The Bard® Quantum™ CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from: (1) venous return (2) intracardiac suction (3) ventricular vent devices (4) arterial-venous shunts It defoams, filters and stores this blood before returning it to the circuit.

Device Description

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text only discusses the "Bard® Quantum™ CVR" and its comparison to predicate devices, focusing on the equivalence of its technological characteristics and performance. It does not provide specific numerical acceptance criteria for a new AI/ML device or its reported performance in those terms. Instead, it states:

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Bard Quantum™ CVR)
Cell Damage	Equivalent to or better than predicate devices	Found to be equivalent to or better
Defoaming Ability	Equivalent to or better than predicate devices	Found to be equivalent to or better
Filtration Efficiency	Equivalent to or better than predicate devices	Found to be equivalent to or better
Biocompatibility	Pass all tests required by ISO 10993	Passed all tests

2. Sample Size and Data Provenance for Test Set:

This document describes a comparison between a new medical device (Bard® Quantum™ CVR) and predicate devices, not an AI/ML system. Therefore, the concept of a "test set" with specific sample sizes from different countries or retrospective/prospective data as used in the context of AI/ML is not directly applicable. The "test set" here refers to the actual physical devices (Bard H6770VR, Cobe HVRF, and Bard H-3700) that underwent bench testing. The provenance isn't specified beyond the manufacturer.

3. Number and Qualifications of Experts for Ground Truth:

Not applicable. The "ground truth" for this medical device is established through physical and chemical performance tests (e.g., measuring cell damage, defoaming ability, filtration efficiency, and biocompatibility) performed in a lab setting, not through expert human interpretation of data.

4. Adjudication Method for Test Set:

Not applicable. There's no human interpretation or adjudication process described for the performance testing. The results are objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This document describes the 510(k) submission for a physical medical device, not an AI/ML system that would involve human readers interpreting cases.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is not an algorithm or AI system, so the concept of standalone algorithm performance is irrelevant.

7. Type of Ground Truth Used:

The ground truth for this device's performance was based on bench testing results (objective measurements of cell damage, defoaming ability, filtration efficiency) and biocompatibility testing standards (ISO 10993).

8. Sample Size for Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "training" for such a device is its engineering design and manufacturing process.

9. How Ground Truth for Training Set Was Established:

Not applicable. There is no training set as this is not an AI/ML device.

Summary

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K960726

CT 30 1996

Bard Vascular Systems Division C.R. Bard, Inc. 25 Computer Drive Haverhill, MA 01832 508-373-1000

(

BARD

510(k) SUMMARY FOR THE BARD® QUANTUM™ CVR

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

Submitter's Information A.

Name:	C.R. Bard, Inc., Bard Vascular Systems Division
Address:	25 Computer Drive, Haverhill, MA 01832
Phone:	(508) 373-1000 extension 3371
Fax:	(508) 374-6200
Contact Person:	Douglas E. Ferguson, Regulatory Affairs Specialist
Date of Preparation:July 12, 1996

B. Device Name:

Trade Name:	Bard® Quantum™ CVR
Common/Usual Name:	Cardiotomy and Venous Reservoir withDefoamer
Classification Name:	Cardiopulmonary Bypass Blood Reservoirwith Cardiopulmonary Bypass Defoamer

C. Predicate Device Name(s):

1. Bard® William Harvey® Cardiotomy Reservoir with MICRO Filter (H-3700) (510(k) #K902856)
1. Cobe HVRF®-3700 Open Venous Reservoir with Integral Cardiotomy Filter

D. Device Description/Indications for Use:

The Bard® Quantum™ CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from:

(1) venous return
intracardiac suction (2)
(3) ventricular vent devices
arterial-venous shunts (4)

It defoams, filters and stores this blood before returning it to the circuit.

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Technological Characteristics Summary E.
The "510(k) Substantial Equivalence Decision-Making Process (Detailed)" decision tree (FDA 92-415, Premarket Notification 510(k): Regulatory Requirements for Medical Devices. Page 51) was utilized to make a determination of substantial equivalence as follows:

Does New Device Have Same Indication Statements? 1.

The Bard® Quantum™ CVR (Bard H6770VR) has the same Yes. indications as the Cobe HVRF although the Bard H6770VR includes additional detail. The Bard H-3700 and the Bard H6770VR have the same indications for use intraoperatively; however the Bard H6770VR will not be indicated for post-operative use as the Bard H-3700 is. Although the wording in the Indications for Use for all of these devices is not identical, all of these devices are indicated for use in extracorporeal systems during cardiopulmonary bypass.

2. Does New Device Have Same Technological Characteristics, e.g., Design, Materials, etc.?

Yes. The Bard H6770VR has the same technological characteristics and the same materials as at least one of the predicate devices or the difference is insignificant.

3. Are the Descriptive Characteristics Precise Enough to Ensure Equivalence?

No. Although the materials and technological characteristics are the same. bench testing is necessary to ensure equivalence because of (1) differences between vendors and manufacturing techniques and (2) the fact that neither of the predicate devices individually include all the same materials and technological characteristics as those of the proposed device.

4. Are Performance Data Available to Assess Equivalence?

Yes. The Bard H6770VR, the Cobe HVRF, and the Bard H-3700 were compared for performance and integrity characteristics. In addition, the Bard H6770VR was subjected to biocompatibility testing.

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Performance Data Demonstrate Equivalence? 5.

Yes. The proposed device was found to be equivalent to or better than the predicated devices or differences were clinically insignificant in terms of cell damage, defoaming ability, and filtration efficiency.

The Bard H6770VR passed all tests of biocompatibility required by the International Standard ISO 10993.

SUBSTANTIALLY EQUIVALENT DETERMINATION:

The Bard H6770VR is substantially equivalent to the predicate devices, the Cobe HVRF and the Bard H-3700.

Regulation Number and Section

§ 870.4230 Cardiopulmonary bypass defoamer.

(a)
Identification. A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.”