(341 days)
The Neuspera Nuity™ System (NNS) is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region.
The Neuspera Nuity™ System (NNS) is also used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant.
The Neuspera Nuity™ System is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The System consists of an implantable pulse generator (IPG), electrode array, surgical implant tools, wireless worn transmitter, clinician programmer, a patient controller, and undergarments. The implantable pulse generator is a miniature implanted neurostimulator, powered by an externally worn wireless transmitter device which contains a rechargeable battery.
Same as the predicate, the Neuspera Nuity™ System utilizes pulsed electrical current to create an energy field that acts on the targeted nerve to inhibit the transmission of pain signals to the brain. The Neuspera Nuity™ System may also be used during the trial period before recommendation for permanent implant.
The Neuspera Nuity™ System (NNS) is comprised of the following components: Neuspera Implanted Pulse Generator (IPG) Or Neuspera Implanted Microstimulator, Electrode Array, Surgical/Implant Tools, Externally Worn Wireless Transmitter, Clinician Programmer and Patient Controller.
The provided text does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any other quantifiable measure. Instead, the document is an FDA 510(k) clearance letter and summary, primarily focusing on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and safety aspects.
Therefore, many of the requested categories cannot be filled as they would relate to a clinical or performance study of the device's diagnostic or therapeutic effectiveness, which is not detailed in this document. The information provided is mainly related to bench testing, engineering comparisons, and biocompatibility.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria for performance metrics (e.g., pain reduction scores, successful stimulation rates) nor does it provide a clinical study to report on these. The closest information available is a comparison of technological characteristics to a predicate and reference device, implying that meeting or being comparable to these characteristics is a form of acceptance.
| Acceptance Criterion (Implicit) | Reported Device Performance (from Tables 1, 2, 3) |
|---|---|
| Intended Use | Subject Device (Neuspera Nuity™ System): Stimulation of peripheral nerves for chronic, intractable pain. Also for trial stimulation (no longer than 30 days). |
| Predicate Device (Neuspera Neurostimulation System K202781): Same. | |
| Reference Device (Nalu Neurostimulation System K183579): Same. | |
| Analysis: Same. Differences in wording do not affect safety and effectiveness of intended use. | |
| Product Code & Class | Subject Device: GZF, Class II |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Regulation Number | Subject Device: 21 CFR §882.5870 |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Classification Name | Subject Device: Implanted peripheral nerve stimulator for pain relief |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Prescription Use? | Subject Device: Yes |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Implant Site | Subject Device: Adjacent to nerves peripheral to central nervous system, excluding craniofacial region. |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Environmental Use | Subject Device: Hospital, Home |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Intended Clinician | Subject Device: Orthopedic, Neurosurgeon, Anesthesiologist |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Intended User | Subject Device: Physician, Layperson |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Mode of Action | Subject Device: RF wireless transmission of energy to charge implanted energy source with stimulation pulse generator to produce stimulation at stimulator electrodes. |
| Predicate Device: Same | |
| Reference Device: RF wireless transmission of energy to produce stimulation at stimulator electrodes. (Note: Reference device description is slightly different from subject/predicate in that it omits "implanted energy source with stimulation pulse generator") | |
| Analysis: Same as K202781 | |
| Software Level of Concern | Subject Device: Moderate |
| Predicate Device: Moderate | |
| Reference Device: Moderate | |
| Analysis: Same | |
| Dimensions (IPG, Electrode Array) | Subject Device: IPG: 2.33 mm diameter, electrode array 1.3 mm diameter, 4.5-5.2 cm total length. Subject devices consist of 2 lengths (30mm and 35mm electrode array lengths). |
| Predicate Device: IPG: 2.33 mm diameter, electrode array 1.3 mm diameter, 5.1 cm total length. Predicate electrode array length is 34mm. | |
| Reference Device: Lead = 1.30 mm diameter, 40 or 60 cm length, IPG = 28 x 11 x 4.9 mm. | |
| Analysis: Differences in electrode array lengths are negligible as therapy output remains the same between subject and predicate devices. | |
| Configuration | Subject Device: Implanted antenna receiver, energy storage capacitor, stimulation pulse generator coupled with electrode arrays. |
| Predicate Device: Same. | |
| Reference Device: Embedded receiver, flexible circuit board. | |
| Analysis: Same as K202781 | |
| Electrical Components | Subject Device: Embedded receiver, flexible circuit board with energy storage and stimulation pulse generator. |
| Predicate Device: Same. | |
| Reference Device: Same. | |
| Analysis: Same | |
| Power Delivery | Subject Device: Radio frequency transmission receiver. |
| Predicate Device: Same. | |
| Reference Device: Coupled receiver radio frequency transmission. | |
| Analysis: Same as K202781 | |
| Electrode Material | Subject Device: Platinum-iridium 90:10 |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Insulation Body Material | Subject Device: Pellethane 2363-55D |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Electrode Array Diameter | Subject Device: 1.30 mm |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Electrode Array Length | Subject Device: 21 mm (Measured Start of First to End of Last Electrode) |
| Predicate Device: Same | |
| Reference Device: 52 mm | |
| Analysis: Same as K202781 | |
| No. of Electrodes per array | Subject Device: 4 |
| Predicate Device: Same | |
| Reference Device: 8 | |
| Analysis: Same as K202781 | |
| Individual Electrode Length | Subject Device: 3 mm |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Electrode Surface Area | Subject Device: 12.25 mm² |
| Predicate Device: Same | |
| Reference Device: 12.25 mm³ (likely a typo, should be mm²) | |
| Analysis: Same | |
| Sterilization | Subject Device: Ethylene Oxide |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Pulse Frequency | Subject Device: 2 to 1500 Hz |
| Predicate Device: 4 to 130 Hz | |
| Reference Device: 2 to 1500 Hz | |
| Analysis: Neuspera Nuity pulse frequency range covers predicate device and is within range of reference device. Therefore, differences do not affect safety and effectiveness. | |
| Pulse Width | Subject Device: 15 to 960 µs |
| Predicate Device: 105 to 960 µs | |
| Reference Device: 12 to 1000 µs | |
| Analysis: Neuspera Nuity pulse width range covers predicate device and is within range of reference device. Therefore, differences do not affect safety and effectiveness. | |
| Current/Voltage Regulated | Subject Device: Voltage or Current |
| Predicate Device: Voltage | |
| Reference Device: Current | |
| Analysis: Adjustable between regulation mode of both predicate and reference devices. Therefore, differences do not affect safety and effectiveness. | |
| Output Current | Subject Device: (300 Ohms) 0 to 5.73 mA*, (500 Ohms) 0 to 5.44 mA*, (800 Ohms) 0 to 5.20 mA* |
| Predicate Device: Same | |
| Reference Device: (all) 0 to 10.2 mA | |
| Analysis: Same as K202781 (*measured with typical therapy pulse width of 240us) | |
| Waveform | Subject Device: Charge balanced (delayed) biphasic asymmetrical |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Pulse Shape | Subject Device: Decaying Exponential |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Maximum Phase Charge | Subject Device: (300 Ohms) 2.88 µC/pulse**, (500 Ohms) 2.74 µC/pulse**, (800 Ohms) 2.43 µC/pulse** |
| Predicate Device: Same | |
| Reference Device: (300 Ohms) 6.8 µC/pulse, (500 Ohms) 6.4 µC/pulse, (800 Ohms) 4.7 µC/pulse | |
| Analysis: Same as K202781 (**measured with maximum pulse width of 960us) | |
| Maximum Charge Density | Subject Device: (300 Ohm) 23.5 µC/cm2**, (500 Ohm) 22.4 µC/cm2**, (800 Ohm) 19.8 µC/cm2** |
| Predicate Device: Same | |
| Reference Device: (300 Ohm) 53.1 µC/cm², (500 Ohm) 50.3 µC/cm², (800 Ohm) 15.9 µC/cm2*** | |
| Analysis: Same as K202781 | |
| Maximum Current Density | Subject Device: (300 Ohm) 46.8 mA/cm2*, (500 Ohm) 44.4 mA/cm2*, (800 Ohm) 42.4 mA/cm2* |
| Predicate Device: Same | |
| Reference Device: (all) 26.5 mA/cm2*** | |
| Analysis: Same as K202781 | |
| Net Charge | Subject Device: 0 µC |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Pulse Delivery Mode | Subject Device: Continuous |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Current Path Options | Subject Device: Bipolar |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Program Cycle | Subject Device: Cycle through programs |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Pulse Pattern | Subject Device: Fine tuning of pulse patterns |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Dosage Time | Subject Device: Cycling ON/OFF 1 second-1 day |
| Predicate Device: Same | |
| Reference Device: Same | |
| Analysis: Same | |
| Biocompatibility | Subject Device: Complies with ISO 10993-1:2018 for long-term implant (>30 days) and limited duration tissue contact ( |
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).