FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Dermadry is a Tap Water Iontophoresis device. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands, feet and underarms. Using the device in any other way than its intended purpose may be dangerous.

Device Description

The Dermadry is a tap water Iontophoresis device intended to treat hyperhidrosis of the hands, feet and underarms. It achieves its action by producing a given low level direct current (DC) level between each of the two applicable members being treated (i.e. the two feet, or the two hands, or the two underarms) for a given amount of time. The current is controlled and transmitted by a controller between two electrodes in separate water basins into which each of the hands or feet are placed, or via two electrodes within water soaked spongeous pockets that are placed in each of the underarms. It is for home use by a single patient (single patient). It is for use by prescription under the direction of a physician or clinician, and is intended for adult patients.

AI/ML Overview

The provided text is a 510(k) summary for the Dermadry Iontophoresis device. It details the device's substantial equivalence to a predicate device (Hidrex PSP1000) and describes its intended use, technology, and performance testing. However, it does not contain information related to specific acceptance criteria for clinical performance, or a study that evaluates device performance with human subjects or a specified ground truth, which would typically involve a multi-reader study or a standalone algorithm performance test.

The "Performance Data" section (Page 8) lists various engineering, electrical safety, biocompatibility, software verification/validation, and usability tests. These are largely for verifying the device's technical specifications and safety profile, not for proving clinical efficacy against specific performance metrics related to treating hyperhidrosis in a clinical trial setting.

Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and ground truth establishment are not present in this document because it is focused on establishing substantial equivalence based on technical and safety specifications rather than clinical performance outcomes against pre-defined metrics.

Here's a breakdown of what can and cannot be answered based on the provided document:

What can be extracted:

Acceptance Criteria & Performance: The document doesn't define quantitative clinical acceptance criteria for its efficacy in treating hyperhidrosis (e.g., X% reduction in sweating). Instead, it argues for substantial equivalence based on the device's technical specifications and safety performance being comparable to or better than the predicate device. The "performance" discussed relates to engineering tests rather than clinical outcomes.

Table of Acceptance Criteria and Reported Device Performance: Not applicable in the context of clinical efficacy. The document focuses on technical specifications and safety as "performance."

Criterion Type	Acceptance Criterion (Implicit/Explicit)	Reported Device Performance
Intended Use	Same as predicate (Treat hyperhidrosis of hands, feet, underarms). Prescription Use, Home Use.	Same. "Dermadry is a Tap Water Iontophoresis device. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands, feet and underarms... Prescription Use Only." (Page 4).
Patient Population	Not raise new safety/effectiveness concerns compared to predicate (unspecified population).	"Difference: For adult patients." (Page 4). Argument: "This should not raise any new questions of safety or effectiveness since this is more specific and restrictive than in the predicate." (Page 6).
Main Technology	Same as predicate (Tap water iontophoresis).	Same. "Tap water iontophoresis: Current applied between contralateral treated areas... via electrodes... in tap water... or via electrodes in sponges wetted with tap water." (Page 5).
Treatment Current/Voltage/Time	Maximums should not raise new safety/effectiveness concerns. Current levels should be effective.	Differences. Dermadry: Hands: 1-15mA max, 48V max, 20 min. Feet: 1-25mA max, 55V max, 20 min. Armpits: 1-8mA max, 30V max, 15 min. (Page 5). Argument: "current levels in the Dermadry are of the same order as those typically used in Iontophoresis device for hyperhidrosis (around 10 - 25 mA). Therefore, these differences do not raise any new questions of safety or effectiveness." (Page 6). Max energy output 1650J over 20 min vs 1890J over 15 min for predicate (Page 7).
Current/Voltage Control	Not raise new safety/effectiveness concerns.	Difference: Dermadry maintains desired current by adjusting voltage (predicate maintains voltage by adjusting current). Argument: "these differences do not raise any new questions of safety or effectiveness." (Page 6).
Max Current Density	Not raise new risk concerns, adequately effective.	Differences. Dermadry values lower (e.g., Hands: 0.10 mA/in2 vs. 0.28 mA/in2 for predicate). Argument: "These should therefore not present any new risk concerns... while still providing adequately effective current levels." (Page 7).
Output Pulsed Current	Not raise new risk concerns, within predicate's available settings or justifiable variation.	Differences. Dermadry fixed at 90% pulse width (predicate user selectable 50-100%). Argument: "Given that the Dermadry setting is within that of available settings in the predicate and that this characteristic is more related to patient comfort, it does not present any new risk concerns." (Page 7).
Polarity Reversal	Not raise new risk concerns, ideally improve safety.	Differences. Dermadry automatic reversal (predicate manual reversal). Argument: "This further ensures that the polarity will be reversed to help minimize pH changes and related effects. Therefore, this does not present any new risk concerns." (Page 7).
Hardware Output Limits	Not raise new risk concerns, ideally improved safety.	Differences. Dermadry 60V / 30mA (predicate 60V / 35mA). Argument: "Given the slightly improved safety level, this does not present any new risk concerns." (Page 7).
Electrical Safety	Per IEC 60601-1 and IEC 60601-1-2.	Tested and Compliant. (Page 8).
Biocompatibility	Per ISO 10993-1 and related FDA Guidance.	Evaluated and Compliant. (Page 8).
Software Verification/Validation	Per IEC 62304 and FDA Guidance.	Tested and Compliant. (Page 8).
Usability Performance	Per IEC 60601-1-6 & IEC 62366-1.	Tested and Compliant. (Page 8).
Home Use Safety	Per IEC 60601-1-11.	Tested and Compliant. (Page 8).

Sample Size for test set and data provenance: Not mentioned. The document focuses on demonstrating substantial equivalence through technical comparative analysis and engineering/safety tests, not clinical performance studies with a test set of patient data.
Number of experts and qualifications for ground truth: Not applicable. No clinical expert review or consensus process for establishing ground truth data is described, as no clinical performance study is detailed.
Adjudication method: Not applicable. No clinical study with expert review.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This type of study would compare human readers' performance with and without an AI assistance, which is not relevant for this type of device (an iontophoresis device, not an imaging AI diagnostic aid). There is no mention of such a study.
Standalone (algorithm-only) performance: Not applicable. This is a physical medical device for treatment, not an algorithm for diagnosis or image analysis.
Type of ground truth used: Not applicable. No clinical ground truth (e.g., pathology, outcomes data) is used to evaluate device performance in a clinical study context. The "ground truth" here is compliance with engineering standards and comparison to a predicate device's technical specifications.
Sample size for training set: Not applicable. This device is not an AI/ML algorithm that requires a training set of data.
How the ground truth for the training set was established: Not applicable, as there's no training set for this device.

In summary:

This FDA 510(k) clearance document is for a medical device (iontophoresis device) that treats hyperhidrosis. The "acceptance criteria" and "study" described in the document are primarily related to proving technical and safety equivalence to a legally marketed predicate device, rather than a clinical performance study with human subjects and a ground truth for efficacy. Therefore, detailed information about clinical study design parameters such as sample size, expert ground truth establishment, MRMC studies, or training sets for AI algorithms is not present.

Summary

Regulation Number and Section

§ 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.