(170 days)
K91-4621, K91-2014
K91-4621, K91-2014
No
The summary describes a passive electrode system for iontophoresis and contains no mention of AI, ML, or any computational processing beyond basic electrical function.
Yes
The device is indicated to introduce ions of soluble salts and other drugs into the body, which implies a therapeutic purpose.
No.
The device is used to introduce ions and drugs into the body, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of physical electrodes (active drug delivery electrode and a return electrode), which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "introduce ions of soluble salts and other drugs into body." This describes a therapeutic or drug delivery function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details electrodes used for iontophoresis, a method of delivering substances through the skin using electrical current. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The device is clearly designed for in vivo (within the living body) drug delivery, not in vitro (in glass, i.e., outside the body) diagnostic testing.
N/A
Intended Use / Indications for Use
The electrode is intended to be used in the clinic. Iontophoresis drug delivery systems are indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.
Io-Drive electrode is indicated to introduce ions of soluble salts and other drugs into body.
Product codes
EGJ
Device Description
The IO-Drive Iontophoresis electrode system consists of an active drug delivery electrode and a return electrode. These electrodes are designed for single patient use. There are multiple sizes of drug delivery electrodes to accommodate placement at different body sites. The size of the return electrode is the same size for all drug delivery electrodes.
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
the clinic
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)
A performance evaluation was performed and based on the evaluation the IO-Drive electrode is similar to the predicate electrodes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K91-4621, K91-2014
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.
0
MAR - 3 2000
SUMMARY OF SAFETY AND EFFECTIVENESS
IO-DRIVE Iontophoresis electrode system Date of Summary: Dec 14, 1999 Page 1 of 1
A. General Provisions
Submitter's Name: Submitter's Address:
Contact Person: Classification Name: Proprietary Name: Common Name: FDA 510 (k)
Selective Med Components, Inc. 6 South Mechanic St. Mt. Vernon, Ohio 43050 Rick Fisher Iontophoresis Device IO-Drive system Iontophoresis electrodes 99-3081
B. Name of Predicate Devices
| - Iomed TransQ | K91-4621 |
|---|---|
| - Empi Dupel | K91-2014 |
C. Device Description
The IO-Drive Iontophoresis electrode system consists of an active drug delivery electrode and a return electrode. These electrodes are designed for single patient use. There are multiple sizes of drug delivery electrodes to accommodate placement at different body sites. The size of the return electrode is the same size for all drug delivery electrodes.
D. Inteneded Use
The electrode is intended to be used in the clinic. Iontophoresis drug delivery systems are indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.
E. Test and Evaluation
A performance evaluation was performed and based on the evaluation the IO-Drive electrode is similar to the predicate electrodes
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract human figures.
Public Health Service
MAR - 3 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard John Fisher III Chief Executive Officer Selective Med Components, Inc. 6 South Mechanic Street Mount Vernon, Ohio 43050
Re: K993081 Trade Name: IO-Drive System Regulatory Class: Class III Product Code: EGJ Dated: December 14, 1999 Received: December 17, 1999
Dear Mr. Fisher:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 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 either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Page 2 - Mr. Richard John Fisher III
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.
If you have any questions regarding this letter, you may contact:
Kevin Lee, M. D. Division of General and Restorative Device Office of Device Evaluation 9200 Corporate Boulevard Rockville, MD 20850 Tel (301) 594-1296
This letter immediately will allow you to begin marketing your devices as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and permits your devices to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for question on the promotion and advertising, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or
3
Page 3 -- Mr. Richard John Fisher III
(301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil R.P. Ogden
James F. Dillard III
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
4
Page 1 of 1
510 (k) NUMBER (IF KNOWN) : K993081
DEVICE NAME:__________________________________________________________________________________________________________________________________________________________________
INDICATIONS FOR USE:
Io-Drive electrode is indicated to introduce ions of soluble salts and other drugs into body.
Nao for Izd
(Division Sign-Off) n Sign-On)
Restorative Restorative Devices Vaa 510(k) Number
Prescription Use YES
(Per 21 CFR 801.109)