(494 days)
(A) Interferential current stimulation, Premodulated Bipolar Mode and Faradic Stimulation Mode is indicated for:
- Symptomatic relief and management of chronic (long term) intractable pain.
- Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain conditions.
(B) Electrical Muscle Stimulation ( Russian and Galvanic-Interrupted ) is indicated for: - Relaxation of Muscle spasm.
- Prevention or Retardation of disuse atrophy.
- Increasing local blood circulation.
- Muscle re-education.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- Maintaining or increasing range of motion.
( C) Galvanic-DC Continuous mode is indicated for :- - Relaxation of muscle spasm.
ANALGESIC PULSER AP-439 is an electrical nerve muscle stimulator with two outputs and four channels. It offers various waveforms including Monophasic, Biphasic, Sinewave & D.C. Line. It has different modes of stimulation such as Faradic, Interferential, DC continuous, and DC Interrupted, with specified maximum output current and voltage for each. It also provides different modulation options for amplitude and frequency.
The provided text is a 510(k) summary for the "Analgesic Pulser AP-439," an Electrical Nerve Muscle Stimulator. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove performance against specific acceptance criteria in the manner one would typically expect for a modern AI/ML device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are implicitly that the device's technical specifications and intended uses are substantially equivalent to legally marketed predicate devices.
| Feature | PREDICATE DEVICE (Sys Stim 226) (selected specifications) | PREDICATE DEVICE (Sys Stim 206) (selected specifications) | PREDICATE DEVICE (Sportx) (selected specifications) | PROPOSED DEVICE (AP-439) Technical Specifications (selected specifications) |
|---|---|---|---|---|
| Primary Indication | Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain. | (Not explicitly detailed as primary, but indications generally align with other predicate) | Symptomatic relief and management of chronic, intractable pain or as an adjunctive treatment in the management of acute post-surgical or post-traumatic pain. | Symptomatic relief and management of chronic (long term) intractable pain. Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain conditions. |
| Waveform | Sinewave and biphasic rectangular pulse | Biphasic, monophasic pulse, DC. | Multiplexed symmetrical rectangular biphasic and unbalanced symmetrical rectangular triphasic. | Monophasic, Biphasic, Sinewave & D.C. Line |
| Max Output Current | 65 mA RMS at 1K load (interferential mode) | 100 mA peak, All pulsed Waveforms. 30 mA max. in DC continuous. | 100 mA at load of 500 ohms. | Faradic - 100 mA pp at 500 Ohm Load; Interferential - 72mA RMS at 500 Ohm Load; DC continuous - 30 mA at 500 Ohm Load; DC Interrupted - 92 mA at 500 Ohm Load |
| Max Output Voltage | 65 V RMS at 1K load (interferential mode) | 0 -- 102 VDC | 100 V at load of 2 K ohms. | Faradic - 132 V peak to peak at load of 10K ohms; Interferential - 50 V RMS at load of 10K ohms; DC continuous - 28 V at load of 10K ohms; DC Interrupted - 60 V at load of 10K ohms. |
| Max Current Density (under 2" electrode) | 3.2 mA/cm² (interferential mode) | Not explicitly listed, but 3.2mA/cm² given for Sys Stim 226 | Not explicitly listed | Interferential: 3.55mA/Sq. cm; Galvanic (D.C. continuous): 1.5 mA/Sq. cm; Galvanic Interrupted: 2.1mA/ Sq.cm; Faradic: 0.592 mA/Sq. cm |
| Phase Duration | 125 us (interferential mode), 50-300 us (biphasic mode) | Narrow pulse: 100 us; Wide pulse: 300 us; AC: 300 us; DC: DC Continuous | Symmetrical biphasic: 1800 us; Unbalanced triphasic: 1800 us and 900 us | Faradic: 100-400 (selectable); IFT: 125 micro sec. phase interval; Russian: 200 micro seconds; Galvanic: D.C. |
Study Description:
The document describes a submission for a 510(k) premarket notification. This process is not a clinical study in the sense of a trial designed to prove device effectiveness or safety through statistical analysis against specific acceptance thresholds. Instead, it's a demonstration that the new device is "substantially equivalent" to one or more devices already legally marketed (predicate devices) in terms of intended use, technological characteristics, and safety and effectiveness.
The "study" here is a comparison of technical specifications and intended uses between the proposed device (Analgesic Pulser AP-439) and three predicate devices: Sys stim 226, Sys stim 206 (both from Mettler Electronics Corp.), and Sportx (from Staodyn). The document argues that the AP-439 has the same intended use as the predicates and its technical specifications are comparable, thus ensuring similar safety and effectiveness.
2. Sample Size for Test Set and Data Provenance
Not applicable. This is not a study involving a test set of patient data, but rather a technical and functional comparison of a new device to existing ones.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth, in the context of clinical expert consensus or pathology for diagnostic devices, is not a concept applied in this 510(k) submission for an electrical stimulator. The "ground truth" here is the established safety and effectiveness of the predicate devices as determined by their prior clearance.
4. Adjudication Method for the Test Set
Not applicable. There is no test set of patient data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a comparison for an electrical stimulation device, not an image-reading or diagnostic AI system that would typically undergo an MRMC study.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a physical electro-mechanical product, not an algorithm. Its performance is demonstrated by its adherence to technical specifications that are comparable to previously cleared devices.
7. Type of Ground Truth Used
The "ground truth" implicitly used is the regulatory clearance and established safety/effectiveness of the predicate devices. The submission argues that because the AP-439 operates on similar principles, has comparable technical specifications, and shares the same intended use as these legally marketed devices, it can be considered substantially equivalent.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that learns from a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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).