StimQ Peripheral Nerve Stimulator (PNS) System

K152178 · Stimq, LLC · GZF · Mar 11, 2016 · Neurology

Device Facts

• Record ID: K152178
• Device Name: StimQ Peripheral Nerve Stimulator (PNS) System
• Applicant: Stimq, LLC
• Product Code: GZF · Neurology
• Decision Date: Mar 11, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The StimQ Peripheral Nerve Stimulator (PNS) 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 StimQ PNS System is not intended to treat pain in the craniofacial region. The StimQ Trial Lead Kit is only used in conjunction with the StimQ Stimulator Receiver Kit. 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.

Device Story

System provides peripheral nerve stimulation for chronic intractable pain; utilizes pulsed electrical current to alter pain signal transmission. Comprised of implantable stimulator (receiver) and externally worn transmitter (SWAG). Implanted percutaneously near peripheral nerves in limbs/torso. Transmitter uses 915 MHz RF power to wirelessly power implant. User operates transmitter via membrane switches to adjust power amplitude/on-off status. Healthcare providers (orthopedic, neurosurgeon, anesthesiologist) perform implantation. Output affects pain signal transmission to brain; provides therapeutic relief. Trial period (max 30 days) determines efficacy before permanent implantation.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and mechanical durability (tensile, flex, torsion).

Technological Characteristics

Implant: Polyurethane (Pellethane 55D) casing, Pt-Ir 90:10 electrodes. 4 or 8 electrode array. 915 MHz RF power transfer. Biphasic, charge-balanced, asymmetrical waveform. Pulse frequency 5-1500 Hz, pulse width 50-500 µs. Sterilization: Ethylene Oxide. Connectivity: Wireless inductive/RF coupling. Standards: AAMI ANSI ISO 14708-3, IEC 60601-1, IEC 60529, ISO 10993-1.

Indications for Use

Indicated for adults with severe intractable chronic pain of peripheral nerve origin in limbs or torso. Contraindicated for craniofacial pain. Used as sole therapy or adjunct in multidisciplinary approach.

Regulatory Classification

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.

Predicate Devices

• Stimwave Freedom SCS System (K150517)
• Stimwave Freedom SCS System (K141399)
• Medtronic Mattrix 3271/3272 Neuromodulation System (K934065)
• Medtronic Xtrel, Model Number 3425 Receiver (K883780)
• ANS Renew Neurostimulation System (K000852)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending downward from the bottom profile.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 11, 2016

StimQ LLC Elizabeth Greene Director of Quality Assurance and Regulatory Affairs 901 East Las Olas Boulevard Suite 201 Fort Lauderdale, Florida 33301

Re: K152178

Trade/Device Name: StimQ Peripheral Nerve Stimulator (PNS) System Regulation Number: 21 CFR 882.5870 Regulation Name: Stimulator, Peripheral Nerve, Implanted (Pain Relief) Regulatory Class: Class II Product Code: GZF Dated: March 8, 2016 Received: March 9, 2016

Dear Ms. 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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

| William J. Heetderks -A | Digitally signed by William J. Heetderks -A |
|-------------------------|---------------------------------------------|
| | DN: c=US, o=U.S. Government, ou=HHS, |
| | ou=NIH, ou=People, |
| | 0.9.2342.19200300.100.1.1=0010149848, |
| | cn=William J. Heetderks -A |
| | Date: 2016.03.11 15:31:15 -05'00' |

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

#### Indications for Use Statement

#### 510(k) Number (if known):

Device Name: StimO Peripheral Nerve Stimulator (PNS) System

#### Indications For Use:

The StimQ Peripheral Nerve Stimulator (PNS) 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 StimQ PNS System is not intended to treat pain in the craniofacial region. The StimQ Trial Lead Kit is only used in conjunction with the StimQ Stimulator Receiver Kit. 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for "stimQ". The word "stim" is written in blue, and the "Q" is written in green and is shaped like a magnifying glass. Behind the word "stimQ" are blue concentric circles that look like sound waves.

# 510(k) Summary

for

# StimQ Peripheral Nerve Stimulator (PNS) System

#### 1. Submission Sponsor

| StimQ LLC | |
|-----------------------------|------------------------------------------------------------------------------|
| 901 East Las Olas Boulevard | |
| Suite 201 | |
| Fort Lauderdale | |
| Florida 33301 | |
| USA | |
| Phone: | 786.475.7228 |
| Fax: | 786.475.7228 |
| Contact: | Elizabeth Greene, Vice President of Quality Assurance and Regulatory Affairs |

### 2. Date Prepared

July 31, 2015

# 3. Device Identification

| Trade/Proprietary Name: | StimQ Peripheral Nerve Stimulator (PNS) System |
|----------------------------|-------------------------------------------------------|
| Common/Usual Name: | Peripheral Nerve Stimulator |
| Classification Name: | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Classification Regulation: | 882.5870 |
| Product Code: | GZF |
| Device Class: | 2 |
| Classification Panel: | Neurology |

### 4. Legally Marketed Predicate Device(s)

Stimwave Freedom SCS System FR8A-A1, FR8A-B1, FR4A-A1, FR4A-B1, LBRD-915-2A (K150517) Stimwave Freedom SCS System FRE4-A001, WAA-A012 (K141399) Medtronic Mattrix 3271/3272 Neuromodulation System (K934065) Medtronic Xtrel, Model Number 3425 Receiver (K883780) ANS Renew Neurostimulation System Transmitter, Model 2508, Receiver Model 3408, Antennae Models 1220 and 1230, Lead Models 3143, 3146, 3153, 3156, 3183 and 3186, Extension Models 3382, 3383, 3341, 3342 and 3343 (K000852)

# 5. Device Description

The StimO LLC (StimO) StimO Peripheral Nerve Stimulator System) is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for StimQ. The logo features the word "stim" in a sans-serif font, followed by a green letter "Q" that is shaped like a magnifying glass. Behind the word "stimQ" are three concentric arcs in blue, resembling sound waves or a signal. The overall design is clean and modern, suggesting a focus on research, analysis, or technology.

electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator) and an externally worn transmitter (StimQ Wearable Antenna Gear (SWAG)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.

#### Freedom-8A and Freedom-4A Stimulator (Receiver Kit)

| Freedom-8A<br>Stimulator,<br>Freedom-4A<br>Stimulator | A polyurethane (Pellethane 55D) casing with an embedded receiver,<br>flexible circuit board and electrodes (Platinum Iridium 90:10) that is<br>placed next to peripheral nerves in the extremities and torso. The<br>Freedom-8A Stimulator has eight (8) electrodes, and the Freedom-4A<br>Stimulator has four (4) electrodes. |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stylet(s) | A stainless steel wire with a polypropylene handle that is inserted into<br>the open central lumen of the stimulator to provide rigidity during<br>implantation. Two (2) stylets are provided in the Receiver Kit, one<br>straight and one bent, each with diameter of 0.25 mm. |
| Needle and<br>Cannula | A 16-gauge stainless steel needle that is packaged inserted in the<br>fluorinated ethylene propylene (FEP) Cannula that acts as a conduit for<br>passage of the Stimulator next to the peripheral nerve. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow<br>pathway in tissue for the Stimulator to pass through easily. The<br>manufacturer of the guidewire is Guidewire Technologies. |

#### StimQ Wearable Antenna Gear (SWAG) Transmitter Kit

| Transmitter | The SWAG Transmitter housing includes the following components: |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| i. | Transmitting (Tx) Antenna - Flexible Dipole Antenna used to transmit microwave energy to the implanted Stimulator; |
| ii. | Microwave Field Stimulator (MFS) – A printed circuit board (PCB) that generates 915 MHz RF power with embedded waveform parameter settings and switches for changing parameter settings as needed by the user; |
| iii. | Switch Membrane - A 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 as well as interpret device power status (On, Off, Charging, Transmitting, and Bluetooth® Connection); |
| iv. | Battery Assembly – A battery and wire assembly coupled with the Wireless Charging Coil Assembly for charging and the MFS for power delivery; |
| v. | Wireless Charging Coil Assembly – Consists of an inductive charging coil and battery that receives energy from the Wireless Battery Charging Pad. The battery charger components on the MFS are used to transfer charge into the 3.7V lithium ion battery by facilitating power transfer and warns the system when battery power is low |

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for StimQ. The logo features the word "stim" in blue, followed by a green letter "Q" that is stylized to resemble a magnifying glass. Behind the "Q" are concentric blue circles, suggesting sound waves or a signal. The overall design is clean and modern, with a focus on the company name and a visual representation of its purpose.

# StimQ Wearable Antenna Gear (SWAG) Transmitter Kit

| Wireless Battery Charging Pad | An off-the-shelf Qi-compliant charging pad (RP-WCN7, RP-WCN12, or RP-WCN13) that uses inductive charging technology to recharge the encased lithium ion battery of the SWAG Transmitter. |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

# StimQ Wearable Antenna Gear (SWAG) Accessory Kit (each packaged separately)

| Upper Arm | A wearable unit, sourced “off-the-shelf,” designed to fit an upper extremity, adjustable from small to extra large sizes constructed of lightweight elastic neoprene fabric that is compatible with the Velcro Hook for attaching the SWAG Transmitter. |
|-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lower Arm | A wearable unit, sourced “off-the-shelf,” designed to fit an upper extremity, adjustable from small to extra large sizes constructed of lightweight elastic neoprene fabric that is compatible with the Velcro Hook for attaching the SWAG Transmitter. |
| Torso | A wearable unit, sourced “off-the-shelf,” designed to fit around the torso, adjustable from small to extra large sizes constructed of lightweight elastic neoprene fabric that is compatible with the Velcro Hook for attaching the SWAG Transmitter. |
| Upper Leg | A wearable unit, sourced “off-the-shelf,” designed to fit a lower extremity, adjustable from small to extra large sizes constructed of lightweight elastic neoprene fabric that is compatible with the Velcro Hook for attaching the SWAG Transmitter. |
| Lower Leg | A wearable unit, sourced “off-the-shelf,” designed to fit a lower extremity, adjustable from small to extra large sizes constructed of lightweight elastic neoprene fabric that is compatible with the Velcro Hook for attaching the SWAG Transmitter. |

Freedom-8A and Freedom-4A Trial Lead (Trial Lead Kit)

| Freedom-8A Trial Lead, Freedom-4A Trial Lead | A polyurethane (Pellethane 55D) casing with an embedded receiver, flexible circuit board and electrodes (Platinum Iridium 90:10) that is placed next to peripheral nerves in the extremities and torso. The Freedom-8A Trial Lead has eight (8) electrodes, and the Freedom-4A Trial Lead has four (4) electrodes. |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stylet(s) | A stainless steel wire with a polypropylene handle that is inserted into the open central lumen of the stimulator to provide rigidity during implantation. Two (2) stylets are provided in the Trial Lead Kit, one straight and one bent each with a diameter of 0.25 mm. |
| Needle and Cannula | A 16-gauge stainless steel needle that is packaged inserted in the fluorinated ethylene propylene (FEP) Cannula that acts as a conduit for passage of the Stimulator next to the peripheral nerve. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow pathway in tissue for the Stimulator to pass through easily. The manufacturer of the guidewire is Guidewire Technologies. |

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for StimQ. The logo has the word "stim" in a dark blue font, followed by a green "Q" that is stylized to look like a magnifying glass. Behind the word and the "Q" are three curved lines that are also dark blue. The curved lines are meant to represent radio waves.

# 6. Indication for Use Statement

The StimO Peripheral Nerve Stimulator (PNS) 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 StimQ PNS System is not intended to treat pain in the craniofacial region. The StimQ Trial Lead Kit is only used in conjunction with the StimQ Stimulator Receiver Kit. 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.

### 7. Substantial Equivalence Discussion

The following table compares the StimQ PNS System to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. Stimwave physically measured Medtronic and ANS predicate devices to obtain the values listed in Table 5A.

| Comparator | StimQ PNS<br>System | Stimwave<br>Freedom<br>SCS System<br>(K150517) | Stimwave<br>Freedom<br>SCS System<br>(K141399) | Medtronic<br>Mattrix<br>3271/3272<br>(K934065) | Medtronic<br>Xtrel, Model<br>Number<br>3425<br>(K883780) | ANS Renew<br>(K000852) |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GZF | GZB | GZB | GZB and<br>GZF | GZB | GZB and<br>GZF |
| Regulation No. | 882.5870 | 882.5880 | 882.5880 | 882.5880 &<br>882.5870 | 882.5880 | 882.5880 &<br>882.5870 |
| Regulation Name | Stimulator,<br>Peripheral<br>Nerve,<br>Implanted<br>(Pain Relief) | Stimulator,<br>Spinal-Cord,<br>Implanted<br>(Pain Relief) | Stimulator,<br>Spinal-Cord,<br>Implanted<br>(Pain Relief) | Stimulator,<br>Spinal-Cord,<br>Implanted<br>(Pain Relief)<br>Stimulator,<br>Peripheral<br>Nerve,<br>Implanted<br>(Pain Relief) | Stimulator,<br>Spinal-Cord,<br>Implanted<br>(Pain Relief) | Stimulator,<br>Spinal-Cord,<br>Implanted<br>(Pain Relief)<br>Stimulator,<br>Peripheral<br>Nerve,<br>Implanted<br>(Pain Relief) |
| Intended Use | Stimulation<br>of peripheral<br>nerves for<br>chronic,<br>intractable<br>pain of<br>peripheral<br>nerve origin | Stimulation<br>of spinal cord<br>for chronic,<br>intractable<br>pain of trunk<br>and lower<br>limbs | Stimulation<br>of spinal cord<br>for chronic,<br>intractable<br>pain of trunk<br>and lower<br>limbs | Stimulation<br>of spinal cord<br>for chronic,<br>intractable<br>pain of trunk<br>and lower<br>limbs; and<br>peripheral<br>nerve origin | Stimulation<br>of spinal cord<br>for chronic,<br>intractable<br>pain of trunk<br>and lower<br>limbs | Stimulation<br>of spinal cord<br>for chronic,<br>intractable<br>pain of trunk<br>and lower<br>limbs; and<br>peripheral<br>nerve origin |
| Implant Site | Peripheral<br>nerves,<br>excluding<br>craniofacial<br>region | Epidural<br>space, L5 to<br>T5 | Epidural<br>space, L5 to<br>T5 | Epidural<br>space, L5 to<br>T5;<br>Peripheral<br>nerves,<br>excluding<br>craniofacial<br>region | Epidural<br>space, L5 to<br>T5 | Epidural<br>space, L5 to<br>T5;<br>Peripheral<br>nerves,<br>excluding<br>craniofacial<br>region |
| Comparator | StimQ PNS<br>System | Stimwave<br>Freedom<br>SCS System<br>(K150517) | Stimwave<br>Freedom<br>SCS System<br>(K141399) | Medtronic<br>Mattrix<br>3271/3272<br>(K934065) | Medtronic<br>Xtrel, Model<br>Number<br>3425<br>(K883780) | ANS Renew<br>(K000852) |
| Environmental | Hospital,<br>Home | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ |
| Intended<br>Clinician | Orthopedic,<br>Neurosurgeon,<br>Anesthesiologist | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ |
| Intended User | Layperson | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ |
| Electrode<br>Material | Platinum-<br>iridium 90:10 | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ |
| Stimulator Body<br>Material | Polyurethane<br>2363-55D | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ |
| Cable Features | Multi-lumen<br>Tube | Multi-lumen<br>Tube | Multi-lumen<br>Tube | Coiled Wires | Coiled Wires | Braided Wire |
| Stimulator<br>Length | 45 cm | 45 cm | 45 cm | 30 to 110 cm | 30 to 110 cm | 30 and 60 cm |
| Diameter | 1.35 mm | 1.35 mm | 1.35 mm | 1.3 mm | 1.3 mm | 1.37 mm |
| Electrode Array<br>Length | 24 mm<br>52 mm | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ |
| No. of Electrodes | 4 or 8 | 4 or 8 | 4 | 4 | 4 | 4 or 8 |
| Electrode Length | 3.0 mm | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ |
| Electrode<br>Spacing | 4.0 mm | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ |
| Electrode<br>Surface Area | 12.72 mm² | 12.72 mm² | 12.72 mm² | 12.25 mm² | 12.25 mm² | "Approx. 13<br>mm²" |
| Method of<br>Introduction | Percutaneous | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ |
| Tissue Contact | Yes | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ |
| Sterilization | Ethylene<br>Oxide (EO) | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ |
| Labeling | Labeled as<br>Sterile,<br>Single Use,<br>Prescription<br>Device | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ |
| Package | Backer card<br>and two<br>sterile<br>pouches | Blister<br>Tray/Tyvek<br>Lid | Blister<br>Tray/Tyvek<br>Lid | Blister<br>Tray/Tyvek<br>Lid | Blister<br>Tray/Tyvek<br>Lid | Blister<br>Tray/Tyvek<br>Lid |
| Pulse Frequency | 5 to 1500<br>Hertz | 2 to 1500<br>Hertz | 2 to 1500<br>Hertz | 5 to 240<br>Hertz | 5 to 1400<br>Hertz | 10 to 1500<br>Hertz |
| Pulse Width | 50 to 500<br>microseconds | 50 to 500<br>microseconds | 50 to 500<br>microseconds | 50 to 500<br>microseconds | 50 to 1000<br>microseconds | 50 to 500<br>microseconds |
| Current/Voltage<br>Regulated | Current | Current | Current | Voltage | Voltage | Current |
| Output Voltage<br>(300 Ω) | 0 to 4.1 V | 0 to 4.1 V | 0 to 6.3 V | 0 to 7 V | 0 to 5.4 V | 0 to 5.7 V |
| Output Voltage<br>(500 Ω) | 0 to 6.4 V | 0 to 6.4 V | 0 to 7.2 V | 0 to 10.8 V | 0 to 7.1 V | 0 to 7.6 V |
| Output Voltage<br>(800 Ω) | 0 to 7.5 V | 0 to 7.5 V | 0 to 8.0 V | 0 to 11.6 V | 0 to 8.4 V | 0 to 9.6 V |
| Output Current<br>(300 Ω) | 0 to 13.5 mA | 0 to 13.5 mA | 0 to 21 mA | 0 to 23.3 mA | 0 to 18.0 mA | 0 to 19.0 mA |
| Comparator | StimQ PNS<br>System | Stimwave<br>Freedom<br>SCS System<br>(K150517) | Stimwave<br>Freedom<br>SCS System<br>(K141399) | Medtronic<br>Mattrix<br>3271/3272<br>(K934065) | Medtronic<br>Xtrel, Model<br>Number<br>3425<br>(K883780) | ANS Renew<br>(K000852) |
| Output Current<br>(500 Ω) | 0 to 12.8 mA | 0 to 12.8 mA | 0 to 15 mA | 0 to 21.6 mA | 0 to 14.2 mA | 0 to 15.2 mA |
| Output Current<br>(800 Ω) | 0 to 9.4 mA | 0 to 9.4 mA | 0 to 10 mA | 0 to 14.5 mA | 0 to 10.5 mA | 0 to 12.0 mA |
| Waveform | Charge<br>Balanced<br>(delayed)<br>Biphasic<br>asymmetrical | Charge<br>Balanced<br>(delayed)<br>Biphasic<br>asymmetrical | Charge<br>Balanced<br>(delayed)<br>Biphasic<br>asymmetrical | Charge<br>Balanced<br>Biphasic<br>asymmetrical | Charge<br>Balanced<br>Biphasic<br>asymmetrical | Charge<br>Balanced<br>(delayed)<br>Biphasic<br>asymmetrical |
| Pulse Shape | Decaying<br>Exponential | Decaying<br>Exponential | Decaying<br>Exponential | Decaying<br>Exponential | Decaying<br>Exponential | Decaying<br>Exponential |
| Average Current<br>Density (300 Ω) | 105.0 mA/cm² | 105.0 mA/cm² | 111.6 mA/cm² | 175.0 mA/cm² | 125.8 mA/cm² | 117.7 mA/cm² |
| Average Current<br>Density (500 Ω) | 95.1 mA/cm² | 95.1 mA/cm² | 96.7 mA/cm² | 151.7 mA/cm² | 101.7 mA/cm² | 103.1 mA/cm² |
| Average Current<br>Density (800 Ω) | 69.0 mA/cm² | 69.0 mA/cm² | 77.0 mA/cm² | 106.7 mA/cm² | 75.8 mA/cm² | 86.2 mA/cm² |
| Maximum Phase<br>Charge* (300 Ω) | 6.8 µC/pulse | 6.8 µC/pulse | 10.5 µC/pulse | 11.7 µC/pulse | 18.0 µC/pulse | 9.5 µC/pulse |
| Maximum Phase<br>Charge* (500 Ω) | 6.4 µC/pulse | 6.4 µC/pulse | 7.2 µC/pulse | 10.8 µC/pulse | 14.2 µC/pulse | 7.6 µC/pulse |
| Maximum Phase<br>Charge* (800 Ω) | 4.7 µC/pulse | 4.7 µC/pulse | 5.0 µC/pulse | 7.3 µC/pulse | 10.5 µC/pulse | 6.0 µC/pulse |
| Maximum Charge<br>Density* (300 Ω) | 53.1 µC/cm² | 53.1 µC/cm² | 82.5 µC/cm² | 97.2 µC/cm² | 150.0 µC/cm² | 73.1 µC/cm² |
| Maximum Charge<br>Density* (500 Ω) | 50.3 µC/cm² | 50.3 µC/cm² | 56.6 µC/cm² | 90.0 µC/cm² | 118.3 µC/cm² | 58.5 µC/cm² |
| Maximum Charge<br>Density* (800 Ω) | 36.9 µC/cm² | 36.9 µC/cm² | 39.3 µC/cm² | 60.4 µC/cm² | 87.5 µC/cm² | 46.2 µC/cm² |
| Maximum<br>Current Density*<br>(300 Ω) | 106.1 mA/cm² | 106.1 mA/cm² | 165.1 mA/cm² | 194.4 mA/cm² | 150.0 mA/cm² | 146.2 mA/cm² |
| Maximum<br>Current Density*<br>(500 Ω) | 100.6 mA/cm² | 100.6 mA/cm² | 113.2 mA/cm² | 180.0 mA/cm² | 118.3 mA/cm² | 116.9 mA/cm² |
| Maximum<br>Current Density*<br>(800 Ω) | 73.9 mA/cm² | 73.9 mA/cm² | 78.6 mA/cm² | 120.8 mA/cm² | 87.5 mA/cm² | 92.3 mA/cm² |
| Net Charge | 0 µC | 0 µC | 0 µC | 0 µC | 0 µC | 0 µC |
| Average Phase<br>Power (300 Ω) | 0.053 W/phase | 0.053 W/phase | 0.060 W/phase | 0.132 W/phase | 0.068 W/phase | 0.070 W/phase |
| Average Phase<br>Power (500 Ω) | 0.073 W/phase | 0.073 W/phase | 0.076 W/phase | 0.166 W/phase | 0.074 W/phase | 0.090 W/phase |
| Average Phase<br>Power (800 Ω) | 0.062 W/phase | 0.062 W/phase | 0.060 W/phase | 0.131 W/phase | 0.066 W/phase | 0.100 W/phase |
| Average Phase<br>Power Density<br>(300 Ω) | 0.42 W/cm²/phase | 0.42 W/cm²/phase | 0.48 W/cm²/phase | 1.10 W/cm²/phase | 0.57 W/cm²/phase | 0.54 W/cm²/phase |
| Average Phase<br>Power Density<br>(500 Ω) | 0.58 W/cm²/phase | 0.58 W/cm²/phase | 0.59 W/cm²/phase | 1.38 W/cm²/phase | 0.62 W/cm²/phase | 0.69 W/cm²/phase |
| Average Phase<br>Power Density<br>(800 Ω) | 0.48 W/cm²/phase | 0.48 W/cm²/phase | 0.60 W/cm²/phase | 1.09 W/cm²/phase | 0.55 W/cm²/phase | 0.77 W/cm²/phase |
| Comparator | StimQ PNS<br>System | Stimwave<br>Freedom<br>SCS System<br>(K150517) | Stimwave<br>Freedom<br>SCS System<br>(K141399) | Medtronic<br>Mattrix<br>3271/3272<br>(K934065) | Medtronic<br>Xtrel, Model<br>Number<br>3425<br>(K883780) | ANS Renew<br>(K000852) |
| Pulse Delivery<br>Mode | Continuous | Continuous | Continuous | Continuous | Continuous | Continuous |
| ON/OFF Times | No Cycling | No Cycling | No Cycling | ON/OFF<br>Cycling<br>Option | ON/OFF<br>Cycling<br>Option | No Cycling |
| Current Path<br>Options | Bipolar | Bipolar | Bipolar | Bipolar | Bipolar | Bipolar |
| Power Delivery | Coupled<br>receiver built<br>into Stimulator<br>body | Same as<br>StimQ | Same as<br>StimQ | Coupled<br>receiver,<br>hardwired<br>connector | Coupled<br>receiver,<br>hardwired<br>connector | Coupled<br>receiver,<br>hardwired<br>connector |
| Transmit<br>Frequency | 915 MHz | 915 MHz | 915 MHz | 2 MHz | 1.60 MHz | 2 MHz |
| Material | Platinum-<br>iridium<br>90:10,<br>Polyurethane<br>2363-55D | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ |
| Sterile | Yes -<br>ethylene<br>oxide | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ | Same as<br>StimQ |
| Single-Use | Yes | Yes | Yes | Yes | Yes | Yes |
| Shelf Life | 2 year | 2 year | 1 year | 1 year | 1 year | 2 years |
| Complies with<br>ISO 10993-1 | Yes | Yes | Yes | Yes | Yes | Yes |
| Safety Testing<br>Passed | Yes | Yes | Yes | Yes | Yes | Yes |

Table 5A. Comparison of Characteristics

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for "stimQ". The word "stim" is written in a dark blue sans-serif font. The "Q" is green and stylized to look like a magnifying glass. Behind the word is a series of curved lines that resemble radio waves, also in dark blue.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for "stimQ". The word "stim" is in blue, and the "Q" is in green. To the right of the word is a graphic of concentric blue circles, which appear to be emanating from the "Q".

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for StimQ. The logo features the word "stim" in dark blue, followed by a green letter "Q" that is shaped like a magnifying glass. Behind the word and the "Q" are three curved lines in dark blue, resembling sound waves or radio waves emanating from the "Q".

(*) asterisk denotes that formulas were used for the calculations.

### 8. Biocompatibility Data

The StimO PNS System uses the same stimulator as the Stimwave Freedom SCS System. Thus, the materials of the StimQ PNS System remain unchanged from the Freedom SCS System (K150517 and K141399). The biocompatibility tests conducted on representative subassemblies of the Freedom SCS System (Freedom-4, K141399) directly apply to the StimQ PNS System. The materials, construction and intended use of the StimQ PNS System is comparable to the predicate device, and have a long history of safety with respect to biocompatibility. The biological safety of the Stimulator 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 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 the StimQ PNS System. The Freedom-8A/4A Stimulator 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 SWAG is intended to be

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for StimQ. The logo features the word "stim" in blue, followed by a green letter "Q" that is stylized to resemble a magnifying glass. Behind the "Q" are three curved blue lines that emanate outward, suggesting sound waves or a signal. The overall design is clean and modern, using a combination of text and graphic elements to represent the brand.

on top of an article of clothing. The User Manual provided to the patient describes that the SWAG should always be worn on top of a layer of clothing. The SWAG does not come into contact with the patient's skin. The categorization by nature of body contact of the SWAG is thus "non-contacting device", and not included in the scope of ISO 10993-1:2009. The StimQ PNS System (similar in form to the Freedom SCS System, K141399 and K150517) meets biological safety and compatibility requirements of ISO 10993-1:2009 and Blue Book Memorandum G95-1.

# 9. Non-Clinical Performance Data

The StimQ PNS System was tested to verify that the performance meets the system design requirements as well as all applicable voluntary standards. The StimQ PNS System complies with all design requirements and applicable voluntary standards.

AAMI ANSI ISO 14708-3:2008 - For protection from temperature change including shipping and storage temperature ranges, the StimQ Stimulator was functional, receiving a safe rating following post visual inspection and passed the change of temperature testing performed as specified by AAMI ANSI ISO 14708-3:2008. For atmospheric pressure change, the StimO Stimulator was functional following post testing functionality inspection and passed atmospheric pressure change testing as specified by AAMI ANSI ISO 14708-3:2008.

For testing external defibrillation exposure, the StimQ Stimulator was verified as functional after exposure to external defibrillation. Thus, the StimQ Stimulator complies with testing as specified by AAMI ANSI ISO 14708-3:2008.

Following the thermal shock testing, the StimQ Stimulator was found to have "no irreversible damage" and fully functional as specified by the manufacturer, and to have no physical anomalies present at the time of inspection. Thus, the StimQ Stimulator complies with the thermal shock design requirements and the applicable standard.

For leakage current testing, the StimQ Stimulator produced zero leakage current on all tested paths for all tested samples. Thus, the StimQ Stimulator complies with the leakage design requirements and the applicable standard.

For testing the insertion and withdrawal of the stimulator within the stylet, the StimQ Stimulator was found to require less than 2.5N of insertion or withdrawal force for all tested stylets in all tested stimulator samples. Visual inspection confirmed no damage was present in any stimulator samples. Thus, the StimO Stimulator complies with design specifications for stylet insertion and withdrawal force.

For mechanical testing, the StimQ Stimulator passed all criteria of the test, showing no visible damage to the stimulator body or functional damage to the components. Mechanical testing included tensile testing, flex testing and torsion testing. Thus, the StimO Stimulator complies with all stimulator mechanical design requirements.

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for StimQ. The logo features the word "stim" in blue, followed by a green letter "Q" that is shaped like a magnifying glass. Behind the word and letter is a series of blue concentric arcs, resembling sound waves or radio waves. The logo is simple and modern, using a combination of text and graphic elements to represent the company.

IEC 60601-1 - For testing the external unit for protection from temperature change, including shipping and storage temperature ranges, the external unit met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Thus, the external unit of the StimO PNS System satisfies the outlined protection from temperature change design requirements and the applicable standard, IEC 60601-1. For atmospheric pressure change testing, the external unit met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Thus, the external unit of the StimO PNS System satisfies the outlined atmospheric pressure change design requirements and the applicable standard, IEC 60601-1. For the push, drop, and impact testing of the external unit, it was determined through testing that the external unit is robust to withstand expected damage in accordance with general safety standards. The external unit met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Thus, the SWAG component of the StimQ PNS System satisfies the outlined push, drop, and impact, design requirements and the applicable standard, IEC 60601-1. For the identification, marking and documents of the external unit it was determined through an analysis of the labeling that the external unit complies with the requirements of the standard. All requirements and markings are clearly identified and viewable either from the external case of the product or from within the accompanying documents. For the means of protection, creepage distances, and air clearances of the external unit it was determined through an analysis of the design that the system satisfies the requirements of the applicable standard, IEC 60601-1.

IEC 60529 - For testing the ingress of water, the external unit met the passing criteria of both of the visual and functional inspections f…