(304 days)
MesoDerm is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
MesoDerm is a device that is a microprocessor controlled iontophoresis drug delivery system. It has a dispersive electrode, which is attached to the microprocessor. An FDA approved conductive grounding pad is also required prior to its use. Introducing ions can be accomplished with MesoDerm's Dispensing Electrode and roller using methods described in the operator's manual. This is accomplished as the 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 product the ions are diffused into the skin.
This document is a 510(k) summary for the MesoDerm iontophoresis device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices (K032968 & K042590 Transderm® System) based on functional and technical specifications.
Therefore, I cannot provide the requested information from the given text.
The document provides the following:
- Device Description: MesoDerm is a microprocessor-controlled iontophoresis drug delivery system.
- Intended Use: Administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
- Technical Specifications: Operating Voltage, Assimilation, Standards Met, Fuses, Operating Temperature, Weight, Material Chassis, Electronics, Exit Channels.
- Substantial Equivalence Chart (Table 12.1): Compares MesoDerm to the Transderm® System across parameters like Indications for Use, Power Supply, Average Pulse Current, Load Impedance, Pulse Frequency, Burst Time, Burst Frequency, Dispenser Head, and Generator.
- Contraindications, Warnings, and Precautions.
- Product Specifications: Roll on Ball (material, diameter, sphericity) and Conductive Grounding Plate (material).
- Conclusion: The device is substantially equivalent to K032968 & K042590.
- Correspondence: A letter from consultants modifying the 510(k) to remove references to a stylus and specific default treatment times.
- FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.
§ 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.