(136 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.
This submission is based upon the established Stimwave product family offering additional surgical kitting options (Spare Lead Kit and Sterile Revision Kit), updates to the surgical kits (Receiver Kit and Trial Lead Kit) to include new accessory components (Needle, and RF Stylet), a new Wearable Antenna Assembly (WAA) model utilizing a Low Energy (LE) Bluetooth module, a USB battery charger, and upgrades to the WaveCrest Application.
The Stimwave Technologies Incorporated (Stimwave) Freedom Spinal Cord SCS System (System) is used for spinal column stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or lower limbs including unilateral pain. The therapy utilizes pulsed electrical current to create an energy field that acts on nerves near the spinal column. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator), receiver component (Receiver), and an externally worn transmitter (Wearable Antenna Assembly (WAA)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.
The Stimwave Freedom Spinal Cord Stimulator (SCS) System (K162161) sought clearance by demonstrating substantial equivalence to its predicate devices (K160600, K150517, and K141399). Therefore, the acceptance criteria and performance are primarily based on non-clinical testing verifying its components meet design requirements and applicable voluntary standards. There was no clinical testing required or performed for this submission as the device's indications for use and underlying technology were considered equivalent to the already legally marketed predicate devices with established safety and efficacy.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance statistics in a pass/fail format typical for classification. Instead, it describes various performance tests and states that the device "complies" or "passed" the criteria of the respective standards. The acceptance criteria essentially align with the requirements of the listed voluntary standards and the device's design specifications for safety and functionality.
| Acceptance Criteria Category | Standard / Test Type | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | ISO 10993-1:2009, Blue Book Memorandum G95-1 | - No negative impacts from materials for cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation (4, 8, and 13 weeks), and subchronic toxicity. |
- Materials (Pellethane 55D, Pt-Ir) have extensive record of chronic and carcinogenetic safety.
- WAA is "noncontacting device" and outside the scope of ISO 10993-1:2009 for body contact.
- Conclusion: Meets biological safety and compatibility requirements. |
| Protection from Temperature Change | AAMI ANSI ISO 14708-3:2008 | - Freedom-8A/4A Stimulator: Functional, safe rating, passed post visual inspection, and passed temperature change testing. - WAA: Met passing criteria of visual and functional inspections, no physical damage, fully operational. |
| Atmospheric Pressure Change | AAMI ANSI ISO 14708-3:2008 | - Freedom-8A/4A Stimulator: Functional following post testing functionality inspection, passed atmospheric pressure change testing. - WAA: Met passing criteria of visual and functional inspections, no physical damage, fully operational. |
| External Defibrillation Exposure | AAMI ANSI ISO 14708-3:2008 | - Freedom-8A/4A Stimulator and Receiver: Verified as functional after exposure. - Conclusion: Complies with testing requirements. |
| Thermal Shock | Applicable Standard (not explicitly named, implies AAMI ANSI ISO 14708-3:2008 context) | - Freedom-8A/4A Stimulator: "No irreversible damage" and fully functional, no physical anomalies present. - Conclusion: Complies with thermal shock design requirements and applicable standard. |
| Leakage Current | Applicable Standard (not explicitly named, implies AAMI ANSI ISO 14708-3:2008 context) | - Freedom-8A/4A Stimulator: Produced zero leakage current on all tested paths for all tested samples. - Conclusion: Complies with leakage design requirements and applicable standard. |
| Stylet Insertion/Withdrawal Force | Design Specifications | - Stylet within Stimulator: Required less than 2.5N insertion/withdrawal force. - Receiver within Stimulator: Required less than 2.2N insertion/withdrawal force.
- Visual inspection confirmed no damage to stimulator samples.
- Conclusion: Complies with design specifications. |
| Mechanical Testing | Design Requirements | - Freedom-8A/4A Stimulator: Passed all criteria of tensile and torsion testing, showing no visible damage to stimulator body or functional damage to components. - Conclusion: Complies with all stimulator mechanical design requirements. |
| WAA Robustness (Push, Drop, Impact, Mold Stress Relief) | IEC 60601-1 | - Determined to be robust to withstand expected damage. Met passing criteria of visual and functional inspections, showed no physical damage, fully operational. - Conclusion: Satisifes design requirements and applicable standard. |
| WAA Identification, Marking, Documents | IEC 60601-1 | - Analysis of labeling determined compliance with requirements. All requirements and markings clearly identified and viewable. - Conclusion: Complies with the requirements of the standard. |
| WAA Means of Protection, Creepage Distances, Air Clearances | IEC 60601-1 | - Analysis of design determined system satisfies requirements. - Conclusion: Satisfies requirements of the applicable standard. |
| Ingress of Water | IEC 60529 | - WAA: Met passing criteria of visual and functional inspections, showed no physical damage, fully operational. - Conclusion: Satisfies design requirements and applicable standard. |
| Particulate Matter | IEC 60529 | - WAA: Met passing criteria of visual and functional inspections, showed no physical damage, fully operational. - Conclusion: Satisfies design requirements and applicable standard. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | - WAA: 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 all test limits, showed no physical damage, and fully operational. - Conclusion: Satisfies the standard. |
| Software Verification | Design Requirements | - Passed all verification tests outlined. - Design requirements for Software Verification met. |
| Overall Compliance | National and International Standards, Design Inputs/Specifications | - Complies with applicable standards for neurostimulators, electrical safety, electromagnetic interference and compatibility, packaging, and sterilization. - Output meets design inputs and specifications.
- Passed all testing.
- Conclusion: Substantially equivalent to legally marketed predicate devices, and differences do not raise questions of safety and effectiveness. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to "tested samples" for hardware components and "analysis of labeling" or "analysis of design" for other aspects. Specific sample sizes for each test are not provided. The data provenance is non-clinical, meaning it's from laboratory and engineering testing, not patient data. No country of origin is specified for the testing data itself, but the submission is from a US company (Fort Lauderdale, Florida). It is by nature retrospective since it refers to testing already completed.
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)
This is not applicable as the submission focuses on non-clinical performance data and engineering verification. The "ground truth" here is adherence to specified voluntary standards (e.g., AAMI ANSI ISO 14708-3:2008, IEC 60601-1, IEC 60529, IEC 60601-1-2) and internal design requirements, rather than expert clinical consensus or patient-derived ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept (adjudication for ground truth establishment) is relevant for studies involving human interpretation or clinical data analysis where disagreements need resolution. The tests described are objective engineering and laboratory tests against predefined criteria.
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, a multi-reader multi-case comparative effectiveness study was not done. This device is a spinal cord stimulator, not an AI-assisted diagnostic or imaging system. 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." and "There was no clinical testing performed on this device since performance testing demonstrated similar performance as the legally marketed predicate devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a medical implant system; it does not involve an algorithm performing a standalone diagnostic or interpretative task. The "software" mentioned (WaveCrest Application) is for controlling the stimulator parameters, not for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the predefined requirements from voluntary international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety, AAMI ANSI ISO 14708-3 for active implantable medical devices) and the device's internal engineering design specifications. The compliance with these standards and specifications serves as the basis for demonstrating safety and effectiveness for substantial equivalence.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no AI/ML component requiring a training set, the concept of establishing ground truth for a training set does not apply.
§ 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).