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

Device Description

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

AI/ML Overview

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

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

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

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

What can be extracted:

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

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

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

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

In summary:

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

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 10, 2020

Dermadry Laboratories Inc. % Louis-Paul Marin President LOK North America Inc. 2025 Michelin Street Laval, Quebec H7L5B7 Canada

Re: K192749

Trade/Device Name: Dermadry Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device Regulatory Class: Class II Product Code: EGJ Dated: November 8, 2019 Received: November 12, 2019

Dear Louis-Paul Marin:

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, Ph.D. Director 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) K192749

Device Name Dermadry

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the logo for Dermadry. The logo consists of two overlapping shapes that resemble the letter 'D'. The top 'D' is a darker shade of blue, while the bottom 'D' is a lighter shade of blue. Below the symbol, the word "Dermadry" is written in a sans-serif font, with the same lighter shade of blue as the bottom 'D' in the symbol.

510(k) Summary

Dermadry Laboratories inc.

Email: regulatory@lok-northamerica.com

9223 Langelier Blvd Montreal, Quebec

1. Type of Subissions Traditional

Preparation Date September 27, 2019 (revised February 9, 2020)

1. Submitter Address
Canada, H1P 3K9 4. Contact Person Louis-Paul Marin, eng, LL.B., LL.M. President of LOK North America Inc. Phone: 1 (450) 781-1578 ext. 225 Fax: 1 (450) 681-9663

5. Identification of the Device

Proprietary Name / Trade Name	Dermadry
Regulation	21 CFR 890.5525
Regulation Name	Iontophoresis device
Classification Identification	Device, Iontophoresis, Other Uses
Classification	II
Panel	Physical Medicine
Product Code	EGJ
Identification of the Predicate	Hidrex PSP1000
510(k) Number	K133033

7. Indications for Use of the Subject Device

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 unintended use and may have dangerous consequences.

8. Device Description

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Image /page/4/Picture/0 description: The image contains the logo for Dermadry. The logo features two interlocking shapes in shades of blue, resembling stylized letters. Below the symbol, the word "Dermadry" is written in a modern, sans-serif font, with the first half in a lighter blue and the second half in a darker blue.

9. Substantial Equivalence Determination

	Predicate Device:Hidrex PSP1000	Proposed Device:Dermadry
Intended Use	Tap water Iontophoresis device intended to treat hyperhidrosis of the hands, feet, and underarms.	SameTap Water Iontophoresis device intended to treat hyperhidrosis of the hands, feet, and underarms.
Indication 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 un-intended use and may have dangerous consequences.Prescription Use Only	SameDermadry is a Tap Water Iontophoresis device. Its intended use is to treat hyperhidrosis (excessive sweating) of the hands, feet and underarms. Using the device in any other way than its intended purpose may be dangerous.Prescription Use Only
Patient Population	Not specified	DifferenceFor adult patients
Home Use	Home Use	SameHome Use
Main Technology	Tap water iontophoresis:Current applied between contralateral treated areas (right/left hands/feet/armpits) via electrodes covered in a towel immersed in tap water into which the members are placed in the case of the hands or feet applications, or alternately via electrodes in sponges wetted with tap water placed within the armpits.	SameTap water iontophoresis:Current applied between contralateral treated areas (right/left hands/feet/armpits) via electrodes covered in a towel immersed in tap water into which the members are placed in the case of the hands or feet applications, or alternately via electrodes in sponges wetted with tap water placed within the armpits.
Main Equipment	- Controller (digital monitor user interface, current/voltage control, soft sensor buttons )- Electrodes- Towel electrode covers for feet/hands- Sponges electrode covers for armpits- Tray for tap water for treatment of feet/hands- Electrical current cable/connectors (6 mm output jack insulated) between controller and electrodes- Power Supply	Same- Controller (digital monitor user interface, current/voltage control, soft sensor buttons )- Electrodes- Towel electrode covers for feet/hands- Sponges electrode covers for armpits- Tray for tap water for treatment of feet/hands- Electrical current cable/connectors (4 mm output jack insulated) between controller and electrodes- Power Supply
Treatment Current/ Voltage/	Hands, Feet, Armpit: up to 60 V max as set by the user, current self-adjusts up	Differences
Time	to 35 mA to maintain desired voltage,unlimited duration set by user with alabelled recommended duration ofapproximately 15 minTreatments have user selectable pulsewidth: 50%, 60%, 70%, 80% and 90% or100%	Hands: 1 to 15mA max as set by theuser, voltage self-adjusts up to 48V tomaintain desired current, 20 minduration limited by controller Feet: 1 to 25mA max as set by the user,voltage self-adjusts up to 55V tomaintain desired current, 20 minduration limited by controller Armpits: 1 to 8mA max as set by theuser, voltage self-adjusts up to 30V tomaintain desired current, 15 minduration limited by controller
		All treatments are with a fixed 90% pulsewidth (not adjustable).
Current/Voltagecontrol	Automatic Control to maintain set/desiredVoltage by automatic adjustment ofamperage	DifferencesAutomatic control to maintain desired/setCurrent by automatic adjustment ofvoltage
Max CurrentDensity[mA/in2] (perelectrodeconductive area)	Hands: 0.28 mA/in2Feet: 0.28 mA/in2Armpit: 4.24 mA/in2	DifferencesHands: 0.10 mA/in2Feet: 0.17 mA/in2Armpit: 1.06 mA/in2
HardwareOutputCurrent/Voltage limits	Max: 60 V DC & 35 mA DC (safety circuitlimit)	DifferencesMax: 60 V DC (also lower software limitsper treatment as noted above), 30 mA DC(per current limiter, also software limit of25 mA)
OutputPulsedCurrent	Monophasic square, pulse-width at 9.9 kHz,user selectable: 50%, 60%, 70%, 80% and90% or 100%	DifferencesMonophasic square, pulse-width at 10 kHz:90%
Polarityreversal	Manual polarity reversal	DifferencesAutomatic polarity reversal every 2.5 minfor the armpits or every 5 min for the handsand feet
Dimensions	Control unit: 7.5"(W) x 2"(H) 5.4"(D)Hard-shell-case: 13.4" x 10.8" x 3.3"Treatment tray: 10.2" x 15.8" x 2.2"Axillary sponges: 2.9" x 3.5" x 1.3"Towel 8.1" x 12.2"Electrodes (feet, hands): 4.5" x 11.2" x 2.4"Electrodes (underarms): 1.9" x 2.2" x 0.6"	Differences:Control unit: 4"(W) x 1.5"(H) x 5.2"(D)Hard-shell-case: 3.4" x 10.8" x 3.3"Treatment tray: N/A (same as case)Axillary sponges: 2.6" x 2.5" x 1"Towel: 8.3" x 12.6"Electrodes (feet, hands): 6.3" x 11.1" x 2.1"Electrodes (underarms): 1.8" x 1.67" x 0.3"
ConductiveArea (inch²)	Towel (face): 98.8Sponge Cushion (2 faces+edges): 36.94Electrode - feet/hands (face+L-edges):122.13Electrode - underarms (2 faces): 8.25	Towel (face): 104.1Sponge Pockets (2 faces+edges): 23.42Electrode - feet/hands (face+L-edges):143.43Electrode - underarms (2 faces+edges): 7.56
Power Supply	AC Adapter: Power Mains supply 100-240V @ 50-60 Hz, Max Power Supply Output: 12 V DC, max 500 mA, 6 VA	DifferencesAC Adapter: Power Mains supply 100-240V @ 50-60 Hz, Max Power Supply Output: 5 V DC, max 1.2 A, 6 VA

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Image /page/5/Picture/1 description: The image shows the logo for Dermadry. The logo consists of two interlocking shapes that resemble the letter 'D' in a stylized font. The word "Dermadry" is written in a sans-serif font below the interlocking shapes. The logo and the text are in shades of blue.

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Image /page/6/Picture/14 description: The image features the logo for Dermadry. The logo consists of two interlocking shapes resembling the letter 'D' in a stylized, rounded form. The upper 'D' is a darker teal color, while the lower 'D' is a lighter teal. Below the symbol, the word "Dermadry" is written in a modern, sans-serif font, also in the lighter teal color.

Intended Use and Indication for Use comparisons:

Both systems have the same general intended use and indications for use. Both are also prescription use & home use.

As to the intended patient population, while in the predicate the intended population group is not specified, in the proposed Dermadry an adult population is specified. This should not raise any new questions of safety or effectiveness since this is more specific and restrictive than in the predicate.

The initial phase of device use is conducted under the supervision of the prescribing healthcare professional. This is similar to the predicate device's first phase of use.

Considering that same intended use, the same indication for use statement, the same home environment of use, and the adult population specificity within that of the proposed device is substantially equivalent to the predicate with respect to the intended use and indications.

Technology Comparisons:

The Dermadry implements the same iontophoresis technology as the predicate utilizing the same main components for the treatment of hyperhidrosis of the hands, feet, and armpits.

The differences as highlighted in the table are of an engineering approach nature. Their discussion in terms of equivalence are as follows:

Differences in the method of controlling the treatment current and treatment current levels: ●

While in the predicate the treatment current is indirectly control of the user set voltage level across the electrodes, in the proposed device the applied current treatment is directly controlled with the system adjusting the voltage across the electrodes to provide the desired current level. As to the treatment current levels, in the predicate, equally for any of the treatment locations, the maximum voltage level that the user can adjust is 60 V, and the current is limited to 35 mA (at any voltage level). In the Dermadry, the directly controlled target current levels have limits depending on treatment location as noted in the table (15, 25, and 8 mA for the hands, feet, and armpits respectively), and the self-adjusting voltages are limited also per the treatment location (48, 55, and 30 V for the hands, feet, and armpits respectively). Therefore, the proposed device treatment current and voltages are in all cases less than the maximums in the predicate with corresponding lower current sensitivity and risk effects. As to effectiveness, although the maximum permissible treatment levels are reduced, the current levels in the Dermadry are of the same order as those typically used in Iontophoresis device for hyperhidrosis (around 10 - 25 mA). Therefore, these differences do not raise any new questions of safety or effectiveness.

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Dermadry

Differences in the treatment durations: ●

In addition, whereas in the predicate the duration is adjusted and set by the user and is not limited by the controller with only a labelled recommended duration of approximately 15 min for all three treatment areas, in the Dermadry the controller limits the duration of the current administration per the selected treatment area (20, 20, and 15 min for the hands, feet, and armpits respectively). These longer durations in the Dermadry for the hand and feet case are implemented corresponding with its lower possible current levels as compared to the predicate. Similarly as per the above point, this controller's limited duration should help further minimize possible sensitivity and risks effects given the fixed set limits. Furthermore, the treatment duration limits in the Dermadry are still comparatively safe relative to the lower recommended durations in the hands and feet cases of the predicate given the lower permissible current and voltage levels and the corresponding total possible total energy that the Dermadry can output to the patient. Considering the maximum current and voltages in the worst treatment cases, the maximum energy that can be output to the patient is 1890 Joules over 15 minutes in the predicate as compared to 1650 Joules over 20 minutes for the Dermadry (see table below).

	Max Current(A)	Max Tension(V)	Duration(min)	Max Energy(J)
Predicate Hidrex	0.035	60	15	1890
Dermadry	0.025	55	20	1650

● Differences in the maximum current densities:

Stemming mainly from the lower current levels in the Dermadry, the current density levels are respectively 64%, 39%, and 75% less in the proposed Dermadry for the hands, feet, and underarms electrodes as compared to the predicate levels. These should therefore not present any new risk concerns similarly as noted in the above points while still providing adequately effective current levels.

Differences in the DC signal pulse width specifications: ●
Whereas in the predicate the pulse width is user selectable (50% to 100% in increments of 10%), in the Dermadry device it is fixed at 90%. Given that the Dermadry setting is within that of available settings in the predicate and that this characteristic is more related to patient comfort, it does not present any new risk concerns.
Differences in the polarity reversal specifications:
Whereas in the predicate the polarity is to be reversed manually by the user (approximately when results are initially felt), in the predicate it's automatically reversed every 5, 5, and 2.5 min for the hands, feet, and armpits respectively. This further ensures that the polarity will be reversed to help minimize pH changes and related effects. Therefore, this does not present any new risk concerns.
Differences in the hardware output current/voltage limits: ●
The predicate outer hardware cut-off safety limits is 60 V / 35 mA. This is slightly lower in the Dermadry at 60 V and 30 mA (current limiter circuit). Given the slightly improved safety level, this does not present any new risk concerns.

● Differences in the output jacks:

The jacks in the Dermadry are is of slightly smaller size as compared to the predicate. They are however insulated as in the predicate, and they equally meet the minimum requirements of safety per IEC 60601-1 as in the predicate.

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Image /page/8/Picture/1 description: The image shows the logo for Dermadry. The logo consists of two interlocking shapes that resemble the letter 'D' in a stylized font. The shapes are colored in shades of blue, with the upper shape being a darker teal and the lower shape a lighter turquoise. Below the shapes, the word "Dermadry" is written in a lowercase sans-serif font, also in the lighter turquoise color.

● Differences in the dimensions:

While there are differences in component dimensions, aside from the effect on current density from the electrodes as discussed above, the differences are only dimensional without raising any new questions of safety and effectiveness.

Differences in the conductive areas:
While there are differences in the conductive areas (lower in the Dermadry underarm electrode and sponge pocket and higher in the feet/hands electrode and towel as compared to the predicate), the lower areas are offset by the lower current levels in the Dermadry with the current densities still be significantly lower than in the predicate without raising new questions of safety or effectiveness as was discussed above under the current density point.

. Differences in the power supply:

While the AC Adapter in the Dermadry has a lower voltage and higher amperage output to the controller than in the predicate, the power output is the same (6 VA) and in both cases the power supply Adapters meet the safety requirements of IEC 60601-1.

Considering the above, the Dermadry proposes the same technology and methods as the predicate to address the same indications. The noted differences in their detail specifications do not present any new questions of safety or effectiveness whereby the two devices are substantially equivalent.

10. Performance Data

-Treatment voltage and amperage accuracy performance testing was performed under simulated conditions.
Electrical safety and Electromagnetic Compatibility per standards IEC 60601-1 and IEC 60601-1--2.
-Biocompatibility Evaluation per ISO 10993-1 and the related FDA Guidance: Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Software verification and validation testing per IEC 62304 and FDA Guidance: Guidance for the -Content of Premarket Submissions for Software Contained in Medical Devices Document, May, 2005.
Usability performance per IEC 60601-1-6 & IEC 62366-1. -
-Home Use safety per IEC 60601-1-11.

As based on the above tests and evaluations, the performance of the Dermadry system do not raise any new safety and effectiveness concerns as compared to the predicate.

11. Conclusion

The Dermadry is substantially equivalent to the currently cleared Hidrex PSP1000 predicate device (510(k) # K133033).

Regulation Number and Section

§ 890.5525 Iontophoresis device.

(a)
Iontophoresis device intended for certain specified uses —(1)Identification. An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body and induce sweating for use in the diagnosis of cystic fibrosis or for other uses if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. When used in the diagnosis of cystic fibrosis, the sweat is collected and its composition and weight are determined.(2)
Classification. Class II (performance standards).(b)
Iontophoresis device intended for any other purposes —(1)Identification. An iontophoresis device intended for any other purposes is a prescription device that is intended to use a current to introduce ions of drugs or non-drug solutions into the body for medical purposes other than those specified in paragraph (a) of this section, meaning that the device is not intended for use in diagnosis of cystic fibrosis, or a specific drug is not specified in the labeling of the iontophoresis device.(2)
Classification. Class II (special controls). The device is classified as class II. The special controls for this device are:(i) The following performance testing must be conducted:
(A) Testing using a drug approved for iontophoretic delivery, or a solution if identified in the labeling, to demonstrate safe use of the device as intended;
(B) Testing of the ability of the device to maintain a safe pH level; and
(C) If used in the ear, testing of the device to demonstrate mechanical safety.
(ii) Labeling must include adequate instructions for use, including sufficient information for the health care provider to determine the device characteristics that affect delivery of the drug or solution and to select appropriate drug or solution dosing information for administration by iontophoresis. This includes the following:
(A) A description and/or graphical representation of the electrical output;
(B) A description of the electrode materials and pH buffer;
(C) When intended for general drug delivery, language referring the user to drug labeling approved for iontophoretic delivery to determine if the drug they intend to deliver is specifically approved for use with that type of device and to obtain relevant dosing information; and
(D) A detailed summary of the device-related and procedure-related complications pertinent to use of the device, and appropriate warnings and contraindications, including the following warning:

Warning: Potential systemic adverse effects may result from use of this device. Drugs or solutions delivered with this device have the potential to reach the blood stream and cause systemic effects. Carefully read all labeling of the drug or solution used with this device to understand all potential adverse effects and to ensure appropriate dosing information. If systemic manifestations occur, refer to the drug or solution labeling for appropriate action.(iii) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.
(iv) Appropriate software verification, validation, and hazard analysis must be performed.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) The elements of the device that may contact the patient must be assessed for sterility, for devices labeled as sterile.
(vii) Performance data must support the shelf life of the elements of the device that may be affected by aging by demonstrating continued package integrity and device functionality over the stated shelf life.