(45 days)
Not Found
No
The device description explicitly states that the electrodes "do not contain active electronics, software or firmware" and are passive components that connect to a separate electronic device. There is no mention of AI or ML in the intended use, device description, or any other section.
No
The device itself delivers drugs, but it is indicated to be used with an "iontophoresis electronic device". The electrodes described are passive components that facilitate the delivery of drugs, but they do not perform the therapeutic function alone. They are accessories to the therapeutic device.
No
The device is described as an iontophoresis electrode intended to introduce soluble salts and other drugs into the body, which is a therapeutic function, not a diagnostic one.
No
The device is described as physical electrodes made of materials like carbon and hydrogel, intended for skin contact and drug delivery. It explicitly states that the electrodes "do not contain active electronics, software or firmware."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Pepin Manufacturing, Inc. iontophoresis electrodes are used to introduce soluble salts and other drugs into the body through the skin. This is an in vivo (within the living body) application, not an in vitro (outside the living body) test.
- Intended Use: The intended use is for drug delivery, not for analyzing a sample from the body to diagnose or monitor a condition.
Therefore, this device 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 Pepin Manufacturing, Inc. iontophoresis electrodes are intended to be used to introduce soluble salts and other dugs into the body.
Product codes (comma separated list FDA assigned to the subject device)
EGJ
Device Description
Iontophoresis electrodes described in this application are single patient use, disposable, nonsterile devices. Fundamentally the iontophoresis electrodes consist of two skin contacting electrodes: a drug delivery electrode and a return electrode. When connected to the user's iontophoresis electronic device, the electrodes localize administration of ionic drug solutions into the body for medical purposes. The electrodes provide the patient contact device. The electrodes are used under the supervision of a physician or other medical professional. The iontophoresis electrodes are intended for use only with approved drugs delivered by iontophoresis technology. There are variations of sizes and shapes of the drug delivery electrode. The size of the return electrode is constant for all drug delivery electrode variations. The iontophoresis electrodes do not include lead wires. The electrode electrical contact is made by a snap on the electrode. Iontophoresis electrodes are used under the direct supervision of a physician or medical professional. The electrodes are placed in contact with the skin to support introduction of soluble salts and other dugs into the body. The iontophoresis electrodes do not contain active electronics, software or firmware. The electrodes connect to the user's iontophoresis electronic device. The drug delivery electrode is a buffed gel covered carbon electrode. The return electrode is a buffered hydrogel material electrode. Electrode material biocompatibility is addressed in the submission.
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
physician or other medical professional
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)
Not Found
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.
K031053, K914264, K925800, K933620, K040495
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
Image /page/0/Picture/1 description: The image shows the logo for Pepin Manufacturing Inc. The logo consists of the letters "PMI" in large, bold, black font on the left side of the image. To the right of the letters, the words "PEPIN MANUFACTURING INC." are stacked vertically in a smaller, thinner font. The text is all in uppercase letters.
510(k) Summary
| Company Name: | Pepin Manufacturing, Inc.
Lake City, MN | |
|----------------------------|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact:
Phone:
Fax: | Jeff Solberg, President
651 345-5655
651 345-5656 | |
| Summary Date: | February 24, 2006 | |
| Trade Name: | Iontophoresis Drug Delivery System Electrodes | |
| Common Name: | Comfort/IO Iontophoresis Electrodes | |
| Classification Name: | 21 CFR 890.5525, Iontophoresis Device | |
| Predicate Device(s): | 510(k) Number:
Manufacture:
Trade Name: | K031053
Selective Med Components, Inc.
Buffered Iontophoresis Drug Delivery System Electrodes |
| | 510(k) Number:
Manufacture:
Trade Name: | K914264, K925800, K933620
Iomed, Inc.
Iontophoresis Drug Delivery Electrodes |
| | 510(k) Number:
Manufacture:
Trade Name: | K040495
North American Industrial Manufacturing Company
Naimco, Inc. Iontophoresis Drug Delivery Electrodes |
Description of Electrodes 1.0
Iontophoresis electrodes described in this application are single patient use, disposable, nonsterile devices. Fundamentally the iontophoresis electrodes consist of two skin contacting electrodes: a drug delivery electrode and a return electrode. When connected to the user's iontophoresis electronic device, the electrodes localize administration of ionic drug solutions into the body for medical purposes.
The electrodes provide the patient contact device. The electrodes are used under the supervision of a physician or other medical professional. The iontophoresis electrodes are intended for use only with approved drugs delivered by iontophoresis technology.
1875 HWY. 61 SOUTH • LAKE CITY, MINNESOTA, U.S.A. 55041 • (651) 345-5655 • FAX (651) 345-5656
Image /page/0/Picture/9 description: The image shows a logo with the letters "QR" stacked on top of each other inside of a square. The letter "Q" is on the bottom and the letter "R" is on the top. There is a star in the upper right corner of the square, above the letter "R". The logo is black and white.
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There are variations of sizes and shapes of the drug delivery electrode. The size of the return electrode is constant for all drug delivery electrode variations. The iontophoresis electrodes do not include lead wires. The electrode electrical contact is made by a snap on the electrode.
lontophoresis electrodes are used under the direct supervision of a physician or medical professional. The electrodes are placed in contact with the skin to support introduction of soluble salts and other dugs into the body.
Intended Use of Electrodes 2.0
The Pepin Manufacturing, Inc. iontophoresis electrodes are intended to be used to introduce soluble salts and other dugs into the body.
Technological Characteristics 3.0
The iontophoresis electrodes do not contain active electronics, software or firmware. The electrodes connect to the user's iontophoresis electronic device. The drug delivery electrode is a buffed gel covered carbon electrode. The return electrode is a buffered hydrogel material electrode. Electrode material biocompatibility is addressed in the submission.
The iontophoresis electrodes have the equivalent technological characteristics to predicate iontophoresis electrodes, including performance specifications, materials, sizes, packaging and labeling. Verification of performance and labeling are provided in the submission.
Conclusions 4.0
The Pepin Manufacturing, Inc. iontophoresis electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised.
2
Image /page/2/Picture/1 description: The image is a black and white logo. The logo consists of a circular border with text around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body or wings. The text around the border appears to be "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2006
Pepin Manufacturing, Inc. c/o Quality & Regulatory Associates, LLC Mr. Gary Syring Principal Consultant 800 Levanger Lanc Stoughton, Wisconsin 53589
Re: K060579
Trade/Device Name: Comfort/IO Iontophoresis Electrodes Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: February 24, 2006 Received: March 6, 2006
Dear Mr. Syring:
We have reviewed your Scetion 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), as long as you comply with all of the Act's requirements relating to drugs labeled or promoted with the devices 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 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 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. Your 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 nasset forth in the quality systems (QS) regulation (21 CFR Part 820); and if appliegable.items (20 tone product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050,
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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 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 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, 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:
Dora Vega, M.D., Ph.D. 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 (301) 594-3090
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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation, please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbrauding DV
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Page 3 -- Mr. Gary Syring
reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Herbert Lerner co
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
5
Indications for Use
510(k) Number (if known): K060579 -
Device Name: Comfort/IO Iontophoresis Electrodes
Indications for Use:
The Pepin Manufacturing, Inc. iontophoresis electrodes are intended to be used to introduce soluble salts and other dugs into the body.
Preseription 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 NEED DI
.. . . .. .. .. .. .. .. .. .. .. .. .. ..
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hicher Lenco
Division Sign Off
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K060715