(304 days)
MesoDerm is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
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.
This document is a 510(k) summary for the MesoDerm iontophoresis device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices (K032968 & K042590 Transderm® System) based on functional and technical specifications.
Therefore, I cannot provide the requested information from the given text.
The document provides the following:
- Device Description: MesoDerm is a microprocessor-controlled iontophoresis drug delivery system.
- Intended Use: Administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
- Technical Specifications: Operating Voltage, Assimilation, Standards Met, Fuses, Operating Temperature, Weight, Material Chassis, Electronics, Exit Channels.
- Substantial Equivalence Chart (Table 12.1): Compares MesoDerm to the Transderm® System across parameters like Indications for Use, Power Supply, Average Pulse Current, Load Impedance, Pulse Frequency, Burst Time, Burst Frequency, Dispenser Head, and Generator.
- Contraindications, Warnings, and Precautions.
- Product Specifications: Roll on Ball (material, diameter, sphericity) and Conductive Grounding Plate (material).
- Conclusion: The device is substantially equivalent to K032968 & K042590.
- Correspondence: A letter from consultants modifying the 510(k) to remove references to a stylus and specific default treatment times.
- FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.
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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.
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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 indicatedfor the administration ofsoluble salts or otherdrugs into the body formedical purposes as analternative to hypodermicinjections. | The TRANSDERM IONTOSystem is a powered drugdelivery system that isindicated for the localadministration of ionic drugsolutions into the body formedical purposes and canbe used as an alternative toinjections. |
| Power Supply | AC 110V~60Hz – 0.25Amax | 9 V DC, 1A max |
| Average Pulse Current | < 5 mA | $\pm$ mA, 2 mA, 3 mA, 4 mA, 5mA, user selectable, ±20% |
| Load Impendance | < 2 KOhm | 0-15 KOhm |
| Pulse Frequency | 200-2000 Hz | 2200 Hz |
| Burst Time | 2 sec | 10 msec. |
| Burst Frequency | 0.25 - 50 Hz | 50 Hz |
| Dispenser Head | Reusable | Disposable |
| Generator | Electrical pulses areproduced by an electronicpulse generator that is ableto generate bursts of pulsesthat are applied to the skinthrough electrodes applied | Electrical pulses areproduced by an electronicpulse generator that is ableto generate bursts of pulsesthat are applied to the skinthrough electrodes applied. |
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Contraindications
MesoDerm is contraindicated in patients sensitive to the drug and in electrically sensitive patients (e.g., pacemaker carriers).
Warnings and Precautions
MesoDerm is not to be used:
- on patients who have an allergy to any medication or solution to be administered -
- subjects with metal and /or electric prosthesis -
- pregnant women -
- subjects with cardiac rhythm disorders -
- subjects with pacemakers -
- subjects with leg thrombophlebitis and phlebitis in acute phase ﺖ
- subjects with large varices -
- epileptic subjects -
- subjects unable to comprehend and /or communicate -
- it is contraindicated for use over damaged or denuded skin or orbital areas
Caution:
Caution (U.S.A.) law restricts this device to sale by or on the order of a physician.
Iontophoresis can cause skin irritation or burns and the patient has to be informed before iontophoresis application.
Standards Met:
MesoDerm conforms to the following standards: EN 55011 (1999) ,EN 61000-4-2 (1998), EN 62-24, EN 61000-4-3 (1997), EN 61000-4 (1994), EN 61000-4-5 (1997), IEC 950.
Product Specifications:
Roll on Ball
Material Choice: Nominal ball diameter: Other Specifications:
Polypropylene
1.4" (35.56mm) Standard diameter tolerance: ± 0.002" (+0.05mm) Sphericity: 0.002" (0.05mm)
Conductive Grounding Plate
Material Choice:
Any FDA cleared grounding pad
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Conclusion: This device is substantially equivalent to the devices approved as K032968 & K042590.
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Image /page/4/Picture/0 description: The image shows the word "Smith" in large, bold, black letters. Below the word "Smith" is the phrase "FDA CONSULTANTS" in a smaller font size. The phrase is flanked by tildes on either side.
Specializing in Regulatory Affairs
April 24, 2007
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
DRAFT
Re: K061849
Dear Dora Vega:
AA Advanced Technology, Inc. has modified their device to remove the stylus referenced in 510(k) K061849. All references and performance information related to the stylus, including information used in labeling will be removed. Any references to default time for each treatment concerning Adipose Tissue, Muscle, Dennis and Epidermis will be removed.
The attached revised 510(k) summary accurately reflects the device under review less the stylus.
If you have any questions concerning this change please contact me at 410-451-0639.
Sincerely,
E.J. Smith
Cc: AA Advanced Technology
1676 Village Green · Suite A · Crofton, Maryland 21114 PHONE: (888) 729-9674 · FAX: (410) 793-0448 WEB SITE: www.fdaconsultants.com · E-MAIL: ESmith9746@aol.com
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Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with three lines forming its body and wings. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AA Advance Technology, Inc. % Smith Associates Mr. E. J. Smith, Consultant 1676 Village Green Crofton, Maryland 21114
APR 3 0 2007
Re: K061849
Trade/Device Name: Mesoderm - Iontophoresis Device Regulation Number: 21 CFR 890.5525 Regulation Name: Iontophoresis Devices Regulatory Class: III Product Code: EGJ Dated: April 3, 2007 Received: April 4, 2007
Dear Mr. 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 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 olavine, subject to the general controls provisions of the Act. The general controls provisions of the Ace 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 publican on the councillation annoncements 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: 17 gistration 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.
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 druss, nor package drugs with your device prior to FDA having approved the drugs for iontophoretic administration. For information on the requirements for marketing new varugs, you may contact:
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Page 2 - Mr. E. J. Smith
Director Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20850
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 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 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): Ko61849
Device Name: MesoDerm
Indications for Use:
部 - 国际娱乐 -
MesoDerm 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(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use(21 CFR 807 Subpart C) | ||
|---|---|---|---|---|
| OF NEEDED | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE | |||
| Concurrence of CDRH, Office\of(D | ||||
| ision Si | ||||
| Division of General, Restorative, | ||||
| Page 1 of 1and Neurological Devices | ||||
| 510 31 1 |
§ 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.