(43 days)
The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile. This device is intended for use during various surgeries where slush and/or cold solution is required.
The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile.
The provided document is a 510(k) premarket notification letter from the FDA to OR Solutions, Inc. regarding their ORS-3000LD Equipment Cover. This document focuses on regulatory approval and classification, not on the technical performance specifications or clinical study results of the device itself.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Information about a standalone performance study.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
This is a regulatory approval letter, indicating the device's classification and its substantial equivalence to a predicate device, allowing it to be marketed. It does not delve into the detailed technical performance data or clinical studies that would typically define acceptance criteria or demonstrate meeting them.
§ 890.5950 Powered heating unit.
(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.