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The vessel cannula will be supplied with a wing or without a wing, with or without a check valve to deliver cardioplegia solution to the heart during cardiopulmonary bypass surgery and to perfuse a vein graft or access the patency of the vessel to be used as a graft during cardiopulmonary bypass surgery.

The aortic root cannula is designed to deliver cardioplegia solution during cardiopulmonary bypass surgery and aspirate air from the aorta at the end of the cardiopulmonary bypass surgery. The aortic root cannula with vent line is designed to deliver cardioplegia solution and vent the heart during cardiopulmonary bypass surgery.

The cardioplegia "Y" perfusion adapter is designed for use with the aortic root cannula and vessel cannula to deliver cardioplegia solution during cardiopulmonary bypass surgery. The cardioplegia "Y" recirculation adapter is designed for recirculating of cardioplegia solution during cardiopulmonary bypass surgery. The cardioplegia straight adapter is designed for use during cardiopulmonary bypass surgery for connecting a cannula or catheter to an administration or vent line. The cardioplegia "Y" venting adapter is designed for use during cardiopulmonary bypass surgery to deliver cardioplegia solution and vent the left heart.

The Vessel Cannula is indicated for use in the delivery of cardiopleqia solution during cardiopulmonary bypass surgery or to perfuse a vein graft or access the patency in a harvested vein which will be used for a graft. The Vessel Cannula is a flexible, tapered, polyvinyl chloride tube with a soft distal tip. The distal tip is composed of two sizes of anchor hubs (3mm distal-3.6mm proximal) designed to accommodate vessels of various diameters. The proximal female luer-lock is designed to securely connect with a standard cardioplegia delivery line. The cannula is available with or without wings and with or without a check valve.

The Aortic Root Cannula is designed to deliver cardioplegia solution during cardiopulmonary bypass surgery. The cannula consists of flexible polyvinyl chloride tubing with a movable sew ring attached to a soft distal tip. The distal tip has a flange with four suture holes. An introducer needle assembly is provided to facilitate entry into the aorta.

The Cardioplegia Straight Adapter is indicated during cardiopulmonary bypass surgery for connecting a cannula or catheter to an administration and or a vent line. The straight adapter consists of flexible polyvinyl tubing, and connecting adapters in a straight configuration.

The Cardioplegia "Y" Venting Adapter is designed to be used in conjunction with cardiopulmonary bypass surgery to deliver cardioplegia solution, and venting the left heart. It may also be used as an extension line by itself. The adapter consists of flexible polyvinyl chloride tubing, "Y" connector, tubing clamps, and connecting adapters in a "Y" configuration.

The Cardioplegia "Y" Recirculation Adapter is indicated for recirculation of cardioplegia solution during cardiopulmonary bypass surgery, to keep the cardioplegia solution at constant temperature. The "Y" recirculation adapter consists of a flexible polyvinyl chloride tubing, "Y" connector, tubing clamps and connecting adapters in a "Y" configuration.

The Cardioplegia "Y" Perfusion Adapter is indicated for use in delivery of cardioplegia solution during cardiopulmonary bypass surgery. "The perfusion adapter consists of polyvinyl chloride tubing, tubing clamps, "Y" connector, and connecting adapters in a "Y" configuration.

This 510(k) submission (K972503) for California Medical Laboratories Inc. devices (Vessel Cannulas, Aortic Root Cannulas, and Cardioplegia Adapters) does not contain a study that establishes acceptance criteria and proves the device meets them in the way modern regulatory submissions typically do.

Instead, this is a Substantial Equivalence (SE) determination based on comparison to legally marketed predicate devices. The "study" here is essentially a comparison of technological characteristics and intended use to existing devices.

Therefore, many of the requested fields about quantitative performance, sample sizes, expert ground truth, adjudication, and MRMC studies are not applicable or cannot be extracted from this document.

Here's a breakdown of what can be inferred or directly stated from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Deliver cardioplegia solution to the heart during cardiopulmonary bypass surgery.
• Perfuse a vein graft or access patency in a harvested vein.
• Aspirate air from the aorta (Aortic Root Cannula).
• Vent the left heart (Aortic Root Cannula with Vent Line, "Y" Venting Adapter).
• Connect cannulas/catheters to administration/vent lines (Straight Adapter).
• Recirculate cardioplegia solution (Recirculation Adapter). | The devices have substantially equivalent intended uses as the predicate devices. This implies they perform these functions comparably. |
  | Technological Characteristics:
• Material (Polyvinyl Chloride).
• Design elements (tapered tube, soft distal tip, anchor hubs, luer-lock, movable sew ring, flange with suture holes, introducer needle, "Y" connectors, tubing clamps, connecting adapters).
• Availability with/without wings, check valve, vent line. | The devices have technologic characteristics which are substantially equivalent to the predicate device. This implies their design and material properties are comparable, leading to comparable performance. |
  | Safety: (Implicit in SE determination) | The FDA's finding of substantial equivalence suggests the device is as safe as the predicate. |
  | Effectiveness: (Implicit in SE determination) | The FDA's finding of substantial equivalence suggests the device is as effective as the predicate for its intended use. |

2. Sample Size Used for the Test Set and Data Provenance

• Not applicable. This submission is based on a comparison to existing predicate devices, not on a new clinical or laboratory test with a defined sample size in the traditional sense. The "test set" would implicitly be the body of evidence and performance of the predicate devices.
• Data Provenance: Not specified. The reference is to "legally marketed devices" in interstate commerce prior to May 28, 1976, or reclassified devices. This implies historical data and established clinical use of the predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices as determined by their long-standing market presence and regulatory clearance. There isn't a specific panel of experts establishing ground truth for a novel "test set" in this context. The FDA's review staff (e.g., Division of Cardiovascular, Respiratory, and Neurological Devices) makes the determination of substantial equivalence.

4. Adjudication Method for the Test Set

• Not applicable. There was no independent test set requiring adjudication in the context of this 510(k) submission. The FDA's review process is its own form of "adjudication."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a physical medical device (cannulas and adapters), not an AI-powered diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. As stated above, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Predicate Device Performance and Regulatory Status: The ground truth is the established safety, effectiveness, and regulatory clearance of the predicate devices (Research Medical, Inc. Vasoplegia Cannula, DLP, Inc. Aortic Root Cannula, DLP, Inc. "Y" Adapter-Coronary Perfusion, DLP, Inc. Straight Adapter, DLP, Inc. "Y" Adapters). The applicant is demonstrating that their new devices are sufficiently similar to these predicates that they can rely on the predicates' existing "ground truth" of performance.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. Device development involves design, manufacturing, and testing, but not machine learning training sets.

9. How the Ground Truth for the Training Set was Established

• Not applicable. See point 8.

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