(56 days)
NAImco, Inc. Iontophoresis Drug Delivery Electrodes are indicated to introduce ions of soluble salts or other drugs into the body.
The Naimco, Inc. Iontophoresis Drug Delivery Electrode System consists of an active drug delivery electrode and a passive return electrode. These electrodes are designed for one use by a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are multiple sizes and shapes of drug delivery electrodes to accommodate placement various sites on the body. The size of the return electrode is the same for all drug delivery electrode sizes. The Naimco, Inc. Iontophoresis Drug Delivery Electrodes have technological characteristics equivalent to those of the predicate devices, including comparable performance specifications, comparable materials including the same buffering agent (Ag/AgCI) and fiberous polyester reservoir materials on the active drug delivery electrodes and the same buffering, self-adhering polymer on the return electrode, multiple shapes and sizes of active the drug delivery electrodes, and equivalent packaging and labeling.
The provided text is a 510(k) summary for Naimco, Inc. Iontophoresis Drug Delivery Electrodes, which is a regulatory submission to the FDA. This type of document is concerned with demonstrating substantial equivalence to predicate devices for market approval rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel medical device.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it relates to performance endpoints derived from clinical or technical studies. The document only states that the Naimco electrodes have "technological characteristics equivalent to those of the predicate devices, including comparable performance specifications."
Here's why the requested information cannot be extracted:
- Acceptance Criteria and Device Performance: The document lists predicate devices and claims "comparable performance specifications" but does not define these specifications or provide quantitative data on how the Naimco device performs against them. This type of information would typically be detailed in a separate test report or clinical study summary, not necessarily in the 510(k) summary itself, which focuses on equivalence.
- Study Details (Sample size, data provenance, expert ground truth, adjudication, MRMC, standalone, training set): None of these details are present because the submission hinges on demonstrating equivalence to existing devices rather than presenting a novel study to establish new performance benchmarks. The "study" here is essentially the comparison to predicate devices, and the "proof" is the FDA's determination of substantial equivalence.
In summary, this document is a regulatory filing for an iontophoresis electrode product, focusing on its equivalence to previously approved devices. It does not contain the detailed clinical or technical study data (performance metrics, study design, ground truth establishment, sample sizes, etc.) that would typically be associated with a description of acceptance criteria and the evidence proving a device meets them for a novel or significantly modified 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.