IO-DRIVE

K993081 · Selectivemed Components, Inc. · EGJ · Mar 3, 2000 · Physical Medicine

Device Facts

• Record ID: K993081
• Device Name: IO-DRIVE
• Applicant: Selectivemed Components, Inc.
• Product Code: EGJ · Physical Medicine
• Decision Date: Mar 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5525
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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.

Device Story

IO-Drive Iontophoresis electrode system consists of active drug delivery electrode and return electrode; designed for single patient use. Multiple sizes of drug delivery electrodes accommodate different body sites; return electrode size is uniform. Device used in clinical settings for local administration of ionic drug solutions into body; serves as alternative to injections. Healthcare provider applies electrodes to patient; system facilitates iontophoretic drug delivery. Benefits include non-invasive drug administration.

Clinical Evidence

Bench testing only. Performance evaluation was conducted to compare the IO-Drive electrode to predicate electrodes, confirming similarity in performance.

Technological Characteristics

Iontophoresis electrode system comprising an active drug delivery electrode and a return electrode. Designed for single patient use. Multiple sizes available for delivery electrodes; uniform size for return electrode. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for the local administration of ionic drug solutions into the body for medical purposes as an alternative to injections. No specific patient population, age, or gender restrictions are provided.

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

• Iomed TransQ (K91-4621)
• Empi Dupel (K91-2014)

Submission Summary (Full Text)

{0}------------------------------------------------

MAR - 3 2000

K993081

# SUMMARY OF SAFETY AND EFFECTIVENESS

IO-DRIVE Iontophoresis electrode system Date of Summary: Dec 14, 1999 Page 1 of 1

## A. General Provisions

Submitter's Name: Submitter's Address:

Contact Person: Classification Name: Proprietary Name: Common Name: FDA 510 (k)

Selective Med Components, Inc. 6 South Mechanic St. Mt. Vernon, Ohio 43050 Rick Fisher Iontophoresis Device IO-Drive system Iontophoresis electrodes 99-3081

## B. Name of Predicate Devices

| - Iomed TransQ | K91-4621 |
|----------------|----------|
| - Empi Dupel | K91-2014 |

## C. Device Description

The IO-Drive Iontophoresis electrode system consists of an active drug delivery electrode and a return electrode. These electrodes are designed for single patient use. There are multiple sizes of drug delivery electrodes to accommodate placement at different body sites. The size of the return electrode is the same size for all drug delivery electrodes.

### D. Inteneded 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. Test and Evaluation

A performance evaluation was performed and based on the evaluation the IO-Drive electrode is similar to the predicate electrodes

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract human figures.

Public Health Service

MAR - 3 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard John Fisher III Chief Executive Officer Selective Med Components, Inc. 6 South Mechanic Street Mount Vernon, Ohio 43050

Re: K993081 Trade Name: IO-Drive System Regulatory Class: Class III Product Code: EGJ Dated: December 14, 1999 Received: December 17, 1999

Dear Mr. Fisher:

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 (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 device 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 (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (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.

{2}------------------------------------------------

#### Page 2 - Mr. Richard John Fisher III

Our substantially equivalent decision does not apply to the drugs that you will label or promote 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.

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 legally marketed predicate devices results 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 Compliance at [phone]. Additionally, for question on the promotion and advertising, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or

{3}------------------------------------------------

Page 3 -- Mr. Richard John Fisher III

[phone], or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil R.P. Ogden

James F. Dillard III

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

{4}------------------------------------------------

Page 1 of 1

510 (k) NUMBER (IF KNOWN) : K993081

DEVICE NAME:__________________________________________________________________________________________________________________________________________________________________

INDICATIONS FOR USE:

Io-Drive electrode is indicated to introduce ions of soluble salts and other drugs into body.

Nao for Izd

(Division Sign-Off) n Sign-On)
Restorative Restorative Devices Vaa 510(k) Number

Prescription Use YES
(Per 21 CFR 801.109)