(164 days)
Not Found
No
The description focuses on the electrical and mechanical components of a tap water iontophoresis device and its mechanism of action, with no mention of AI or ML.
Yes.
The device is used to treat hyperhidrosis (excessive sweating), which is a medical condition, by driving an electrical current through affected areas to reduce sweat production.
No
The device is described as a treatment for hyperhidrosis, not a diagnostic tool. Its intended use is to "treat patients with hyperhidrosis" by driving an electrical current through the skin.
No
The device description clearly outlines physical components such as electrodes, electrode cables, a main unit, an AC adapter, water bins, sponges, and towels, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: This device directly treats a medical condition (hyperhidrosis) by applying an electrical current to the skin. It does not analyze any biological samples.
- Intended Use: The intended use is to treat hyperhidrosis, not to diagnose or monitor it through the analysis of biological samples.
Therefore, the Hidroxa SE30 is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of this tap-water iontophoresis device is to treat patients with hyperhidrosis (excessive sweating) of the palms, feet, armpits.
Product codes
EGJ
Device Description
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. Iontophoresis 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
palms, feet, armpits
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home by the patient themselves or at a clinic with the aid of a medical professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
N/A - no clinical tests submitted, referenced or relied om for this 510k application.
Non-Clinical Tests:
- Usability testing: Extensive usability testing was conducted to ensure the device's safety and user friendliness.
- Firmware testing: The firmware underwent detailed testing to confirm reliable performance, ensuring the software supports the device's operational requirements effectively.
- 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.
- Material and biocompatibility testing: The evaluation of materials and their biocompatibility ensured all evice components are safe for patient contact.
- 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.
- Batch testing: A plan for batch testing has been established to ensure quality control in the production phase.
- External testing at a test house: The device's adherence to international standards was confirmed through test house, emphasizing the device's compliance with global safety and performance benchmarks.
Conclusions: The Hidrox SE30 has been evaluated to ensure its safety, efficacy, and reliability through the above discussed testing regimen. All requirements have been covered by these tests/verifications and all requirements were deemed fulfilled. The width and depth of these tests/verifications confirm that the Hidroxa SE30 has been subjected to a thorough analysis, in line with necessary specifications for safety and performance and passed all these tests and evaluation coverage is deemed adequate to validate the device's conformance to the established criteria and therefore its safety, performance and effectiveness. It is deemed to be as effective, safe and perform at least as well as the predicate, the HidrexPSP1000 (K133033).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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October 11, 2024
Hidroxa Medical AB Sandra Eriksson Mirkovic, MD Hidroxa Medical AB Bjorndammsterrassen 114 Partille, 43342 Sweden
Re: K241267
Trade/Device Name: Hidroxa SE30 Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device Regulatory Class: Class II Product Code: EGJ Dated: May 6, 2024 Received: September 17, 2024
Dear Dr. Eriksson Mirkovic:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Hidroxa SE30
Indications for Use (Describe)
The intended use of this tap-water iontophoresis device is to treat patients with hyperhidrosis (excessive sweating) of the palms, feet, armpits.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
| 510(k) #: | K241267 | 510(k) Summary | Prepared on: 2024-09-17 |
|---|---|---|---|
| ----------- | --------- | ---------------- | ------------------------- |
Contact Details
| Applicant Name | Hidroxa Medical AB |
|---|---|
| Applicant Address | Bjorndammsterrassen 114 - Partille N/A 43342 Sweden |
| Applicant Contact Telephone | +46762611200 |
| Applicant Contact | Dr. Sandra Eriksson Mirkovic |
| Applicant Contact Email | kundtjanst@hidroxa.com |
Device Name
| Device Trade Name | Hidroxa SE30 |
|---|---|
| Common Name | lontophoresis device |
| Classification Name | Device, lontophoresis, Other Uses |
| Regulation Number | 890.5525 |
| Product Code(s) | EGJ |
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K133033 | Hidrex PSP1000 | EGJ |
Device Description SummaryThe 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
5
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.
Intended Use/Indications for Use
The intended use of this tap-water iontophoresis device is to treat patients with hyperhidrosis (excessive sweating) of the palms, feet, armpits.
Indications for Use Comparison
The indications for use for the Hidroxa SE30 is the predicate device, the Hidrex PSP1000: To treat hyperhidrosis (pathological sweating) affecting hands, feet, and underarms with iontophoresis.
Technological Comparison
The Hidroxa SE30 and the predicate, the Hidrex PSP1000, share similar operational principles and are intended for the same indication. Key parameters such as treatment method, intended use, and basic functionality are closely aligned between the two devices. Both are designed to deliver controlled electrical currents through water to treat focal hyperhidrosis, and they operate within a similar range of electrical outputs.
Technical differences between the Hidroxa SE30 and the predicate, the Hidrex PSP 1000, are minor and do not significantly impact the clinical outcomes or safety profile of the devices. These include minor variations in maximum current output, and user interface elements. The predicate, the Hidrer PSP 1000, offers a slightly higher maximum current output and more customizable settings, while the Hidroxa SE30 has features that simplify operation.
The comparison demonstrates that the Hidroxa SE30 is at least as safe and effective as the predicate device, the Hidrex PSP 1000, for the intended use of treating focal hyperhidrosis. The minor technical variations do not detract from the equivalence in therapeutic effect and safety profile between the two devices, supporting the the Hidroxa SE30 is substantially equivalent to the predicate device, the Hidrex PSP1000.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
These evaluations have been carried out in accordance with the relevant safety and performance standards, ensuring a detailed and methodical review of the device's functionalities and safety.
Usability testing: Extensive usability testing was conducted to ensure the device's safety and user friendliness.
Firmware testing: The firmware underwent detailed testing to confirm reliable performance, ensuring the software supports the device's operational requirements effectively.
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.
Material and biocompatibility testing: The evaluation of materials and their biocompatibility ensured all evice components are safe for patient contact.
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.
Batch testing: A plan for batch testing has been established to ensure quality control in the production phase.
External testing at a test house The device's adherence to international standards was confirmed through test house, emphasizing the device's compliance with global safety and performance benchmarks.
Through the above discussed testing regiment ing from usability to biocompatibility and batch testing, the Hidrox SE30 has been evaluated to ensure its safety, efficacy, and reliability. This testing underpins the clinical use, demonstrating a thorough and committed approach to quality and patient safety.
All requirements have been covered by these tests/verifications and all requirements were deemed fuffilled. The width and depth of these tests/verfications confirm that the Hidroxa SE30 has been subjected to a thorough analysis, in line with necessary specifications
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
6
for safety and performance and passed all these tests and evaluation coverage is deemed adequate to validate the device's conformance to the established criteria and therefore its safety, performance and effectiveness.
N/A - no clinical tests submitted, referenced or relied om for this 510k application.
The above mentioned tests/verifications of the Hidroxa SE30 has been subjected to an extensive analysis, in line with necessary specifications for safety and passed all these tests and evaluations. This testing/evaluation coverage is deemed adequate to validate the device's conformance to the established criteria and therefore its safety, performance and effectiveness. It is deemed to be as effective, safe and perform at least as well as the predicate, the HidrexPSP1000 (K133033).