(70 days)
Not Found
No
The description focuses on electrical pulse generation and drug delivery via iontophoresis, with no mention of AI or ML components.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections," which describes a therapeutic function.
No
Explanation: The device is described as a "powered iontophoresis drug delivery system" used for the "local administration of ionic drug solutions into the body." Its function is to deliver medication, not to diagnose a condition.
No
The device description clearly outlines physical hardware components including a probe, power supply/support, disposable drug delivery cap electrode, electronic pulse generator, and a TRANS-BASE module. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the TRANSDERM IONTO System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "local administration of ionic drug 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 details a system for applying electrical pulses to the skin to facilitate drug delivery. This aligns with a therapeutic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the TRANSDERM IONTO 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 TRANSDERM IONTO System is a powered iontophoresis drug delivery system that is indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.
Product codes
EGJ
Device Description
The TRANSDERM IONTO System consists of a probe, power supply/support, and a disposable drug delivery cap clectrode. Flectrical pulses are produced by an electronic pulse generator that is able to generate bursts of pulses that are applied to the skin through electrodes applied to a plastic plate (the applicator). The design of the device provides one channel output. The TRANSDERM IONTO System requires a DC supply of 9 V, 1.0 A max. This power source is supplied by, the TRANS-BASE module which is connected to mains through a removable supply cord and is equipped with a proper connector receptacle to fit the connector malc mounted on TRANSDERM IONTO probe supply cable. The TRANS-BASE is equipped with a 15 w AC-DC switch mode power module. The drug delivery cap electrode is adhered to the patient's skin and then saturated with ionic solution. Once the drug delivery cap electrode is affixed to the patient's skin, the TRANSDERM IONTO probe's applicator head can be attached to the internal side of the drug delivery cap electrode.
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
Performance testing and the applicable IEC 60601-1 standards testing was performed.
Key Metrics
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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| DEC - 2 2003 | SUMMARY OF SAFETY AND EFFECTIVENESS | K032968 | |||
|---|---|---|---|---|---|
| I. | GENERAL INFORMATION | ||||
| A. | Submitted By: | Mattioli Engineering Corporation | |||
| 7918 Jones Branch Drive | |||||
| Suite 600 | |||||
| McLean, VA 22102 |
Tel: 703-312-6000
Fax: 703-243-9139 | | |
| | | Contact Person: | Ms. Linda Ferri
At address above | | |
| | B. | Device Trade Name:
Common Name:
Classification Name: | TRANSDERM IONTO System
Iontophoresis Device
Device, Iontophoresis, Specific Uses | | |
| | C. | Predicate Devices: | | | |
| | | Manufacturer | Product Name | 510(k) No. | |
| | | Life-Tech, Inc.
Life-Tech, Inc. | Microphor®
Iontophor® II | K913601
K863166 | |
| II. | | DEVICE DESCRIPTION | | | |
II. DESCRIPTION
The TRANSDERM IONTO System consists of a probe, power supply/support, and a disposable drug delivery cap clectrode.
Flectrical pulses are produced by an electronic pulse generator that is able to generate bursts of pulses that are applied to the skin through electrodes applied to a plastic plate (the applicator). The design of the device provides one channel output.
The TRANSDERM IONTO System requires a DC supply of 9 V, 1.0 A max. This power source is supplied by, the TRANS-BASE module which is connected to mains through a removable supply cord and is equipped with a proper connector receptacle to fit the connector malc mounted on TRANSDERM IONTO probe supply cable. The TRANS-BASE is equipped with a 15 w AC-DC switch mode power module.
The drug delivery cap electrode is adhered to the patient's skin and then saturated with ionic solution. Once the drug delivery cap electrode is affixed to the
1
patient's skin, the TRANSDERM IONTO probe's applicator head can be attached to the internal side of the drug delivery cap electrode.
III. INDICATIONS FOR USE
The TRANSDERM IONTO System is a powered iontophorcsis drug delivery system that is indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.
IV. TECHNOLOGICAL COMPARISON
The TRANSDERM IONTO System, Microphor® (K913601), and Iontophor® II (K863166) have similar indications for use and overall function and perform in a similar manner with respect to iontophoretic drug delivery. Performance testing supports that there is no significant difference between the TRANSDERM IONTO System and the Iontophor® II. The TRANSDERM IONTO System utilizes a plastic plate containing electrodes and an adhesive drug delivery can electrode to administer the ionic solution to the patient rather than the lead wires and adhesive clectrodes of the Microphor® and Iontophor® II.
V. TESTING
Performance testing and the applicable IEC 60601-1 standards testing was performed.
VI. CONCLUSIONS
The TRANSDERM IONTO System is substantially equivalent to the legally marketed iontophoretic devices in intended use and performance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's wings and a wavy line representing its body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 2003
Mattioli Engineering Corporation C/o Ms. Melissa Mahall Bio-Reg Associates, Inc. 11800 Baltimore Avenue, Suite 105 Beltsville, Maryland 20705
Re: K032968
Trade/Device Name: TRANSDERM IONTO System Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: November 20, 2003 Received: November 24, 2003
Dear Ms. Mahall:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalcnt (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 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 practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither 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 Ecderal 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
3
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.
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 promotor 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 20857
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 usc 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.
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Page 3 - Ms. Melissa Mahall
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 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,
for Mark A. Wilkerson
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
Enclosure
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INDICATIONS FOR USE
K032968 510(k) Number: Device Name: TRANSDERM IONTO System Mattioli Enginecring Corporation
Indications for Use:
Sponsor Name:
The TRANSDERM IONTO System is a powered iontophoresis drug delivery system that is indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.
Prescription Use 风 (21 CFR 801 Subpart D)
And/Or
Over-The-Counter Use □ (21 CFR 807 Subpart C)
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Milkman
Jivision Sign-C Division of General, Restorative and Neurological f 510(k) Number -