(105 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 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 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.
The provided text concerns a 510(k) premarket notification for the Freedom Spinal Cord Stimulator (SCS) System (K170141). This document primarily focuses on demonstrating substantial equivalence to a predicate device (K162161) rather than detailing a study that establishes acceptance criteria and proves the device meets those criteria from scratch.
The submission states: "This submission is identical to K162161, but includes summaries of performance testing to support MR Conditional labeling of the Freedom-8A SCS System. No modifications to the Freedom SCS System of K162161 were made in support of this submission." This indicates that the device's fundamental performance was established in the prior K162161 submission, and K170141 specifically addresses MR Conditional labeling.
Therefore, many of the requested details regarding acceptance criteria for a new study, sample sizes for test sets, expert involvement for ground truth, and adjudication methods are not present in this document as it relies on pre-existing data and a demonstration of substantial equivalence rather than a de novo clinical trial or performance study proving new criteria.
However, based on the information provided, we can extract the types of performance tests conducted and the standards against which the device was evaluated, which serve implicitly as acceptance criteria for demonstrating equivalent performance to the predicate device and for MR Conditional labeling.
Here's an attempt to answer the questions based on the provided text, highlighting where information is absent due to the nature of this 510(k) submission:
Acceptance Criteria and Device Performance (Implicit from Compliance Statements)
The document doesn't explicitly list "acceptance criteria" in a table form with numerical targets and then report performance against them for all aspects. Instead, it states compliance with various standards and successful completion of tests. The "acceptance criteria" are implied by the standards cited and the statement that the device "complies" or "passed" these tests.
1. A table of acceptance criteria and the reported device performance
| Category / Test | Implicit Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2009 and G95-1 (cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation, subchronic toxicity). No negative impacts from materials. | "The Freedom SCS System meets biological safety and compatibility requirements of ISO 10993-1:2009 and Blue Book Memorandum G95-1." No negative impacts demonstrated. Materials (Pellethane 55D, Pt-Ir 90:10) have extensive safety record. |
| Temperature Change (AAMI ANSI ISO 14708-3:2008) | Functional, safe rating, passed visual inspection and temperature change testing. | "Freedom-8A/4A Stimulator was functional, receiving a safe rating following post visual inspection and passed the change of temperature testing." |
| Atmospheric Pressure Change (AAMI ANSI ISO 14708-3) | Functional, passed visual inspection and atmospheric pressure change testing. | "Freedom-8A/4A Stimulator were functional following post testing functionality inspection and passed atmospheric pressure change testing." |
| External Defibrillation Exposure (AAMI ANSI ISO 14708-3) | Stimulator & Receiver functional after exposure. | "Freedom-8A/4A Stimulator and Receiver were verified as functional after exposure to external defibrillation." |
| Thermal Shock | No irreversible damage, fully functional, no physical anomalies. | "Freedom-8A/4A Stimulator was found to have 'no irreversible damage' and fully functional... no physical anomalies present." |
| Leakage Current | Zero leakage current on all tested paths/samples. | "Freedom-8A/4A Stimulator was produced zero leakage current on all tested paths for all tested samples." |
| Stylet & Receiver Insertion/Withdrawal Force | Stylet: < 2.5N; Receiver: < 2.2N. No damage upon visual inspection. | "Stylet was found to require less than 2.5N of insertion or withdrawal force... Receiver/RF Stylet was found to require less than 2.2N... Visual inspection confirmed no damage." |
| Mechanical Testing (Tensile & Torsion) | No visible damage to stimulator body or functional damage to components. | "Freedom-8A/4A Stimulator passed all criteria of the test, showing no visible damage to the stimulator body or functional damage to the components." |
| MRI RF Induced Heating (ASTM F2182-11a) | Maximum temperature increase lower than allowable limit for 1.5T and 3T MRI exposure. Device presence not cause injury. | "Freedom-8A Stimulator produced a maximum temperature increase lower than the allowable limit for the 1.5T and 3T MRI procedure and thus passed both. ...its presence would not cause injury to the patient." |
| MRI Image Artifacts (ASTM F2119-07) | No image artifacts in 1.5T or 3T MRI procedures. | "Freedom-8A Stimulator showed that it does not produce image artifacts in 1.5T or 3T MRI procedures." |
| MRI Magnetically Induced Displacement (ASTM F2052-06) | No harm to patient due to displacement. Passes ASTM acceptance criteria for deflection angle in 1.5T and 3T MRI systems. | "Freedom-8A Stimulator showed that it does not harm the patient due to its displacement by forces induced by 1.5T or 3T MRI exposure. ...passes the ASTM acceptance criteria for deflection angle..." |
| MRI Magnetically Induced Torque (ASTM F2213-06) | No harm to patient due to torque. | "Freedom-8A/4A Stimulator must show that it does not harm the patient due to its torque... Freedom-8A Stimulator will not present an additional risk or hazard to a patient in the 1.5T MRI or 3T environments or less with regard to torque." |
| Post-MR Exposure Stimulation Waveforms | No component damage, full functionality, performance not affected. | "Stimulation waveforms following post-exposure showed no component damage had occurred after MR exposure. ...fully functional following standard 1.5T or 3T MR procedures and its performance or functionality is not affected." |
| WAA Temperature Change (IEC 60601-1) | Met passing criteria of visual and functional inspections. No physical damage, fully operational. | "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." |
| WAA Atmospheric Pressure Change (IEC 60601-1) | Met passing criteria of visual and functional inspections. No physical damage, fully operational. | "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." |
| WAA Push, Drop, Impact, Mold Stress (IEC 60601-1) | Robust to withstand expected damage. Met passing criteria of visual and functional inspections. No physical damage, fully operational. | "WAA is robust to withstand expected damage... met the passing criteria... showed no physical damage and was fully operational." |
| WAA Identification, Marking, Documents (IEC 60601-1) | Compliance with requirements regarding clear identification and viewable markings/documents. | "Determined through an analysis of the labeling that the WAA complies with the requirements... All requirements and markings are clearly identified and viewable." |
| WAA Protection, Creepage, Air Clearances (IEC 60601-1) | Compliance with requirements. | "Determined through an analysis of the design that the system satisfies the requirements..." |
| WAA Ingress of Water (IEC 60529) | Met passing criteria of visual and functional inspections. No physical damage, fully operational. | "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." |
| WAA Particulate Matter (IEC 60529) | Met passing criteria of visual and functional inspections. No physical damage, fully operational. | "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." |
| WAA Electromagnetic Compatibility (IEC 60601-1-2) | 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. | "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." |
| Software Verification | Passed all verification tests, met design requirements. | "Software of the Freedom SCS System passed all verification tests outlined and the design requirements for Software Verification have been met." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated for each test. The document mentions "all tested samples," "all tested stylets," etc., implying a sample was used, but the exact number is not provided.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests described are primarily bench testing and engineering evaluations, not clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. The document describes non-clinical performance testing (bench testing, engineering evaluations). There is no mention of human experts establishing "ground truth" for these technical performance tests in the way one would for diagnostic AI. The "ground truth" for these tests comes from adherence to specific engineering and material standards (e.g., ASTM, ISO, IEC).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically relevant for human reader studies or where expert consensus is needed to establish ground truth in complex or ambiguous cases. This document details engineering and compliance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. This is a medical device (spinal cord stimulator), not an AI diagnostic tool that assists human readers. The submission explicitly states: "There was no clinical testing required to support the medical device, as the indications for use are equivalent to the legally marketed predicate devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This isn't an algorithm that performs a standalone diagnostic function. It's a medical device. The "performance" described is the device's physical and electrical characteristics and its ability to function within specified parameters, especially regarding MR compatibility.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the conventional sense of ground truth for diagnostic AI. The ground truth for these tests is defined by established engineering standards, material properties, and functional specifications of the device components (e.g., force measurements, electrical outputs, temperature limits, artifact presence).
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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Image /page/0/Picture/2 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 a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mav 2, 2017
Stimwave Technologies Incorporated Elizabeth Greene Vice President Of Ouality Assurance And Regulatory Affairs 901 East Las Olas Boulevard. Suite 201 Fort Lauderdale, Florida 33301
Re: K170141
Trade/Device Name: Freedom Spinal Cord Stimulator (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: March 31, 2017 Received: April 4, 2017
Dear Elizabeth Greene:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
| William J. | Digitally signed by William J. Heetderks -S |
|---|---|
| Heetderks -S | DN: c=US, o=U.S. Government, ou=HHS, |
| ou=FDA, ou=People, | |
| 0.9.2342.19200300.100.1.1=0010149848, | |
| cn=William J. Heetderks -S | |
| Date: 2017.05.02 16:14:57 -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
510(k) Number (if known) K170141
Device Name
Freedom Spinal Cord Stimulator (SCS) System
Indications for Use (Describe)
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 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary For Freedom Spinal Cord Stimulator (SCS) System K170141
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
January 13, 2017
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, PDBT-915-2A (K162161)
5. Device Description
This submission is identical to K162161, but includes summaries of performance testing to support MR Conditional labeling of the Freedom-8A SCS System. No modifications to the Freedom SCS System of K162161 were made in support of this submission.
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
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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.
| Freedom-8AStimulator,Freedom-4AStimulator | A polyurethane (Pellethane 55D) casing with an embedded receiver, flexiblecircuit board and electrodes (Platinum Iridium 90:10) that is placed in thepatient's epidural space. The Freedom-8A Stimulator has eight (8) electrodes, andthe Freedom-4A Stimulator has four (4) electrodes. Identical to K162161. |
|---|---|
| Receiver | A copper and PEEK cable with dual couplers; placed within the center lumen ofthe Freedom-8A or Freedom-4A Stimulator with the distal end combination ofReceiver and Stimulator being placed under the skin. Two (2) Receivers areprovided with each kit. Identical to K162161. |
| Stylet(s) | A stainless steel wire with a polypropylene handle that is inserted into the opencentral lumen of the stimulator to provide rigidity during implantation. Two (2)stylets are provided in the Receiver Kit, one straight and one bent, each withdiameter of 0.30 mm. Identical to K162161. |
| Needle | A 13-gauge stainless steel needle that acts as a conduit for passage of theStimulator into the epidural space. Identical to K162161. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow pathway inthe epidural space for the Stimulator to pass through easily. Identical to K162161. |
| Suture SleeveCap | A polyurethane (Pellethane 55D) cap that is placed over the proximal end of theStimulator. The Suture Sleeve Cap is attached to the Freedom-8A/4A Stimulatorand can be sutured to tissue to reduce the possibility of device migration. Identicalto K162161. |
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 RF power with embedded waveform parameter settings and switches for changing parameter settings as needed by the user. Identical to K162161; |
| B. Switch Membrane – An elastomeric silicon rubber pad that corresponds to switches on the MFS that allows the user to turn the device on/off or increase or decrease power amplitude as well as interpret device power status (On, Off, Charging, Transmitting, and Bluetooth® Connection). Identical to K162161; |
| C. Battery Assembly – A battery and wire assembly for charging and the MFS for power delivery. Identical to K162161. |
| 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. Identical to K162161. |
| Charger Kit |
An off-the-shelf battery charger that uses a power adapter and USB to micro-Battery Charger USB cable to recharge the encased lithium ion battery of the WAA. Identical to K162161.
Freedom-8A and Freedom-4A Spare Lead (Spare Lead Kit)
| Freedom-8A | A polyurethane (Pellethane 55D) casing with an embedded receiver, flexible |
|---|---|
| Spare Lead, | circuit board and electrodes (Platinum Iridium 90:10) that is placed in the |
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| Freedom-4A | patient's epidural space. The Freedom-8A Spare Lead has eight (8) electrodes, | |
|---|---|---|
| Spare Lead | and the Freedom-4A Spare Lead has four (4) electrodes. Identical to K162161. | |
| 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 to K162161. | ||
| 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 to K162161. | ||
| Needle | A 13-gauge stainless steel needle that acts as a conduit for passage of the Spare | |
| Lead into the epidural space. Identical to K162161. | ||
| 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 to | ||
| K162161. | ||
| Suture | Sleeve A polyurethane (Pellethane 55D) cap that is placed over the proximal end of the | |
| Cap | 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 to K162161. |
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, flexiblecircuit board and electrodes (Platinum Iridium 90:10) that is placedpercutaneously in the patient's epidural space. The Freedom-8A Trial Lead haseight (8) electrodes, and the Freedom-4A Trial Lead has four (4) electrodes.Identical to K162161. |
|---|---|
| RF Stylet | A copper and PEEK cable with dual couplers; placed within the center lumen ofthe Freedom-8A or Freedom-4A Trial Lead with the distal end combination ofRF Stylet and Trial Lead being placed under the skin. Two (2) RF Stylets areprovided with each kit. Identical to K162161. |
| Stylet(s) | A stainless steel wire with a polypropylene handle that is inserted into the opencentral 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 adiameter of 0.30 mm. Identical to K162161. |
| Needle | A 13-gauge stainless steel needle that acts as a conduit for passage of the TrialLead into the epidural space. Identical to K162161. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow pathway inthe epidural space for the Trial Lead to pass through more easily. Identical toK162161. |
Sterile Revision Kit
| Stylet(s) | A stainless steel wire with a polypropylene handle that is inserted into the opencentral lumen of the stimulator to provide rigidity during implantation. Two(2) stylets are provided in the Sterile Revision Kit, one straight and one bentwith a diameter of 0.30 mm. Identical to K162161. |
|---|---|
| Needle | A 13-gauge stainless steel needle that acts as a conduit for passage of theStimulator/Lead into the epidural space. Identical to K162161. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow pathway inthe epidural space for the Stimulator/Lead to pass through easily. Identical toK162161. |
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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(Predicate - K162161) | Stimwave Freedom SCS System(Subject device) |
|---|---|---|
| Product Code | GZB | Same as K162161 |
| Regulation No. | 882.5880 | Same as K162161 |
| Regulation Name | Stimulator, Spinal-Cord,Implanted (Pain Relief) | Same as K162161 |
| Intended Use | Stimulation of spinal cord forchronic, intractable pain of trunk andlower limbs | Same as K162161 |
| Mode of Action | RF wireless transmission of energyto produce stimulation atStimulator electrodes. WAA sendsa pulsed RF signal on a carrierfrequency of 915MHz to theStimulator | Same as K162161 |
| Implant Site | Epidural space, L5 to T5 | Same as K162161 |
| Environmental Use | Hospital, Home | Same as K162161 |
| Intended Clinician | Orthopedic, Neurosurgeon,Anesthesiologist | Same as K162161 |
| Intended User | Layperson | Same as K162161 |
| Electrode Material | Platinum-iridium 90:10 | Same as K162161 |
| Stimulator Body Material | Polyurethane 2363-55D | Same as K162161 |
| Cable Features | Multi-lumen Tube | Same as K162161 |
| Stimulator Length | 45 centimeters | Same as K162161 |
| Diameter | 1.35 millimeters | Same as K162161 |
| Electrode Array Length | 24.0 millimeters52.0 millimeters | Same as K162161 |
| No. of Electrodes | 4 or 8 | Same as K162161 |
| Electrode Length | 3.0 millimeters | Same as K162161 |
| Electrode Spacing | 4.0 millimeters | Same as K162161 |
| Electrode Surface Area | $12.72 mm^2$ | Same as K162161 |
| Method of Introduction | Percutaneous and Anchor Incision | Same as K162161 |
| Tissue Contact | Yes | Same as K162161 |
| Sterilization | Ethylene Oxide (EO) | Same as K162161 |
| Labeling | Labeled as Sterile, Single Use,Prescription Device | Same as K162161 |
| Comparator | Stimwave Freedom SCS System(Predicate - K162161) | Stimwave Freedom SCS System(Subject device) |
| Package | Backer card and two sterilepouches | Same as K162161 |
| Pulse Frequency | 5 to 1500 Hertz | Same as K162161 |
| Pulse Width | 50 to 500 microseconds | Same as K162161 |
| Current/Voltage Regulated | Current | Same as K162161 |
| Output Voltage (300 Ω) | 0 to 4.1 V | Same as K162161 |
| Output Voltage (500 Ω) | 0 to 6.4 V | Same as K162161 |
| Output Voltage (800 Ω) | 0 to 7.5 V | Same as K162161 |
| Output Current (300 Ω) | 0 to 13.5 mA | Same as K162161 |
| Output Current (500 Ω) | 0 to 12.8 mA | Same as K162161 |
| Output Current (800 Ω) | 0 to 9.4 mA | Same as K162161 |
| Waveform | Charge Balanced (delayed)Biphasic asymmetrical | Same as K162161 |
| Polarity | Programmable(Anode, Cathode, or Off) | Same as K162161 |
| Pulse Shape | Decaying Exponential | Same as K162161 |
| Avg. Current Density (300 Ω) | 105.0 mA/cm² | Same as K162161 |
| Avg. Current Density (500 Ω) | 95.1 mA/cm² | Same as K162161 |
| Avg. Current Density (800 Ω) | 69.0 mA/cm² | Same as K162161 |
| Max. Phase Charge* (300 Ω) | 6.8 µC/pulse | Same as K162161 |
| Max. Phase Charge* (500 Ω) | 6.4 µC/pulse | Same as K162161 |
| Max. Phase Charge* (800 Ω) | 4.7 µC/pulse | Same as K162161 |
| Max. Charge Density* (300 Ω) | 53.1 µC/cm² | Same as K162161 |
| Max. Charge Density* (500 Ω) | 50.3 µC/cm² | Same as K162161 |
| Max. Charge Density* (800 Ω) | 36.9 µC/cm² | Same as K162161 |
| Max. Current Density* (300 Ω) | 106.1 mA/cm² | Same as K162161 |
| Max. Current Density* (500 Ω) | 100.6 mA/cm² | Same as K162161 |
| Max. Current Density* (800 Ω) | 73.9 mA/cm² | Same as K162161 |
| Net Charge | 0 µC | Same as K162161 |
| Avg. Phase Power (300 Ω) | 0.053 W/phase | Same as K162161 |
| Avg. Phase Power (500 Ω) | 0.073 W/phase | Same as K162161 |
| Avg. Phase Power (800 Ω) | 0.062 W/phase | Same as K162161 |
| Avg. Phase Power Density (300 Ω) | 0.42 W/cm²/phase | Same as K162161 |
| Avg. Phase Power Density (500 Ω) | 0.58 W/cm²/phase | Same as K162161 |
| Avg. Phase Power Density (800 Ω) | 0.48 W/cm²/phase | Same as K162161 |
| Pulse Delivery Mode | Continuous | Same as K162161 |
| ON/OFF Times | No Cycling | Same as K162161 |
| Current Path Options | Bipolar | Same as K162161 |
| Power Delivery | Embedded receiver and coupledreceiver in lumen of Stimulatorbody | Same as K162161 |
| Transmit Frequency | 915 MHz | Same as K162161 |
| Material | Platinum-iridium 90:10,Polyurethane 2363-55D | Same as K162161 |
| Sterile | Yes - ethylene oxide | Same as K162161 |
| Contract Sterilizer | Steris Isomedix Services | Same as K162161 |
| Single-Use | Yes | Same as K162161 |
| Shelf Life | 2 year | Same as K162161 |
| Complies with ISO 10993-1 | Yes | Same as K162161 |
| Safety Testing Passed | Yes | Same as K162161 |
| MR Conditional | No, MR Unsafe | Yes |
| Accessories | Receiver/RF Stylet, Stylet(s),Guidewire, Needle, Suture SleeveCap | Same as K162161 |
| Charger | USB Charger | Same as K162161 |
| Wearable Antenna Assembly | Aluminum transmitter and | Same as K162161 |
| Comparator | Stimwave Freedom SCS System(Predicate - K162161) | Stimwave Freedom SCS System(Subject device) |
| separate, connected Antenna | ||
| Software Level of Concern | Moderate | Same as K162161 |
| iPad Application | WaveCrestTM | Same as K162161 |
| Kits | Receiver Kit, Spare Lead Kit, TrialLead Kit, Sterile Revision Kit, WAAKit, Charger Kit | Same as K162161 |
Table 5A. Comparison of Characteristics
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(*) asterisk denotes that formulas were used for the calculations.
8. Biocompatibility Data
Materials of this submission are identical to K162161. The materials of the Freedom-8A/4A Stimulator in direct contact with tissue remain unchanged from the Freedom SCS System (K162161) and thus, the biocompatibility tests conducted on representative subassemblies of the Freedom SCS System (Freedom-4, K141399) directly apply to the Freedom SCS System (K162161, and this submission). 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
No modifications to the Freedom SCS System of K162161 were made in support of this submission. 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,
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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 this submission is leveraged from K162161 and 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 this submission is leveraged from K160600 and K162161, 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 this submission is leveraged from K162161, 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 this submission is leveraged from K162161, 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 this submission is leveraged from K162161, and is directly applicable for demonstration of device safety and efficacy as the Freedom-8A/4A Stimulator remains the same. The Receiver/RF Stylet testing presented for this submission is leveraged from K162161, 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,
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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 this submission is leveraged from K162161, 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 magnetic resonance imaging (MRI) radio frequency (RF) induced heating as related to specific absorbance rate (SAR), the Freedom-8A Stimulator produced a maximum temperature increase lower than the allowable limit for the 1.5T and 3T MRI procedure and thus passed the 1.5T and 3T testing. The Freedom-8A Stimulator produced a maximum temperature increase lower than the allowable limit for the 1.5T and 3T MRI procedure and thus passed both.
ASTM F2182-11a - In accordance with F2182-11a - American Society for Testing and Materials (ASTM) International Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging, the Freedom-8A/4A Stimulator showed that its presence would not cause injury to the patient with the implant during an MRI procedure. The Freedom-8A Stimulator is a passive implant that is not powered while the external unit is not transmitting to it.
ASTM F2119-07 - In accordance with F2119-07 - American Society for Testing and Materials (ASTM) International Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, the Freedom-8A Stimulator showed that it does not produce image artifacts in 1.5T or 3T MRI procedures.
ASTM F2052-06 - In accordance with F2052-06 - The American Society for Testing and Materials (ASTM) International Designation Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, the Freedom-8A Stimulator showed that it does not harm the patient due to its displacement by forces induced by 1.5T or 3T MRI exposure. The Freedom-8A Stimulator passes the ASTM acceptance criteria for deflection angle in a 1.5T and 3T MRI system. The Freedom-8A Stimulator will not present an additional risk or hazard to a patient when used in their tested MR environment
ASTM F2213-06 - In accordance with F2213-06 - American Society for Testing and Materials (ASTM) International Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment, the Freedom-8A/4A Stimulator must show that it does not harm the patient due to its torque by forces induced by MRI exposure. The Freedom-8A Stimulator will not present an additional risk or hazard to a patient in the 1.5T MRI or 3T environments or less with regard to torque.
The stimulation waveforms following post-exposure showed no component damage had occurred after MR exposure. During testing, no component damage was observed in any waveform. Based on these test results, the Freedom-8A Stimulator will be fully functional following standard 1.5T or 3T MR procedures and its performance or
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functionality is not affected by such exposures.
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. This testing presented for this submission is leveraged from K162161 and is directly applicable for demonstration of device safety and efficacy as the WAA remains the same.
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 outlined Particulate Matter design requirements and the applicable standard, IEC 60529. This testing presented for this submission is leveraged from K162161 and is directly applicable for demonstration of device safety and efficacy as the WAA remains the same.
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. This testing presented for this submission is leveraged from K162161 and is directly applicable for demonstration of device safety and efficacy as the WAA remains
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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. This testing presented for this submission is leveraged from K162161 and is directly applicable for demonstration of device safety and efficacy as the Freedom SCS System remains the same.
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 device (K162161), and the Freedom SCS System (this submission), 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 device 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/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 device, and materials for the implanted stimulator are the same as the legally marketed predicate device.
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It has been shown in this 510(k) submission that the differences between the Freedom SCS System and the legally marketed predicate device do not raise any questions regarding its safety and effectiveness as compared to legally marketed predicate device. Freedom SCS System, as designed and manufactured, is determined to be substantially equivalent to the referenced legally marketed predicate device.
§ 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).