(234 days)
To stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older
The MagVenture Pain Therapy is a magnetic stimulator system that provides brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves and provide relief of chronic intractable, post-traumatic and post-surgical pain. The subject device is intended to be used in hospitals and clinics such as pain management clinics. The device consists of Magnetic Stimulator, Stimulation Coils, Liquid Cool Unit (optional), and a Trolley. All coils of the MagVenture Pain Therapy have a built-in thermo sensor to measure the temperature of the coil surfaces to prevent high temperature on the skin of the patient or operator. The temperature allowed by the system is maximum 43°C or between 44°C for less than 10 minutes. The system will automatically disable if this maximum temperature is reached.
The provided document is a 510(k) Premarket Notification for the MagVenture Pain Therapy device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to prove safety and effectiveness. Therefore, the information regarding specific acceptance criteria and a study proving those criteria are not directly presented in the format requested for a device with novel claims.
However, based on the document, we can infer acceptance criteria from the comparison to the predicate device and the discussion of technological characteristics. The study proving the device meets these inferred criteria is essentially a comparison study against the predicate device and an assessment of why any differences do not raise new questions of safety or effectiveness.
Here's an attempt to answer your questions based on the provided text, recognizing the limitations of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for a 510(k) are typically that the new device is "substantially equivalent" to a predicate device, meaning it has the same intended use and either has the same technological characteristics or, if it has different technological characteristics, those do not raise different questions of safety and effectiveness. The performance is reported by comparing it to the predicate.
| Acceptance Criteria (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance (MagVenture Pain Therapy) |
|---|---|
| Intended Use: Stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older. | Same as predicate device, Axon Therapy (K210021). |
| Anatomical Sites: Similar range of application areas. | Same as predicate device. |
| Treatment Facilities: Hospitals & Clinics. | Same as predicate device. |
| Treatment Time: 13 min per session (800 seconds). | Same as predicate device. |
| Pulse Amplitude: 0-100%. | Same as predicate device. |
| On-cycle duty period: 2-800 seconds (0.5 Hz and up to 400 pulses) | Same as predicate device. |
| Off-cycle reset period: N/A. | Same as predicate device. |
| Pulse Mode: Standard. | Same as predicate device. |
| Maximum coil temperature: 43°C (system automatically disables if reached). | Same as predicate device (predicate 41°C, but both disable at max). |
| Software/Firmware/Microprocessor control: Yes. | Same as predicate device. |
| Power Source: Similar electrical specifications. | Similar (subject: 120V~, 50/60 Hz; predicate: 110V to 220V ac, 50/60 Hz). Deemed "Same". |
| User Interface: LED display. | Same as predicate device. |
| Sterilization: Non-sterile when used. | Same as predicate device. |
| Electrical Safety: Complies with IEC60601-1 v3.1. | Complies with IEC60601-1 v3.1 (from predicate). Deemed "Same". |
| Mechanical Safety: Complies with IEC60601-1 v3.1. | Complies with IEC60601-1 v3.1 (from predicate). Deemed "Same". |
| Chemical Safety: Complies with IEC60601-1 v3.1. | Complies with IEC60601-1 v3.1 (from predicate). Deemed "Same". |
| Thermal Safety: Complies with IEC60601-1 v3.1. | Complies with IEC60601-1 v3.1 (from predicate). Deemed "Same". |
| Radiation Safety: No radiation generated. | Complies (from predicate, implies no radiation). Deemed "Same". |
| Biocompatibility: Complies with ISO 10993. | Complies with ISO 10993 (from predicate). Deemed "Same". |
| Standards: Company complies with EN ISO 13485. | Complies (from predicate). Deemed "Same". |
| Pulse frequency: Acceptable range without new safety/effectiveness questions. | 0.1-30 Hz (pps) for R30, 0.1-100 Hz (pps) for X100. Predicate: 0-2 Hz (pps). Deemed "Substantially equivalent" because 0.5 Hz is shared and higher rates are physiologically within range. |
| Maximum repetition rate: Acceptable rate without new safety/effectiveness questions. | 30 pps for R30, 100 pps for X100. Predicate: 2 pps. Deemed "Substantially equivalent" for reasons similar to pulse frequency. |
| Pulse Width: Biphasic (similar µsec). | Biphasic (280-320 µsec). Predicate: Biphasic (290 µsec). Deemed "Substantially equivalent". |
| Maximum output power: Acceptable power without new safety/effectiveness questions. | 100% at 15 pps for subject. Predicate: 100% at 2 pps. Deemed "Substantially equivalent" because both achieve 100% at 2 pps. |
| Waveform: Biphasic functionality. | Biphasic (and Monophasic for X100). Predicate: Biphasic. Deemed "Substantially equivalent" because all can do biphasic. |
| Peak Magnetic Field at coil surface (T): No new issues. | 1.15-2.6 T*. Predicate: Not publicly available. Deemed "Substantially equivalent". |
| Peak Magnetic Field Gradient dB/dt in coil center at 20mm distance from coil surface: No new issues. | 9-24 kT/s*. Predicate: Not publicly available. Deemed "Substantially equivalent". |
| Housing Material Construction: No new safety issues. | Stimulator: Aluminum, Aluzinc; Coils: PVC, ABS, PA, POM. Predicate: Stimulator: Al sheet EN AW 5754; Coil: ABS. Deemed "Substantially equivalent". |
| Applied Parts: Magnetic coils, no new safety issues. | Various coils (MMC-140-II, MCF-140, RT-120-II, MMC-90, MCF-125, Cool-B65, Cool-125). Predicate: Magnetic coil 60BF-NL. Deemed "Substantially equivalent". |
| Applied Parts area: Acceptable coil dimensions. | Butterfly coils: 150 mm; Circular coils:110-126 mm; Special coils: 160x80 mm. Predicate: 160 mm. Deemed "Substantially equivalent". |
The "study" demonstrating these criteria are met is the comparison presented in the 510(k) submission, specifically the "Comparison of Technological Characteristics" table and the "Substantial Equivalence Notes" which explain why differences do not raise new safety or effectiveness questions.
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the traditional sense of a clinical trial. Instead, the "testing" references non-clinical testing performed on the predicate device (K094019) and the argument that the current device is "identical in all features (e.g., design, dimensions, materials, biocompatibility), except for the indications for use." Therefore, "no new bench testing is needed."
This implies that the "data provenance" for the foundational performance characteristics comes from the testing previously conducted for the predicate devices (MagPro Family device K094019 and Axon Therapy K210021), not a new test set for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a 510(k) submission based on substantial equivalence, not a de novo clinical study with a new "test set" requiring expert ground truth establishment. The ground truth for safety and effectiveness is established by the prior clearance of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, there is no new clinical "test set" with adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator for Pain Relief, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (magnetic stimulator), not an algorithm or AI system. Its performance is intrinsic to the device's physical operation, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the safety and effectiveness of the device's underlying technology and performance characteristics is established through:
- Prior FDA clearances: The substantial equivalence relies on the fact that the predicate devices (MagPro Family and Axon Therapy) were previously cleared by the FDA based on their demonstrated safety and effectiveness.
- Compliance with recognized standards: The document explicitly states compliance with standards like IEC60601-1 v3.1 (electrical, mechanical, chemical, thermal safety) and ISO 10993 (biocompatibility). These standards represent established "ground truths" for various aspects of device safety.
- Physiological understanding: The justification for wider pulse frequencies and repetition rates refers to the "range of physiological action potentials (from 0.05 to 500 Hz) of the human nervous system," indicating an appeal to established physiological knowledge as a "ground truth" for safety.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires 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).