(87 days)
No
The document describes a traditional electrical stimulation device and does not mention any AI or ML components or capabilities.
Yes
Explanation: The device is indicated for "pain management" and "provides therapeutic relief for chronic, intractable pain," directly stating its therapeutic purpose.
No
Explanation: The device is a stimulator intended for pain management, not for diagnosing a condition. It provides therapeutic relief rather than identifying or characterizing a disease.
No
The device description explicitly states the system is comprised of implantable stimulators, a receiver component, and an externally worn transmitter, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- StimQ System Function: The StimQ Peripheral Nerve Stimulator System is an implanted device that uses electrical stimulation to manage pain. It directly interacts with the patient's body and 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.
- Device Description: The description details an implantable stimulator, receiver, and external transmitter, all components of a therapeutic device, not an in vitro diagnostic test.
Therefore, the StimQ Peripheral Nerve Stimulator System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
GZF
Device Description
This submission builds upon the existing StimQ product family by incorporating identical products from other regulatory submissions (cleared) for use in peripheral pain indications:
- A. Freedom Spinal Cord Stimulator (SCS) System, K170141:
- Wearable Antenna Assembly (WAA) known in this submission as the i. StimQ Wearable Antenna Gear (SWAG);
- ii. WaveCrest software;
- iii. Use of the Receivers/RF Stylets:
- iv. Battery Charger;
- V. Contract sterilizer;
- vi. Kitting options.
- B. StimO PNS System, K152178:
- i. Freedom-4A and Freedom-8A Stimulators;
- ii. SWAG Accessory Kits.
The StimQ Stimulator presented in this submission is identical to the Freedom-4A Stimulator (K150517, K152178, K160600, K162161 and K170141) with a minor design modification to add tines to the body of the stimulator for migration mitigation.
This submission also includes performance testing to support MR Conditional Labeling for the Freedom-4A Stimulator with Receiver as well as the StimQ Stimulator with Receiver.
The SWAG Transmitting (Tx) Antenna utilizes a lightweight, flexible dipole antenna identical in functionality to the Tx Antenna of K170141, but designed to be mindful of peripheral indications (arms, ankles, etc.).
The StimQ LLC (StimQ) StimQ Peripheral Nerve Stimulator System (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 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, Freedom-4A or Stim(), receiver component (Receiver/RF Stylet), 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.
Receiver Kit
| StimQ Stimulator | Freedom-8A, A polyurethane (Pellethane 55D) casing with an embedded receiver, Freedom-4A, flexible circuit board and electrodes (Platinum Iridium 90:10) that is placed next to peripheral nerves in the extremities and torso. The Freedom-8A Stimulator has eight (8) electrodes, while the Freedom-4A and StimQ Stimulators each have four (4) electrodes. Freedom-8A and Freedom-4A Stimulators are identical to K152178 and K170141. The StimQ Stimulator is identical to Freedom-4A in terms of function, with the addition of polyurethane (Pellethane 55D) tines proximal to the electrodes. |
| Receiver | A copper and PEEK cable with dual couplers; placed within the center lumen of the Stimulator with the distal end combination of Receiver and Stimulator being placed under the skin. Two (2) Receivers are provided with each kit. Identical to K170141. |
| Stylet | A stainless steel wire with a polypropylene handle that is inserted into the open central lumen of the stimulator to provide rigidity during implantation. One (1) bent stylet is provided in the Receiver Kit. Identical to K170141. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow pathway for the Stimulator to pass through easily. Identical to K152178 and K170141. |
| Introducer Assembly | A 15-gauge stainless steel dilator and yellow Hytrel introducer assembly that is used to create a pathway for the stimulator to be placed next to peripheral nerves for the Stimulator to pass through easily. Functionally identical to the Needle and Cannula Assembly of K152178. |
SWAG Transmitter Kit
SWAG The WAA housing includes the following components:
- A. Microwave Field Stimulator (MFS) A printed circuit board (PCB) that generates RF power with embedded waveform parameter settings and switches for changing parameter settings as needed by the user. Identical to K170141:
- 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 as well as interpret device power status (On. Off. Charging, Transmitting, and Bluetooth® Connection). Identical to K152178 and K170141;
- C. Battery Assembly A battery and wire assembly for charging and the MFS for power delivery. Identical to K170141.
Transmitting (Tx) Antenna Assembly - An antenna and coaxial cable assembly that is attached to the SWAG that is used to transmit microwave energy to the implanted Stimulator. Similar in form and function to the Tx Antenna of K170141, but a smaller form factor. Similar in form and function to the Tx Antenna of K170141, but a smaller form factor
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 SWAG Transmitter. Identical to K152178. |
| 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 SWAG Transmitter. Identical to K152178. |
| 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 the SWAG Transmitter. Identical to K152178. |
| 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 SWAG Transmitter. Identical to K152178. |
| 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 SWAG Transmitter. Identical to K152178. |
Charger Kit
| Battery Charger | An off-the-shelf battery charger that uses a power adapter and USB to micro-USB cable to recharge the encased lithium ion battery of the SWAG Transmitter. Identical to K170141. |
Spare Lead Kit
| Freedom-8A, Freedom-4A, StimQ Spare 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 Spare Lead has eight (8) electrodes, while the Freedom-4A and StimQ Spare Leads each have four (4) electrodes. Freedom-8A and Freedom-4A Spare Leads are identical to K170141. The StimQ Stimulator is identical to Freedom-4A in terms of function, with the addition of polyurethane (Pellethane 55D) tines proximal to the electrodes. |
| RF Stylet | A copper and PEEK cable with dual couplers; placed within the center lumen of the Spare Lead with the distal end combination of RF Stylet and Spare Lead being placed under the skin. Two (2) RF Stylets are provided with each kit. Identical to K170141. |
| Stylet | A stainless steel wire with a polypropylene handle that is inserted into the open central lumen of the stimulator to provide rigidity during implantation. One (1) bent stylet is provided in the Receiver Kit. Identical to K170141. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow pathway for the Spare Lead to pass through easily. Identical to K152178 and K170141. |
| Introducer Assembly | A 15-gauge stainless steel dilator and yellow Hytrel introducer assembly that is used to create a pathway for the stimulator to be placed next to peripheral nerves for the Stimulator to pass through easily. Functionally identical to the Needle and Cannula Assembly of K152178. |
Trial Lead Kit
| Freedom-8A, 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. Identical to K152178 and K170141. |
| RF Stylet | A copper and PEEK cable with dual couplers; placed within the center lumen of the Freedom-8A or Freedom-4A Trial Lead with the distal end combination of RF Stylet and Trial Lead being placed under the skin. Two (2) RF Stylets are provided with each kit. Identical to K170141. |
| Stylet | A stainless steel wire with a polypropylene handle that is inserted into the open central lumen of the stimulator to provide rigidity during implantation. One (1) bent stylet is provided in the Receiver Kit. Identical to K170141. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow pathway for the Stimulator to pass through easily. Identical to K152178 and K170141. |
| Introducer Assembly | A 15-gauge stainless steel dilator and yellow Hytrel introducer assembly that is used to create a pathway for the stimulator to be placed next to peripheral nerves for the Stimulator to pass through easily. Functionally identical to the Needle and Cannula Assembly of K152178. |
Sterile Revision Kit
| Stylet | A stainless steel wire with a polypropylene handle that is inserted into the open central lumen of the stimulator to provide rigidity during implantation. One (1) bent stylet is provided in the Receiver Kit. Identical to K170141. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow pathway for the Stimulator to pass through easily. Identical to K152178 and K170141. |
| Introducer Assembly | A 15-gauge stainless steel dilator and yellow Hytrel introducer assembly that is used to create a pathway for the stimulator to be placed next to peripheral nerves for the Stimulator to pass through easily. Functionally identical to the Needle and Cannula Assembly of K152178. |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral nerves, excluding craniofacial region. Limbs and torso.
Indicated Patient Age Range
Adults
Intended User / Care Setting
Intended Clinician: Orthopedic, Neurosurgeon, Anesthesiologist
Intended User: Layperson
Environmental Use: Hospital, Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No modifications were made to the components of K170141 (Freedom-8A/4A Stimulators, SWAG, WaveCrest, Battery Charger, Sterilization, Kitting Options) in support of the device safety and performance of this submission. The StimQ PNS System testing is leveraged from prior cleared premarket notifications where components were 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 Stimulators were 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 Stimulators were functional following post testing functionality inspection and passed atmospheric pressure change testing as specified by AAMI ANSI ISO 14708-3:2008. This testing presented for this submission is leveraged from K170141 and K141399, and is directly applicable for demonstration of device safety and efficacy as the packaging and the Stimulators remains the same. The Receiver/RF Stylet is a passive component that does not impact the outcome of the leveraged tests for safety and effectiveness.
For testing external defibrillation exposure, the Stimulator and Receiver were verified as functional after exposure to external defibrillation. Thus, the StimQ PNS System complies with testing as specified by AAMI ANSI ISO 14708-3:2008. The Receiver/RF Stylet testing presented for this submission is leveraged from K170141. and is directly applicable for demonstration of device safety and efficacy as Receiver/RF Stylet remains the same.
Following the thermal shock testing, the Stimulators were 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 Stimulators comply with the thermal shock design requirements and the applicable standard. This testing presented for this submission is leveraged from K170141, and is directly applicable for demonstration of device safety and efficacy as the Stimulators remains the same. The Receiver/RF Stylet is a passive component that does not impact the outcome of the leveraged tests for safety and effectiveness.
For leakage current testing, the Stimulators produced zero leakage current on all tested paths for all tested samples. Thus, the Stimulators comply with the leakage design requirements and the applicable standard. This testing presented for this submission is leveraged from K170141 and K141399, and is directly applicable for demonstration of device safety and efficacy as the Stimulators remains the same. The Receiver/RF Stylet is a passive component that does not impact the outcome of the leveraged tests for safety and effectiveness.
For testing the insertion and withdrawal of the stylet within the Stimulator, the stylet was found to require less than 2.5N of insertion or withdrawal force for all tested stylets in all tested stimulator samples. For testing the insertion and withdrawal of the Receiver within the Stimulator, the Receiver/RF Stylet was found to require less than 2.2N 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 Stimulator and Receiver/RF Stylet comply with design specifications for stylet insertion and withdrawal force. The Stimulator testing presented for this submission is leveraged from K170141 and K141399, and is directly applicable for demonstration of device safety and efficacy as the Stimulators remains the same. The Receiver/RF Stylet testing presented for this submission is leveraged from K170141, and is directly applicable for demonstration of device safety and efficacy, as Receiver/RF Stylet remains the same.
For mechanical testing, the Stimulators 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 and torsion testing. Thus, the Stimulators comply with all stimulator mechanical design requirements. This testing presented for this submission is leveraged from K170141 and K141399, and is directly applicable for demonstration of device safety and efficacy as the Stimulators remains the same. The Receiver/RF Stylet is a passive component that does not impact the outcome of the leveraged tests for safety and effectiveness.
For magnetic resonance imaging (MRI) radio frequency (RF) induced heating as related to specific absorbance rate (SAR), the Freedom-4A and StimO Stimulator produced a maximum temperature increase lower than the allowable limit for the 1.5T MRI procedure and thus passed the 1.5T testing. The Freedom-4A and Stimulator produced a maximum temperature increase lower than the allowable limit for the 1.5T MRI procedure and thus passed both.
ASTM F2182-11a - In accordance with F2182-11a - American Society for Testing and Materials (ASTM) International Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging, the Freedom-4A Stimulator showed that its presence would not cause injury to the patient with the implant during an MRI procedure. The Freedom-4A (StimQ) Stimulator with Receiver is a passive implant that is not powered while the external unit is not transmitting to it.
IEC 60601-1 - The SWAG was tested for compliance with IEC 60601-1. For testing the SWAG for protection from temperature change, including shipping and storage temperature ranges, the SWAG 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 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 SWAG 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 of the StimQ PNS System satisfies the outlined atmospheric pressure change design requirements and the applicable standard, IEC 60601-1. For the push, drop, impact and mold stress relief testing of the SWAG, it was determined through testing that the SWAG is robust to withstand expected damage in accordance with general safety standards. The SWAG 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 StimO PNS System 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 the SWAG it was determined through an analysis of the labeling that the SWAG 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 SWAG it was determined through an analysis of the design that the system satisfies the requirements of the applicable standard, IEC 60601-1. This testing presented for this submission is leveraged from K170141 and is directly applicable for demonstration of device safety and efficacy as the SWAG, identical to the WAA of K170141, remains the same.
IEC 60529 - The SWAG was tested for compliance with IEC 60529. For testing the ingress of water, the SWAG 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 Ingress of Water design requirements and the applicable standard IEC 60529. For particulate matter testing, the SWAG 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 Particulate Matter design requirements and the applicable standard. IEC 60529. This testing presented for this submission is leveraged from K170141 and is directly applicable for demonstration of device safety and efficacy as the SWAG, identical to the WAA of K170141, remains the same.
IEC 60601-1-2 - The SWAG was tested for compliance with IEC 60601-1-2. For testing the SWAG for electromagnetic compatibility, the unit met all acceptance criteria for emissions, low-frequency magnetic fields, immunity, electrostatic discharge, radiated RF electromagnetic fields, electrical fast transients and magnetic fields. The SWAG operated within all test limits and showed no physical damage and was fully operational. Thus, the SWAG for the StimO PNS System satisfies the IEC 60601-1-2 standard. This testing presented for this submission is leveraged from K170141 and is directly applicable for demonstration of device safety and efficacy as the SWAG, identical to the WAA of K170141, remains the same.
The StimQ PNS System complies with the applicable standards for neurostimulators, electrical safety, electromagnetic interference and compatibility, packaging, and sterilization. The software of the StimQ PNS System passed all verification tests outlined and the design requirements for Software Verification have been met. The device passed all the testing in accordance with national and international standards. This testing presented for this submission is leveraged from K170141 and is directly applicable for demonstration of device safety and efficacy as the StimQ PNS System remains the same.
Following performance testing. it has been determined that the StimO PNS System is substantially equivalent to legally marketed predicate devices for the therapeutic relief for chronic, intractable pain of peripheral nerve origin.
Due to the similarities between the legally marketed predicate devices (K170141 and K152178), and the StimO PNS System (this submission), StimO has leveraged applicable performance testing in addition to completed a number of tests that demonstrates substantial equivalence to the legally marketed predicate devices. The StimO PNS System meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety confirms that the output meets the design inputs and specifications. The StimO PNS System passed all testing stated above as shown by the acceptable results obtained.
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 this submission supports the substantial equivalence of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Stimwave Freedom SCS System FR8A/FR4A, PDBT-915-2A (K170141); StimO PNS System, K152178; Freedom-4A Stimulator (K150517, K152178, K160600, K162161 and K170141); K141399
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).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 4, 2017
Stimwave Technologies Incorporated % Elizabeth Greene Vice President of Ouality Assurance and Regulatory Affairs 901 East Las Olas Boulevard . Suite 201 Fort Lauderdale, Florida 33301
Re: K171366
Trade/Device Name: StimO Peripheral Nerve Stimulator System Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZF Dated: July 14, 2017 Received: July 19, 2017
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. 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 of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
William J. Heetderks -S 2017.08.04 13:20:28 -04'00'
- 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)
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Image /page/3/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". To the right of the text, there are three concentric semi-circles in dark blue, resembling sound waves or a signal emanating from the "Q". The green "Q" is partially integrated into the semi-circles, creating a visual connection between the text and the wave-like graphic.
510(k) Summary for StimQ Peripheral Nerve Stimulator (PNS) System
1. Submission Sponsor
Stimwave Technologies Incorporated, DBA 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
May 5, 2017
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: | Class II |
| Classification Panel: | Neurology |
4. Legally Marketed Predicate Device(s)
StimQ PNS System FR8A/FR4A, PDBT-915-1A (K152178) Stimwave Freedom SCS System FR8A/FR4A, PDBT-915-2A (K170141)
5. Device Description
This submission builds upon the existing StimQ product family by incorporating identical products from other regulatory submissions (cleared) for use in peripheral pain indications:
- A. Freedom Spinal Cord Stimulator (SCS) System, K170141:
- Wearable Antenna Assembly (WAA) known in this submission as the i. StimQ Wearable Antenna Gear (SWAG);
- ii. WaveCrest software;
- iii. Use of the Receivers/RF Stylets:
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Image /page/4/Picture/0 description: The image shows the logo for stimQ. The logo features the word "stim" in dark blue font, followed by a green letter "Q" that is stylized to resemble a magnifying glass. Behind the "Q" are several concentric semi-circles in dark blue, resembling sound waves or radar signals. The overall design is clean and modern, suggesting a focus on technology or research.
- iv. Battery Charger;
- V. Contract sterilizer;
- vi. Kitting options.
- B. StimO PNS System, K152178:
- i. Freedom-4A and Freedom-8A Stimulators;
- ii. SWAG Accessory Kits.
The StimQ Stimulator presented in this submission is identical to the Freedom-4A Stimulator (K150517, K152178, K160600, K162161 and K170141) with a minor design modification to add tines to the body of the stimulator for migration mitigation.
This submission also includes performance testing to support MR Conditional Labeling for the Freedom-4A Stimulator with Receiver as well as the StimQ Stimulator with Receiver.
The SWAG Transmitting (Tx) Antenna utilizes a lightweight, flexible dipole antenna identical in functionality to the Tx Antenna of K170141, but designed to be mindful of peripheral indications (arms, ankles, etc.).
The StimQ LLC (StimQ) StimQ Peripheral Nerve Stimulator System (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 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, Freedom-4A or Stim(), receiver component (Receiver/RF Stylet), 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.
Receiver Kit
| Freedom-8A, A polyurethane (Pellethane 55D) casing with an embedded receiver, | |
|---|---|
| Freedom-4A, flexible circuit board and electrodes (Platinum Iridium 90:10) that is placed | |
| StimQ | next to peripheral nerves in the extremities and torso. The Freedom-8A |
| Stimulator | Stimulator has eight (8) electrodes, while the Freedom-4A and StimQ |
| Stimulators each have four (4) electrodes. Freedom-8A and Freedom-4A | |
| Stimulators are identical to K152178 and K170141. The StimQ Stimulator | |
| is identical to Freedom-4A in terms of function, with the addition of | |
| polyurethane (Pellethane 55D) tines proximal to the electrodes. | |
| Receiver | A copper and PEEK cable with dual couplers; placed within the center |
| lumen of the Stimulator with the distal end combination of Receiver and | |
| Stimulator being placed under the skin. Two (2) Receivers are provided | |
| with each kit. Identical to K170141. |
5
Image /page/5/Picture/0 description: The image shows the logo for StimQ. The logo features the word "stim" in a simple, lowercase font, followed by a stylized "Q". The "Q" is formed by a green circle with a line extending from the bottom right, resembling a magnifying glass. Behind the "Q" are several concentric, curved lines in blue, suggesting sound waves or a signal.
| Receiver Kit | |
|---|---|
| Stylet | A stainless steel wire with a polypropylene handle that is inserted into the open central lumen of the stimulator to provide rigidity during implantation. One (1) bent stylet is provided in the Receiver Kit. Identical to K170141. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow pathway for the Stimulator to pass through easily. Identical to K152178 and K170141. |
| Introducer Assembly | A 15-gauge stainless steel dilator and yellow Hytrel introducer assembly that is used to create a pathway for the stimulator to be placed next to peripheral nerves for the Stimulator to pass through easily. Functionally identical to the Needle and Cannula Assembly of K152178. |
SWAG Transmitter Kit
SWAG The WAA housing includes the following components:
- A. Microwave Field Stimulator (MFS) A printed circuit board (PCB) that generates RF power with embedded waveform parameter settings and switches for changing parameter settings as needed by the user. Identical to K170141:
- 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 as well as interpret device power status (On. Off. Charging, Transmitting, and Bluetooth® Connection). Identical to K152178 and K170141;
- C. Battery Assembly A battery and wire assembly for charging and the MFS for power delivery. Identical to K170141.
Transmitting (Tx) Antenna Assembly - An antenna and coaxial cable assembly that is attached to the SWAG that is used to transmit microwave energy to the implanted Stimulator. Similar in form and function to the Tx Antenna of K170141, but a smaller form factor. Similar in form and function to the Tx Antenna of K170141, but a smaller form factor
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 SWAG
Transmitter. Identical to K152178. |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 SWAG
Transmitter. Identical to K152178. |
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Image /page/6/Picture/0 description: The image shows the logo for "stimQ". The word "stim" is written in blue, and the "Q" is written in green. Behind the word "stimQ" are several curved lines that resemble radio waves.
SWAG Accessory Kit (each packaged separately)
| 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 the SWAG Transmitter. Identical to K152178. |
|---|---|
| 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 SWAG Transmitter. Identical to K152178. |
| 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 SWAG Transmitter. Identical to K152178. |
Charger Kit
| Battery | An off-the-shelf battery charger that uses a power adapter and USB to |
|---|---|
| Charger | micro-USB cable to recharge the encased lithium ion battery of the |
| SWAG Transmitter. Identical to K170141. |
Spare Lead Kit
| Freedom-8A,
Freedom-4A,
StimQ
Spare 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 Spare Lead has eight (8) electrodes, while the Freedom-4A and StimQ Spare Leads each have four (4) electrodes. Freedom-8A and Freedom-4A Spare Leads are identical to K170141. The StimQ Stimulator is identical to Freedom-4A in terms of function, with the addition of polyurethane (Pellethane 55D) tines proximal to the electrodes. |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| RF Stylet | A copper and PEEK cable with dual couplers; placed within the center lumen of the Spare Lead with the distal end combination of RF Stylet and Spare Lead being placed under the skin. Two (2) RF Stylets are provided with each kit. Identical to K170141. |
| Stylet | A stainless steel wire with a polypropylene handle that is inserted into the open central lumen of the stimulator to provide rigidity during implantation. One (1) bent stylet is provided in the Receiver Kit. Identical to K170141. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow pathway for the Spare Lead to pass through easily. Identical to K152178 and K170141. |
| Introducer
Assembly | A 15-gauge stainless steel dilator and yellow Hytrel introducer assembly that is used to create a pathway for the stimulator to be placed next to peripheral nerves for the Stimulator to pass through easily. Functionally identical to the Needle and Cannula Assembly of K152178. |
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Image /page/7/Picture/0 description: The image is a logo for a company called "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 "Q" are three curved lines, also in dark blue, that resemble sound waves or radio waves emanating from the "Q".
| Trial Lead Kit | |||||
|---|---|---|---|---|---|
| Freedom-8A, | |||||
| 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. Identical | |||||
| to K152178 and K170141. | |||||
| RF Stylet | A copper and PEEK cable with dual couplers; placed within the | ||||
| center lumen of the Freedom-8A or Freedom-4A Trial Lead with | |||||
| the distal end combination of RF Stylet and Trial Lead being | |||||
| placed under the skin. Two (2) RF Stylets are provided with each | |||||
| kit. Identical to K170141. | |||||
| Stylet | A stainless steel wire with a polypropylene handle that is inserted | ||||
| into the open central lumen of the stimulator to provide rigidity | |||||
| during implantation. One (1) bent stylet is provided in the | |||||
| Receiver Kit. Identical to K170141. | |||||
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a | ||||
| hollow pathway for the Stimulator to pass through easily. Identical | |||||
| to K152178 and K170141. | |||||
| Introducer | |||||
| Assembly | A 15-gauge stainless steel dilator and yellow Hytrel introducer | ||||
| assembly that is used to create a pathway for the stimulator to be | |||||
| placed next to peripheral nerves for the Stimulator to pass through | |||||
| easily. Functionally identical to the Needle and Cannula Assembly | |||||
| of K152178. | |||||
| Sterile Revision Kit | |||||
| Stylet | A stainless steel wire with a polypropylene handle that is inserted | ||||
| into the open central lumen of the stimulator to provide rigidity | |||||
| during implantation. One (1) bent stylet is provided in the | |||||
| Receiver Kit. Identical to K170141. | |||||
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a | ||||
| hollow pathway for the Stimulator to pass through easily. Identical | |||||
| to K152178 and K170141. | |||||
| Introducer | |||||
| Assembly | A 15-gauge stainless steel dilator and yellow Hytrel introducer | ||||
| assembly that is used to create a pathway for the stimulator to be | |||||
| placed next to peripheral nerves for the Stimulator to pass through | |||||
| easily. Functionally identical to the Needle and Cannula Assembly |
6. Indication for Use Statement
of K152178.
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
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Image /page/8/Picture/0 description: The image shows the logo for "stimQ". The word "stim" is written in a simple, sans-serif font in a dark blue color. The "Q" is stylized in green and is partially encircled by a series of concentric, curved lines in dark blue, resembling sound waves or a signal emanating from the "Q". The overall design is clean and modern.
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 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 | StimQ PNS System
(This Submission) | StimQ PNS System
(K152178) | Freedom SCS
System (K170141 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Product Code | GZF | Same as StimQ | GZB |
| Regulation No. | 882.5870 | Same as StimQ | 882.5880 |
| Regulation Name | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Same as StimQ | Stimulator, Spinal-Cord, Implanted (Pain Relief) |
| Intended Use | Stimulation of peripheral nerves for chronic, intractable pain of peripheral nerve origin | Same as StimQ | Stimulation of spinal cord for chronic, intractable pain of trunk and lower limbs |
| Implant Site | Peripheral nerves, excluding craniofacial region | Epidural space, L5 to T5 | Epidural space, L5 to T5 |
| Mode of Action | RF wireless transmission of energy to produce stimulation at Stimulator electrodes. SWAG sends a pulsed RF signal on a carrier frequency of 915MHz to the Stimulator | Same as StimQ | Same as StimQ |
| Environmental Use | Hospital, Home | Same as StimQ | Same as StimQ |
| Intended Clinician | Orthopedic, Neurosurgeon, Anesthesiologist | Same as StimQ | Same as StimQ |
| Intended User | Layperson | Same as StimQ | Same as StimQ |
| Electrode Material | Platinum-iridium 90:10 | Same as StimQ | Same as StimQ |
| Stimulator Body Material | Polyurethane 2363-55D | Same as StimQ | Same as StimQ |
| Cable Features | Multi-lumen Tube | Same as StimQ | Same as StimQ |
| Stimulator Length | 45 centimeters | Same as StimQ | Same as StimQ |
| Diameter | 1.35 millimeters | Same as StimQ | Same as StimQ |
| Electrode Array Length | 24 millimeters
52 millimeters | Same as StimQ | Same as StimQ |
| Comparator | StimQ PNS System
(This Submission) | StimQ PNS System
(K152178) | Freedom SCS
System (K170141) |
| No. of Electrodes | 4 or 8 | Same as StimQ | Same as StimQ |
| Electrode Length | 3.0 millimeters | Same as StimQ | Same as StimQ |
| Electrode Spacing | 4.0 millimeters | Same as StimQ | Same as StimQ |
| Electrode Surface Area | 12.72 mm2 | Same as StimQ | Same as StimQ |
| Method of Introduction | Percutaneous | Same as StimQ | Percutaneous and
Anchor Incision |
| Tissue Contact | Yes | Same as StimQ | Same as StimQ |
| Sterilization | Ethylene Oxide (EO) | Same as StimQ | Same as StimQ |
| Labeling | Labeled as Sterile,
Single Use, Prescription
Device | Same as StimQ | Same as StimQ |
| Package | Backer card and two
sterile pouches | Blister Tray/Tyvek
Lid | Same as StimQ |
| Pulse Frequency | 5 to 1500 Hertz | Same as StimQ | Same as StimQ |
| Pulse Width | 50 to 500 microseconds | Same as StimQ | Same as StimQ |
| Current/Voltage Regulated | Current | Same as StimQ | Same as StimQ |
| Output Voltage (300 Ω) | 0 to 4.1 V | Same as StimQ | Same as StimQ |
| Output Voltage (500 Ω) | 0 to 6.4 V | Same as StimQ | Same as StimQ |
| Output Voltage (800 Ω) | 0 to 7.5 V | Same as StimQ | Same as StimQ |
| Output Current (300 Ω) | 0 to 13.5 mA | Same as StimQ | Same as StimQ |
| Output Current (500 Ω) | 0 to 12.8 mA | Same as StimQ | Same as StimQ |
| Output Current (800 Ω) | 0 to 9.4 mA | Same as StimQ | Same as StimQ |
| Waveform | Charge Balanced
(delayed) Biphasic
asymmetrical | Same as StimQ | Same as StimQ |
| Polarity | Programmable (Anode,
Cathode, or Off) | Same as StimQ | Same as StimQ |
| Pulse Shape | Decaying Exponential | Same as StimQ | Same as StimQ |
| Avg. Current Density (300 Ω) | 105.0 mA/cm2 | Same as StimQ | Same as StimQ |
| Avg. Current Density (500 Ω) | 95.1 mA/cm2 | Same as StimQ | Same as StimQ |
| Avg. Current Density (800 Ω) | 69.0 mA/cm2 | Same as StimQ | Same as StimQ |
| Max. Phase Charge* (300 Ω) | 6.8 µC/pulse | Same as StimQ | Same as StimQ |
| Max. Phase Charge* (500 Ω) | 6.4 µC/pulse | Same as StimQ | Same as StimQ |
| Max. Phase Charge* (800 Ω) | 4.7 µC/pulse | Same as StimQ | Same as StimQ |
| Max. Charge Density* (300 Ω) | 53.1 µC/cm2 | Same as StimQ | Same as StimQ |
| Max. Charge Density* (500 Ω) | 50.3 µC/cm2 | Same as StimQ | Same as StimQ |
| Max. Charge Density* (800 Ω) | 36.9 µC/cm2 | Same as StimQ | Same as StimQ |
| Max. Current Density* (300 Ω) | 106.1 mA/cm2 | Same as StimQ | Same as StimQ |
| Max. Current Density* (500 Ω) | 100.6 mA/cm2 | Same as StimQ | Same as StimQ |
| Max. Current Density* (800 Ω) | 73.9 mA/cm2 | Same as StimQ | Same as StimQ |
| Net Charge | 0 µC | Same as StimQ | Same as StimQ |
| Avg. Phase Power (300 Ω) | 0.053 W/phase | Same as StimQ | Same as StimQ |
| Avg. Phase Power (500 Ω) | 0.073 W/phase | Same as StimQ | Same as StimQ |
| Avg. Phase Power (800 Ω) | 0.062 W/phase | Same as StimQ | Same as StimQ |
| Avg. Phase Power Density (300 Ω) | 0.42 W/cm2/phase | Same as StimQ | Same as StimQ |
| Avg. Phase Power Density (500 Ω) | 0.58 W/cm2/phase | Same as StimQ | Same as StimQ |
| Avg. Phase Power Density (800 Ω) | 0.48 W/cm2/phase | Same as StimQ | Same as StimQ |
| Pulse Delivery Mode | Continuous | Same as StimQ | Same as StimQ |
| ON/OFF Times | No Cycling | Same as StimQ | Same as StimQ |
| Current Path Options | Bipolar | Same as StimQ | Same as StimQ |
| Comparator | StimQ PNS System
(This Submission) | StimQ PNS System
(K152178) | Freedom SCS
System (K170141) |
| Power Delivery | Embedded receiver and
coupled receiver in
lumen of Stimulator
body | Coupled receiver
built into Stimulator
body | Same as StimQ |
| Transmit Frequency | 915 MHz | Same as StimQ | Same as StimQ |
| Material | Platinum-iridium 90:10,
Polyurethane 2363-55D | Same as StimQ | Same as StimQ |
| Sterile | Yes - ethylene oxide | Same as StimQ | Same as StimQ |
| Contract Sterilizer | Steris Isomedix
Services | Life Science
Outsourcing | Same as StimQ |
| Single-Use | Yes | Same as StimQ | Same as StimQ |
| Shelf Life | 2 year | Same as StimQ | Same as StimQ |
| Complies with ISO 10993-1 | Yes | Same as StimQ | Same as StimQ |
| Safety Testing Passed | Yes | Same as StimQ | Same as StimQ |
| MR Conditional | Yes, FR4A/STQ4 MR
Conditional | No, MR Unsafe | Yes |
| Accessories | Receiver/RF Stylet,
Stylet, Introducer
Assembly, Guidewire | Receiver/RF Stylet,
Stylet(s), Guidewire,
Needle and Cannula | Receiver/RF
Stylet, Stylet(s),
Guidewire,
Needle, Suture
Sleeve Cap |
| Charger | USB Charger | Wireless Charger | Same as StimQ |
| Wearable Antenna Assembly | Aluminum transmitter
and separate, connected
Antenna | Fabric-encased
plastic transmitter | Same as StimQ |
| Software Level of Concern | Moderate | Same as StimQ | Same as StimQ |
| iPad Application | WaveCrestTM | Same as StimQ | Same as StimQ |
| Kits | Receiver Kit, Spare
Lead Kit, Trial Lead
Kit, Sterile Revision
Kit, SWAG Kits,
Charger Kit | Receiver Kit, Trial
Lead Kit, WAA Kit, | Same as StimQ |
Table 5A. Comparison of Characteristics
9
Image /page/9/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 resemble sound waves or radio waves, giving the impression of stimulation or inquiry.
10
Image /page/10/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 "Q" are concentric dark blue lines that resemble sound waves or a radar display.
(*) asterisk denotes that formulas were used for the calculations.
8. Biocompatibility Data
Materials of this submission are identical to K141399, K152178, K162161, and K170141. The materials of the Freedom-8A/4A and StimQ Stimulator in direct contact with tissue remain unchanged from the Freedom SCS System (K170141 and K141399) and thus, the biocompatibility tests conducted on representative subassemblies of the Freedom SCS System (Freedom-4. K141399) directly apply to the StimO 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 Stimulators (same as the Freedom-4 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
11
Image /page/11/Picture/0 description: The image shows the logo for "stimQ". The word "stim" is written in blue, and the "Q" is written in green. To the right of the word is a series of blue concentric arcs, which are meant to represent radio waves. The green "Q" is also shaped like a magnifying glass.
with tissue/bone. The results for the biocompatible testing of the Stimulators (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 the StimQ PNS System. The 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 Receiver/RF Stylet is never in direct or indirect contact with tissue. The SWAG is intended to be 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 Stim() PNS System meets biological safety and compatibility requirements of ISO 10993-1:2009 and Blue Book Memorandum G95-1.
9. Non-Clinical Performance Data
No modifications were made to the components of K170141 (Freedom-8A/4A Stimulators, SWAG, WaveCrest, Battery Charger, Sterilization, Kitting Options) in support of the device safety and performance of this submission. The StimQ PNS System testing is leveraged from prior cleared premarket notifications where components were 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 Stimulators were 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 Stimulators were functional following post testing functionality inspection and passed atmospheric pressure change testing as specified by AAMI ANSI ISO 14708-3:2008. This testing presented for this submission is leveraged from K170141 and K141399, and is directly applicable for demonstration of device safety and efficacy as the packaging and the Stimulators remains the same. The Receiver/RF Stylet is a passive component that does not impact the outcome of the leveraged tests for safety and effectiveness.
For testing external defibrillation exposure, the Stimulator and Receiver were verified as functional after exposure to external defibrillation. Thus, the StimQ PNS System complies with testing as specified by AAMI ANSI ISO 14708-3:2008. The Receiver/RF Stylet testing presented for this submission is leveraged from K170141. and is directly applicable for demonstration of device safety and efficacy as Receiver/RF Stylet remains the same.
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Image /page/12/Picture/0 description: The image shows a logo for a company or product called "stimQ". The word "stim" is written in a dark blue, sans-serif font. The "Q" is in green and is stylized to resemble a magnifying glass. Behind the "Q" are several concentric, curved lines in dark blue, suggesting a signal or wave emanating from the "Q".
Following the thermal shock testing, the Stimulators were 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 Stimulators comply with the thermal shock design requirements and the applicable standard. This testing presented for this submission is leveraged from K170141, and is directly applicable for demonstration of device safety and efficacy as the Stimulators remains the same. The Receiver/RF Stylet is a passive component that does not impact the outcome of the leveraged tests for safety and effectiveness.
For leakage current testing, the Stimulators produced zero leakage current on all tested paths for all tested samples. Thus, the Stimulators comply with the leakage design requirements and the applicable standard. This testing presented for this submission is leveraged from K170141 and K141399, and is directly applicable for demonstration of device safety and efficacy as the Stimulators remains the same. The Receiver/RF Stylet is a passive component that does not impact the outcome of the leveraged tests for safety and effectiveness.
For testing the insertion and withdrawal of the stylet within the Stimulator, the stylet was found to require less than 2.5N of insertion or withdrawal force for all tested stylets in all tested stimulator samples. For testing the insertion and withdrawal of the Receiver within the Stimulator, the Receiver/RF Stylet was found to require less than 2.2N 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 Stimulator and Receiver/RF Stylet comply with design specifications for stylet insertion and withdrawal force. The Stimulator testing presented for this submission is leveraged from K170141 and K141399, and is directly applicable for demonstration of device safety and efficacy as the Stimulators remains the same. The Receiver/RF Stylet testing presented for this submission is leveraged from K170141, and is directly applicable for demonstration of device safety and efficacy, as Receiver/RF Stylet remains the same.
For mechanical testing, the Stimulators 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 and torsion testing. Thus, the Stimulators comply with all stimulator mechanical design requirements. This testing presented for this submission is leveraged from K170141 and K141399, and is directly applicable for demonstration of device safety and efficacy as the Stimulators remains the same. The Receiver/RF Stylet is a passive component that does not impact the outcome of the leveraged tests for safety and effectiveness.
For magnetic resonance imaging (MRI) radio frequency (RF) induced heating as related to specific absorbance rate (SAR), the Freedom-4A and StimO Stimulator produced a maximum temperature increase lower than the allowable limit for the 1.5T MRI procedure and thus passed the 1.5T testing. The Freedom-4A and Stimulator produced a maximum temperature increase lower than the allowable limit for the 1.5T MRI procedure and thus passed both.
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Image /page/13/Picture/0 description: The image shows the logo for stimQ. The logo features the word "stim" in a sans-serif font, with the "Q" stylized as a magnifying glass. Behind the word, there are concentric semi-circles, resembling radio waves or a signal emanating from the "Q" magnifying glass. The word "stim" is in a dark blue color, while the magnifying glass is in green.
ASTM F2182-11a - In accordance with F2182-11a - American Society for Testing and Materials (ASTM) International Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging, the Freedom-4A Stimulator showed that its presence would not cause injury to the patient with the implant during an MRI procedure. The Freedom-4A (StimQ) Stimulator with Receiver is a passive implant that is not powered while the external unit is not transmitting to it.
IEC 60601-1 - The SWAG was tested for compliance with IEC 60601-1. For testing the SWAG for protection from temperature change, including shipping and storage temperature ranges, the SWAG 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 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 SWAG 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 of the StimQ PNS System satisfies the outlined atmospheric pressure change design requirements and the applicable standard, IEC 60601-1. For the push, drop, impact and mold stress relief testing of the SWAG, it was determined through testing that the SWAG is robust to withstand expected damage in accordance with general safety standards. The SWAG 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 StimO PNS System 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 the SWAG it was determined through an analysis of the labeling that the SWAG 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 SWAG it was determined through an analysis of the design that the system satisfies the requirements of the applicable standard, IEC 60601-1. This testing presented for this submission is leveraged from K170141 and is directly applicable for demonstration of device safety and efficacy as the SWAG, identical to the WAA of K170141, remains the same.
IEC 60529 - The SWAG was tested for compliance with IEC 60529. For testing the ingress of water, the SWAG 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 Ingress of Water design requirements and the applicable standard IEC 60529. For particulate matter testing, the SWAG 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 Particulate Matter design requirements and the applicable standard. IEC 60529. This
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Image /page/14/Picture/0 description: The image shows the logo for stimQ. The logo features the word "stim" in a lowercase, sans-serif font, with the "Q" in green. To the right of the word is a stylized graphic of concentric arcs in blue, resembling sound waves or a signal. The green "Q" is integrated into the graphic, with its tail extending to the outer arc, creating a visual connection between the text and the graphic element.
testing presented for this submission is leveraged from K170141 and is directly applicable for demonstration of device safety and efficacy as the SWAG, identical to the WAA of K170141, remains the same.
IEC 60601-1-2 - The SWAG was tested for compliance with IEC 60601-1-2. For testing the SWAG for electromagnetic compatibility, the unit met all acceptance criteria for emissions, low-frequency magnetic fields, immunity, electrostatic discharge, radiated RF electromagnetic fields, electrical fast transients and magnetic fields. The SWAG operated within all test limits and showed no physical damage and was fully operational. Thus, the SWAG for the StimO PNS System satisfies the IEC 60601-1-2 standard. This testing presented for this submission is leveraged from K170141 and is directly applicable for demonstration of device safety and efficacy as the SWAG, identical to the WAA of K170141, remains the same.
The StimQ PNS System complies with the applicable standards for neurostimulators, electrical safety, electromagnetic interference and compatibility, packaging, and sterilization. The software of the StimQ PNS System passed all verification tests outlined and the design requirements for Software Verification have been met. The device passed all the testing in accordance with national and international standards. This testing presented for this submission is leveraged from K170141 and is directly applicable for demonstration of device safety and efficacy as the StimQ PNS System remains the same.
Following performance testing. it has been determined that the StimO PNS System is substantially equivalent to legally marketed predicate devices for the therapeutic relief for chronic, intractable pain of peripheral nerve origin.
Due to the similarities between the legally marketed predicate devices (K170141 and K152178), and the StimO PNS System (this submission), StimO has leveraged applicable performance testing in addition to completed a number of tests that demonstrates substantial equivalence to the legally marketed predicate devices. The StimO PNS System meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety confirms that the output meets the design inputs and specifications. The StimO PNS System passed all testing stated above as shown by the acceptable results obtained.
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 this submission supports the substantial equivalence of the device.
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Image /page/15/Picture/0 description: The image shows the logo for StimQ. The logo features the word "stim" in a sans-serif font, followed by a stylized "Q" in green. The "Q" is partially surrounded by a series of concentric, semi-circular lines in blue, resembling sound waves or a radar display. The overall design is clean and modern, suggesting a focus on technology or communication.
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. The StimQ PNS System has the same intended use as the legally marketed predicates device and is implanted percutaneous next to the peripheral nerves of the torso and extremities. Performance tested verified that the StimQ PNS System complies with all applicable voluntary standards such as IEC 60601-1, AAMI ANSI ISO 14708-3, and IEC 60529. The StimQ PNS System also meets the design requirements where no applicable standard could be used. This included Receiver/RF Stylet performance testing, stimulator body durability testing, programmable parameters, as well as power and performance of the SWAG. 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 implanted stimulator are the same as the legally marketed predicate devices.
It has been shown in this 510(k) submission that the difference between the StimQ PNS System and the legally marketed predicate devices do not raise any questions regarding its safety and effectiveness as compared to legally marketed predicate devices. StimQ PNS System, as designed and manufactured, is determined to be substantially equivalent to the referenced legally marketed predicate devices.