The Bard® Quantum™ SVR is designed to function in an extracorporeal circuit. The flexible venous reservoir receives dynamic blood from: venous return (1) suctioned blood from the cardiotomy reservoir (2) The venous reservoir stores this blood prior to returning it to the circuit. The Bard® Quantum™ SVR is designed to function for up to 6 hours in an extracorporeal circuit.

Device Description

The Bard® Quantum™ SVR is designed to function in an extracorporeal circuit. The flexible venous reservoir receives dynamic blood from: (1) venous return (2) suctioned blood from the cardiotomy reservoir The venous reservoir stores this blood prior to returning it to the circuit.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Testing of Performance and Integrity)	Reported Device Performance (Bard® Quantum™ SVR)
Equivalence or superiority to predicate devices (Avecor Affinity and Medtronic MVR 1600) in performance and integrity characteristics.	Equivalent to or better than predicate devices in performance and integrity.
Clinically insignificant differences compared to predicate devices.	Differences were clinically insignificant.
Meeting biocompatibility standards.	Passed all biocompatibility testing.
Minimum operating volume statistically equivalent to predicate devices for reopening the reservoir.	Statistically equivalent to both predicate devices for minimum volume to re-open the reservoir.
Maximum volume comparable to predicate devices (capacity, not a safety concern).	Similar to predicate devices.
Materials same as or similar to predicate devices, used in similar locations.	Same materials, each used in one of the predicate devices in a similar location.

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

The document does not explicitly state a specific numerical "sample size" in terms of units of devices for the performance and integrity testing. It refers to a comparison of "the Bard H6440VR, the Avecor Affinity, and the Medtronic MVR Series" and then indicates "Results for this testing may be found in Appendix 2." Without Appendix 2, the exact number of units tested for each device cannot be determined from this text alone.

Data Provenance: The study appears to be retrospective in the sense that the predicate devices were already on the market, and the new device was compared against their established characteristics and performance. The testing itself would have been conducted by the manufacturer, C.R. Bard, Inc. The manufacturing location is listed as Haverhill, MA, USA, which implies the testing would have been done in the USA.

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

This type of information is not applicable (N/A) to this medical device submission. The Bard® Quantum™ SVR is a physical device (reservoir) for an extracorporeal circuit, not an AI/software device that requires expert review for "ground truth" establishment in the context of diagnostic or interpretive tasks. The "ground truth" here is objective physical and functional performance measurements, not expert interpretations.

4. Adjudication Method for the Test Set

This type of information is not applicable (N/A) for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human readers or experts when establishing ground truth, typically in image interpretation or diagnostic studies. This is a bench testing scenario.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is used to assess the impact of AI assistance on human reader performance, which is not relevant for a physical medical device like a cardiopulmonary bypass blood reservoir.

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

No, a standalone performance study in the context of an algorithm or AI was not done. This is a physical device, not an algorithm. The performance testing was of the device itself.

7. The Type of Ground Truth Used

The ground truth used for the acceptance criteria and performance evaluation of the Bard® Quantum™ SVR consisted of:

Objective physical measurements: For characteristics like minimum operating volume, maximum volume, material composition, and integrity.
Biocompatibility testing results: Standardized tests demonstrating the material's compatibility with biological systems.
Comparison to legally marketed predicate devices: The "ground truth" for acceptable performance was largely defined by the established performance and safety profiles of the Avecor Affinity and Medtronic MVR 1600 Softshell Venous Reservoirs, which were considered substantially equivalent.

8. The Sample Size for the Training Set

This information is not applicable (N/A). There is no "training set" in the context of traditional physical medical device testing for 510(k) submissions. Training sets are relevant for machine learning algorithms.

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

This information is not applicable (N/A) for the same reason as #8.

Summary

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AUG 6 1998

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.

A. Submitter's Information

Name:	C.R. Bard, Inc., Bard Cardiopulmonary Division
Address:	25 Computer Drive, Haverhill, MA 01832
Phone:	(978) 373-1000 extension 3371
Fax:	(978) 374-6200
Contact Person:	Sandra Perreand, Regulatory Affairs Manager
Date of Preparation:	April 23, 1998

B. Device Name:

Trade Name:	Bard® Quantum™ SVR
Common/Usual Name:	Cardiotomy and Venous Reservoir
Classification Name:	Cardiopulmonary Bypass Blood Reservoir

C. Predicate Device Name(s):

1. Avecor Affinity 321 Softshell Venous Reservoir Bag, K935717
1. Medtronic MVR 1600 Softshell Venous Reservoir Bag, K920774

D. Device Description/Indications for Use:

The Bard® Quantum™ SVR is designed to function in an extracorporeal circuit. The flexible venous reservoir receives dynamic blood from:

(1) venous return
(2) suctioned blood from the cardiotomy reservoir

The venous reservoir stores this blood prior to returning it to the circuit.

E. Technological Characteristics Summary

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:

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Does New Device Have Same Indication Statements? 1.

The Bard® Quantum™ SVR (Bard H6440VR) has the same Yes. indications as the AVECOR Affinity Venous Reservoir Bag and the Medtronic MVR 1600 Softshell Venous Reservoir. 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 H6440VR has the same technological characteristics and the same materials as at least one of the predicate devices in each category as shown in Table IV-1 or the difference is insignificant as follows.

As explained above, the Bard H6440VR has the same indications as the Avecor Affinity and the Medtronic MVR 1600 although the Bard H6440VR includes additional detail. The contraindications for the proposed device are standard phraseology and do not reflect a restriction in the use of the device. The minimum operating volume for the proposed device was statistically equivalent to both the Medtronic MVR 1600 Softshell Venous Reservoir and the Avecor Affinity VR 321 Softshell Reservoir for minimum volume to re-open the reservoir. The maximum volume of the device is simply a measure of capacity and is not a safety or efficacy concern for the device and is similar to those of the predicate devices. The materials of the device are the same as those materials used elsewhere in the device, and each material is used in one of the predicate devices in a similar location. The device was tested for biocompatibility as described in Section III and Appendix 1 and passed all testing.

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

No. Although the materials and technological characteristics are the same, differences between vendors and manufacturing techniques and the fact that neither of the predicate devices individually include all the same materials and technological characteristics as those of the proposed device necessitate bench testing to ensure equivalence.

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Are Performance Data Available to Assess Equivalence? 4.

Yes. The Bard H6440VR, the Avecor Affinity, and the Medtronic MVR Series were compared for performance and integrity characteristics as described in Section IV.5. Results for this testing may be found in Appendix 2.

In addition, as previously mentioned, the Bard H6440VR was subjected to biocompatibility testing (see summary in Section III and results in Appendix 1).

5. Performance Data Demonstrate Equivalence?

Yes. The performance of the Bard H6440VR was equivalent to or better than those of the predicate devices or the differences were clinically insignificant as further described in Section IV.5.

A summary of the performance and integrity testing may be found in Section IV.5. More in depth protocols and results may be found in Appendix 2. Following the summary of the performance and integrity testing is a summary of the biocompatibility testing.

SUBSTANTIALLY EQUIVALENT DETERMINATION:

The Bard H6440VR is substantially equivalent to the predicate devices, the Avecor Affinity and the Medtronic MVR 1600 Softshell Venous Reservoirs.

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5 1038 તાલુ

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sandra Perreand Bard Cardiopulmonary Division C.R. Bard, Inc. 25 Computer Drive Haverhill, MA 01832

Re : K981628 Bard® Quantum™ SVR (Softshell Venous Reservoir) Requlatory Class: II (Two) Product Code: DTN May 6, 1998 Dated: Received: May 7, 1998

Dear Ms. Perreand:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Sandra Perreand

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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1-981628 INDICATIONS FOR USE D.

Device Name: Bard® Quantum™ SVR (Softshell Venous Reservoir)

Indications for Use:

The Bard® Quantum™ SVR is designed to function in an extracorporeal circuit. The flexible venous reservoir receives dynamic blood from:

venous return (1)
suctioned blood from the cardiotomy reservoir (2)

The venous reservoir stores this blood prior to returning it to the circuit.

The Bard® Quantum™ SVR is designed to function for up to 6 hours in an extracorporeal circuit.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K9816281

Prescription Use (Per 21 CFR 801.109)	X	OR	Over-the-Counter Use ______
---------------------------------------	----------	----	-----------------------------

Bard
® Quantum
TM SVR 510(k) Submission
8

Regulation Number and Section

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.