(109 days)
No
The summary describes a passive electrode system and does not mention any computational or algorithmic components, let alone AI/ML.
Yes
The device is described as "designed for use with the Dupel Iontophoresis System (K903093) which is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections," clearly indicating a therapeutic purpose.
No
The device is described as electrodes for the local administration of ionic solutions into the body, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states it consists of physical electrodes, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "local administration of ionic solutions into the body for medical purposes and can be used 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 electrodes for delivering substances into the body, not for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of diagnostic information being generated.
Therefore, the Dupel® II Buffered Iontophoresis Electrodes are a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The Dupel® II Buffered Iontophoresis Electrode System is designed for use with the Dupel Iontophoresis Drug Delivery System. It is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.
Product codes (comma separated list FDA assigned to the subject device)
EGJ
Device Description
The Dupel® II Buffered Iontophoresis Electrode System consists of an active drug delivery electrode and a passive return electrode. Both electrodes have buffering capability for up to a 160mAmin treatment session. These electrodes are designed for single patient, one application use. There are multiple sizes and shapes of drug delivery electrodes to accommodate placement at different body sites. The size of the return electrode is the same for all drug delivery electrode sizes.
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 Test Results: The following parameters were evaluated and/or tested: electrical resistance; pH buffering ability; fill rate, and material biocompatibility. The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements, is acceptable for its intended use and is equivalent to the predicate electrodes.
Conclusion from Testing: The data obtained from the design qualification tests demonstrate that this electrode is as safe, as effective and performs as well as the current Empi Electrode. In conclusion, the test results verified that the modified product is substantially equivalent to the currently marketed product.
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.
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.
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
SUMMARY OF 510(k) SAFETY AND EFFECTIVENESS INFORMATION
Image /page/0/Picture/1 description: The image shows the word "Empi" in a bold, italicized font. The letters are black and the background is white. There is a registered trademark symbol to the right of the letter "i".
Cost Effective Health Care Solutions
MAY 30 199
Empi, Inc. 599 Cardigan Road St. Paul, Minnesota 55126-3965 USA
612-415-9000 FAX 612-415-7305
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K970491
| Applicant name: | Empi, Inc. | |
|---|---|---|
| Applicant address: | 599 Cardigan Road | |
| St. Paul, MN 55126-3965 | ||
| Contact person: | Stacy Mattson, Regulatory Affairs Manager | |
| Phone: | 612-415-7354 | |
| FAX: | 612-415-7314 | |
| Date Prepared: | February 6, 1997 | |
| Identification: | ||
| Classification Name: | Iontophoresis Device | |
| Common/Usual Name: | Iontophoresis Electrode | |
| Trade/Proprietary Name: | Dupel® II Buffered Iontophoresis Electrode System |
Predicate Device:
Empi Buffered Iontophoresis Electrode (K912015)
Product Description:
The Dupel® II Buffered Iontophoresis Electrode System consists of an active drug delivery electrode and a passive return electrode. Both electrodes have buffering capability for up to a 160mAmin treatment session. These electrodes are designed for single patient, one application use. There are multiple sizes and shapes of drug delivery electrodes to accommodate placement at different body sites. The size of the return electrode is the same for all drug delivery electrode sizes.
Intended Use:
The Dupel II Buffered Iontophoresis Electrode System is designed for use with the Dupel Iontophoresis Drug Delivery System. It is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.
1
Image /page/1/Picture/1 description: The image shows the word "Empi" in a bold, sans-serif font. The letters are black and slightly slanted to the right. A small circle with an "R" inside is located to the right of the "i", indicating a registered trademark.
Cost Effective Health Care Solutions
Empi, Inc. 599 Cardigan Road St. Paul, Minnesota 55126-3965 USA
612-415-9000 FAX 612-415-7305
Comparison of Technological Differences Between Original Electrodes and Modified Electrodes:
The modifications to the drug delivery electrode do not significantly impact the original product specifications for the Dupel® Buffered Iontophoresis Electrodes. The ability to buffer remains the same, the fill rate is the same, the active area is essentially the same, and the level of material biocompatibility is the same. The two parameters which have changed are electrical resistance and fill volume. The lowered resistance specification on the modified electrode may lengthen the device battery life. The fill volume has increased slightly but this parameter relates to convenience and does not impact the amount of drug that is delivered.
Assessment of Performance Data:
Non-Clinical Test Results
The following parameters were evaluated and/or tested: electrical resistance; pH buffering ability; fill rate, and material biocompatibility. The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements, is acceptable for its intended use and is equivalent to the predicate electrodes.
Conclusion from Testing
The data obtained from the design qualification tests demonstrate that this electrode is as safe, as effective and performs as well as the current Empi Electrode. In conclusion, the test results verified that the modified product is substantially equivalent to the currently marketed product.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be slightly faded or aged. The image is a close-up of the seal, with no other objects or details visible.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stacy Mattson, RAC, BSN Regulatory Affairs Manager ... ... Empi, Inc. 599 Cardigan Road St. Paul, Minnesota 55126-3965
MAY 30 1997
K970491 Re : Dupel® II Buffered Iontophoresis Electrode System Requlatory Class: III Product Code: EGJ Dated: May 16, 1997 Received: May 19, 1997
Dear Ms. Mattson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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), as long as you comply with all of the Act's requirements relating to drugs labeled or promoted with the device as described below. 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 practices, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations (CFR), Title 21, Parts 800 to 895. में substantially equivalent determination assumes compliance with
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Page 2 - Stacy Mattson, RAC, BSN
the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will-verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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
As you are aware, Iontophoresis devices that are intended to use a direct current to introduce ions of soluble salts or other drug 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 II. 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 II devices is classified into class III (21 CFR 890. 5525) .
We published our strategy for calling for premarket approval (PMA) applications in the enclosed Federal Register, dated May 6, 1994.
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Page 3 - Stacy Mattson, RAC, BSN
I would also like to inform you that in the future, FDA intends to issue a proposed rule amending its regulations to require the filling of a PMA for all class III iontophoresis The announcement will be published in the Federal devices. Register. FDA intends that if a final rule is issued, based on the proposed rule, PMA's will be required to be submitted within 90 days of the effective date of the final rule.
This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. Arı FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice regarding labeling for your device in accordance with 21 CFR Part 801, promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health .
Enclosures
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510(k) Number: (if known): .
Device Name: Dupel® II Buffered Iontophoresis Electrode System
Indications for Use:
The Dupel® II Buffered Iontophoresis Electrodes are designed for use with the Dupel Iontophoresis System (K903093) which is indicated for the local administration of ionic solutions into the body for medical purposes and can be used as an alternative to injections.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K970499 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The Counter Use | |
|---|---|---|---|
| --------------------------------------- | -- | ---- | ---------------------- |
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Premarket NotificationPremarket Notification Dupel® II Buffered Iontophoresis Electrode System