(30 days)
The Hybresis system is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
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 Empi Hybresis integrated transdermal patch incorporates both a drug electrode and a return electrode. The patch is designed for a single-patient, one-application use and can only be used with Empi's Hybresis dose controller. The Hybresis dose controller provides control of the current and therefore dosage delivered.
The Hybresis dose controller is a small, battery-powered, microprocessor-controlled Iontophoresis device which delivers direct current (DC) to the integrated transdermal patch which is placed on intact skin.
This document is a 510(k) Summary for the Hybresis Iontophoresis Drug Delivery System. It is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results in the format requested.
Therefore, the requested information about acceptance criteria and a study proving the device meets them, specifically in the context of device performance metrics like accuracy, sensitivity, or specificity, is not present in the provided text.
The document states:
- Non-clinical Testing: "Verification of the Hybresis includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions. Validation testing for the Hybresis includes testing to show the device meets user needs according to marketing requirements." (Page 1)
- Clinical Testing: "No prospective clinical studies are required to demonstrate safety and efficacy of the in support of applications for regulatory approval/clearance in the target markets. The Hybresis does not differ from the predicate devices in technological characteristics or intended use, where the device has a significant influence on clinical endpoints, and where prospective clinical studies would be necessary to determine safety and efficacy equivalence." (Page 1)
This indicates that the device's acceptance criteria are related to its electrical and mechanical specifications and user needs, which were assessed through non-clinical verification and validation testing. However, the specific quantitative acceptance criteria and the detailed results of those tests are not provided in this summary.
Given the nature of the device (an iontophoresis drug delivery system) and the type of submission (510(k) for substantial equivalence, specifically a modification for naming and contraindications), the focus is on maintaining equivalence to a predicate device rather than proving novel clinical efficacy or diagnostic performance. Therefore, a clinical study as would be seen for an AI/CADe device with metrics like sensitivity/specificity is explicitly stated as not required.
In summary, based only on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance (as no clinical test set is described).
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone algorithm performance.
- Type of ground truth used (as no clinical ground truth assessment is detailed).
- Sample size for the training set.
- How ground truth for the training set was established.
The document does mention "electrical and mechanical tests" and "validation testing" but does not detail the criteria or results.
§ 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.