(250 days)
ActhyDerm is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
ActhyDerm is a device that is a microprocessor controlled iontophoresis drug delivery system. The microprocessor bas four pre-set programs for penetration of the 1) epidermis, 2) dermis, 3) adipose, 4) muscle. It has a dispersive electrode and roller electrodes. An FDA approved conductive grounding pad is also required prior to its use. Introducing ions can be accomplished with ActhyDerm's Dispensing Electrode and roller using methods described with operator's manual: roller conducts current to the skin via the product to be delivered. The product has a positive charge, the current coming into the roller has a positive charge and when they meet the current are diffused into the skin are diffused into the skin.
The provided text describes the ActhyDerm iontophoresis device, its intended use, and its substantial equivalence to a predicate device (MesoDerm). However, it does not contain information on specific acceptance criteria for device performance, nor details of a study proving the device meets such criteria.
The document states that "The electrical performance of the ActhyDerm meets the requirements of the following standards: EN 60601-1 (1998), EN 62-24 (1997), 60601-1-2 (1998), ENS5011 (1999), EN 61000-4-2 (1998), EN 61000-4-3 (1997), EN 61000-4 (1998), En61000-4-2 (1998), EN 61000-4-3 (1997), EN 61000-4 (1998), EN550 (1998), EN 61000-4-3 (1997), EN 61000-4 (1998), En61000-4-5." This indicates adherence to electrical safety and electromagnetic compatibility standards, but not performance-based acceptance criteria related to its drug delivery function.
The FDA's decision is based on substantial equivalence to the predicate device, MesoDerm, due to identical intended use, materials, design, and technological characteristics. This means the ActhyDerm is considered as safe and effective as the legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a dedicated study.
Therefore, the requested information cannot be fully provided from the given text.
Here's a breakdown of what CANNOT be extracted from the document:
- A table of acceptance criteria and the reported device performance: This information is not present. The document only lists electrical safety standards that the device meets.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or clinical study data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set data requiring expert ground truth is presented.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. The device is not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is an iontophoresis drug delivery system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the document serves as a 510(k) summary for a medical device (ActhyDerm) demonstrating substantial equivalence to a predicate device (MesoDerm) based on technical characteristics and intended use, and compliance with electrical safety standards. It does not include performance data from studies against specific acceptance criteria.
§ 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.