Device Information

Indications

The CardioCurve Steerable Sheath is indicated for introducing cardiovascular devices to the epicardial or endocardial surfaces of the heart, including the left side, through the interatrial septum.

• MedDRA Code: 10007541 (Catheter introduction)

Intended Use

The device is used for minimally invasive procedures to access the heart’s surfaces for cardiovascular devices.

Availability

Prescription use only (21 CFR 801 Subpart D).

Contraindications

According to regulatory documents, there are no specific contraindications, but the general risk factors related to cardiovascular device introductions apply.

Limitations

The device must be used by trained professionals in appropriate settings such as hospitals or cardiovascular labs.

Study Results

Performance testing confirmed the CardioCurve Steerable Sheath meets all design specifications and critical performance attributes. Testing included fatigue and wear, fluid leakage, and strength tests, ensuring the device is effective and safe.

Regulatory Information

The device complies with quality system regulations, good manufacturing practices, and labeling requirements. It was found to be substantially equivalent to the predicate device, K210185.

Manufacturer Information

• CIRCA Scientific Inc.
• 14 Inverness Drive East, Suite H-136, Englewood, Colorado 80112
• Contact: Alice Ouyang (Regulatory Affairs Manager)

Predicate Device Information

• Device Name: CardioCurve Steerable Sheath 510(k) Number: K210185
• Is the predicate device an earlier version of the same device?
  • Yes
• Substantially equivalent based on similar intended use and technological characteristics.
• The CardioCurve Steerable Sheath (K240004) differs from the predicate device (K210185) by replacing the Tuohy Borst adapter with a cap, shortening the dilator shaft, and relocating the hemostasis valve to the exterior of the sheath handle. The Instructions for Use (IFU) were updated to reflect these design changes without affecting safety or effectiveness.

Implications

This device will facilitate safer and more efficient catheter-based procedures in cardiac care. It offers precise control and minimal risk of complications during heart interventions.

References

1. CardioCurve Steerable Sheath. 510(k) Number: K240004. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K240004.
2. CIRCA Scientific Inc. https://www.circascientific.com/