(304 days)
Not Found
No
The description focuses on microprocessor control for iontophoresis and does not mention AI or ML.
Yes
The device is indicated for the administration of drugs into the body for medical purposes, which is a therapeutic function.
No
The device description indicates that MesoDerm is a drug delivery system, specifically an iontophoresis system for administering soluble salts or other drugs. Its purpose is therapeutic (drug delivery), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states it is a "microprocessor controlled iontophoresis drug delivery system" with physical components like a "dispersive electrode" and a "roller," indicating it is a hardware device, not software-only.
Based on the provided information, the MesoDerm device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that MesoDerm is for the "administration of soluble salts or other drugs into the body for medical purposes." This describes a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The description details a system that uses iontophoresis to deliver substances into the body through the skin. This is a method of administering treatment, not analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. MesoDerm's function is to deliver substances into the body, which is the opposite of what an IVD does.
N/A
Intended Use / Indications for Use
MesoDerm is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
Product codes
EGJ
Device Description
MesoDerm is a device that is a microprocessor controlled iontophoresis drug delivery system. It has a dispersive electrode, which is attached to the microprocessor. An FDA approved conductive grounding pad is also required prior to its use.
Introducing ions can be accomplished with MesoDerm's Dispensing Electrode and roller using methods described in the operator's manual. This is accomplished as the roller conducts current to the skin via the product to be delivered. The product has a positive charge, the current coming into the roller has a positive charge and when they meet the product the ions are diffused into the skin.
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)
K032968 & K042590 Transderm® System, Transderm Ionto System
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
K061/849
APR 3 0 2007
AA Advanced Technologies Inc. 6422 W. Belmont Ave. Chicago, Illinois 60634 USA
Image /page/0/Picture/3 description: The image shows the word "DRAFT" in large, bold, outlined letters. The letters are arranged diagonally, starting from the upper left and descending to the lower right. The word is slightly tilted, giving it a dynamic appearance. The background is plain and white.
510(k) Summary
Company:
AA Advanced Technology Inc. MesoDern
Contact Person:
Address:
6422 W. Belmont Ave. Chicago, Illinois 60634
1-800-706-1186
Phone: Fax:
Product Code:
1-773-481-2516
EGJ
Classification Name:
Device, Iontophoresis, Specific Uses
Codes of Federal Regulations: 21 CFR 890.5525
Predicate Device:
K032968 & K042590 Transderm® System, Transderm Ionto System
Device Description:
MesoDerm is a device that is a microprocessor controlled iontophoresis drug delivery system. It has a dispersive electrode, which is attached to the microprocessor. An FDA approved conductive grounding pad is also required prior to its use.
Introducing ions can be accomplished with MesoDerm's Dispensing Electrode and roller using methods described in the operator's manual. This is accomplished as the roller conducts current to the skin via the product to be delivered. The product has a positive charge, the current coming into the roller has a positive charge and when they meet the product the ions are diffused into the skin.
Indication for Use:
MesoDerm is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
1
MesoDerm
| Operating Voltage: | 110V~60HZ |
|---|---|
| Assimilation: | 25W |
| Standards Met: | EN 60601-1 & 60601-1-2, EN 55011, EN 61000-4-2, EN 62-24, EN 61000-4-3, EN 61000-4, and EN 61000-4-5, IEC 950 (Reference Section 3) |
| Fuses: | 2 of 250mA Type T (retarded) |
| Operating Temperature: | 10-50° C Relative Humidity 10-100% |
| Weight: | 8Kg |
| Material Chassis: | Aluminum |
| Electronics: | Microprocessor Controlled |
Exit Channels
Galvanically insulated, protected by extra voltage and limited in electrical current
Substantial Equivalent Chart 12.1
. .
Table 12.1 Substantial Equivalence Chart
| Parameters | MesoDerm | Transderm® System |
|---|---|---|
| 510(k) Number | K032968 & K042590 | |
| Indications for Use: | MesoDerm is indicated | |
| for the administration of | ||
| soluble salts or other | ||
| drugs into the body for | ||
| medical purposes as an | ||
| alternative to hypodermic | ||
| injections. | The TRANSDERM IONTO | |
| System is a powered 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. | ||
| Power Supply | AC 110V~60Hz – 0.25A | |
| max | 9 V DC, 1A max | |
| Average Pulse Current |