(80 days)
No
The device description mentions a "microprocessor controlled device" which is common in many medical devices and does not inherently indicate AI/ML. There are no mentions of AI, ML, deep learning, or any related concepts in the provided text. The performance studies focus on electrical output and substantial equivalence, not on AI/ML performance metrics.
Yes
The device is intended to introduce drugs into the body for medical purposes, which is a therapeutic function.
No
The device description clearly states its purpose is to introduce drugs into the body, acting as an alternative to injections. It controls current strength and duration, calculates total charge, and monitors current flow and impedance, all related to drug delivery, not diagnosis.
No
The device description explicitly states it is a "battery-powered, solid state, microprocessor controlled device," indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is intended to "introduce ions of soluble salts or other drugs into the body for medical purposes." This is a therapeutic or drug delivery function, not a diagnostic test performed on a specimen outside the body.
- Lack of Diagnostic Information: The intended use and device description focus on the mechanism of drug delivery and the control of electrical parameters. There is no mention of analyzing biological samples or providing diagnostic information about a patient's condition.
Therefore, this device falls under the category of a therapeutic or drug delivery device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes, as an alternative to hypodermic injection when it is advisable to avoid the pain that may accompany needle insertion and drug injection, and when it is advisable to minimize the infiltration of carrier fluids or to avoid the damage that may be caused by needle insertion when tissue is traumatized.
Product codes
EGJ
Device Description
The iontophoresis device is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes. The iontophoretic technology operates on the principle that an electic potential will cause ions in solution to migrate according to their electrical charges. Further, the quantity and distribution of a drug delivered into or across the skin by iontophoresis is dependent upon the charge and size (molecular weight) of the ion, strength of the electircal current being applied, electrode composition, duration of current flow and several other factors. The Medion™ is a battery-powered, solid state, microprocessor controlled device which controls current strength and duration, calculates total charge delivered and monitors current flow and electrode/tissue impedance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
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
Bench and other test data confirm that the electrical output of the Medion 6000 meets specifications fully, that the device operates as described above, and that it is substantially equivalent to the Phoresor 800 series (K934335).
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
KO30476
10F3
XV. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Separate Page)
A. General Provisions
Submitter: Richard Fisher, Selective Med Components, Inc., Mount Vernon, OH. Phone: 740-397-7838. Registration No: 1528764 Contact Person: Richard Fisher Classification: Class III. Classification Name: Iontophoresis Device, 21 CFR 890.5525, Code EGJ Common or usual name: Iontophoresis Device Proprietary Name: Medion™ 6000 Series
B. Name of Predicate Devices
Iomed Phoresor II Model PM 900 Iomed Phoresor II Model PM 800 R. A. Fischer MD-2 Iontophoresis Unit K982668 K933445* K895365
C. Device Description:
The iontophoresis device is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes. The iontophoretic technology operates on the principle that an electic potential will cause ions in solution to migrate according to their electrical charges. Further, the quantity and distribution of a drug delivered into or across the skin by iontophoresis is dependent upon the charge and size (molecular weight) of the ion, strength of the electircal current being applied, electrode composition, duration of current flow and several other factors. The Medion™ is a battery-powered, solid state, microprocessor controlled device which controls current strength and duration, calculates total charge delivered and monitors current flow and electrode/tissue impedance.
D. Intended Use:
Intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes, as an alternative to hypodermic injection when it is advisable to avoid the pain that may accompany needle insertion and drug injection, and when it is advisable to minimize the infiltration of carrier fluids or to avoid the damage that may be caused by needle insertion when tissue is traumatized.
1
Image /page/1/Picture/0 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text includes 'KO20476' on the top line and '20P3' on the bottom line. The handwriting is somewhat rough, with varying stroke thicknesses, and the text is slightly tilted.
E. Non-Clinical Test
Bench and other test data confirm that the electrical output of the Medion 6000 meets specifications fully, that the device operates as described above, and that it is substantially equivalent to the Phoresor 800 series (K934335).
F. Conclusions
The Medion 6000 is equivalent to the Phoresor8 II, Model PM900 cleared in K982668, and to the Phoresor8 II Model PM800 cleared in K933445 by Iomed, Inc. It is also equivalent to the MD-2 Iontophoresis Unit cleared by the R. A. Fischer Co., Inc., in K895365. However, it is more closely similar to the Phoresor units since the Fischer unit may deliver up to 20 mA of current. Therefore, the Medion™ is best compared to the Phoresor Model PM 800/900 units.
The "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed. The decision tree appears in Appendix V.
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Image /page/2/Picture/0 description: The image shows a handwritten text that appears to be in Russian. The text includes the numbers 0476 and 3083. The handwriting is somewhat messy and difficult to read, with some characters overlapping or being partially obscured. The image is in black and white, with the text appearing in black against a white background.
We believe we have provided sufficient information to allow the determination of substantial equivalence for this device. There are no specific guidance document on the subject but we have complied with all the terms of the general guidance documents for preparation of premarket notifications-510(k)s. If additional information or explanation is needed, please call me at 740-397-7838 or fax me at 740-397-6112. Alternately, you may contact Dr. H. N. Dunning at 301-229-2138, 8309 Bryant Dr., Bethesda, MD 20817.
Sincerely yours
hard Fisher Rie President
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 3 2002
Mr. Richard Fisher President Selective Med Components, Inc. 6 Mechanic Street Mt. Vernon, OH 43050
Re: K020476
Trade/Device Name: Medion 6000 Series Regulation Number: 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: February 7, 2002 Received: February 12, 2002
Dear Mr. Fisher:
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) that do not require approval of a premarket approval application (PMA). 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 such additional controls. Existing major regulations affecting your device can he 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.
4
Page 2 - Mr. Richard Fisher
This letter will allow you to begin marketing your device as described in your Section 510(k) remarket notification. The FDA finding of substantial equivalence of your device to a legally premated noticate 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 (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours,
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
XIII. Indications for Use: [Separate Page]
510(k) Number: NA
Device Name: Medion 6000 Series
Indications for Use:
Intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes, as an alternative to hypodermic injection when it is advisable to avoid the pain that may accompany needle insertion and drug injection, and when it is advisable to minimize the infiltration of carrier fluids or to avoid the damage that may be caused by needle insertion when tissue is traumatized.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use and Neurological Devices
Over-The-Counter Use
(Optional Format 1-2-96)