(101 days)
Iontophoresis Electrodes are intended to be used to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.
The proposed device is indicated for the administration of soluble salts or other drugs into the body for medical purposes. The Iontophoresis Electrodes utilize adhesive electrodes have both anode and cathode electrodes that adhere to the skin. The electrodes may either be connected by leads (wires) to a separate controller Forming a current loop. The portion of the active electrode that contacts the skin also has a drug/solution reservoir. End users saturate the reservoir with the ionic solution to be delivered. The reservoir contacts the electrode and the drug/solution is delivered to the patient transdermally.
Five models (Small, Medium, Large, Butterfly and Return Electrode) are included in this series products, and they have the same intended purposes, working theories and specifications.
The provided document describes the acceptance criteria and the study that proves the device meets those criteria for the Iontophoresis Electrodes (K232020).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison to a predicate device (Iontophoresis Drug Delivery Electrodes, K040495) to demonstrate substantial equivalence, rather than setting explicit numerical acceptance criteria for a new device's performance. The "acceptance criteria" are implied by the predicate device's specifications and the non-clinical test conclusions.
| Acceptance Criteria (Implied by Predicate & Standards Compliance) | Reported Device Performance (Proposed Device) | Remark |
|---|---|---|
| Product Code: EGJ | EGJ | Same |
| Regulation Number: 21 CFR 890.5525 | 21 CFR 890.5525 | Same |
| Indications for Use: Introduce soluble salts and other drugs into the body as an alternative to hypodermic injection. | Introduce soluble salts and other drugs into the body as an alternative to hypodermic injection. | Same |
| Patient Population: Patients requiring iontophoresis treatment | Patients requiring iontophoresis treatment | Same |
| Usage Environment: Hospitals, medical clinics | Hospitals, medical clinics | Same |
| Design (Electrode Size): Comparable to predicate sizes (e.g., Small, Medium, Large, Butterfly, Return Electrode) | ION-T01 (69x69 mm), ION-T02 (82x82 mm), ION-T03 (88x88 mm), ION-T04 (84x94 mm), ION-T05 (64x64 mm) | Same (Note 1 - differences in design requirements, not affecting safety/performance) |
| Main Materials: Silver/Silver Chloride (Ag/AgCl), Buffering Agent, PU Conductive carbon film | Silver/Silver Chloride (Ag/AgCl), Buffering Agent, PU Conductive carbon film | Same |
| Anatomical Sites: For body surface skin | For body surface skin | Same |
| Working mode: Must be used as a complete set, consisting of an active drug delivery electrode and a passive return electrode. | Must be used as a complete set, consisting of an active drug delivery electrode and a passive return electrode. | Same |
| Compatibility with other devices: Designed for use with iontophoresis devices only. | Designed for use with iontophoresis devices only. | Same |
| Impedance: 2MΩ ~ 10MΩ | 2MΩ ~ 10MΩ | Same |
| System current: 4.0mA | 4.0mA | Same |
| Maximum Dosage: 80 mA-min | 80 mA-min | Same |
| Fill Volume: Comparable to predicate fill volumes (e.g., 1.5cc, 2.5cc, 4.0cc, 2.0cc for specific models) | 1.5cc (ION-T01), 2.5cc (ION-T02), 4.0cc (ION-T03), 2.0cc (ION-T04) | Same |
| Biocompatibility (Cytotoxicity): No Cytotoxicity | No Cytotoxicity | Same |
| Biocompatibility (Skin sensitization): No evidence of sensitization | No evidence of sensitization | Same |
| Biocompatibility (Irritation): No evidence of irritation | No evidence of irritation | Same |
| EMC, Electrical Safety (Electrical safety): Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same |
| EMC, Electrical Safety (EMC): Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no sample size for a clinical test set or information on its provenance. The testing was non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical study was conducted that would require expert ground truth. The evaluation focused on non-clinical performance and safety based on recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study was conducted.
5. 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 Electrode, which is a physical device for drug delivery, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical study was conducted. The "ground truth" for the non-clinical tests was established by compliance with international standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, ISO 10993-23) and comparison to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not a machine learning model.
§ 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.