(64 days)
The NewLife Sciences LLC, Model TMR, is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
The NewLife Sciences LLC, Model TMR, consists of a control console, two Treatment Probes (electrodes), and a Security Cartridge. The system operates on 115V wall current. Treatment, intended to take place under the supervision of a physician in a medical setting, consists of applying very low current to painful tissue and associated trigger points with the Treatment Probes.
The provided 510(k) summary for the NewLife Sciences LLC, Model TMR, is for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of device falls under a classification where clinical performance studies establishing new safety or effectiveness criteria are typically not required, especially when substantial equivalence to existing predicate devices is being claimed for a Class II device. The summary explicitly states: "NewLife Sciences LLC, Model TMR is identical to the MediPhysics Pain Centers of America (K032928) which has been determined to be substantially equivalent to the cited predicate devices based on intended use, indications for use, design characteristics, and technological characteristics and that the differences between the NewLife Sciences TMR ard cited predicate devices are minor and raise no new issues of safety or effectiveness."
Therefore, the performance section only states "The NewLife Sciences TMR has been systematically tested and test results demonstrate that it fulfills design and performance specifications.", which likely refers to engineering and bench testing to confirm the device operates according to its technical specifications, rather than a clinical study with human subjects to prove clinical efficacy against specific acceptance criteria. This is common for predicate pathway 510(k) submissions where the device is substantially equivalent to legally marketed devices.
Given this, I cannot provide the detailed information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment because such a clinical study, as typically described for new performance claims, was not part of this 510(k) submission. The FDA letter confirms the substantial equivalence determination but does not mention any specific clinical performance data from patient studies.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).