Iontophoretic drug delivery devices 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).

Device Description

An iontophoresis device is a device that is intended to use electrical current to introduce ions of water-soluble salts or 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 magnitude of the electrical current applied, patch composition, duration of current flow, and numerous other factors.

The IOMED, Inc. Champion integrated transdermal patch incorporates both a drug electrode and a return electrode. The patch is designed for a single-patient, oneapplication use and can only be used with IOMED's Champion dose controller. The Champion dose controller provides control of the current and therefore dosage delivered.

The Champion dose controller is a small, battery-powered, microprocessor-controlled iontophoretic device which delivers direct current (DC) to the integrated transdermal patch which is placed on intact skin.

AI/ML Overview

The provided document, K063465, is a 510(k) premarket notification for the "Champion Iontophoresis Drug Delivery System." This submission focuses on establishing substantial equivalence to predicate devices and demonstrating general safety and effectiveness through in vitro drug delivery and biocompatibility testing. It is not a study describing acceptance criteria and device performance in the context of a typical algorithm or diagnostic device evaluation.

Therefore, many of the requested elements are not applicable or cannot be extracted from this document, as they pertain to clinical trials, algorithm performance metrics, or expert adjudication which are not relevant to the approval of this physical drug delivery device.

However, I can extract information related to the in vitro testing and safety assessments that were presented as part of the submission to demonstrate the device's functionality and safety.

Here's a breakdown of the available and unavailable information based on your request:

1. A table of acceptance criteria and the reported device performance

Note: The document does not explicitly state quantitative "acceptance criteria" in the format typically seen for algorithm performance (e.g., sensitivity, specificity thresholds). Instead, it describes tests performed and their outcomes which serve to demonstrate the device's functionality and safety in comparison to predicate devices and established standards.

Acceptance Criteria (Implicit)	Reported Device Performance
Drug Delivery Functionality: The device should effectively deliver both negatively and positively charged drugs (analogous to predicate devices). (Implicit, based on intended use and comparison to predicate devices utilizing the same materials).	Effective Drug Delivery Demonstrated: "This testing shows that both negatively and positively charged drugs can be effectively delivered using the integrated transdermal patch to be used with the Champion Iontophoretic Drug Delivery System."Specifics: In vitro testing used dexamethasone sodium phosphate (negative) and lidocaine hydrochloride (positive) as model drugs. Quantified by radioassay (3H-dexamethasone and 14C-lidocaine) in skin and receptor solution.
Biocompatibility/Irritation: Materials used in the patch should be biocompatible and cause acceptable levels of dermal irritation, consistent with predicate devices and safety standards. (Implicit, based on predicate device history and industry standards for medical devices). The predicate device (RH-801/GS) showed acceptable irritation levels.	Acceptable Biocompatibility/Irritation: "The materials used in the Champion integrated transdermal patch are identical to those used in the RH-801/GS and the RH-950."Predicate Device Performance (RH-801/GS): - Rated as a mild irritant (0.5) during lidocaine administration (< 2.0 is mild irritant).- Non-irritant during Dexamethasone administration from a Dexamethasone/lidocaine (1:2) mixture.- Non-irritant during Dexamethasone administration alone.(Scores based on Primary Dermal Irritation Index: 0.0=nonirritant, 0.1-2.0=mild, 2.1-5.9=moderate, 6.0+=severe).
Material Equivalence: Key components affecting drug delivery and biocompatibility should be identical to those of legally marketed predicate devices. (Implicit, as a basis for claiming substantial equivalence).	Material Equivalence Confirmed: "The materials used in the Champion integrated transdermal patch are identical to those used in the RH-801/GS and the RH-950."

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated in terms of specific numbers of skin samples or animals for the in vitro drug delivery study. The description "freshly excised hairless mouse skin" suggests a number of samples were used, but the exact count is not given. For biocompatibility, "rabbits" were used, but the number is not specified in this summary.
Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: The studies described (in vitro drug delivery, primary dermal irritation) were experimental studies performed for the submission, making them prospective in nature regarding the data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an expert-driven adjudication of images or clinical cases. The "ground truth" for the drug delivery study was the quantified amount of drug in skin/receptor solution, measured scientifically. For biocompatibility, it was based on established dermal irritation scoring methods.

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

Not applicable. No adjudication by human readers/experts was involved in these in vitro and animal studies.

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

Not applicable. This is not an AI/algorithm-assisted diagnostic device, nor is it a multi-reader study.

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

Not applicable. This is a physical drug delivery device, not an algorithm.

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

Drug Delivery: The "ground truth" was quantitative measurement of drug concentration in skin and receptor solution using radioassay (3H and 14C tracers).
Biocompatibility/Irritation: The "ground truth" was the Primary Dermal Irritation Index score, which is an objective measurement of skin reaction (e.g., erythema, edema) based on a standardized scale, typically observed and scored by trained personnel.

8. The sample size for the training set

Not applicable. This is not a machine learning device; therefore, there is no "training set."

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

Not applicable (as there is no training set).

Summary

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K063465

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FEB 2 8 2007

SUMARY OF SAFETY AND EFFECTIVENESS Iontophoresis Drug Delivery Device Date of Summary: 15 Nov 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:	Champion Iontophoretic Drug Delivery System
Common Name:	Iontophoresis Drug Delivery Device

B. Name of Predicate Device(s)

. Iontophoresis Device: K974855 and K982668 Iontophoresis Drug Delivery Device IOMED, Inc. Phoresor® II PM900
. Iontophoresis Device: K932621 Iontophoresis Drug Delivery Device IOMED, Inc. TQ1 RH-801/GS
. Iontophoresis Device: K033192 Iontophoresis Drug Delivery Electrode IOMED, Inc. RH-950

C. Device Description

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D. Intended Use

Iontophoretic devices 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 Delivery

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. Drug quantifications in the skin and receptor solution was performed by radioassay using 3H-dexamethasone sodium phosphate and 14C-lidocaine hydrochloride tracers. The materials used in the Champion integrated transdermal patch are identical to those used in the RH-801/GS and the RH-950.

This testing shows that both negatively and positively charged drugs can be effectively delivered using the integrated transdermal patch to be used with the Champion Iontophoretic Drug Delivery System.

Safety and Biocompatibility

Primary dermal irritation studies were previously 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 (nonirritant), 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 non-irritant during a Dexamethasone administration from a Dexamethasone/lidocaine (1:2) mixture, and a non-irritant during Dexamethasone administration alone. The materials used in the Champion integrated transdermal patch are identical to those used in the RH-801/GS and the RH-950.

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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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IOMED, Inc. % Mr. Curtis Jenson Director, Ouality and Regulatory 2441 South 3850 West, Suite A Salt Lake City, Utah 84120-9941

FEB 2 8 2007

Re: K063465

Trade/Device Name: Champion Iontophoresis Drug Delivery Device Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: February 6, 2007 Received: February 7, 2007

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 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 (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 20857

As you are aware, there are concerns relating to the fact that no drug is currently labeled for administration via an iontophoresis device. The Agency currently is evaluating fais public tealth concern regarding the safety and effectiveness of this route of administration of drugs, and in the near future will inform manufacturers of certain additional steps the Agency believes are necessary to address this concern.

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, permite 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 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 ts toll free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

F.A

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

Applicant: Iomed, Inc.

510(k) Number (if known):

Device Name: Champion Iontophoretic Drug Delivery System

Indications For Use: Iontophoretic drug delivery devices 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 IONTOCANNE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).

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)

Division of General, Restorative, and Neurological I 510(k) Number

(Division Sign-Off)

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.