(22 days)
Not Found
No
The device description details a system that measures skin impedance and controls current delivery based on pre-defined thresholds and timers, without any indication of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
Yes
The device is described as administering "soluble salts into the body for medical purposes," which directly indicates a therapeutic function.
No.
The device is intended for administering soluble salts into the body, not for diagnosing medical conditions. While it measures skin impedance, this is for monitoring the drug delivery process, not for diagnostic purposes.
No
The device description clearly outlines hardware components such as an electronic module, LED indicator, active electrode, and return electrode, all incorporated into a physical patch. The operation sequence describes the interaction of these hardware components with the user and the body.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection." This describes a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The device description details a system for delivering a dose of medication through the skin using iontophoresis. It measures skin impedance to ensure proper delivery, but it does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information about a patient's health status.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Detecting or measuring analytes in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly designed for delivering a substance into the body, which is a therapeutic action, not for testing something from the body for diagnostic purposes.
N/A
Intended Use / 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.
Product codes
EGJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
D. Device Description [21 CFR 807.92(a)(4)]
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.
2
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
3
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