The COBE® VVR 4000" Filtered Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours, and for postoperative chest drainage collection and autotransfusion.

Device Description

The COBE® VVR 4000" Filtered Hardshell Venous Reservoir, a sealed hardshell venous reservoir with defoamer and integral cardiotomy filter, is a sterile device with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. It is designed for collection and return of postoperative chest drainage, and for storage and filtration of blood during adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours.

The maximum capacity of the COBE® VVR 4000™ Filtered Hardshell Venous Reservoir is approximately 4000 ml. The device operates at venous blood flow rates up to 8 liters/minute, cardiotomy flow rates up to 4 liters/minute, or at a combined maximum flow rate of 8 liters/minute.

During cardiopulmonary bypass, the device receives the patient's venous blood (under vacuum assisted or non-vacuum assisted venous return conditions) and also receives cardiotomy suction blood and filters it prior to returning it to the circulating blood volume. Entrained air is removed from both the venous blood and cardiotomy blood by the defoamer.

Following cardiopulmonary bypass, the device may be converted for use in postoperative chest drainage. Shed blood which has been stored in the reservoir less than six hours may be autotransfused for blood volume replacement.

The major components of the reservoir are the bucket, the defoamer, and the cardiotomy filter. The bucket serves both as a primary structural component of the device and as a transparent vessel to contain excess blood volume and to allow for the monitoring of changes in blood volume. The ports provide blood tubing connections between the reservoir and the patient, the defoamer serves to remove gross air from the incoming venous and cardiotomy suction blood, and the filter removes particles from cardiotomy suction blood.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device and its substantial equivalence to predicate devices, rather than a study proving the device meets explicit acceptance criteria through quantitative performance metrics. As such, direct answers to many of the requested points (e.g., sample sizes, expert qualifications, adjudicated ground truth, MRMC studies, effect sizes) cannot be extracted from this documentation.

However, I can infer the "acceptance criteria" based on the tests performed for substantial equivalence. The "study" in this context refers to the in-vitro testing comparing the COBE® VVR 4000™ to its predicate devices.

Acceptance Criteria and Reported Device Performance (Inferred from Substantial Equivalence Claim)

The "acceptance criteria" are not explicitly stated with numerical thresholds. Instead, the device is deemed to meet acceptance criteria by demonstrating "substantial equivalence" to predicate devices through in-vitro tests and biocompatibility testing. The reported "performance" is that it performs comparably or acceptably to the established predicate devices.

Acceptance Criteria (Inferred)	Reported Device Performance
Biocompatibility (equivalent to predicate devices)	Passed biocompatibility tests
Filtration Efficiency (equivalent to predicate devices)	Demonstrated acceptable filtration efficiency
Minimum Operating Volume (equivalent to predicate devices)	Demonstrated acceptable minimum operating volume
Pressure Relief Valve Operation (equivalent to predicate devices)	Demonstrated acceptable pressure relief valve operation
Reservoir Implosion Resistance (equivalent to predicate devices)	Demonstrated acceptable reservoir implosion resistance
Blood Cell Damage (equivalent to predicate devices)	Demonstrated acceptable levels of blood cell damage

Detailed Information based on the provided text:

A table of acceptance criteria and the reported device performance:
See the table above. The "acceptance criteria" are implied by the requirement to demonstrate substantial equivalence to the predicate devices across these performance categories. The "reported device performance" is that it met this equivalence.
Sample size used for the test set and the data provenance:
The document does not specify exact sample sizes for the in-vitro tests (e.g., how many units were tested for filtration efficiency). The data provenance is implied to be from COBE Cardiovascular, Inc.'s internal testing, as part of their 510(k) submission. The data is retrospective in the sense that it was generated for the submission, not a prospective clinical trial. There is no mention of country of origin of the data beyond the manufacturer's location in the USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. For device performance testing, "ground truth" is typically established through standardized measurement methods and comparison against engineering specifications or predicate device performance, not by expert consensus in the way a diagnostic algorithm might be evaluated.
Adjudication method for the test set:
Not applicable in the context of in-vitro device performance testing as described. Adjudication is typically for resolving disagreements in expert interpretations, which is not the nature of these tests.
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:
No, an MRMC study was not done. This device is a hardware component (venous reservoir), not an AI-assisted diagnostic or therapeutic tool. Therefore, human reader improvement with AI assistance is not relevant to this device's evaluation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the testing described ("in-vitro tests") can be considered "standalone" in the sense that it evaluates the device's technical performance characteristics independently. However, the term "algorithm" is not applicable here as it's a physical medical device, not a software algorithm.
The type of ground truth used:
The ground truth for the in-vitro tests would have been established by engineering standards, validated measurement techniques, and potentially the established performance characteristics of the predicate devices. For example, "filtration efficiency" would have a quantifiable ground truth based on particle count, and "blood cell damage" would have a ground truth based on established methods for measuring hemolysis or other cellular injury.
The sample size for the training set:
Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.

Summary

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MAY 25 1999

510(k) Summary

SUBMITTER:	COBE Cardiovascular, Inc.14401 W. 65th WayArvada, CO 80004
CONTACT PERSON:	Lynne LeonardPhone: (303) 467-6586Fax:(303) 467-6429
DATE PREPARED:	January 21, 1999
DEVICE TRADE NAME:	COBE® VVR 4000™ Filtered Hardshell Venous Reservoir
COMMON/USUAL NAME:	Filtered Venous Reservoir with Integral Cardiotomy Filter
CLASSIFICATION NAMES:	Cardiopulmonary Bypass Blood Reservoir with Defoamerand Cardiotomy Suction Line Blood Filter;Autotransfusion Apparatus
PREDICATE DEVICES:	COBE® HVR™ 4000 Filtered Hardshell Venous ReservoirBaxter/Bentley BMR-4500G Filtered Venous ReservoirBaxter/Bentley HSR-4000 Filtered Venous Reservoir

DEVICE DESCRIPTION:

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INDICATIONS FOR USE

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The COBE® VVR 4000" Filtered Hardshell Venous Reservoir is substantially equivalent to the currently marketed COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir (K984456). The two devices are identical except that the COBE® VVR 4000™ Filtered Hardshell Venous Reservoir has a gasketed lid ioint, vent port, and pressure relief valve. Both the COBE® VVR 4000™ Filtered Hardshell Venous Reservoir and the COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir are intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours. The COBE® VVR 4000™ Filtered Hardshell Venous Reservoir has the added indication of postoperative chest drainage collection and autotransfusion of the collected blood.

The COBE® VVR 4000™ Filtered Hardshell Venous Reservoir is also substantially equivalent to the Baxter/Bentley BMR-4500G Filtered Venous Reservoir. Both devices are sealed hardshell venous reservoirs with a defoamer and integral cardiotomy filter, designed for storage and filtration of blood during adult surgical procedures requiring cardiopulmonary bypass. The COBE® VVR 4000" Filtered Hardshell Venous Reservoir has the added indication of postoperative chest drainage collection and autotransfusion of the collected blood.

The COBE® VVR 4000™ Filtered Hardshell Venous Reservoir is also substantially equivalent to the Baxter/Bentley HSR-4000 Filtered Venous Reservoir. Both devices are sealed hardshell venous reservoirs with a defoamer and integral cardiotomy filter, designed for storage and filtration of blood during adult surgical procedures requiring cardiopulmonary bypass, and for postoperative chest drainage collection and autotransfusion of the collected blood.

Biocompatibility and in-vitro tests were performed to demonstrate that the COBE® VVR 4000" Filtered Hardshell Venous Reservoir is substantially equivalent to the COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir, the Baxter/Bentley BMR-4500G Filtered Venous Reservoir, and the Baxter/Bentley HSR-4000 Filtered Venous Reservoir.

In-vitro testing consisted of:

Filtration Efficiency Minimum Operating Volume Pressure Relief Valve Operation Reservoir Implosion Resistance Blood Cell Damage

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 25 1999

Ms. Lynne Leonard Manager, Regulatory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004-3599

K990239 Re : COBE® VVR 4000™ Filtered Hardshell Venous Reservoir Regulatory Class: III (Three) Product Code: 74 DTP - DTN Dated: January 22, 1999 Received: January 25, 1999

Dear Ms. Leonard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marice 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, Drug, 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 Requlations, 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 Requlation (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 regulations.

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Page 2 - Ms. Lynne Leonard

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 regulation (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. Callahon

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

Enclosure

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510(k) Premarket Notification

Indications For Use

510(k) Number (If known): K910239

COBE® VVR 4000™ Filtered Hardshell Venous Reservoir Device Name:

Indications For Use:

The COBE® VVR 4000* Filtered Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours, and for postoperative chest drainage collection and autotransfusion.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

Prescription Use
(Per 21 CFR 801.109)
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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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.