(136 days)
No
The summary describes a peripheral nerve stimulator that uses pulsed electrical waveforms and does not mention any AI or ML components in its description, performance studies, or key metrics.
Yes
The device is indicated for "pain management in adults who have severe intractable chronic pain of peripheral nerve origin" and is described as providing "therapeutic relief for chronic, intractable pain."
No
The device description and intended use clearly state that Moventis PNS is used for peripheral nerve stimulation to provide therapeutic pain relief, which is a treatment, not a diagnostic, function.
No
The device description explicitly states that the Moventis PNS is comprised of a percutaneous Implanted Pulse Generator (pIPG) and a preprogrammed External Transmitter (ETx), which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Moventis PNS Function: The Moventis PNS is a device that is implanted and uses electrical stimulation to directly interact with peripheral nerves within the body. 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." This is a therapeutic intervention, not a diagnostic test performed on a sample.
- Device Description: The description details an implanted pulse generator and an external transmitter that deliver electrical waveforms to the nerves. This is a physical intervention, not a laboratory analysis.
Therefore, based on the provided information, the Moventis PNS is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Moventis PNS 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 Moventis PNS is not intended to treat pain in the craniofacial region.
Product codes
GZF
Device Description
Moventis PNS is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain originating from peripheral nerves. The therapy utilizes pulsed electrical waveforms to create an electrical energy field that acts on afflicted peripheral nerves to alter the transmission of pain signals from those nerves to the brain. Moventis PNS is comprised of percutaneous Implanted Pulse Generator (pIPG) and a preprogrammed External Transmitter (ETx) worn outside the body over the general area of the pIPG to provide signal and power.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral nerves
Indicated Patient Age Range
adults
Intended User / Care Setting
Hospital, Home
Intended Clinician: Orthopedic, Neurosurgeon, Anesthesiologist
Intended User: Layperson
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
There was no clinical testing required to support the medical device, as the indications for use are equivalent to the legally marketed predicate devices. These types of devices, including the legally marketed predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in K200848 supports the substantial equivalence of the device.
Moventis PNS was tested to verify that the performance meets the system design requirements as well as all applicable voluntary standards. Moventis PNS complies with all design requirements and applicable voluntary standards.
ISO 14708-3:2017: The ETx (non-implantable) demonstrated compliance to the appropriate requirements of IEC 60601-1:2005 + A 1:2012 and passed all tests for electrical safety, electromagnetic interference, and wireless coexistence.
For usability of the ETx (non-implantable and not connected to an electrical power source), demonstrated compliance to the appropriate requirements of IEC 62366:2015, meeting the acceptance criteria of the usability validation plan, mitigating risks as far as possible.
The packaging of Moventis PNS was verified to protect the devices from shock, stacking, vibration as well as temperature, pressure, and humidity variations commonly associated with storage and handling conditions in compliance with ISO 11607-1. The markings for Moventis PNS demonstrates compliance with durability and legibility requirements.
Moventis PNS is validated for ethylene oxide (EO) sterilization as specified by ISO 14708-3:2017 in compliance with ISO 11135:2014 and verified no unacceptable release of particulate matter at time of implantation.
Moventis PNS has demonstrated biocompatibility in compliance with ISO 10993-1.
Moventis PNS is verified to protect patients from electrical harm as specified by ISO 14708-3:2017. By design, the direct current density at the surface of the electrodes is verified below 0.75u A/mm2 and pIPG complies with requirements to withstand dielectric strength testing exposure.
Moventis PNS is verified to protect patients from heating harm and does not exceed heating limits. Moventis PNS has demonstrated safe operation in the presence of external influences including external defibrillation, ultrasound, and electromagnetic fields and have no irreversible damage following exposure to changes in electric fields.
Moventis PNS has demonstrated that any gradual, long term changes in materials do not result in unacceptable risks and has been mitigated as far as possible. Verification includes testing data with Moventis PNS, material selection, and risk evaluation.
The Moventis PNS pIPG was verified as functional after exposure to external defibrillation, complying with testing as specified by ISO 14708-3:2017.
Moventis PNS passed all criteria of the mechanical force test, demonstrating functionality following free-fall tests in accordance with IEC 60601-1:2005 + A 1:2012, and showed no visible damage to the pIPG body or functional damage to the components. Mechanical testing of the pIPG included tensile testing, flex testing and torsion testing.
Moventis PNS demonstrated safe operation following exposure to electrostatic discharge in compliance with IEC 60601-1:2005 + A1:2012 and IEC 60601-1-2:2014. Moventis PNS demonstrated protection from damage caused by electrostatic discharge.
Moventis PNS passed all criteria of the atmospheric pressure and temperature test, exhibiting no change to device specification or damage following exposure to absolute pressure or changes in temperature.
IEC 60601-1: Moventis PNS was tested for compliance with IEC 60601-1:2005 + A1:2012 and demonstrated protection from temperature change, including shipping and storage temperature ranges, meeting the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Moventis PNS satisfies the outlined protection from temperature change design requirements and the applicable standard, IEC 60601-1. Moventis PNS met the passing criteria of both of the visual and functional inspections following the atmospheric pressure change testing, showed no physical damage and was fully operational. Moventis PNS satisfies the outlined atmospheric pressure change design requirements and the applicable standard, IEC 60601-1. For push, drop, impact and mold stress relief testing of Moventis PNS, it was determined through testing that the design is robust to withstand expected damage in accordance with general safety standards, meeting the passing criteria of both of the visual and functional inspections following the testing, showing no physical damage and full operation. Moventis PNS satisfies the outlined push, drop, impact, and mold stress relief design requirements and the applicable standard, IEC 60601-1. For the identification, marking and documents of Moventis PNS, it was determined through an analysis of the labeling that compliance with the requirements of the standard is demonstrated. All requirements and markings are clearly identified and viewable either from the packaging product or within the accompanying documents. For the means of protection, creepage distances, and air clearances of Moventis PNS was determined through an analysis of the design that the system satisfies the requirements of the applicable standard, IEC 60601-1.
IEC 60529: Moventis PNS was tested for compliance with IEC 60529. For testing the ingress of water. Moventis PNS met the passing criteria of both of the visual and functional inspections following the testing, showing no physical damage and was fully operational. Thus, satisfying the outlined Ingress of Water design requirements and the applicable standard IEC 60529. For particulate matter testing, Moventis PNS met the passing criteria of both of the visual and functional inspections following the testing, showing no physical damage and was fully operational. Thus, satisfying the outlined Particulate Matter design requirements and the applicable standard, IEC 60529.
IEC 60601-1-2: Moventis PNS was tested for compliance with IEC 60601-1-2. For electromagnetic compatibility testing, Moventis PNS met all acceptance criteria for emissions, low-frequency magnetic fields, immunity, electrostatic discharge, radiated RF electromagnetic fields, and magnetic fields. For all tests, Moventis PNS operated within all test limits and showed no physical damage and was fully operational. Thus, satisfying the IEC 60601-1-2 standard.
Moventis PNS complies with the applicable standards for neurostimulators, electrical safety, electromagnetic interference and compatibility, biocompatibility, packaging, and sterilization, meeting all the requirements for overall design, sterilization, biocompatibility, and electrical safety confirms that the output meets the design inputs and specifications, passing all testing stated above as shown by the acceptable results obtained. Moventis PNS passed all the testing in accordance with national and international standards.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
August 14, 2020
Micron Medical Corporation Elizabeth Greene Chief Compliance Officer 606 Banyan Trail Boca Raton, Florida 33431
Re: K200848
Trade/Device Name: Stimulator Kit, External Transmitter, External Transmitter Kit Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted peripheral nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZF Dated: May 15, 2020 Received: May 19, 2020
Dear Elizabeth Greene:
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
1
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 medical devices and radiation-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,
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Moventis PNS
Indications for Use (Describe)
Moventis PNS 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 Moventis PNS is not intended to treat pain in the craniofacial region.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
for
Moventis PNS
1. Submission Sponsor
Micron Medical Corporation Address: 606 Banyan Trail Boca Raton Florida, 33431 USA Phone/Fax: 888.691.0585 Contact: Elizabeth Greene, Chief Compliance Officer
2. Date Prepared
March 30, 2020
3. Device Identification
| Trade/Proprietary Name: | Moventis PNS |
|---|---|
| Common/Usual Name: | Peripheral Nerve Stimulator |
| Classification Name: | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Classification Regulation: | 882.5870 |
| Product Code: | GZF |
| Device Class: | Class II |
| Classification Panel: | Neurology |
4. Legally Marketed Predicate Device(s)
| K141399 | Freedom SCS System | FRE4-A000 |
|---|---|---|
| K171366 | StimQ PNS System | STQ4, PDBT-915-2A |
5. Device Description
Moventis PNSTM is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain originating from peripheral nerves. The therapy utilizes pulsed electrical waveforms to create an electrical energy field that acts on afflicted peripheral nerves to alter the transmission of pain signals from those nerves to the brain. Moventis PNS is comprised of percutaneous Implanted Pulse Generator (pIPG) and a preprogrammed External Transmitter (ETx) worn outside the body over the general area of the pIPG to provide signal and power.
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Image /page/4/Picture/0 description: The image shows the logo for Micron Medical. The word "micron" is written in blue, and the word "medical" is written in green below it. To the right of the word "micron" are three curved lines that are also blue, resembling a sound wave.
pIPG Kits
Moventis PNS has three (3) pIPG Kits consisting of the following components.
| pIPG(s) | Percutaneous implanted pulse generator comprised of an embedded receiver, flexible integrated circuit board, encased by polyurethane (Pellethane 55D) tubing and tines with four (4) electrodes (Platinum Iridium 90:10). pIPG electrodes are placed next to peripheral nerves. |
|---|---|
| Stylet | Curved stainless-steel wire with a polypropylene handle inserted into pIPG to provide rigidity during implantation. |
| Introducers | Stainless steel dilator and yellow Hytrel introducer assembly used to create a pathway for placement of pIPG next to peripheral nerves. |
ETx Kit
Moventis PNS has one (1) External Transmitter Kit consisting of the following:
| ETx | External Transmitter (ETx) housing includes the following components: |
|---|---|
| A. Microwave Field Stimulator (MFS) – A printed circuit board (PCB) | |
| that generates RF power with embedded waveform parameter setting; | |
| B. Switch Membrane – An elastomeric silicon rubber pad that | |
| corresponds to switches on the MFS that allows the user to turn the | |
| device on/off or increase or decrease power amplitude, or select | |
| program; | |
| C. Battery Assembly – Battery and wire assembly for charging and MFS | |
| power delivery. | |
| D. Transmitting Antenna – Antenna and coaxial cable assembly that is | |
| attached to the ETx used to transmit energy to pIPG. | |
| Battery Charger | Off-the-shelf battery charger that uses a power adapter micro-USB cable. |
6. Indication for Use Statement_
Moventis PNS 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. Moventis PNS is not intended to treat pain in the craniofacial region.
7. Substantial Equivalence Discussion
The following table compares Moventis PNS to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Comparator | New Device | Predicate Device (Primary) | Predicate Device |
|---|---|---|---|
| Device Name | Moventis PNS | StimQ PNS System | Freedom SCS System |
| Regulatory Decision | K200848 | K171366 | K141399 |
| Product Code | GZF | Same as Moventis | GZB |
| Regulation No. | 882.5870 | Same as Moventis | 882.5880 |
| Regulation Name | Stimulator, Peripheral Nerve, | ||
| Implanted (Pain Relief) | Same as Moventis | Stimulator, Spinal-Cord | |
| Implanted (Pain Relief) |
Table 5A. Comparison of the technological characteristics of Moventis PNS to predicate devices
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Image /page/5/Picture/0 description: The image shows the logo for Micron Medical. The word "micron" is written in blue, and the word "medical" is written in green below it. To the right of the word "micron" are three curved lines that appear to be a signal symbol.
Micron Medical Corporation (Micron) Traditional 510(k) Premarket Notification Submission K200848
| Comparator | New Device | Predicate Device (Primary) | Predicate Device | ||||
|---|---|---|---|---|---|---|---|
| Intended Use | Stimulation of peripheral | ||||||
| nerves for chronic, | |||||||
| intractable pain of peripheral | |||||||
| nerve origin | Same as Moventis | Stimulation of spinal | |||||
| nerves for chronic, | |||||||
| intractable pain of | |||||||
| trunk and lower limbs | |||||||
| Mode of Action | RF wireless transmission of | ||||||
| energy to produce | |||||||
| stimulation. ETx sends | |||||||
| pulsed RF signal on carrier | |||||||
| frequency (915MHz) to | |||||||
| pIPG. | RF wireless transmission | ||||||
| of energy to produce | |||||||
| stimulation. SWAG sends | |||||||
| pulsed RF signal on carrier | |||||||
| frequency (915MHz) to | |||||||
| Stimulator. | Same as Moventis | ||||||
| Implant Site | Peripheral nerves, excluding | ||||||
| craniofacial region | Same as Moventis | Epidural space, L5 to | |||||
| T5 | |||||||
| Environmental Use | Hospital, Home | Same as Moventis | Same as Moventis | ||||
| Intended Clinician | Orthopedic, Neurosurgeon, | ||||||
| Anesthesiologist | Same as Moventis | Same as Moventis | |||||
| Intended User | Layperson | Same as Moventis | Same as Moventis | ||||
| Electrode Material | Platinum-iridium 90:10 | Same as Moventis | Same as Moventis | ||||
| pIPG Body Material | Polyurethane 2363-55D | Same as Moventis | Same as Moventis | ||||
| pIPG Length | 45 cm | Same as Moventis | Same as Moventis | ||||
| pIPG Diameter | 1.35 mm | Same as Moventis | Same as Moventis | ||||
| Electrode Array Length | 24.0 mm | 24.0 mm (FR4A/SRAY) | Same as Moventis | ||||
| No. of Electrodes | 4 | 4 (FR4A/SRAY) | Same as Moventis | ||||
| Electrode Length | 3.0 millimeters | Same as Moventis | Same as Moventis | ||||
| Electrode Spacing | 4.0 mm | Same as Moventis | Same as Moventis | ||||
| Electrode Surface Area | 12.72 mm2 | Same as Moventis | Same as Moventis | ||||
| Method of Introduction | Percutaneous | Same as Moventis | Same as Moventis | ||||
| Tissue Contact | Yes | Same as Moventis | Same as Moventis | ||||
| Sterilization | Ethylene Oxide (EO) | Same as Moventis | Same as Moventis | ||||
| Labeling | Sterile, Single Use, | ||||||
| Prescription Use | Same as Moventis | Same as Moventis | |||||
| Pulse Frequency | 5 to 1,500 Hz | Same as Moventis | Same as Moventis | ||||
| Pulse Width | 50 to 500 µsec | Same as Moventis | Same as Moventis | ||||
| Polarity | Fixed | Programmable | Same as Moventis | ||||
| Waveform | Charge Balanced (delayed) | ||||||
| Biphasic asymmetrical | Same as Moventis | Same as Moventis | |||||
| Pulse Shape | Decaying Exponential | Same as Moventis | Same as Moventis | ||||
| Current/Voltage Regulated | Current | Same as Moventis | Same as Moventis | ||||
| Output Voltage (300 Ω) | 0 to 7.0 V | 0 to 4.1 V | 0 to 6.3 V | ||||
| Output Voltage (500 Ω) | 0 to 8.3 V | 0 to 6.4 V | 0 to 7.2 V | ||||
| Output Voltage (800 Ω) | 0 to 9.4 V | 0 to 7.5 V | 0 to 8.0 V | ||||
| Output Current (300 Ω) | 0 to 23.3 mA | 0 to 13.5 mA | 0 to 21.0 mA | ||||
| Output Current (500 Ω) | 0 to 16.6 mA | 0 to 12.8 mA | 0 to 15.0 mA | ||||
| Output Current (800 Ω) | 0 to 11.7 mA | 0 to 9.4 mA | 0 to 10.0 mA | ||||
| Avg. Cur. Density* (300Ω) | 139.5 mA/cm2 | 105.0 mA/cm2 | 111.6 mA/cm2 | ||||
| Avg. Cur. Density* (500Ω) | 100.2 mA/cm2 | 95.1 mA/cm2 | 96.7 mA/cm2 | ||||
| Avg. Cur. Density* (800Ω) | 68.5 mA/cm2 | 69.0 mA/cm2 | 77.0 mA/cm2 | ||||
| Max. Phase Charge* (300Ω) | 2.9 µC/pulse | 6.8 µC/pulse | 10.5 µC/pulse | ||||
| Max. Phase Charge* (500Ω) | 2.9 µC/pulse | 6.4 µC/pulse | 7.2 µC/pulse | ||||
| Max. Phase Charge* (800Ω) | 2.9 µC/pulse | 4.7 µC/pulse | 5.0 µC/pulse | ||||
| Max. Charge Density* (300Ω) | 23.2 µC/cm2 | 53.1 µC/cm2 | 82.5 µC/cm2 | ||||
| Max. Charge Density* (500Ω) | 23.2 µC/cm2 | 50.3 µC/cm2 | 56.6 µC/cm2 | ||||
| Max. Charge Density* (800Ω) | 22.6 µC/cm2 | 36.9 µC/cm2 | 39.3 µC/cm2 | ||||
| Max. Cur. Density* (300Ω) | 183.3 mA/cm2 | 106.1 mA/cm2 | 165.1 mA/cm2 | ||||
| Max. Cur. Density* (500Ω) | 130.2 mA/cm2 | 100.6 mA/cm2 | 113.2 mA/cm2 | ||||
| Max. Cur. Density* (800Ω) | 91.9 mA/cm2 | 73.9 mA/cm2 | 78.6 mA/cm2 | ||||
| Net Charge | 0 µC | Same as Moventis | Same as Moventis | ||||
| Avg. Phase Power* (300Ω) | 0.077 W/phase | 0.053 W/phase | 0.060 W/phase | ||||
| Avg. Phase Power* (500Ω) | Avg. Phase Power* (800Ω) | 0.068 W/phase | 0.052 W/phase | 0.073 W/phase | 0.062 W/phase | 0.076 W/phase | 0.060 W/phase |
| Avg. Phase Power Density* (300Ω) | 0.60 W/cm2/phase | 0.42 W/cm2/phase | 0.48 W/cm2/phase |
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Image /page/6/Picture/0 description: The image contains the logo for Micron Medical. The word "micron" is written in blue, and the word "medical" is written in green below it. To the right of the word "micron" are three curved lines that resemble sound waves.
Micron Medical Corporation (Micron) Traditional 510(k) Premarket Notification Submission K200848
| Comparator | New Device | Predicate Device (Primary) | Predicate Device |
|---|---|---|---|
| Avg. Phase Power Density* (500Ω) | 0.50 W/cm2/phase | 0.58 W/cm2/phase | 0.59 W/cm2/phase |
| Avg. Phase Power Density* (800Ω) | 0.40 W/cm2/phase | 0.48 W/cm2/phase | 0.60 W/cm2/phase |
| Pulse Delivery Mode | Continuous | Same as Moventis | Same as Moventis |
| ON/OFF Times | ON/OFF Cycling Option | No Cycling | No Cycling |
| Current Path Options | Bipolar | Same as Moventis | Same as Moventis |
| Power Delivery | Coupled (fully integrated) | ||
| receiver built into pIPG | Embedded receiver and | ||
| coupled receiver in lumen | Same as Moventis | ||
| Transmit Frequency | 915 MHz | Same as Moventis | Same as Moventis |
| Material | Platinum-iridium 90:10, | ||
| Polyurethane 2363-55D | Same as Moventis | Same as Moventis | |
| Sterile | Yes - ethylene oxide | Same as Moventis | Same as Moventis |
| Single-Use | Yes | Same as Moventis | Same as Moventis |
| Shelf Life | 2 year | Same as Moventis | 1 year |
| Complies with ISO 10993-1 | Yes | Same as Moventis | Same as Moventis |
| Safety Testing Passed | Yes | Same as Moventis | Same as Moventis |
| MR Conditional | No | Yes | Yes |
| Accessories | Stylet and Introducer | Stylet, Guidewire, | |
| Introducer Assembly | Stylets, Guidewire, | ||
| Tuohy Needle, | |||
| Introducer Assembly | |||
| Software Level of Concern | Moderate | Same as Moventis | Same as Moventis |
| Programming Application | Not Applicable, | ||
| ETx is pre-programmed | WaveCrestTM | WaveCrestTM |
*formula-derived
8. Biocompatibility Data _____________________________________________________________________________________________________________________________________________________
The materials, construction and intended use of Moventis PNS are comparable to the predicate devices and have a long history of safety with respect to biocompatibility. The biological safety of the pIPG (same as the Freedom-4 Stimulator, K141399) was evaluated in accordance to ISO 10993-1:2009 and guidance document Blue Book Memorandum G95-1 Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing. Under these, for the stated indications for use, the device was classified as a (C), implant device in contact with tissue/bone. The results for the biocompatible testing of the pIPG (same as the Freedom-4 Stimulator) for cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation (4, 8, and 13 weeks), and subchronic toxicity demonstrated no negative impacts from the materials that are used in Moventis PNS. The pIPG materials in direct tissue contact include Pellethane 55D and Pt-Ir (90:10), both having an extensive record (previously cleared and approved) of chronic and carcinogenetic safety. The User Manual provided to the patient describes that ETx is intended to be worn on top of an article of clothing and not against the skin. The categorization by nature of body contact of the ETx is a "non-contacting device" and not included in the scope of ISO 10993-1:2009. Moventis PNS meets biological safety and compatibility requirements of ISO 10993-1:2009 & Blue Book Memorandum G95-1.
9. Non-Clinical Performance Data
Moventis PNS was tested to verify that the performance meets the system design requirements as well as all applicable voluntary standards. Moventis PNS complies with all design requirements and applicable voluntary standards.
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Image /page/7/Picture/0 description: The image shows the logo for Micron Medical. The word "micron" is written in blue, and the word "medical" is written in green below it. To the right of the word "micron" are three curved lines that are also blue, which appear to be a symbol for sound waves.
ISO 14708-3:2017: The ETx (non-implantable) demonstrated compliance to the appropriate requirements of IEC 60601-1:2005 + A 1:2012 and passed all tests for electrical safety, electromagnetic interference, and wireless coexistence.
For usability of the ETx (non-implantable and not connected to an electrical power source), demonstrated compliance to the appropriate requirements of IEC 62366:2015, meeting the acceptance criteria of the usability validation plan, mitigating risks as far as possible.
The risks associated with wireless communication with the implantable part of Moventis PNS are mitigated as far as possible by implementation of risk analysis, evaluation, control, and safety by design in compliance with ISO 14971:2019, protecting the patient from harm.
The packaging of Moventis PNS was verified to protect the devices from shock, stacking, vibration as well as temperature, pressure, and humidity variations commonly associated with storage and handling conditions in compliance with ISO 11607-1. The markings for Moventis PNS demonstrates compliance with durability and legibility requirements.
Moventis PNS is validated for ethylene oxide (EO) sterilization as specified by ISO 14708-3:2017 in compliance with ISO 11135:2014 and verified no unacceptable release of particulate matter at time of implantation. Moventis PNS has demonstrated biocompatibility in compliance with ISO 10993-1.
Moventis PNS is verified to protect patients from electrical harm as specified by ISO 14708-3:2017. By design, the direct current density at the surface of the electrodes is verified below 0.75u A/mm2 and pIPG complies with requirements to withstand dielectric strength testing exposure.
Moventis PNS is verified to protect patients from heating harm and does not exceed heating limits. Moventis PNS has demonstrated safe operation in the presence of external influences including external defibrillation, ultrasound, and electromagnetic fields and have no irreversible damage following exposure to changes in electric fields. Where applicable, product labeling indicates medical procedures that are contraindicated for use with Moventis PNS. Residual risks associated with Moventis PNS is mitigated as far as possible.
Through design and device evaluation, Moventis PNS has demonstrated that any gradual, long term changes in materials do not result in unacceptable risks and has been mitigated as far as possible. Verification includes testing data with Moventis PNS, material selection, and risk evaluation.
The Moventis PNS pIPG was verified as functional after exposure to external defibrillation, complying with testing as specified by ISO 14708-3:2017.
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Image /page/8/Picture/0 description: The image shows the logo for Micron Medical. The word "micron" is written in blue, and the word "medical" is written in green below it. To the right of the words are three curved lines that are also blue, which appear to be a symbol for radio waves.
Moventis PNS passed all criteria of the mechanical force test, demonstrating functionality following free-fall tests in accordance with IEC 60601-1:2005 + A 1:2012, and showed no visible damage to the pIPG body or functional damage to the components. Mechanical testing of the pIPG included tensile testing, flex testing and torsion testing. Thus, the pIPGs comply with all mechanical design requirements. Moventis PNS demonstrated safe operation following exposure to electrostatic discharge in compliance with IEC 60601-1:2005 + A1:2012 and IEC 60601-1-2:2014. Moventis PNS demonstrated protection from damage caused by electrostatic discharge.
Moventis PNS passed all criteria of the atmospheric pressure and temperature test, exhibiting no change to device specification or damage following exposure to absolute pressure or changes in temperature.
IEC 60601-1: Moventis PNS was tested for compliance with IEC 60601-1:2005 + A1:2012 and demonstrated protection from temperature change, including shipping and storage temperature ranges, meeting the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Moventis PNS satisfies the outlined protection from temperature change design requirements and the applicable standard, IEC 60601-1. Moventis PNS met the passing criteria of both of the visual and functional inspections following the atmospheric pressure change testing, showed no physical damage and was fully operational. Moventis PNS satisfies the outlined atmospheric pressure change design requirements and the applicable standard, IEC 60601-1. For push, drop, impact and mold stress relief testing of Moventis PNS, it was determined through testing that the design is robust to withstand expected damage in accordance with general safety standards, meeting the passing criteria of both of the visual and functional inspections following the testing, showing no physical damage and full operation. Moventis PNS satisfies the outlined push, drop, impact, and mold stress relief design requirements and the applicable standard, IEC 60601-1. For the identification, marking and documents of Moventis PNS, it was determined through an analysis of the labeling that compliance with the requirements of the standard is demonstrated. All requirements and markings are clearly identified and viewable either from the packaging product or within the accompanying documents. For the means of protection, creepage distances, and air clearances of Moventis PNS was determined through an analysis of the design that the system satisfies the requirements of the applicable standard, IEC 60601-1.
IEC 60529: Moventis PNS was tested for compliance with IEC 60529. For testing the ingress of water. Moventis PNS met the passing criteria of both of the visual and functional inspections following the testing, showing no physical damage and was fully operational. Thus, satisfying the outlined Ingress of Water design requirements and the applicable standard IEC 60529. For particulate matter testing, Moventis PNS met the passing criteria of both of the visual and functional inspections following the testing, showing no physical damage and was fully operational. Thus, satisfying the outlined Particulate Matter design requirements and the applicable standard, IEC 60529.
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Image /page/9/Picture/0 description: The image shows the logo for Micron Medical. The word "micron" is written in blue, and the word "medical" is written in green below it. To the right of the words are three curved lines in blue, which appear to be a symbol for sound waves.
IEC 60601-1-2: Moventis PNS was tested for compliance with IEC 60601-1-2. For electromagnetic compatibility testing, Moventis PNS met all acceptance criteria for emissions, low-frequency magnetic fields, immunity, electrostatic discharge, radiated RF electromagnetic fields, and magnetic fields. For all tests, Moventis PNS operated within all test limits and showed no physical damage and was fully operational. Thus, satisfying the IEC 60601-1-2 standard.
Moventis PNS complies with the applicable standards for neurostimulators, electrical safety, electromagnetic interference and compatibility, biocompatibility, packaging, and sterilization, meeting all the requirements for overall design, sterilization, biocompatibility, and electrical safety confirms that the output meets the design inputs and specifications, passing all testing stated above as shown by the acceptable results obtained. Moventis PNS passed all the testing in accordance with national and international standards.
Following performance testing, it has been determined that Moventis PNS is substantially equivalent to legally marketed predicate devices for the therapeutic relief for chronic, intractable pain of peripheral nerve origin.
10. Clinical Performance Data
There was no clinical testing required to support the medical device, as the indications for use are equivalent to the legally marketed predicate devices. These types of devices, including the legally marketed predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in K200848 supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to legally marketed predicate devices when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Moventis PNS has the same intended use as the legally marketed predicate devices. Performance tested verified that Moventis PNS complies with all applicable voluntary standards such as IEC 60601-1, ISO 14708-3, and IEC 60529. Moventis PNS also meets the design requirements where no applicable standard could be used. This includes pIPG body durability testing, programmable parameters, as well as performance of the ETx. There were no recognized performance standards for this device. There was no clinical testing performed on this device since performance testing demonstrated similar performance as the legally marketed predicate devices, and materials for the pIPG are the same as the legally marketed predicate devices.
It has been shown in K200848 that the difference between Moventis PNS and the legally marketed predicate devices do not raise any questions regarding safety and effectiveness. Moventis PNS, as designed and manufactured, is determined to be substantially equivalent to the referenced legally marketed predicate devices.