(103 days)
The Biocor SVR Softshell Venous Reservoir is indicated for use in procedures requiring the dynamic storage of blood when used with a membrane oxygenator during procedures up to 6 hours in duration.
Not Found
This document is a 510(k) clearance letter for a medical device (Minntech Corporation's Biocor 200 Soft Shell Venous Reservoir), not a study report or a summary of acceptance criteria and performance data.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC study, standalone performance), ground truth, and training set information is not present in the provided text.
The document only states that the device is "substantially equivalent" to predicate devices for its indicated use, which is for dynamic storage of blood when used with a membrane oxygenator during cardiopulmonary bypass procedures up to 6 hours in duration. The substantial equivalence determination is based on the general controls provisions of the Act and compliance with GMP requirements.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.