(60 days)
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.
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. 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.
The provided text is a 510(k) summary for the ActivaTek Trivarion Buffered Iontophoresis Electrode System. It focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, and mode of operation. Crucially, this document does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically found in performance testing reports for new medical device functionalities.
The sections below are filled out based on the absence of the requested information in the provided text.
Acceptance Criteria and Device Performance
The provided document does not specify acceptance criteria or report device performance data in the manner typically seen for clinical or analytical performance studies. The 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, and mode of operation.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Study Information
The provided document does not describe a specific study designed to prove the device meets acceptance criteria related to its performance beyond demonstrating substantial equivalence to predicate devices. The information presented is typical of a 510(k) submission which relies on comparison to existing legally marketed devices.
- Sample size used for the test set and data provenance: Not applicable. No test set for performance evaluation is described.
- Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
- Adjudication method for the test set: Not applicable. No test set adjudication is described.
- 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 electrode system, not an AI-assisted diagnostic tool for which MRMC studies would be relevant.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an iontophoresis electrode system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is described.
- The sample size for the training set: Not applicable. This device is an iontophoresis electrode system, not a machine learning algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.