Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm375446
Timestamp: 2018-12-10 17:12:04
Document Index: 434576972

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

Mectra Labs, Inc. 11/14/13
2 Quality Way
Re: Electro-Lube, Magnified Insufflation Needle
A Light Insufflation Endoscopic Needle
Refer to CPT1300223
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).
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
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.
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.
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.