(104 days)
Iontophoretic drug delivery devices are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).
An iontophoresis device is a device that is intended to use electrical current to introduce ions of water-soluble salts or drugs into the body for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent on the charge and molecular weight of the ion, the magnitude of the electrical current applied, patch composition, duration of current flow, and numerous other factors.
The IOMED, Inc. Champion integrated transdermal patch incorporates both a drug electrode and a return electrode. The patch is designed for a single-patient, oneapplication use and can only be used with IOMED's Champion dose controller. The Champion dose controller provides control of the current and therefore dosage delivered.
The Champion dose controller is a small, battery-powered, microprocessor-controlled iontophoretic device which delivers direct current (DC) to the integrated transdermal patch which is placed on intact skin.
The provided document, K063465, is a 510(k) premarket notification for the "Champion Iontophoresis Drug Delivery System." This submission focuses on establishing substantial equivalence to predicate devices and demonstrating general safety and effectiveness through in vitro drug delivery and biocompatibility testing. It is not a study describing acceptance criteria and device performance in the context of a typical algorithm or diagnostic device evaluation.
Therefore, many of the requested elements are not applicable or cannot be extracted from this document, as they pertain to clinical trials, algorithm performance metrics, or expert adjudication which are not relevant to the approval of this physical drug delivery device.
However, I can extract information related to the in vitro testing and safety assessments that were presented as part of the submission to demonstrate the device's functionality and safety.
Here's a breakdown of the available and unavailable information based on your request:
1. A table of acceptance criteria and the reported device performance
Note: The document does not explicitly state quantitative "acceptance criteria" in the format typically seen for algorithm performance (e.g., sensitivity, specificity thresholds). Instead, it describes tests performed and their outcomes which serve to demonstrate the device's functionality and safety in comparison to predicate devices and established standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Drug Delivery Functionality: The device should effectively deliver both negatively and positively charged drugs (analogous to predicate devices). (Implicit, based on intended use and comparison to predicate devices utilizing the same materials). | Effective Drug Delivery Demonstrated: "This testing shows that both negatively and positively charged drugs can be effectively delivered using the integrated transdermal patch to be used with the Champion Iontophoretic Drug Delivery System." |
Specifics: In vitro testing used dexamethasone sodium phosphate (negative) and lidocaine hydrochloride (positive) as model drugs. Quantified by radioassay (3H-dexamethasone and 14C-lidocaine) in skin and receptor solution. |
| Biocompatibility/Irritation: Materials used in the patch should be biocompatible and cause acceptable levels of dermal irritation, consistent with predicate devices and safety standards. (Implicit, based on predicate device history and industry standards for medical devices). The predicate device (RH-801/GS) showed acceptable irritation levels. | Acceptable Biocompatibility/Irritation: "The materials used in the Champion integrated transdermal patch are identical to those used in the RH-801/GS and the RH-950."
Predicate Device Performance (RH-801/GS):
- Rated as a mild irritant (0.5) during lidocaine administration (
§ 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.