(60 days)
Not Found
No
The description focuses on the physical components and the mechanism of iontophoresis, with no mention of AI or ML. The reference to "microprocessor controlled constant current generators" does not inherently imply AI/ML; it refers to standard electronic control.
Yes
The device is intended for the administration of soluble salts into the body for medical purposes, functioning as an alternative to hypodermic injection, which serves a therapeutic role.
No
The device is described as an "Iontophoresis Electrode System" intended for the administration of soluble salts into the body, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the system consists of physical components: a disposable, single-use iontophoresis electrode, a return electrode, and an isopropyl alcohol patch. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "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 test performed on samples taken from the body.
- Device Description: The description details electrodes used to deliver substances into the body via iontophoresis. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to deliver substances into the body.
N/A
Intended Use / Indications for Use
The Trivarion Buffered Iontophoresis Electrode 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 Trivarion Buffered Iontophoresis Electrode System consists of a disposable, single-use iontophoresis electrode and return electrode. A packaged 70% isopropyl alcohol patch (Becton Dickinson, Franklin Lakes, NJ 07417) is also included.
The Trivarion lontophoresis Electrode System does not include the iontophoresis electrical generator or the electrical lead wires. Commercially available, FDA approved microprocessor controlled constant current generators such as the lomed phoresor or EMPI Dupel may be connected to the Trivarion electrodes.
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 E 510(k) Summary
AUG 0 1 2006
- A. General Provisions
| Submitter's Name: | ActivaTek Inc |
|---|---|
| Submitter's Address: | C/O PETERS SCOFIELD PRICE |
| 340 Broadway Centre | |
| 111 E. Broadway | |
| Salt Lake City, UT 84111 | |
| Contact Person: | David Scofield |
| dws@psplawyers.com | |
| (801) 322-2002 (ph); (801) 322-2003 (fax) |
Classification Name: Iontophoresis, other uses 21 CFR 890.5525 Proprietary Name: ActivaTek Trivarion Buffered Iontophoresis Electrode System Common Name: Iontophoresis Electrode
- B. Date of preparation of this Summary: 5-31-2006
- C. Name of Predicate Devices to which equivalence is claimed:
The ActivaTek Trivarion Iontophoresis Electrode is substantially equivalent to the identified iontophoresis electrodes in intended use, materials of construction, and mode of operation.
D. Device Description
The Trivarion Buffered Iontophoresis Electrode System consists of a disposable, single-use iontophoresis electrode and return electrode. A packaged 70% isopropyl alcohol patch (Becton Dickinson, Franklin Lakes, NJ 07417) is also included.
The Trivarion lontophoresis Electrode System does not include the iontophoresis electrical generator or the electrical lead wires. Commercially available, FDA approved microprocessor controlled constant current generators such as the lomed phoresor or EMPI Dupel may be connected to the Trivarion electrodes.
1
-
E. Statement of Intended Use Compared to Predicate Device(s)
The ActivaTek Trivarion Iontophoresis Electrode System has the same intended use as the above identified predicate devices and other iontophoresis devices, i.e., it is intended to be used for the local administration of ionic solutions into the body for medical purposes and as an alternative to injections. -
F. Discussion of Technological Characteristics:
The Trivarion Iontophoresis Electrode is buffered by the use of silver-silver chloride for administered doses in the range of 40-80 mAmp*min for both polarities, negative and positive.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG () 1 2006
Activa Tek, Inc. % Peters Scofield Price Mr. David Scofield 340 Broadway Centre 111 East Broadway Salt Lake City, Utah 84111
Re: K061522
Trade/Device Name: Trivarion Buffered Iontophoresis Electrode System Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: July 19, 2006 Received: July 20, 2006
Dear Mr. Scofield:
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 cither class II (Special Controls) or class 111 (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.
Our substantially equivalent decision does not apply to the drugs that you will label or promote & a was 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
3
Page 2 - Mr. David Scofield
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.
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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark A. Miller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): K061522
Device Name: Trivarion Buffered Iontophoresis Electrode System
Indications For Use: The Trivarion Buffered Iontophoresis Electrode 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.
Mark A. McKeen
vision Sign-Off) Lavision of General. Restorative and Neurological Devices
Number K06/522
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)