(156 days)
Not Found
No
The description focuses on the physical components and the principle of operation of iontophoresis, which is based on electrical fields. There is no mention of AI, ML, image processing, or any data-driven algorithms.
No
Explanation: The device is used for the administration of soluble salts into the body for medical purposes, which is a therapeutic action.
No
The device is intended for the administration of soluble salts into the body for medical purposes, which is a therapeutic function, not a diagnostic one. It uses iontophoresis to deliver substances, not to detect or analyze medical conditions.
No
The device description explicitly states it contains an "electronic module, an Active Electrode, and a Return Electrode" and describes the principle of operation involving an "electrical field across intact skin to propel charged ions," indicating it is a hardware device with electrical components.
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 device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Principle of Operation: The principle of operation is iontophoresis, which uses an electrical field to propel charged ions into the skin and underlying tissue. This is a method of delivering substances to the body, not analyzing substances from the body.
- Device Description: The description focuses on the components involved in delivering the electrical current and holding the device to the skin. There is no mention of components or processes related to analyzing biological samples.
IVD devices are typically used to test things like blood, urine, tissue, etc., to gain information about a patient's health status. This device is designed to deliver medication or other substances into the patient.
N/A
Intended Use / Indications for Use
The Activatek ActivaPatch ET Iontophoresis Patch 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 ET 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 ActivaPatch ET lontophoresis Patch contains an electronic module, an Active Electrode, and a Return Electrode. These elements are incorporated under an adhesive non-woven fabric covering which adheres the device to the skin. The overall dimensions of the ActivaPatch ET are 5.7 inches (length), 3.4 inches (width), and 0.2 inches (thickness).
Principle of Operation: Iontophoresis is a process that uses an electrical field across intact skin to propel charged ions into the skin and underlying tissue. The electrodes (Active and Return) are applied directly to the skin to transit the electric field. If the ion is negatively charged, then the negative electrode is designated the Active Electrode and the positive electrode is the Return Electrode. The total dose of all ions transported through the skin is proportional to the total current passed between the electrodes. Units of iontophoresis dosages are conventionally given in terms of mAmp*min, calculated by multiplying the amount of current by the time of application of the current.
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)
There are no applicable Guidance Documents specifically associated with this type of medical device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K030395 EMPI Action Patch, K061522 Activatek Trivarion Iontophoresis Electrode, K033192 Iomed RH-950 Iontophoresis Patch
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K132832
Section 5
FEB 1 3 2014
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 09-05-2013 [21 CFR 807.92(a)(1)].
Applicant Name and Address [21 CFR 807.92(a)(1)] A.
ActivaTek Inc.
2734 S. 3600 West
Unit F
West Valley, UT 84119
Tel: (800) 680-5520
Fax: (800) 680-5520
B. Contact Information
ActivaTek Inc.
2734 S. 3600 West
Unit F
West Valley, UT 84120
Tel: (800)-680-5520
Fax: (800) 680-5520
Contact person: Jamal Yanaki, President & CEO
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C. Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade Name: ActivaPatch ET Iontophoresis Patch Device Common Name: Iontophoresis Patch Electrode Classification Name: Iontophoresis, other uses 21 CFR 890.5525 Product Code: EGJ Device Classification: Class III
D. Predicate Devices [21 CFR 807.92(a)(3)]
The ActivaPatch ET lontophoresis Patch uses similar technology and physical output fied characteristics as the following predicate devices: K030395 EMPI Action Patch K061522 Activatek Trivarion Iontophoresis Electrode K033192 Iomed RH-950 Iontophoresis Patch
E. Device Description [21 CFR 807.92(a)(4)]
The Activatek ActivaPatch ET 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 ActivaPatch ET lontophoresis Patch contains an electronic module, an Active Electrode, and a Return Electrode. These elements are incorporated under an adhesive non-woven fabric covering which adheres the device to the skin. The overall dimensions of the ActivaPatch ET are 5.7 inches (length), 3.4 inches (width), and 0.2 inches (thickness).
Principle of Operation: Iontophoresis is a process that uses an electrical field across intact skin to propel charged ions into the skin and underlying tissue. The electrodes (Active and Return) are applied directly to the skin to transit the electric field. If the ion is negatively charged, then the negative electrode is designated the Active Electrode and the positive electrode is the Return Electrode. The total dose of all ions transported through the skin is proportional to the total current passed between the electrodes. Units of iontophoresis dosages are conventionally given in terms of mAmp*min, calculated by multiplying the amount of current by the time of application of the current.
2
Device Specifications and Comparison to Predicates [21 CFR 807.92(a)(6)] F.
The ActivaPatch ET Intophoresis Patch delivers a calibrated dose of 80 mAmpmin. It operates with a voltage of 3V. Both the Action Patch (K030398) and the RH-950 (K033192) deliver identical dosages of 80 mAmpmin. The operating voltage of the ActivaPatch ET is intermediate between the Action Patch at 10.5 Volts and the RH-950 at 1.55 Volts. The ActivaPatch ET delivers the calibrated dosage of 80 mAmp*min by way of a calibrated shunt resistor, similar to the Action Patch (K030395). The indications for use and intended use are similar to the EMPI Action Patch and the Iomed RH-950 (K033192). Both patches are to be placed in clinic, worn home, and removed by patient.
The materials used for patient contacting parts evolved from the ActivaTek Trivarion Iontophoresis Electrodes (K061522). The ActivaPatch ET has Active and Return Electrodes that are made of identical materials as used in the Trivarion fontophoreisis Electrodes. The adhesive backing is similar between the ActivaPatch ET and the Trivarion systems.
Indications for Use [21 CFR 807.92(a)(5)] G.
The Activatek ActivaPatch ET Intophoresis Patch is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.
H. Performance Data [21 CFR 807.92(b)(2)]
There are no applicable Guidance Documents specifically associated with this type of medical device.
I. Conclusion [21 CFR 807.92(b)(3)]
The ActivaTek ActivaPatch ET lontophoresis Patch was found to be substantially equivalent to the predicate devices in terms of technology, function and intended use. The indications for use are identical to the previously cleared devices (K033192) Iomed RH-950 Iontophoresis Patch. The dosage circuitry is similar to the EMPI Action Patch (K030395). The electrode composition is similar to the Activatek Trivarion Electrode (K061522). The ActivaTek ActivaPatch ET is substantially equivalent in intended use, materials of construction, mode of operation, and performance characteristics. We believe that there are no new questions of safety or efficacy raised by the introduction of the ActivaTek ActivaPatch ET Iontophoresis System.
3
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2014
ActivaTek Inc. Jamal Yanaki, President & CEO 2734 S. 3600 West, Unit F West Valley City, UT 84119
Re: K132832
Trade/Device Name: ActivaPatch ET Iontophoresis Patch Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: January 7, 2014 Received: January 8, 2014
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), that do not require approval of a premarket approval application (PMA), 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.
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
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Page 2 - Mr. Jamal Yanaki
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 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 (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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Page 3 – Mr. Jama! Yanaki
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132832
Device Name
Activatek ActivaPatch ET Iontophoresis Patch
Indications for Use (Describe)
The Activatek ActivaPatch ET Iontophoresis Patch is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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