NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE

K052019 · North Coast Medical, Inc. · EGJ · Nov 4, 2005 · Physical Medicine

Device Facts

• Record ID: K052019
• Device Name: NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE
• Applicant: North Coast Medical, Inc.
• Product Code: EGJ · Physical Medicine
• Decision Date: Nov 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5525
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

North Coast Buffered Iontophoresis Electrodes are intended to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.

Device Story

Device consists of active drug delivery electrode and passive return electrode; designed for single-patient, single-use. Electrodes facilitate local administration of ionic drug solutions into body via iontophoresis. Available in various sizes/shapes for different body locations. Operated by healthcare professionals. Device functions as interface for iontophoresis equipment; enables non-invasive drug delivery as alternative to hypodermic injection. Benefits include localized drug administration without needle penetration.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological and functional comparisons to legally marketed predicate devices.

Technological Characteristics

Passive iontophoresis electrodes consisting of active drug delivery and return components. Multiple sizes and shapes available. Materials and design are equivalent to predicate devices. No internal energy source; requires external iontophoresis controller. Single-use, disposable.

Indications for Use

Indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injection. Prescription use.

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 (K031053)
• TransQe Electrodes (K932620)
• Iogel Electrodes (K932621)
• Dupel B.L.U.E. Electrodes (K983484)

Submission Summary (Full Text)

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K052019

# NOW - 4 2005

## 510(k) Summary

[as required by 21CFR section 807.92(c)]

#### Submitter Information

| Name: | North Coast Medical, Inc. |
|-----------------|--------------------------------------------------|
| Address: | 18305 Sutter Blvd.<br>Morgan Hill, CA 95037-2845 |
| Phone: | 408-776-5000<br>1-800-821-9319 |
| Fax: | 1-877-213-9300 |
| Contact Person: | Tarhan Kayihan |
| Date Prepared: | July 21, 2005 |

### Device Information

| Device Name: | North Coast Buffered Iontophoresis Electrodes |
|----------------------|-----------------------------------------------------------------|
| 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 North Coast Buffered Iontophoresis Electrodes are substantially equivalent to the following legally marketed devices:

| Trade Name | Manufacturer | 510(k) Number |
|-------------------------------------------------|--------------------------|---------------|
| Buffered Iontophoresis Drug Delivery Electrodes | Selective Med Components | K031053 |
| TransQe Electrodes | Iomed, Inc. | K932620 |
| Iogel Electrodes | Iomed, Inc. | K932621 |
| Dupel B.L.U.E. Electrodes | Empi, Inc. | K983484 |

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#### Device Description

North Coast Buffered Iontophoresis Electrodes consist of an active drug delivery clectrode and a passive return electrode. These electrodes are designed for one use by a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are several sizes and shapes of drug delivery electrodes to accommodate placement on various locations on the body. The size of the return electrode is the same for all drug delivery electrode sizes. North Coast Buffered Iontophoresis Electrodes 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 labeling.

#### Intended Use

North Coast Buffered Iontophoresis Electrodes are intended to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.

Taikan Kayhan 7/21/05

Tarhan Kayihan Regulatory Compliance Administrator

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 2005

Mr. Tarhan Kavihan Regulatory Compliance Administrator North Coast Medical, Inc 18305 Sutter Boulevard Morgan Hill California 95037-2845

Re: K052019

Trade/Device Name: North Coast Buffered Iontophoresis Electrode Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: October 20, 2005 Received: October 24, 2005

Dear Mr. Kayihan:

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 Codc 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. Tarhan Kayihan

Our substantially equivalent decision does not apply to the drugs that you will label or promote Our substantially equivalent accessed as a sectiber label nor promote your device for use with 101 uSC with your device. - therever, your device prior to FDA having approved the drugs for Specific drugs, nor package arage with your 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 AS you are aware, toneophers in a the body and induce sweating for use in the diagnosis of cystic of softeer bare of 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 adequate anroctoris for the untended to use a direct current to introduce ions of soluble salts or fother 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 apple rat (1 1 1 1 1 1 1 1 9 4, 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 [phone]. Also, please note the regulation entitled, "Misbranding by

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## Page 3 – Mr.Tarhan Kayihan

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,

Signature

Mark N. Melkerson Acting 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 (if known): K052019

Device Name: North Coast Buffered Iontophoresis Electrode

Indications For Use:

Iontophoresis is indicated 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)

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

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510(k) Number K052019