(60 days)
Not Found
No
The device description and performance studies focus on the physical principles of iontophoresis and the electrical control of drug delivery, with no mention of AI or ML algorithms for analysis, prediction, or control.
Yes
The device is indicated for "administration of soluble salts or other drugs into the body for medical purposes," which directly serves a therapeutic function by delivering medication.
No
This device is used for drug delivery (iontophoresis) and is not intended to diagnose medical conditions.
No
The device description explicitly states that the system consists of physical components: an active delivery electrode, a return electrode, and a handle. It also mentions attaching to a "Phoresor" device which provides current control, indicating a hardware component.
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 administration of drugs into the body for medical purposes, specifically as an alternative to injections and for dermal administration. This is a therapeutic application, not a diagnostic one.
- Device Description: The device uses a direct current to introduce ions into the body through the skin. This is a method of drug delivery, not a method for examining specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
- Performance Studies: The performance studies focus on drug delivery rate in vitro (using excised skin) and primary dermal irritation in vivo (in rabbits). These studies evaluate the device's ability to deliver drugs and its safety when applied to the skin, not its ability to diagnose a condition or provide diagnostic information.
- Key Metrics: The key metrics are related to dermal irritation, which is a measure of the device's safety during drug delivery, not a diagnostic metric.
IVD devices are used to examine specimens such as blood, urine, or tissue in vitro to provide information about a person's health. This device operates in vivo (on the living body) to deliver medication.
N/A
Intended Use / Indications for Use
Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).
Product codes
EGJ
Device Description
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 for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent on the charge and molecular weight of the ion, the strength of the electrical current applied, electrode composition, duration of current flow, and numerous other factors.
The IOMED, Inc. MW-1000 iontophoresis system consists of an active delivery electrode and a return electrode. The electrodes are designed for a single-patient, oncapplication use and should be used with IOMED's approved iontophoretic dose controller. The active delivery electrode is attached to a handle which is used to guide the device over the area to be treated. The handle is designed to be reused.
The IOMED, Inc. MW-1000 iontophoresis system is designed to attach to IOMED's approved Phoresor . These devices provide control of the current and therefore dosage delivered.
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)
Drug delivery rate measurements of both negatively and positively charged drugs were performed in vitro in freshly excised hairless mouse skin using the method described by Petelenz et. Al., J Controlled Release 20 (1992), 55-56. Commercial formulations of dexamethasone sodium phosphate (0.4% w/v dexamethasone phosphate equivalent) and lidocaine hydrochloride (4% w/v) were used as model drugs for cathodal (-) and anodal (+) iontophoresis, respectively. Drugs quantization in the skin and receptor solution was performed by radioassay using 3H-dexamethasone sodium phosphate and 14C-lidocaine hydrochloride tracers. The MW-1000 drug electrode is identical to that used for the RH-801/GS with the exception of the skin fixation material. This difference will not affect the results of this testing. This testing shows that both negatively and positively charged drugs can be effectively delivered using the drug electrode to be used with the MW-1000.
Primary dermal irritation studies were carried out in rabbits in accordance with FDA regulations for Good Laboratory Practices using Dexamethasone sodium phosphate and lidocaine hydrochloride as model compounds. Using standard Primary Dermal Irritation Index scores of 0.0 (non-irritant), 0.1 - 2.0 (mild irritant), 2.1 - 5.9 (moderate irritant), and 6.0 and greater (severe irritant), the RH-801/GS was rated as a mild irritant (0.5) during lidocaine administration, a nonirritant during a Dexamethasone administration from a Dexamethasone/lidocaine (1:2) mixture, and a non-irritant during Dexamethasone administration alone. This testing was done as part of the RH-801/GS 510(k) (K932621). The materials used in the MW-1000 drug electrode are identical to those used for the RH-801/GS with the exception of the skin fixation material. This difference will not affect the results of this testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 description: The image shows the word "IOMED" in a bold, sans-serif font. The letters are all capitalized except for the "i", which is lowercase. The word is slightly slanted to the right, giving it a dynamic appearance. The color of the text is black, and the background is white.
MAR 3 1 2006
SUMARY OF SAFETY AND EFFECTIVENESS Iontophoresis Electrode
Date of Summary: 27 January 2006
A. General Provisions
| Submitter's Name: | IOMED, Inc. |
|---|---|
| Submitter's Address: | 2441 South 3850 West, Suite A |
| Salt Lake City, UT 84120-9941 | |
| Contact Person: | Curtis Jensen |
| Director, Quality and Regulatory | |
| Classification Name: | Iontophoresis Device |
| 21 CFR 890.5525 | |
| Proprietary Name: | MW-1000 Iontophoretic Drug Delivery Electrode |
| Common Name: | Iontophoresis Drug Delivery Electrode |
B. Name of Predicate Device(s)
- Iontophoresis Device:K932621 . Iontophoresis Drug Delivery Electrode IOMED, Inc. RH-801/GS Iontophoretic Drug Delivery Electrode
- . Iontophoresis Device: K042590 Iontophoresis Drug Delivery System Mattioli Engineering Transderm Ionto System, MK 2
C. Device Description
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 for medical purposes. Iontophoresis technology is based on the principle that an electric potential will cause ions in solution to migrate according to their electrical charges. The quantity and distribution of a drug delivered into and across the skin by iontophoresis is dependent on the charge and molecular weight of the ion, the strength of the electrical current applied, electrode composition, duration of current flow, and numerous other factors.
The IOMED, Inc. MW-1000 iontophoresis system consists of an active delivery electrode and a return electrode. The electrodes are designed for a single-patient, oncapplication use and should be used with IOMED's approved iontophoretic dose controller. The active delivery electrode is attached to a handle which is used to guide the device over the area to be treated. The handle is designed to be reused.
The IOMED, Inc. MW-1000 iontophoresis system is designed to attach to IOMED's approved Phoresor . These devices provide control of the current and therefore dosage delivered.
1
D. Intended Use
Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).
E. Drug Delivery and Biocompatibility
Drug Deliverv
Drug delivery rate measurements of both negatively and positively charged drugs were performed in vitro in freshly excised hairless mouse skin using the method described by Petelenz et. Al., J Controlled Release 20 (1992), 55-56. Commercial formulations of dexamethasone sodium phosphate (0.4% w/v dexamethasone phosphate equivalent) and lidocaine hydrochloride (4% w/v) were used as model drugs for cathodal (-) and anodal (+) iontophoresis, respectively. Drugs quantization in the skin and receptor solution was performed by radioassay using 3H-dexamethasone sodium phosphate and 14C-lidocaine hydrochloride tracers. The MW-1000 drug electrode is identical to that used for the RH-801/GS with the exception of the skin fixation material. This difference will not affect the results of this testing.
This testing shows that both negatively and positively charged drugs can be effectively delivered using the drug electrode to be used with the MW-1000.
Safety and Biocompatibility
Primary dermal irritation studies were carried out in rabbits in accordance with FDA regulations for Good Laboratory Practices using Dexamethasone sodium phosphate and lidocaine hydrochloride as model compounds. Using standard Primary Dermal Irritation Index scores of 0.0 (non-irritant), 0.1 - 2.0 (mild irritant), 2.1 - 5.9 (moderate irritant), and 6.0 and greater (severe irritant), the RH-801/GS was rated as a mild irritant (0.5) during lidocaine administration, a nonirritant during a Dexamethasone administration from a Dexamethasone/lidocaine (1:2) mixture, and a non-irritant during Dexamethasone administration alone.
This testing was done as part of the RH-801/GS 510(k) (K932621). The materials used in the MW-1000 drug electrode are identical to those used for the RH-801/GS with the exception of the skin fixation material. This difference will not affect the results of this testing.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.
Public Health Service
MAR 3 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IOMED, Inc c/o Mr. Curtis Jensen Director, Quality and Regulatory 2441 South 3850 West, Suite A Salt Lake City, Utah 84120
Re: K060236 Trade/Device Name: MW - 1000 Iontophoretic Drug Delivery Electrode Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: January 27, 2006 Received: January 30, 2006
Dear Mr. Jensen:
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), 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. 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.
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Page 2 - Mr. Curtis Jensen
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:
Kevin Lee, M.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) 594-1296
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, please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by
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Page 3 – Mr. Curtis Jensen
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,
Helent Semer
/ Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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Indications for Use
Applicant: Iomed, Inc.
510(k) Number (if known):
Device Name: MW-1000 Iontophoretic Drug Delivery Electrode
Indications For Use: Iontophoretic drug delivery electrodes are indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodernic injections. They are also indicated for iontophoretic dermal administration of IONTOCAINE® (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution).
Division of General, Restorative, 1 and Neurological Devices
510(k) Number K060236
Prescription Use (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
004