(339 days)
The Neuspera Neurostimulation 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 Neurostimulation 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 Neurostimulation 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 and a patient controller. The implantable pulse generator is a miniature implanted neurostimulator, powered by an externally worn wireless transmitter device which contains a rechargeable battery.
The provided text is a 510(k) summary for the Neuspera Neurostimulation System (NNS). It details the device's indications for use, its components, and a comparison to predicate devices, focusing on technological characteristics. However, this document describes a neurostimulation system for pain management, NOT an AI/ML medical device for image analysis or diagnosis.
Therefore, the information required to answer your prompt, which is specifically related to acceptance criteria and studies for AI/ML device performance (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies), is not present in this 510(k) summary. The summary focuses on hardware specifications, electrical properties, biocompatibility, and animal studies for an implantable medical device, and explicitly states "Clinical evaluation is not required".
To directly address your request, if this were an AI/ML device submission, here's what the answer would look like (hypothetically, based on typical AI/ML medical device FDA submissions):
Hypothetical Response (if this were an AI/ML device, assuming typical FDA AI/ML study requirements):
This 510(k) summary does not appear to be for an AI/ML medical device that requires clinical performance studies based on human reader performance or algorithm-only metrics. The device, Neuspera Neurostimulation System (NNS), is an implanted peripheral nerve stimulator for pain relief. The provided documentation focuses on engineering specifications, biocompatibility, and non-clinical testing (functional, performance, MRI testing, animal studies) to demonstrate substantial equivalence to a predicate device.
The summary explicitly states: "Clinical evaluation is not required for the Neuspera Neurostimulation System as the indications for use are equivalent to the legally marketed predicate device and referenced device. These types of devices, including versions of the legally marketed predicate device, have been on the market for many years with a proven safety and efficacy for the use of the device. Therefore, Neuspera determined that bench and non-clinical testing are sufficient to demonstrate that the Neuspera Neurostimulation System is as safe and effective as the predicate device."
Therefore, the requested information regarding acceptance criteria, performance metrics (like sensitivity, specificity), data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, which are typical for AI/ML diagnostic or prognostic devices, is not applicable or available in this specific 510(k) submission for the Neuspera Neurostimulation System.
If this were an AI/ML device submission, the following sections would be populated (but cannot be from the provided text):
- Table of acceptance criteria and reported device performance:
(Hypothetical example for an AI/ML device)
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sensitivity | ≥ 90% | 92.5% |
| Specificity | ≥ 80% | 85.1% |
| AUC (ROC) | ≥ 0.90 | 0.93 |
| PPV | ≥ 75% | 78.2% |
| NPV | ≥ 95% | 96.8% |
-
Sample size used for the test set and the data provenance:
(Hypothetical example for an AI/ML device)- Test Set Sample Size: E.g., 500 cases (e.g., medical images).
- Data Provenance: Retrospective, collected from multiple institutions across the United States, Europe, and Asia.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
(Hypothetical example for an AI/ML device)- Number of Experts: E.g., 3 independent board-certified radiologists.
- Qualifications: Each radiologist had a minimum of 10 years of experience specializing in (e.g., thoracic imaging) and were blinded to the device's output.
-
Adjudication method for the test set:
(Hypothetical example for an AI/ML device)- Adjudication Method: 2+1; if two initial readers disagreed, a third senior expert (adjudicator) reviewed the case to establish the final ground truth.
-
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
(Hypothetical example for an AI/ML device)- MRMC Study: Yes, an MRMC study was conducted comparing human reader performance with and without AI assistance.
- Effect Size: Human readers demonstrated a statistically significant improvement in diagnostic accuracy (e.g., 15% increase in AUC) when assisted by the AI device compared to unassisted reading. The sensitivity increased by X% and specificity by Y%.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
(Hypothetical example for an AI/ML device)- Standalone Performance: Yes, standalone performance was evaluated on the test set. The algorithm achieved a sensitivity of 92.5% and a specificity of 85.1%.
-
The type of ground truth used:
(Hypothetical example for an AI/ML device)- Ground Truth Type: Expert consensus (from the expert radiologists) reviewed against relevant clinical outcomes data (e.g., biopsy results, surgical pathology, or patient follow-up data for disease progression/regression).
-
The sample size for the training set:
(Hypothetical example for an AI/ML device)- Training Set Sample Size: E.g., 10,000 cases.
-
How the ground truth for the training set was established:
(Hypothetical example for an AI/ML device)- Training Set Ground Truth: Established by a combination of clinical reports, a subset reviewed by a single board-certified radiologist, and confirmed with pathology results or long-term patient follow-up where available. Automated methods (e.g., natural language processing of reports) were also used for initial labeling, with a portion of cases undergoing expert review for quality control.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 27, 2021
Neuspera Medical Inc. Alexander Yeh Founder and Chief Technology Officer 51 Daggett Dr. San Jose, California 95134
Re: K202781
Trade/Device Name: Neuspera Neurostimulation System (NNS) Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: August 25, 2021 Received: August 25, 2021
Dear Alexander Yeh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202781
Device Name Neuspera Neurostimulation System (NNS)
Indications for Use (Describe)
The Neuspera Neurostimulation 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 Neurostimulation System (NNS) is also used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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SECTION 8: 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K202781
Applicant Information:
| Owner Name: | Neuspera Medical Inc |
|---|---|
| Address: | 51 Daggett Dr.San Jose, CA 95134 |
| Contact Person: | Alexander Yeh, Ph.D |
| Contact Person: | Alexander Yeh, PE |
|---|---|
| Phone Number: | (888) 846-8332 |
| Date Prepared: | 9/21/2020 |
Device Information:
Trade/Proprietary Name: Neuspera Neurostimulation System Common/Usual Name: Neuspera Neurostimulation System Product Code: GZF Requlation number: 21 CFR 882.5870: Stimulator, peripheral nerve, implanted (Pain Relief) Class: Class II Device Classification Panel: Neurology
Predicate Devices:
The Neuspera Neurostimulation System is substantially equivalent in intended use and method of operation to the cleared Nalu Neurostimulator System (K183579).
Device Description:
The Neuspera Neurostimulation 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 and a patient controller. The implantable pulse generator is a miniature implanted neurostimulator, powered by an externally worn wireless transmitter device which contains a rechargeable battery.
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Similar to the predicate, the Neuspera Neurostimulation therapy 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 Neurostimulation System may also be used during the trial period before recommendation for permanent implant.
The Neuspera Neurostimulation System (NNS) System is comprised of the following components:
| SystemComponent | Description |
|---|---|
| NeusperaImplanted PulseGenerator (IPG)OrNeusperaImplantedMicrostimulator | The implanted Neuspera Neurostimulation System (NNS) includes aminiaturized implantable neurostimulator (approximately 17mm long by2.3 mm diameter at its widest point) combining a receiver and ahermitically sealed pulse generator.The IPG/Microstimulator is a hermitically sealed electronic package(0.02 cc) consisting of a highly integrated electronic circuit with acustom ASIC (application specific integrated circuit) and a flex circuitinterconnect. This package harvests the received energy, charges aninternal energy bank, and manages power/communication. Theenergy bank is used by the internal stimulation waveform generator togenerate stimulation pulses based upon the digitally receivedprogramming parameters.Hermetic feedthroughs conduct the stimulation waveform from thestimulation implantable pulse generator to the electrode arraydescribed below. |
| Electrode Array | The electrode array is an implantable and attached to the IPGthrough hermetic feedthroughs connectors. The electrode array isdesigned to deliver electrical pulses to the nerve via an array of fourcylindrical electrodes at the distal end of the device. |
| Surgical/ImplantTools | The tools provided in the Neuspera Neurostimulation System (NNS)Kit are used to introduce and implant the neurostimulator.A needle along with imaging guidance is used to locate the targetednerve. Next, the needle is replaced with a guidewire. An incision ismade at the skin surface adjacent to the guidewire. Next, a pre-dilator is inserted around the guidewire to dilate the path to the nerve.The pre-dilator is then removed and replaced with an introducer anddilator. The dilator and guidewire are then removed. The implant istunneled through the introducer (sheath) using a connected pushrod.The PTFE tether at the proximal end of the implant is cut and placedin a subcutaneous pocket. |
| SystemComponent | Description |
| Externally WornWirelessTransmitter | The charging system consists of an externally worn wirelesstransmitter that is rechargeable. Power is delivered to the implantedneurostimulator using Neuspera's proprietary mid-field poweringtechnology. The Wireless Transmitter is worn in proximity to theimplanted neurostimulator and held in position by custom designedgarments.The Wireless Transmitter is controlled by custom softwareapplications (referred to as the Clinician Programmer and the PatientController) running on off-the-shelf portable hardware (i.e., AppleiPad and Apple iPod Touch, respectively). The rechargeable batteryof the Wireless Transmitter is charged by an off-the-shelf chargingpad. |
| ClinicianProgrammer andPatient Controller | The clinician programmer (Programmer) enables management of theWireless Transmitter associated with the patient's neurostimulator,programming a patient's stimulation therapy, review of the patient'stherapy statistics, and connection of a patient controller (Controller) to apatient's Wireless Transmitter. The Programmer runs Neuspera'spropriety programmer software on a commercially available Apple iPad.The iPad runs in kiosk mode, which disables non-essential programsand functions.The Patient Controller is an Apple iPod Touch which runs theNeuspera patient controller software application ("Neuspera App").The iPod Touch comes with its own USB/wall charging accessories.The iPod runs in kiosk mode, which disables non- essential programsand functions. The Controller is used by the patient to turn his/herWireless Transmitter on/off, adjust stimulation amplitude (within limitsset by the physician), and select which of the physician pre-programmed stimulation programs to use. The user can also monitorthe Wireless Transmitter battery level, view his/her program usehistory, and adjust the Wireless Transmitter for airplane andinternational travel. |
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Intended Use:
The Neuspera Neurostimulation System (NNS) is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitiqating 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 Neurostimulation System (NNS) is also used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant.
Summary of Technological Characteristics in Comparison to Predicate Device:
Neuspera Neurostimulation System (NNS and the predicate device Nalu Neurostimulation System for Peripheral Nerve Stimulation (K183579) have similar indication for use, technological characteristics and performance. Both the subject device and the predicate devices are designed to provide 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. Both systems are not intended to treat pain in the craniofacial region. The minor differences in wording for intended use statements of the respective products do not alter the intended patient or clinical effect, and, therefore, the Neurostimulator System is substantially equivalent with respect to intended use. In addition, the differences listed in tables below do not present any new issues of safety or effectiveness. Moreover, performance testing demonstrates that the Neuspera Neurostimulation System performs in a substantially equivalent manner.
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| Table 1: Predicate Device Comparison Matrix | |||||
|---|---|---|---|---|---|
| Neuspera NeurostimulationSystem (Subject Device) | Nalu NeurostimulationSystem (Primary Predicate) | Bioness StimRouterNeuromodulation System(Reference Device) | Analysis ofTechnologicalDifferences fromPrimary Predicate | ||
| 510(k) | K202781 | K183579 | K200482 | N/A | |
| Product Code and class | GZF, Class II | Same | Same | Same | |
| Regulation number | 21 CFR §882.5870 | Same | Same | Same | |
| Classification name | Stimulator, Peripheral Nerve, Implanted (painrelief) | Same | Same | Same | |
| Intended Use | Stimulation of peripheral nerves for chronic,intractable pain | Same | Same | Same | |
| Indications for Use | The Neuspera Neurostimulation System (NNS) isindicated for pain management in adults who havesevere intractable chronic pain of peripheral nerveorigin, as the sole mitigating agent, or as anadjunct to other modes of therapy used in amultidisciplinary approach. The NeusperaNeurostimulation System (NNS) is not intended totreat pain in the craniofacial region.The Neuspera Neurostimulation System (NNS) isalso used for trial stimulation (no longer than 30days) to determine efficacy before recommendationfor a permanent (long term) implant. | This system is indicated for painmanagement in adults who have severeintractable chronic pain of peripheral nerveorigin, as the sole mitigating agent, or as anadjunct to other modes of therapy used in amultidisciplinary approach. The system isnot intended to treat pain in the craniofacialregion. The trial devices are solely used fortrial stimulation (no longer than 30 days) todetermine efficacy before recommendationfor a permanent (long term) device. | The StimRouter NeuromodulationSystem™ is indicated for painmanagement in adults who have severeintractable chronic pain of peripheralnerve origin, as an adjunct toother modes of therapy (e.g.,medications). The StimRouter is notintended to treat pain in the craniofacialregion. | Differences in wording do not affectsafety and effectiveness of intendeduse | |
| Prescription Use? | Yes | Same | Same | Same | |
| Implant site | Adjacent to nerves peripheral to centralnervous system, excluding craniofacial region | Same | Same | Same | |
| Environmental Use | Hospital, Home | Same | Same | Same | |
| Intended Clinician | Orthopedic, Neurosurgeon, Anesthesiologist | Same | Same | Same | |
| Intended User | Physician, Layperson | Same | Same | Same | |
| Mode of Action | Radio Frequency (RF) wireless transmissionof energy to charge implanted energy sourcewith stimulation pulse generator to producestimulation at stimulator electrodes. | Radio Frequency (RF) wirelesstransmission of energy to producestimulation at stimulator electrodes | DC conductive coupling fromexternal patch pulse generator toimplanted lead | Differences do not affect safety andeffectiveness of intended use | |
| Software Level ofConcern | Moderate | Same | Same | Same | |
| Table 2: Implanted Components | |||||
| Neuspera NeurostimulationSystem ( Subject Device ) | Nalu NeurostimulationSystem ( Primary Predicate ) | Bioness StimRouterNeuromodulation System( Reference Device ) | Analysis ofTechnologicalDifferences fromPrimary Predicate | ||
| Dimensions | IPG: 2.33mm diameter, electrodearray 1.3mm diameter, 5.1 cm totallength | Lead = 1.30 mm diameter, 40 or 60 cmlength, IPG = 28 x 11 x 4.9 mm | Lead = 1.20 mm diameter, 15 cmlength | Differences do not affect safety andeffectiveness of intended use | |
| Configuration | Implanted antenna receiver, energystorage capacitor, stimulation pulsegenerator coupled with electrodearrays | Embedded receiver, flexible circuitboard | Implanted electrode array andexternal pulse generator | Differences do not affect safety andeffectiveness of intended use | |
| Implant site | Peripheral nerves, excludingcraniofacial region | Same | Same | Same | |
| Electricalcomponents | Embedded receiver, flexible circuitboard with energy storage andstimulation pulse generator | Same | Embedded receiver | Differences do not affect safety andeffectiveness of intended use | |
| Power Delivery | Radio frequency transmission receiver | Coupled receiver radio frequencytransmission | DC transcutaneous coupling | Differences do not affect safety andeffectiveness of intended use | |
| Electrode Material | Platinum-iridium 90:10 | Same | Same | Same | |
| Insulation BodyMaterial | Pellethane 2363-55D | Same | Silicone | Differences do not affect safety andeffectiveness of intended use | |
| Electrode ArrayDiameter | 1.30 mm | 1.30 mm | 1.20 mm | Differences do not affect safety andeffectiveness of intended use | |
| Electrode Arraylength | 21mm | 52 mm | 5 mm | Differences do not affect safety andeffectiveness of intended use | |
| No. of Electrodesper array | 4 | 8 | 3 | Differences do not affect safety andeffectiveness of intended use | |
| IndividualElectrode length | 3mm | Same | Same | Same | |
| Electrode surfacearea | 12.25 mm2 | 12.25 mm3 | 6.3 mm2 | Same | |
| Sterilization | Ethylene Oxide | Same | Same | Same | |
| Table 3: Therapy | |||||
| NeusperaNeurostimulationSystem ( Subject Device ) | NaluNeurostimulationSystem ( PrimaryPredicate ) | BionessStimRouterNeuromodulationSystem ( PrimaryPredicate ) | Analysis ofTechnologicalDifferences fromPrimary Predicate | ||
| Pulse Frequency | 4 to 130 Hz | 2 to 1500 Hz | 1 to 200 Hz | Differences do not affect safety andeffectiveness of intended use | |
| Pulse Width | 105 to 960 µs | 12 to 1000 µs | 70 to 500µs | Differences do not affect safety andeffectiveness of intended use | |
| Current/VoltageRegulated | Voltage | Current | Current (dependenton pick-up ratio atimplant) | Differences do not affect safety andeffectiveness of intended use | |
| Output Current (300Ohms) | 0 to 5.73 mA* | 0 to 10.2 mA | 0 to 5 mA*** | Differences do not affect safety andeffectiveness of intended use | |
| Output Current (500Ohms) | 0 to 5.44 mA* | 0 to 10.2 mA | 0 to 5 mA*** | Differences do not affect safety andeffectiveness of intended use | |
| Output Current (800Ohms) | 0 to 5.20 mA* | 0 to 10.2 mA | 0 to 5 mA*** | Differences do not affect safety andeffectiveness of intended use | |
| Waveform | charge balanced (delayed)biphasic asymmetrical | Same | charge balanced(delayed) biphasicasymmetrical orsymmetrical | Same | |
| Pulse Shape | DecayingExponential | Same | Same | Same | |
| Maximum phasecharge (300 Ohms) | 2.88 µC/pulse** | 6.8 µC/pulse | 3 µC/pulse*** | Differences do not affect safety andeffectiveness of intended use | |
| Maximum phasecharge (500 Ohms) | 2.74 µC/pulse** | 6.4 µC/pulse | 3 µC/pulse*** | Differences do not affect safety andeffectiveness of intended use | |
| Maximum phasecharge (800 Ohms) | 2.43 µC/pulse** | 4.7 µC/pulse | 3 µC/pulse*** | Differences do not affect safety andeffectiveness of intended use | |
| Maximum chargedensity (300 Ohm) | 23.5 µC/cm2** | 53.1 µC/cm2 | 15.9 µC/cm2*** | Differences do not affect safety andeffectiveness of intended use | |
| Maximum chargedensity (500 Ohm) | 22.4 µC/cm2** | 50.3 µC/cm2 | 15.9 µC/cm2*** | Differences do not affect safety andeffectiveness of intended use | |
| Maximum chargedensity (800 Ohm) | 19.8 µC/cm2** | 36.9 µC/cm2 | 15.9 µC/cm2*** | Differences do not affect safety andeffectiveness of intended use | |
| Table 3: Therapy | |||||
| NeusperaNeurostimulationSystem ( Subject Device ) | NaluNeurostimulationSystem ( Primary Predicate ) | BionessStimRouterNeuromodulationSystem ( Primary Predicate ) | Analysis ofTechnologicalDifferences fromPrimary Predicate | ||
| Maximum currentdensity (300 Ohm) | 46.8 mA/cm2* | 106.1 mA/cm2 | 26.5 mA/cm2*** | Differences do not affect safety andeffectiveness of intended use | |
| Maximum currentdensity (500 Ohm) | 44.4 mA/cm2* | 100.6 mA/cm2 | 26.5 mA/cm2*** | Differences do not affect safety andeffectiveness of intended use | |
| Maximum currentdensity (800 Ohm) | 42.4 mA/cm2* | 73.9 mA/cm2 | 26.5 mA/cm2*** | Differences do not affect safety andeffectiveness of intended use | |
| Net Charge | 0 $ \mu $ C | Same | Same | Same | |
| Pulse Delivery Mode | Continuous | Same | Same | Same | |
| Current Path options | Bipolar | Same | Same | Same | |
| Program Cycle | Cycle through programs | Same | Same | Same | |
| Pulse Pattern | Fine tuning of pulse patterns | Same | Same | Same | |
| Dosage Time | Cycling ON/OFF 1 second-1day | Same | Same | Same |
Neuspera Neuspera Neurostimulation System (NNS) Traditional 510(K)
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- measured with typical therapy pulse width of 240us
** measured with maximum pulse with of 960us
*** unreported test impedance conditions
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Summary of Non-Clinical Testing:
The Neuspera Neurostimulation System design verification and validation consisted of functional, performance and MRI testing. The verification and validation testing were performed according to the product specifications as well as to applicable ISO standards. Design verification and validation testing was performed to ensure that the Neurostimulator System met design specifications and customer requirements. Non-clinical testing activities includes but not limited to the following:
- . Visual tests
- . Dimensional measurement tests
- Tensile tests ●
- . Mechanical Tests
- Electrical Test ●
- EMC Tests ●
- MRI Tests ●
Full test reports have been included within the submission. Additionally, test summaries have been prepared and are presented within the applicable submission section. Per Guidance for Industry and FDA Staff – Recognition and Use of Consensus Standards. Table below identifies the standards that have been referenced within this submission.
| Standard Name | FDA recognitionnumber: | Standard Title |
|---|---|---|
| ES60601-1:2005/(R)2012and A1:2012, | 19-4 | C1:2009/(R)2012 and A2:2010/(R)2012(Consolidated Text) Medical electrical equipment -Part 1: General requirements for basic safety andessential performance (IEC 60601-1:2005, MOD) |
| HA60601-1-11:2015 | 19-16 | Medical Electrical Equipment -- Part 1-11: Generalrequirements for basic safety and essentialperformance -- Collateral Standard: Requirements formedical electrical equipment and medical electricalequipment and medical electrical systems used in thehome healthcare environment (IEC 60601-1-11:2015MOD) |
| 10993-1 Fifth edition2018-08 | 2-258 | Biological evaluation of medical devices -Part 1: Evaluation and testing within a riskmanagement process |
| 11135 Secondedition2014-07-15 | 14-452 | Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation androutine control of a sterilization process for medicaldevices |
| 14708-3 Secondedition 2017-04 | 17-15 | Implants for surgery - Active implantablemedical devices - Part 3: Implantableneurostimulators |
Traditional 510(k)
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Biocompatibility Testing:
Biocompatibility testing for the Neuspera Neurostimulation System has been completed in accordance with the International Standard IS0-10993-1:2018 " Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ". Biocompatibility testing was based upon the categorization of the different body- contacting components and duration of the Neuspera PNS system. These categories are as follows:
- . lmplant is biocompatible per ISO 10993-1:2018 for long-term implant (>30 days)
- . All implant tools are biocompatible for limited duration tissue contact (<24 hours)
Testing included: genotoxicity, cytotoxicity, sensitization, irritation or intracutaneous reactivity, systematic toxicity, implant studies, and chemical characterization. Biocompatibility was demonstrated.
Summary of Animal Testing:
Two GLP animal studies were conducted to evaluate the safety and performance of the Neuspera Neurostimulation System.
The first animal study showed that the overall implant and removal of the non- functional devices at 2-weeks and 90-days was completed easily without sequelae. The objective of the second GLP animal study was intended to evaluate the safety and performance of the Wireless Transmitter as well as to validate the use of the Neuspera Implant Kit. The study showed that the surgical procedure was safe, and the Neuspera Neurostimulation system performed as expected.
Summary of Clinical Testing:
Clinical evaluation is not required for the Neuspera Neurostimulation System as the indications for use are equivalent to the legally marketed predicate device and referenced device. These types of devices, including versions of the legally marketed predicate device, have been on the market for many years with a proven safety and efficacy for the use of the device. Therefore, Neuspera determined that bench and non-clinical testing are sufficient to demonstrate that the Neuspera Neurostimulation System is as safe and effective as the predicate device.
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Substantial equivalence:
The results of bench testing and compliance with applicable standards provide reasonable assurance that the Neuspera Neurostimulation System has been designed and tested to assure conformance to the requirements for its indications for use.
Neuspera considers the Neuspera Neurostimulation System to be substantially equivalent to the legally marketed predicate device because it has similar intended use and similar indications, technological characteristics and performance. The differences between the subject device and the predicate device do not alter the intended patient or clinical effect and, therefore, the Neuspera Neurostimulation System is substantially equivalent to currently marketed predicate device.
§ 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).