Search Results

The RMI Hemoconcentrator Preference Pack is a medical device convenience pack that is intended to allow RMI customers to specify their preference for one or more of the following devices that will be provided in their hemoconcentrator pack :

• Rinse-Required Hemoconcentrator with tubing set and prime lines, LCH-500-A
• Pre-Rinsed BioFilterTM 140 Hemoconcentrator, HEM-001
• 24 inch Hemoconcentrator Tubing Set, TS-024
• 36 inch Hemoconcentrator Tubing Set, TS-036
• Hemoconcentrator Adapter Set, HEM-001 Adapters --
• Hemoconcentrator Waste Bag, WB-001
• BioFilterTM 140 with Adapter Set, HEM-001-A -
• BioFilterTM 140 with 24 inch Tubing Set, HEM-024 (
• BioFilter™ 140 with 36 inch Tubing Set, HEM-036 I
• BioFilterTM 140 with 24 inch Tubing Set and Maste Bag, HEM-O24-B
• Biofilter TM 140 with 36 inch Tubing Set and Waste Bag, HEM-024-B
• Hemoconcentrator Pole Mount, WEW OV
• Hemoconcentrator Pole Mount, HEM-OIH

The hemoconcentrator is intended for relief or mitigation of overhadration in patients undergoing cardiopulmonary bypass procedures and to decrease the concentration of plasma water in blood.

Not Found

This document is a 510(k) premarket notification for the RMI Hemoconcentrator Preference Pack. The FDA has determined that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain information on acceptance criteria or a study that proves the device meets acceptance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials or performance studies with specific statistical acceptance criteria as might be seen for devices undergoing PMA (Premarket Approval) or for AI/ML-based software as a medical device (SaMD).

The provided text only includes:

• Predicate Device Identification: A list of previously cleared or pre-amendment devices to which the RMI Hemoconcentrator Preference Pack claims substantial equivalence.
• FDA Clearance Letter: Official communication from the FDA confirming the device's substantial equivalence and allowing it to be marketed.
• Intended Use Statement: Describes the purpose of the hemoconcentrator (relief of overhydration during cardiopulmonary bypass and decrease plasma water concentration in blood) and the various components that can be included in the preference pack.

Therefore, I cannot fulfill the request to describe acceptance criteria and associated study details based on the provided text.

Ask a specific question about this device