities that result in the misbranding or adulteration of the Electro-Lube, MAGI, and ALIEN devices, such as the commercial distribution of the devices for the uses discussed above.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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 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 Operations Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the identification number CPT1300223when 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: Ms. LaShanda Long at (301)796-5465 or (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.
Steven D. Silverman
Office of Compliance
Center for Devices and