K Number
K970203
Device Name
EPIX VT
Manufacturer
Date Cleared
1997-04-14

(83 days)

Product Code
Regulation Number
882.5890
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Epix® VT is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
Device Description
The Epix® VT is a dual channel TENS device with twelve pre-programmed output modes. It is powered by a standard 9V rechargeable battery with a maximum output of 60mA. The Epix® VT has the ability to monitor the pain level of the user before and after a treatment session, number of treatment sessions, the intensity range of each treatment session and the length of each treatment session. Using this information, the Epix® VT calculates and displays the percentage of sessions with pain relief, the number of sessions used, the average session length, the most frequent change in pain relief and the most frequent intensity range used. The Epix VT System requires the use of a set of lead wires and one or two pair of electrodes. The lead wires used with the Epix® VT have a protected safety connector which attaches to the device and either a snap or pin style connector which attaches to the electrode.
More Information

Not Found

No
The device description focuses on basic data monitoring and calculation, not complex pattern recognition or learning algorithms. The "Mentions AI, DNN, or ML" field is also "Not Found".

Yes.
The device is intended for the symptomatic relief and management of chronic pain and adjunctive treatment for acute pain, which falls under therapeutic use.

No

The device description indicates that the Epix® VT monitors pain levels and calculates pain relief, but this information is displayed for the user and does not state that it is used to diagnose a medical condition. The Intended Use/Indications for Use section specifies symptomatic relief and management of pain, which is therapeutic, not diagnostic.

No

The device description explicitly states it is a dual channel TENS device powered by a battery and requires lead wires and electrodes, indicating it is a hardware device with embedded software, not a software-only medical device.

Based on the provided information, the Epix® VT is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use is for the symptomatic relief and management of pain. This is a therapeutic application, not a diagnostic one.
  • Device Description: The device is a TENS (Transcutaneous Electrical Nerve Stimulation) device, which delivers electrical impulses to the body for pain relief. It measures and displays information about treatment sessions and pain levels, but it does not analyze biological samples (like blood, urine, or tissue) to diagnose a condition.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
    • Analysis of biological samples.
    • Detection or measurement of analytes (substances in the body).
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions.

Therefore, the Epix® VT is a therapeutic device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Epix® VT is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain. This is identical to the indications for use for the Epix® XL.

Product codes

Not Found

Device Description

The Epix® VT is a dual channel TENS device with twelve pre-programmed output modes. It is powered by a standard 9V rechargeable battery with a maximum output of 60mA.

The Epix® VT has the ability to monitor the pain level of the user before and after a treatment session, number of treatment sessions, the intensity range of each treatment session and the length of each treatment session. Using this information, the Epix® VT calculates and displays the percentage of sessions with pain relief, the number of sessions used, the average session length, the most frequent change in pain relief and the most frequent intensity range used.

The Epix VT System requires the use of a set of lead wires and one or two pair of electrodes. The lead wires used with the Epix® VT have a protected safety connector which attaches to the device and either a snap or pin style connector which attaches to the electrode.

The currently distributed Empi TENS electrodes require no modification and are compatible for use with the Epix® VT System.

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)

Non-Clinical Test Results
Design Qualification testing was developed based upon the hazard analysis and available voluntary standards for electromedical devices. The following testing was performed and the results showed that the product meets specifications and functions as expected.

    1. Firmware testing 3. Simulated Misuse/Safety testing
    1. Functional testing 4. Electromagnetic Immunity and Radiated Emissions testing

Conclusion

The results of all testing done show that this design meets all specifications, is equivalent to currently marketed products and is acceptable for its intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Empi Epix® XL TENS System (K881114 and K951503)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K970203

Cost Effective Health Care Solutions

APR 1 4 1997

Empi, Inc. 599 Cardigan Road St. Paul. Minnesota 55126-3965 USA

612-415-9000 FAX 612-415-7305

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant name:Empi, Inc.
Applicant address:599 Cardigan Road
St. Paul, MN 55126-3965
Phone:612-586-7354
FAX:612-415-7314
Contact person:Stacy Mattson, Regulatory Affairs Manager
Date Prepared:January 15, 1997
Trade/Proprietary Name:Epix® VT TENS System
Classification Name:Transcutaneous Electrical Nerve Stimulator (TENS) per 21 CFR
882.5890
Common/Usual Name:TENS System
Predicate Device:Empi Epix® XL TENS System (K881114 and K951503)

Device Description

The Epix® VT is a dual channel TENS device with twelve pre-programmed output modes. It is powered by a standard 9V rechargeable battery with a maximum output of 60mA.

The Epix® VT has the ability to monitor the pain level of the user before and after a treatment session, number of treatment sessions, the intensity range of each treatment session and the length of each treatment session. Using this information, the Epix® VT calculates and displays the percentage of sessions with pain relief, the number of sessions used, the average session length, the most frequent change in pain relief and the most frequent intensity range used.

The Epix VT System requires the use of a set of lead wires and one or two pair of electrodes. The lead wires used with the Epix® VT have a protected safety connector which attaches to the device and either a snap or pin style connector which attaches to the electrode.

The currently distributed Empi TENS electrodes require no modification and are compatible for use with the Epix® VT System.

Intended Use:

The Epix® VT is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain. This is identical to the indications for use for the Epix® XL.

1

Image /page/1/Picture/0 description: The image shows the word "Empi" in a bold, stylized font. The letters are slanted to the right, giving the word a dynamic appearance. A registered trademark symbol is located to the lower right of the letter "i".

Cost Effective Health Care Solutions

Empi, Inc. 599 Cardigan Road St. Paul, Minnesota 55126-3965 USA

612-415-9000 FAX 612-415-7305

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (CONT.)

Comparison of Technological Differences between Equivalent Device and New Device:

All the critical functional output parameters are the same in the Epix® VT and the Epix XL. These parameters are the pulse width , the pulse rate (frequency), the waveform, the amplitude (intensity) range, and power source. The main differences between the devices are related to the user interface. The user controls have been changed from knobs and switches to membrane push buttons and an LCD in the Epix® VT. Push buttons are easier to use and control the setting of the adjustable parameters such as amplitude. The output jacks for the lead wire connection in the Epix® VT are designed for a safety connector which has no exposed metal to insert into inappropriate outlets such as wall sockets. The Epix VT has 2 frequency options for the Multi-Modulation Mode and 1 frequency option for Modulated Rate Mode. These frequencies are offered in the predicate device along with other frequency options. The Burst mode was also removed due to the similarity between the Ramped Burst and Burst modes. These changes in the output options simplify the choices for determining a comfortable stimulation for the user and do not impact the performance or efficacy of the device. They only limit the number of choices with regard to patient preference. The Epix VT has an added feature of recording and displaying the user's response to treatment. This is accomplished through a 6 point pain scale which turns the device ON or OFF. During a treatment session the device also monitors the session length and intensity range used. This information is accessed through the LCD. These added features do not impact the efficacy or safety of the device.

Assessment of Performance Data

Non-Clinical Test Results

Design Qualification testing was developed based upon the hazard analysis and available voluntary standards for electromedical devices. The following testing was performed and the results showed that the product meets specifications and functions as expected.

    1. Firmware testing 3. Simulated Misuse/Safety testing
    1. Functional testing 4. Electromagnetic Immunity and Radiated Emissions testing

Conclusion

The results of all testing done show that this design meets all specifications, is equivalent to currently marketed products and is acceptable for its intended use.