(559 days)
Not Found
No
The description focuses on electrical stimulation parameters (DC and pulsed current with adjustable pulse-width) and standard device components. There is no mention of AI, ML, or any features that would suggest algorithmic learning or adaptation based on data.
Yes
The device is intended to treat a pathological condition (hyperhidrosis) and uses "therapy" modes, indicating its therapeutic purpose.
No.
The device is intended to treat hyperhidrosis (excessive sweating), not to diagnose it. It is a therapeutic device that delivers electrical current.
No
The device description explicitly lists hardware components such as a control unit, power supply/safety wall adapter, and application accessories (treatment cover towel, treatment electrode, axillary sponge cushions).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to treat hyperhidrosis (excessive sweating) by applying electrical current to the skin. This is a therapeutic treatment applied directly to the patient's body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device Description: The description details a system that delivers electrical current to the skin via electrodes and applicators. This is a physical intervention, not a diagnostic test performed on a sample.
- Anatomical Site: The device is applied to the hands, feet, and underarms – external parts of the body for treatment.
The device is a therapeutic device used for a medical condition, not a diagnostic tool.
N/A
Intended Use / Indications for Use
This Tap-Water-Iontophoresis device is intended to treat hyperhidrosis (pathological sweating) affecting hands, feet, and underarms. Any other use or usage beyond this scope is considered use and may have dangerous consequences.
Product codes
EGJ
Device Description
HIDREX iontophoresis devices are primarily intended for treating hyperhidrosis1 (excessive sweating) of hands and/or feet. Provided the optional axillary applicators are utilized, the system can also be used for treating axillary hyperhidrosis.
Control unit:
The control unit is connected with the power supply/safety wall adapter. The unit includes all connection-jackets to attach the accessories for the treatment. It includes the control-buttons to choose the therapy-mode. Dimension: 190 x 137 x 49 mm
Power supply / safety wall adapter that is connected with the control unit (secondary plug). The primary plug is connected to the AC-socket in the wall.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands, feet, underarms
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Care Setting: Not Found (but implies home use for maintenance therapy and doctor supervision for initial phase)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed:
- To demonstrate electrical safety, software-validation and performance, non-clinical tests were performed according to IEC 60601-1 Medical electrical equipment -General requirements for safety
- To demonstrate safety of the software, non-clinical validation was performed according to IEC 60601-1 Medical electrical equipment - General requirements for safety -- clause 14 Programmable electrical medical systems
- To demonstrate electromagnetic compatibility, non-clinical tests were performed according to IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
Key results: Not explicitly stated, but the conclusion states "The subject device HIDREX PSP1000 is as safe, as effective and performs more comfortable than the predicate devices."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized caduceus or a symbol representing health and medicine. The emblem features a series of lines or strokes that form a shape reminiscent of a bird or a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2015
Hidrex Gmbh % Stefanie Bankston Official Correspondent 2611 Shark Circle Texas City, TX 77591
Re:
K133033 Trade/Device Name: Hidrex PSP1000 Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device Regulatory Class: Class III Product Code: EGJ Dated: February 23, 2015 Received: February 27, 2015
Dear Ms. Bankston,
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 (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. 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Our substantially equivalent decision does not apply to the drugs that you will label or promote for use with your device. Therefore, you may neither label nor promote your device for use with
1
specific drugs, nor package drugs with your device prior to FDA having approved the drugs for iontophoretic administration. For information on the requirements for marketing new drugs, you may contact:
Director Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857
As you are aware, there are concerns relating to the fact that no drug is currently labeled for administration via an iontophoresis device. The Agency currently is evaluating this public health concern regarding the safety and effectiveness of this route of administration of drugs, and in the near future will inform manufacturers of certain additional steps the Agency believes are necessary to address this concern.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Felipe Aquel -S
- Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K133033
Device Name HIDREX PSP1000
Indications for Use (Describe)
This Tap-Water-Iontophoresis device is intended to treat hyperhidrosis (pathological sweating) affecting hands, feet, and underarms. Any other use or usage beyond this scope is considered use and may have dangerous consequences.
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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3
Image /page/3/Picture/0 description: The image shows the logo for HIDREX. The logo is in blue and orange. To the right of the HIDREX logo are three additional logos: MED, VET, and REHA.
510(k) SUMMARY
July 24, 2014
Office of Device Evaluation U.S. Food & Drug Administration
Dear Madame/Sir;
In accordance with Section 510(k) of the Federal Food & Drug and Cosmetic Act, and in conformance with 21 CFR Part 807, pre-market notification is hereby made of the intention of HIDREX GmbH to introduce into interstate commercial distribution the iontophoresis device HIDREX PSP1000.
Applicant: HIDREX GmbH Otto-Hahn-Str. 12 D-42579 Heiligenhaus Phone_: +49 (0)2056 98 11 0 Fax +49 (0)2056 98 11 31 Email: info@hidrex.de
User fee Organization Number:348050
| Contact Person: | Mr. Andreas Kaemper
Phone: +49 (0)2056 98 11 0
Email: kaemper@hidrex.de |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| US-agent: | Mrs. Stefanie D. Bankston
BEO MedConsulting Berlin GmbH
3001 Ferndale Dr
League City TX 77573
Phone: 713-483 46 17
Email: s.bankston@beoberlin.com |
Device:
- Proprietary: HIDREX PSP1000 a.
- b. Common Name: Iontophoresis device, Other uses
- Regulation description: lontophoresis device C.
- ರ. Device Class: III
- Regulation Number: 890.5525 e.
- Review Panel: Physical Medicine f.
- இ. Product Code: EGJ
Predicate Device Information:
We claim substantial equivalence for the subject device in intended use, design and function to the predicate device MD-1A (K964208) by R.A. Fischer CO. CORP and to the predicate device Drionic (K831320) by General Medical Company.
Intended Use / Indication for Use:
4
Image /page/4/Picture/0 description: The image shows the logo for HIDREX. The word "HIDREX" is written in blue, except for the "I", which is orange and has an orange circle below it. To the right of the main logo are three smaller logos, stacked vertically, with the words "MED", "VET", and "REHA" in blue and green, each preceded by a small orange graphic.
This Tap-Water-lontophoresis device is intended to treat hyperhidrosis (pathological sweating) affecting hands, feet and underarms.
Any other use or usage bevond this scope is considered un-intended use and may have dangerous consequences.
Scientific Concept:
lontophoresis is a physical process in which ions flow diffusively in a medium driven by an electric field. Iontophoresis is to be distinguished from the carriage of uncharged molecules by diffusive fluxes of other molecules, especially of solvent molecules.
ln the treatment of hyperhidrosis, tap water is often the chosen solution for mild and medium forms.
Since 1968, tap water iontophoresis has been employed as the method of choice for treating palmoplantar hyperhidrosis. Special electrodes also allow treatment of axillary hyperhidrosis. Tap water iontophoresis also can extend symptom -free intervals in dyshidrotic palmar eczema. The mechanism action is most likely a functional disturbance of the secretory mechanism of eccrine acini. During the induction phase, treatments are carried out once daily. Current direction may be switched before each treatment or, even better, kept constant until one side, preferably the dominant hand on the anode, is sweating normally. Then polarity is switched until both hands are adequately treated. During the weekly maintenance therapy, current direction is switched before each treatment. The most comfortable means of iontophoretic treatment employs pulsed direct current of high frequency (5-10 kHz) which is better tolerated than continuous direct current. Side effects are minimal and transient. Only slight skin irritation or sensations of discomfort may occur during treatment. Electric burns and shocks can be avoided by following routine precautions. Contraindications for tap water iontophoresis are metallic implants, such as cardiac pacemakers, or orthopaedic joint or bone implants, if they are within the electric circuit.
Device Description:
HIDREX iontophoresis devices are primarily intended for treating hyperhidrosis1 (excessive sweating) of hands and/or feet. Provided the optional axillary applicators are utilized, the system can also be used for treating axillary hyperhidrosis.
| Control unit:
The control unit is connected with the
power supply/safety wall adapter. The
unit includes all connection-jackets to
attach the accessories for the
treatment. It includes the control-
buttons to choose the therapy-mode.
| Dimension: 190 x 137 x 49 mm | Image: Control unit |
|---|---|
| Power supply / safety wall adapter | |
| that is connected with the control unit | |
| (secondary plug). The primary plug is | |
| connected to the AC-socket in the | |
| wall. | Image: Power supply |
5
Image /page/5/Picture/0 description: The image shows the logo for HIDREX, a company that specializes in medical, veterinary, and rehabilitation equipment. The logo is composed of the word "HIDREX" in blue, with the "I" in orange and a circle below it. To the right of the main logo are the words "MED", "VET", and "REHA", each with a small orange graphic to the left.
6
Image /page/6/Picture/0 description: The image shows the logo for HIDREX. The logo is split into two parts. The first part shows the word "HIDREX" in blue, except for the "I", which is orange and has an orange dot below it. The second part shows three words stacked on top of each other: "MED", "VET", and "REHA", each preceded by an orange crescent shape with a small circle inside. The words "MED" and "REHA" are in blue, while "VET" is in green.
Image /page/6/Figure/1 description: The image shows two medical devices for hand and feet treatment. The first device is a treatment cover towel, which is an applicator for hand and feet treatment. The towel covers the treatment electrodes and has to be watered with tap water before the treatment starts, and its dimensions are 8.1" x 12.2". The second device is a treatment electrode, which is an accessory for hand and feet treatment, and its dimensions are 4.5" x 11.2 x 2.4".
Control unit
Image /page/6/Figure/3 description: The image shows two diagrams of a device with labels. The first diagram shows the side of the device with the therapy system's main ON/OFF switch labeled as '1'. The second diagram shows the back of the device with a 12V DC connector labeled as '3' and jacks for connecting the dual connecting cable set labeled as '2'.
7
Image /page/7/Picture/0 description: The image shows the logo for HIDREX, which is written in blue with an orange exclamation point. To the right of the logo are three smaller logos, MED, VET, and REHA. Each of these logos has an orange semi-circle with a small circle above the letters, which are blue for MED and REHA, and green for VET.
Image /page/7/Figure/1 description: The image shows a control panel for a device labeled HIDREX PSP1000 MED. The panel features a main display, several LED indicators for user settings, amperes, pulsed current, and dive mode. There are also buttons for adjusting time and dose, with labels indicating '+' and '-' functions for each. The panel's layout includes indicators and buttons arranged in a user-friendly manner.
| 1 Display | Main Display to show therapeutic settings |
|---|---|
| 2 Button | Adjustment to lower the dose |
| 3 Button | Adjustment to raise the dose |
| 4 Button | Adjustment to decrease the therapeutic time-span |
| 5 Button | Adjustment to increase the therapeutic time-span |
| 6 LED-Indicator | 3 Indicators to show user settings / application mode |
| 7 LED Indicator | 1 Indicator to show therapeutic mode activated: current |
| 8 LED Indicator | 1 Indicator to show therapeutic mode activated: pulsed current |
| 9 LED Indicator | 1 Indicator to show 'ready for treatment' (electric circuit closed) |
Current Density of Applicators and Electrodes
| Applicator | Conductive
Area
[sqin] | Max.Density
at 30mA
[mA/sqin] | PeakDensity
at 35mA
[mA/sqin] |
|--------------------------------------------------------|------------------------------|-------------------------------------|-------------------------------------|
| Hand-Feet, Hard Shell Case
individual Water Surface | 112.13 | 0.26 | 0.31 |
| Hand-Feet, Ergonomic Tray
individual Water Surface | 90.88 | 0.33 | 0.38 |
| Hand-Feet, individual Electrode | 122.13 | 0.24 | 0.28 |
| Hand-Feet, individual Cover Towel | 98.8 | 0.30 | 0.35 |
| Axillary, Sponge Cushions | 36.75 | 0.81 | 0.95 |
| Axillary, individual Electrode | 8.25 | 3.63 | 4.24 |
8
Image /page/8/Picture/0 description: The image shows the logo for HIDREX, with the "I" in HIDREX replaced by an orange exclamation point. To the right of the HIDREX logo are three additional logos, stacked vertically. The top logo is MED, the middle logo is VET, and the bottom logo is REHA. Each of these logos has an orange semi-circle to the left of the text.
Function:
The HIDREX treatment concept comprises two treatment phases:
Phase 1: The initial phase (therapy initiation) is conducted under a doctor's supervision with the doctor's or the patient's device. During this stage, patients learn to administer treatments. For therapy initiation, three weekly treatments of approximately 15 minutes each should be scheduled (not more than one treatment per day). Sweat secretion will normalize after approximately 10 treatments.
Phase 2: Long term treatment (maintenance therapy) is necessary because the HIDREX treatment effect is reversible. Patients should conduct maintenance therapy sessions by themselves at home and with their own unit. Depending on the severity of the condition, maintenance therapy involves one to three weekly sessions of approximately 15 minutes each.
The Hidrex PSP1000 with changeable pulse-width allows the innovative adjustment of the pulse-intensity.
Extensive trials showed that the efficiency of pulsed current could be increased dramatically. The effectiveness is not reduced at all compared to direct current when the pulse-width is 90%. The possible pulse-widths are 50%, 60%,70%, 80%, 90% and 100%
Application:
Image /page/8/Picture/8 description: The image shows two different scenarios of iontophoresis treatment. In the first scenario, a person is placing their feet on two orange pads that are connected to a blue device with wires. The device displays the number 15.30. In the second scenario, a person is placing their hands on the same type of pads, which are also connected to the same blue device.
feet
hands
Performance data:
| DC current output
(automatically
regulated) | max. 60 V
max. 35 mA |
|----------------------------------------------------------|------------------------------------|
| Pulsed current
output
(automatically
regulated) | max. 60 V
max. 35 mA
9.9 kHz |
9
Image /page/9/Picture/0 description: The image shows the logo for HIDREX, with the "I" in HIDREX being an orange exclamation point. To the right of the HIDREX logo are three additional logos. The first is MED, the second is VET, and the third is REHA. Each of these logos has an orange semi-circle to the left of the text.
Comparison to legally marketed device MD-1A (K964208) by R.A. Fischer CO. CORP (Substantial Equivalence):
| The Chart below summarizes the similarities and differences: | ||
|---|---|---|
| DEVICE | ||
| HIDREX PSP1000 | SE-DEVICE | |
| MD-1A (K964208) | ||
| Indication for use | This Tap-Water-lontophoresis | |
| device is intended to treat | ||
| hyperhidrosis (pathological | ||
| sweating) affecting hands, feet and | ||
| underarms. | The MD-1a / MD-2 Galvanic units | |
| are indicated for use in the treatment | ||
| of palmar or plantar hyperhidrosis | ||
| (abnormal sweating not related to | ||
| exercise or resulting from another | ||
| underlying condition) using the | ||
| technique of tapwater iontophoresis. | ||
| Performance | ||
| DC current output | max. 60 V | |
| max. 35 mA | data not available | |
| 0-10 and 0-50 mA | ||
| Pulsed current | ||
| output | max. 60 V | |
| max. 35 mA | ||
| 9.9 kHz | ||
| 5 output modes (pulse-width: | ||
| 50%, 60%, 70%, 80% and 90%) | -- | |
| Polarity reversal (to | ||
| alternate POS and | ||
| NEG application) | manual | manual |
| Automatic current | ||
| regulation | Yes | Only over-current protection |
| Timer | Yes | -- |
| Display | LCD-multi character display to | |
| display all session settings | -- | |
| Microprocessor | ||
| controlled with built- | ||
| in self-test | Yes | -- |
| Controls | ||
| Meter | digital Monitor | analog meter |
| Intensity | soft sensor buttons | analog switch/knob |
| Output Jacks | 6mm insulated connectors | 6mm insulated connectors |
| Application-accessory | ||
| Feet | plastic case with towel inside | plastic tray / case with towel inside |
| Hands | plastic tray / case with towel inside | plastic tray / case with towel inside |
| Axillary applicators | Pads | -- |
| Dimensions | ||
| Control unit | 7,5" (W) x 2" (H) 5,4" (D) | |
| Approximately 1 lb | 10" (W) x 4" (H) 12" (D) | |
| Approximately 5 lb | ||
| Hard-shell-case | 13.4" x10.8" x 3.3" | data not available |
| Treatment tray | 10.2" x 15.75" x 2.2" | data not available |
| Axillary sponge | ||
| cushions | 2.9" x 3.45" x 1.3" | data not available |
| Towel | 8.1" x 12.2" | data not available |
| Electrodes (feet, | ||
| hands) | 4.5" x 11.2" x 2.4" | data not available |
| Electrodes | ||
| (underarms) | 1.9" x 2.17" x 0.6" | data not available |
| Conductive area [sqin] |
rizes the similarities and diffe e Chart belo
10
| HIDREX | MED |
|---|---|
| VET | |
| REHA |
| Hard shell Case | 112.13 | data not available |
|---|---|---|
| Treatment tray | 90.88 | data not available |
| Towel | 98.8 | data not available |
| Sponge Cushion | 36.75 | data not available |
| Electrode (feet, hands) | 122.13 | data not available |
| Electrode (underarms) | 8.25 | data not available |
| Density at 30mA | ||
| [mA/sqin] | ||
| Hard shell Case | 0.26 | data not available |
| Treatment tray | 0.33 | data not available |
| Towel | 0.30 | data not available |
| Sponge Cushion | 0.81 | data not available |
| Electrode (feet, hands) | 0.24 | data not available |
| Electrode (underarms) | 3.63 | data not available |
| Stimulating device | ||
| Signal type | Monophasis square, at DC: pulsed square signal, selectable in increments of 10 from 50% to 100% | data not available |
| Leakage current Type BF | Patient leakage current AC: | |
| +000.9 μΑ | ||
| Patient leakage current AC SFC: | ||
| +000.4 μΑ | ||
| Patient leakage current DC: | ||
| +000.0 μΑ | ||
| Patient leakage current NAT: | ||
| +004.2 μΑ | data not available | |
| Energy output to patient | treatment time: 10 Minutes | |
| W = 9,8 V * 0,0008 A * 600 s = | ||
| 4,704 Ws | ||
| treatment time: 15 Minutes | ||
| W = 9,8 V * 0,0008 A * 900 s = | ||
| 7,056 Ws | ||
| 1 min => 0,47 Ws = 0,47 J | data not available | |
| Power supply | ||
| external | internal | |
| 100-240 V~ / 50-60 Hz | 100-240 V~ / 50-60 Hz | |
| Input | 400mA | data not available |
| 12 V= | -- | |
| output | max. 500mA | -- |
| 6 VA | -- | |
| Certification | ||
| CE | YES | NO |
| Standards | IEC 60601-1:2007 | ? |
| GMP | Yes | Yes |
Difference's Analysis
These technical differences were identified:
| Subject device (sd) | Predicate device (pd) | ||
|---|---|---|---|
| 1. | DC-current output max. 35mA | DC-current output 0-10 and 0-50mA | |
| The pd has two output ranges because it uses an analog Ampere-meter. It is very | |||
| likely to make reading-mistakes using a wide-range-scale while operating in a low- | |||
| current mode. Therefore, the manufacturer suggests to use the low-range-scale (0- | |||
| 10mA), while using the device in the low-current-mode. However, it is still likely to | |||
| make mistakes. | |||
| The sd has a display that shows digital digits. No matter what the current-mode is, it | |||
| is unlikely to make reading-mistakes. Therefore there is no need to have separated | |||
| scale-ranges. | |||
| 2. | DC and pulsed-current output | Only DC-current output | |
| A pulse-width of 100% (no pause) is corresponding to the classical DC method. | |||
| However, pulse-width-method makes the sensation for the user more present because of | |||
| the physiological 10kHz frequency. The pulsed current output modes are more sensitive. | |||
| So the risk of skin-irritation is reduced. | |||
| 3. | Automatic current regulation and over- | ||
| current protection | Over-current protection | ||
| The pd, due to its basic concept with analog technology, has a manual current | |||
| adjustment. The patient/user has to read continuously the analog meter to stay with | |||
| the appreciated settings. | |||
| The sd has a microprocessor that is able to watch physical conditions. The sd can | |||
| automatically adjust the current and keep the therapeutic settings based on the | |||
| patient's settings. Physical changes caused by the patient, like position or | |||
| movements, can automatically be compensated. | |||
| 4. | Timer | ||
| The pd has no timer. The patient has to measure and check the time span for the | |||
| treatment-session by himself. | |||
| The sd has a timer that automatically starts the countdown when the treatment | |||
| starts. The patient's benefit is the automatic ending of the treatment session. The risk | |||
| for an overdose is reduced. | |||
| 5. | Display | Analog meter | |
| The pd has an analog Ampere-meter. It is very likely to make reading-mistakes using | |||
| a wide-range-scale while operating in a low-current mode. It is also necessary to | |||
| have god visibility to be able to read the relatively small numbers on the meter. | |||
| Reading mistakes are likely. | |||
| The sd has a display with big digital digits. The display shows the setting as well as | |||
| the current. The possibility to make reading mistakes is unlikely. | |||
| 6. | microprocessor | Analog technology | |
| The pd operates based on analog technology. | |||
| The sd operates based on digital technology. The advantage is to be able to check | |||
| and control the treatment-parameter during the session, to reduce the weight of the | |||
| device and offer more adjustment for treatment-parameter. | |||
| 7. | Digital Monitor | Analog meter | |
| The pd has an analog Ampere-meter. It is very likely to make reading-mistakes using | |||
| a wide-range-scale while operating in a low-current mode. It is also necessary to | |||
| have god visibility to be able to read the relatively small numbers on the meter. | |||
| Reading mistakes are likely. | |||
| The sd has a display with big digital digits. The display shows the setting as well as | |||
| the current. The possibility to make reading mistakes is unlikely. | |||
| 8. | Soft sensor buttons | Analog switch/knob | |
| Analog switches and knobs are subject to corrosion. It is likely that their precision | |||
| and even functionality is reduced after a few years of use. | |||
| The sd has foil-insulated micro-switches. They last much longer and it is unlikely that | |||
| they loose their functionality at all. | |||
| 9. | Application accessory axillary-sponge | No axillary-sponge | |
| Some patients suffer also from axillary hyperhidrosis. To offer effective treatment | |||
| also for these patients the sd has specialized accessory. | |||
| 10. | External power supply | Internal Power supply | |
| The pd has an internal power supply while the sd has an external power supply. | |||
| There are no significant differences concerning safety or comfort. A break in the | |||
| power supply can be fixed more easily with an external one. |
11
Image /page/11/Picture/0 description: The image shows the logo for HIDREX, which is written in blue with an orange exclamation point. To the right of the HIDREX logo are three other logos stacked on top of each other. The top logo is MED, the middle logo is VET, and the bottom logo is REHA. The text for each of these logos is in a different color, and each logo has an orange graphic to the left of the text.
12
Image /page/12/Picture/0 description: The image shows the logo for HIDREX, with the "I" in HIDREX replaced by an orange exclamation point. To the right of the HIDREX logo are three additional logos, stacked vertically. The top logo is MED, the middle logo is VET, and the bottom logo is REHA. Each of these logos also has an orange graphic to the left of the text.
The above mentioned differences between the subject device and the predicate device are due to technological progress. The subject device and its modern technology increase the comfort and benefit for the patient in using the device. Misuse or misunderstanding by using an analog meter is impossible with the clear digital-display of the subject device. All settings are protocolled and displayed in the display. This avoids mistakes in the user-setting. The additional benefit of the pulsed-current is demonstrated in several clinical trials. The safety of the device was demonstrated in non-clinical tests according to recognized standards.
Comparison between materials and principles of use
The HIDREX PSP1000 as well as the predicate device MD-1A GALVANIC UNIT by R.A. Fischer Co. (K964208) use a standard housing made from ABS-Plastic. This housing material is non-toxic and used with many other devices. The same is true for the trays/cases that are used to apply the therapy. None of these materials is in direct contact with the skin for medical purpose. Both devices, the subject device as well as the predicate device, use standard-household-towels that are in direct contact with the patients skin.
The system components are the same. Both systems consist of a central-unit and application components. The subject device has in addition to the foot- and hand-applicator also an axillary applicator. Therefore the subject device offers more benefit to the user than the predicate device.
The principles of use are basically the same. The subject device uses a modern technology like LCD-display to display the setting etc., micro-buttons to adjust and digital controlled processes, while the predicate device has analog technology, like an analog meter to display the current, analog resistor-knob for adjustments and no digital control. Therefore the subject device offers higher comfort and control and advanced usability.
The performance of the subject device and the predicate device are similar concerning the standard dc-current-therapy. The subject device offers a pulsed current in addition, which makes the sensation for the user more present because of the physiological 10kHz frequency.
13
Image /page/13/Picture/0 description: The image shows the logo for HIDREX, which is written in blue letters except for the "I" which is orange. To the right of the logo are three other logos, MED, VET, and REHA. Each of these logos has a small orange circle to the left of the word, and the words are written in blue except for VET which is green.
In conclusion the differences between the subject device and the predicate device don't lead to any harm of the patient or third persons. Comfort and usability is increased with the subject device compared to the predicate device.
Comparison to legally marketed device Drionic (K831320) by General Medical Company (Substantial Equivalence):
| LILA ATIALL RAINIL ARIIIIIIMIILAA FITA AIIIIIIIIIIIIIIIIII AILAANI | |||||
|---|---|---|---|---|---|
| DEVICE | |||||
| HIDREX PSP1000 | SE-DEVICE | ||||
| Drionic (K831320) | |||||
| Indication for use | This Tap-Water-lontophoresis | The Drionic device is indicated for | |||
| device is intended to treat | use in the treatment of hyperhidrosis | ||||
| hyperhidrosis (pathological | (abnormal sweating) affecting | ||||
| sweating) affecting hands, feet and | hands, feet and underarms. It uses | ||||
| underarms. | the technique of tap water | ||||
| iontophoresis. | |||||
| Performance | |||||
| max. 60 V | hand or feet treatment: 9V | ||||
| underarm treatment: 18V | |||||
| DC current output | |||||
| max. 35 mA | hand or feet treatment: 6-14mA | ||||
| underarm treatment: 1-2,5mA | |||||
| max. 60 V | -- | ||||
| Pulsed current | max. 35 mA | -- | |||
| output | 9.9 kHz | -- | |||
| 5 output modes (pulse-width: 50%, | -- | ||||
| 60%, 70%, 80% and 90%) | |||||
| Polarity reversal | |||||
| (to alternate POS | manual | No | |||
| and NEG | |||||
| application) | |||||
| Automatic current | |||||
| regulation | Yes | No | |||
| Timer | Yes | No | |||
| Display | LCD-multi character display to | No | |||
| display all session settings | |||||
| Microprocessor | |||||
| controlled with | Yes | No | |||
| built-in self-test | |||||
| Controls | |||||
| Meter | digital Monitor | No | |||
| Intensity | soft sensor buttons | analog control wheel | |||
| Output Jacks | 6mm insulated connectors | No | |||
| Application- | |||||
| accessory | |||||
| Feet | plastic tray / case with towel inside | data not available | |||
| Hands | plastic tray / case with towel inside | data not available | |||
| Axillary applicators | Pads | data not available | |||
| Dimensions | |||||
| size | Control unit: | hand or feet unit: | |||
| 7,5" (W) x 2" (H) 5,4" (D) | 11,6" (W) x 2,2" (H) 4,9" (D) | ||||
| underarm unit: | |||||
| 4,4" (W) x 0,6" (H) 4,3" (D) | |||||
| weight | Approximately 1 Ib | 0,825 lb or 0,374 lb | |||
| Hard-shell-case | 13.4" x10.8" x 3.3" | data not available |
The Chart below summarizes the similarities and differences:
14
Image /page/14/Picture/0 description: The image shows the logos for HIDREX, MED, VET, and REHA. The HIDREX logo is in blue and orange, with the "I" in HIDREX being orange and having a circle below it. The MED logo is in blue and orange, the VET logo is in green and orange, and the REHA logo is in blue and orange.
| Treatment tray | 10.2" x 15.75" x 2.2" | data not available |
|---|---|---|
| Axillary sponge | ||
| cushions | 2.9" x 3.45" x 1.3" | data not available |
| Towel | 8.1" x 12.2" | data not available |
| Electrodes (feet, | ||
| hands) | 4.5" x 11.2" x 2.4" | data not available |
| Electrodes | ||
| (underarms) | 1.9" x 2.17" x 0.6" | data not available |
| Conductive area | ||
| [sqin] | ||
| Hard shell Case | 112.13 | data not available |
| Treatment tray | 90.88 | data not available |
| Towel | 98.8 | data not available |
| Sponge Cushion | 36.75 | data not available |
| Electrode (feet, | ||
| hands) | 122.13 | data not available |
| Electrode | ||
| (underarms) | 8.25 | data not available |
| Density at 30mA | ||
| [mA/sqin] | ||
| Hard shell Case | 0.26 | data not available |
| Treatment tray | 0.33 | data not available |
| Towel | 0.30 | data not available |
| Sponge Cushion | 0.81 | data not available |
| Electrode (feet, | ||
| hands) | 0.24 | data not available |
| Electrode | ||
| (underarms) | 3.63 | data not available |
| Stimulating device | ||
| Signal type | Monophasis square, at DC: pulsed | |
| square signal, selectable in | ||
| increments of 10 from 50% to 100% | data not available | |
| Leakage current | ||
| Type BF | Patient leakage current AC: +000.9 | |
| μΑ | ||
| Patient leakage current AC SFC: | ||
| +000.4 µA | ||
| Patient leakage current DC: +000.0 | ||
| μΑ | ||
| Patient leakage current NAT: +004.2 | ||
| μΑ | data not available | |
| Energy output to | ||
| patient | treatment time: 10 Minutes | |
| W = 9,8 V * 0,0008 A * 600 s = | ||
| 4,704 Ws | ||
| treatment time: 15 Minutes | ||
| W = 9,8 V * 0,0008 A * 900 s = | ||
| 7,056 Ws | ||
| 1 min => 0,47 Ws = 0,47 J | data not available | |
| Power supply | ||
| external | ||
| 100-240 V~/50-60 Hz | internal | |
| Input | hand or feet treatment: 9V | |
| underarm treatment: 18V | ||
| 400mA | data not available | |
| output | hand or feet treatment: 9V | |
| underarm treatment: 18V | ||
| max. 500mA | -- | |
| 6 VA | -- | |
| Certification | ||
| CE | YES | NO |
| Standards | IEC 60601-1:2007 | No Standards |
| GMP | Yes | data not available |
15
Image /page/15/Picture/0 description: The image shows the logo for HIDREX, with the "I" in HIDREX being an orange exclamation point. To the right of the HIDREX logo are three smaller logos, MED, VET, and REHA. Each of these logos has an orange semi-circle with a small circle inside of it to the left of the text.
Comparison between principles of use
The HIDREX PSP1000 has nearly the same system components as the predicate device Drionic by General Medical Company (K831320). Both systems consist of a unit for hand and foot treatment and an application component for underarm treatment.
The principles of use are basically the same. The subject device uses a modern technology like LCD-display to display the setting etc., micro-buttons to adjust and digital controlled processes, while the predicate device has old technology like an analog control wheel to adjust the intensity, a light to display the operating state and no digital control. Therefore the subject device offers higher comfort and control and an advanced usability.
The performance of the subject device and the predicate device are the same concerning the standard dc-current-therapy. In addition the subject device offers a pulsed current which makes the sensation for the user more present because of the physiological 10kHz frequency.
Difference's Analysis
These technical differences were identified:
| Subject device (sd) | Predicate device (pd) | |
|---|---|---|
| 1. | DC-current output max. 35mA | |
| The pd has two output ranges because it has no Ampere-meter. | ||
| The sd has a display that shows digital digits. No matter what the current-mode is, it | ||
| is unlikely to make reading-mistakes. Therefore there is no need to have separated | ||
| scale-ranges. | DC-current output 6-14mA and 1-2,5mA | |
| 2. | DC and pulsed-current output | |
| A pulse-width of 100% (no pause) is corresponding to the classical DC method. | ||
| However, pulse-width-method makes the sensation for the user more present because of | ||
| the physiological 10kHz frequency. . The pulsed current output modes are more | ||
| sensitive. So the risk of skin-irritation is reduced. | Only DC-current output | |
| 3. | Polarity reversal (to alternate POS and | |
| NEG application) | ||
| The pd has no possibility to change the polarity. | ||
| The sd provides a manual adjustable reversible polarity. The user is able to change | ||
| between positive and negative application. | -- | |
| 4. | Automatic current regulation and over- | |
| current protection | ||
| The pd has a manual adjustment. The patient/user has to advance the control wheel | ||
| until there is a comfortable tingle. During the treatment-session the patient/ user is | ||
| responsible for the intensity by himself without any technical help. | No automatic regulation or protection |
16
Image /page/16/Picture/0 description: The image shows the logo for HIDREX, with the "I" in HIDREX being an orange exclamation point. To the right of the HIDREX logo are three other logos, MED, VET, and REHA. Each of these logos has an orange semi-circle to the left of the text.
| | The sd has a microprocessor that is able to watch physical conditions. The sd can
automatically adjust the current and keep the therapeutic settings based on the
patient's settings. Physical changes caused by the patient, like position or | | | |
|-----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--|--|
| | movements, can automatically be compensated. This reduces the risk of a harmful
high intensity. | | | |
| 5. | Timer | | | |
| | The pd has no timer. The patient has to measure and check the time span for the | | | |
| | treatment-session by himself. | | | |
| | | | | |
| | The sd has a timer that automatically starts the countdown when the treatment | | | |
| | starts. The patient's benefit is the automatic ending of the treatment session. The risk | | | |
| | for an overdose is reduced. | | | |
| | | | | |
| 6. | Display | | | |
| | The pd has no display or any other possibility to check setting and current. | | | |
| | | | | |
| | The sd has a display with big digital digits. The display shows the setting as well as | | | |
| | the current. The possibility to make reading mistakes is unlikely. | | | |
| | | | | |
| 7. | Microprocessor | Analog technology | | |
| | The pd operates based on analog technology. | | | |
| | | | | |
| | The sd operates based on digital technology. The advantage is to be able to check | | | |
| | and control the treatment-parameter during the session, to reduce the weight of the | | | |
| | device and offer more adjustment for treatment-parameter. | | | |
| | | | | |
| 8. | Digital Monitor | | | |
| | The pd has no digital monitor. | | | |
| | | | | |
| | The sd has a display with big digital digits. The display shows the setting as well as | | | |
| | the current. The possibility to make reading mistakes is unlikely. | | | |
| | | | | |
| 9. | Soft sensor buttons | Analog switch/knob | | |
| | Analog switches and knobs are subject to corrosion. It is likely that their precision | | | |
| | and even functionality is reduced after a few years of use. | | | |
| | The sd has foil-insulated micro-switches. They last much longer and it is unlikely that | | | |
| | they loose their functionality at all. | | | |
| | | | | |
| | | | | |
| 10. | External power supply | Internal Power supply | | |
| | The pd has an internal power supply while the sd has an external power supply. | | | |
| | There are no significant differences concerning safety or comfort. A break in the | | | |
| | power supply can be fixed more easily with an external one. | | | |
The above mentioned differences between the subject device and the predicate device are due to technological progress. The subject device and its modern technology increases the comfort and benefit for the patient in using the device. Because of the automatic current regulation and protection the risk of a harmful high intensity and of an overdose is reduced. All settings are protocolled and displayed in the display. This avoids mistakes in the user-setting. The additional benefit of the pulsed-current is demonstrated in several clinical trials. The attached trial is an explanation as to why the higher levels of voltage and current do not affect safety and effectiveness of the subject device. Furthermore, the safety of the device was demonstrated in non-clinical tests according to recognized standards.
17
Image /page/17/Picture/0 description: The image shows the logo for HIDREX, with the "I" in HIDREX replaced by an orange exclamation point. To the right of the HIDREX logo are three additional logos, each with an orange circle and a word in blue or green. The words are MED, VET, and REHA.
In conclusion the differences between the subject device and the predicate device don't lead to any harm of the patient or third persons. Comfort and usability is increased with the subject device compared to the predicate device.
Non-clinical tests:
To demonstrate substantial equivalence we performed non-clinical tests according recognized standards:
- To demonstrate electrical safety, software-validation and performance, non-clinical . tests were performed according to IEC 60601-1 Medical electrical equipment -General requirements for safety
- To demonstrate safety of the software, non-clinical validation was performed . according to IEC 60601-1 Medical electrical equipment - General requirements for safety -- clause 14 Programmable electrical medical systems
- . To demonstrate electromagnetic compatibility, non-clinical tests were performed according to IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
Quality Assurance and Manufacturing Controls:
HIDREX GmbH operates to an established and certified quality management system according to ISO 13485 requirements.
Conclusion:
The subject device HIDREX PSP1000 is as safe, as effective and performs more comfortable than the predicate devices.