(91 days)
K042912-InterX 5000
Not Found
No
The description focuses on the physical components and function of an electrode accessory, explicitly stating it contains no active electrical components and serves as an extension to a separate electrostimulation device. There is no mention of AI or ML in the intended use, device description, or any of the other sections.
No
The device is an accessory (electrode) for a TENS and/or Powered Muscle Stimulator, which are therapeutic devices. However, the electrode itself does not directly provide therapy; it facilitates the delivery of electrical stimulation from another device.
No
The device is described as an "electrode" intended for "applying electrical stimulation" in conjunction with TENS and Powered Muscle Stimulator devices, which are therapeutic rather than diagnostic. It "serves as an extension to the device to allow the user to apply treatment."
No
The device description clearly states it is a physical electrode made of stainless steel and silicone rubber with wiring and a connector cable. It is an accessory to a separate electrostimulation device and does not contain any software components.
Based on the provided information, the InterX500 Flexible Array Electrode is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The InterX500 Flexible Array Electrode is an accessory for an electrostimulation device. Its purpose is to apply electrical stimulation to the surface of unbroken skin for therapeutic purposes (likely pain relief or muscle stimulation, based on the associated devices).
- No Specimen Testing: The device does not involve collecting or analyzing any biological specimens from the body. It directly interacts with the skin.
Therefore, the function and intended use of the InterX500 Flexible Array Electrode clearly fall outside the scope of In Vitro Diagnostics.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device 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.
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): 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.
K042912-InterX 5000
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
§ 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).
0
Image /page/0/Picture/0 description: The image shows the date "MAR 2 9 2006". The month is March, the day is the 9th, and the year is 2006. The text is in a simple, sans-serif font and is left-aligned.
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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.
1
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