(339 days)
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on hardware components and basic neurostimulation functionality.
Yes
The device is indicated for "pain management" and provides "therapeutic relief for chronic, intractable pain," directly addressing a health condition.
No
Explanation: The device is a neurostimulation system indicated for pain management. Its purpose is therapeutic relief, not diagnosis. While it can be used for trial stimulation to determine efficacy, this is part of its therapeutic application rather than a diagnostic one.
No
The device description explicitly lists hardware components such as an implantable pulse generator, electrode array, surgical implant 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 Neurostimulation System Function: The Neuspera Neurostimulation System is an implantable device that directly stimulates peripheral nerves to manage pain. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "pain management in adults who have severe intractable chronic pain of peripheral nerve origin" and for "trial stimulation." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details components like an implantable pulse generator, electrode array, and external transmitter, all of which are consistent with a neurostimulation system, not an IVD.
The information provided clearly indicates that the Neuspera Neurostimulation System is a therapeutic device used for pain management through direct nerve stimulation, not a diagnostic device that analyzes samples.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
GZF
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.
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:
Neuspera Implanted Pulse Generator (IPG) Or Neuspera Implanted Microstimulator: The implanted Neuspera Neurostimulation System (NNS) includes a miniaturized implantable neurostimulator (approximately 17mm long by 2.3 mm diameter at its widest point) combining a receiver and a hermitically sealed pulse generator. The IPG/Microstimulator is a hermitically 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 Neurostimulation 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 iPad runs in kiosk mode, which disables non-essential programs and functions. 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 iPod runs in kiosk mode, which disables non- essential programs and functions. 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:
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
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
1
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
2
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.
4
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:
| System
| Component | Description |
|---|---|
| Neuspera | |
| Implanted Pulse | |
| Generator (IPG) | |
| Or | |
| Neuspera | |
| Implanted | |
| Microstimulator | The implanted Neuspera Neurostimulation System (NNS) includes a |
| miniaturized implantable neurostimulator (approximately 17mm long by | |
| 2.3 mm diameter at its widest point) combining a receiver and a | |
| hermitically sealed pulse generator. | |
| The IPG/Microstimulator is a hermitically 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 Neurostimulation 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 iPad runs in kiosk mode, which disables non-essential programs | |
| and functions. | |
| 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 iPod runs in kiosk mode, which disables non- essential programs | |
| and functions. 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
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.
7
| Table 1: Predicate Device Comparison Matrix | |||||
|---|---|---|---|---|---|
| Neuspera Neurostimulation | |||||
| System (Subject Device) | Nalu Neurostimulation | ||||
| System (Primary Predicate) | Bioness StimRouter | ||||
| Neuromodulation System | |||||
| (Reference Device) | Analysis of | ||||
| Technological | |||||
| Differences from | |||||
| Primary 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 (pain | ||||
| relief) | Same | Same | Same | ||
| Intended Use | Stimulation of peripheral nerves for chronic, | ||||
| intractable pain | Same | Same | Same | ||
| Indications for 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 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. | The StimRouter Neuromodulation | ||||
| System™ is indicated for pain | |||||
| management in adults who have severe | |||||
| intractable chronic pain of peripheral | |||||
| nerve origin, as an adjunct to | |||||
| other modes of therapy (e.g., | |||||
| medications). The StimRouter is not | |||||
| intended to treat pain in the craniofacial | |||||
| region. | 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 | ||
| 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 produce | |||||
| stimulation at stimulator electrodes | DC conductive coupling from | ||||
| external patch pulse generator to | |||||
| implanted lead | Differences do not affect safety and | ||||
| effectiveness of intended use | |||||
| Software Level of | |||||
| Concern | Moderate | Same | Same | Same | |
| Table 2: Implanted Components | |||||
| Neuspera Neurostimulation | |||||
| System ( Subject Device ) | Nalu Neurostimulation | ||||
| System ( Primary Predicate ) | Bioness StimRouter | ||||
| Neuromodulation System | |||||
| ( Reference Device ) | Analysis of | ||||
| Technological | |||||
| Differences from | |||||
| Primary Predicate | |||||
| Dimensions | IPG: 2.33mm diameter, electrode | ||||
| array 1.3mm diameter, 5.1 cm total | |||||
| length | Lead = 1.30 mm diameter, 40 or 60 cm | ||||
| length, IPG = 28 x 11 x 4.9 mm | Lead = 1.20 mm diameter, 15 cm | ||||
| length | Differences do not affect safety and | ||||
| effectiveness of intended use | |||||
| Configuration | Implanted antenna receiver, energy | ||||
| storage capacitor, stimulation pulse | |||||
| generator coupled with electrode | |||||
| arrays | Embedded receiver, flexible circuit | ||||
| board | Implanted electrode array and | ||||
| external pulse generator | Differences do not affect safety and | ||||
| effectiveness of intended use | |||||
| 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 | Embedded receiver | Differences do not affect safety and | ||
| effectiveness of intended use | |||||
| Power Delivery | Radio frequency transmission receiver | Coupled receiver radio frequency | |||
| transmission | DC transcutaneous coupling | Differences do not affect safety and | |||
| effectiveness of intended use | |||||
| Electrode Material | Platinum-iridium 90:10 | Same | Same | Same | |
| Insulation Body | |||||
| Material | Pellethane 2363-55D | Same | Silicone | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Electrode Array | |||||
| Diameter | 1.30 mm | 1.30 mm | 1.20 mm | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Electrode Array | |||||
| length | 21mm | 52 mm | 5 mm | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| No. of Electrodes | |||||
| per array | 4 | 8 | 3 | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Individual | |||||
| Electrode length | 3mm | Same | Same | Same | |
| Electrode surface | |||||
| area | 12.25 mm2 | 12.25 mm3 | 6.3 mm2 | Same | |
| Sterilization | Ethylene Oxide | Same | Same | Same | |
| Table 3: Therapy | |||||
| Neuspera | |||||
| Neurostimulation | |||||
| System ( Subject Device ) | Nalu | ||||
| Neurostimulation | |||||
| System ( Primary | |||||
| Predicate ) | Bioness | ||||
| StimRouter | |||||
| Neuromodulation | |||||
| System ( Primary | |||||
| Predicate ) | Analysis of | ||||
| Technological | |||||
| Differences from | |||||
| Primary Predicate | |||||
| Pulse Frequency | 4 to 130 Hz | 2 to 1500 Hz | 1 to 200 Hz | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Pulse Width | 105 to 960 µs | 12 to 1000 µs | 70 to 500µs | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Current/Voltage | |||||
| Regulated | Voltage | Current | Current (dependent | ||
| on pick-up ratio at | |||||
| implant) | Differences do not affect safety and | ||||
| effectiveness of intended use | |||||
| Output Current (300 | |||||
| Ohms) | 0 to 5.73 mA* | 0 to 10.2 mA | 0 to 5 mA*** | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Output Current (500 | |||||
| Ohms) | 0 to 5.44 mA* | 0 to 10.2 mA | 0 to 5 mA*** | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Output Current (800 | |||||
| Ohms) | 0 to 5.20 mA* | 0 to 10.2 mA | 0 to 5 mA*** | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Waveform | charge balanced (delayed) | ||||
| biphasic asymmetrical | Same | charge balanced | |||
| (delayed) biphasic | |||||
| asymmetrical or | |||||
| symmetrical | Same | ||||
| Pulse Shape | Decaying | ||||
| Exponential | Same | Same | Same | ||
| Maximum phase | |||||
| charge (300 Ohms) | 2.88 µC/pulse** | 6.8 µC/pulse | 3 µC/pulse*** | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Maximum phase | |||||
| charge (500 Ohms) | 2.74 µC/pulse** | 6.4 µC/pulse | 3 µC/pulse*** | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Maximum phase | |||||
| charge (800 Ohms) | 2.43 µC/pulse** | 4.7 µC/pulse | 3 µC/pulse*** | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Maximum charge | |||||
| density (300 Ohm) | 23.5 µC/cm2** | 53.1 µC/cm2 | 15.9 µC/cm2*** | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Maximum charge | |||||
| density (500 Ohm) | 22.4 µC/cm2** | 50.3 µC/cm2 | 15.9 µC/cm2*** | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Maximum charge | |||||
| density (800 Ohm) | 19.8 µC/cm2** | 36.9 µC/cm2 | 15.9 µC/cm2*** | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Table 3: Therapy | |||||
| Neuspera | |||||
| Neurostimulation | |||||
| System ( Subject Device ) | Nalu | ||||
| Neurostimulation | |||||
| System ( Primary Predicate ) | Bioness | ||||
| StimRouter | |||||
| Neuromodulation | |||||
| System ( Primary Predicate ) | Analysis of | ||||
| Technological | |||||
| Differences from | |||||
| Primary Predicate | |||||
| Maximum current | |||||
| density (300 Ohm) | 46.8 mA/cm2* | 106.1 mA/cm2 | 26.5 mA/cm2*** | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Maximum current | |||||
| density (500 Ohm) | 44.4 mA/cm2* | 100.6 mA/cm2 | 26.5 mA/cm2*** | Differences do not affect safety and | |
| effectiveness of intended use | |||||
| Maximum current | |||||
| density (800 Ohm) | 42.4 mA/cm2* | 73.9 mA/cm2 | 26.5 mA/cm2*** | Differences do not affect safety and | |
| effectiveness 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-1 | ||||
| day | Same | Same | Same |
Neuspera Neuspera Neurostimulation System (NNS) Traditional 510(K)
8
9
10
- measured with typical therapy pulse width of 240us
** measured with maximum pulse with of 960us
*** unreported test impedance conditions
11
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 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 |
Traditional 510(k)
12
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 (