(101 days)
Not Found
No
The summary describes a passive electrode system for drug delivery and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The intended use states that the device is for "the administration of soluble salts or other drugs into the body for medical purposes," which clearly indicates a therapeutic function.
No
This device is designed for the administration of drugs into the body, not for diagnosing medical conditions. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it consists of physical electrodes (active drug delivery electrode and passive 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 for the administration of drugs into the body for medical purposes, specifically as an alternative to hypodermic injection. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as electrodes designed for the local administration of ionic drug solutions into the body. This aligns with a therapeutic delivery system.
- Lack of Diagnostic Elements: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples for diagnostic purposes. This device operates in vivo (within the body) for therapeutic drug delivery.
N/A
Intended Use / Indications for Use
Iontophoresis is indicated for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection.
Product codes (comma separated list FDA assigned to the subject device)
EGJ
Device Description
North Coast Buffered Iontophoresis Electrodes consist of an active drug delivery clectrode and a passive return electrode. These electrodes are designed for one use by a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are several sizes and shapes of drug delivery electrodes to accommodate placement on various locations on the body. The size of the return electrode is the same for all drug delivery electrode sizes. North Coast Buffered Iontophoresis Electrodes have technological characteristics equivalent to those of the predicate devices, including comparable design, materials, multiple shapes and sizes of active drug delivery electrodes, and equivalent packaging and labeling.
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 (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.
K031053, K932620, K932621, K983484
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
NOW - 4 2005
510(k) Summary
[as required by 21CFR section 807.92(c)]
Submitter Information
| Name: | North Coast Medical, Inc. |
|---|---|
| Address: | 18305 Sutter Blvd. |
| Morgan Hill, CA 95037-2845 | |
| Phone: | 408-776-5000 |
| 1-800-821-9319 | |
| Fax: | 1-877-213-9300 |
| Contact Person: | Tarhan Kayihan |
| Date Prepared: | July 21, 2005 |
Device Information
| Device Name: | North Coast Buffered Iontophoresis Electrodes |
|---|---|
| Common Name: | Iontophoresis Electrodes |
| Classification Name: | Device, Iontophoresis, Other Uses (per 21 CFR section 890.5525) |
Predicate Devices
Based on technical, functional, and physical comparisons, the North Coast Buffered Iontophoresis Electrodes are substantially equivalent to the following legally marketed devices:
| Trade Name | Manufacturer | 510(k) Number |
|---|---|---|
| Buffered Iontophoresis Drug Delivery Electrodes | Selective Med Components | K031053 |
| TransQe Electrodes | Iomed, Inc. | K932620 |
| Iogel Electrodes | Iomed, Inc. | K932621 |
| Dupel B.L.U.E. Electrodes | Empi, Inc. | K983484 |
1
Device Description
North Coast Buffered Iontophoresis Electrodes consist of an active drug delivery clectrode and a passive return electrode. These electrodes are designed for one use by a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are several sizes and shapes of drug delivery electrodes to accommodate placement on various locations on the body. The size of the return electrode is the same for all drug delivery electrode sizes. North Coast Buffered Iontophoresis Electrodes have technological characteristics equivalent to those of the predicate devices, including comparable design, materials, multiple shapes and sizes of active drug delivery electrodes, and equivalent packaging and labeling.
Intended Use
North Coast Buffered Iontophoresis Electrodes are intended to introduce soluble salts and other drugs into the body as an alternative to hypodermic injection.
Taikan Kayhan 7/21/05
Tarhan Kayihan Regulatory Compliance Administrator
2
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 2005
Mr. Tarhan Kavihan Regulatory Compliance Administrator North Coast Medical, Inc 18305 Sutter Boulevard Morgan Hill California 95037-2845
Re: K052019
Trade/Device Name: North Coast Buffered Iontophoresis Electrode Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis device Regulatory Class: III Product Code: EGJ Dated: October 20, 2005 Received: October 24, 2005
Dear Mr. Kayihan:
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 Codc 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.
3
Page 2 - Mr. Tarhan Kayihan
Our substantially equivalent decision does not apply to the drugs that you will label or promote Our substantially equivalent accessed as a sectiber label nor promote your device for use with 101 uSC with your device. - therever, your device prior to FDA having approved the drugs for Specific drugs, nor package arage with your 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 AS you are aware, toneophers in a the body and induce sweating for use in the diagnosis of cystic of softeer bare of 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 adequate anroctoris for the untended to use a direct current to introduce ions of soluble salts or fother 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 apple rat (1 1 1 1 1 1 1 1 9 4, 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by
4
Page 3 – Mr.Tarhan Kayihan
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,
Signature
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
5
Indications for Use
510(k) Number (if known): K052019
Device Name: North Coast Buffered Iontophoresis Electrode
Indications For Use:
Iontophoresis is indicated for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K052019