(90 days)
The Empi Dupel Transport Smart Iontophoresis System can be used for the local administration of ionic solutions into the body for medical purposes and as an alternative to injections.
The Empi Dupel Transport Iontophoresis System is a disposable, single-use iontophoresis device with a self-contained battery and electrical circuitry. The system includes a power module, delivery electrode, return electrode and lead wires. The Dupel Transport is capable of delivering both negatively and positively charged ionic solutions. The device uses a microprocessor to precisely control the delivery time of 3 hours. An LED is utilized to confirm the device is turned on and provides an indication of how much time is remaining in the treatment period.
Here's a summary of the acceptance criteria and the study information regarding the Empi Dupel Transport Iontophoresis System, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical tests | Meets product specifications over a range of operating and storage conditions |
| Mechanical tests | Meets product specifications over a range of operating and storage conditions |
| Marketing requirements | Meets marketing requirements |
| Delivering both negatively and positively charged ionic solutions | Capable of delivering both negatively and positively charged ionic solutions |
| Precise control of delivery time | Uses a microprocessor to precisely control the delivery time of 3 hours |
| Indication of device "on" and remaining treatment time | An LED confirms the device is turned on and provides an indication of how much time is remaining |
Study Information
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Sample size used for the test set and the data provenance: Not applicable. No clinical studies were conducted that involved a "test set" in the context of evaluating a medical device's diagnostic or predictive performance on patient data. Non-clinical testing was performed on the device itself. The text explicitly states: "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."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical studies were conducted that involved human interpretation or a "ground truth" derived from expert consensus.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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. This device is an iontophoresis system, not an imaging or diagnostic AI system that would typically involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "non-clinical testing" which included "electrical and mechanical tests" and "validation testing...to show the device meets according to marketing requirements." These tests would be considered standalone for the device's functional performance, but not in the context of an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be defined by the device's product specifications and marketing requirements. For example, if a specification states the device must deliver a specific current for a specific duration, the measured current and duration from the device's operation would be compared against that specification.
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The sample size for the training set: Not applicable. No training set was involved as this is not an AI/machine learning device. The non-clinical tests verified the device against engineering specifications and marketing requirements.
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How the ground truth for the training set was established: Not applicable.
§ 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.