(29 days)
This kit is intended for use by trained physicians only, to assist in vessel cannulation for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This kit is intended for use for up to 6 hours.
The Bio-Medicus Insertion Kits are used during cardiopulmonary bypass procedures. The product contains the necessary components to achieve insertion of the Adult and Pediatric Bio-Medicus Femoral Cannulae and Introducer. Each kit is comprised of: Seldinger needle, Scalpel blade, Catheter tipped syringe, Stepped dilators, Guidewire. The Bio-Medicus Insertion Kits are all supplied sterile, and non-pyrogenic and are for single use only.
The provided document does not contain any information regarding acceptance criteria or a study that proves a device meets those criteria for an AI/ML medical device.
This document is a 510(k) premarket notification for a medical device called the "Bio-Medicus Insertion Kit," which is used for cardiopulmonary bypass procedures. The FDA letter confirms that the device is substantially equivalent to a previously marketed predicate device.
The document discusses:
- The trade name and common name of the device.
- The regulatory classification (Class II, product code DWF).
- Indications for use.
- Device description (components like Seldinger needle, scalpel blade, etc.).
- Comparison to a predicate device, noting the primary change is the replacement of dilators with those supplied by a different manufacturer (Medcomp).
- Standard regulatory information required for a 510(k) submission, such as contact information, registration numbers, and compliance with general controls.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment, as these details are not present in the provided text. This device is not an AI/ML medical device.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).