The ActivaTek ActivaPatch Iontophoresis System is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.

Device Description

The ActivaTek ActivaPatch Iontophoresis System (Iontophoresis Patch) consists of a self-contained, disposable single-use iontophoresis patch, instructions for use, and an alcohol prep pad containing 70% isopropyl alcohol.

The Iontophoresis Patch consists of an electronic module, an LED indicator, an active electrode, and a return electrode. These elements are incorporated under an adhesive foam covering which adheres the device to the skin. Its dimensions are 5.7 inches (length), 3.4 inches (width), and 0.2 inches (thickness).

The Iontophoresis Patch is designed to deliver a calibrated and fixed half dose of 40 mAmpminutes and a full dose of 80 mAmpminutes.

The ActivaPatch Iontophoresis System sequence of operation is signaled by its LED.

a) The operator applies the ActivaPatch to the skin.
b) The operator then pulls the tab located on the outer surface of the patch.
c) In the Initial Skin Impedance Measurement Phase, the ActivaPatch measures voltage across the active and return electrodes to indicate the level of skin impedance. For high skin impedance, the LED flashes once every 4 seconds. This indicates that the skin impedance is too high for iontophoretic delivery. The treatment timer is not started. For moderate skin impedances, the LED flashes pulses four times every 30 seconds. The patch continues to monitor the skin impedance but does not turn on the treatment timer. When the skin impedance becomes optimal, the LED blinks once every 30 seconds. This indicates that the impedance is appropriate to start an iontophoretic treatment session and the ActivaPatch starts the treatment timer.
d) In the First Half Dose Delivery Phase, the ActivaPatch LED continues to blink once every 30 seconds. This phase lasts 80 minutes and delivers an ionic dosage of 40 mA*minutes. At the end of the First Half Dose Delivery, the LED blinks short-long-short sequences every 30 seconds for 3 minutes. This signals to the user that the transition to the Second Half Dose Delivery Phase has begun.
e) During the Second Half Dose Delivery Phase, the ActivaPatch LED blinks two pulses every 30 seconds. During this final phase, another 40 mA*minute dose is delivered. At the end of the delivery, the power in the device is automatically shut off and the LED does not blink.
f) If at any time the skin impedance increases to high levels (e.g., the electrode falls off of the skin site) the ActivaPatch goes into the Skin Measurement Phase and the LED flashes pulses once every 4 seconds. The treatment timer is suspended and restarts when the skin impedance falls to optimal levels.

AI/ML Overview

The provided text is a 510(k) summary for the ActivaTek ActivaPatch Iontophoresis System. It focuses on establishing substantial equivalence to predicate devices rather than directly presenting a study with acceptance criteria and measured performance.

Therefore, many of the requested items (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not available in this type of regulatory submission. This document aims to demonstrate that the new device is as safe and effective as existing, legally marketed devices, rather than proving its "performance" against specific acceptance criteria in a detailed clinical study.

However, I can extract the acceptance criteria as implied by the device's specifications and the implicit "performance" is that it functions as described and is equivalent to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Device Description/Specifications)	Reported Device Performance (as described)
Dose Delivery:
- Calibrated half dose	40 mAmp*minutes
- Calibrated full dose	80 mAmp*minutes
Voltage:	6V
Operational Signaling (LED):	Functions as described for:
- High skin impedance	Flashes once every 4 seconds
- Moderate skin impedance	Flashes four times every 30 seconds
- Optimal skin impedance (treatment start)	Blinks once every 30 seconds
- First Half Dose Delivery (80 mins, 40mA*min)	Blinks once every 30 seconds
- Transition to Second Half Dose Delivery (3 mins)	Blinks short-long-short sequences every 30 seconds
- Second Half Dose Delivery (40mA*min)	Blinks two pulses every 30 seconds
- End of Delivery	LED does not blink (power shut off)
- Increased skin impedance during treatment	Flashes once every 4 seconds (timer suspended)
Intended Use:
- Administration of soluble salts for medical purposes	Stated as "intended to be used for..."
- Alternative to hypodermic injection	Stated as "intended to be used for..."
Substantial Equivalence:	Found substantially equivalent to EMPI Action Patch (K030395) and ActivaTek Trivarion Buffered Iontophoresis Electrode (K061522).

The "study that proves the device meets the acceptance criteria" is implicitly the technical and performance testing conducted by ActivaTek Inc. to demonstrate that the device functions according to its design specifications, allowing the FDA to determine substantial equivalence. Details of these specific tests are not provided in this 510(k) summary but would be part of the full 510(k) submission. The FDA's letter states: "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..." This indicates that the submitted documentation (including test reports, bench data, etc., which are not in this summary) was sufficient for their decision.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not provided in the 510(k) summary. Given the nature of an iontophoresis patch, testing would likely involve bench testing (electrical output, dosage accuracy, impedance monitoring), biocompatibility, and potentially limited human use studies for skin irritation or functionality, rather than large-scale clinical trials that would have clearly defined test sets and data provenance.

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)
Not applicable and not provided. The function of this device is largely objective (delivering a specific electrical dose) and does not involve subjective interpretation requiring expert ground truth in the way medical imaging AI might.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable and not provided.

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 device is an iontophoresis patch, not an AI or imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, but a hardware medical device with some automated operational sequences. Its "standalone" performance would be its ability to deliver the specified dose and manage impedance as described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a device like an iontophoresis patch, the "ground truth" for its performance would be derived from:

Bench Test Measurements: Direct electrical measurements of current, voltage, time, and calculated dosage.
Engineering Specifications: Adherence to defined parameters (e.g., 40 mAmpminutes, 80 mAmpminutes, 6V).
Predicate Device Equivalence: Demonstrating that its performance characteristics are comparable to legally marketed predicate devices, which themselves have an established safety and efficacy profile.

8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that would require a "training set."

9. How the ground truth for the training set was established
Not applicable.

Summary

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K091326

Section 6 510(K) Summary

MAY 27 2009

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date is May 5, 2009.

A. Contact Information [21 CFR 807.92(a)(1)].

ActivaTek Inc. 2734 S. 3600 West, Unit F West Valley, UT 84120

Tel: 1-801-969-0883 Fax: 1-800-680-5520 Contact person: Jamal Yanaki

B. Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name: ActivaPatch Iontophoresis System

Device Common Name: Iontophoresis Patch Electrode

Classification Name: Iontophoresis, other uses

Product Code: EGJ

Panel: Physical Medicine

Device Classification: Class III

C. Predicate Devices [21 CFR 807.92(a)(3)]

The ActivaTek ActivaPatch Iontophoresis System uses the same materials as the following predicate device: Trivarion Buffered Iontophoresis Electrode System K061522 manufactured by ActivaTek, Inc.

The ActivaTek ActivaPatch Iontophoresis System uses similar technology and has equivalent physical output characteristics as the following predicate device: Action Patch Iontophoresis System K030395 manufactured by EMPI, Inc.

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D. Device Description [21 CFR 807.92(a)(4)]

The Iontophoresis Patch is designed to deliver a calibrated and fixed half dose of 40 mAmpminutes and a full dose of 80 mAmpminutes.

The ActivaPatch Iontophoresis System sequence of operation is signaled by its LED.

a) The operator applies the ActivaPatch to the skin.
b) The operator then pulls the tab located on the outer surface of the patch.
c) In the Initial Skin Impedance Measurement Phase, the ActivaPatch measures voltage across the active and return electrodes to indicate the level of skin impedance. For high skin impedance, the LED flashes once every 4 seconds. This indicates that the skin impedance is too high for iontophoretic delivery. The treatment timer is not started. For moderate skin impedances, the LED flashes pulses four times every 30 seconds. The patch continues to monitor the skin impedance but does not turn on the treatment timer. When the skin impedance becomes optimal, the LED blinks once every 30 seconds. This indicates that the impedance is appropriate to start an iontophoretic treatment session and the ActivaPatch starts the treatment timer.
d) In the First Half Dose Delivery Phase, the ActivaPatch LED continues to blink once every 30 seconds. This phase lasts 80 minutes and delivers an ionic dosage of 40 mA*minutes. At the end of the First Half Dose Delivery, the LED blinks short-long-short sequences every 30 seconds for 3 minutes. This signals to the user that the transition to the Second Half Dose Delivery Phase has begun.
e) During the Second Half Dose Delivery Phase, the ActivaPatch LED blinks two pulses every 30 seconds. During this final phase, another 40 mA*minute dose is delivered. At the end of the delivery, the power in the device is automatically shut off and the LED does not blink.
f) If at any time the skin impedance increases to high levels (e.g., the electrode falls off of the skin site) the ActivaPatch goes into the Skin Measurement Phase and the LED flashes pulses once every 4 seconds. The treatment timer is suspended and restarts when the skin impedance falls to optimal levels.

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E. Device Specification [21 CFR 807.92(a)(6)]

The ActivaPatch Iontophoresis System delivers a calibrated half dose of 40 mAmp and a full dose of 80 mAmps. It operates with a voltage of 6V.

F. Indications for Use [21 CFR 807.92(a)(5)]

The ActivaTek ActivaPatch Iontophoresis System is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.

G. Conclusion [21 CFR 807.92(a)(3)]

Technologically, the ActivaPatch Iontophoresis System was found to be substantially equivalent to the currently cleared EMPI Action Patch (K030395) and ActivaTek Trivarion Buffered Iontophoresis Electrode (K061522). The indications are identical to the previously cleared EMPI Action Patch (K030395). We believe that there are no new questions of safety or efficacy raised by the introduction of the ActivaTek ActivaPatch Iontophoresis System.

6-3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes on its wing, representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAY 27 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ActivaTek, Inc. % Mr. Jamal Yanaki President & CEO 2734 S. 3600 W. Unit F Salt Lake City, Utah 84119

Re: K091326

Trade/Device Name: ActivaTek ActivaPatch Iontophoresis System Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: May 3, 2009 Received: May 9, 2009

Dear Mr. Yanaki:

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 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. Jamal Yanaki

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, there are concerns relating to the fact that no drug is currently labeled for administration via an iontophoresis device. The Agency currently is evaluating this public health 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, 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.

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Page 3 - Mr. Jamal Yanaki

Also, please not 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 N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 5 Indications for Use

510(k) Number (if known):_ 1< (3 9 1326

Device Name: ActivaTek ActivaPatch Iontophoresis System

Indications for Use:

The ActivaTek ActivaPatch Iontophoresis System is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

__. (Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091326

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.