(341 days)
No
The summary describes a neurostimulation system that delivers pulsed electrical current. There is no mention of AI/ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device is indicated for pain management in adults with severe intractable chronic pain of peripheral nerve origin and is used for peripheral nerve stimulation to provide therapeutic relief.
No
The device is a therapeutic neurostimulator for pain management. While it includes a "trial stimulation" period, this is to determine the efficacy of the therapy before permanent implantation, not to diagnose a condition. Its primary function is to deliver electrical current for pain relief.
No
The device description explicitly lists multiple hardware components including an implantable pulse generator, electrode array, surgical tools, and a wireless worn transmitter.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Neuspera Nuity™ System Function: The description clearly states that the Neuspera Nuity™ System is used for peripheral nerve stimulation to provide therapeutic relief for chronic pain. It is an implanted device that delivers electrical pulses directly to nerves.
- Lack of Sample Analysis: The device does not analyze any samples taken from the body. Its function is to directly interact with the nervous system.
Therefore, based on the provided information, the Neuspera Nuity™ System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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.
Product codes
GZF
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.
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 a permanent implant.
The Neuspera Nuity™ System (NNS) is comprised of the following components:
- Neuspera Implanted Pulse Generator (IPG) Or Neuspera Implanted Microstimulator: The implanted Neuspera Nuity™ System (NNS) includes a miniaturized implantable neurostimulator (approximately 17 mm long by 2.3 mm diameter at its widest point) combining a receiver and a hermetically sealed pulse generator. The IPG/Microstimulator is a hermetically sealed electronic package (0.02 cc) 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 energy bank, and manages power/communication. The energy bank is used by the internal stimulation waveform generator to generate stimulation pulses based upon the digitally received programming parameters. Hermetic feedthroughs conduct the stimulation waveform from the stimulation implantable pulse generator to the electrode array described below.
- Electrode Array: The electrode array is an implantable and attached to the IPG through hermetic feedthroughs connectors. The electrode array is designed to deliver electrical pulses to the nerve via an array of four cylindrical electrodes at the distal end of the device.
- Surgical/Implant Tools: The tools provided in the Neuspera Nuity™ System (NNS) Kit are used to introduce and implant the neurostimulator. A needle along with imaging guidance is used to locate the targeted nerve. Next, the needle is replaced with a guidewire. An incision is made 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 and dilator. The dilator and guidewire are then removed. The implant is tunneled through the introducer (sheath) using a connected pushrod. The PTFE tether at the proximal end of the implant is cut and placed in a subcutaneous pocket.
- Externally Worn Wireless Transmitter: The charging system consists of an externally worn wireless transmitter that is rechargeable. Power is delivered to the implanted neurostimulator using Neuspera's proprietary mid-field powering technology. The Wireless Transmitter is worn in proximity to the implanted neurostimulator and held in position by custom designed garments. The Wireless Transmitter is controlled by custom software applications (referred to as the Clinician Programmer and the Patient Controller) running on off-the-shelf portable hardware (i.e., Apple iPad and Apple iPod Touch, respectively). The rechargeable battery of the Wireless Transmitter is charged by an off-the-shelf charging pad.
- Clinician Programmer and Patient Controller: The clinician programmer (Programmer) enables management of the Wireless Transmitter associated with the patient's neurostimulator, programming a patient's stimulation therapy, review of the patient's therapy statistics, and connection of a patient controller (Controller) to a patient's Wireless Transmitter The Programmer runs Neuspera's propriety programmer software on a commercially available Apple iPad. The Patient Controller is an Apple iPod Touch which runs the Neuspera patient controller software application ("Neuspera App"). The iPod Touch comes with its own USB/wall charging accessories. The Controller is used by the patient to turn his/her Wireless Transmitter on/off, adjust stimulation amplitude (within limits set by the physician), and select which of the physician pre-programmed stimulation programs to use. The user can also monitor the Wireless Transmitter battery level, view his/her program use history, and adjust the Wireless Transmitter for airplane and international travel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Adjacent to nerves peripheral to central nervous system, excluding craniofacial region
Indicated Patient Age Range
Adults
Intended User / Care Setting
Intended Clinician: Orthopedic, Neurosurgeon, Anesthesiologist
Intended User: Physician, Layperson
Environmental Use: Hospital, Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 (
§ 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).
0
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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.
1
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
2
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.
4
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:
| System
| Component | Description |
|---|---|
| Neuspera | |
| Implanted Pulse | |
| Generator (IPG) | |
| Or | |
| Neuspera | |
| Implanted | |
| Microstimulator | The implanted Neuspera Nuity™ System (NNS) includes a miniaturized |
| implantable neurostimulator (approximately 17 mm long by 2.3 mm | |
| diameter at its widest point) combining a receiver and a hermetically | |
| sealed pulse generator. |
The IPG/Microstimulator is a hermetically sealed electronic package (0.02
cc) 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 energy
bank, and manages power/communication. The energy bank is used by the
internal stimulation waveform generator to generate stimulation pulses
based upon the digitally received programming parameters.
Hermetic feedthroughs conduct the stimulation waveform from the
stimulation implantable pulse generator to the electrode array described
below. |
| Electrode Array | The electrode array is an implantable and attached to the IPG through
hermetic feedthroughs connectors. The electrode array is designed to
deliver electrical pulses to the nerve via an array of four cylindrical
electrodes at the distal end of the device. |
| Surgical/Implant
Tools | The tools provided in the Neuspera Nuity™ System (NNS) Kit are used
to introduce and implant the neurostimulator.
A needle along with imaging guidance is used to locate the targeted
nerve. Next, the needle is replaced with a guidewire. An incision is
made 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 and dilator. The
dilator and guidewire are then removed. The implant is tunneled through
the introducer (sheath) using a connected pushrod. The PTFE tether at
the proximal end of the implant is cut and placed in a subcutaneous
pocket. |
| System
Component | Description |
| Externally Worn
Wireless
Transmitter | The charging system consists of an externally worn wireless transmitter that
is rechargeable. Power is delivered to the implanted neurostimulator using
Neuspera's proprietary mid-field powering technology. The Wireless
Transmitter is worn in proximity to the implanted neurostimulator and held
in position by custom designed garments.
The Wireless Transmitter is controlled by custom software applications
(referred to as the Clinician Programmer and the Patient Controller) running
on off-the-shelf portable hardware (i.e., Apple iPad and Apple iPod Touch,
respectively). The rechargeable battery of the Wireless Transmitter is
charged by an off-the-shelf charging pad. |
| Clinician
Programmer and
Patient Controller | The clinician programmer (Programmer) enables management of the Wireless
Transmitter associated with the patient's neurostimulator, programming a
patient's stimulation therapy, review of the patient's therapy statistics, and
connection of a patient controller (Controller) to a patient's Wireless Transmitter
The Programmer runs Neuspera's propriety programmer software on a
commercially available Apple iPad.
The Patient Controller is an Apple iPod Touch which runs the Neuspera
patient controller software application ("Neuspera App"). The iPod Touch
comes with its own USB/wall charging accessories. The Controller is used
by the patient to turn his/her Wireless Transmitter on/off, adjust stimulation
amplitude (within limits set by the physician), and select which of the
physician pre-programmed stimulation programs to use. The user can also
monitor the Wireless Transmitter battery level, view his/her program use
history, and adjust the Wireless Transmitter for airplane and international
travel. |
5
6
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.
7
| Table 1: Subject and Predicate Devices Comparison Matrix | ||||
|---|---|---|---|---|
| Neuspera Nuity™ System (Subject | ||||
| Device) | ||||
| K221303 | Neuspera Neurostimulation | |||
| System (Primary Predicate) | ||||
| K202781 | Nalu Neurostimulation System | |||
| (Reference Device) | ||||
| K183579 | Analysis of Technological | |||
| Differences from Primary | ||||
| Predicate | ||||
| 510(k) | K221303 | K202781 | K183579 | N/A |
| Product Code and | ||||
| class | GZF, Class II | Same | Same | Same |
| Regulation number | 21 CFR §882.5870 | Same | Same | Same |
| Classification name | Implanted peripheral nerve stimulator | |||
| for pain relief | Same | Same | Same | |
| Intended Use | Stimulation of peripheral nerves for | |||
| chronic, intractable pain | Same | Same | Same | |
| Indications 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 Neuspera Nuity™ | ||||
| System (NNS) 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 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 | ||||
| Neuspera Neurostimulation | ||||
| System (NNS) 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. | This system 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 trial | ||||
| devices are solely used for trial | ||||
| stimulation (no longer than 30 days) | ||||
| to determine efficacy before | ||||
| recommendation for a permanent | ||||
| (long term) device. | Differences in wording do not | |||
| affect safety and effectiveness | ||||
| of intended use | ||||
| Prescription Use? | Yes | Same | Same | Same |
| Implant site | Adjacent to nerves peripheral to | |||
| central nervous system, excluding | ||||
| craniofacial region | Same | Same | Same | |
| Table 1: Subject and Predicate Devices Comparison Matrix | ||||
| Neuspera Nuity™ System (Subject | ||||
| Device) | ||||
| K221303 | Neuspera Neurostimulation | |||
| System (Primary Predicate) | ||||
| K202781 | Nalu Neurostimulation System | |||
| (Reference Device) | ||||
| K183579 | Analysis of Technological | |||
| Differences from Primary | ||||
| Predicate | ||||
| 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 | |||
| transmission of energy to charge | ||||
| implanted energy source with | ||||
| stimulation pulse generator to | ||||
| produce stimulation at stimulator | ||||
| electrodes. | Radio Frequency (RF) wireless | |||
| transmission of energy to charge | ||||
| implanted energy source with | ||||
| stimulation pulse generator to | ||||
| produce stimulation at stimulator | ||||
| electrodes. | Radio Frequency (RF) wireless | |||
| transmission of energy to produce | ||||
| stimulation at stimulator electrodes | Same as K202781 | |||
| Software Level of | ||||
| Concern | Moderate | Moderate | Moderate | Same |
8
| Table 2: Implanted Components Comparison | ||||
|---|---|---|---|---|
| Neuspera Nuity™ System | ||||
| (Subject Device) | ||||
| K221303 | Neuspera Neurostimulation | |||
| System (Primary Predicate) | ||||
| K202781 | Nalu Neurostimulation System | |||
| (Reference Device) | ||||
| K183579 | Analysis of Technological | |||
| Differences from Primary | ||||
| Predicate | ||||
| Dimensions | IPG: 2.33 mm diameter, electrode | |||
| array 1.3 mm diameter, 4.5-5.2 cm | ||||
| total length | IPG: 2.33 mm diameter, electrode | |||
| array 1.3 mm diameter, 5.1 cm | ||||
| total length | Lead = 1.30 mm diameter, 40 or | |||
| 60 cm length, IPG = 28 x 11 x | ||||
| 4.9 mm | The subject devices consist of 2 | |||
| lengths (including distal strain | ||||
| relief): 30 mm and 35 mm | ||||
| electrode array lengths. The | ||||
| electrode array length of the | ||||
| predicate (not including distal strain | ||||
| relief) is 34 mm. The proximal | ||||
| circuitry housing assembly remains | ||||
| the same length between the | ||||
| subject and predicate devices. | ||||
| The difference in lengths of the | ||||
| electrode arrays are negligible as | ||||
| Table 2: Implanted Components | ||||
| Neuspera Nuity ™ System | ||||
| (Subject Device) | ||||
| K221303 | Neuspera Neurostimulation | |||
| System (Primary Predicate) | ||||
| K202781 | Nalu Neurostimulation System | |||
| (Reference Device) | ||||
| K183579 | Analysis of Technological | |||
| Differences from Primary | ||||
| Predicate | ||||
| the therapy output remains the | ||||
| same between the subject devices | ||||
| and the predicate device. | ||||
| Configuration | Implanted antenna receiver, | |||
| energy storage capacitor, | ||||
| stimulation pulse generator | ||||
| coupled with electrode arrays | Implanted antenna receiver, | |||
| energy storage capacitor, | ||||
| stimulation pulse generator | ||||
| coupled with electrode arrays | Embedded receiver, flexible | |||
| circuit board | Same as K202781 | |||
| Implant site | Peripheral nerves, excluding | |||
| craniofacial region | Same | Same | Same | |
| Electrical | ||||
| components | Embedded receiver, flexible circuit | |||
| board with energy storage and | ||||
| stimulation pulse generator | Same | Same | Same | |
| Power Delivery | Radio frequency transmission | |||
| receiver | Same | Coupled receiver radio frequency | ||
| transmission | Same as K202781 | |||
| Electrode | ||||
| Material | Platinum-iridium 90:10 | Same | Same | Same |
| Insulation Body | ||||
| Material | Pellethane 2363-55D | Same | Same | Same |
| Electrode Array | ||||
| Diameter | 1.30 mm | Same | Same | Same |
| Electrode Array | ||||
| length | ||||
| (Measured Start | ||||
| of First to End of | ||||
| Last Electrode) | 21 mm | Same | 52 mm | Same as K202781 |
| No. of | ||||
| Electrodes per | ||||
| array | 4 | Same | 8 | Same as K202781 |
| Individual | ||||
| Electrode length | 3 mm | Same | Same | Same |
| Electrode | ||||
| surface 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 Neurostimulation | |||
| System (Primary Predicate) | ||||
| K202781 | Nalu Neurostimulation | |||
| System (Reference Device) | ||||
| K183579 | Analysis of Technological | |||
| Differences from Primary Predicate | ||||
| Pulse Frequency | 2 to 1500 Hz | 4 to 130 Hz | 2 to 1500 Hz | 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 | 15 to 960 µs | 105 to 960 µs | 12 to 1000 µs | 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 | Voltage or Current | Voltage | Current | Adjustable between regulation mode of |
| both predicate and reference devices. | ||||
| Therefore, differences do not affect | ||||
| safety 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) biphasic | ||||
| asymmetrical | Same | Same | Same | |
| Pulse Shape | Decaying | |||
| Exponential | Same | Same | Same | |
| Maximum phase | ||||
| charge (300 | ||||
| Ohms) | 2.88 µC/pulse** | Same | 6.8 µC/pulse | Same as K202781 |
| Maximum phase | ||||
| charge (500 | ||||
| Ohms) | 2.74 µC/pulse** | Same | 6.4 µC/pulse | Same as K202781 |
| Maximum phase | ||||
| charge (800 | ||||
| Ohms) | 2.43 µC/pulse** | Same | 4.7 µC/pulse | Same as K202781 |
| Table 3: Therapy Comparison | ||||
| Neuspera Nuity System | ||||
| (Subject Device) | ||||
| K221303 | Neuspera Neurostimulation | |||
| System (Primary Predicate) | ||||
| K202781 | Nalu Neurostimulation | |||
| System (Reference Device) | ||||
| K183579 | Analysis of Technological | |||
| Differences from Primary Predicate | ||||
| Maximum charge | ||||
| density (300 Ohm) | 23.5 µC/cm2** | Same | 53.1 µC/cm² | Same as K202781 |
| Maximum charge | ||||
| density (500 Ohm) | 22.4 µC/cm2** | Same | 50.3 µC/cm² | Same as K202781 |
| Maximum charge | ||||
| density (800 Ohm) | 19.8 µC/cm2** | Same | 15.9 µC/cm2*** | Same as K202781 |
| Maximum current | ||||
| density (300 Ohm) | 46.8 mA/cm2* | Same | 26.5 mA/cm2*** | Same as K202781 |
| Maximum current | ||||
| density (500 Ohm) | 44.4 mA/cm2* | Same | 26.5 mA/cm2*** | Same as K202781 |
| Maximum current | ||||
| density (800 Ohm) | 42.4 mA/cm2* | Same | 26.5 mA/cm2*** | Same as K202781 |
| Net Charge | 0 µC | 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-1 day | Same | Same | Same |
9
10
Neuspera Neuspera Nuity™ System (NNS)
11
- measured with typical therapy pulse width of 240us
** measured with maximum pulse with of 960us
*** unreported test impedance conditions
12
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 recognition
number: | Standard Title |
|--------------------------------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ES60601-
1:2005/(R)2012
and 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 and essential
performance (IEC 60601-1:2005, MOD) |
| HA60601-1-11:2015 | 19-16 | Medical Electrical Equipment -- Part 1-11: General
requirements for basic safety and essential
performance -- Collateral Standard: Requirements for
medical electrical equipment and medical electrical
equipment and medical electrical systems used in the
home healthcare environment (IEC 60601-1-11:2015
MOD) |
| 10993-1 Fifth edition
2018-08 | 2-258 | Biological evaluation of medical devices -
Part 1: Evaluation and testing within a risk
management process |
| 11135 Second
edition 2014-07-15 | 14-452 | Sterilization of health-care products - Ethylene oxide -
Requirements for the development, validation and
routine control of a sterilization process for medical
devices |
| 14708-3 Second
edition 2017-04 | 17-15 | Implants for surgery - Active implantable
medical devices - Part 3: Implantable
neurostimulators |
13
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 (