K Number
K200482
Device Name
StimRouter Neuromodulation System
Manufacturer
Date Cleared
2020-03-27

(29 days)

Product Code
Regulation Number
882.5870
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The StimRouter Neuromodulation System consists of two main parts - the implantable lead, and the external (to the body) accessories. Accessories for the StimRouter include a clinician programmer with software (CPS), a patient programmer, disposable hydrogel electrode patch, external pulse transmitter (EPT), and an EPT stimulation tester (EPTT). The StimRouter Neuromodulation System is provided with three labeling documents: the Clinician's Guide, the Procedure Manual and the User's Guide. Only the Procedure Manual has been modified to include an alternative implantation procedure for situations in which an open implantation of the implantable StimRouter Lead is indicated. The complete StimRouter System consists of three kits: A Lead and Lead Introducer Kit, a Clinician Kit and User Kit. The Lead Kit contains the StimRouter implantable multielectrode lead with integrated receiver, used for peripheral nerve stimulation. The Lead receives an electrical signal transmitted transcutaneously by the EPT which is mounted on an electrode patch on the skin and delivers that electrical signal down the lead's length to a target peripheral nerve. The Lead is supplied in Lead Loader that is used during intraoperative testing of the lead and to verify proper placement during implantation. The Lead and Lead Introducer Kit consists of two stimulation probes, two stimulation cables, and introducer set, a lead adapter, a Tunneling Needle and a Tunneling Needle Stylet. The included tools and components allow for insertion of the StimRouter Lead and confirmation of optimal location of the stimulation electrode contacts of the StimRouter Lead. The Clinician Kit is used for the programming of the StimRouter patient programmer and the EPT. The components of the Clinician Kit are a tablet PC with programming software and the accessories for connecting to the Patient Programmer and the EPT. The User Kit contains the patient-use components of the StimRouter System. The components are the Patient Programmer and the EPT. After the EPT is programmed, the StimRouter electrode interfaces with the EPT and function to delivery stimulation to the implanted lead receiver.
More Information

Not Found

No
The summary describes a hardware-based neuromodulation system with programming software, but there is no mention of AI or ML capabilities in the device description, intended use, or specific sections for AI/ML details.

Yes
The device is indicated for pain management in adults with severe intractable chronic pain of peripheral nerve origin, which is a therapeutic purpose.

No

The StimRouter Neuromodulation System is described as a device for pain management that delivers electrical signals for stimulation. Its components are used for implantation, programming, and delivering stimulation, not for diagnosing a condition or disease.

No

The device description clearly outlines multiple hardware components, including an implantable lead, external pulse transmitter, patient programmer, and a tablet PC with programming software. While software is a component, the system is not solely software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for pain management by stimulating peripheral nerves. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
  • Device Description: The device consists of an implantable lead and external components for delivering electrical stimulation. It does not involve analyzing biological samples (like blood, urine, or tissue) to diagnose a condition.
  • Lack of IVD Characteristics: The description does not mention any components or processes related to in vitro testing, such as reagents, assays, or analysis of biological specimens.

Therefore, the StimRouter Neuromodulation System is a therapeutic device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

GZF

Device Description

The StimRouter Neuromodulation System consists of two main parts - the implantable lead, and the external (to the body) accessories. Accessories for the StimRouter include a clinician programmer with software (CPS), a patient programmer, disposable hydrogel electrode patch, external pulse transmitter (EPT), and an EPT stimulation tester (EPTT). The StimRouter Neuromodulation System is provided with three labeling documents: the Clinician's Guide, the Procedure Manual and the User's Guide. Only the Procedure Manual has been modified to include an alternative implantation procedure for situations in which an open implantation of the implantable StimRouter Lead is indicated

The Bioness StimRouter Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the management of severe, intractable, chronic pain of peripheral nerve origin in adults, as an adjunct to other modes of therapy (e.g. medications). The StimRouter is not intended to treat pain in the craniofacial region.

The complete StimRouter System consists of three kits: A Lead and Lead Introducer Kit, a Clinician Kit and User Kit. The Lead Kit contains the StimRouter implantable multielectrode lead with integrated receiver, used for peripheral nerve stimulation. The Lead receives an electrical signal transmitted transcutaneously by the EPT which is mounted on an electrode patch on the skin and delivers that electrical signal down the lead's length to a target peripheral nerve. The Lead is supplied in Lead Loader that is used during intraoperative testing of the lead and to verify proper placement during implantation.

The Lead and Lead Introducer Kit consists of two stimulation probes, two stimulation cables, and introducer set, a lead adapter, a Tunneling Needle and a Tunneling Needle Stylet. The included tools and components allow for insertion of the StimRouter Lead and confirmation of optimal location of the stimulation electrode contacts of the StimRouter Lead.

The Clinician Kit is used for the programming of the StimRouter patient programmer and the EPT. The components of the Clinician Kit are a tablet PC with programming software and the accessories for connecting to the Patient Programmer and the EPT.

The User Kit contains the patient-use components of the StimRouter System. The components are the Patient Programmer and the EPT. After the EPT is programmed, the StimRouter electrode interfaces with the EPT and function to delivery stimulation to the implanted lead receiver.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Peripheral nerve

Indicated Patient Age Range

adults

Intended User / Care Setting

Clinician, Patient (home use with Patient Programmer and EPT)

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)

Not Found

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.

K190047

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.

Not Found

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).

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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

March 27, 2020

Bioness Inc. Sageev George Senior Regulatory Affairs Specialist 25103 Rye Canyon Loop Valencia, California 91355

Re: K200482

Trade/Device Name: StimRouter Neuromodulation System Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: February 25, 2020 Received: February 27, 2020

Dear Sageev George:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

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,

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) K200482

Device Name StimRouter Neuromodulation System

Indications for Use (Describe)

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.

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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Image /page/3/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange star-like symbol on the left and the word "Bioness" in gray on the right. There is also a small orange dot above the "i" in "Bioness".

3. 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

I.Submitter Information
Company:Bioness Inc.
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Phone Number: (661) 902-5324
Fax: (661) 362-4851
Email: mercedes.bayani@bioness.com
Contact:Sageev George
Regulatory Affairs Manager, Implantables
Phone Number: (661) 902-5336
Fax Number: (661) 362-4851
Email: sageev.george@bioness.com

Mercedes Bayani
Global Vice-President, Clinical & Regulatory Affairs
Phone Number: (661) 902-5324
Fax Number: (661) 362-4851
Email: mercedes.bayani@bioness.com |
| | Date Prepared: | February 25, 2020 |
| II. | Name of Device | |
| | Device Trade Name: | StimRouter Neuromodulation System |
| | Classification Name: | Implantable peripheral nerve stimulator for pain relie |
| | Common Name: | Implantable Neurostimulator |
| | Product Code: | GZF |
| | Regulation Number: | 21 CFR §882.5870 |
| | Device Class: | Class II |
| | Panel Identification: | Neurology |
| III. | Predicate Device | |
| | Predicate Manufacturer: | Bioness Inc. |
| | Predicate Trade Name: | StimRouter Neuromodulation System |
| | Predicate 510(k): | K190047 |

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Device Description IV.

The StimRouter Neuromodulation System consists of two main parts - the implantable lead, and the external (to the body) accessories. Accessories for the StimRouter include a clinician programmer with software (CPS), a patient programmer, disposable hydrogel electrode patch, external pulse transmitter (EPT), and an EPT stimulation tester (EPTT). The StimRouter Neuromodulation System is provided with three labeling documents: the Clinician's Guide, the Procedure Manual and the User's Guide. Only the Procedure Manual has been modified to include an alternative implantation procedure for situations in which an open implantation of the implantable StimRouter Lead is indicated

The Bioness StimRouter Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the management of severe, intractable, chronic pain of peripheral nerve origin in adults, as an adjunct to other modes of therapy (e.g. medications). The StimRouter is not intended to treat pain in the craniofacial region.

The complete StimRouter System consists of three kits: A Lead and Lead Introducer Kit, a Clinician Kit and User Kit. The Lead Kit contains the StimRouter implantable multielectrode lead with integrated receiver, used for peripheral nerve stimulation. The Lead receives an electrical signal transmitted transcutaneously by the EPT which is mounted on an electrode patch on the skin and delivers that electrical signal down the lead's length to a target peripheral nerve. The Lead is supplied in Lead Loader that is used during intraoperative testing of the lead and to verify proper placement during implantation.

The Lead and Lead Introducer Kit consists of two stimulation probes, two stimulation cables, and introducer set, a lead adapter, a Tunneling Needle and a Tunneling Needle Stylet. The included tools and components allow for insertion of the StimRouter Lead and confirmation of optimal location of the stimulation electrode contacts of the StimRouter Lead.

The Clinician Kit is used for the programming of the StimRouter patient programmer and the EPT. The components of the Clinician Kit are a tablet PC with programming software and the accessories for connecting to the Patient Programmer and the EPT.

The User Kit contains the patient-use components of the StimRouter System. The components are the Patient Programmer and the EPT. After the EPT is programmed, the StimRouter electrode interfaces with the EPT and function to delivery stimulation to the implanted lead receiver.

V. Indications for Use

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.

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Image /page/5/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange star-like symbol on the left and the word "Bioness" in gray on the right. The star-like symbol is made up of several curved lines that converge in the center. The word "Bioness" is written in a sans-serif font, and there is a small circle above the "s" at the end of the word.

Comparison of Technological Characteristics VI.

The subject device is a modified version of the StimRouter Neuromodulation System previously cleared in K190047. A comparison of the technological characteristics of the two is presented below. As noted in the Predicate Device Comparison Matrix below, other than the update of the Procedure Manual to include an alternative implantation procedure for situations in which an open implantation of the implantable StimRouter Lead is indicated, there are no other modifications with respect to the K190047 predicate all other technological characteristics are equivalent.

| | Subject Device (Modified
StimRouter) | Predicate (StimRouter
cleared in K190047) | Equivalency
Assessment |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Bioness Inc. | Bioness Inc. | Same |
| 510(k) number | To be Determined | K190047 | - |
| Intended use | 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. | 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. | Same |
| | Implantable Lead and Lead Introducer Kit | | |
| Packaging | | | |
| Packaging | No changes | Tray Material: PETG
Lid Material: 1073B Tyvek
Lid Adhesive: TPT-021C | Same |
| StimRouter Lead | | | |
| StimRouter Lead | No changes | Implanted Lead: Length:
15cm, Diameter: 1.2mm,
Helical coil design, Anchors,
silicone insulator sheathe | Same |
| StimRouter Lead
Receiver End | No changes | 12mm receiver electrode,
captures portion of signal
generated by EPT | Same |
| StimRouter Lead
Stimulating End | No changes | 3 cylindrical stimulating
electrodes: Materials:
Platinum Iridium, Surface
Area: 6.3 mm², Max charge
per pulse: 3 µC, Max charge
density: 15.9 µC/cm² | Same |
| Introduction method | No changes | Percutaneous | Same |
| Tunneling Needle and
Tunneling Needle
Stylet | No changes | Stainless steel hollow needle
and solid stylet used to
implant receiver end of Lead | Same |
| | Subject Device (Modified
StimRouter) | Predicate (StimRouter
cleared in K190047) | Equivalency
Assessment |
| StimRouter Loader | No changes | Stainless Steel Tube with
Reed Connector | Same |
| Stimulation Probe | No changes | Stainless steel wire coated w/
titanium nitride and insulated
tubing | Same |
| Stimulation Cable | No changes | 2m long Cable for connecting
external peripheral nerve
stimulator with Stimulation
Probe, StimRouter Loader or
StimRouter Lead Adaptor | Same |
| Introducer Set | No changes | 11cm long dilator & sheath
used for routing stimulation
end of Lead from incision to
target stimulation point | Same |
| Lead Adaptor | No changes | 5.5 cm stainless steel cylinder
which connects to Lead,
allowing connection of
Stimulation cable | Same |
| Gel Electrodes | No changes | Nonsterile gel electrodes
(5cm diameter) used when
stimulation applied to
Stimulation Probe or
Stimulation Lead. Comes
with 1.5m long electrode
cable | Same |
| Clinician Kit | | | |
| Clinician's Programmer | | | |
| Hardware | No changes | Vanquisher IP67 8-inch
tablet running Window 10
Home | Same |
| Software | No changes | Clinician Programmer
Software used for storing
patient info, session data,
logs, patient stimulation
profile, and programming,
testing and saving of
stimulation programs on
tablet, and downloading of
programs to Patient
Programmer and EPT | Same |
| Stimulation Frequencies
available for Patient
Programmer and EPT
stimulation programs | No changes | 1, 2, 5, 10, 12, 15, 20, 30, 40,
50, 60, 70, 80, 90, 100, 120,
140, 160, 180, 200 Hz | Same |
| | Subject Device (Modified StimRouter) | Predicate (StimRouter cleared in K190047) | Equivalency Assessment |
| Tester | No changes | Used to confirm EPT is delivering stimulation by providing audio feedback when stimulation is applied | Same |
| | User Kit | | |
| External Pulse Transmitter (EPT) | | | |
| External Pulse Transmitter Description | No change | Generates stimulation signals, transmitting them transcutaneously through StimRouter Electrode to StimRouter Lead. Responds to wireless commands from Patient Programmer. Snaps onto StimRouter Electrode, Rechargeable lithium battery | Same |
| EPT Stimulation | No Change | EPT Max output: 30mA,
Amplitude at Lead: 0-5mA (20% max pick-up ratio)
Stimulation Signal:
Monopolar, Biphasic, Charge Balanced, RF-based,
Pulse Freq: 1-200 Hz, Max Compliance Voltage: 100V,
Pulse Width: 70-500 µsec, Charge per phase limit:15 µC
Ramp Up/Down feature | Same |
| EPT Stimulation Frequencies | No change | 1, 2, 5, 10, 12, 15, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180, 200 Hz | Same |
| Patient Programmer | | | |
| Patient Programmer Description | No change | Communicates wirelessly (RF) with EPT to do the following: start/stop stimulation, adjust stimulation intensity, selection of one of 8 possible stimulation programs | Same |
| Patient Programmer Stimulation Frequencies | No change | 1, 2, 5, 10, 12, 15, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180, 200 Hz | Same |
| | Subject Device (Modified
StimRouter) | Predicate (StimRouter
cleared in K190047) | Equivalency
Assessment |
| StimRouter Electrodes | No change | Reusable electrodes with gel
pad that adhere to skin and
transmit EPT stimulation
signal to StimRouter Lead,
Includes 2 snaps for EPT
attachment | Same |
| Labeling: Update to Procedure Manual (MODIFIED FROM PREDICATE)
Addition of New Section Detailing Alternative Implantation Procedure for StimRouter Lead
Summary: The new section provides details on the implantation of the StimRouter Lead when open
implantation of the Lead is indicated and treating physician believes that the StimRouter System would be
useful in treating the pain associated with target nerve. | | | |
| Implantation of Lead
Procedure | The updated Procedure
Manual still includes the
minimally invasive procedure
for Lead implantation but
includes an alternate implant
procedure for situations where
open implantation of the Lead
is indicated, for example
when the area around the
target nerve has been exposed
(e.g., nerve decompression
procedures). The new
procedure details how the
Lead can be placed and
fixated next to target nerve
and how the Tunneling
Needle and Stylet can be used
to place receiver end of Lead. | The Procedure Manual details
a minimally invasive
procedure for implanting the
StimRouter Lead using a
single stab incision,
Stimulator Probe for target
point identification, insertion
of the Lead stimulating end
using Introducer Set, and
insertion of Lead receiver end
using Tunneling Needle and
Stylet. | Similar: The new
procedure is being
provided for
situations in which
the surgical field
has been previously
opened and does
not introduce
additional risks to
the patient. Also,
the new method of
placing the Lead
allows for similarly
effective
stimulation of target
nerve and receipt of
stimulation from
EPT. |

Predicate Device Comparison

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Image /page/8/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left and the word "Bioness" in gray on the right. The sun-like symbol is made up of several curved lines that radiate outward from a central point. The word "Bioness" is written in a sans-serif font, and there is a small circle above the "ss".

Design Control Activities

Bioness Inc. established, and continues to document and maintain, a system for identifying and addressing hazards associated with the design, manufacture and use of a medical device throughout its lifecycle. This system includes procedures for estimating, evaluating, controlling, and/or reducing risk such that the medical benefit outweighs the residual risk associated with the use of the devices that are marketed by Bioness Inc. These procedures address the risk management requirements of ISO 13485, ISO 14971:2012, the Medical Device Directive (MDD) and the Quality System Regulation (QSR).

This system was used to assess the impact of the modifications of the original StimRouter Neuromodulation System and to determine what verification and validation activities may be

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required based on this assessment. The methods and results of the Risks vs. Benefits Assessment are provided in the Design Controls section of this submission. The results of the analysis are as follows:

  • Verification activities are not required, as there is no change to the design of the ● StimRouter.
  • Validation activities are not required - lead placement using this alternate approach is visible to the implanting physician due to the open nature of the procedure. The novel component involved during StimRouter lead implantation using this alternate technique is the process of using sutures and/or surgical glue to anchor the lead and prevent migration. These are commonly used surgical procedures employed by trained physicians and are not unique to the StimRouter implantation. As such, these process steps do not require usability testing.
  • The potential hazardous situation resulting from the alternate surgical approach has been identified as "Undesired motor neuron stimulation, due to poor placement of the lead during implant or migration after implant". The specific harm associated with this failure mode has the same end effect (severity) as overstimulation of contraindicated nerves – a failure mode which is currently listed within the risk documentation (HA-00011) and the current state of the art information. As such, the Risk vs. Benefits assessment remains unchanged, where the benefits accrued from the use of the device outweigh any identified residual risk.

VII. Conclusions

Based on the system maintained by Bioness Inc. for identifying and addressing hazards associated with the design, manufacture and use of a medical device throughout its lifecycle, Bioness Inc. concludes that the Risks vs. Benefits assessment remains unchanged, where the benefits accrued from the use of the device outweigh any identified residual risk. Therefore, the subject device StimRouter Neuromodulation System, which has modifications as compared to the predicate StimRouter Neuromodulation System (cleared in K190047), is substantially equivalent to the predicate device in terms of safety and effectiveness for its indication of 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 subject device continues to not be intended to treat pain in the craniofacial region.