(219 days)
Type 297: Can be used on its own as a lumbar support device or as a conductive garment for use with cleared Transcutaneous Electrical Nerve Stimulation (TENS) devices for the following: The symptomatic relief and management of chronic and intractable pain in the lower back region. Assists in correctly positioning and repositioning pads on difficult to reach locations of the lower back. Lumbar support.
Type 298: Can be used on its own as a lumbar support device only.
The Baxolve XP Conductive Garment Accessory and Lumbar Support Kit (Types 297 and 298) is an innovative and comfortable to wear lumbar support belt. It is intended to help relieve lower back pain. The belt is supplied with a detachable sacral pad ("pelotte") that is covered with a stretch towel cover and can be attached to the inside of the belt. For additional comfort, this pelotte includes an array of flexible rubber fingers that ensure the compressive force and it can accommodate movement during walking. The belt may be used simply as a lumbar support device and can provide an adjustable degree of compression to the lumbo-sacral region due to the elasticated nature of the belt itself. To optimize support in the lumbar spine area, Baxolve XP incorporates "Duopress", an easy to adjust twin compression Compression may be increased with the optional detachable external belt system. compression straps. The type 297 version of the Baxolve XP garment may be connected to transcutaneous Electrical Nerve Stimulation (TENS) devices manufactured by Bio-Medical Research Ltd. and is supplied with a pack of four adhesive pads, four electrode stud covers and instructions for use. The type 298 Baxolve XP garment is similar to the type 297 garment except it is intended as a stand-alone lumbar support device. For purposes of hygiene, the Baxolve XP garment may be cleaned and instructions for device care are included in the user manual.
The provided document is a 510(k) premarket notification for a medical device called the "Baxolve XP Conductive Garment Accessory & Lumbar Support Kit". It focuses on establishing substantial equivalence to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, the document explicitly states: "No clinical studies have been submitted as part of this premarket notification."
This means that the document does not contain the information requested regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established from a study proving criteria.
Instead, the document primarily addresses:
- Contact details and device name
- Regulatory classification and product codes
- Identification of equivalent legally marketed predicate devices (Neurotech Baxolve, K023913; Ultrastim Kit, K013532)
- Description of the device and its intended use/indications for use
- Statement that there are no technological characteristics that could affect safety or effectiveness
- Compliance with quality system regulations (21 CFR 820, I.S. EN ISO 13485:2003) and risk management standards (EN ISO 14971:2007)
- Confirmation of CE marking
The FDA's letter (pages 3-4) confirms the substantial equivalence determination but also notes that this does not mean the device complies with all requirements of the Act or other federal statutes and regulations. The marketing of the device is permitted based on its substantial equivalence to predicate devices, not on specific clinical performance metrics demonstrated through a new study.
§ 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).