IontoDC is a bench-top, battery powered, microcontrollercontrolled iontophoresis device that delivers direct current to a drug delivery electrode placed on the patient's skin. This current expedites the migration of ionic drug solutions through the skin into localized tissue.

AI/ML Overview

This 510(k) premarket notification describes the IontoDC, an iontophoresis device. The review of the provided document indicates that the submission focuses on demonstrating substantial equivalence based on technological characteristics and performance testing against predicate devices, rather than a clinical study evaluating the device's efficacy in treating a specific condition or detecting a disease. Therefore, many of the requested items related to clinical studies, such as sample sizes for test and training sets, expert qualifications, and comparative effectiveness studies, are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IontoDC device are implicitly the electrical output parameters and safety standards of the predicate devices and relevant IEC standards. The document outlines a comparison of the IontoDC's parameters with two predicate devices: Dynatron® ibox (primary) and ActivaDose II (reference).

Parameter	Acceptance Criteria (Predicate Devices - IBox & ActivaDose II)	IontoDC Reported Performance	Comparison Outcome
Indications For Use	Introduce ions of soluble salts or other drugs into the body.	Identical to primary predicate (Dynatron® ibox).	Identical to Primary Predicate
Power source	Battery Powered.	Battery Powered.	Identical
Number, Size, and Type of Batteries	One 9V (ActivaDose II), Two 1.5V AA (Dynatron® ibox).	Two 9 Volt Alkaline batteries.	Not identical, but complies with IEC 60601-1; difference does not raise safety issues (Note 1).
Output Jacks	1 (ActivaDose II), 2 (Dynatron® ibox).	2.	Identical to Primary Predicate
Current Intensity	0.0 - 4.0 mA DC (ActivaDose II), 0.5 - 4.0 mA DC (Dynatron® ibox).	1.0 - 2.0 mA DC.	Lower maximum current (2 mA vs 4 mA) but all devices comply with IEC 60601-1; difference does not raise new safety or effectiveness issues (Note 2).
Current Accuracy	+/- 10% (Dynatron® ibox).	+/- 1%.	Better accuracy (1% vs 10%) but both comply with IEC 60601-1; difference does not raise new safety or effectiveness issues (Note 3).
Current Precision	0.1 mA (ActivaDose II, Dynatron® ibox).	0.1 mA.	Identical
Voltage at Electrodes	80 Volts (ActivaDose II), +/- 0-46 Volts (Dynatron® ibox).	+/- 0-40 Volts.	Slightly different/lowest, but all comply with IEC 60601-1; difference does not raise new safety or effectiveness issues (Note 4).
Electrode Cable Jacks	-- (ActivaDose II), Custom 2-pin polarized (Dynatron® ibox).	Shielded banana.	Different type, but both ensure reliable connection; difference does not raise new questions of safety and effectiveness (Note 5).
Maximum Total Deliverable Dose	80 mA-min (ActivaDose II), 3360 mA-min (Dynatron® ibox).	80 mA-min.	Identical to Reference Device (ActivaDose II).
Single Treatment Deliverable Dose	0 - 80 mA-min (ActivaDose II), 1 - 160 mA-min (Dynatron® ibox).	10mA - 80 mA-min.	Slightly different range, but upper limit does not exceed predicate devices; difference does not raise new safety or effectiveness issues (Note 6).
Number of 40 mA-min. Treatments	2 (ActivaDose II), 89 (Dynatron® ibox).	2.	Identical to Reference Device (ActivaDose II).
Minimum Treatment Time	1.5 seconds (ActivaDose II), 15 seconds (Dynatron® ibox).	10 min.	Longer, but can be manually adjusted; difference does not raise new safety or effectiveness issues (Note 7).
Maximum Treatment Time	20 minutes (ActivaDose II), 100 minutes (Dynatron® ibox).	40 min.	More than one predicate, less than another, but can be manually adjusted; difference does not raise new safety or effectiveness issues (Note 8).
Timing Accuracy	+/- 1 second (ActivaDose II, Dynatron® ibox).	+/- 3 second.	Different, but does not raise new safety or effectiveness issues for iontophoretic use (Note 9).
Polarity Options	Positive (+), Negative (-), Dual Polarity (NO) (ActivaDose II, Dynatron® ibox).	Positive (+), Negative (-), Dual Polarity (YES).	Identical (for Positive/Negative) and identical to reference device for Dual Polarity (meaning both IontoDC and ActivaDose II do not have it, or it aligns with whichever predicate is being compared for that feature).
Low Battery Warning	YES (During Treatment and At Power-On for both).	YES (During Treatment and At Power-On).	Identical
Overcurrent Warning	YES, if >2.2 mA (ActivaDose II), YES, at 4 mA (Dynatron® ibox).	YES, if >2.2 mA.	Different threshold due to lower maximum current (2mA); difference does not raise safety or effectiveness issues (Note 10).
Certificates	IEC 60601-1, CSA/NRTL (both predicates).	IEC 60601-1, CSA/NRTL.	Identical
Dimensions (in.)	Varied (7.91"x5.9"x2.83" for ActivaDose II, 6.1"x3.5"x1.9" for Dynatron® ibox).	Not provided, but stated as "different".	Different, but does not raise safety or effectiveness issues (Note 11).
Weight (lbs., oz.)	Varied (1 lb 3oz for ActivaDose II, 0.4 lbs for Dynatron® ibox).	Not provided, but stated as "different".	Different, but does not raise safety or effectiveness issues (Note 12).
Display	Digital Display (ActivaDose II, Dynatron® ibox).	Organic Light Emitting Diodes (OLED).	Identical to Reference Device (ActivaDose II) (likely referring to the function of displaying digital information).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. The submission relies on bench testing and compliance with international standards (IEC 60601-1, IEC 60601-1-2) for electrical output parameters and EMC, and software verification and validation. There is no clinical test set mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. There was no clinical test set requiring expert consensus for ground truth. The "ground truth" for this device's performance is compliance with established electrical and safety standards, as measured by engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a hardware device (iontophoresis device), not an AI/imaging diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This device is not an algorithm. Bench testing evaluated the device's performance in isolation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating substantial equivalence for this device is based on:
- Compliance with recognized electrical safety and EMC standards: IEC 60601-1 (medical electrical equipment general requirements for basic safety and essential performance) and IEC 60601-1-2 (medical electrical equipment electromagnetic compatibility).
- Bench testing measurements: Direct comparison of the electrical output parameters of the IontoDC device against those of the predicate devices.
- Software verification and validation: As per FDA guidance for a "Moderate" level of concern software.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of an AI/imaging device. The device's design and manufacturing processes are likely informed by engineering principles and iterations, but not a data-driven training set in the typical AI sense.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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Public Health Service

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May 1, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Soterix Medical,inc. Abhishek Datta Chief Technology Officer 237 W 35 St. 1401 New York, New York 10001

Re: K170291

Trade/Device Name: IontoDC Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device Regulatory Class: Class II Product Code: EGJ Dated: January 31, 2017 Received: January 31, 2017

Dear Abhishek Datta:

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 (reporting of medical device

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related 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 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.

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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,

Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170291

Device Name IontoDC

Indications for Use (Describe)

IontoDC is intended to use a direct current to introduce ions of soluble salts or other drugs into the body.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

Date Prepared: December 26, 2016 Submitter Information: Company Name: Soterix Medical, Inc. 237 W 35 ST. 1401 Company Address: New York, NY 10001 Contact Person: Abhishek Datta Phone: 888-990-8327 Fax: 212-315-3232 Device Information: IontoDC Trade Name: Common Name: IontoDC Classification Name: Iontophoresis Device (21 CFR 890.5525, Product Code EGI) Device Class: Class II Predicate Device: 1. Dynatron® ibox Iontophoresis device (K043047) Dynatronics Corporation Class III (primary predicate ) 2. ActivaDose II (K020476) Selective Med Components, Inc. acquired by Activatek Inc. Class III (reference device) Device Description: IontoDC is a bench-top, battery powered, microcontrollercontrolled iontophoresis device that delivers direct current to a drug delivery electrode placed on the patient's skin. This current expedites the migration of ionic drug solutions through the skin into localized tissue. Intended Use: IontoDC is intended to use a direct current to introduce ions of soluble salts or other drugs into the body. IontoDC uses the same technological principle as the Technological Comparison: predicate device to accomplish its intended use, namely the introduction of ions to the body through direct current. The technology is based on the principle that an electric potential will cause ions in solution to migrate according to their

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electrical charges. A technical comparison of the electrical output parameters of the device with the predicate device has been completed and supports a substantial equivalence determination.

Basis for Equivalence:

-Performance testing:	Bench testing demonstrated that the electrical output parameters of the IontoDC device are substantially equivalent to those of the predicate device. The subject device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC. Software verification and validation testing were conducted and documented per FDA's Guidance for Industry and Staff. The software for this device was considered as a "Moderate" level of concern.
-Labeling:	The labeling of IontoDC device is substantially equivalent to that of the predicate device.
-Discussion of Clinical Tests Performed:	Not Applicable.
Conclusions from Testing:	The intended use and the basic technological characteristic of the IontoDC device are equivalent with those of the predicate device. The IontoDC device complies with the requirement of IEC 60601-1 and IEC 60601-1-2. Bench testing and safety report documentation supports the conclusion that electrical output is substantially equivalent to the predicate device, and any differences between the devices do not pose new questions of safety and effectiveness. Thus IontoDC device is substantially equivalent to the predicate device.

Parameter	IontoDC	ActivaDose II(Reference Device)	Dynatron® IBox(PrimaryPredicate)	Comparison
510(k)	To Be Determined	K020476	K043047	--
Device Name	IontoDC	ActivaDose II	Dynatron® ibox	--
Manufacturer	Soterix Medical,Inc.	ActivaTek. Inc.	DynatronicsCorporation	--
Parameter	IontoDC	ActivaDose II(Reference Device)	Dynatron® IBox(PrimaryPredicate)	Comparison
Indications ForUse	IontoDC isintended to use adirect current tointroduce ions ofsoluble salts orother drugs intothe body.	The ActivaDose IIIontophoresisDelivery Unit isindicated for theadministration ofsoluble salts or otherdrugs into the bodyfor medical purposesas an alternative tohypodermicinjection insituations when it isadvisable to avoidthe pain that mayaccompany needleinsertion and druginjection, when it isadvisable tominimize theinfiltration of carrierfluids, or to avoidthe damage causedby needle insertionwhen tissue istraumatized.	Dynatron® iboxiontophoresisSystem is intendedto use a directcurrent tointroduce ions ofsoluble salts orother drugs into thebody.	Identical toPrimaryPredicate
Power source	Battery Powered	Battery Powered	Battery Powered	Identical
Number, Size, andType of Batteries	Two 9 VoltAlkaline batteries	One 9V DCAlkaline Battery	Two 1.5 Volt AAAlkaline batteries	SENote 1
Output Jacks	2	1	2	Identical toPrimaryPredicate
Current Intensity	1.0 - 2.0 mA DC	0.0 - 4.0 mA DC	0.5 - 4.0 mA DC	SENote 2
Current Accuracy	+/- 1%	--	+/- 10%	SE
Parameter	IontoDC	ActivaDose II(Reference Device)	Dynatron® IBox(PrimaryPredicate)	Comparison
				Note 3
Current Precision	0.1 mA	0.1 mA	0.1 mA	Identical
Voltage atElectrodes	+/- 0-40 Volts	80 Volts	+/- 0-46 Volts	SENote 4
Electrode CableJacks	Shielded banana	--	Custom 2-pinpolarized	SENote 5
Maximum TotalDeliverable Dose	80 mA-min	80 mA-min	3360 mA-min	Identical toReferenceDevice
Single TreatmentDeliverable Dose	10mA - 80 mA-min	0 - 80 mA-min	1 - 160 mA-min	SENote 6
Number of 40 mA-min. Treatments	2	2	89	Identical toReferenceDevice
MinimumTreatment Time	10 min	1.5 seconds	15 seconds	SENote 7
MaximumTreatment Time	40 min	20 minutes	100 minutes	SENote 8
Timing Accuracy	+/- 3 second	+/- 1 second	+/- 1 second	SENote 9
PolarityOptions:	Positive (+)	YES	YES	YES	Identical
	Negative (-)	YES	YES	YES	Identical
	DualPolarity	NO	NO	YES	Identical toReferenceDevice
Parameter		IontoDC	ActivaDose II(Reference Device)	Dynatron® Ibox(Primary Predicate)	Comparison
	(+/-)
LowBatteryWarning:	DuringTreatment	YES	YES	YES, at 2.0 Vremaining	Identical
	AtPower-On	YES	YES	YES, if <2.2 Vremaining	Identical
OvercurrentWarning		YES, if >2.2 mA	YES, at 4 mA	Yes, if >6 mA onany channel	SENote 10
Certificates:	IEC60601-1	YES		YES	Identical
	CSA/NRTL	YES		YES	Identical
Dimensions (in.) [Lx W x H]		7.91" x 5.9" x2.83"	6.1" x 3.5" x 1.9"	4.5" x 2.66" x1.25"	SENote 11
Weight (lbs., oz.)[Without batteryor electrodecables]		1 lb 3oz	.4 lbs	3.6 oz.	SENote 12
Display		Digital Display	Digital Display	Organic LightEmitting Diodes(OLED)	Identical toReferenceDevice

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Note 1:

The number of batteries used in subject device is different than the predicate device but all devices comply to IEC 60601-1 requirements. So the difference will not raise any safety issue.

Note 2:

The subject device can deliver a maximum of 2 mA of current as opposed to a maximum 4mA delivered by each of the predicates but all devices comply to IEC 60601-1 requirements. The differences in functional specifications will not raise any new safety and effectiveness issues.

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Note 3:

The subject device has a current accuracy of 1% which is different than the 10% accuracy provided by the predicate. While both devices comply to IEC 60601-1 requirements, increased current accuracy in subject device ensures more accurate measurements. The differences in functional specifications will not raise any new safety and effectiveness issues.

Note 4:

The voltage provided by the subject device is slightly different than the predicate devices and is the lowest of all. All devices comply with IEC 60601-1 requirements so the differences in functional specifications will not raise any new safety and effectiveness issues.

Note 5:

The electrode cable jacks of the subject device is shielded banana while it is 2-pin polarized jack for the predicate device. Both jacks ensure a reliable connection so the difference does not raise new questions of safety and effectiveness.

Note 6:

The single treatment deliverable dose range for the subject device is slightly different than the predicate device. The upper limit of the total deliverable dose however does not exceed any of the predicate devices. This difference in functional specification will not raise any safety and effectiveness issue.

Note 7:

The minimum treatment time of the subject device is more than the predicate devices but this can be manually adjusted by pressing abort for any desired treatment time. This difference in functional specification does not raise any new safety and effectiveness issue.

Note 8:

The maximum treatment time of the subject device is more than one predicate device but less than the other. The treatment time can however be manually adjusted by pressing abort for any desired treatment time. This difference in functional specification does not raise any new safety and effectiveness issue.

Note 9:

The timing accuracy of the subject device is different than the predicate devices. This difference does not raise new safety and effectiveness issue for iontophoretic use.

Note 10:

The subject device can deliver a maximum of 2 mA and as a result the overcurrent warning threshold is is different than the predicate devices. This difference in functional specification will not raise a safety and effectiveness issue.

Note 11:

The subject device has different dimensions than the predicate devices. This difference in functional specification will not raise a safety and effectiveness issue.

Note 12:

The subject device has a different weight than the predicate devices. This difference in functional specification will not raise a safety and effectiveness issue.

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.