(90 days)
Not Found
No
The description mentions a microprocessor for precise control and an LED for indication, but there is no mention of AI, ML, or related concepts.
Yes
The device is used for the "local administration of ionic solutions into the body for medical purposes," which indicates a therapeutic intent.
No
The device is described for the "local administration of ionic solutions into the body for medical purposes and as an alternative to injections," indicating a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a disposable, single-use iontophoresis device with a self-contained battery, electrical circuitry, power module, delivery electrode, return electrode, and lead wires, indicating it is a hardware device with embedded software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "local administration of ionic solutions into the body for medical purposes and as an alternative to injections." This describes a therapeutic or drug delivery device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the mechanism of delivering ionic solutions through iontophoresis, a method of drug delivery. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is to facilitate the movement of substances into the body, not to analyze substances from the body.
Therefore, the Empi Dupel Transport Smart Iontophoresis System falls under the category of a therapeutic or drug delivery device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Empi Dupel Transport Smart Iontophoresis System can be used for the local administration of ionic solutions into the body for medical purposes and as an alternative to injections.
Product codes (comma separated list FDA assigned to the subject device)
EGJ
Device Description
The Empi Dupel Transport Iontophoresis System is a disposable, single-use iontophoresis device with a self-contained battery and electrical circuitry. The system includes a power module, delivery electrode, return electrode and lead wires. The Dupel Transport is capable of delivering both negatively and positively charged ionic solutions. The device uses a microprocessor to precisely control the delivery time of 3 hours. An LED is utilized to confirm the device is turned on and provides an indication of how much time is remaining in the treatment period.
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
Not Found
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 Testing: Verification of the Empi Dupel Transport Iontophorcsis System includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions. Validation testing for the Dupel Transport Iontophoresis System includes testing to show the device meets according to marketing requirements.
Clinical Testing: No prospective clinical studies are required to demonstrate safety and efficacy of the in support of applications for regulatory approval/clearance in the target markets. The Dupel Transport Iontophoresis does not differ from the predicate devices in technological characteristics or intended use, where the device has a significant influence on clinical endpoints, and where prospective clinical studies would be necessary to determine safety and efficacy equivalence. The Product does not fit the profile of devices that might require clinical data per FDA guidance document 95-4158.
Conclusion: The non-clinical testing demonstrates that the Empi Dupel Transport Iontophoresis System is substantially equivalent the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Empi Action Patch® Iontophoresis System (K030395), Empi Dupel® Iontophoresis System (K915444), Empi Dupel B.L.U.E.® Iontophoresis Electrode (K970491, K983484)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5525 Iontophoresis device.
(a)
Iontophoresis device intended for certain specified uses —(1)Identification. An iontophoresis device is a device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body and induce sweating for use in the diagnosis of cystic fibrosis or for other uses if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug. When used in the diagnosis of cystic fibrosis, the sweat is collected and its composition and weight are determined.(2)
Classification. Class II (performance standards).(b)
Iontophoresis device intended for any other purposes —(1)Identification. An iontophoresis device intended for any other purposes is a prescription device that is intended to use a current to introduce ions of drugs or non-drug solutions into the body for medical purposes other than those specified in paragraph (a) of this section, meaning that the device is not intended for use in diagnosis of cystic fibrosis, or a specific drug is not specified in the labeling of the iontophoresis device.(2)
Classification. Class II (special controls). The device is classified as class II. The special controls for this device are:(i) The following performance testing must be conducted:
(A) Testing using a drug approved for iontophoretic delivery, or a solution if identified in the labeling, to demonstrate safe use of the device as intended;
(B) Testing of the ability of the device to maintain a safe pH level; and
(C) If used in the ear, testing of the device to demonstrate mechanical safety.
(ii) Labeling must include adequate instructions for use, including sufficient information for the health care provider to determine the device characteristics that affect delivery of the drug or solution and to select appropriate drug or solution dosing information for administration by iontophoresis. This includes the following:
(A) A description and/or graphical representation of the electrical output;
(B) A description of the electrode materials and pH buffer;
(C) When intended for general drug delivery, language referring the user to drug labeling approved for iontophoretic delivery to determine if the drug they intend to deliver is specifically approved for use with that type of device and to obtain relevant dosing information; and
(D) A detailed summary of the device-related and procedure-related complications pertinent to use of the device, and appropriate warnings and contraindications, including the following warning:
Warning: Potential systemic adverse effects may result from use of this device. Drugs or solutions delivered with this device have the potential to reach the blood stream and cause systemic effects. Carefully read all labeling of the drug or solution used with this device to understand all potential adverse effects and to ensure appropriate dosing information. If systemic manifestations occur, refer to the drug or solution labeling for appropriate action.(iii) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.
(iv) Appropriate software verification, validation, and hazard analysis must be performed.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) The elements of the device that may contact the patient must be assessed for sterility, for devices labeled as sterile.
(vii) Performance data must support the shelf life of the elements of the device that may be affected by aging by demonstrating continued package integrity and device functionality over the stated shelf life.
0
MAY 1 4 2007
510(k) Summary
| 510(k) Owner's Name: | Empi |
|---|---|
| Address: | 599 Cardigan Rd. |
| St. Paul, MN 55126 | |
| Phone number: | 651-415-7344 |
| Fax number: | 651-415-7497 |
| Email: | swalrod@empi.com |
| Contact person: | Sandra Walrod, Regulatory Affairs Associate |
| Date prepared: | February 9, 2007 |
| Trade name: | Empi Dupel® Transport Iontophoresis System |
| Common name: | Iontophoresis Device |
| Classification name: | Iontophoresis Device (21 CFR 890.5525) |
| Product Code: | EGJ |
| Classification: | Class III |
| Predicate devices: | Empi Action Patch® Iontophoresis System (K030395), Empi Dupel® Iontophoresis System (K915444), Empi Dupel B.L.U.E.® Iontophoresis Electrode (K970491, K983484) |
Device Description:
The Empi Dupel Transport Iontophoresis System is a disposable, single-use iontophoresis device with a self-contained battery and electrical circuitry. The system includes a power module, delivery electrode, return electrode and lead wires. The Dupel Transport is capable of delivering both negatively and positively charged ionic solutions. The device uses a microprocessor to precisely control the delivery time of 3 hours. An LED is utilized to confirm the device is turned on and provides an indication of how much time is remaining in the treatment period.
Intended Use:
The Empi Dupel Transport Smart Iontophoresis System can be used for the local administration of ionic solutions into the body for medical purposes and as an alternative to injections.
Comparison to predicate:
1
compared to the Action Patch Iontophoresis System. Like the Dupel Iontophoresis System the Dupel Transport is capable of delivering both negatively charged ionic solutions. The Empi Dupel Transport Iontophoresis System uses the similar battery power source as the Empi Action Patch Iontophoresis System. The major differences between the Action Patch and the Dupel Transport are the ability to accommodate both positive and negative ionic drugs, the timing mechanism which is controlled by a microprocessor in the Dupel Transport and the case housing.
Non-clinical Testing:
Verification of the Empi Dupel Transport Iontophorcsis System includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions. Validation testing for the Dupel Transport Iontophoresis System includes testing to show the device meets according to marketing requirements.
Clinical Testing:
No prospective clinical studies are required to demonstrate safety and efficacy of the in support of applications for regulatory approval/clearance in the target markets. The Dupel Transport Iontophoresis does not differ from the predicate devices in technological characteristics or intended use, where the device has a significant influence on clinical endpoints, and where prospective clinical studies would be necessary to determine safety and efficacy equivalence. The Product does not fit the profile of devices that might require clinical data per FDA guidance document 95-4158.
Conclusion:
The non-clinical testing demonstrates that the Empi Dupel Transport Iontophoresis System is substantially equivalent the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2007
Empi % Ms. Sandra Walrod Regulatory Affairs Associate 599 Cardigan Road St. Paul. Minnesota 55126
Re: K070427
Trade/Device Name: Empi Dupel Transport Iontophoresis System Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device Regulatory Class: III Product Code: EGJ Dated: February 9, 2007 Received: February 13, 2007
Dear Ms. Walrod:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Ms. Sandra Walrod
Our substantially equivalent decision does not apply to drugs 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-3 10) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland
As you are aware, iontophoresis devices that are 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, were classified into Class 11. An iontophoresis device that is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes other than those specified for class 11 devices is classified into Class 111 (21 CFR 890.5525). We published our strategy for calling for premarket approval (PMA) applications in the enclosed Federal Register, dated May 6, 1994, and the enclosed memorandum, dated April 19, 1994, and the enclosed Federal Register, dated August 22, 2000.
If you have any questions regarding this letter, you may contact:
Brian Benson Food and Drug Administration Center for Devices and Radiological Health Division of General, Restorative and Neurological Devices 9200 Corporate Boulevard (HFZ-410) Rockville, Maryland 20850 (240) 276-3805
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small
4
Page 3 - Ms. Sandra Walrod
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buellner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Empi Dupel Transport Iontophoresis System
Indications for Use:
The Empi Dupel Transport Smart Iontophoresis System can be used for the local administration of ionic solutions into the body for medical purposes and as an alternative to injections.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Signature
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | Confidential K070427 |
|---|---|
| --------------- | ---------------------- |
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