(93 days)
Not Found
No
The description focuses on the physical components and the principle of iontophoresis, which is based on electrical current and ion migration. While it mentions a "microprocessor-controlled device" that controls current and monitors parameters, this is standard for many medical devices and does not indicate AI/ML. There is no mention of learning, adaptation, or complex pattern recognition.
Yes
The device is an iontophoretic drug delivery electrode, explicitly indicated for the administration of soluble salts or other drugs into the body for medical purposes, functioning as an alternative to hypodermic injections. This direct application of drugs for medical purposes qualifies it as a therapeutic device.
No
Explanation: The device is described as an "Iontophoretic drug delivery electrode" intended for the administration of drugs into the body, not for diagnostic purposes. Its function is to deliver substances, not to identify or characterize medical conditions.
No
The device description clearly outlines physical components (electrodes, fabric, carbon conductive element, adhesive tape) and mentions its use with a separate hardware system (Phoresor® Iontophoretic Drug Delivery Systems). This indicates it is a hardware device, not software-only.
Based on the provided text, 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 through the skin, as an alternative to injections. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description focuses on the mechanism of drug delivery via iontophoresis and the components of the electrodes used for this purpose. It does not describe any components or processes related to testing samples in vitro (outside the body) to diagnose a condition.
- Performance Studies: The performance studies described relate to drug delivery efficacy and biocompatibility with the skin, which are relevant to a therapeutic device. There are no studies mentioned that involve analyzing biological samples for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to deliver a substance into the body, not to analyze something from the body.
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 (comma separated list FDA assigned to the subject device)
KTB, 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 RH-900 consists of an active delivery electrode and a passive return electrode. Both electrodes have buffering capability for up to an 80mA-min treatment. These electrodes are designed for a single-patient, one-application use.
This electrode is recommended for use with the Phoresor® Iontophoretic Drug Delivery Systems (Iomed, Inc., Salt Lake City, UT 84120). This system is a 9-volt battery powered, solid state, microprocessor-controlled device that controls current levels and duration, calculates total charge delivered and monitors current flow and electrode/skin impedance.
The RH-900 electrode consists of a dry, monolithic, impregnated nonwoven polyester fabric liquid containment element designed to be hydrated with an aqueous solution immediately prior to use. It also has a carbon conductive element and an adhesive tape border for skin fixation. All components in contact with the skin are known GRAS materials and/or are listed in the National Formulary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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: Iontophoretic transport with the RH-900 electrode of both negative and positive charged drugs was compared to transport with currently marketed electrodes in hairless mouse skin in vitro by methods described by Petelenz et al., J Controlled Release 20 (1992), 55-56. Model drugs used for these comparisons were radiolabeled dexamethazone sodium phosphate (-) (corticosteroid) and lidocaine hydrochloride (+) (local anesthetic). The testing shows that these model drugs can be comparably delivered using the RH-900.
Biocompatibility: Primary dermal irritation studies were carried out in rabbits in accordance with FDA regulations for Good Laboratory Practices (GLP) using normal saline. The protocol was designed according to ISO 10993-10:2002, and the device was tested from both positive and negative polarities. The results of the testing showed that the RH-900 was rated negligible (0.4) when operated from the negative polarity and slight (0.6) from the positive polarity. These scores are based on the following scale: 0.0 to 0.4: negligible; 0.5 to 1.9: slight; 2.0 to 4.9: moderate; 5.0 to 8.0: severe. These scores are comparable to the Iomed, Inc. RH-806/GS (TransO2/GS) marketed electrode.
Cytotoxicity testing was performed on the hydratable non-woven material following GLP procedures. Test results show a cytotoxic grade of 2 (on a 0 to 4 scale). This indicates 'mild' reactivity. This meets USP and ISO 10993-10 requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Dermal Irritation Scores:
- Negative polarity: 0.4 (negligible)
- Positive polarity: 0.6 (slight)
Cytotoxicity Grade: 2 (mild reactivity on a 0 to 4 scale)
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.
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 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 text is black against a white background.
JUL 1 0 2003
SUMARY OF SAFETY AND EFFECTIVENESS Iontophoresis Electrode
Date of Summary: 7 April 2003
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 |
| Quality and Regulatory Manager | |
| Classification Name: | Iontophoresis Device |
| 21 CFR 890.5525 | |
| Proprietary Name: | RH-900 |
| Common Name: | Iontophoresis Drug Delivery Electrode |
B. Name of Predicate Device(s)
- Iontophoresis Device K932620 Iontophoresis Drug Delivery Electrode Iomed, Inc. RH-806/GS (TransO2/GS)
- . Iontophoresis Device K983484 Iontophoresis Drug Delivery Electrode Empi Dupel B.L.U.E.TM (Bi-layer Ultra Electrode)
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 RH-900 consists of an active delivery electrode and a passive return electrode. Both electrodes have buffering capability for up to an 80mA-min treatment. These electrodes are designed for a single-patient, one-application use.
This electrode is recommended for use with the Phoresor® Iontophoretic Drug Delivery Systems (Iomed, Inc., Salt Lake City, UT 84120). This system is a 9-volt battery powered, solid state, microprocessor-controlled device that controls current
1
levels and duration, calculates total charge delivered and monitors current flow and electrode/skin impedance.
The RH-900 electrode consists of a dry, monolithic, impregnated nonwoven polyester fabric liquid containment element designed to be hydrated with an aqueous solution immediately prior to use. It also has a carbon conductive element and an adhesive tape border for skin fixation. All components in contact with the skin are known GRAS materials and/or are listed in the National Formulary.
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 Delivery
Iontophoretic transport with the RH-900 electrode of both negative and positive charged drugs was compared to transport with currently marketed electrodes in hairless mouse skin in vitro by methods described by Petelenz et al., J Controlled Release 20 (1992), 55-56 (see 'Performance' section of this document). Model drugs used for these comparisons were radiolabeled dexamethazone sodium phosphate (-) (corticosteroid) and lidocaine hydrochloride (+) (local anesthetic). The testing shows that these model drugs can be comparably delivered using the RH-900.
Biocompatibility
Primary dermal irritation studies were carried out in rabbits in accordance with FDA regulations for Good Laboratory Practices (GLP) using normal saline. The protocol was designed according to ISO 10993-10:2002, and the device was tested from both positive and negative polarities.
The results of the testing showed that the RH-900 was rated negligible (0.4) when operated from the negative polarity and slight (0.6) from the positive polarity. These scores are based on the following scale:
- -0.0 to 0.4: negligible
- 0.5 to 1.9: slight -
- 2.0 to 4.9: moderate -
- -5.0 to 8.0: severe
These scores are comparable to the Iomed, Inc. RH-806/GS (TransO2/GS) marketed electrode. The difference in scales from the testing of the predicate device makes an exact comparison difficult, but it was rated in the lowest range
2
(mild irritant). Similar scores from the Empi B.L.U.E.™ are not available for comparison.
Although data is available showing that there are no known health hazards associated with the RH-900 hydratable non-woven material, cytotoxicity test results were not available. Therefore cytotoxicity testing was performed on the hydratable non-woven material following GLP procedures. This is the only material that is used in the RH-900 that has no cytotoxicity data available for it. All other materials are GRAS. Test results show a cytotoxic grade of 2 (on a 0 to 4 scale). This indicates 'mild' reactivity. This meets USP and ISO 10993-10 requirements and shows that all the materials used in the RH-900 are safe to come in limited contact with intact patient skin.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 2003
Mr. Curtis Jensen Ouality and Regulatory Manager lomed. Inc. 2441 South 3850 West, Suite A Salt Lake City, Utah 84120-1191
Re: K031115
Trade/Device Name: RH-900 Iontophoretic Drug Delivery Electrode Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: II and III Product Code: KTB, EGJ Dated: April 7, 2003 Received: April 8, 2003
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
4
Page 2 - Mr. Curtis Jensen
forth in the quality systems (OS) 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 drugs for use with your device. Therefore, you may neither label nor promote your device for use with specific drugs other than Iontocaine (Lidocaine HCl 2% and Epinephrine 1:100,000 Topical Solution), nor package drugs with vour 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 (301) 594- 4659. Also, please note the regulation entitled, "Misbranding by
5
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,
Mark A. Milheim
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
6
Indications for Use Statement
Applicant: Iomed, Inc. KO31115 510(k) Number (if known): Device Name: RH-900 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). eral, Restorative and Neurological Devices 510(k) Number. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)