The TRANSDERM IONTO System is a powered iontophoresis drug delivery system that is 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 Description

The TRANSDERM IONTO System consists of a probe, power supply/support, and a disposable drug delivery cap clectrode. Flectrical pulses are produced by an electronic pulse generator that is able to generate bursts of pulses that are applied to the skin through electrodes applied to a plastic plate (the applicator). The design of the device provides one channel output. The TRANSDERM IONTO System requires a DC supply of 9 V, 1.0 A max. This power source is supplied by, the TRANS-BASE module which is connected to mains through a removable supply cord and is equipped with a proper connector receptacle to fit the connector malc mounted on TRANSDERM IONTO probe supply cable. The TRANS-BASE is equipped with a 15 w AC-DC switch mode power module. The drug delivery cap electrode is adhered to the patient's skin and then saturated with ionic solution. Once the drug delivery cap electrode is affixed to the patient's skin, the TRANSDERM IONTO probe's applicator head can be attached to the internal side of the drug delivery cap electrode.

AI/ML Overview

This document describes a 510(k) premarket notification for the TRANSDERM IONTO System, an iontophoresis device. It's important to note that 510(k) submissions primarily demonstrate substantial equivalence to a predicate device rather than fulfilling specific, independent performance criteria based on a clinical study where the device's performance would be compared against a 'ground truth' developed by experts. As such, many of the typical acceptance criteria and study details for an AI/ML device (like those related to expert consensus, adjudication, and specific performance metrics like AUC, sensitivity, specificity, and F1 score) are not directly applicable or reported in this type of submission.

Therefore, the following table summarizes the information relevant to a 510(k) for a medical device aiming for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance
Intended Use	Must have the same intended use as legally marketed predicate devices.	The TRANSDERM IONTO System is a powered iontophoresis drug delivery system indicated for the local administration of ionic drug solutions for medical purposes, as an alternative to injections. This is "similar" to predicate devices.
Technological Characteristics	Must have similar technological characteristics or demonstrate that any differences do not raise new questions of safety and effectiveness.	The system consists of a probe, power supply/support, and a disposable drug delivery cap electrode. It generates electrical pulses through electrodes on a plastic plate. Differences from predicates involve the use of a plastic plate with electrodes and an adhesive drug delivery cap electrode, rather than lead wires and adhesive electrodes. The submission claims "no significant difference" in performance.
Performance Safety	Must meet applicable safety standards and demonstrate safe operation.	"Performance testing and the applicable IEC 60601-1 standards testing was performed."
Electrical Safety	Compliance with relevant electrical safety standards.	The device requires a 9V DC supply, powered by a TRANS-BASE module connected to mains. The TRANS-BASE includes a 15W AC-DC switch mode power module. Compliance with IEC 60601-1 is stated.

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

Sample size for the test set: Not directly applicable or explicitly stated in this 510(k) summary. Performance testing for a device like this would typically involve engineering and bench testing, potentially some in-vivo animal studies, or very limited human testing for specific parameters, but not a large-scale clinical trial with a "test set" in the sense of AI/ML evaluation.
Data provenance: Not specified. Testing would likely be conducted in a laboratory or clinical setting, but details like country of origin or retrospective/prospective nature of data are not relevant for this type of submission.

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

This is not applicable for a 510(k) submission focused on substantial equivalence for an iontophoresis device. Ground truth, in the context of expert consensus, is typically used for diagnostic or screening AI/ML devices where human interpretation is the gold standard. For this device, "ground truth" would relate to objectively measurable physical or electrical parameters.

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

Not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, often in diagnostic AI/ML contexts to establish a robust ground truth. This type of device's performance is evaluated by objective engineering and safety standards.

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. An MRMC study is relevant for diagnostic or screening devices where human readers (e.g., radiologists, pathologists) interpret cases with and without AI assistance. The TRANSDERM IONTO System is a drug delivery device, not a diagnostic imaging or screening tool.

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

Not applicable. The TRANSDERM IONTO System is a physical device that delivers medication, not an algorithm. Its performance is inherent to its physical operation and electrical characteristics, rather than a separate "standalone algorithm."

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

The concept of "ground truth" as typically defined for AI/ML diagnostic studies is not applicable. Instead, the device's performance is assessed against established engineering standards (e.g., IEC 60601-1) and objective physical and electrical specifications derived from predicate devices or general medical device safety requirements. For instance, parameters like current output, voltage, safety mechanisms, and drug delivery capabilities would be measured against predefined benchmarks.

8. The sample size for the training set

Not applicable. This device is hardware for drug delivery, not an AI/ML system that requires a "training set."

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

Not applicable. As the device is not an AI/ML system, there is no training set or associated ground truth.

Summary

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	DEC - 2 2003			SUMMARY OF SAFETY AND EFFECTIVENESS
I.			GENERAL INFORMATION
	A.	Submitted By:	Mattioli Engineering Corporation7918 Jones Branch DriveSuite 600McLean, VA 22102Tel: 703-312-6000Fax: 703-243-9139
		Contact Person:	Ms. Linda FerriAt address above
	B.	Device Trade Name:Common Name:Classification Name:	TRANSDERM IONTO SystemIontophoresis DeviceDevice, Iontophoresis, Specific Uses
	C.	Predicate Devices:
		Manufacturer	Product Name	510(k) No.
		Life-Tech, Inc.Life-Tech, Inc.	Microphor®Iontophor® II	K913601 K863166
II.		DEVICE DESCRIPTION

II. DESCRIPTION

The TRANSDERM IONTO System consists of a probe, power supply/support, and a disposable drug delivery cap clectrode.

Flectrical pulses are produced by an electronic pulse generator that is able to generate bursts of pulses that are applied to the skin through electrodes applied to a plastic plate (the applicator). The design of the device provides one channel output.

The TRANSDERM IONTO System requires a DC supply of 9 V, 1.0 A max. This power source is supplied by, the TRANS-BASE module which is connected to mains through a removable supply cord and is equipped with a proper connector receptacle to fit the connector malc mounted on TRANSDERM IONTO probe supply cable. The TRANS-BASE is equipped with a 15 w AC-DC switch mode power module.

The drug delivery cap electrode is adhered to the patient's skin and then saturated with ionic solution. Once the drug delivery cap electrode is affixed to the

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patient's skin, the TRANSDERM IONTO probe's applicator head can be attached to the internal side of the drug delivery cap electrode.

III. INDICATIONS FOR USE

The TRANSDERM IONTO System is a powered iontophorcsis drug delivery system that is indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.

IV. TECHNOLOGICAL COMPARISON

The TRANSDERM IONTO System, Microphor® (K913601), and Iontophor® II (K863166) have similar indications for use and overall function and perform in a similar manner with respect to iontophoretic drug delivery. Performance testing supports that there is no significant difference between the TRANSDERM IONTO System and the Iontophor® II. The TRANSDERM IONTO System utilizes a plastic plate containing electrodes and an adhesive drug delivery can electrode to administer the ionic solution to the patient rather than the lead wires and adhesive clectrodes of the Microphor® and Iontophor® II.

V. TESTING

Performance testing and the applicable IEC 60601-1 standards testing was performed.

VI. CONCLUSIONS

The TRANSDERM IONTO System is substantially equivalent to the legally marketed iontophoretic devices in intended use and performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's wings and a wavy line representing its body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 2003

Mattioli Engineering Corporation C/o Ms. Melissa Mahall Bio-Reg Associates, Inc. 11800 Baltimore Avenue, Suite 105 Beltsville, Maryland 20705

Re: K032968

Trade/Device Name: TRANSDERM IONTO System Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: November 20, 2003 Received: November 24, 2003

Dear Ms. Mahall:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalcnt (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 cither 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 Ecderal 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

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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.

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 promotor 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, 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 usc 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.

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Page 3 - Ms. Melissa Mahall

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 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,

for Mark A. Wilkerson

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

Enclosure

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INDICATIONS FOR USE

K032968 510(k) Number: Device Name: TRANSDERM IONTO System Mattioli Enginecring Corporation

Indications for Use:

Sponsor Name:

Prescription Use 风 (21 CFR 801 Subpart D)

And/Or

Over-The-Counter Use □ (21 CFR 807 Subpart C)

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milkman

Jivision Sign-C Division of General, Restorative and Neurological f 510(k) Number -

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.