(331 days)
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No
The document describes a standard TENS unit with preprogrammed regimens and output level controls. There is no mention of AI, ML, or any features that would suggest adaptive or learning capabilities. The performance studies focus on functional equivalence to a predicate device and meeting international standards, not on the performance of an AI/ML algorithm.
Yes
The device is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain, which are therapeutic purposes.
No
The "Intended Use / Indications for Use" states that the device is for "symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain," which describes a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it is a dual channel TENS device powered by a battery and requires leadwires and electrodes, indicating it is a hardware device.
Based on the provided information, the Epix XL TENS Unit 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 unit, which delivers electrical stimulation to the skin. This is a physical therapy modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The Epix XL TENS Unit directly interacts with the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Epix XL TENS Unit is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
Product codes
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Device Description
The Epix XL is a dual channel TENS device with four conventioual modes of operation, eight preprogrammed regimens and a choice of two levels of output (0-40mA or 0-60mA). It is powered by a standard 9V alkaline or NiCad rechargeable battery. All operation modes produce the Empi Bi-Sourced® waveform.
The Epix XL System requires the use of a set of leadwires and one or two pair of cutaneous stimulation electrodes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The Epix XL Model 995 performs identically to the Epix XL Model 989 with the exception of an added function to prevent the stimulator from delivering current from a no output condition (no battery or device is turned OFF) to a rapid increase in current (fresh battery without turning the device OFF or manually turning the potentiometer up too quickly from start up of the device). This is an added feature which is required to meet international device standards. This function does not impact the performance of the device, thus does not require clinical testing to establish equivalence.
The functional testing was performed and the results analyzed against product specifications demonstrating that the product meets requirements and is acceptable for its intended use.
Key Metrics
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Predicate Device(s)
Epix XL Model 989
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
510(k) SUMMARY OF SAFETY AND EFFECT
MAR 20 1996 Applicant name: Empi. Inc. Applicant address: 5255 East River Rd. Fridley, MN 55421 Stacy Mattson, Regulatory Affairs Manager Contact person: 612-586-7354 Phone: April 11, 1995 Date Prepared: Classification Name: Transcutaneous Electrical Nerve Stimulator TENS unit Common/Usual Name: Trade/Proprietary Name: Epix XL TENS Unit, Model 995 Empi Epix XL Model 989 Equivalent Devices:
Product/System Description
The Epix XL is a dual channel TENS device with four conventioual modes of operation, eight preprogrammed regimens and a choice of two levels of output (0-40mA or 0-60mA). It is powered by a standard 9V alkaline or NiCad rechargeable battery. All operation modes produce the Empi Bi-Sourced® waveform.
The Epix XL System requires the use of a set of leadwires and one or two pair of cutaneous stimulation electrodes.
Intended Use:
The Epix XL TENS Unit is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
Comparison of Equivalent Devices to the New Device:
Summary of Technical Differences
The Epix XL Model 995 is technical to the Epix XL 989 with the exception of a change in the LED lights from red to green. No testing is needed to establish equivalence.
Summary of Performance - Nonclinical
The Epix XL Model 995 performs identically to the Epix XL Model 989 with the exception of an added function to prevent the stimulator from delivering current from a no output condition (no battery or device is turned OFF) to a rapid increase in current (fresh battery without turning the device OFF or manually turning the potentiometer up too quickly from start up of the device). This is an added feature which is required to meet international device standards. This function does not impact the performance of the device, thus does not require clinical testing to establish equivalence.
Product Verification and Validation
The functional testing was performed and the results analyzed against product specifications demonstrating that the product meets requirements and is acceptable for its intended use.
1
COMPARISON OF PRODUCT SPECIFICATIONS
The Epix XL Model 995 is substantially equivalent to the Epix XL Model 989. The similarities in the two
products can be seen in the following chart.
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Shortines See rady - to and the
| Product Characteristics | Epix XL Model 989 | Epix XL Model 995 |
|---|---|---|
| Indications for Use | Symptomatic relief and management of | |
| chronic, intractable pain and adjunctiv | ||
| treatment for post-surgical and post | ||
| trauma acute pain. | Symptomatic relief and management of | |
| chronic, intractable pain and adjunctiv | ||
| treatment for post-surgical and post | ||
| trauma acute pain. | ||
| No. Of Output Channels | 2 | 2 |
| Standards | AAMI/ANSI NS4-1985 | |
| IEC 601-2-10 | ||
| IEC 601-1-2 | AAMI/ANSI NS4-1985 | |
| IEC 601-2-10 | ||
| IEC 601-1-2 | ||
| Control mechanism | Microprocessor, masked | Microprocessor, masked |
| Amplitude (voltage) Range | 0-40Vpp (normal) | |
| 0-60Vpp (high) | 0-40Vpp (normal) | |
| 0-60Vpp (high) | ||
| Maximum Output Voltage | 120Vpp, 1MΩ | 120Vpp, 1MΩ |
| Channel Interaction | ≤ 5% | ≤ 5% |
| Pulse Width | 0-400µs at 50% of peak amplitude | 0-400µs at 50% of peak amplitude |
| Waveform | Symmetrical, bi-phasic | Symmetrical, bi-phasic |
| Zero Net DC | yes; achieved through the transformer | yes; achieved through the transformer |
| Max. Charge per Pulse | 20µC into a 500 Ohm load | 20µC into a 500 Ohm load |
| Adjustable Pulse Rates | 2, 10, 20, 40, 60, 80, 100, 150 Hz | 2, 10, 20, 40, 60, 80, 100, 150 Hz |
| Standard Output Modes* | Continuous (C), Burst (B), Modulated | |
| Rate (R), Multi-Modulated (M) | Continuous (C), Burst (B), Modulated | |
| Rate (R), Multi-Modulated (M) | ||
| Preprogrammed | ||
| Output Modes* | Extremely Low Frequency (ELF) | |
| Dual Pulse (DP) | ||
| High Frequency (HF) | ||
| Bi-Modal (BM) | ||
| Ramped Burst (RB) | ||
| Modulated Amplitude (MA) | ||
| Alternating Ramped Burst (ARB) | ||
| Random Modulation (RAM) | Extremely Low Frequency (ELF) | |
| Dual Pulse (DP) | ||
| High Frequency (HF) | ||
| Bi-Modal (BM) | ||
| Ramped Burst (RB) | ||
| Modulated Amplitude (MA) | ||
| Alternating Ramped Burst (ARB) | ||
| Random Modulation (RAM) | ||
| High Amplitude Shutdown | ||
| (Output Interlock) | No | Yes |
| Housing Materials | ABS Plastic | ABS Plastic |
| Output Type | constant voltage | |
| 200Ω - 1kΩ | constant voltage | |
| 200Ω - 1KΩ | ||
| Minimum Electrode Size | ||
| (active area) | NeuroEase .25in² (1.6cm²) | NeuroEase .25in² (1.6cm²) |
| Maximum RMS Current | ||
| Density | 30.9mA/in2 | |
| (4.88mA/cm²) | 30.9mA/in2 | |
| (4.88mA/cm²) | ||
| Product Characteristics | Epix XL Model 989 | Epix XL Model 995 |
| Maximum Power Density | 243 W/in2 (38 mW/cm2) | 243 W/in2 (38 mW/cm2) |
| Maximum Average Phase | ||
| Current (specify load) | 77mA, 200Ω load | 77mA, 200Ω load |
| Maximum Enclosure | ||
| Leakage Current | 100μA | 100μA |
| Automatic Overload Trip | NA | NA |
| Automatic No Load Trip | NA | NA |
| Patient Override Control | NA | NA |
| Max. Patient Leakage Current | 100μA | 100μA |
| Output Indicator | YES red | YES-green |
| Low Battery Indicator | YES, yellow | YES, yellow |
| Size | 3.7in.x2.5in.x0.84in. | 3.7in.x2.5in.x0.84in. |
| Weight | 145 gm with battery | 145 gm with battery |
| Power Source | 9 V Alkaline Battery or equivalent | |
| Empi rechargeable battery | 9 V Alkaline Battery or equivalent | |
| Empi rechargeable battery |
Page 2 of 3
2
Comparison of Product Specifications (cont.)
The shaded areas show where there are differences between the two devices.
Page 3 of 3
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