(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: |
§ 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).