(170 days)
Io-Drive electrode is indicated to introduce ions of soluble salts and other drugs into body.
The IO-Drive Iontophoresis electrode system consists of an active drug delivery electrode and a return electrode. These electrodes are designed for single patient use. There are multiple sizes of drug delivery electrodes to accommodate placement at different body sites. The size of the return electrode is the same size for all drug delivery electrodes.
The provided document, K993081, describes the IO-DRIVE Iontophoresis electrode system. This submission is a 510(k) premarket notification, indicating that the device aims to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than proving novel safety and effectiveness through extensive clinical trials.
Based on the provided information, the following can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices: The IO-Drive electrode system should function similarly to the Iomed TransQ (K91-4621) and Empi Dupel (K91-2014) in terms of delivering ionic drug solutions into the body via iontophoresis. | "A performance evaluation was performed and based on the evaluation the IO-Drive electrode is similar to the predicate electrodes." |
| Intended Use Equivalence: The device should have the same intended use as predicate devices. | "The electrode is intended to be used in the clinic. Iontophoresis drug delivery systems are indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections." This matches the general indications for iontophoresis devices. |
| Safety and Material Compatibility: While not explicitly detailed as acceptance criteria, substantial equivalence implies the materials and design are safe for single patient use as an external electrode. | The device consists of an active drug delivery electrode and a return electrode, designed for single patient use, with multiple sizes to accommodate different body sites. This description is consistent with typical iontophoresis electrode designs. |
| Manufacturing Quality: Compliance with Current Good Manufacturing Practice (GMP) requirements. | The FDA letter states: "A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective study details). The "performance evaluation" mentioned is very high-level and does not provide these specifics. For a 510(k) submission focused on substantial equivalence, such detailed clinical trial data with specific test sets and provenance is often not required if the device is sufficiently similar to predicates and performance can be established through bench testing or limited clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Given the nature of a 510(k) submission relying on "performance evaluation" for substantial equivalence, it's unlikely that an extensive expert-adjudicated test set in the traditional sense was used to establish ground truth for a novel "device performance" metric. Instead, the "ground truth" for comparison would be the established performance characteristics of the predicate devices.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or reported in this document. The submission is for a medical device (electrode system), not an imaging or diagnostic AI algorithm, so an MRMC study would generally not be applicable in this context.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not performed or reported. This device is an electrode system for drug delivery, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this 510(k) submission is primarily performance characteristics and established safety/effectiveness profiles of the predicate devices. The IO-Drive electrode system's "performance evaluation" aimed to show similarity to these predicates. The FDA's substantial equivalence determination implies that the new device is as safe and effective as the predicate devices based on available information, which might include design comparisons, material testing, and limited functional testing, rather than an independent "ground truth" based on clinical outcomes.
8. Sample Size for the Training Set
This information is not applicable/not provided. The IO-Drive system is an electrode, not an AI algorithm, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as above.
§ 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.