(86 days)
The Retrograde Cardioplegia Cannula with Duratio Treatment is indicated for use in the delivery of blood or cardioplegic solution intraoperatively.
Extracorporeal circuit components with the Duraflo treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.
This device is for short-term use only (
The Baxter Research Medical Retrograde Cardioplegia Cannula with Duratio Treatment is a dual lumen cannula. The distal tip contains multiple infusion holes and an opening into the separate pressure monitoring lumen. A soft, low-pressure, self-inflating balloon surrounds the distal body (proximal to the flow holes). Inflation is accomplished via the differential pressure that occurs within the cannula during influsion. The balloon will deflate spontaneously when flow is stopped. The cannula is furnished with an introducer stylet. Each device is Individually packaged sterile and non-pyrogenic in a sealed, peed-type pouch.
The device is treated with Baxter Healthcare Corporation's proprietary Heparin coating, Duraflo.
Here's an analysis of the provided text regarding the Retrograde Cardioplegia Cannula with Duraflo Treatment, focusing on acceptance criteria and supporting studies.
It's important to note that the provided 510(k) summary (K991170) does not contain the detailed information typically associated with acceptance criteria and studies demonstrating device performance against those criteria as would be expected for an AI/ML or diagnostic device. This document is for a physical medical device (a catheter) and relies on substantial equivalence to predicate devices, rather than primary performance studies in the way you might be expecting.
Therefore, I will interpret your request within the context of what information is available in this 510(k) submission for a non-AI device.
Acceptance Criteria and Study for Retrograde Cardioplegia Cannula with Duraflo Treatment (K991170)
Given that this 510(k) is for a physical medical device (a cannula) rather than a software or diagnostic device, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" is framed differently. The primary mechanism for clearance in this case is demonstrating substantial equivalence to existing legally marketed predicate devices. The "performance" being evaluated is whether the new device functions similarly and is as safe and effective as the predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Review) | Reported Device Performance (Summary) |
|---|---|
| Intended Use Equivalence: Device indicates for same clinical purpose. | Indicated for "delivery of blood or cardioplegic solution intraoperatively" and "use in cardiopulmonary surgery when a heparin-treated blood path is desired." Matches or is consistent with predicate devices. |
| Technological Equivalence: Same fundamental technology. | "The proposed device consists of a device identical to the device cited as predicate Device A, which has been treated with the Duraflo treatment included in Predicate Device B." Uses established cannula design with an existing heparin coating. |
| Material Equivalence: Made of similar, safe, and biocompatible materials. | Materials are considered equivalent or safe, given its "identical" nature to Predicate A and the known safety of the Duraflo treatment (from Predicate B). |
| Design Equivalence: Similar structural and functional design. | "The proposed device consists of a device identical to the device cited as predicate Device A..." (RC-014 cannula design). The added Duraflo treatment is a surface modification, not a fundamental design change to the cannula's physical structure. |
| Safety and Effectiveness Equivalence: No new safety or effectiveness concerns. | The FDA granted clearance, indicating that the device is deemed "substantially equivalent" in safety and effectiveness to the predicate devices. No new questions of safety or effectiveness are raised. |
| Short-term Use: Device is acceptable for short-term use. | Indicated for "short-term use only ( |
§ 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).