PHORESOR II,MODEL PM900

K982668 · Iomed, Inc. · EGJ · Mar 2, 1999 · Physical Medicine

Device Facts

• Record ID: K982668
• Device Name: PHORESOR II,MODEL PM900
• Applicant: Iomed, Inc.
• Product Code: EGJ · Physical Medicine
• Decision Date: Mar 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5525
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Phoresor Iontophoretic Drug Delivery System is indicated for the administration of soluble salts and other drugs into the body for medical purposes as an alternative to hypodermic injection in situations when it is advisable to avoid the pain that may accompany needle insertion and drug injection, when it is advisable to minimize the infiltration of carrier fluids, or to avoid the damage caused by needle insertion when tissue is traumatized. It is also indicated for production of local dermal anesthesia using Iontocaine™ (brand of lidocaine hydrochloride 2% and epinephrine 1:100,000 Topical Solution).

Device Story

Phoresor II Model PM900 is a 9V battery-powered, microprocessor-controlled iontophoresis device. It uses direct current to drive ionized drugs into the body. Input parameters (current strength, duration) are entered via pushbuttons. The device monitors current flow and electrode/tissue impedance; it automatically manages ramp-up, delay, and repeat cycles if resistance limits are reached. It calculates total charge delivered. Used in clinical settings to replace hypodermic injections, reducing patient pain and tissue trauma. Healthcare providers use the device to deliver specific medications, such as Iontocaine for local anesthesia. The device provides a non-invasive alternative for drug delivery, benefiting patients by avoiding needle insertion.

Clinical Evidence

Bench testing only. No clinical data provided. Testing confirmed that the output of the PM900 is functionally identical to the predicate device.

Technological Characteristics

9V battery-powered, microprocessor-controlled, solid-state iontophoresis device. Features pushbutton input for current and duration, digital monitoring of current and electrode/tissue impedance. Software redesigned into logical modules. Operates via direct current to induce ion migration.

Indications for Use

Indicated for patients requiring administration of soluble salts or drugs via iontophoresis as an alternative to hypodermic injection to avoid needle-related pain, fluid infiltration, or tissue trauma. Also indicated for local dermal anesthesia using Iontocaine (lidocaine HCl 2% and epinephrine 1:100,000).

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

• Phoresor® II, Model PM800 (K934335)

Submission Summary (Full Text)

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3/2/99

# 510(K) SUMMARY

K98 2668

### Submitter:

IOMED, Inc. 3385 West 1820 South Salt Lake City UT 84104 Tel: [phone] Fax: [phone]

Contact:

W. Tim Miller Executive Vice President General Manager, Clinical Systems

Device Name:

Iontophoresis Device Iontophoretic Device Modification Phoresor® II, Model PM900

### Predicate Device:

Iontophoresis Device Phoresor® II , Model PM800 K934335

# Description of Device:

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 for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent upon the charge and size (molecular weight) of the ion, the strength of the electrical current being applied, electrode composition, duration of current flow, and numerous other factors.

ThePhoresor® II, Model PM900 iontophoretic device is a 9V battery-powered, solid state, microprocessorcontrolled device which controls current strength and duration, calculates total charge delivered, and monitors current flow and electrode/tissue impedance.

## Intended Use of Device:

Indications for use of the predicate and Phoresor® II iontophoretic drug delivery device are identical. This device is intended to be used for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections when it is advisable to avoid the pain that may accompany needle insertion and drug injection; when it is advisable to minimize the infiltration of carrier fluids; to avoid the damage caused by needle insertion when tissue is traumatized. It is Iso indicated for production of local dermal anesthesia using lontocaine™, brand of Lidocaine HCI 2% and Epinephrine 1:100,000.

Date: July 25, 1998

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510(K) Summary July 25, 1998 Page 2

## Technical Characteristics:

The Phoresor® II, Model PM900 iontophoretic device and the presently marketed Phoresor® II, Model PM800 have the same technical characteristics except that the dose (total charge) is preset and the current levels are entered via pushbutton instead of rotary knobs. In both units, after the initial setup, there is an automatic delay and repeat of ramp up after a resistance limit occurs, and a current holdback in lieu of a voltage reject. In addition to the software modifications that were required to implement the functions, the software, as a whole, was re-designed into logical modules as required by Good Manufacturing Practices.

### Non-clinical Performance Summary:

Testing data confirms that the output(s) of the Phoresor® II, Model PM900 are functionally identical to the predicate device, the IOMED Phoresor® II, Model PM800.

### Conclusions:

Through non-clinical testing, design review, analysis and validation, and failure mode and effects analysis, the IOMED Phoresor® II, Model PM900 is found to be substantially equivalent to the 10MED Phoresor® II, Model PM800.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 1999

Mr. W. Tim Miller Executive Vice President Iomed, Inc. 3385 West 1820 South Salt Lake City, Utah 84104

Re: K982668 Phoresor® II Model PM 900 Regulatory Class: III Product Code: EGJ Dated: July 25, 1998 Received: July 31, 1998

Dear Mr. Miller:

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, Druq, 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 administration of soluble salts and other drugs into the body for medical purposes and for production of local dermal anesthesia using Iontocaine™ (brand of lidocaine hydrochloride 2% and epinephrine 1:100,000 Topical Solution).

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 regulations affecting your device can be found in the Code of

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Page 2 - Mr. W. Tim Miller

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 (QS) 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.

Our substantially equivalent decision does not apply to any specific drugs other than Iontocaine that you might 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 Druq 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.

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

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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

Enclosure

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# Statement of

# INDICATIONS FOR USE

The Phoresor Iontophoretic Drug Delivery System is indicated for the administration of soluble salts and other I he 1 hotest Tontophored Drag Don'try a just and alternative to hypodermic injection in situations when it is advisable to avoid the pain that may accompany needle insertion and drug injection, when it is advisable to minimize the infiltration of carrier fluids, or to avoid the damage caused by needle insertion when tissue is traumatized. It is also indicated for production of local dermal anesthesia using Iontocaine™ (brand of lidocaine hydrochloride 2% and epinephrine 1:100,000 Topical Solution).

Prescription Use . (Per 21 CFR 801.109)