DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE

K983484 · Empi · EGJ · Dec 28, 1998 · Physical Medicine

Device Facts

• Record ID: K983484
• Device Name: DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE
• Applicant: Empi
• Product Code: EGJ · Physical Medicine
• Decision Date: Dec 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5525
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Iontophoresis drug delivery systems are indicated 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 Dupel® Buffered Iontophoresis Electrode System comprises an active drug delivery electrode and a passive return electrode; both feature buffering capability for up to 160mA min treatment sessions. Designed for single-patient, one-application use, the system includes various sizes and shapes of drug delivery electrodes to accommodate different body sites, while the return electrode size remains constant. Used in clinical settings, the device facilitates the transdermal delivery of ionic drug solutions via direct current. By providing a non-invasive alternative to injections, the system enables localized therapeutic drug administration.

Clinical Evidence

Performance evaluation conducted comparing the new small electrode to predicate electrodes. Metrics included irritation (Primary Dermal Irritation Index), maximum comfortable current, conformance, adherence, and leakage. Results indicated the device is similar to predicates. Non-clinical animal testing confirmed the device is a non-irritant or irritation is barely perceptible when used with 2% lidocaine hydrochloride and epinephrine 1:100,000.

Technological Characteristics

System consists of active drug delivery and passive return electrodes with buffering capability. Designed for single-patient use. Materials verified for biocompatibility. Operates via direct current for iontophoresis. No software or electronic components described; purely passive electrode system.

Indications for Use

Indicated for patients requiring local administration of ionic drug 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

• Empi Dupel II Iontophoresis Electrodes
• Empi Iontophoresis Buffered Electrodes
• Iomed Trans Q1 (RH-800) (K970491, K914621, K925806, K912015)

Submission Summary (Full Text)

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DEC 28 1998

Image /page/0/Picture/1 description: The image contains the handwritten text "K983484" on the top left. On the bottom right, the image contains the word "Empi." The word "Empi" is written in a bold, italicized font. There is a registered trademark symbol next to the word "Empi."

### Cost Effective Health Care Solutions

## SUMMARY OF SAFETY AND EFFECTIVENESS Small Iontophoresis Electrode Date of Summary: October 2, 1998

Page 1 of 2

Empi. Inc. 599 Cardigan Road St. Paul, Minnesota 55126-4099 USA

651-415-9000 FAX [phone]

- A. General Provisions
Submitter's Name: Submitter's Address:

Contact Person:

Classification Name:

Proprietary Name: Common Name:

Empi, Inc. 599 Cardigan Road St. Paul, Minnesota 55126-3965 Carolyn M. Steele Husten Regulatory Affairs Manager Iontophoresis Device 21 CFR 890.5525 Dupel B.L.U.E Small Iontophoresis Electrode Iontophoresis Electrode

#### Name of Predicate Devices B.

| | | | | Empi Dupel II Iontophoresis Electrodes |
|--|--|--|--|----------------------------------------|
|--|--|--|--|----------------------------------------|

Empi Iontophoresis Buffered Electrodes

- . Iomed Trans Q1 (RH-800)
- K970491 K914621 and K925806 K912015
#### Device Description C.

The Dupel® Buffered Iontophoresis Electrode System consists of an active drug delivery electrode and a passive return electrode. Both electrodes have buffering capability for up to a 160mA min treatment session. These electrodes are designed for single patient, one application use. There are multiple sizes and shapes of drug delivery electrodes to accommodate placement at different body sites. The size of the return electrode is the same for all drug delivery electrode sizes.

#### D. Intended Use

.

The electrode is intended to be used in the clinic. Iontophoresis drug delivery systems are indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.

#### E. Non-Clinical and Clinical Test Summary

## Non-Clinical Tests

The following parameters were verified: electrical resistance, pH buffering ability; fill rate, and material biocompatibility. The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements, is acceptable for its intended use and is equivalent to the predicate electrodes.

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Image /page/1/Picture/0 description: The image shows the word "Empi" in a bold, sans-serif font. The letters are black and slightly slanted to the right. A small registered trademark symbol is located to the right of the letter "i".

## Cost Effective Health Care Solutions

# SUMMARY OF SAFETY AND EFFECTIVENESS

Small Iontophoresis Electrode Date of Summary: October 2, 1998

Page 2 of 2

Empi, Inc. 599 Cardigan Road St. Paul, Minnesota 55126-4099 USA

651-415-9000 FAX [phone]

#### Non-Clinical Animal Tests

Using the standard Primary Dermal Irritation Index scores shown below the small electrode and the currently marketed small electrode was rated as a non-irritant or irritation barely perceptible after the 1st treatment when administered 2% lidocaine hydrochloride and epinephrine 1:100,000 (Lidocaine).

#### Clinical Tests

A performance evaluation of the new small electrode was conducted.. Based on the preliminary results the small electrode (current submission) is similar to the predicate electrode in terms of irritation, maximum comfortable current, conformance, adherence and leakage.

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most complete and the bottom profile being the least complete.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 28 1998

Ms. Carolyn M. Steele Husten Regulatory Affairs Manager EMPI, Inc. 599 Cardigan Road St. Paul, Minnesota 55126-4099

K983484 Re: Dupel B.L.U.E™ Small Iontophoresis Electrode Requlatory Class: III Product Code: EGJ Dated: October 2, 1998 Received: October 5, 1998

Dear Ms. Husten

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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. This substantially equivalent decision applies to indications for the local administration of ionic drug solutions into the body for medical purpose and can be used as an alternative to injections.

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 practices, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with

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Page 2 - Ms. Carolyn M. Steele Husten

the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

Our substantially equivalent decision does not apply to any specific drugs 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 Labelinq 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 diaqnosis 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.

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Page 3 - Ms. Carolyn M. Steele Husten

If you have any questions regarding this letter, you may contact:

Kevin Lee, M. D. Division of General and Restorative Device Office of Device Evaluation 9200 Corporate Boulevard Rockville, MD 20850 Tel [phone]

This letter immediately will allow you to begin marketing your devices as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your devices to An roll rinaring on and on the sults in a classification for your devices and permits your devices to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of regulation (21 oll) 594–4659. Additionally, for question on compriation and advertising, please contact the Office of Compliance at [phone]. Other general information on oomprianoo as (lities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N. Millerson

Ph.D. , M. D. Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: (if known): Unknown at time of submission Device Name: Small Iontophoresis Electrode Indications for Use:

Iontophoresis drug delivery systems are indicated for the local administration of ionic drug 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)

| Prescription Use | X |
|----------------------|----------------------|
| (Per 21 CFR 801.109) | |
| OR | Over-The Counter Use |
| | |

Mark n. melkun

(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | K983484 |
|---------------|---------|
|---------------|---------|