(164 days)
The intended use of this tap-water iontophoresis device is to treat patients with hyperhidrosis (excessive sweating) of the palms, feet, armpits.
The medical Hidroxa SE30 is a tap water iontophoresis to treat focal hyperhidrosis to treat focal hyperhidrosis is considered state of the art and is one of the first line of treatments in many country's Clinical guidelines.
The Hidroxa SE30 iontophoresis device consists of two electrodes (Aluminium) which are connected to the main unit with one electrode cable each. The electrodes come in two different types. The small electrodes are used to treat hyperhidrosis of the armpits. The electrodes are covered by sponges pockets (cellulose), soaked in tap water and placed directly in the armain unit, one AC-adapter and two electrode cables. The large electrodes are used to treat hyperhidrosis of the palms and feet. Tap water is poured into two water bins and one large electrode is placed in each water bin. One towel (cotton) is placed over each of the electrodes to cover them. One hand/foot is then placed on each towel covered electrode. Treatment is performed by the main unit driving an electrical current through the intected treatment areas indirectly through the water in two water bins or via the electrodes in the alectrodes themselves will never be in direct contact with the skin, but instead cover the sponge pockets/towels during treatment. The main unit is powered from the wall mains using an AC adapter.
The treatment consists of two phases; 1. The initial phase consists of daily to every third day treatments (20 minutes) until desired results are seen. (Ordinary 12 treatments). When the desired results are achieved, switching to the maintenance schedule means treatments (ordinary 20 minutes) 1-3 three times per week to maintain the results.
This treatment can be done at home by the patient themselves or at a clinic with the aid of a medical professional.
The mechanism of action for tap water iontophoresis as a treatment of hyperhidrosis is not fully understood. Several hypotheses have been proposed in different medical papers. One of them is that the ions in the water form a mechanical blockage that prevents sweat from coming out of the sweat glands, resulting in less sweating. Another theory is that the treatment affects the nerve impulses connected to the sweat glands which leads to reduced activity in the glands and thus reduced or seized sweat production. Recent studies suggest that iontophoresis increases the threshold value in the nerve cells so that more stimuli is required for an action potential, a signal to the sweat gland, to arise. lontophoresis is generally considered to be a safe and effective treatment for hyperhidrosis in many cases but not a cure. Regular maintenance treatments are needed to maintain the achieved results.
The provided text is a 510(k) summary for the Hidroxa SE30 iontophoresis device. It describes the device, its intended use, and a comparison to a predicate device (Hidrex PSP1000). The document explicitly states: "N/A - no clinical tests submitted, referenced or relied on for this 510k application."
Therefore, based on the provided text, there is no study described that proves the device meets acceptance criteria related to its clinical effectiveness. The acceptance criteria and testing mentioned pertain to non-clinical aspects such as usability, firmware, longevity, materials, pH changes, and adherence to international standards.
Here's the breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or detailed reported performance values for clinical efficacy. It lists categories of non-clinical tests and states that "all requirements were deemed fulfilled."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Usability | "Extensive usability testing was conducted to ensure the device's safety and user friendliness." (Deemed fulfilled) |
| Firmware | "The firmware underwent detailed testing to confirm reliable performance, ensuring the software supports the device's operational requirements effectively." (Deemed fulfilled) |
| Longevity and Shelf Life | "Endurance testing assessed the device's long-term durability, while shelf life testing confirmed its stability over the intended storage period. The transport and storage protocols were evaluated and validated to be adequate." (Deemed fulfilled) |
| Material and Biocompatibility | "The evaluation of materials and their biocompatibility ensured all device components are safe for patient contact." (Deemed fulfilled) |
| pH Testing | "Testing of the pH changes of the water during treatment within safe levels during the whole treatment sessions during all test cycles for all test setups." (Deemed fulfilled) |
| Batch Testing | "A plan for batch testing has been established to ensure quality control in the production phase." (Deemed fulfilled) |
| External Testing (Int. Standards) | "The device's adherence to international standards was confirmed through test house, emphasizing the device's compliance with global safety and performance benchmarks." (Deemed fulfilled) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical studies were submitted or relied upon. For the non-clinical tests mentioned, specific sample sizes (e.g., number of units for longevity) and data provenance are not detailed in this summary.
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 studies were submitted or relied upon.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies were submitted or relied upon.
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 device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an iontophoresis device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical studies were submitted or relied upon. For the non-clinical tests, the "ground truth" would be the engineering specifications, safety standards, and user expectations.
8. The sample size for the training set
Not applicable, as no clinical studies or AI/algorithm training were involved.
9. How the ground truth for the training set was established
Not applicable, as no clinical studies or AI/algorithm training were involved.
In summary: The provided 510(k) summary explicitly states that no clinical tests were submitted, referenced, or relied upon for this application. The substantial equivalence determination is based on the device's similarity to a predicate device (Hidrex PSP1000) in terms of operational principles, intended use, and basic functionality, along with non-clinical testing covering safety and performance aspects like usability, firmware, longevity, materials, and adherence to international standards.
§ 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.