(199 days)
The COLDFLO™ models combine cold and compression therapies. This combination is intended to provide a temporary increase in the circulation of fluids from the treated limb, reducing minor pain and swelling. The device may also enhance healing secondary to the reduction of swelling in the limb.
The Cold Flo® is a device that combines the function of two devices traditionally used for providing cold therapy and massage therapy. Like a Powered Inflatable Tube Massager, the Cold Flo® provides massage therapy through a pump providing compression to the affected limb. This pressure, depending on the Cold Flo® model, is either sequential or intermittent. At the same time, the Cold Flo® delivers cold therapy by circulating cold water through the limb sleeve, like a Cold Water Circulating Pack. The single version contains one chamber that inflates or deflates to provide intermittent pressure. The sequential version contains 3 chambers that inflate and deflate sequentially (from distal to proximal), and an inner sleeve through which the cold water flows. The Cold Flo® sleeve is made of nylon and poly-ether-urethane.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the Bio Compression Cold Flo®, which aims to establish substantial equivalence to predicate devices for regulatory clearance. It describes the device's intended use, technological characteristics, and compares it to other similar devices.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts for ground truth, or adjudication methods for any test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- A standalone algorithm performance study.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- The sample size for a training set or how its ground truth was established, as this is a medical device, not an AI/ML algorithm requiring such training.
The document primarily focuses on demonstrating that the Cold Flo® is substantially equivalent to existing legally marketed devices, which is the typical pathway for 510(k) clearance.
§ 890.5720 Water circulating hot or cold pack.
(a)
Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.