(141 days)
None
No
The description focuses on the electrical and mechanical aspects of the device for iontophoresis and explicitly states "Not Found" for mentions of AI, DNN, or ML, and descriptions of training/test sets.
Yes
The device description explicitly states, "The Saalio® unit is a therapeutic device for the treatment of primary focal hyperhidrosis."
No
Explanation: The device is described as a "therapeutic device for the treatment of primary focal hyperhidrosis," indicating its purpose is to treat a condition, not diagnose one.
No
The device description clearly outlines hardware components including a control device, external power supply, cables, electrodes, trays, and sponge pads, which are integral to its function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a therapeutic device that uses tap water iontophoresis to treat hyperhidrosis by applying an electric current directly to the body parts (hands, feet, underarms). It does not analyze any samples taken from the body.
- Intended Use: The intended use is to treat a condition (hyperhidrosis) by applying a physical therapy method, not to diagnose or monitor a condition through the analysis of biological samples.
Therefore, based on the provided information, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Tap water iontophoresis device 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
The Saalio® unit is a therapeutic device for the treatment of primary focal hyperhidrosis, i.e. excessive sweating of defined body parts. The control device is powered by an external power supply and connected to two electrodes by means of two single cables. The electrodes are brought in contact with the body parts to be treated via a conductive water passage, thus closing the electric circuit. The control device conducts direct current or pulsed direct current) through the body parts.
Depending on the body part to be treated, different electrodes are used. For the treatment of hands and feet, two generous sized silicone electrodes are placed into two travs filled with tap water. The electrodes are covered with foam inserts so as to prevent the body parts to be treated making direct contact with the electrodes. For the treatment of armpits, two smaller silicone electrodes are inserted into sponge pads which have been saturated with tap water. These are then tucked under the armpits for the duration of the treatment. It must be insured that the sponge material is always sufficiently saturated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands, feet, and underarms
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 according to recognized standards to demonstrate electrical safety, electromagnetic compatibility, safety in Home Healthcare Environment, and biocompatibility.
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
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.
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October 18, 2019
Saalmann Medical GmbH & Co. KG % Michael Vent Official Correspondent BEO MedConsulting Berlin GmbH Helmholtzstr. 2 Berlin, DE 10587
Re: K191436
Trade/Device Name: Saalio® Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device Regulatory Class: Class II Product Code: EGJ Dated: September 16, 2019 Received: September 19, 2019
Dear Michael Vent:
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. 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 located 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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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).
Sincerely.
For Vivek Pinto, PhD Division Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191436
Device Name Saalio®
Indications for Use (Describe)
Tap water iontophoresis device 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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K191436
510(k) SUMMARY
October 17, 2019
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 Saalmann® medical GmbH & Co. KG to introduce into interstate commercial distribution the iontophoresis device Saalio®.
Applicant:
Saalmann® medical GmbH & Co. KG Südbahnstraße 34 32547 Bad Oeynhausen Germany Phone: +49 (0)5731 25450 0 Fax +49 (0)5731 25450 11 Email: info@saalmann-medical.de www.saalmann-medical.de
FDA User Fee Organization Number: 492636
Contact Person: Dr. Rolf Eilers Phone: +49 (0)5731 25450 0 Email: info@saalmann-medical.de
Device:
Proprietary: Saalio® a.
- b. Common Name: Iontophoresis device, Other uses
- Regulation description: Iontophoresis device C.
- d. Device Class: II
- Requlation Number: 890.5525 e.
- Review Panel: Physical Medicine f.
- Product Code: EGJ g.
Predicate Device Information
We claim substantial equivalence for the subject device in intended use, design and function to the predicate device HIDREX PSP1000 manufactured by HIDREX GmbH (K133033).
Intended Use / Indication for Use
Tap water iontophoresis device 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.
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Image /page/4/Picture/0 description: The image shows the word "SAALMANN" in red font. The word is written in all capital letters. There is a registered trademark symbol to the right of the word.
Device Description:
The Saalio® unit is a therapeutic device for the treatment of primary focal hyperhidrosis, i.e. excessive sweating of defined body parts. The control device is powered by an external power supply and connected to two electrodes by means of two single cables. The electrodes are brought in contact with the body parts to be treated via a conductive water passage, thus closing the electric circuit. The control device conducts direct current or pulsed direct current) through the body parts.
Depending on the body part to be treated, different electrodes are used. For the treatment of hands and feet, two generous sized silicone electrodes are placed into two travs filled with tap water. The electrodes are covered with foam inserts so as to prevent the body parts to be treated making direct contact with the electrodes. For the treatment of armpits, two smaller silicone electrodes are inserted into sponge pads which have been saturated with tap water. These are then tucked under the armpits for the duration of the treatment. It must be insured that the sponge material is always sufficiently saturated.
Image /page/4/Figure/4 description: The image shows the Saallo device and its accessories for treating hands, feet, and armpits. The device allows users to adjust treatment parameters such as current setting in mA, duration of treatment in minutes, current type (direct or pulsed), and direction of current. The size of the device is 4.7" (W) x 2.5" (H) x 5.9" (D). The set for hands and feet includes 1 control device, 2 treatment trays, 2 silicone tray electrodes, 2 foam inserts, 2 electrode cables, 1 power supply, 1 operating instructions, and 1 textile bag, with a tray size of 11.1" x 15.4" x 2.2", while the set for armpits includes 1 control device, 1 pair of underarm electrodes with sponge pads, 2 electrode cables, 1 power supply, 1 operating instructions, and 1 textile bag.
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Performance data:
| DC current output | max. 58 V | |
|---|---|---|
| max. 30 mA | ||
| Pulsed current output | max. 58 V | |
| max. 30 mA | ||
| 10 kHz | ||
| 1 output mode (pulse-width: 50%) | ||
| Signal type | Monophasic square, at DC: fixed pulsed square signal | Monophasic square, at DC: pulsed square signal |
| Polarity reversal | manual | |
| Output regulation | Automatic current regulation | |
| Timer | Yes | |
| Display | LCD graphics display with LED backlight | |
| Self-test | Microprocessor controlled with built-in self-test |
Comparison to legally marketed device HIDREX PSP1000 (K133033) by HIDREX GmbH (Substantial Equivalence):
The Chart below summarizes the similarities and differences.
| | SUBJECT DEVICE
SAALIO® | PREDICATE DEVICE
Hidrex PSP 1000
(K133033) |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Tap water iontophoresis device intended to treat hyperhidrosis (pathological sweating) affecting hands, feet, and underarms. Any other use or usage beyond this scope is considered un-intended use and may have dangerous consequences. | This Tap-Water-lontophoresis device is intended to treat hyperhidrosis (pathological sweating) affecting hands, feet and underarms. Any other use or usage beyond this scope is considered un-intended use and may have dangerous consequences. |
| Prescription Use Only | Yes | Yes |
| Performance | | |
| DC current output | max. 58 V
max. 30 mA | max. 60 V
max. 35 mA |
| Pulsed current output | max. 58 V
max. 30 mA
10 kHz
1 output mode (pulse-width: 50%) | max. 60 V
max. 35 mA
9.9 kHz
5 output modes (pulse-width: 50%, 60%, 70%, 80% and 90%) |
| Signal type | Monophasic square, at DC: fixed pulsed square signal (50%) | Monophasic square, at DC: pulsed square signal |
| Polarity reversal (to alternate POS and NEG application) | manual | manual |
| Automatic current regulation | Yes | Yes |
| Timer | Yes | Yes |
| Display | LCD graphics display with LED backlight to display all session settings | LCD-multi character display to display all session settings |
| Microprocessor controlled with built-in self-test | Yes | Yes |
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| Controls | ||
|---|---|---|
| Meter | digital Monitor | digital Monitor |
| Intensity | soft sensor buttons | soft sensor buttons |
| Output Jacks | 4 mm insulated connectors | 4 / 6mm insulated connectors |
| Application-accessory | ||
| Feet | treatment tray with | |
| silicone/graphite electrode and | ||
| foam inserts inside | plastic case with metal electrode | |
| and towel inside | ||
| Hands | treatment tray with | |
| silicone/graphite electrode and | ||
| foam inserts inside | plastic tray / case with metal | |
| electrode and towel inside | ||
| Axillary applicators | silicone/graphite electrode covered | |
| by a sponge pouch | metal electrode covered by a | |
| sponge pouch | ||
| Dimensions | ||
| Control unit | 4.7" (W) x 2.5" (H) 5.9" (D) | 7,5" (W) x 2" (H) 5,4" (D) |
| Hard-shell-case | Non-existent | 13.4" x10.8" x 3.3" |
| Treatment tray | 11.1" x 15.4" x 2.2" | 10.2" x 15.75" x 2.2" |
| Axillary sponge | ||
| cushions | 2.6" x 3.7" x 0.5" | 2.9" x 3.45" x 1.3" |
| Foam Insert | 9.8" x 13.0" | 8.1" x 12.2" (Towel) |
| Electrodes (feet, hands) | 7.9" x 11.4" x 0.1" | 4.5" x 11.2" x 2.4" |
| Electrodes (underarms) | 1.9" x 3.0" x 0.1" | 1.9" x 2.17" x 0.6" |
| Power supply | ||
| Type | external | external |
| Input | 100-240 V~ / 50-60 Hz | 100-240 V~ / 50-60 Hz |
| 160-80mA | 400mA | |
| Output | 24V, max. 300 mA | 12V, max. 500mA |
| 7.2 VA | 6 VA | |
| Certification | ||
| CE | YES | YES |
| GMP/ISO 13485 | YES | YES |
Difference's Analysis
These differences were identified:
| Subject device (sd) | Predicate device (pd) | |
|---|---|---|
| 1. | Tray electrodes made of silicone/graphite | Tray electrodes made of metal |
| The tray electrodes of the sd are made of silicone filled with high portion of graphite | ||
| (typically used for TENS devices). The electrical conductivity is high, the electrode soft and | ||
| without sharp edges. The inserted graphite is electrically inert. |
The whole electrode of the sd is completely flat and covered with a foam insert, any skin
contact is prevented.
Conclusion:
The electrodes of the SD are substantially equivalent to the PD ones. | The tray electrode of the pd is made of aluminum or stainless steel.
Based on experiences metal electrodes tend to corrode due to the galvanic circumstances
during the treatment. The metal electrode is bended on the top side upwards and not
protected against skin contact, which may lead to skin irritation or burn due to high current
and power densities at this site. |
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| 2. | Flexible underarm electrodes | Stiff/flat underarm electrodes |
|---|---|---|
| The underarm electrode of the pd is also made of metal. Therefore, the electrode is flat and rigid. The surface structure at the underarms differs from patient to patient. In order to compensate these variation, the flat electrode is covered by a relatively thick sponge cushion. A vertically placed sponge cushion tends leak, so that the conducting surface is reduced. This situation might lead to high current and power densities. | ||
| The underarm electrode of the sd is made of flexible silicone, which easily follows the individual underarm surface topology. This allows the sponge pouch to be flatter, which keeps the whole tap water inside the pouch structure. This result in more stable and controllable current densities and minimizes the risk of high current and power densities. | ||
| Conclusion: | ||
| The electrodes of the SD are substantially equivalent to the PD ones. | ||
| 3. | Pulsed current: 1 output mode (pulse-width: | |
| 50%) | Pulsed current: 5 output modes (pulse-width: | |
| 50%, 60%, 70%, 80% and 90%) | ||
| The pd offers 5 different output modes for the pulsed current. The direct current (100% pulse-width) is generally accepted as the most effective type of current. The pulsed current with 50% pulse-width is an accepted alternative. | ||
| The sd is just offering the direct current and the pulsed current with 50% band-width. For the user there are just two adjustments possible to support the ease of use. | ||
| Conclusion: | ||
| The output mode of the SD is substantially equivalent to the PD. | ||
| 4. | Soft Bag | Hard shell case |
| The sd comes along with a soft bag, which allows easy evaporation of any remaining moisture. The two trays are ergonomically shaped with an arm cushion and large enough to allow the parallel treatment of hands and feet at once. | ||
| Conclusion: | ||
| The soft bag of the SD is substantially equivalent to hard shell case of the PD. | The pd offers a hard shell case for storing the device and for using the two halves as treatment trays. The hard shell case is too small to allow a parallel treatment of hands and feet at once. Furthermore, storing the wet equipment in the hard shell case supports generating bad smell. |
Non-clinical tests:
To demonstrate substantial equivalence, we performed non-clinical tests according recognized standards:
- Non-clinical tests according to IEC 60601-1 Medical electrical equipment General ● requirements for safety were performed in a third party laboratory to demonstrate electrical safety.
- . Non-clinical tests 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 were performed in a third party laboratory to demonstrate electromagnetic compatibility.
- Non-clinical tests according to IEC 60601-1-11: Medical Electrical Equipment Part 1-11: ● General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment were performed in a third party laboratory to demonstrate safety in Home Healthcare Environment.
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Image /page/8/Picture/0 description: The image shows the word "SAALMANN" in red font. The font is sans-serif and appears to be a slightly condensed style. There is a registered trademark symbol to the right of the word.
- Non-clinical tests according to ISO 10993-5 Biological Evaluation Of Medical Devices Part 5: ● Tests For In Vitro Cytotoxicity and ISO 10993-10 Biological Evaluation Of Medical Devices -Part 10: Tests For Irritation And Skin Sensitization were performed in a third party laboratory to demonstrate biocompatibility.
Quality Assurance and Manufacturing Controls:
Saalman® medical GmbH & Co. KG operates to an established and certified quality management system.
Conclusion:
The subject device Saalio® is substantially equivalent to the predicate device.