(136 days)
No
The summary does not mention AI, ML, or any related concepts like algorithms for data analysis, image processing, or adaptive stimulation based on patient data. The focus is on hardware updates, kitting options, and standard electrical stimulation therapy.
Yes
The "Intended Use / Indications for Use" section states that the system is used for "chronic, intractable pain of the trunk and/or lower limbs." The "Device Description" section further clarifies that the system "is used for spinal column stimulation to provide therapeutic relief for chronic, intractable pain." These statements indicate that the device is intended to treat a medical condition, which is the definition of a therapeutic device.
No
This device is a spinal cord stimulator intended for therapeutic relief of chronic pain, not for diagnosing conditions. The trial period mentioned is to determine the device's efficacy, not to diagnose a patient's condition.
No
The device description explicitly states the system is comprised of implantable stimulators, receiver components, and an externally worn transmitter (Wearable Antenna Assembly), in addition to software upgrades. This indicates significant hardware components are part of the medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of chronic, intractable pain through spinal cord stimulation. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as an implantable stimulator and external components that deliver electrical current to nerves. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is clearly a therapeutic medical device used for pain management.
N/A
Intended Use / Indications for Use
The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. The Freedom-8A Trial Lead Kit is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and the Freedom-4A Trial Lead Kit is used for either the Receiver Kit Freedom-4A Stimulator or the Receiver Kit Freedom-8A Stimulator. 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 (comma separated list FDA assigned to the subject device)
GZB
Device Description
This submission is based upon the established Stimwave product family offering additional surgical kitting options (Spare Lead Kit and Sterile Revision Kit), updates to the surgical kits (Receiver Kit and Trial Lead Kit) to include new accessory components (Needle, and RF Stylet), a new Wearable Antenna Assembly (WAA) model utilizing a Low Energy (LE) Bluetooth module, a USB battery charger, and upgrades to the WaveCrest Application.
The Stimwave Technologies Incorporated (Stimwave) Freedom Spinal Cord SCS System (System) is used for spinal column stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or lower limbs including unilateral pain. The therapy utilizes pulsed electrical current to create an energy field that acts on nerves near the spinal column. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator), receiver component (Receiver), and an externally worn transmitter (Wearable Antenna Assembly (WAA)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.
A polyurethane (Pellethane 55D) casing with an embedded receiver, flexible circuit board and electrodes (Platinum Iridium 90:10) that is placed in the patient's evidural space. The Freedom-8A Stimulator has eight (8) electrodes, and the Freedom-4A Stimulator has four (4) electrodes. Identical to K150517 and K160600.
A copper and PEEK cable with dual couplers; placed within the center lumen of the Freedom-8A or Freedom-4A 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 K160600, but quantity is increased from one to two.
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 Receiver Kit, one straight and one bent, each with diameter of 0.30 mm. Similar to K150517 and K160600, but with a larger diameter.
A 13-gauge stainless steel needle that acts as a conduit for passage of the Stimulator into the epidural space. Similar to K141399, but provided with a larger gauge.
A stainless steel, rigid, solid core guidewire used to create a hollow pathway in the evidural space for the Stimulator to pass through easily. Identical to K141399, K150517, and K160600.
A polyurethane (Pellethane 55D) cap that is placed over the proximal end of the Stimulator. The Suture Sleeve Cap is attached to the Freedom-8A/4A Stimulator and can be sutured to tissue to reduce the possibility of device migration. Identical to K141399, K150517, and K160600.
WAA: The WAA housing includes the following components:
A. 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. Similar to K150517 with design updates for USB charging and PCB layout;
B. 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). Identical to the component used for K152178 (StimQ PNS System);
C. Battery Assembly – A battery and wire assembly for charging and the MFS for power delivery. New component for WAA.
Transmitting (Tx) Antenna Assembly – An antenna and coaxial cable assembly that is attached to the WAA that is used to transmit microwave energy to the implanted Stimulator. Similar design and functionality as K152178, with design updates for indication.
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 WAA. New accessory component used to recharge the WAA.
Freedom-8A Spare Lead, Freedom-4A Spare Lead: A polyurethane (Pellethane 55D) casing with an embedded receiver, flexible circuit board and electrodes (Platinum Iridium 90:10) that is placed in the patient's epidural space. The Freedom-8A Spare Lead has eight (8) electrodes, and the Freedom-4A Spare Lead has four (4) electrodes. Identical in design and functionality to the Freedom-8A and Freedom-4A Stimulator.
RF Stylet: A copper and PEEK cable with dual couplers; placed within the center lumen of the Freedom-8A or Freedom-4A 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 in design and functionality to the Receiver.
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 Spare Lead Kit, one straight and one bent, each with diameter of 0.30 mm. Identical in design and functionality to the stylets in the Receiver Kit.
Needle: A 13-gauge stainless steel needle that acts as a conduit for passage of the Spare Lead into the epidural space. Identical in design and functionality to the needle in the Receiver Kit.
Guidewire: A stainless steel, rigid, solid core guidewire used to create a hollow pathway in the epidural space for the Spare Lead to pass through easily. Identical in design and functionality to the guidewire in the Receiver Kit.
Suture Sleeve Cap: A polyurethane (Pellethane 55D) cap that is placed over the proximal end of the Stimulator. The Suture Sleeve Cap is attached to the Freedom-8A/4A Spare Lead and can be sutured to tissue to reduce the possibility of device migration. Identical in design and functionality to the Suture Sleeve Cap in the Receiver 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 percutaneously in the patient's epidural space. The Freedom-8A Trial Lead has eight (8) electrodes, and the Freedom-4A Trial Lead has four (4) electrodes. Identical in design and functionality to the Freedom-8A and Freedom-4A Stimulator.
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 in design and functionality to the Receiver.
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 with a diameter of 0.30 mm. Identical in design and functionality to the stylets in the Receiver Kit.
Needle: A 13-gauge stainless steel needle that acts as a conduit for passage of the Trial Lead into the epidural space. Identical in design and functionality to the needle in the Receiver Kit.
Guidewire: A stainless steel, rigid, solid core guidewire used to create a hollow pathway in the epidural space for the Trial Lead to pass through more easily. Identical in design and functionality to the guidewire in the Receiver Kit.
Sterile Revision Kit:
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 Sterile Revision Kit, one straight and one bent with a diameter of 0.30 mm. Identical in design and functionality to the stylets in the Receiver Kit.
Needle: A 13-gauge stainless steel needle that acts as a conduit for passage of the Stimulator/Lead into the epidural space. Identical in design and functionality to the needle in the Receiver Kit.
Guidewire: A stainless steel, rigid, solid core guidewire used to create a hollow pathway in the epidural space for the Stimulator/Lead to pass through easily. Identical in design and functionality to the guidewire in the Receiver Kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Epidural space, L5 to T5 (Spinal column)
chronic, intractable pain of the trunk and/or lower limbs
Indicated Patient Age Range
Not Found
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)
Non-Clinical Performance Data: The Freedom SCS System was tested to verify that the performance meets the system design requirements as well as all applicable voluntary standards. The Freedom SCS System complies with all design requirements and applicable voluntary standards.
Leveraged testing from K150517:
- AAMI ANSI ISO 14708-3:2008 for protection from temperature change (functional following post visual inspection, passed temperature change testing).
- Atmospheric pressure change testing (functional following post testing functionality inspection, passed atmospheric pressure change testing).
- External defibrillation exposure (Freedom-8A/4A Stimulator and Receiver verified as functional).
- Thermal shock testing (Freedom-8A/4A Stimulator found to have "no irreversible damage" and fully functional).
- Leakage current testing (Freedom-8A/4A Stimulator produced zero leakage current).
- Insertion and withdrawal force of stylet within Stimulator (required less than 2.5N).
- Insertion and withdrawal force of Receiver within Stimulator (required less than 2.2N).
- Mechanical testing (tensile and torsion testing; passed all criteria, no visible or functional damage).
Leveraged testing from K160600:
- External defibrillation exposure on Receiver/RF Stylet.
- Insertion and withdrawal force of Receiver within Stimulator.
IEC 60601-1:
- WAA protection from temperature change (met passing criteria, no physical damage, fully operational).
- WAA atmospheric pressure change testing (met passing criteria, no physical damage, fully operational).
- WAA push, drop, impact and mold stress relief testing (robust, met passing criteria, no physical damage, fully operational).
- WAA identification, marking and documents (complies with requirements).
- WAA means of protection, creepage distances, and air clearances (satisfies requirements).
IEC 60529:
- WAA ingress of water (met passing criteria, no physical damage, fully operational).
- WAA particulate matter testing (met passing criteria, no physical damage, fully operational).
IEC 60601-1-2:
- WAA electromagnetic compatibility (met all acceptance criteria for emissions, low-frequency magnetic fields, immunity, electrostatic discharge, radiated RF electromagnetic fields, electrical fast transients and magnetic fields; operated within test limits, no physical damage, fully operational).
Key results: The Freedom SCS System complies with the applicable standards for neurostimulators, electrical safety, electromagnetic interference and compatibility, packaging, and sterilization. The software passed all verification tests. The device passed all testing in accordance with national and international standards. The performance testing demonstrated similar performance as the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Stimwave Freedom SCS System FR8A/FR4A, LBRD-915-2A (K160600), Stimwave Freedom SCS System FR8A/FR4A, LBRD-915-2A (K150517), Stimwave Freedom SCS System FRE4-A001, FRT4-A001, WAA-A012 (K141399)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, with three human profiles forming the staff and a cloth draped around the base.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2016
Stimwave Technologies Incorporated Elizabeth Greene Vice President of Quality Assurance and Regulatory Affairs 901 East Las Olas Boulevard, Suite 201 Fort Lauderdale, Florida 33301
Re: K162161
Trade/Device Name: Freedom Spinal Cord Stimulation (SCS) System Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: November 16, 2016 Received: November 18, 2016
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 (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 (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 -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: 2016.12.16 14:42:53 -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): K162161
Device Name: Freedom Spinal Cord Stimulator (SCS) System
Indications For Use:
The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. The Freedom-8A Trial Lead Kit is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and the Freedom-4A Trial Lead Kit is used for either the Receiver Kit Freedom-4A Stimulator or the Receiver Kit Freedom-8A Stimulator. 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 Stimwave Technologies. The word "stim" is in dark blue, and the word "wave" is in green. Below the words "stim wave" is the word "TECHNOLOGIES" in dark blue. To the right of the word "wave" are three curved lines in dark blue that resemble radio waves.
510(k) Summary
for
Freedom Spinal Cord Stimulator (SCS) System
1. Submission Sponsor
| Stimwave Technologies Incorporated | |
|---|---|
| 901 East Las Olas Boulevard | |
| Suite 201 | |
| Fort Lauderdale | |
| Florida 33301 | |
| USA | |
| Phone: | 800.965.5134 |
| Fax: | 800.965.5134 |
| Contact: | Elizabeth Greene, Vice President of Quality Assurance and Regulatory Affairs |
2. Date Prepared
September 7, 2016
3. Device Identification
| Trade/Proprietary Name: | Freedom Spinal Cord Stimulator (SCS) System |
|---|---|
| Common/Usual Name: | Spinal Cord Stimulator |
| Classification Name: | Stimulator, Spinal-Cord, Implanted (Pain Relief) |
| Classification Regulation: | 882.5880 |
| Product Code: | GZB |
| Device Class: | Class II |
| Classification Panel: | Neurology |
4. Legally Marketed Predicate Device(s)
Stimwave Freedom SCS System FR8A/FR4A, LBRD-915-2A (K160600) Stimwave Freedom SCS System FR8A/FR4A, LBRD-915-2A (K150517) Stimwave Freedom SCS System FRE4-A001, FRT4-A001, WAA-A012 (K141399)
5. Device Description
This submission is based upon the established Stimwave product family offering additional surgical kitting options (Spare Lead Kit and Sterile Revision Kit), updates to the surgical kits (Receiver Kit and Trial Lead Kit) to include new accessory components (Needle, and RF Stylet), a new Wearable Antenna Assembly (WAA) model utilizing a Low Energy (LE) Bluetooth module, a USB battery charger, and upgrades to the WaveCrest Application.
4
Image /page/4/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in large, blue, lowercase letters. The word "wave" is in large, green, lowercase letters. Below the words is the word "TECHNOLOGIES" in smaller, blue, uppercase letters inside of a blue oval. To the right of the words is a blue graphic of concentric arcs.
The Stimwave Technologies Incorporated (Stimwave) Freedom Spinal Cord SCS System (System) is used for spinal column stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or lower limbs including unilateral pain. The therapy utilizes pulsed electrical current to create an energy field that acts on nerves near the spinal column. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator), receiver component (Receiver), and an externally worn transmitter (Wearable Antenna Assembly (WAA)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.
A polyurethane (Pellethane 55D) casing with an embedded receiver, Freedom-8A Stimulator. flexible circuit board and electrodes (Platinum Iridium 90:10) that is Freedom-4A placed in the patient's evidural space. The Freedom-8A Stimulator Stimulator has eight (8) electrodes, and the Freedom-4A Stimulator has four (4) electrodes. Identical to K150517 and K160600. Receiver A copper and PEEK cable with dual couplers; placed within the center lumen of the Freedom-8A or Freedom-4A 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 K160600, but quantity is increased from one to two. A stainless steel wire with a polypropylene handle that is inserted Stylet(s) into the open central lumen of the stimulator to provide rigidity during implantation. Two (2) stylets are provided in the Receiver Kit, one straight and one bent, each with diameter of 0.30 mm. Similar to K150517 and K160600, but with a larger diameter. Needle A 13-gauge stainless steel needle that acts as a conduit for passage of the Stimulator into the epidural space. Similar to K141399, but provided with a larger gauge. Guidewire A stainless steel, rigid, solid core guidewire used to create a hollow pathway in the evidural space for the Stimulator to pass through easily. Identical to K141399, K150517, and K160600. Suture Sleeve Cap A polyurethane (Pellethane 55D) cap that is placed over the proximal end of the Stimulator. The Suture Sleeve Cap is attached to the Freedom-8A/4A Stimulator and can be sutured to tissue to reduce the possibility of device migration. Identical to K141399, K150517, and K160600.
Freedom-8A and Freedom-4A Stimulator (Receiver Kit)
Wearable Antenna Assembly (WAA Kit)
| WAA | The WAA housing includes the following components: |
|---|---|
| A. 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. Similar to K150517 with design updates for USB charging and PCB layout; | |
| Wearable Antenna Assembly (WAA Kit) | |
| B. 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). Identical to the component used for | |
| K152178 (StimQ PNS System); | |
| C. Battery Assembly – A battery and wire assembly for charging and | |
| the MFS for power delivery. New component for WAA. | |
| Transmitting (Tx) Antenna Assembly – An antenna and coaxial cable | |
| assembly that is attached to the WAA that is used to transmit | |
| microwave energy to the implanted Stimulator. Similar design and | |
| functionality as K152178, with design updates for indication. | |
| 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 | |
| WAA. New accessory component used to recharge the WAA. | |
| Freedom-8A and Freedom-4A Spare Lead (Spare Lead Kit) | |
| Freedom-8A | |
| Spare Lead, | |
| Freedom-4A | |
| Spare Lead | A polyurethane (Pellethane 55D) casing with an embedded receiver, |
| flexible circuit board and electrodes (Platinum Iridium 90:10) that is | |
| placed in the patient's epidural space. The Freedom-8A Spare Lead | |
| has eight (8) electrodes, and the Freedom-4A Spare Lead has four (4) | |
| electrodes. Identical in design and functionality to the Freedom-8A | |
| and Freedom-4A Stimulator. | |
| RF Stylet | A copper and PEEK cable with dual couplers; placed within the |
| center lumen of the Freedom-8A or Freedom-4A 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 in design and functionality to the Receiver. | |
| 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 Spare Lead | |
| Kit, one straight and one bent, each with diameter of 0.30 mm. | |
| Identical in design and functionality to the stylets in the Receiver Kit. | |
| Needle | A 13-gauge stainless steel needle that acts as a conduit for passage of |
| the Spare Lead into the epidural space. Identical in design and | |
| functionality to the needle in the Receiver Kit. | |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow |
| pathway in the epidural space for the Spare Lead to pass through | |
| easily. Identical in design and functionality to the guidewire in the | |
| Receiver 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 percutaneously in the patient's epidural space. The Freedom-8A Trial Lead has eight (8) electrodes, and the Freedom-4A Trial Lead has four (4) electrodes. Identical in design and functionality to the Freedom-8A and Freedom-4A Stimulator. |
| 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 in design and functionality to the Receiver. |
| 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 with a diameter of 0.30 mm. Identical in design and functionality to the stylets in the Receiver Kit. |
| Needle | A 13-gauge stainless steel needle that acts as a conduit for passage of the Trial Lead into the epidural space. Identical in design and functionality to the needle in the Receiver Kit. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow pathway in the epidural space for the Trial Lead to pass through more easily. Identical in design and functionality to the guidewire in the Receiver Kit. |
5
Image /page/5/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in a large, purple, sans-serif font. Below and to the right of "stim" is the word "wave" in a green, sans-serif font. Below "stim wave" is the word "TECHNOLOGIES" in a smaller, blue, sans-serif font inside of a rounded rectangle. To the right of the words is a graphic of three concentric arcs in a blue-purple color.
Wearable Antenna Assembly (WAA Kit)
6
Image /page/6/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in a blue sans-serif font, and the word "wave" is in a green sans-serif font. Below the words "stim wave" is the word "TECHNOLOGIES" in a smaller blue sans-serif font with a blue line above and below the word. To the right of the words is a graphic of blue concentric semi-circles.
Suture Sleeve Cap A polyurethane (Pellethane 55D) cap that is placed over the proximal end of the Stimulator. The Suture Sleeve Cap is attached to the Freedom-8A/4A Spare Lead and can be sutured to tissue to reduce the possibility of device migration. Identical in design and functionality to the Suture Sleeve Cap in the Receiver Kit.
Freedom-8A and Freedom-4A Trial Lead (Trial Lead Kit)
Sterile Revision Kit
| 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 Sterile Revision Kit, one straight and one bent with a diameter of 0.30 mm. Identical in design and functionality to the stylets in the Receiver Kit. |
|---|---|
| Needle | A 13-gauge stainless steel needle that acts as a conduit for passage of the Stimulator/Lead into the epidural space. Identical in design and functionality to the needle in the Receiver Kit. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow pathway in the epidural space for the Stimulator/Lead to pass through easily. Identical in design and functionality to the guidewire in the Receiver Kit. |
7
Image /page/7/Picture/0 description: The image contains the logo for Stimwave Technologies. The word "stim" is in blue, and the word "wave" is in green. Below the words is the word "TECHNOLOGIES" in blue. To the right of the words are three curved lines that look like sound waves in blue.
6. Indication for Use Statement
The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. The Freedom-8A Trial Lead Kit is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and the Freedom-4A Trial Lead Kit is used for either the Receiver Kit Freedom-4A Stimulator or the Receiver Kit Freedom-8A Stimulator. 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 Stimwave Freedom SCS 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.
| Comparator | Stimwave
Freedom SCS
System
(K162161) | Stimwave
Freedom SCS
System
(K160600) | Stimwave
Freedom SCS
System
(K150517) | Stimwave
Freedom SCS
System
(K141399) |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------|
| Product Code | GZB | Same as K162161 | Same as K162161 | Same as K162161 |
| Regulation No. | 882.5880 | Same as K162161 | Same as K162161 | Same as K162161 |
| Regulation Name | Stimulator, Spinal-Cord,
Implanted (Pain Relief) | Same as K162161 | Same as K162161 | Same as K162161 |
| Intended Use | Stimulation of spinal cord for
chronic, intractable pain of
trunk and lower limbs | Same as K162161 | Same as K162161 | Same as K162161 |
| Mode of Action | RF wireless transmission of
energy to produce
stimulation at Stimulator
electrodes. WAA sends a
pulsed RF signal on a carrier
frequency of 915MHz to the
Stimulator | Same as K162161 | Same as K162161 | Same as K162161 |
| Implant Site | Epidural space, L5 to T5 | Same as K162161 | Same as K162161 | Same as K162161 |
| Environmental
Use | Hospital, Home | Same as K162161 | Same as K162161 | Same as K162161 |
| Intended Clinician | Orthopedic, Neurosurgeon,
Anesthesiologist | Same as K162161 | Same as K162161 | Same as K162161 |
| Intended User | Layperson | Same as K162161 | Same as K162161 | Same as K162161 |
| Electrode
Material | Platinum-iridium 90:10 | Same as K162161 | Same as K162161 | Same as K162161 |
| Stimulator Body
Material | Polyurethane 2363-55D | Same as K162161 | Same as K162161 | Same as K162161 |
| Cable Features | Multi-lumen Tube | Same as K162161 | Same as K162161 | Same as K162161 |
| Stimulator Length | 45 centimeters | Same as K162161 | Same as K162161 | Same as K162161 |
| Diameter | 1.35 millimeters | Same as K162161 | Same as K162161 | Same as K162161 |
| Electrode Array
Length | 24.0 millimeters
52.0 millimeters | Same as K162161 | Same as K162161 | Same as K162161 |
| Comparator | Stimwave
Freedom SCS
System
(K162161) | Stimwave
Freedom SCS
System
(K160600) | Stimwave
Freedom SCS
System
(K150517) | Stimwave
Freedom SCS
System
(K141399) |
| No. of Electrodes | 4 or 8 | Same as K162161 | Same as K162161 | 4 |
| Electrode Length | 3.0 millimeters | Same as K162161 | Same as K162161 | Same as K162161 |
| Electrode Spacing | 4.0 millimeters | Same as Freedom | Same as K162161 | Same as K162161 |
| Electrode Surface Area | 12.72 mm² | Same as K162161 | Same as K162161 | Same as K162161 |
| Method of Introduction | Percutaneous and Anchor
Incision | Same as K162161 | Same as K162161 | Same as K162161 |
| Tissue Contact | Yes | Same as K162161 | Same as K162161 | Same as K162161 |
| Sterilization | Ethylene Oxide (EO) | Same as K162161 | Same as K162161 | Same as K162161 |
| Labeling | Labeled as Sterile, Single
Use, Prescription Device | Same as K162161 | Same as K162161 | Same as K162161 |
| Package | Backer card and two sterile
pouches | Same as K162161 | Same as K162161 | Blister
Tray/Tyvek Lid |
| Pulse Frequency | 5 to 1500 Hertz | Same as K162161 | Same as K162161 | 2 to 1500 Hertz |
| Pulse Width | 50 to 500 microseconds | Same as K162161 | Same as K162161 | Same as K162161 |
| Current/Voltage Regulated | Current | Same as K162161 | Same as K162161 | Same as K162161 |
| Output Voltage (300 Ω) | 0 to 4.1 V | Same as K162161 | Same as K162161 | 0 to 6.3 V |
| Output Voltage (500 Ω) | 0 to 6.4 V | Same as K162161 | Same as K162161 | 0 to 7.2 V |
| Output Voltage (800 Ω) | 0 to 7.5 V | Same as K162161 | Same as K162161 | 0 to 8.0 V |
| Output Current (300 Ω) | 0 to 13.5 mA | Same as K162161 | Same as K162161 | 0 to 21 mA |
| Output Current (500 Ω) | 0 to 12.8 mA | Same as K162161 | Same as K162161 | 0 to 15 mA |
| Output Current (800 Ω) | 0 to 9.4 mA | Same as K162161 | Same as K162161 | 0 to 10 mA |
| Waveform | Charge Balanced (delayed)
Biphasic asymmetrical | Same as K162161 | Same as K162161 | Same as K162161 |
| Polarity | Programmable
(Anode, Cathode, or Off) | Same as K162161 | Same as K162161 | Fixed |
| Pulse Shape | Decaying Exponential | Same as K162161 | Same as K162161 | Same as K162161 |
| Avg. Current Density (300 Ω) | 105.0 mA/cm² | Same as K162161 | Same as K162161 | 111.6 mA/cm² |
| Avg. Current Density (500 Ω) | 95.1 mA/cm² | Same as K162161 | Same as K162161 | 96.7 mA/cm² |
| Avg. Current Density (800 Ω) | 69.0 mA/cm² | Same as K162161 | Same as K162161 | 77.0 mA/cm² |
| Max. Phase Charge* (300 Ω) | 6.8 µC/pulse | Same as K162161 | Same as K162161 | 10.5 µC/pulse |
| Max. Phase Charge* (500 Ω) | 6.4 µC/pulse | Same as K162161 | Same as K162161 | 7.2 µC/pulse |
| Max. Phase Charge* (800 Ω) | 4.7 µC/pulse | Same as K162161 | Same as K162161 | 5.0 µC/pulse |
| Max. Charge Density* (300 Ω) | 53.1 µC/cm² | Same as K162161 | Same as K162161 | 82.5 µC/cm² |
| Max. Charge Density* (500 Ω) | 50.3 µC/cm² | Same as K162161 | Same as K162161 | 56.6 µC/cm² |
| Max. Charge Density* (800 Ω) | 36.9 µC/cm² | Same as K162161 | Same as K162161 | 39.3 µC/cm² |
| Comparator | Stimwave
Freedom SCS
System
(K162161) | Stimwave
Freedom SCS
System
(K160600) | Stimwave
Freedom SCS
System
(K150517) | Stimwave
Freedom SCS
System
(K141399) |
| Max. Current
Density* (300 Ω) | 106.1 mA/cm² | Same as K162161 | Same as K162161 | 165.1 mA/cm² |
| Max. Current
Density* (500 Ω) | 100.6 mA/cm² | Same as K162161 | Same as K162161 | 113.2 mA/cm² |
| Max. Current
Density* (800 Ω) | 73.9 mA/cm² | Same as K162161 | Same as K162161 | 78.6 mA/cm² |
| Net Charge | 0 μC | Same as K162161 | Same as K162161 | Same as K162161 |
| Avg. Phase Power
(300 Ω) | 0.053 W/phase | Same as K162161 | Same as K162161 | 0.060 W/phase |
| Avg. Phase Power
(500 Ω) | 0.073 W/phase | Same as K162161 | Same as K162161 | 0.076 W/phase |
| Avg. Phase Power
(800 Ω) | 0.062 W/phase | Same as K162161 | Same as K162161 | 0.060 W/phase |
| Avg. Phase Power
Density (300 Ω) | 0.42 W/cm²/phase | Same as K162161 | Same as K162161 | 0.48 W/cm²/phase |
| Avg. Phase Power
Density (500 Ω) | 0.58 W/cm²/phase | Same as K162161 | Same as K162161 | 0.59 W/cm²/phase |
| Avg. Phase Power
Density (800 Ω) | 0.48 W/cm²/phase | Same as K162161 | Same as K162161 | 0.60 W/cm²/phase |
| Pulse Delivery
Mode | Continuous | Same as K162161 | Same as K162161 | Same as K162161 |
| ON/OFF Times | No Cycling | Same as K162161 | Same as K162161 | Same as K162161 |
| Current Path
Options | Bipolar | Same as K162161 | Same as K162161 | Same as K162161 |
| Power Delivery | Embedded receiver and
coupled receiver in lumen of
Stimulator body | Same as K162161 | Coupled receiver,
built into
Stimulator body | Coupled receiver,
built into
Stimulator body |
| Transmit
Frequency | 915 MHz | Same as K162161 | Same as K162161 | Same as K162161 |
| Material | Platinum-iridium 90:10,
Polyurethane 2363-55D | Same as K162161 | Same as K162161 | Same as K162161 |
| Sterile | Yes - ethylene oxide | Same as K162161 | Same as K162161 | Same as K162161 |
| Contract
Sterilizer | Steris Isomedix Services | Life Science
Outsourcing | Life Science
Outsourcing | Oscor, Inc. |
| Single-Use | Yes | Same as K162161 | Same as K162161 | Same as K162161 |
| Shelf Life | 2 year | Same as K162161 | Same as K162161 | 1 year |
| Complies with
ISO 10993-1 | Yes | Same as K162161 | Same as K162161 | Same as K162161 |
| Safety Testing
Passed | Yes | Same as K162161 | Same as K162161 | Same as K162161 |
| MR Conditional | No, MR Unsafe | Same as K162161 | Same as K162161 | Yes |
| Accessories | Receiver/RF Stylet,
Stylet(s), Guidewire,
Needle, Suture Sleeve Cap | Receiver,
Stylet(s),
Guidewire,
Needle, Suture
Sleeve Cap | Stylet(s),
Guidewire,
Needle, Suture
Sleeve Cap | Stylet(s),
Guidewire,
Needle, Suture
Sleeve Cap |
| Charger | USB Charger | Wireless Charger | Wireless Charger | Wireless Charger |
| Wearable
Antenna
Assembly | Aluminum transmitter and
separate, connected Antenna | ABS plastic
transmitter
contained in a
wearable athletic
pouch belt | ABS plastic
transmitter
contained in a
wearable athletic
pouch belt | Thermoplastic
polyurethane
body worn device |
| Comparator | Stimwave
Freedom SCS
System
(K162161) | Stimwave
Freedom SCS
System
(K160600) | Stimwave
Freedom SCS
System
(K150517) | Stimwave
Freedom SCS
System
(K141399) |
| Software Level of
Concern | Moderate | Same as K162161 | Same as K162161 | Same as K162161 |
| iPad Application | WaveCrest™ 2.2 | WaveCrest™ | WaveCrest™ | WaveCrest™ |
| Kits | Receiver Kit, Spare Lead Kit,
Trial Lead Kit, Sterile Revision
Kit, WAA Kit, Charger Kit | Receiver Kit,
Trial Lead Kit,
WAA Kit | Receiver Kit,
Trial Lead Kit,
WAA Kit | Receiver Kit,
Trial Lead Kit,
WAA Kit |
Table 5A. Comparison of Characteristics
8
Image /page/8/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in dark blue, and the word "wave" is in green. The word "TECHNOLOGIES" is in dark blue and is inside of a dark blue rounded rectangle. To the right of the word "wave" are three dark blue curved lines that resemble radio waves.
9
Image /page/9/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in a dark blue font, and the word "wave" is in a green font. To the right of the word "wave" is a graphic of three curved lines that resemble radio waves. Underneath the word "stimwave" is the word "TECHNOLOGIES" in a smaller, dark blue font.
10
Image /page/10/Picture/0 description: The image contains the logo for Stimwave Technologies. The word "stim" is in a blue sans-serif font on the top left. Below that, the word "wave" is in a green sans-serif font. Below that, the word "TECHNOLOGIES" is in a blue sans-serif font with a blue line above and below it. To the right of the word "wave" are three concentric semi-circles in a blue color.
(*) asterisk denotes that formulas were used for the calculations.
8. Biocompatibility Data
The materials of the Freedom-8A/4A Stimulator (K162161) in direct contact with tissue remain unchanged from the Freedom SCS System (K141399, K150517, and K160600) and thus, the biocompatibility tests conducted on representative subassemblies of the Freedom SCS System (Freedom-4, K141399) directly apply to the Freedom SCS System (K150517, K160600, and K162161). The materials, construction and intended use of the Freedom SCS System is comparable to the predicate device, and have a long history of safety with respect to biocompatibility. The biological safety of the Freedom-8A/4A Stimulator (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 with tissue/bone. The results for the biocompatible testing of the Freedom-8A/4A Stimulator (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 Freedom SCS System. The Freedom-8A/4A Stimulator materials in direct tissue contact include Pellethane 55D (Stimulator) and Pt-Ir (90:10) (Stimulator only), 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 WAA is intended to be on top of a thin shirt or article of clothing around the midsection of the patient. The User Manual provided to the patient describes that the WAA should always be worn on top of a layer of clothing. The WAA does not come into contact with the patient's skin. The categorization by nature of body contact of the WAA is thus "noncontacting device", and not included in the scope of ISO 10993-1:2009. The Freedom SCS System meets biological safety and compatibility requirements of ISO 10993-1:2009 and Blue Book Memorandum G95-1.
9. Non-Clinical Performance Data
The Freedom SCS System was tested to verify that the performance meets the system design requirements as well as all applicable voluntary standards. The Freedom SCS System complies with all design requirements and applicable voluntary standards.
11
Image /page/11/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in blue, and the word "wave" is in green. To the right of the word "wave" are three curved lines that resemble radio waves. Underneath the words "stim wave" is the word "TECHNOLOGIES" in blue.
Stimwave Technologies Incorporated Traditional 510(k) Premarket Submission Freedom Spinal Cord Stimulator System
AAMI ANSI ISO 14708-3:2008 - For protection from temperature change including shipping and storage temperature ranges, the Freedom-8A/4A 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 Freedom-8A/4A Stimulator 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 K162161 is leveraged from K150517 and is directly applicable for demonstration of device safety and efficacy as the packaging and the Freedom-8A/4A Stimulator 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 Freedom-8A/4A Stimulator and Receiver were verified as functional after exposure to external defibrillation. Thus, the Freedom SCS System complies with testing as specified by AAMI ANSI ISO 14708-3:2008. The Receiver/RF Stylet testing presented for K162161 is leveraged from K160600 and is directly applicable for demonstration of device safety and efficacy as Receiver/RF Stylet remains the same.
Following the thermal shock testing, the Freedom-8A/4A 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 Freedom-8A/4A Stimulator comply with the thermal shock design requirements and the applicable standard. This testing presented for K162161 is leveraged from K150517 and is directly applicable for demonstration of device safety and efficacy as the Freedom-8A/4A Stimulator 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 Freedom-8A/4A Stimulator was produced zero leakage current on all tested paths for all tested samples. Thus, the Freedom-8A/4A Stimulator comply with the leakage design requirements and the applicable standard. This testing presented for K162161 is leveraged from K150517 and is directly applicable for demonstration of device safety and efficacy as the Freedom-8A/4A Stimulator 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 Freedom-8A/4A Stimulator and Receiver/RF Stylet comply with design specifications for stylet insertion and withdrawal force. The Stimulator testing presented for K162161 is leveraged from K150517 and is directly applicable for demonstration of device safety and efficacy as the
12
Image /page/12/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in large, bold, dark blue font, and the word "wave" is in large, bold, green font. Below the words "stim wave" is the word "TECHNOLOGIES" in a smaller, dark blue font, inside of a dark blue rectangle with rounded corners. To the right of the words is a graphic of three curved lines, which are also dark blue.
Freedom-8A/4A Stimulator remains the same. The Receiver/RF Stylet testing presented for K162161 is leveraged from K160600 and is directly applicable for demonstration of device safety and efficacy as Receiver/RF Stylet remains the same.
For mechanical testing, the Freedom-8A/4A 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 and torsion testing. Thus, the Freedom-8A/4A Stimulator comply with all stimulator mechanical design requirements. This testing presented for K162161 is leveraged from K150517 and is directly applicable for demonstration of device safety and efficacy as the Freedom-8A/4A Stimulator 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.
IEC 60601-1 - The WAA was tested for compliance with IEC 60601-1. For testing the WAA for protection from temperature change, including shipping and storage temperature ranges, the WAA 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 WAA of the Freedom SCS System satisfies the outlined protection from temperature change design requirements and the applicable standard, IEC 60601-1. For atmospheric pressure change testing, the WAA 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 WAA of the Freedom SCS 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 WAA, it was determined through testing that the WAA is robust to withstand expected damage in accordance with general safety standards. The WAA 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 WAA component of the Freedom-8A/4A SCS 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 WAA it was determined through an analysis of the labeling that the WAA 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 WAA it was determined through an analysis of the design that the system satisfies the requirements of the applicable standard, IEC 60601-1.
IEC 60529 - The WAA was tested for compliance with IEC 60529. For testing the ingress of water, the WAA 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 WAA component of the Freedom SCS System satisfies the outlined Ingress of Water design requirements and the applicable standard IEC 60529. For particulate matter testing, the WAA 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 WAA component of the Freedom SCS System satisfies the
13
Image /page/13/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in a large, blue, sans-serif font on the top left. To the right of "stim" is the word "wave" in a green, sans-serif font. Below "stim wave" is the word "TECHNOLOGIES" in a smaller, blue, sans-serif font inside of a blue rounded rectangle. To the right of the words is a graphic of three concentric semi-circles in blue.
outlined Particulate Matter design requirements and the applicable standard, IEC 60529.
IEC 60601-1-2 - The WAA was tested for compliance with IEC 60601-1-2. For testing the WAA 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 WAA operated within all test limits and showed no physical damage and was fully operational. Thus, the WAA for the Freedom SCS System satisfies the IEC 60601-1-2 standard.
The Freedom SCS System complies with the applicable standards for neurostimulators, electrical safety, electromagnetic interference and compatibility, packaging, and sterilization. The software of the Freedom SCS 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.
Following performance testing, it has been determined that the Freedom SCS System is substantially equivalent to legally marketed predicate devices for the therapy for chronic, intractable pain of the trunk and/or lower limbs, including unilateral pain.
Due to the similarities between the legally marketed predicate devices (K141399, K150517, and K160600), and the Freedom SCS System (K162161), Stimwave Technologies Incorporated has leveraged applicable performance testing in addition to completed a number of tests that demonstrates substantial equivalence to the legally marketed predicate devices. The Freedom SCS System meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety confirms that the output meets the design inputs and specifications. The Freedom SCS 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 vears 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.
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 Freedom SCS System has the same intended use as the legally marketed predicates devices and is implanted percutaneous into the epidural space ranging from T5 to L5. Performance tested verified that the Freedom SCS
14
Image /page/14/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in a large, purple, sans-serif font. The word "wave" is in a large, green, sans-serif font. The word "TECHNOLOGIES" is in a smaller, purple, sans-serif font and is inside of a rounded rectangle. To the right of the words is a series of three curved lines that are purple and resemble radio waves.
Stimwave Technologies Incorporated Traditional 510(k) Premarket Submission Freedom Spinal Cord Stimulator System
System complies with all applicable voluntary standards such as IEC 60601-1, AAMI ANSI ISO 14708-3, and IEC 60529. The Freedom SCS 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 WAA. 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 Freedom SCS System and the legally marketed predicate devices do not raise any questions regarding its safety and effectiveness as compared to legally marketed predicate devices. Freedom SCS System, as designed and manufactured, is determined to be substantially equivalent to the referenced legally marketed predicate devices.