(91 days)
The InterX500 Flexible Array Electrode is intended to be used with authorized InterX TENS and/or Powered Muscle Stimulator devices for the purpose of applying electrical stimulation.
The InterX500 Flexible Array Electrode consists of stainless steel electrodes assembled in a biomedical grade silicone rubber. The electrodes are connected to each other by wiring through a connector cable. There is no power to the InterX500 Flexible Array Electrode unless it is connected to interactive electrostimulation device provided by Neuro Resource Group, Inc. The InterX500 Flexible Array Electrode is placed directly onto unbroken skin and does not use any conductive gels. The connector is medically recognized and cannot be plugged into an AC socket. The InterX500 Flexible Array Electrode is an optional external electrode accessory for an interactive electrostimulation device provided by Neuro Resource Group. The electrode serves as an extension to the device to allow the user to apply treatment in larger and less accessible areas by the electrodes on the interactive electrostimulation device. The InterX500 Flexible Array Electrode is intended to be used with a Neuro Resource Group, Inc. provided electrostimulation device and does not contain any active electrical components. The cable is a two conductor cable using two 24 AWG single wires tinned with copper. The cable is UL and CSA approved.
The provided text is a 510(k) summary for a medical device called the "InterX500 Flexible Array Electrode." It describes the device, its intended use, and its classification, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested table and study details. This document is a regulatory submission for substantial equivalence, not a performance study report.
Here's what the document does contain or imply:
- Device Name: InterX500 Flexible Array Electrode
- Intended Use/Indications for Use: "The InterX500 Flexible Array Electrode is intended to be used with authorized InterX TENS and/or Powered Muscle Stimulator devices for the purpose of applying electrical stimulation."
- Predicate Device: K042912 - InterX 5000
- Classification Regulation: 21 CFR 882.1320 (Electroencephalograph – but this seems to be a misclassification as the device is for electrical stimulation, not EEG. The product code GXY is for "Electrode, Patient, Intracavitary, Therapeutic, Stimulating" so the regulation number might be a typo in the FDA letter.)
- Regulatory Class: II
The document focuses on establishing substantial equivalence to a predicate device, which primarily relies on demonstrating similar technological characteristics and intended use, and often includes safety testing (e.g., biocompatibility, electrical safety) but not necessarily advanced performance metrics in a clinical study context.
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RESOURCE NEURO GROUP
510(k) Summary
Submitter Information:
Contact:
Krista Oakes Tel: 972-665-1810 Fax: 972-665-1814
Date Prepared:
December 19, 2005
Product Name & Classification:
Classification Regulation: 882.1320 Panel: Neurology, Physical Medicine Product Code: GXY Trade Name(s): InterX 500 Flexible Array Electrode
Predicate Device:
K042912-InterX 5000
Description:
The InterX500 Flexible Array Electrode consists of stainless steel electrodes assembled in a biomedical grade silicone rubber. The electrodes are connected to each other by wiring through a connector cable. There is no power to the InterX500 Flexible Array Electrode unless it is connected to interactive electrostimulation device provided by Neuro Resource Group, Inc. The InterX500 Flexible Array Electrode is placed directly onto unbroken skin and does not use any conductive gels.
The connector is medically recognized and cannot be plugged into an AC socket. The InterX500 Flexible Array Electrode is an optional external electrode accessory for an interactive electrostimulation device provided by Neuro Resource Group. The electrode serves as an extension to the device to allow the user to apply treatment in larger and less accessible areas by the electrodes on the interactive electrostimulation device. The InterX500 Flexible Array Electrode is intended to be used with a Neuro Resource Group, Inc. provided electrostimulation device and does not contain any active electrical components. The cable is a two conductor cable using two 24 AWG single wires tinned with copper. The cable is UL and CSA approved.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2006
Neuro Resource Group c/o Ms. Krista Oakes Vice President, Regulatory Affairs 1100 Jupiter Road - Suite 190 Plano, Texas 75074
Re: K053626
Trade/Device Name: InterX500 Flexible Array Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GXY Dated: March 9, 2006 Received: March 15, 2006
Dear Ms. Oakes:
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 such 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); good manufacturing practice requirements as set
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Page 2 - Ms. Krista Oakes
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. 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 (21 CFR Part 801), 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
Sincerely yours.
Sincerely yours,
Hubert Lenoir
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) # (if known): K053626
Device Name: InterX500 Flexible Array Electrode
Indications for Use:
The InterX500 Flexible Array Electrode is intended to be used with authorized InterX TENS and/or Powered Muscle Stimulator devices for the purpose of applying electrical stimulation.
Prescription Use x (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)
Hubert Lemonda
Division of General, Restorative, and Neurological Devices
510(k) Number K053624
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).