TRANSDERM IONTO SYSTEM, MK 2

K042590 · Mattioli Engineering Corp. · EGJ · Oct 14, 2004 · Physical Medicine

Device Facts

• Record ID: K042590
• Device Name: TRANSDERM IONTO SYSTEM, MK 2
• Applicant: Mattioli Engineering Corp.
• Product Code: EGJ · Physical Medicine
• Decision Date: Oct 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5525
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The TRANSDERM IONTO System MK 2 is a powered iontophoresis drug delivery system for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.

Device Story

The TRANSDERM IONTO System MK 2 is a powered iontophoresis device designed for local drug delivery. It consists of a probe, a power supply (TRANS-BASE), and a disposable drug delivery cap electrode. The device utilizes an electric motor with an unbalanced weight to generate mechanical vibrations, which are transmitted to a plastic plate held against the patient's skin via the electrode. An electronic pulse generator produces bursts of electrical pulses, delivered through electrodes on the applicator, to facilitate iontophoretic drug transport. The system operates on a 9V DC supply. By applying electrical current, the device enables the transdermal administration of ionic drugs, serving as an alternative to traditional injections. The device is intended to decrease the patient's perception of electrical currents during the procedure. It is used in a clinical setting to deliver ionic solutions; the healthcare provider manages the application and monitors the delivery process.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by performance testing and compliance with applicable safety standards, including IEC 60601-1 and 21 CFR 898.

Technological Characteristics

Powered iontophoresis device; 9V DC power supply (TRANS-BASE module with 15W AC-DC switch mode power); mechanical vibration via electric motor with unbalanced weight; electronic pulse generator for single-channel output; disposable drug delivery cap electrode; compliant with IEC 60601-1 and 21 CFR 898.

Indications for Use

Indicated for local administration of ionic drug solutions into the body for medical purposes as an alternative to injections. No specific age or gender restrictions provided.

Regulatory Classification

Identification

An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body and induce sweating for use in the diagnosis of cystic fibrosis or for other uses if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. When used in the diagnosis of cystic fibrosis, the sweat is collected and its composition and weight are determined. Additionally, an iontophoresis device intended for any other purposes is a prescription device that is intended to use a current to introduce ions of drugs or non-drug solutions into the body for medical purposes other than those specified in paragraph (a) of this section, meaning that the device is not intended for use in diagnosis of cystic fibrosis, or a specific drug is not specified in the labeling of the iontophoresis device.

Special Controls

*Classification.* Class II (special controls). The device is classified as class II. The special controls for this device are:(i) The following performance testing must be conducted: (A) Testing using a drug approved for iontophoretic delivery, or a solution if identified in the labeling, to demonstrate safe use of the device as intended; (B) Testing of the ability of the device to maintain a safe pH level; and (C) If used in the ear, testing of the device to demonstrate mechanical safety. (ii) Labeling must include adequate instructions for use, including sufficient information for the health care provider to determine the device characteristics that affect delivery of the drug or solution and to select appropriate drug or solution dosing information for administration by iontophoresis. This includes the following: (A) A description and/or graphical representation of the electrical output; (B) A description of the electrode materials and pH buffer; (C) When intended for general drug delivery, language referring the user to drug labeling approved for iontophoretic delivery to determine if the drug they intend to deliver is specifically approved for use with that type of device and to obtain relevant dosing information; and (D) A detailed summary of the device-related and procedure-related complications pertinent to use of the device, and appropriate warnings and contraindications, including the following warning: *Warning:* Potential systemic adverse effects may result from use of this device. Drugs or solutions delivered with this device have the potential to reach the blood stream and cause systemic effects. Carefully read all labeling of the drug or solution used with this device to understand all potential adverse effects and to ensure appropriate dosing information. If systemic manifestations occur, refer to the drug or solution labeling for appropriate action.(iii) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety. (iv) Appropriate software verification, validation, and hazard analysis must be performed. (v) The elements of the device that may contact the patient must be demonstrated to be biocompatible. (vi) The elements of the device that may contact the patient must be assessed for sterility, for devices labeled as sterile. (vii) Performance data must support the shelf life of the elements of the device that may be affected by aging by demonstrating continued package integrity and device functionality over the stated shelf life.

Predicate Devices

• TRANSDERM IONTO System (K032968)

Submission Summary (Full Text)

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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: [phone]<br>Fax: [phone] | |
|----|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | 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

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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.

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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.

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### 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 [phone]

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

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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 [phone] or [phone], 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

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# 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