TRANSDERM IONTO SYSTEM, MK 2

{0}------------------------------------------------ TRANSDERM IONTO System MK 2 Summary of Safety and Effectiveness 9/23/2004 ### SUMMARY OF SAFETY AND EFFECTIVENESS #### GENERAL INFORMATION I. | A. | Submitted By: | Mattioli Engineering Corporation<br>7918 Jones Branch Drive<br>Suite 600<br>McLean, VA 22102<br><br>Tel: 703-312-6000<br>Fax: 703-243-9139 | | |----|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------| | | Contact Person: | Ms. Linda Ferri<br>At address above | | | B. | Device Trade Name:<br>Common Name:<br>Classification Name: | TRANSDERM IONTO System MK 2<br>Iontophoresis Device<br>Device, Iontophoresis, Specific Uses | | | C. | Predicate Devices: | | | | | Manufacturer | Product Name | 510(k) No. | | | Mattioli Engineering Corporation | TRANSDERM IONTO System | K032968 | #### II. DEVICE DESCRIPTION The TRANSDERM IONTO System MK 2 consists of a probe, power supply/support, and a disposable drug delivery cap electrode. The TRANSDERM IONTO System MK 2 generates mechanical vibrations that are produced by an electric motor which has an unbalanced weight applied on the device shaft. The vibrations are transmitted by the motor body to a plastic plate that is held in contact with the skin through the disposable drug delivery cap electrode. Electrical pulses are produced by an electronic pulse generator that is able to generate bursts of pulses that are applied to the skin through electrodes applied to a plastic plate (the applicator). The design of the device provides one channel output. The TRANSDERM IONTO System MK 2 requires a DC supply of 9 V, 1.0 A max. This power source is supplied by, the TRANS-BASE module which is connected to mains through a removable supply cord and is equipped with a proper connector receptacle to fit the connector male mounted on TRANSDERM {1}------------------------------------------------ IONTO probe supply cable. The TRANS-BASE is equipped with a 15 w AC-DC switch mode power module. The drug delivery cap electrode is adhered to the patient's skin and then saturated The urug delivery cap electrug delivery cap electrode is affixed to the while solution: "Oneo the artig changes": applicator head can be attached pation internal side of the drug delivery cap electrode. #### INDICATIONS FOR USE III. The TRANSDERM IONTO System MK 2 is a powered iontophoresis drug The TNANODEREN 107. For the local administration of ionic drug uch very system that is fir medical purposes and can be used as an alternative to injections. #### TECHNOLOGICAL COMPARISON IV. The TRANSDERM IONTO System MK 2 and the TRANSDERM IONTO The TVANSDEREN FOR the same indications for use and overall function and Dystem (11052700) in the same manner with respect to iontophoretic drug delivery. perform in the same supports that the TRANSDERM IONTO System MK 2 decreases the patient's perception of the electrical currents. #### TESTING V. Performance testing and the applicable IFC 60601-1 standards testing including 21 CFR 898 was performed. #### CONCLUSIONS VI. The TRANSDERM IONTO System MK 2 is substantially equivalent to the legally marketed iontophoretic devices in intended use and performance. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/2/Picture/2 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## OCT 1 4 2004 Mattioli Engineering Corporation C/o Ms. Melissa Mahall Bio-Reg Associates, Inc. 11800 Baltimore Avenue Suite 105 Beltsville Maryland 20705 K042590 Re: Trade/Device Name: TRANSDERM IONTO System MK 2 Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: September 23, 2004 Received: September 23, 2004 Dear Ms. Mahall: We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your Section - FQty premained is substantially equivalent (for the indications felerenced above and nave determined in the enclicate devices marketed in interstate for use stated in the encrosule) to regally manet date of the Medical Device Amendments, or to commerce provision to May 20, 1976, the exactions of the Federal Food, Drug, uevices mat nave been reculssives in accemply with all of the Act's requirements relating to allu Cosment Act (Trel), as long as you veally-y . You may, therefore, market the drings tabled of promoted while de reovisions of the Act. The general controls provisions of de vice, subject to the general vonanual registration, listing of devices, good manufacturing ure fret merade roundbitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (bes above) and cregulations affecting your device can be It may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may round in the Oous of recements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean I reast of advised that I Dri of issualite of our device complies with other requirements of the Act that I DA has inado a determinations administered by other Federal agencies. You must or any I cacar statuted and regirements, including, but not limited to: registration and listing (21 Comply with an the Her s requirements)01); good manufacturing practice requirements as set CFR Part 6077, adoning (21 CFR Part 820); and if applicable, the electronic form in the qualis (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ ### Page 2 - Ms. Mellisa Mahall Our substantially equivalent decision does not apply to drugs for use with your device. Our substantially equivalent dees not uppy to ange use with specific drugs other than Intocaine (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution), nor package drugs lontocalle (Lidocatile TCT 276 and Epuspillate the drugs for iontophoretic administration. For with your do rece proce procements for marketing new drugs, you may contact: > Director Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland As you are aware, iontophoresis devices that are intended to use a direct current to introduce ions AS you are aware, lomophoresis actrees as and induce sweating for use in the diagnosis of cystic of soluble sats or other uses into the eno of the drug intended for use with the device bears adequate directions for the device's use with that drug, were classified into Class II. An adequate anrochons for the untended to use a direct current to introduce ions of soluble salts or lomopilores is de rice may is medical purposes other than those specified for class II devices is other urags into the body for meason papp. We published our strategy for calling for premarket to approval (PMA) applications in the enclosed Federal Register, dated May 6, 1994, and the approval (1 Nr.) applications in the enclosed Federal Register, dated August 22, 2000. If you have any questions regarding this letter, you may contact: Kevin Lee, M.D. Food and Drug Administration Center for Devices and Radiological Health Division of General, Restorative and Neurological Devices 9200 Corporate Boulevard (HFZ-410) Rockville, Maryland 20850 (301) 594-1296 This letter will allow you to begin marketing your device as described in your Section 510(k) Fills lotter will and in yourse finding of substantial equivalence of your device to a legally premarket notification. "Te results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation, please contact the Office If you desire specific acritor of . Also, please note the regulation entitled, "Misbranding by {4}------------------------------------------------ Page 3 - Ms. Mellisa Mahall reference to premarket notification' (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, rincriational and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Marli A. Milkersen Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosures {5}------------------------------------------------ # INDICATIONS FOR USE 510(k) Number: TRANSDERM IONTO System MK 2 Device Name: Mattioli Engineering Corporation Sponsor Name: Indications for Use: The TRANSDERM IONTO System MK 2 is a powered iontophoresis drug delivery THE TIGHTODEREN TOTTO Byocal administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections. Prescription Use × (21 CFR 801 Subpart D) And/Or Over-The-Counter Use (21 CFR 807 Subpart C) Do Not Write Below This Line – Continue on Another Page if Needed Concurrence of CDRH, Office of Device Evaluation (ODE) Mark N. Millerson Division of General. Restorative, and Neurological Devices **510(k) Number** K042590