EMPI ACTION PATCH IONTOPHORESIS SYSTEM

K030395 · Empi · EGJ · Apr 8, 2003 · Physical Medicine

Device Facts

• Record ID: K030395
• Device Name: EMPI ACTION PATCH IONTOPHORESIS SYSTEM
• Applicant: Empi
• Product Code: EGJ · Physical Medicine
• Decision Date: Apr 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5525
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Empi Action Patch Iontophoresis System is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.

Device Story

Empi Action Patch is a disposable, single-use, self-contained iontophoresis device. It integrates a battery, electrical circuitry, and active/return electrodes into a single adhesive patch. The device delivers a calibrated, fixed dose of ionic solution (1–160 mAmp*min) over a set duration. An LED indicator extinguishes upon completion of the dose, signaling the user to remove the patch. It operates at a low output voltage (10.5V) to ensure safety during extended delivery sessions. The device is intended for medical use as an alternative to injections. It utilizes an immobilized buffer system to control pH for chemical safety.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics, design, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Disposable, single-use, self-contained iontophoresis patch. Features integrated battery, electrical circuitry, and electrodes. Uses immobilized buffer system for pH control. Adhesive foam backing identical to Empi Buffered Iontophoresis Electrodes. Output voltage: 10.5V. Fixed-dose control (current * time) via electronic circuitry. LED indicator for dose completion.

Indications for Use

Indicated for patients requiring local administration of ionic solutions into the body for medical purposes as an alternative to injections.

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

• Birch Point IontoPatch (K992708)
• Empi Dupel B.L.U.E. Iontophoresis Electrode (K983484)
• Empi Dupel Dual-Chamber Iontophoresis System (K915444)
• Empi Buffered Iontophoresis Electrodes (K912015)

Submission Summary (Full Text)

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K030395

# Section E

APR 0 8 2003

# 510(k) Summary

- A. General Provisions

| Submitter's Name: | Empi Corp. |
|----------------------|------------------------------------------------------------------------------|
| Submitter's Address: | 599 Cardigan Road<br>St. Paul, Minnesota 55126-3965 |
| Contact Person: | Suzan Onel and Donald R. Stone<br>[phone] (ph); [phone] (fax) |
| Classification Name: | Iontophoresis Device<br>21 CFR 890.5525 |
| Proprietary Name: | Empi Action Patch Iontophoresis System (also<br>known as the “Action Patch”) |
| Common Name: | Iontophoresis Device |

- B. Date of preparation of this Summary: January 31, 2003
- C. Name of Predicate Devices to which equivalence is claimed:
- Birch Point IontoPatch K992708 ●
- Empi Dupel B.L.U.E. Iontophoresis Electrode K983484 ●
- Empi Dupel Dual-Chamber Iontophoresis System K915444 .
- Empi Buffered Iontophoresis Electrodes K912015 ●

The Empi Action Patch is substantially equivalent to the identified Empi Dupel iontophoresis devices in intended use, materials of construction, and mode of operation. The Empi Action Patch is substantially equivalent to the Birch Point IontoPatch in terms of intended use and self contained design. The Action Patch uses the identical adhesive foam backing as that used in the Empi Buffered Iontophoresis Electrodes.

- D. Device Description
The Empi Action Patch Iontophoresis System is a disposable single-use iontophoresis device with a self-contained battery and electrical circuitry. A single adhesive patch unifies both the battery-powered iontophoresis device and the active and return electrodes. The Empi Action Patch is designed to deliver a calibrated and fixed dose of ionic solution (between 1 and 160 mAmp * min.) over a specified time. After delivery of the specified dose, an LED indicator light extinguishes indicating that that the Patch can be removed.

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- Statement of Intended Use Compared to Predicate Device(s) E.
The Empi Action Patch has the same intended use as the above identified predicate devices and other iontophoresis devices, i.e., it is intended to be used for the local administration of ionic solutions into the body for medical purposes and as an alternative to injections.

- F. Discussion of Technological Characteristics:
Like the Birch Point IontoPatch, the Empi Action Patch is a disposable, selfcontained, single use iontophoresis device in a unified patch form. In terms of outward appearance and intended use, it is substantially equivalent to the IontoPatch. In terms of design, both incorporate a battery to supply current to the electrodes and a means of electronically controlling a fixed dose (current * time). Both devices extend the duration of an iontophoresis session beyond that typical for multiple component systems, such as the Empi Dupel iontophoresis system designed to be used during a clinic visit. Since the duration is longer, both unified patch devices require a maximal output voltage that is less than predicate multicomponent systems such as the Dupel. The IontoPatch outputs 1 volt, and the Action Patch produces 10.5 volts: both significantly less than the maximal voltage of the Dupel system of 60 volts. This adds an intrinsic safety factor to both unified patch devices in that the maximal current density is also less than that of the predicate multicomponent devices designed for shorter iontophoresis sessions.

The Empi Action Patch uses an immobilized buffer system to control pH, a major determinant of chemical safety during iontophoresis. This buffering system is identical to the Dupel B.L.U.E. iontophoresis electrode in terms of mechanism of action, materials, and function.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Empi Corporation c/o Ms. Suzan Onel Kirkpatrick & Lockhart LLP 1800 Massachusetts Avenue, NW Suite 200 Washington, DC 20036-1221

APR 0 8 2003

Re: K030395

Trade/Device Name: EMPI Action Patch Iontophoresis System Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: February 5, 2003 Received: February 5, 2003

Dear Ms. Onel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act), as long as you comply with all of the Act's requirements relating to drugs labeled or promoted with the devices as described below. You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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### Page 2 - Ms. Suzan Onel

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Our substantially equivalent decision does not apply to drugs for use with your device. Therefore, you may neither label nor promote your device for use with specific drugs, nor package drugs with your device prior to FDA having approved the drugs for iontophoretic administration. For information on the requirements 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 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, were classified into Class II. An iontophoresis device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes other than those specified for class II devices is classified into Class III (21 CFR 890.5525). We published our strategy for calling for premarket approval (PMA) applications in the enclosed Federal Register, dated May 6, 1994, and the enclosed memorandum, dated April 19, 1994, and 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 of Compliance at (301) 594- 4659. Also, please note the regulation entitled, "Misbranding by

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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], or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark A. Millheiser

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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## Appendix A1

### 510(k) Number (if known):

## Device Name: Empi Action Patch Iontophoresis System

#### Indications for Use:

The Empi Action Patch Iontophoresis System is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Mark N. Milkus

(Division Sign-Off) Division of General, Restorative and Neurological Device

510(k) Number

K030395mnm
K030395mnm

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use

(Per 21 CFR 801.109)