VENX REVOLUTION

{0}------------------------------------------------ K110355 510(k) Summary VENX LLC 510(k) Notification Submission APR 2 2 2011 Date: January 31, 2011 Submitted by: VENX LLC 2701 NW 2nd Avenue, Suite 218 Boca Raton, FL 33431 > 561-237-5008 Phone: 561-237-5040 Fax: Contact: Navroze Mehta Manual Surgical Instrument Common Name: Manual Surgical Instrument Trade Name: VENX REVOLUTION™ Classification Name: Classification: Class I per 21 CFR 878.4800 Predicate Device: Advanced Medical Products, Arachnophlebectomy Needle (K000932) ## Description: The VENX REVOLUTION™ is a sterile, disposable, single patient use surgical instrument for the disruption and destruction of spider veins located in the lower extremities of the body. The device is made available in several sizes to accommodate a range of veins that form in the lower body. The VENX REVOLUTION™ consists of a thermoplastic handle containing a lever actuated rack and gear mechanism for rotating a shaft extending from the handle. At the end of the shaft are stainless steel, needle-like tines sharpened and spaced appropriately to straddle veins located just below the surface of the skin. Once the tines are in place straddling the vein, the levers are actuated causing the shaft to rotate approximately 360° or more. Actuating the levers causes internal springs to compress. Once the levers have rotated the shaft 360° and the tines have disrupted the vein, releasing the levers allows the compressed springs to return the tines to their original position. The device is then withdrawn and re-inserted at another position within the clinician-selected area to repeat the operation on the same vein or on another vein. The procedure is repeated until all veins within the selected area have been treated. ## Intended Use: The VENX REVOLUTION™ is a manual surgical instrument intended for use in the destruction of spider veins in the lower extremities of the body. ## Comparison to Predicate Devices: The VENX REVOLUTION™ differs from the predicate device only in the mechanism for rotating the device tines. The predicate device relied on the clinician to manually rotate the pen-like device within the fingers to disrupt the vein. The VENX REVOLUTION™™ {1}------------------------------------------------ 110355 Page 2 of 2 VENX LLC 510(k) Notification Submission incorporates a lever-actuated mechanism to rotate the tines a minimum 360° by actuating levers with the fingers. The basic construction, and available sizes of the tines remain unchanged. ## Testing: Bench testing has been conducted using simulated actual use conditions comparing the new device and its ability to disrupt and destruct spider veins to that of the predicate device. The results of the testing show the new device to perform as intended and equivalent to the predicate device. Testing included tine deformation, cycle life, and rotating mechanism operation. #### Conclusion: In accordance with the Food, Drug, and Cosmetic Act and 21 CFR 807, and based on the information provided in the premarket notification, VENX LLC concludes that the VENX REVOLUTION™ is safe, effective and substantially equivalent to the predicate device discussed herein. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Venx. ILC % MRI Medical Mr. Ira Duesler 4700 S. Overland Drive Tucson, Arizona 85714 # APR 2 2 2011 Re: K110355 Trade Name: Venx Revolution™ Classification Regulation Name and Number: Manual Surgical Instrument for General Use, 21 CFR 878.4800 Regulatory Class: Class I Exempt Product Code: 79 GAH (Stylet, Surgical, General & Plastic Surgery) Dated: January 31, 2011 Received: February 7, 2011 Dear: Mr. Duesler We have reviewed your premarket notification submission and have found this device to be exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (Act). Therefore, you may immediately begin marketing this device as described in your premarket notification. The final classification regulation for your device appears in Title 21 of the Code of Federal Regulations (CFR) 878.4800. We suggest that you review this regulation since it may grant other exemptions from certain general controls of the Act. Your device classification regulation name, regulatory class, and product code are shown above. When listing your device with the Food and Drug Administration, please use this product code. In the future, new but substantially equivalent devices which fall within the above classification regulation name and meet the classification criteria may be marketed without sending a premarket notification submission to the Food and Drug Administration. We suggest, however, that you review 21 CFR Section 878.9 to determine whether or not your new device meets the limitations of exemption from Section 510(k) of the Act. If you have any questions regarding this letter, please contact George J.Mattamal, Ph.D at (301) 796-6396 or the Division of Small Manufacturers, International and Consumer Assistance at its {3}------------------------------------------------ Page 2 - Mr. Ira Duesler toll free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsmamain.html. Sincerely yours, A.J. B. n h fer Mark N. Melkerson Director Division of Surgical, Orthopedic and Reconstructive Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ Indications For Use 510(k) Number (if known): K110355 Device Name: VENX REVOLUTION™ Indications For Use: The VENX REVOLUTION™ is a manual surgical instrument intended for use in the destruction of spider veins in the lower extremities of the body. Prescription Device × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nel R.P. Ayde firmen (Division Sign Off) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K110355 d