(177 days)
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.
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 or bilateral 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 (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.
This document describes the Stimwave Freedom Spinal Cord Stimulator (SCS) System (K160600) and its acceptance criteria, relying heavily on substantial equivalence to previously cleared predicate devices (K150517, K141399). Therefore, the "study that proves the device meets the acceptance criteria" largely refers to non-clinical performance data and the demonstration of equivalence to existing devices, rather than a de novo clinical trial.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of "acceptance criteria" with explicit numerical targets and corresponding "reported device performance" in a quantitative way for each criterion. Instead, it describes compliance with design requirements and applicable voluntary standards. The "reported device performance" is generally stated as "passed all criteria," "complies with," or "met the passing criteria."
However, we can infer some criteria and their met status from the non-clinical performance data section:
| Feature/Criterion Subjected to Testing | Acceptance Criteria (Inferred from standard/design requirement) | Reported Device Performance |
|---|---|---|
| Environmental Performance (AAMI ANSI ISO 14708-3:2008) | ||
| Temperature Change (Shipping & Storage) | Device functional, safe rating, no visual/physical anomalies | Passed post visual inspection and change of temperature testing. |
| Atmospheric Pressure Change | Device functional, no visual/physical anomalies | Passed atmospheric pressure change testing. |
| External Defibrillation Exposure | Device functional after exposure | Verified as functional after exposure. |
| Thermal Shock | No irreversible damage, fully functional, no physical anomalies | Passed, 'no irreversible damage' and fully functional. |
| Leakage Current | Zero leakage current on all paths | Produced zero leakage current. |
| Mechanical Performance | ||
| Stylet Insertion & Withdrawal Force | Less than 2.5N insertion/withdrawal force | Required less than 2.5N of force. |
| Receiver Insertion & Withdrawal Force | Less than 2.2N insertion/withdrawal force | Required less than 2.2N of force. |
| Visual Inspection (after insertion/withdrawal) | No damage present in stimulator samples | Confirmed no damage. |
| Tensile Testing (Stimulator) | No visible or functional damage to stimulator | Passed all criteria, no visible/functional damage. |
| Torsion Testing (Stimulator) | No visible or functional damage to stimulator | Passed all criteria, no visible/functional damage. |
| Wearable Antenna Assembly (WAA) Performance (IEC 60601-1) | ||
| Temperature Change (Shipping & Storage) | WAA functional, no physical damage | Met passing criteria, no physical damage, fully operational. |
| Atmospheric Pressure Change | WAA functional, no physical damage | Met passing criteria, no physical damage, fully operational. |
| Push, Drop, Impact, Mold Stress Relief | WAA robust to withstand expected damage, functional, no physical damage | Determined robust, met passing criteria, no physical damage, fully operational. |
| Identification, Marking, Documents | Complies with standard requirements, clear identification | Analysis of labeling determined compliance. |
| Means of Protection, Creepage Distances, Air Clearances | Satisfies standard requirements | Analysis of design determined satisfaction. |
| WAA Ingress Protection (IEC 60529) | ||
| Ingress of Water | WAA functional, no physical damage | Met passing criteria, no physical damage, fully operational. |
| Particulate Matter | WAA functional, no physical damage | Met passing criteria, no physical damage, fully operational. |
| Electromagnetic Compatibility (IEC 60601-1-2) | ||
| Radiated RF Electromagnetic Fields | Met all acceptance criteria | Met all acceptance criteria, operated within all limits. |
| Radiated Immunity | Met all acceptance criteria | Met all acceptance criteria, operated within all limits. |
| Wireless Coexistence | Met all acceptance criteria | Met all acceptance criteria, operated within all limits. |
| Software Verification | Met design requirements, passed verification tests | Passed all verification tests, design requirements met. |
| Overall Safety and Effectiveness | Substantially equivalent to legally marketed predicate devices | Determined substantially equivalent after all testing. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of units tested for each non-clinical performance test (e.g., how many stimulators for thermal shock, how many WAAs for drop tests). It uses general terms like "all tested samples," "representative subassemblies," and "all tested paths for all tested samples."
- Data Provenance: The data is entirely non-clinical performance data, meaning it's derived from lab testing and analysis of the device itself.
- It is not patient data from a specific country or collected retrospectively/prospectively.
- A significant portion of the testing (e.g., for WAA, environmental performance, mechanical performance, biocompatibility) is "leveraged" from previous 510(k) submissions (K150517 and K141399) because the components or their relevant characteristics remained unchanged. New testing was performed where modifications or new components were introduced (e.g., specific tests for the Receiver).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device's safety and effectiveness were demonstrated through non-clinical performance testing and substantial equivalence, not through a study involving expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
Not applicable. This was not a study requiring adjudication of expert opinions on patient data. The non-clinical tests have objective pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is typically associated with diagnostic imaging devices where human readers interpret medical images. This is a medical implant (spinal cord stimulator) for pain relief, and its submission relies on non-clinical performance and equivalence to predicates, not a comparative effectiveness study with human readers interpreting imaging.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
In a sense, all the non-clinical performance testing described (environmental, mechanical, electrical safety, EMC, software verification) can be considered "standalone" in that it evaluates the device's inherent performance characteristics without human involvement in its operation/interpretation during the test, other than setting up and monitoring the test itself. There is no "algorithm" in the sense of AI being evaluated here, but rather the electro-mechanical and software functions of the device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance studies is adherence to established engineering specifications, design requirements, and recognized voluntary standards (e.g., AAMI ANSI ISO 14708-3, IEC 60601-1, IEC 60529, IEC 60601-1-2, ISO 10993-1). For biocompatibility, it's the biological response demonstrating no negative impacts as per ISO 10993-1. For the overall submission, the "ground truth" of safety and effectiveness is tied to its substantial equivalence to previously cleared predicate devices for the same intended use.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device that would require such data for its development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, suggesting a sense of community and care.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2016
Stimwave Technologies Incorporated Elizabeth Greene Vice President of Quality Assurance And Regulatory Affairs 901 E Las Olas Blvd, Suite 201 Fort Lauderdale, Florida 33301
Re: K160600
Trade/Device Name: Freedom Spinal Cord Stimulator System Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZB Dated: July 19, 2016 Received: July 25, 2016
Dear Ms. Greene,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
{1}------------------------------------------------
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 yours,
William J. Heetderks -A
Digitally signed by William J. Heetderks -A
DN: c=US, o=U.S. Government, ou=HHS,
ou=NIH, ou=People,
0.9.2342.19200300.100.1.1=0010149848,
cn=William J. Heetderks -A
Date: 2016.08.26 13:36:41 -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
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Indications for Use Statement
510(k) Number (if known): K160600
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)
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Image /page/3/Picture/0 description: The image shows 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 is a graphic of concentric circles in blue.
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
February 29, 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 (K150517) Stimwave Freedom SCS System FRE4-A001, FRT4-A001, WAA-A012 (K141399)
5. Device Description
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 or bilateral 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 (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.
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Image /page/4/Picture/0 description: The image shows 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, inside of a rounded rectangle. To the right of the words are three curved lines that look like radio waves, also in blue.
Freedom-8A and Freedom-4A Stimulator (Receiver Kit)
| Freedom-8AStimulator,Freedom-4AStimulator | A polyurethane (Pellethane 55D) casing with an embedded receiver,flexible circuit board and electrodes (Platinum Iridium 90:10) that isplaced in the patient's epidural space. The Freedom-8A Stimulatorhas eight (8) electrodes, and the Freedom-4A Stimulator has four (4)electrodes. |
|---|---|
| Freedom Receiver | A copper and PEEK cable with dual couplers; placed within thecenter lumen of the Freedom-8A or Freedom-4A Stimulator with thedistal end combination of Receiver and Stimulator being placedunder the skin. One (1) Receiver is provided with each kit. |
| Stylet(s) | A stainless steel wire with a polypropylene handle that is insertedinto the open central lumen of the stimulator to provide rigidityduring implantation. Two (2) stylets are provided in the Receiver Kit,one straight and one bent, each with diameter of 0.25 mm. |
| Needle andCannulaAssembly | An assembly that includes a 16-gauge stainless steel needle that ispackaged inserted in the fluorinated ethylene propylene (FEP)Cannula that acts as a conduit for passage of the Stimulator into theepidural space. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollowpathway in the epidural space for the Stimulator to pass through moreeasily. |
| Suture Sleeve Cap | A polyurethane (Pellethane 55D) cap that is placed over the proximalend of the Stimulator. The Suture Sleeve Cap is attached to theFreedom-8A/4A Stimulator and can be sutured to tissue to reduce thepossibility of device migration. |
Wearable Antenna Assembly (WAA Kit)
| WAA | The WAA housing includes the following components:i. Transmitting (Tx) Antenna – Antenna used to transmit microwave energy to the implanted Stimulator;ii. Microwave Field Stimulator (MFS) – A printed circuit board (PCB) that generates 915 MHz RF power with embedded waveform parameter settings and switches for changing parameter settings as needed by the user;iii. Button Cover – A silicon pad that corresponds to switches on the MFS that allows the user to turn the device on/off or increase or decrease power amplitude as well as interpret device power status (On, Off, Charging, Transmitting, and Bluetooth® Connection);iv. Battery Assembly – A battery and wire assembly coupled with the Wireless Charging Coil Assembly for charging and the MFS for power delivery;v. Wireless Charging Coil Assembly – Consists of an inductive charging coil and battery that receives energy from the Wireless Battery Charging Pad. The battery charger components on the |
|---|---|
| ----- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/5/Picture/0 description: The image is a logo for Stimwave Technologies. The word "stim" is in blue, and the word "wave" is in green. The word "TECHNOLOGIES" is in blue and is underlined by a blue line. To the right of the words is a blue circular wave design.
Wearable Antenna Assembly (WAA Kit)
| MFS are used to transfer charge into the 3.7V lithium ion batteryby facilitating power transfer and warns the system when batterypower is low. | |
|---|---|
| Wireless BatteryCharging Pad | An off-the-shelf Qi-compliant charging pad (RP-WCN7, RP-WCN12, or RP-WCN13) that uses inductive charging technology torecharge the encased lithium ion battery of the WAA. |
| Athletic PouchBelt | An off-the-shelf assembly constructed of lightweight nylon meshwith an adjustable belt, and a zipper pouch for housing the WAA. |
| Freedom-8A and Freedom-4A Trial Lead (Trial Lead Kit) | |
| Freedom-8ATrial Lead,Freedom-4ATrial Lead | A polyurethane (Pellethane 55D) casing with an embedded receiver,flexible circuit board and electrodes (Platinum Iridium 90:10) that isplaced percutaneously in the patient's epidural space. The Freedom-8A Trial Lead has eight (8) electrodes, and the Freedom-4A TrialLead has four (4) electrodes. |
| Stylet(s) | A stainless steel wire with a polypropylene handle that is insertedinto the open central lumen of the stimulator to provide rigidityduring implantation. Two (2) stylets are provided in the Trial LeadKit, one straight and one bent with a diameter of 0.25 mm. |
| Needle andCannulaAssembly | An assembly that includes a 16-gauge stainless steel needle that ispackaged inserted in the fluorinated ethylene propylene (FEP)Cannula that acts as a conduit for passage of the stimulator into theepidural space. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollowpathway in the epidural space for the Trial Lead to pass through moreeasily |
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.
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Image /page/6/Picture/0 description: The image is a logo for a company called Stimwave Technologies. The word "stim" is in blue, and the word "wave" is in green. Below the words "stim wave" is the word "TECHNOLOGIES" in blue. To the right of the word "wave" is a blue graphic of three curved lines that resemble radio waves.
Table 5A. Comparison of Characteristics
| Comparator | Stimwave FreedomSCS System(K160600) | Stimwave FreedomSCS System(K150517) | Stimwave FreedomSCS System(K141399) |
|---|---|---|---|
| Product Code | GZB | Same as K160600 | Same as K160600 |
| Regulation No. | 882.5880 | Same as K160600 | Same as K160600 |
| Regulation Name | Stimulator, Spinal-Cord,Implanted (Pain Relief) | Same as K160600 | Same as K160600 |
| Intended Use | Stimulation of spinalcord for chronic,intractable pain of trunkand lower limbs | Same as K160600 | Same as K160600 |
| Implant Site | Epidural space, L5 to T5 | Same as K160600 | Same as K160600 |
| Environmental Use | Hospital, Home | Same as K160600 | Same as K160600 |
| Intended Clinician | Orthopedic,Neurosurgeon,Anesthesiologist | Same as K160600 | Same as K160600 |
| Intended User | Layperson | Same as K160600 | Same as K160600 |
| Electrode Material | Platinum-iridium 90:10 | Same as K160600 | Same as K160600 |
| Stimulator Body Material | Polyurethane 2363-55D | Same as K160600 | Same as K160600 |
| Cable Features | Multi-lumen Tube | Same as K160600 | Same as K160600 |
| Stimulator Length | 45 centimeters | Same as K160600 | Same as K160600 |
| Diameter | 1.35 millimeters | Same as K160600 | Same as K160600 |
| Electrode Array Length | 24.0 millimeters52.0 millimeters | Same as K160600 | 24.0 millimeters |
| No. of Electrodes | 4 or 8 | Same as K160600 | 4 |
| Electrode Length | 3.0 millimeters | Same as K160600 | Same as K160600 |
| Electrode Spacing | 4.0 millimeters | Same as K160600 | Same as K160600 |
| Electrode Surface Area | 12.72 mm2 | Same as K160600 | Same as K160600 |
| Method of Introduction | Percutaneous | Same as K160600 | Same as K160600 |
| Tissue Contact | Yes | Same as K160600 | Same as K160600 |
| Sterilization | Ethylene Oxide (EO) | Same as K160600 | Same as K160600 |
| Labeling | Labeled as Sterile, SingleUse, Prescription Device | Same as K160600 | Same as K160600 |
| Package | Backer card and twosterile pouches | Same as K160600 | Blister Tray/Tyvek Lid |
| Pulse Frequency | 5 to 1500 Hertz | Same as K160600 | 2 to 1500 Hertz |
| Pulse Width | 50 to 500 microseconds | Same as K160600 | Same as K160600 |
| Current/Voltage Regulated | Current | Same as K160600 | Same as K160600 |
| Output Voltage (300 Ω) | 0 to 4.1 V | Same as K160600 | 0 to 6.3 V |
| Output Voltage (500 Ω) | 0 to 6.4 V | Same as K160600 | 0 to 7.2 V |
| Output Voltage (800 Ω) | 0 to 7.5 V | Same as K160600 | 0 to 8.0 V |
| Output Current (300 Ω) | 0 to 13.5 mA | Same as K160600 | 0 to 21 mA |
| Output Current (500 Ω) | 0 to 12.8 mA | Same as K160600 | 0 to 15 mA |
| Output Current (800 Ω) | 0 to 9.4 mA | Same as K160600 | 0 to 10 mA |
| Waveform | Charge Balanced(delayed) Biphasicasymmetrical | Same as K160600 | Same as K160600 |
| Pulse Shape | Decaying Exponential | Same as K160600 | Same as K160600 |
| Average Current Density(300 Ω) | 105.0 mA/cm2 | Same as K160600 | 111.6 mA/cm2 |
| Average Current Density(500 Ω) | 95.1 mA/cm2 | Same as K160600 | 96.7 mA/cm2 |
| Average Current Density(800 Ω) | 69.0 mA/cm2 | Same as K160600 | 77.0 mA/cm2 |
| Comparator | Stimwave FreedomSCS System(K160600) | Stimwave FreedomSCS System(K150517) | Stimwave FreedomSCS System(K141399) |
| Maximum Phase Charge*(300 Ω) | 6.8 µC/pulse | Same as K160600 | 10.5 µC/pulse |
| Maximum Phase Charge*(500 Ω) | 6.4 µC/pulse | Same as K160600 | 7.2 µC/pulse |
| Maximum Phase Charge*(800 Ω) | 4.7 µC/pulse | Same as K160600 | 5.0 µC/pulse |
| Maximum Charge Density*(300 Ω) | 53.1 µC/cm² | Same as K160600 | 82.5 µC/cm² |
| Maximum Charge Density*(500 Ω) | 50.3 µC/cm² | Same as K160600 | 56.6 µC/cm² |
| Maximum Charge Density*(800 Ω) | 36.9 µC/cm² | Same as K160600 | 39.3 µC/cm² |
| Maximum Current Density*(300 Ω) | 106.1 mA/cm² | Same as K160600 | 165.1 mA/cm² |
| Maximum Current Density*(500 Ω) | 100.6 mA/cm² | Same as K160600 | 113.2 mA/cm² |
| Maximum Current Density*(800 Ω) | 73.9 mA/cm² | Same as K160600 | 78.6 mA/cm² |
| Net Charge | 0 µC | Same as K160600 | Same as K160600 |
| Average Phase Power(300 Ω) | 0.053 W/phase | Same as K160600 | 0.060 W/phase |
| Average Phase Power(500 Ω) | 0.073 W/phase | Same as K160600 | 0.076 W/phase |
| Average Phase Power(800 Ω) | 0.062 W/phase | Same as K160600 | 0.060 W/phase |
| Average Phase PowerDensity (300 Ω) | 0.42 W/cm²/phase | Same as K160600 | 0.48 W/cm²/phase |
| Average Phase PowerDensity (500 Ω) | 0.58 W/cm²/phase | Same as K160600 | 0.59 W/cm²/phase |
| Average Phase PowerDensity (800 Ω) | 0.48 W/cm²/phase | Same as K160600 | 0.60 W/cm²/phase |
| Pulse Delivery Mode | Continuous | Same as K160600 | Same as K160600 |
| ON/OFF Times | No Cycling | Same as K160600 | Same as K160600 |
| Current Path Options | Bipolar | Same as K160600 | Same as K160600 |
| Power Delivery | Embedded receiver andcoupled receiver in lumenof Stimulator body | Coupled receiver, builtinto Stimulator body | Coupled receiver, builtinto Stimulator body |
| Transmit Frequency | 915 MHz | Same as K160600 | Same as K160600 |
| Material | Platinum-iridium 90:10,Polyurethane 2363-55D | Same as K160600 | Same as K160600 |
| Sterile | Yes - ethylene oxide | Same as K160600 | Same as K160600 |
| Single-Use | Yes | Same as K160600 | Same as K160600 |
| Shelf LifeComplies with ISO 10993-1 | 2 yearYes | Same as K160600Same as K160600 | 1 yearSame as K160600 |
| Safety Testing Passed | Yes | Same as K160600 | Same as K160600 |
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Image /page/7/Picture/0 description: The image contains 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" are three curved lines that are dark blue. Underneath the words "stim wave" is the word "TECHNOLOGIES" in a dark blue font inside of a dark blue rounded rectangle.
(*) asterisk denotes that formulas were used for the calculations.
Table 5B identifies the differences between the cleared Freedom SCS System (K150517) and the modifications identified by this Traditional Premarket Notification.
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Image /page/8/Picture/0 description: The image shows 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, inside of a blue rounded rectangle. To the right of the words is a blue circular design that looks like radio waves.
Table 5B. Comparison of the similarities and differences between FDA-cleared Stimwave product (Freedom-8A/4A) and products submitted in this Traditional Premarket Notification (Freedom-8A/4A with Receiver).
| Criteria | Freedom-8A/4A | Freedom-8A/4A with Receiver |
|---|---|---|
| Product Code | GZB | Same as Freedom-8A/4A |
| Regulation No. | 882.5880 | Same as Freedom-8A/4A |
| Regulation Name | Stimulator, Spinal-Cord, Implanted (PainRelief) | Same as Freedom-8A/4A |
| Intended Use | Stimulation of spinal column for chronic,intractable pain of trunk and lower limbs | Same as Freedom-8A/4A |
| Mode of Action | RF wireless transmission of energy toproduce therapeutic stimulation at theStimulator. The external WAA sends apulsed RF signal on a carrier frequencyof 915 MHz to a passive, implantedReceiver within the Stimulator | Same as Freedom-8A/4A |
| No. of Electrodes | 8 or 4 | Same as Freedom-8A/4A |
| MRI Conditional | No, MR Unsafe | Same as Freedom-8A/4A |
| Electrode Material | Platinum-Iridium 90:10 | Same as Freedom-8A/4A |
| Stimulator Body Material | Polyurethane 2363-55D | Same as Freedom-8A/4A |
| Polarity | Programmable(Anode, Cathode, or Off) | Same as Freedom-8A/4A |
| Packaging | Backer card & 2 Tyvek sterile pouches | Same as Freedom-8A/4A |
| Sterilization | Ethylene Oxide (EO) | Same as Freedom-8A/4A |
| Accessories | Guidewire, Stylet(s), Coude Needle,Cannula, Suture Sleeve Cap | Same as Freedom-8A/4A |
| Pulse Frequency | 5 to 1500 Hz | Same as Freedom-8A/4A |
| Pulse Width | 50 to 500 μs | Same as Freedom-8A/4A |
| Output Current (500 Ω) | 0 to 12.8 mA | Same as Freedom-8A/4A |
| Transmit Frequency | 915 MHz | Same as Freedom-8A/4A |
| Power Delivery | Coupled receiver, built into Stimulatorbody | Embedded receiver and coupledreceiver in lumen of Stimulator body |
| Wearable AntennaAssembly (WAA) | ABS plastic transmitter contained in awearable athletic pouch belt | Same as Freedom-8A/4A |
| iPad Application | WaveCrest™ | Same as Freedom-8A/4A |
| Software Level of Concern | Moderate | Same as Freedom-8A/4A |
8. Biocompatibility Data
The materials of the Freedom SCS System (Freedom-8A/4A Stimulator) in direct contact with tissue remain unchanged from the Freedom SCS System (K150517 and K141399) 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 and this Traditional Premarket Notification). 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
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Image /page/9/Picture/0 description: The image is a logo for a company called "Stimwave Technologies". The word "stim" is written in a dark blue, sans-serif font, and the word "wave" is written in a green, sans-serif font. Below the words "stim wave" is the word "TECHNOLOGIES" in a smaller, dark blue, sans-serif font. To the right of the words is a graphic of three curved lines that resemble radio waves, also in dark blue.
Stimwave Technologies Incorporated Traditional 510(k) Premarket Submission Freedom Spinal Cord Stimulator (SCS) System
for the biocompatible testing for cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation (4, 8, and 13 weeks), and subchronic toxicity demonstrated no negative impacts from the materials that are used in the 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 is never in direct or indirect contact with tissue. The WAA remains unchanged from K150517 to this Traditional Premarket Notification and 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 (same as K141399 and K150517) meets biological safety and compatibility requirements of ISO 10993-1:2009 and Blue Book Memorandum G95-1.
9. Non-Clinical Performance Data
The 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.
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 K160600 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 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 with Receiver was 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
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 K160600 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 is a passive component that does not impact the outcome of the leveraged tests for safety and effectiveness.
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Image /page/10/Picture/0 description: The image is a logo for Stimwave Technologies. The word "stim" is in dark blue, and the word "wave" is in green. Below the two words is the word "TECHNOLOGIES" in dark blue, inside of a rounded rectangle. To the right of the words is a series of concentric arcs in dark blue.
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 K160600 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 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 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 complies with design specifications for stylet insertion and withdrawal force. The Stimulator testing presented for K160600 is leveraged from K150517 and is directly applicable for demonstration of device safety and efficacy as the Freedom-8A/4A Stimulator 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 K160600 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 is a passive component that does not impact the outcome of the leveraged tests for safety and effectiveness.
IEC 60601-1 - The 60601-1 testing presented for K160600 is leveraged from K150517 and is directly applicable for demonstration of device safety and efficacy as the WAA remains the same. 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
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Image /page/11/Picture/0 description: The image is a 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, inside of a dark blue rounded rectangle. To the right of the words "stim wave" are concentric circles in dark blue.
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 IEC 60529 testing presented for K160600 is leveraged from K150517 and is directly applicable for demonstration of device safety and efficacy as the WAA remains the same. 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 of the Freedom SCS System satisfies the outlined Particulate Matter design requirements and the applicable standard, IEC 60529.
IEC 60601-1-2 - The WAA remains the same from K150517 to K160600. Thus, the testing for electromagnetic compatibility for emissions, magnetic fields, electrostatic discharge, and radiated RF electromagnetic fields is leveraged from K150517, and is directly applicable for demonstration of device safety and efficacy. For testing the Freedom SCS System for electromagnetic compatibility for radiated RF electromagnetic fields, radiated immunity, and wireless coexistence, the System met all acceptance criteria. For both leveraged and new testing, the WAA operated within all test limits and showed no physical damage and was fully operational. Thus, the WAA for the Freedom-8A/4A SCS System satisfies the IEC 60601-1-2 standard. This testing presented for K160600 is both leveraged from K150517 and new for K160600 and is directly applicable for demonstration of device safety and efficacy as the WAA remains the same.
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, both leveraged and new, 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 or bilateral pain.
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Image /page/12/Picture/0 description: The image shows 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, and to the right of the words is a blue circular wave graphic.
Due to the similarities between the legally marketed predicate device (K150517), and the Freedom SCS System (K160600). 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 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.
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 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 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.
§ 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).