(67 days)
Monitoring combined pressure and electrical impedance (volume) in the cardiovascular system
The Cath-Cath-Catheter is a disposable/single use, sterile pressure-volume catheter transducer that combines one or two pressure transducers and a series of electrodes mounted at various locations along the distal segment of the catheter body. It terminates in one electrical connection at the proximal end.
The medical device in question is the Millar Instruments Cardia-Cath, a Pressure-Volume (PV) Catheter Transducer. The provided text outlines the acceptance criteria and corresponding study results for this device, primarily focusing on verification testing, biocompatibility, sterility, and accelerated aging, demonstrating its substantial equivalence to a legally marketed predicate device (Millar model SPC-550).
Here's an organized breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Verification Testing (BP-22) | - Catheters must meet the same specifications as the legally marketed predicate device as defined in its IFU. |
- Compliance with BP-22 standard requirements.
- Temperature Error Band at Zero Pressure: ≤ 3.24 mmHg (for predicate device).
- Sensitivity Error Band: ≤ 3.16% (for predicate device). | - All tested catheters met the testing requirements and complied with BP-22 standard requirements.
- Deviation 1: Temperature Error Band at Zero Pressure relaxed to 3.5 mmHg.
- Deviation 2: Sensitivity Error Band relaxed to 3.5%.
- The modified device IFU includes the new (relaxed) values to ensure end-users obtain the same level of data accuracy. |
| Transportation Testing | - Compliance with ASTM D4169-08 standards for fully packaged finished product. - Samples must pass all tests including bubble leak and packaging integrity.
- No impact on device functionality (safety and effectiveness) after transportation testing. | - Samples passed all tests including bubble leak test and packaging integrity, as per DDL report No: 1009057 Rev. A.
- Functionality testing (Millar reference VRP-2010-0423-01 VAL-180) confirmed no impact on device functionality, safety, and effectiveness. |
| Biocompatibility (ISO 10993-1) | - Requirements for External communicating device, circulating blood, contact duration A-Limited (
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).