COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D

K080580 · Axelgaard Mfg. Co., Ltd. · EGJ · Jun 18, 2008 · Physical Medicine

Device Facts

• Record ID: K080580
• Device Name: COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D
• Applicant: Axelgaard Mfg. Co., Ltd.
• Product Code: EGJ · Physical Medicine
• Decision Date: Jun 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5525
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.

Device Story

Comfort Iontophoresis Electrodes are single-use, disposable electrodes designed for local administration of ionic drug solutions into the body. The system comprises an active drug delivery electrode and a passive return electrode. The device is used in hospitals and medical clinics by clinicians. The electrodes feature a silver/silver chloride (Ag/AgCl) buffering agent on a polyester conductive layer, a cotton blend reservoir, and a non-irritating adhesive backing. The device is applied to the skin at various anatomical sites. It is designed for use with external iontophoresis devices, with a maximum current of 4 mA and a maximum dosage of 80 mA-minutes. By facilitating transdermal drug delivery, the device serves as an alternative to hypodermic injection, potentially reducing patient discomfort associated with needles.

Clinical Evidence

No clinical data. Substantial equivalence is based on technical, functional, and physical comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: Ag/AgCl buffering agent, polyester conductive layer, cotton blend reservoir, non-irritating adhesive. Dimensions: Various shapes (Small Square, Butterfly, Medium Square, Large Square, Return Electrode). Energy: Passive electrode system for use with external iontophoresis devices (max 4 mA, 80 mA-minutes). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injection. Intended for use by clinicians on patients requiring iontophoresis treatment.

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

• Buffered Iontophoresis Drug Delivery Electrodes (K052019)
• Dynatron Ion (K060814)

Submission Summary (Full Text)

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K080580

JUN I 8 2008

## 510 Summary

(As required by 21CFR section 807.92(c)

#### Submitter Information

Axelgaard Manufacturing Co., Ltd. Name:

| Address: | 520 Industrial Way<br>Fallbrook, CA 92028 |
|----------|-------------------------------------------|
|----------|-------------------------------------------|

760-451-8000 Phone:

760-723-2356 Fax:

Contact Person: Dan Jeffery

Revised June 16, 2008 Date Prepared:

#### Device Information

| Device Name: | Comfort Iontophoresis Electrodes<br>Buffered Iontophoresis Electrode Treatment Kit |
|----------------------|------------------------------------------------------------------------------------|
| Common Name: | Iontophoresis Electrodes |
| Classification Name: | Device, Iontophoresis, Other Uses (per 21 CFR section 890.5525) |

#### Predicate Devices

Based on technical, functional, and physical comparisons, the Comfort Iontophoresis Electrodes (Buffered lontophoresis Electrode Treatment Kit) are substantially equivalent to the following legally marketed devices of North Coast Medical and Dynatronics Axelgaard Manufacturing Co, Ltd has manufactured this product for both North Coast Medical and Dynatronics for the past two years.

| Trade Name | Manufacturer/Distributor | 510(k) Number |
|-------------------------------------------------|--------------------------|---------------|
| Buffered Iontophoresis Drug Delivery Electrodes | North Coast Medical | K052019 |
| Dynatron Ion | Dynatronics | K060814 |

#### Device Description

Comfort lontophoresis Electrodes (Buffered lontophoresis Electrode Treatment Kit) consist of an active drug delivery electrode and a passive return electrodes are designed for one use on a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are four sizes and for the roundinen a releaser of roles to accommodate placement on various locations on the body. The size of the return electrode is the same for all drug delivery electrode sizes as the maximum delivery of 80 milliamp-minutes is the same regardless of size. Comfort lontophoresis Electrodes (Buffered lontophoresis Electrode Treatment Kit) have technological characteristics equivalent to those of the predicate devices, including comparable design, materials, multiple shapes and sizes of active drug delivery electrodes, and equivalent packaging and abeling.

#### Intended Use

Comfort lontophoresis Electrodes (Buffered lontophoresis Electrode Treatment Kit) are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.

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Image /page/1/Picture/1 description: The image shows the logo for AXELGAARD. The logo features a stylized graphic to the left of the company name, "AXELGAARD," which is written in all capital letters. Below the company name, there is additional text, likely indicating the company's business or legal status.

## Substantial Equivalence Comparison

- 1. Predicate device names:
- A. North Coast Medical Buffered Iontophoresis Electrodes
- B. Dynatron Ion

### 2. Predicate 510(k) number

- A. K052019
- B. K060814

#### 3. Comparison with predicate:

Comfort lontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) are equivalent to North Coast Medical Buffered Iontophoresis Electrodes (previously cleared under K0502019) and Dynatron Ion Ovacificalibal Barrero William Show the similarities, equivalencies, and differences between the proposed and predicate devices.

#### Similarities

| Item | Comfort Iontophoresis<br>Electrodes (Buffered<br>Iontophoresis Electrode<br>Treatment Kit) | North Coast Buffered<br>Iontophoresis Electrodes | Dynatron Ion |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed Device | Predicate Device<br>(K052019 | Predicate device<br>(K060814) |
| Intended use | Iontophoresis is indicated<br>for the administration of<br>soluble salts or other drugs<br>into the body for medical<br>purposes and can be used<br>as an alternative to<br>hypodermic injection. | Iontophoresis is indicated<br>for the administration of<br>soluble salts or other drugs<br>into the body for medical<br>purposes and can be used<br>as an alternative to<br>hypodermic injection. | Iontophoresis is indicated<br>for the administration of<br>soluble salts or other drugs<br>into the body for medical<br>purposes and can be used<br>as an alternative to<br>hypodermic injection. |
| Target population | Medical professionals with<br>patients requiring<br>iontophoresis treatment. | Medical professionals with<br>patients requiring<br>iontophoresis treatment. | Medical professionals with<br>patients requiring<br>iontophoresis treatment. |
| Design | Shapes: Small Square,<br>Butterfly, Medium Square,<br>Large Square, Return<br>Electrode. | Shapes: Small Square,<br>Butterfly, Medium Square,<br>Large Square, Return<br>Electrode. | Shapes: Small Square,<br>Butterfly, Medium Square,<br>Large Square, Return<br>Electrode. |
| Materials | Buffering Agent –<br>Silver/SilverChloride<br>(Ag/AgCl).<br>Conductive layer on<br>polyester. | Buffering Agent –<br>Silver/SilverChloride<br>(Ag/AgCl).<br>Conductive layer on<br>polyester. | Buffering Agent –<br>Silver/SilverChloride<br>(Ag/AgCl).<br>Conductive layer on<br>polyester. |
| Chemical safety | Electrodes backed with<br>non-irritating adhesive. | Electrodes backed with<br>non-irritating adhesive. | Electrodes backed with<br>non-irritating adhesive. |
| Anatomical sites | For epidermal use (various<br>locations). | For epidermal use (various<br>locations). | For epidermal use (various<br>locations). |
| Energy<br>used/delivered | Not to exceed 80mA-<br>minutes total dosage | Not to exceed 80mA-<br>minutes total dosage. | Not to exceed 80mA-<br>minutes total dosage |

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Image /page/2/Picture/1 description: The image shows the logo for AXELGAARD MANUFACTURING CO., LTD. The logo features a stylized graphic to the left of the company name. The text is in a simple, sans-serif font and is stacked, with the company name on top and the company type below.

| Item | Comfort Iontophoresis<br>Electrodes (Buffered<br>Iontophoresis Electrode<br>Treatment Kit)<br>Proposed Device | North Coast Buffered<br>Iontophoresis Electrodes<br>Predicate Device<br>(K052019) | Dynatron Ion<br>Predicate device<br>(K060814) |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Compatibility with<br>other devices | Designed for use with<br>iontophoresis devices only. | Designed for use with<br>iontophoresis devices only. | Designed for use with<br>iontophoresis devices only. |
| Where used | Hospitals, medical clinics. | Hospitals, medical clinics. | Hospitals, medical clinics. |
| Electrical safety | Does not have electrode<br>wires. | Does not have electrode<br>wires. | Does not have electrode<br>wires. |
| Electrode Fill<br>Volume (treatment<br>fluid volume) | Small Square (1.5 to 2.0cc)<br>Butterfly (2.0 to 2.5cc)<br>Medium Square (2.5 to<br>3.0cc)<br>Large Square (4.0 to 4.5cc) | Small Square (1.5 to 2.0cc)<br>Butterfly (2.0 to 2.5cc)<br>Medium Square (2.5 to<br>3.0cc)<br>Large Square (4.0 to 4.5cc) | Small Square (1.5 to 2.0cc)<br>Butterfly (2.0 to 2.5cc)<br>Medium Square (2.5 to<br>3.0cc)<br>Large Square (4.0 to 4.5cc) |

# Equivalencies

| Item | Comfort lontophoresis<br>Electrodes (Buffered<br>lontophoresis Electrode | North Coast Buffered<br>Iontophoresis Electrodes | Dynatron Ion |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Treatment Kit) | Predicate Device<br>(K052019 | Predicate device<br>(K060814) |
| | Proposed Device | | |
| Design (Electrode<br>Size) | Electrode Size -<br>Small Square (2.75"x2.75")<br>Butterfly (3.75"x3.38")<br>Medium Square<br>(3.25"x3.25")<br>Large Square (3.50"x3.50")<br>Return Electrode<br>(2.20"x1.82") | Electrode Size -<br>Small Square (2.75"x2.75")<br>Butterfly (3.75"x3.38")<br>Medium Square<br>(3.25"x3.25")<br>Large Square (3.50"x3.50")<br>Return Electrode<br>(2.20"x1.82") | Electrode Size -<br>Small Square (2.75"x2.75")<br>Butterfly (3.75"x3.38")<br>Medium Square<br>(3.25"x3.25")<br>Large Square (3.50"x3.50")<br>Return Electrode<br>(2.20"x1.82") |
| Design (Active<br>Area) | Active Area -<br>Small Square (7.6 cm²)<br>Butterfly (8.3 cm²)<br>Medium Square (11.4 cm²)<br>Large Square (18.1 cm²)<br>Return Electrode (25.5 cm²) | Active Area -<br>Small Square (7.6 cm²)<br>Butterfly (8.3 cm²)<br>Medium Square (11.4 cm²)<br>Large Square (18.1 cm²)<br>Return Electrode (25.5 cm²) | Active Area -<br>Small Square (7.6 cm²)<br>Butterfly (8.3 cm²)<br>Medium Square (11.4 cm²)<br>Large Square (18.1 cm²)<br>Return Electrode (25.5 cm²) |
| Maximum Current | 4 mA | 4mA | 4mA |
| Maximum Dosage | 80 mA-minutes | 80 mA-minutes | 80 mA-minutes |
| Materials | Reservoir Layer - Cotton<br>Blend | Reservoir Layer - Cotton<br>Blend | Reservoir Layer - Cotton<br>Blend |

#### Differences

Differences other than the packaging and labeling information specific to the distributing company.

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Image /page/3/Picture/1 description: The image shows the logo for AXELGARD. The logo consists of a stylized letter "A" followed by the word "AXELGARD" in capital letters. Below the word "AXELGARD" is the text "WWW.AXELGARD.CO.LTD".

#### Discussion

In comparing the Comfort lontophoresis Electrodes (Buffered lontophoresis Electrode Treatment Kit) (proposed device) to the North Coast Medical, North Coast Buffered lontophoresis Electrodes (predicate device), and the Dynatronics, Dynatron Ion (predicate device ), it must be noted that there are no product differences since Axelgaard Manufacturing Co., Ltd. manufactures both these electrodes. Additionally, the packaging/labeling differences are not substantial enough to deny equivalence between the three products.

The intended use, operation, and target population of the three products are almost identical. Also, the product shapes are the same, so they can conform to the same anatomical locations. The product size is the same so there will be no difference with adhesion and coverage of the affected area. Since the same buffering agents are used, as well as non-irritating backing, conduction and adhesion of the electrodes shall be safe as the same. The reservoir layer is composed of the same materials. Finally, the products are applied identically, and they use comparable power sources.

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Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services, USA. 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 eagle with its wings spread, clutching a caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 18 2008

Axelgaard Manufacturing Company, Limited % Mr. Dan P. Jeffery President 520 Industrial Way Fallsbrook, California 92028-2244

K080580 Re:

> Trade Name: Comfort Iontophoresis Electrodes / Buffered Iontophoresis Electrode Treatment Kit Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device Regulatory Class: Class III Product Code: EGJ Dated: April 28, 2008 Received: April 30, 2008

Dear Mr. Jeffery:

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) that do not require approval of a premarket approval application (PMA). 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 such 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 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.

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Page 2 - Mr. Dan P. Jeffery

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.

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 (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/1 description: The image shows the logo for ANFLGAARD. The logo consists of a stylized graphic to the left of the text "ANFLGAARD" in all caps. Below the company name is the text "MANUFACTURING CO. LTD." in a smaller font size. The text and graphic are in a dark color, contrasting with the background.

#### Indications for Use

http://www.fda.gov/cdrh/ode/indicate.pdf

K080280 510K Number:

Comfort Iontophoresis Electrodes Device Name Buffered Iontophoresis Electrode Treatment Kit

## Indications for Use:

Iontophoresis is indicated by clinicians for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

(As required by 21CFR section 807.92(c))

Neilke Ogle for mkm

Page 1 of 1

and Neurological

**510(k) Number** K080580
Page 1

K080580

6/16/2008