(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 IIPredicate Device: SameReference Device: SameAnalysis: Same |
| Regulation Number | Subject Device: 21 CFR §882.5870Predicate Device: SameReference Device: SameAnalysis: Same |
| Classification Name | Subject Device: Implanted peripheral nerve stimulator for pain reliefPredicate Device: SameReference Device: SameAnalysis: Same |
| Prescription Use? | Subject Device: YesPredicate Device: SameReference Device: SameAnalysis: Same |
| Implant Site | Subject Device: Adjacent to nerves peripheral to central nervous system, excluding craniofacial region.Predicate Device: SameReference Device: SameAnalysis: Same |
| Environmental Use | Subject Device: Hospital, HomePredicate Device: SameReference Device: SameAnalysis: Same |
| Intended Clinician | Subject Device: Orthopedic, Neurosurgeon, AnesthesiologistPredicate Device: SameReference Device: SameAnalysis: Same |
| Intended User | Subject Device: Physician, LaypersonPredicate Device: SameReference Device: SameAnalysis: 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: SameReference 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: ModeratePredicate Device: ModerateReference Device: ModerateAnalysis: 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 90:10Predicate Device: SameReference Device: SameAnalysis: Same |
| Insulation Body Material | Subject Device: Pellethane 2363-55DPredicate Device: SameReference Device: SameAnalysis: Same |
| Electrode Array Diameter | Subject Device: 1.30 mmPredicate Device: SameReference Device: SameAnalysis: Same |
| Electrode Array Length | Subject Device: 21 mm (Measured Start of First to End of Last Electrode)Predicate Device: SameReference Device: 52 mmAnalysis: Same as K202781 |
| No. of Electrodes per array | Subject Device: 4Predicate Device: SameReference Device: 8Analysis: Same as K202781 |
| Individual Electrode Length | Subject Device: 3 mmPredicate Device: SameReference Device: SameAnalysis: Same |
| Electrode Surface Area | Subject Device: 12.25 mm²Predicate Device: SameReference Device: 12.25 mm³ (likely a typo, should be mm²)Analysis: Same |
| Sterilization | Subject Device: Ethylene OxidePredicate Device: SameReference Device: SameAnalysis: Same |
| Pulse Frequency | Subject Device: 2 to 1500 HzPredicate Device: 4 to 130 HzReference Device: 2 to 1500 HzAnalysis: 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 µsPredicate Device: 105 to 960 µsReference Device: 12 to 1000 µsAnalysis: 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 CurrentPredicate Device: VoltageReference Device: CurrentAnalysis: 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: SameReference Device: (all) 0 to 10.2 mAAnalysis: Same as K202781 (*measured with typical therapy pulse width of 240us) |
| Waveform | Subject Device: Charge balanced (delayed) biphasic asymmetricalPredicate Device: SameReference Device: SameAnalysis: Same |
| Pulse Shape | Subject Device: Decaying ExponentialPredicate Device: SameReference Device: SameAnalysis: 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: SameReference Device: (300 Ohms) 6.8 µC/pulse, (500 Ohms) 6.4 µC/pulse, (800 Ohms) 4.7 µC/pulseAnalysis: 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: SameReference 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: SameReference Device: (all) 26.5 mA/cm2***Analysis: Same as K202781 |
| Net Charge | Subject Device: 0 µCPredicate Device: SameReference Device: SameAnalysis: Same |
| Pulse Delivery Mode | Subject Device: ContinuousPredicate Device: SameReference Device: SameAnalysis: Same |
| Current Path Options | Subject Device: BipolarPredicate Device: SameReference Device: SameAnalysis: Same |
| Program Cycle | Subject Device: Cycle through programsPredicate Device: SameReference Device: SameAnalysis: Same |
| Pulse Pattern | Subject Device: Fine tuning of pulse patternsPredicate Device: SameReference Device: SameAnalysis: Same |
| Dosage Time | Subject Device: Cycling ON/OFF 1 second-1 dayPredicate Device: SameReference Device: SameAnalysis: Same |
| Biocompatibility | Subject Device: Complies with ISO 10993-1:2018 for long-term implant (>30 days) and limited duration tissue contact (<24 hours) for tools. Tested for genotoxicity, cytotoxicity, sensitization or intracutaneous reactivity, systematic toxicity, implant studies, and chemical characterization.Predicate Device: Implied equivalence.Reference Device: Implied equivalence.Analysis: Biocompatibility demonstrated. |
| Electrical Safety/Performance | Subject Device: Conforms to ES60601-1:2005/(R)2012, HA60601-1-11:2015, and 14708-3 Second edition 2017-04.Predicate Device: Implied equivalence.Reference Device: Implied equivalence.Analysis: Conforms to relevant standards. |
| Sterilization Validation | Subject Device: Conforms to 11135 Second edition 2014-07-15 (Ethylene Oxide sterilization).Predicate Device: Implied equivalence.Reference Device: Implied equivalence.Analysis: Conforms to relevant standards for sterilization. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Non-clinical testing activities" including visual tests, dimensional measurement tests, tensile tests, mechanical tests, electrical tests, EMC tests, and MRI tests. These are bench tests, not clinical studies with patients. Therefore, clinical "sample size" and "data provenance" (country/retrospective/prospective) are not applicable to the non-clinical testing described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The document refers to non-clinical (bench) testing and substantial equivalence, not a clinical study involving expert interpretation or "ground truth" establishment for diagnostic or therapeutic outcomes in patients.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there is no clinical "test set" in the context of expert adjudication described in the document.
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
This is not applicable. The device is a neurostimulation system for pain management, not an AI-assisted diagnostic or interpretative tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical neurostimulation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of a clinical performance study. For the non-clinical tests mentioned (e.g., electrical, mechanical, biocompatibility), the "ground truth" would be established by validated test methods and reference standards, rather than expert consensus or pathology data from patients.
8. The sample size for the training set
This is not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for an AI/ML algorithm described in the document.
In summary:
The provided document is an FDA 510(k) clearance, which focuses on demonstrating substantial equivalence to a previously cleared predicate device. It primarily relies on non-clinical (bench) testing, engineering comparisons, and adherence to recognized standards to assure safety and effectiveness. It does not contain a detailed report of a clinical performance study with specific acceptance criteria, sample sizes for patient data, expert adjudication, or AI/ML algorithm validation.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 11, 2023
Neuspera Medical Inc. Alexander Yeh, PhD Founder and Chief Technology Officer 51 Daggett Dr. San Jose, California 95134
Re: K221303
Trade/Device Name: Neuspera Nuity System Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: March 8, 2023 Received: March 9, 2023
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.
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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 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 (QS) 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.
VivekJ. Pinto -S
Vivek Pinto, PhD 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)
K221303
Device Name Neuspera Neurostimulation (NuityTM) System
Indications for Use (Describe)
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.
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: K221303
Applicant Information:
| Submitter | Neuspera Medical Inc |
|---|---|
| Address: | 51 Daggett Dr.San Jose, CA 95134 |
| Contact Person: | Alexander Yeh. Ph.D |
| Contact Person: | Alexander Yeh, Ph. |
| Phone Number: | (888) 846-8332 |
| Date Prepared: | 5/2/2022 |
Device Information:
Trade/Proprietary Name: Neuspera Nuity™ System Common/Usual Name: Neuspera Neurostimulation System Product Code: GZF (Stimulator, peripheral nerve, implanted (Pain Relief) Regulation number: 21 CFR 882.5870 (Implanted peripheral nerve stimulator for pain relief) Class: Class II Device Classification Panel: Neurology
Predicate Device:
The Neuspera Nuity™ System is substantially equivalent in intended use and technological characteristics to the cleared Neurostimulation System (K202781).
Reference Device:
Nalu Neurostimulation System for Peripheral Nerve Stimulation (K183579)
Device Description:
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.
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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:
| SystemComponent | Description |
|---|---|
| NeusperaImplanted PulseGenerator (IPG)OrNeusperaImplantedMicrostimulator | The implanted Neuspera Nuity™ System (NNS) includes a miniaturizedimplantable neurostimulator (approximately 17 mm long by 2.3 mmdiameter at its widest point) combining a receiver and a hermeticallysealed pulse generator.The IPG/Microstimulator is a hermetically sealed electronic package (0.02cc) consisting of a highly integrated electronic circuit with a custom ASIC(application specific integrated circuit) and a flex circuit interconnect.This package harvests the received energy, charges an internal energybank, and manages power/communication. The energy bank is used by theinternal stimulation waveform generator to generate stimulation pulsesbased upon the digitally received programming parameters.Hermetic feedthroughs conduct the stimulation waveform from thestimulation implantable pulse generator to the electrode array describedbelow. |
| Electrode Array | The electrode array is an implantable and attached to the IPG throughhermetic feedthroughs connectors. The electrode array is designed todeliver electrical pulses to the nerve via an array of four cylindricalelectrodes at the distal end of the device. |
| Surgical/ImplantTools | The tools provided in the Neuspera Nuity™ System (NNS) Kit are usedto 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 isinserted around the guidewire to dilate the path to the nerve. The pre-dilator is then removed and replaced with an introducer and dilator. Thedilator and guidewire are then removed. The implant is tunneled throughthe introducer (sheath) using a connected pushrod. The PTFE tether atthe proximal end of the implant is cut and placed in a subcutaneouspocket. |
| SystemComponent | Description |
| Externally WornWirelessTransmitter | The charging system consists of an externally worn wireless transmitter thatis rechargeable. Power is delivered to the implanted neurostimulator usingNeuspera's proprietary mid-field powering technology. The WirelessTransmitter is worn in proximity to the implanted neurostimulator and heldin position by custom designed garments.The Wireless Transmitter is controlled by custom software applications(referred to as the Clinician Programmer and the Patient Controller) runningon off-the-shelf portable hardware (i.e., Apple iPad and Apple iPod Touch,respectively). The rechargeable battery of the Wireless Transmitter ischarged by an off-the-shelf charging pad. |
| ClinicianProgrammer andPatient Controller | The clinician programmer (Programmer) enables management of the WirelessTransmitter associated with the patient's neurostimulator, programming apatient's stimulation therapy, review of the patient's therapy statistics, andconnection of a patient controller (Controller) to a patient's Wireless TransmitterThe Programmer runs Neuspera's propriety programmer software on acommercially available Apple iPad.The Patient Controller is an Apple iPod Touch which runs the Neusperapatient controller software application ("Neuspera App"). The iPod Touchcomes with its own USB/wall charging accessories. The Controller is usedby the patient to turn his/her Wireless Transmitter on/off, adjust stimulationamplitude (within limits set by the physician), and select which of thephysician pre-programmed stimulation programs to use. The user can alsomonitor the Wireless Transmitter battery level, view his/her program usehistory, and adjust the Wireless Transmitter for airplane and internationaltravel. |
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Indication for Use:
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.
Summary of Technological Characteristics in Comparison to Predicate Device:
All of the physical attributes for the proposed Neuspera Nuity™ Neurostimulation System and the predicate and reference devices share the same technological characteristics and have no differences that would impact safety or effectiveness. Bench testing was conducted to demonstrate changes to the therapeutic attributes are within parameters of reference devices. In conclusion, testing and comparison of characteristics in table below demonstrate that the subject and predicate device are substantially equivalent.
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| Table 1: Subject and Predicate Devices Comparison Matrix | ||||
|---|---|---|---|---|
| Neuspera Nuity™ System (SubjectDevice)K221303 | Neuspera NeurostimulationSystem (Primary Predicate)K202781 | Nalu Neurostimulation System(Reference Device)K183579 | Analysis of TechnologicalDifferences from PrimaryPredicate | |
| 510(k) | K221303 | K202781 | K183579 | N/A |
| Product Code andclass | GZF, Class II | Same | Same | Same |
| Regulation number | 21 CFR §882.5870 | Same | Same | Same |
| Classification name | Implanted peripheral nerve stimulatorfor pain relief | Same | Same | Same |
| Intended Use | Stimulation of peripheral nerves forchronic, intractable pain | Same | Same | Same |
| Indications for Use | The Neuspera Nuity™ System (NNS)is indicated for pain management inadults who have severe intractablechronic pain of peripheral nerveorigin, as the sole mitigating agent, oras an adjunct to other modes oftherapy used in a multidisciplinaryapproach. The Neuspera Nuity™System (NNS) is not intended to treatpain in the craniofacial region.The Neuspera Nuity™ System (NNS)is also used for trial stimulation (nolonger than 30 days) to determineefficacy before recommendation for apermanent (long term) implant. | The Neuspera NeurostimulationSystem (NNS) is indicated forpain management in adults whohave severe intractable chronicpain of peripheral nerve origin,as the sole mitigating agent, oras an adjunct to other modes oftherapy used in amultidisciplinary approach. TheNeuspera NeurostimulationSystem (NNS) is not intended totreat pain in the craniofacialregion. The NeusperaNeurostimulation System (NNS)is also used for trial stimulation(no longer than 30 days) todetermine efficacy beforerecommendation for apermanent (long term) implant. | This system is indicated for painmanagement in adults who havesevere intractable chronic pain ofperipheral nerve origin, as the solemitigating agent, or as an adjunct toother modes of therapy used in amultidisciplinary approach. Thesystem is not intended to treat painin the craniofacial region. The trialdevices are solely used for trialstimulation (no longer than 30 days)to determine efficacy beforerecommendation for a permanent(long term) device. | Differences in wording do notaffect safety and effectivenessof intended use |
| Prescription Use? | Yes | Same | Same | Same |
| Implant site | Adjacent to nerves peripheral tocentral nervous system, excludingcraniofacial region | Same | Same | Same |
| Table 1: Subject and Predicate Devices Comparison Matrix | ||||
| Neuspera Nuity™ System (SubjectDevice)K221303 | Neuspera NeurostimulationSystem (Primary Predicate)K202781 | Nalu Neurostimulation System(Reference Device)K183579 | Analysis of TechnologicalDifferences from PrimaryPredicate | |
| 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) wirelesstransmission of energy to chargeimplanted energy source withstimulation pulse generator toproduce stimulation at stimulatorelectrodes. | Radio Frequency (RF) wirelesstransmission of energy to chargeimplanted energy source withstimulation pulse generator toproduce stimulation at stimulatorelectrodes. | Radio Frequency (RF) wirelesstransmission of energy to producestimulation at stimulator electrodes | Same as K202781 |
| Software Level ofConcern | Moderate | Moderate | Moderate | Same |
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| Table 2: Implanted Components Comparison | ||||
|---|---|---|---|---|
| Neuspera Nuity™ System(Subject Device)K221303 | Neuspera NeurostimulationSystem (Primary Predicate)K202781 | Nalu Neurostimulation System(Reference Device)K183579 | Analysis of TechnologicalDifferences from PrimaryPredicate | |
| Dimensions | IPG: 2.33 mm diameter, electrodearray 1.3 mm diameter, 4.5-5.2 cmtotal length | IPG: 2.33 mm diameter, electrodearray 1.3 mm diameter, 5.1 cmtotal length | Lead = 1.30 mm diameter, 40 or60 cm length, IPG = 28 x 11 x4.9 mm | The subject devices consist of 2lengths (including distal strainrelief): 30 mm and 35 mmelectrode array lengths. Theelectrode array length of thepredicate (not including distal strainrelief) is 34 mm. The proximalcircuitry housing assembly remainsthe same length between thesubject and predicate devices.The difference in lengths of theelectrode arrays are negligible as |
| Table 2: Implanted Components | ||||
| Neuspera Nuity ™ System(Subject Device)K221303 | Neuspera NeurostimulationSystem (Primary Predicate)K202781 | Nalu Neurostimulation System(Reference Device)K183579 | Analysis of TechnologicalDifferences from PrimaryPredicate | |
| the therapy output remains thesame between the subject devicesand the predicate device. | ||||
| Configuration | Implanted antenna receiver,energy storage capacitor,stimulation pulse generatorcoupled with electrode arrays | Implanted antenna receiver,energy storage capacitor,stimulation pulse generatorcoupled with electrode arrays | Embedded receiver, flexiblecircuit board | Same as K202781 |
| Implant site | Peripheral nerves, excludingcraniofacial region | Same | Same | Same |
| Electricalcomponents | Embedded receiver, flexible circuitboard with energy storage andstimulation pulse generator | Same | Same | Same |
| Power Delivery | Radio frequency transmissionreceiver | Same | Coupled receiver radio frequencytransmission | Same as K202781 |
| ElectrodeMaterial | Platinum-iridium 90:10 | Same | Same | Same |
| Insulation BodyMaterial | Pellethane 2363-55D | Same | Same | Same |
| Electrode ArrayDiameter | 1.30 mm | Same | Same | Same |
| Electrode Arraylength(Measured Startof First to End ofLast Electrode) | 21 mm | Same | 52 mm | Same as K202781 |
| No. ofElectrodes perarray | 4 | Same | 8 | Same as K202781 |
| IndividualElectrode length | 3 mm | Same | Same | Same |
| Electrodesurface area | 12.25 mm² | Same | 12.25 mm³ | Same |
| Sterilization | Ethylene Oxide | Same | Same | Same |
| Table 3: Therapy Comparison | ||||
| Neuspera Nuity™System (Subject Device)K221303 | Neuspera NeurostimulationSystem (Primary Predicate)K202781 | Nalu NeurostimulationSystem (Reference Device)K183579 | Analysis of TechnologicalDifferences from Primary Predicate | |
| Pulse Frequency | 2 to 1500 Hz | 4 to 130 Hz | 2 to 1500 Hz | Neuspera Nuity pulse frequency rangecovers predicate device and is withinrange of reference device. Therefore,differences do not affect safety andeffectiveness |
| Pulse Width | 15 to 960 µs | 105 to 960 µs | 12 to 1000 µs | Neuspera Nuity pulse width rangecovers predicate device and is withinrange of reference device. Therefore,differences do not affect safety andeffectiveness |
| Current/VoltageRegulated | Voltage or Current | Voltage | Current | Adjustable between regulation mode ofboth predicate and reference devices.Therefore, differences do not affectsafety and effectiveness. |
| Output Current(300 Ohms) | 0 to 5.73 mA* | Same | 0 to 10.2 mA | Same as K202781 |
| Output Current(500 Ohms) | 0 to 5.44 mA* | Same | 0 to 10.2 mA | Same as K202781 |
| Output Current(800 Ohms) | 0 to 5.20 mA* | Same | 0 to 10.2 mA | Same as K202781 |
| Waveform | charge balanced(delayed) biphasicasymmetrical | Same | Same | Same |
| Pulse Shape | DecayingExponential | Same | Same | Same |
| Maximum phasecharge (300Ohms) | 2.88 µC/pulse** | Same | 6.8 µC/pulse | Same as K202781 |
| Maximum phasecharge (500Ohms) | 2.74 µC/pulse** | Same | 6.4 µC/pulse | Same as K202781 |
| Maximum phasecharge (800Ohms) | 2.43 µC/pulse** | Same | 4.7 µC/pulse | Same as K202781 |
| Table 3: Therapy Comparison | ||||
| Neuspera Nuity System(Subject Device)K221303 | Neuspera NeurostimulationSystem (Primary Predicate)K202781 | Nalu NeurostimulationSystem (Reference Device)K183579 | Analysis of TechnologicalDifferences from Primary Predicate | |
| Maximum chargedensity (300 Ohm) | 23.5 µC/cm2** | Same | 53.1 µC/cm² | Same as K202781 |
| Maximum chargedensity (500 Ohm) | 22.4 µC/cm2** | Same | 50.3 µC/cm² | Same as K202781 |
| Maximum chargedensity (800 Ohm) | 19.8 µC/cm2** | Same | 15.9 µC/cm2*** | Same as K202781 |
| Maximum currentdensity (300 Ohm) | 46.8 mA/cm2* | Same | 26.5 mA/cm2*** | Same as K202781 |
| Maximum currentdensity (500 Ohm) | 44.4 mA/cm2* | Same | 26.5 mA/cm2*** | Same as K202781 |
| Maximum currentdensity (800 Ohm) | 42.4 mA/cm2* | Same | 26.5 mA/cm2*** | Same as K202781 |
| Net Charge | 0 µC | Same | Same | Same |
| Pulse DeliveryMode | Continuous | Same | Same | Same |
| Current Pathoptions | Bipolar | Same | Same | Same |
| Program Cycle | Cycle through programs | Same | Same | Same |
| Pulse Pattern | Fine tuning of pulsepatterns | Same | Same | Same |
| Dosage Time | Cycling ON/OFF 1second-1 day | Same | Same | Same |
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Neuspera Neuspera Nuity™ System (NNS)
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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:
Non-clinical testing activities for the Neuspera Nuity™ System includes but are 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 - Part1: General requirements for basic safety and essentialperformance (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 Secondedition 2014-07-15 | 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 |
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Biocompatibility Testing:
Biocompatibility testing for the Neuspera Nuity 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:
- Implant 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 or intracutaneous reactivity, systematic toxicity, implant studies, and chemical characterization. Biocompatibility was demonstrated.
Substantial equivalence:
The subject device of this 510(k) is substantially equivalent to the predicate since it has identical intended use and the change in software, and differences in technological characteristics do not raise new questions of safety and effectiveness.
§ 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).