(90 days)
No
The summary describes a standard iontophoresis device controlled by a microcontroller, with no mention of AI, ML, or related concepts. The performance studies focus on electrical output and safety standards, not algorithmic performance.
Yes
The device is intended to introduce ions of soluble salts or other drugs into the body using direct current, which is a therapeutic function.
No
Explanation: The device is described as introducing ions of soluble salts or drugs into the body, and its main function is to deliver direct current to a drug delivery electrode. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "bench-top, battery powered, microcontrollercontrolled iontophoresis device" that delivers direct current, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the IontoDC device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to introduce ions or drugs into the body through the skin. This is an in vivo application, meaning it interacts directly with a living organism.
- Device Description: The description reinforces this by explaining how it delivers current to an electrode placed on the patient's skin to facilitate drug migration through the skin into localized tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests outside of the living body on biological samples. The IontoDC device operates on the body.
N/A
Intended Use / Indications for Use
IontoDC is intended to use a direct current to introduce ions of soluble salts or other drugs into the body.
Product codes
EGJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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.
Key Metrics
- Current Intensity: 1.0 - 2.0 mA DC
- Current Accuracy: +/- 1%
- Current Precision: 0.1 mA
- Voltage at Electrodes: +/- 0-40 Volts
- Maximum Total Deliverable Dose: 80 mA-min
- Single Treatment Deliverable Dose: 10mA - 80 mA-min
- Number of 40 mA-min. Treatments: 2
- Minimum Treatment Time: 10 min
- Maximum Treatment Time: 40 min
- Timing Accuracy: +/- 3 second
Predicate Device(s)
Reference Device(s)
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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Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle.
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
1
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.
2
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
3
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
5
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
(Primary
Predicate) | Comparison | |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------|
| 510(k) | To Be Determined | K020476 | K043047 | -- | |
| Device Name | IontoDC | ActivaDose II | Dynatron® ibox | -- | |
| Manufacturer | Soterix Medical,
Inc. | ActivaTek. Inc. | Dynatronics
Corporation | -- | |
| Parameter | IontoDC | ActivaDose II
(Reference Device) | Dynatron® IBox
(Primary
Predicate) | Comparison | |
| Indications For
Use | IontoDC is
intended to use a
direct current to
introduce ions of
soluble salts or
other drugs into
the body. | The ActivaDose II
Iontophoresis
Delivery Unit is
indicated for the
administration of
soluble salts or other
drugs into the body
for medical purposes
as an alternative to
hypodermic
injection in
situations when it is
advisable to avoid
the pain that may
accompany needle
insertion and drug
injection, when it is
advisable to
minimize the
infiltration of carrier
fluids, or to avoid
the damage caused
by needle insertion
when tissue is
traumatized. | Dynatron® ibox
iontophoresis
System is intended
to use a direct
current to
introduce ions of
soluble salts or
other drugs into the
body. | Identical to
Primary
Predicate | |
| Power source | Battery Powered | Battery Powered | Battery Powered | Identical | |
| Number, Size, and
Type of Batteries | Two 9 Volt
Alkaline batteries | One 9V DC
Alkaline Battery | Two 1.5 Volt AA
Alkaline batteries | SE
Note 1 | |
| Output Jacks | 2 | 1 | 2 | Identical to
Primary
Predicate | |
| Current Intensity | 1.0 - 2.0 mA DC | 0.0 - 4.0 mA DC | 0.5 - 4.0 mA DC | SE
Note 2 | |
| Current Accuracy | +/- 1% | -- | +/- 10% | SE | |
| Parameter | IontoDC | ActivaDose II
(Reference Device) | Dynatron® IBox
(Primary
Predicate) | Comparison | |
| | | | | Note 3 | |
| Current Precision | 0.1 mA | 0.1 mA | 0.1 mA | Identical | |
| Voltage at
Electrodes | +/- 0-40 Volts | 80 Volts | +/- 0-46 Volts | SE
Note 4 | |
| Electrode Cable
Jacks | Shielded banana | -- | Custom 2-pin
polarized | SE
Note 5 | |
| Maximum Total
Deliverable Dose | 80 mA-min | 80 mA-min | 3360 mA-min | Identical to
Reference
Device | |
| Single Treatment
Deliverable Dose | 10mA - 80 mA-
min | 0 - 80 mA-min | 1 - 160 mA-min | SE
Note 6 | |
| Number of 40 mA-
min. Treatments | 2 | 2 | 89 | Identical to
Reference
Device | |
| Minimum
Treatment Time | 10 min | 1.5 seconds | 15 seconds | SE
Note 7 | |
| Maximum
Treatment Time | 40 min | 20 minutes | 100 minutes | SE
Note 8 | |
| Timing Accuracy | +/- 3 second | +/- 1 second | +/- 1 second | SE
Note 9 | |
| Polarity
Options: | Positi
ve (+) | YES | YES | YES | Identical |
| | Negat
ive (-) | YES | YES | YES | Identical |
| | Dual
Polar
ity | NO | NO | YES | Identical to
Reference
Device |
| Parameter | | IontoDC | ActivaDose II
(Reference Device) | Dynatron® Ibox
(Primary Predicate) | Comparison |
| | (+/-) | | | | |
| Low
Battery
Warning: | Durin
g
Treat
ment | YES | YES | YES, at 2.0 V
remaining | Identical |
| | At
Powe
r-On | YES | YES | YES, if 2.2 mA | YES, at 4 mA | Yes, if >6 mA on
any channel | SE
Note 10 |
| Certificate
s: | IEC
60601
-1 | YES | | YES | Identical |
| | CSA/
NRT
L | YES | | YES | Identical |
| Dimensions (in.) [L
x W x H] | | 7.91" x 5.9" x
2.83" | 6.1" x 3.5" x 1.9" | 4.5" x 2.66" x
1.25" | SE
Note 11 |
| Weight (lbs., oz.)
[Without battery
or electrode
cables] | | 1 lb 3oz | .4 lbs | 3.6 oz. | SE
Note 12 |
| Display | | Digital Display | Digital Display | Organic Light
Emitting Diodes
(OLED) | Identical to
Reference
Device |
6
7
8
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.
9
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.