(127 days)
Not Found
No
The description focuses on the electrical and physical principles of iontophoresis and does not mention any AI/ML components or functions.
Yes
The device is described as an "Iontophoretic Drug Delivery System" intended to "introduce ions of soluble salts or other drugs into the body for medical purposes," which directly aligns with the definition of a therapeutic device.
No
The device is described as an "Iontophoretic Drug Delivery System" intended to introduce drugs into the body, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is an "active; self-contained Iontophoretic Drug Delivery System" with an "Integrated battery mechanism within the butterfly-designed soft electrode," indicating it is a hardware device with integrated components for drug delivery.
Based on the provided information, the E-STRIP device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "introduce ions of soluble salts or other drugs into the body for medical purposes." This describes a therapeutic or drug delivery function, not a diagnostic test performed on samples outside the body.
- Device Description: The description focuses on the mechanism of delivering substances into the body via iontophoresis. It doesn't mention analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The E-STRIP is a drug delivery device, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The E-STRIP device is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes.
Product codes (comma separated list FDA assigned to the subject device)
EGJ
Device Description
The E-STRIP is an active; self- contained Iontophoretic Drug Delivery System. An Integrated battery mechanism within the butterfly-designed soft electrode provides the E-STRIP with the capacity to deliver safe and complete iontophoresis therapy. The delivery rate of medicine is determined by applied voltage, skin resistance, and Conductivity of the medication/ saline solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows a logo with the text "EMSO, INC." to the right of a square containing a stylized "e". Above the logo, the text "OCT 1 4 2003" is printed. The logo and text appear to be stamped or printed, with some imperfections and variations in ink density. The overall image has a high-contrast, black-and-white appearance.
510 (K) Summary
General Information on Submitter
EEMSO, Inc. 6120 peeler Street Dallas, Texas 75235 Telephone: (214) 956-0077 (214) 956-0848 Facsimile:
II General Information on Device
| Proprietary Name: | E-STRIP |
|---|---|
| Common Name: | Iontophoretic Treatment System |
| Classification: | Iontophoresis Device |
| 21 C.F.R. 890.5525 (b) |
III Predicate Devices
| Iomed Phoresor II Model PM 700 | K872040 |
|---|---|
| With Trans Q 2 electrodes | K914264 |
| Life-Tech Iontophor II Model 6111 PM/DX | ???????? |
| With Meditrode electrodes | |
| Ionto Patch | K992708 |
Device Description IV
The E-STRIP is an active; self- contained Iontophoretic Drug Delivery System. An Integrated battery mechanism within the butterfly-designed soft electrode provides the E-STRIP with the capacity to deliver safe and complete iontophoresis therapy. The delivery rate of medicine is determined by applied voltage, skin resistance, and Conductivity of the medication/ saline solution.
V Intended Uses
The E-STRIP device is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes.
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VI Technological Characteristics of the Device Compared to Predicate Devices
The technological characteristics of the E-STRIP are similar to those of the listed Predicate devices. As the source of current, the 1.55 VDC, 22 MAH (1320 mA-Minute) internal battery drives both positive and negative charged drug molecules Transdermally. Compared to traditional iontophoresis therapy, which requires a Current-generating device, lead wires and multiple electrode patches, the E-STRIP is Self-sustaining.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 2003
EEMSO, Inc. C/o Mr. Larry R. Pilot McKenna Long & Aldridge LLP 1900 K Street, NW Washington, DC 20006
K031769 Re: E-STRIP Regulatory Class: III Product Code: EGJ Dated: June 9, 2003 Received: June 9, 2003
Dear Mr. Pilot
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 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 (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. Larry R. Pilot
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 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 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 reference to premarket notification"(21 CFR Part 807.97). You may
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Page 3 - Mr. Larry R. Pilot
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,
Sincerely yours,
Mark McMillan
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
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Indications For Use Statement
The E-STRIP device is intended to use a direct current to introduce ions of soluble salts or other drugs into the body for medical purposes.
for Mark N. Mellema
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031769