SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7

K031053 · Selectivemed Components, Inc. · EGJ · May 20, 2003 · Physical Medicine

Device Facts

• Record ID: K031053
• Device Name: SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
• Applicant: Selectivemed Components, Inc.
• Product Code: EGJ · Physical Medicine
• Decision Date: May 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5525
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.

Device Story

System consists of active drug delivery electrode and passive return electrode; designed for single-patient, one-time use. Electrodes facilitate local administration of ionic drug solutions into body as alternative to hypodermic injection. Active electrodes feature fibrous polyester reservoirs; return electrodes utilize self-adhering polymer. Both electrode types incorporate Ag/AgCl buffering agents. Device is used in clinical settings; operated by healthcare professionals. Output is delivery of ionic medication via direct current. Benefits include non-invasive drug administration.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and material comparisons to predicate devices.

Technological Characteristics

Components: Active drug delivery electrode, passive return electrode. Materials: Ag/AgCl buffering agent, fibrous polyester reservoir (active), self-adhering polymer (return). Form factor: Multiple shapes/sizes for active electrodes. Energy: Designed for use with external direct current iontophoresis power source. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for the introduction of ions of soluble salts or other drugs into the body via iontophoresis.

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

• IO-Drive Electrodes (K993081)
• TransQe Electrodes (K932620)
• Iogel Electrodes (K932621)
• Dupel B.L.U.E. Electrodes (K983484)
• Meditrode Electrodes (K882554)

Submission Summary (Full Text)

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# SelectiveMed Components, Ir

MAY 2 0 2003

## 510(k) SUMMARY [as required by 21 CFR 807.92(c)] Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery Electrodes

- I. Date Prepared: March 28, 2003
#### II. Submitter Information

Name: Selective Med Components, Inc. Address: 201 West High Street, Mount Vernon, Ohio 43050 740-397-7838 Telephone: Contact Person: Richard J. Fisher

#### Device Identification Information III.

| Trade Name(s): | Selective Med Components, Inc.<br>Buffered Iontophoresis Drug Delivery Electrodes |
|----------------------|-----------------------------------------------------------------------------------|
| Common Name: | Iontophoresis Electrode |
| Classification Name: | Device. Iontophoresis. Other Uses |

#### IV. Predicate Devices

The Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery Electrr are substantially equivalent to the following legally marketed devices:

| Trade Name | Manufacturer | 510(k) Number |
|---------------------------|--------------------------------|---------------|
| IO-Drive Electrodes | Selective Med Components, Inc. | K993081 |
| TransQe Electrodes | Iomed, Inc. | K932620 |
| Iogel Electrodes | Iomed, Inc. | K932621 |
| Dupel B.L.U.E. Electrodes | Empi, Inc. | K983484 |
| Meditrode Electrodes | Life-Tech, Inc. | K882554 |

Address: , South Mechanic Street ount Vernon, OH 43050

Toll Free Phone: [phone] International Phone: [phone] Toll Free Fax: [phone]

Website / www.selectiv KO31053

しくさ

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K031053
2012

## 510(k) SUMMARY [as required by 21 CFR 807.92(c)] Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery Electrodes

#### V. Device Description

The Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery Electrode System consists of an active drug delivery electrode 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 multiple sizes and shapes of drug delivery electrodes to accommodate placement various sites on the body. The size of the return electrode is the same for all drug delivery electrode sizes. The SMC Buffered Iontophoresis Drug Delivery Electrodes have technological characteristics equivalent to those of the predicate devices, including comparable performance specifications, comparable materials including the same buffering agent (Ag/AgCl) and fiberous polyester reservoir materials on the active drug delivery electrodes and the same buffering, self-adhering polymer on the return electrode, multiple shapes and sizes of active the drug delivery electrodes, and equivalent packaging and labeling.

## VI. Intended Use

Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.

Richard K. Fisher

Fisher

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MAY 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard J. Fisher President Selective Med Components, Inc. 201 West High Street Mount Vernon, Ohio 43050

Re: K031053

> Trade/Device Name: Selective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: March 28, 2003 Received: April 2, 2003

Dear Mr. Fisher:

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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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 McMillan

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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510(k) Number (if known):

K031053

Device Name: Selective Med Components, Inc., Buffered Iontophoresis Drug Delivery System Electrodes.

Indications for Use:

Selective Med Components, Inc., Buffered Iontophoresis Drug Delivery System Electrodes are indicated to introduce ions of soluble salts or other drugs into the body.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Mark N. Millerson

eral, Restorative and Neurological Devices

510(k) Number -

Prescription use _____________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)