(30 days)
The MYOtherm XP with Cortiva bioactive surface is a device intended for the mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratiopulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardion is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.
The MYOtherm XP cardioplegia delivery system is a device intended for the mixing, warming/cooling, and delivery of bxvgenated blood/cardioplegia solution in a predetermined rationulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.
The Cortiva coated and Uncoated MYOtherm XP™ Cardioplegia Delivery System is designed to mix arterial blood from an oxygenator with sanguineous cardioplegia solution in specific ratios, depending upon the system chosen. The patient delivery line is packaged separately to allow for ease of sterile transfer to the operative field prior to connection to the delivery outlet of the cardioplegia system. A pressure monitoring line, three-way stopcock, and gauge protector, as well as a pressure relief line with pressure relief valve are preconnected.
The Cortiva coating is a BioActive Surface that is non-leaching and provides thromboresistant blood contact surface. The A10378001, CBXP41 and the CBXP41B MYOtherm Cardioplegia Delivery Systems are identical except for the bypass loop. The XP41B and CBXP41B contains a bridge between the blood and crystalloid line allowing the physician to deliver 100% blood, if needed.
The male-to-male Luer connector component 61399405213 that is the 'subject' of this special 510(k) connects with MYOtherm via a pressure relief valve and tubing. 61399405213 gets connected to a pressure relief valve on one end, and a cap on the other end. A perfusionist can remove the cap to connect a PVC tubing of choice, during Cardioplegia intervention.
This document K240190 describes a Special 510(k) submission for the Medtronic MYOtherm XP™ Cardioplegia Delivery System. The submission focuses on a change in the polycarbonate resin used in a component (connector 61399405213).
Therefore, the acceptance criteria and study described pertain to the biocompatibility of the device with the new resin formulation, rather than a clinical performance study involving AI or human readers.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Biological Endpoint) | Reported Device Performance (Result) |
|---|---|
| ISO MEM Elution Cytotoxicity | Pass |
| Guinea Pig Maximization Sensitization | Pass |
| Intracutaneous Reactivity | Pass |
| In Vitro Skin Irritation | Pass |
| Acute Systemic Toxicity | Pass |
| Material-mediated Pyrogenicity | Pass |
| Hemolysis (extract and direct) | Pass |
| Complement Activation SC5b-9 | Pass |
| ASTM Partial Thromboplastin Time (PTT) | Pass |
| Platelet and Leukocyte Count | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of animals for in vivo tests, number of samples for in vitro tests) used for each biocompatibility test. It only states that "The samples built for the testing included the connector component with proposed resin formulation."
The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated. However, biocompatibility testing is typically conducted in a laboratory setting under controlled conditions.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
This information is not applicable to a biocompatibility study. Biocompatibility tests follow established ISO standards, and the "ground truth" is determined by the specific biological reactions observed against predetermined criteria for each test. These results are usually interpreted by qualified toxicologists or biologists, but the document does not specify their number or qualifications.
4. Adjudication Method for the Test Set
This is not applicable to biocompatibility studies, which rely on objective measurements and established pass/fail criteria according to international standards (e.g., ISO 10993 series).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study is focused on the biocompatibility of a material change in a medical device, not on diagnostic accuracy involving human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI software.
7. The Type of Ground Truth Used
The "ground truth" for this study is based on the objective biological and physiochemical responses observed in the standardized biocompatibility tests. These tests assess potential adverse biological effects such as cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, complement activation, and hemostatic changes, according to recognized international standards (e.g., ISO 10993).
8. The Sample Size for the Training Set
This is not applicable as this study is a biocompatibility assessment of a material change, not a machine learning model. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of study.
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).