Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodernic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).

Device Description

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 on the charge and molecular weight of the ion, the strength of the electrical current applied, electrode composition, duration of current flow, and numerous other factors.

The IOMED, Inc. MW-1000 iontophoresis system consists of an active delivery electrode and a return electrode. The electrodes are designed for a single-patient, oncapplication use and should be used with IOMED's approved iontophoretic dose controller. The active delivery electrode is attached to a handle which is used to guide the device over the area to be treated. The handle is designed to be reused.

The IOMED, Inc. MW-1000 iontophoresis system is designed to attach to IOMED's approved Phoresor . These devices provide control of the current and therefore dosage delivered.

AI/ML Overview

Here's an analysis of the provided text regarding the IOMED MW-1000 Iontophoretic Drug Delivery Electrode, structured to address your specific questions about acceptance criteria and supporting studies:

This document primarily describes an Iontophoresis device and its substantial equivalence to predicate devices, focusing on regulatory approval for marketing rather than detailed performance study results that would typically include specific quantitative acceptance criteria for a new AI/medical device. The "acceptance criteria" here are largely related to safety and biocompatibility and demonstration of drug delivery capability being equivalent or superior to predicate devices, rather than a quantifiable performance metric like sensitivity or specificity.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Drug Delivery Effectiveness	Positive: "This testing shows that both negatively and positively charged drugs can be effectively delivered using the drug electrode to be used with the MW-1000." (Implied acceptance criterion: Device must effectively deliver both negatively and positively charged drugs.)
Biocompatibility / Primary Dermal Irritation	Mild Irritant (0.5 IDI): "rated as a mild irritant (0.5) during lidocaine administration." Non-Irritant: "a non-irritant during a Dexamethasone administration from a Dexamethasone/lidocaine (1:2) mixture, and a non-irritant during Dexamethasone administration alone." (Implied acceptance criterion: Device must demonstrate acceptable levels of biocompatibility/dermal irritation, ideally non-irritant or mild irritant, consistent with predicate devices and safety standards for skin contact devices.)
Substantial Equivalence (Regulatory)	Achieved: "determined the device is substantially equivalent... to legally marketed predicate devices." (Acceptance criterion: Device must demonstrate substantial equivalence to predicate devices to obtain 510(k) clearance.)

Detailed breakdown of study information based on your questions:

1. A table of acceptance criteria and the reported device performance:
Provided above. The acceptance criteria are largely implied by the context of a 510(k) submission, focusing on safety, biocompatibility, and functional equivalence to existing devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Drug Delivery Study:
- Test Set: "freshly excised hairless mouse skin." The number of mice or skin samples is not specified.
- Data Provenance: Not explicitly stated, but an in-vitro study.
Safety and Biocompatibility (Primary Dermal Irritation) Study:
- Test Set: "rabbits." The number of rabbits used is not specified.
- Data Provenance: Not explicitly stated, but carried out "in accordance with FDA regulations for Good Laboratory Practices." This suggests a prospective study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Drug Delivery Study: The "ground truth" here is the actual amount of drug delivered and quantified. This would have been established through a laboratory process (radioassay) by trained lab personnel, not necessarily "experts" in the clinical sense (like radiologists). No specific number or qualifications are given for these personnel in the document.
Safety and Biocompatibility Study: The "ground truth" (irritation scores) would have been established by trained personnel, likely toxicologists or veterinarians, following standard protocols. The document states "Using standard Primary Dermal Irritation Index scores," implying a standardized evaluation, but does not specify the number or qualifications of the evaluators.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable / Not Specified: For in-vitro drug delivery and animal irritation studies, the concept of "adjudication" as typically applied to human clinical image or diagnostic interpretation (e.g., 2+1 expert consensus for ground truth) does not apply. Results are typically based on quantitative measurements and standardized scoring protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No: This device is an iontophoresis electrode, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable: This is a hardware device for drug delivery, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Drug Delivery: Quantitative measurement of radiolabeled drugs in skin and receptor solutions (radioassay).
Biocompatibility: Standardized Primary Dermal Irritation Index scores based on visual assessment of skin reactions in rabbits.

8. The sample size for the training set:

Not Applicable: This is a hardware device, not a machine learning algorithm that requires a "training set." The study data presented is for validation/testing of the device's physical properties and function.

9. How the ground truth for the training set was established:

Not Applicable: As there is no training set, this question is not applicable.

Summary Takeaway:

The provided document is a 510(k) summary for a medical device (iontophoresis electrode). It focuses on demonstrating substantial equivalence to predicate devices through in-vitro and animal studies rather than presenting quantifiable clinical performance metrics typically associated with AI or diagnostic devices. The "acceptance criteria" revolve around regulatory compliance, demonstrable drug delivery function, and acceptable safety/biocompatibility profiles as measured by established laboratory methods.

Summary

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MAR 3 1 2006

SUMARY OF SAFETY AND EFFECTIVENESS Iontophoresis Electrode

Date of Summary: 27 January 2006

A. General Provisions

Submitter's Name:	IOMED, Inc.
Submitter's Address:	2441 South 3850 West, Suite ASalt Lake City, UT 84120-9941
Contact Person:	Curtis JensenDirector, Quality and Regulatory
Classification Name:	Iontophoresis Device21 CFR 890.5525
Proprietary Name:	MW-1000 Iontophoretic Drug Delivery Electrode
Common Name:	Iontophoresis Drug Delivery Electrode

B. Name of Predicate Device(s)

Iontophoresis Device:K932621 . Iontophoresis Drug Delivery Electrode IOMED, Inc. RH-801/GS Iontophoretic Drug Delivery Electrode
. Iontophoresis Device: K042590 Iontophoresis Drug Delivery System Mattioli Engineering Transderm Ionto System, MK 2

C. Device Description

The IOMED, Inc. MW-1000 iontophoresis system is designed to attach to IOMED's approved Phoresor . These devices provide control of the current and therefore dosage delivered.

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D. Intended Use

Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).

E. Drug Delivery and Biocompatibility

Drug Deliverv

Drug delivery rate measurements of both negatively and positively charged drugs were performed in vitro in freshly excised hairless mouse skin using the method described by Petelenz et. Al., J Controlled Release 20 (1992), 55-56. Commercial formulations of dexamethasone sodium phosphate (0.4% w/v dexamethasone phosphate equivalent) and lidocaine hydrochloride (4% w/v) were used as model drugs for cathodal (-) and anodal (+) iontophoresis, respectively. Drugs quantization in the skin and receptor solution was performed by radioassay using 3H-dexamethasone sodium phosphate and 14C-lidocaine hydrochloride tracers. The MW-1000 drug electrode is identical to that used for the RH-801/GS with the exception of the skin fixation material. This difference will not affect the results of this testing.

This testing shows that both negatively and positively charged drugs can be effectively delivered using the drug electrode to be used with the MW-1000.

Safety and Biocompatibility

Primary dermal irritation studies were carried out in rabbits in accordance with FDA regulations for Good Laboratory Practices using Dexamethasone sodium phosphate and lidocaine hydrochloride as model compounds. Using standard Primary Dermal Irritation Index scores of 0.0 (non-irritant), 0.1 - 2.0 (mild irritant), 2.1 - 5.9 (moderate irritant), and 6.0 and greater (severe irritant), the RH-801/GS was rated as a mild irritant (0.5) during lidocaine administration, a nonirritant during a Dexamethasone administration from a Dexamethasone/lidocaine (1:2) mixture, and a non-irritant during Dexamethasone administration alone.

This testing was done as part of the RH-801/GS 510(k) (K932621). The materials used in the MW-1000 drug electrode are identical to those used for the RH-801/GS with the exception of the skin fixation material. This difference will not affect the results of this testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.

Public Health Service

MAR 3 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IOMED, Inc c/o Mr. Curtis Jensen Director, Quality and Regulatory 2441 South 3850 West, Suite A Salt Lake City, Utah 84120

Re: K060236 Trade/Device Name: MW - 1000 Iontophoretic Drug Delivery Electrode Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: January 27, 2006 Received: January 30, 2006

Dear Mr. Jensen:

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 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. Curtis Jensen

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, 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 (301) 594-1296

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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by

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Page 3 – Mr. Curtis Jensen

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 (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Helent Semer

/ Mark N. Melkerson 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

Applicant: Iomed, Inc.

510(k) Number (if known):

Device Name: MW-1000 Iontophoretic Drug Delivery Electrode

Indications For Use: Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodernic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).

Division of General, Restorative, 1 and Neurological Devices

510(k) Number K060236

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

004

Regulation Number and Section

§ 890.5525 Iontophoresis device.

(a)
Iontophoresis device intended for certain specified uses —(1)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.(2)
Classification. Class II (performance standards).(b)
Iontophoresis device intended for any other purposes —(1)Identification. 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.(2)
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.