(83 days)
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.
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 provided text describes a medical device, the Epix® VT TENS System, and its comparison to a predicate device for 510(k) submission. However, it does not contain specific acceptance criteria, a detailed study proving device performance against those criteria, or information on sample sizes, ground truth establishment, or expert involvement as requested.
The document primarily focuses on:
- Device Description: What the Epix® VT is and its features.
- Intended Use: The medical conditions it's designed to treat, which are identical to its predicate device.
- Technological Differences: How it differs from the predicate device (Epix® XL TENS System), primarily in user interface (buttons vs. knobs, LCD display), safety connectors, and a slight reduction in frequency options for some modes, along with added data recording/display features.
- Non-Clinical Test Results (Summary): A general statement that design qualification testing was performed based on hazard analysis and voluntary standards, including firmware, functional, simulated misuse/safety, and electromagnetic compatibility testing. It concludes that "the results showed that the product meets specifications and functions as expected."
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance study as this information is not present in the provided text.
The document states: "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." This is a general conclusion, not a detailed breakdown of acceptance criteria and performance data.
Here's a breakdown of what is not available in the provided text, corresponding to your request:
- A table of acceptance criteria and the reported device performance: Not provided. The text only vaguely states "meets specifications."
- Sample size used for the test set and the data provenance: Not mentioned. The document only lists types of non-clinical tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study with "ground truth" is described. The device is a TENS unit, and its assessment is primarily functional and safety-related rather than diagnostic.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a TENS device, not an AI diagnostic algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
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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 RoadSt. 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 CFR882.5890 |
| 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.
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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.
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- Firmware testing 3. Simulated Misuse/Safety testing
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- 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.
§ 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).