(208 days)
Not Found
No
The device description focuses on biofeedback and human adjustment based on tissue impedance changes, not on automated learning or decision-making by the device itself. The "interactive" aspect refers to the device providing feedback to the operator for manual adjustments.
Yes
The device's intended uses clearly state its purpose is for symptomatic relief and management of pain, relaxing muscle spasms, increasing local blood circulation, muscle reeducation, and maintaining or increasing range of motion, all of which are therapeutic applications.
No
The device's intended use is for symptomatic relief and management of pain, and various therapeutic applications, not for diagnosing conditions. While it monitors impedance changes, this is used for treatment adjustment, not diagnosis.
No
The device description clearly states it is a "small handheld device in a plastic case" with physical components like electrodes, buttons, an LCD display, and a battery, indicating it is a hardware device with integrated software.
Based on the provided information, the InterX5000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- InterX5000 Function: The InterX5000 is a device that applies electrical stimulation to the skin surface for therapeutic purposes (pain relief, muscle relaxation, etc.). It interacts directly with the body's tissues and does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes therapeutic applications for pain management and muscle function, not diagnostic testing of biological samples.
- Device Description: The description details a handheld device with electrodes that are placed on the skin. There is no mention of collecting or analyzing biological specimens.
Therefore, the InterX5000 falls under the category of a therapeutic electrical stimulator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The InterX5000 is indicated for:
- symptomatic relief and management of chronic, intractable pain ■
- adjunctive treatment in the management of post-surgical and post-traumatic 트 pain
- 트 relaxing muscle spasms
- increasing local blood circulation
- immediate post surgical stimulation of calf muscles to prevent venous 트 thrombosis
- . muscle reeducation
- 트 maintaining or increasing range of motion
- preventing or retarding disuse atrophy ■
Product codes (comma separated list FDA assigned to the subject device)
GZJ, IPF
Device Description
InterX means "Interactive". InterX technology is designed to work by introducing very brief pulses of electricity into the tissue and immediately monitoring impedance changes as the tissue responds. Stimulation and sensing take place via a concentric electrode system that is moved over the skin surface, and a digital display enables the operator to follow the course of the treatments and adjust the output.
The InterX 5000 consists of a small handheld device in a plastic case. It is powered by one nine-volt alkaline battery. On the upper face of the machine there are two LED's, an LCD display and 5 control buttons. The underside of the machine two metal surfaces that form the poles of a treatment electrodes are placed directly on the unbroken skin and do not use any conductive material or gel.
On the side of the machine is one socket for a standard 3.5mm stereo jack socket that connects to the main electrodes of the machine to an optional external electrode accessory. The device's electrodes are disabled when the optional external electrode accessory is attached. The optional external electrode accessories only serve as an extension and allow the user to apply treatment in a areas which may not be accessible by the main unit electrodes. user to apply ucannell in a accessories intended for use with the InterX 5000 have any active electrical components.
The waveform is a high amplitude, short-duration bi-polar pulse (circuitry in the device integrates time and dosage delivered). A digital display monitors the biofeedback process in mtegrates thire and dosage convolling the operator to track changes in the tissues being treated and make appropriate adjustments to the output characteristics if necessary. This interaction and human adjustment continues throughout the length of the InterX treatment. The result is that the body experiences a conditioned training process that enhances the body's ability to effectively reduce and manage the level of pain.
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)
Performance bench testing was conducted to characterize the electrical performance of the InterX5000 as compared to published data of predicate devices.
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
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a document with the title "Image 2000" at the top. The document contains information about a user named GARCIA, DIANE M (dmp), and a folder named K042912 - 8 pages. The company is NEURO RESOURCE GROUP, INC. (NEURRESOGROU), and the product is STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF (GZJ). The summary indicates the product is INTERX5000, the date requested is Mon Jan 07 11:47:39 2008, the date printed is Mon Jan 07 11:48:16 2008, and the printer is file.
1
Image /page/1/Picture/0 description: The image shows the words "Table of Contents" in a large, bold, black font. The words are arranged in a slight arc, giving the impression of a curved line. The background is plain white, which makes the text stand out.
| CORRESPONDENCE - 3 pages | 1 |
|---|---|
| ORIGINAL - 3 pages | 4 |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
MAY 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Krista Oakes Vice President, Regulatory Affairs Neuro Resource Group, Inc. 1100 Jupiter Road, Suite 190 Plano, Texas 75074
Re: K042912
Trade/Device Name: InterX5000 Regulation Numbers: 21 CFR 882.5890 Regulation Names: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: April 14, 2005 Received: April 18, 2005
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 docs 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 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.
3
Page 2 - Ms. Krista Oakes
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/industry/support/index.html.
Sincerely yours,
Hytl Rhodes
Miriam Provost, Ph.D.
Mirian Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) # (if known): K042912
Device Name: InterX5000
Indications for Use:
The InterX5000 is indicated for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain.
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)
Htp. Curda
ign-Off (Division' Division of General, Restorative. and Neurological Devices
KOYZ912 510(k) Number ___
5
APPENDIX A
SUMMARY OF SAFETY AND EFFECTIVENESS
6
Image /page/6/Picture/0 description: The image shows the logo for Neuro Resource Group. The logo consists of the letters "NRG" inside of a rounded rectangle. Below the logo, the words "NEURO RESOURCE GROUP" are written in block letters.
510(k) Summary
Submitter Information:
Contact:
Krista Oakes Tel: 972-438-5202 Fax: 972-401-9161
Date Prepared:
September 30, 2004
Product Name & Classification:
Classification Regulation: 882.5950, 890.5850, Panel: Neurology, Physical Medicine Product Code: GZJ, IPF Trade Name(s): InterX5000
Predicate Device:
K041575 - Fenzian Treatment System K951951 - EMPI Focus 795 K870947 - Dynatron 500 Electrical Muscle Stimulator
Description:
InterX means "Interactive". InterX technology is designed to work by introducing very brief pulses of electricity into the tissue and immediately monitoring impedance changes as the tissue responds. Stimulation and sensing take place via a concentric electrode system that is moved over the skin surface, and a digital display enables the operator to follow the course of the treatments and adjust the output.
The InterX 5000 consists of a small handheld device in a plastic case. It is powered by one nine-volt alkaline battery. On the upper face of the machine there are two LED's, an LCD display and 5 control buttons. The underside of the machine two metal surfaces that form the poles of a treatment electrodes are placed directly on the unbroken skin and do not use any conductive material or gel.
On the side of the machine is one socket for a standard 3.5mm stereo jack socket that connects to the main electrodes of the machine to an optional external electrode accessory. The device's electrodes are disabled when the optional external electrode accessory is
7
attached. The optional external electrode accessories only serve as an extension and allow the user to apply treatment in a areas which may not be accessible by the main unit electrodes. user to apply ucannell in a accessories intended for use with the InterX 5000 have any active electrical components.
The waveform is a high amplitude, short-duration bi-polar pulse (circuitry in the device integrates time and dosage delivered). A digital display monitors the biofeedback process in mtegrates thire and dosage convolling the operator to track changes in the tissues being treated and make appropriate adjustments to the output characteristics if necessary. This interaction and human adjustment continues throughout the length of the InterX treatment. The result is that the body experiences a conditioned training process that enhances the body's ability to effectively reduce and manage the level of pain.
Intended Use:
The InterX5000 is indicated for:
- symptomatic relief and management of chronic, intractable pain ■
- adjunctive treatment in the management of post-surgical and post-traumatic 트 pain
- 트 relaxing muscle spasms
- increasing local blood circulation
- immediate post surgical stimulation of calf muscles to prevent venous 트 thrombosis
- . muscle reeducation
- 트 maintaining or increasing range of motion
- preventing or retarding disuse atrophy ■
Comparison to Predicate Devices:
- . Does the new Device have the same indications for use? Yes
- Does the new Device have the same Technological Characteristics? Yes l
- Are Descriptive Characteristics precise enough to ensure Equivalence? Yes.
- Are Performance Data available to assess Equivalence? Yes
- Performance Data Demonstrate Equivalence? Yes
A comparison matrix has been provided as part of this premarket notification.
Performance Data & Conclusions:
Performance bench testing was conducted to characterize the electrical performance of the InterX5000 as compared to published data of predicate devices.