(101 days)
The St. Jude Medical™ CPS Direct™, Mediguide™ Enabled slittable outer guide catheter is designed for intracardiac access of the venous system of the heart and to serve as a conduit during implantation for the delivery of contrast medium and St. Jude Medical™ devices (including implantable left heart leads and delivery tools), and support of fluids where minimizing blood loss is essential. The CPS Direct™, Mediguide Enabled slittable outer guide catheter are used with the Mediguide™ System to enable realtime tip positioning and navigation. The Mediguide™ system is indicated for use as an adjunct to fluoroscopy. In addition, the CPS Direct™, Mediguide™ Enabled slittable outer guide catheters can work with inner catheters as a system.
The St. Jude Medical CPS Direct MediGuide Enabled slittable outer guide catheter is made from PEBAX and reinforced with a stainless steel braid. The shaft has progressively decreasing durometers of PEBAX from the proximal to the distal end with a soft, atraumatic distal tip. The distal end is embedded with a sensor coil to enable device tip projection onto the MediGuide system and tungsten stripes for fluoroscopic visibility. The hub contains an integrated hemostasis valve and the proximal shaft is integrated into the hub creating a slit channel. The hub contains a sideport with extension tubing for contrast delivery, aspiration or saline flush using a 3-way stopcock. In addition, the hub contains a port for the connector cable.
The provided text does not contain any information about acceptance criteria or a study proving the device meets them.
The document is a 510(k) summary for a medical device (CPS Direct™ MediGuide™ Enabled Outer Guide Catheter and accessories) submitted to the FDA. It focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance.
Here's a breakdown of what the document does contain, which highlights the absence of the requested information:
- Submitter and Contact Information: Basic administrative details.
- Date Prepared: Date of the submission.
- Trade Name and Classification: Device identification and regulatory classification.
- Product Code: Specific code for the device type.
- Predicate Device: Identifies the legally marketed devices to which the new device is compared for substantial equivalence.
- Device Description: Physical characteristics and components of the new catheter.
- Intended Use: What the device is designed to do.
- Comparison to Predicate Devices: Explicitly states that the new device has "similar intended use and the same fundamental scientific technology as the predicate devices" and that "performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the subject device." However, it does not detail this performance testing or its results.
- Conclusion: Declares substantial equivalence based on design, technology, operation, materials, and indications for use.
- FDA Correspondence: Official letter from the FDA granting 510(k) clearance, affirming substantial equivalence.
- Indications for Use Statement: A formal statement of the device's intended use, marked for prescription use.
Therefore, I cannot provide the requested table and study details because the information is not present in the provided text. This type of detailed performance data and acceptance criteria is typically found in the full 510(k) submission, not usually in the publicly available summary.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).