ActhyDerm is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.

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.

AI/ML Overview

The provided text describes the ActhyDerm iontophoresis device, its intended use, and its substantial equivalence to a predicate device (MesoDerm). However, it does not contain information on specific acceptance criteria for device performance, nor details of a study proving the device meets such criteria.

The document states that "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 (1998), EN 61000-4-3 (1997), EN 61000-4 (1998), En61000-4-5." This indicates adherence to electrical safety and electromagnetic compatibility standards, but not performance-based acceptance criteria related to its drug delivery function.

The FDA's decision is based on substantial equivalence to the predicate device, MesoDerm, due to identical intended use, materials, design, and technological characteristics. This means the ActhyDerm is considered as safe and effective as the legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a dedicated study.

Therefore, the requested information cannot be fully provided from the given text.

Here's a breakdown of what CANNOT be extracted from the document:

A table of acceptance criteria and the reported device performance: This information is not present. The document only lists electrical safety standards that the device meets.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or clinical study data is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set data requiring expert ground truth is presented.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is an iontophoresis drug delivery system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the document serves as a 510(k) summary for a medical device (ActhyDerm) demonstrating substantial equivalence to a predicate device (MesoDerm) based on technical characteristics and intended use, and compliance with electrical safety standards. It does not include performance data from studies against specific acceptance criteria.

Summary

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JUN 1 6 2009

K083016

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.

トイストライブに入れています。【お気に入れたためにはMondonens】 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

Parameters	MesoDerm	ActhyDerm
510(k) Number	K061849	ActhyDerm
Indications for Use:	MesoDerm is indicated for theadministration of soluble saltsor other drugs into the bodyfor medical purposes as analternative to hypodermicinjections.	ActhyDerm is indicated forthe administration of solublesalts or other drugs into thebody for medical purposes asan alternative to hypodermicinjections.
Power SupplyAverage Pulse CurrentLoad ImpendancePulse FrequencyBurst TimeBurst FrequencyDispenser HeadGenerator	AC 110V~60Hz - 0.25A max<5 mA<2 KOhm200-2000Hz2s0.25 - 50HzReusableElectrical pulses are producedby an electronic pulsegenerator that is able togenerate bursts of pulses thatare applied to the skin throughelectrodes applied	AC 110V~60Hz - 0.25A max<5 mA<2 KOhm200-2000Hz2s0.25 - 50HzReusableElectrical pulses are producedby an electronic pulsegenerator that is able togenerate bursts of pulses thatare applied to the skin throughelectrodes applied

Substantial Equivalence Discussion of Similarities and Differences:

ActhyDerm is identical to the predicate device in:

Intended Use �
Materials 0
. Design
Technological Characteristics 0

The ActhyDerm introduces no new questions concerning the safety or effectiveness and is thus substantially equivalent to the predicate device.

NONCLINICAL AND CLINICAL TEST

807.92(b)

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SAFETY and EFFECTIVENESS

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参考文献

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Microlab Americas Incorporated % E J Smith Regulatory Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

JUN 1 6 2009

Re: K083016

Trade/Device Name: ActhyDerm Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Device Regulatory Class: III Product Code: EGJ Dated: May 7, 2009 Received: May 21, 2009

Dear E J Smith:

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) that do not require approval of a premarket approval application (PMA). 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); medical device reporting

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Page 2-E J Smith

(reporting of medical device-related adverse events) (21 CFR 803); 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.

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, there are concerns relating to the fact that no drug is currently labeled for administration via an iontophoresis device. The Agency currently is evaluating this public health concern regarding the safety and effectiveness of this route of administration of drugs, and in the near future will inform manufacturers of certain additional steps the Agency believes are necessary to address this concern.

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 vour 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 reference to premarket notification" (21CFR 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.

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Sincerely yours, ·

Mark N. Melkerson

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: ActhyDerm

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.

Prescription Use 2 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083016

Page of

Regulation Number and Section

§ 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.