(79 days)
The Dynatron® Ion™ iontophoresis electrode is designed for clinical use to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.
The Dynatron® Ion™ iontophoresis electrode is indicated to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection
The Dynatron® Ion™ iontophoresis electrode consists of an active drug delivery electrode and a return electrode. Electrodes are designed for single patient use.
This 510(k) submission does not contain a study to prove acceptance criteria were met. Instead, it relies on substantial equivalence to a predicate device.
Here's why and what information is available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
There is no table of acceptance criteria or reported device performance for the Dynatron® Ion™ iontophoresis electrode in this document. The submission asserts "substantial equivalence" to a predicate device rather than presenting performance data against defined criteria.
2. Sample Size Used for the Test Set and Data Provenance:
No test set was used for this device as detailed in the submission. The submission relies on substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No test set was used for performance evaluation against ground truth.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring expert adjudication was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was conducted. The submission does not compare the new device's performance to human readers with or without AI assistance.
6. Standalone Performance Study:
No standalone (algorithm only without human-in-the-loop performance) study was conducted for the Dynatron® Ion™ iontophoresis electrode.
7. Type of Ground Truth Used:
Not applicable. No ground truth was established for a testing phase of this device, as its approval is based on substantial equivalence.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML device and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, this is not an AI/ML device and does not involve a training set with established ground truth.
Summary of the Submission's Approach:
The submission for the Dynatron® Ion™ iontophoresis electrode is a 510(k) premarket notification which seeks to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (the North Coast Buffered Iontophoresis Electrode, cleared under K052019).
The core argument for safety and effectiveness is that:
- "The Dynatron® Ion™ iontophoresis electrode shares the same or similar basic characteristics, features and intended use as the predicate device"
- "There are no substantive differences between the product defined in this 510(k) submission and the predicate device."
- "They are similar to the technologies that are currently used in other similar medical devices."
- "The product is safe and effective when used as indicated in specific applications under a clinician's supervision/therapy program."
Therefore, no new studies or performance data are presented to establish acceptance criteria or demonstrate the device's performance against such criteria. The device's safety and effectiveness are inferred from its similarity to an already cleared device.
§ 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.