(250 days)
Not Found
No
The description mentions a microprocessor with pre-set programs, but there is no indication of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes.
The device is used for the administration of drugs into the body for medical purposes, which is a therapeutic function.
No
The device description states its purpose is for "administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections," which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "microprocessor controlled iontophoresis drug delivery system" with physical components like electrodes and requires a grounding pad, indicating it is a hardware device with software control, not a software-only device.
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, which is a therapeutic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a drug delivery system that uses iontophoresis to facilitate the penetration of substances into the skin. This is a method of administering treatment, not performing a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on the device's operation.
Therefore, ActhyDerm is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ActhyDerm 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 (comma separated list FDA assigned to the subject device)
EGJ
Device Description
ActhyDerm is a device that is a microprocessor controlled iontophoresis drug delivery system. The microprocessor bas four pre-set programs for penetration of the 1)epidermis, 2) dermis, 3) adipose, 4) muscle. It has a dispersive electrode and roller electrodes. An FDA approved conductive grounding pad is also required prior to its use.
Introducing ions can be accomplished with ActhyDerm's Dispensing Electrode and roller using methods described with operator's manual: 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 current are diffused into the skin are diffused into the skin.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The electrical performance of the ActhyDerm meets the requirements of the following standards: EN 60601-1 (1998, EN 62-24 (1997), 60601-1-2 (1998), ENS5011 (1999), EN 61000-4-2 (1998), EN 61000-4-3 (1997), EN 61000-4 (1998), En61000-4-2 (1998), EN 61000-4-3 (1997), EN 61000-4 (1998), EN550), EN5500 (1998), EN 61000-4-3 (1997), EN 61000-4 (1998), En61000-4-5
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.
0
JUN 1 6 2009
510(k) Summary 807.92(c)
SPONSOR
807.92(a)(1)
Company Name: Company Address
Telephone: Fax: Contact Person:
Microlab Americas Inc. 405 Rowntree Dairy Road, Unit 1 Woodbridge, Canada L4L 8H1 905-264-1935 905-264-5571 David Vanslingerland
Summary Preparation Date: September 16, 2008
DEVICE NAME
807.92(a)(2)
Trade Name: ActhyDerm Common Name: Iontophoresis Device Classification Name: Device, Iontophoresis, Other Uses Regulation Number: 21 CFR 890.5525 Product Code: EGJ Device Class: III
PREDICATE DEVICE
| Company | Product | 807.92(a)(3)
510(k) # |
|----------------------------|----------|--------------------------|
| AA Advanced Technology Inc | Mesoderm | K061849 |
DEVICE DESCRIPTION
807.92(a)(4) ActhyDerm is a device that is a microprocessor controlled iontophoresis drug delivery system. The microprocessor bas four pre-set programs for penetration of the 1) epidermis, 2) dermis, 3) adipose, 4) muscle. It has a dispersive electrode and roller electrodes. An FDA approved conductive grounding pad is also required prior to its use.
Introducing ions can be accomplished with ActhyDerm's Dispensing Electrode and roller using methods described with operator's manual: 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 current
are diffused into the skin are diffused into the skin.
DEVICE INTENDED USE
807.92(a)(5)
and anywhile and works in affect with a beach a
ActhyDerm is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
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1
COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)
| Parameters | MesoDerm | ActhyDerm |
|---|---|---|
| 510(k) Number | K061849 | ActhyDerm |
| 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. | ActhyDerm is indicated for | |
| the administration of soluble | ||
| salts or other drugs into the | ||
| body for medical purposes as | ||
| an alternative to hypodermic | ||
| injections. | ||
| Power Supply | ||
| Average Pulse Current | ||
| Load Impendance | ||
| Pulse Frequency | ||
| Burst Time | ||
| Burst Frequency | ||
| Dispenser Head | ||
| Generator | AC 110V~60Hz - 0.25A max |