The COBE® Vacuum Relief Check Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excessive vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent flow of air into the heart.

Device Description

The COBE® Vacuum Relief Check Valve is a sterile device with a non-pyrogenic fluid pathway. It is for single use only and is not to be resterilized by the user. The device consists of a housing with a 1/4" inlet port and a combination 1/4" and 3/8" outlet port (to accommodate either 1/4" or 3/8" ID tubing on the outlet side). It contains a unidirectional valve which prevents retrograde flow and an umbrella valve that opens under excessive vacuum, allowing air in to relieve the excessive vacuum pressure in the line. In addition, the device contains an over-pressure relief band which opens under excess positive pressure, allowing blood to escape. Arrows molded into the housing indicate the direction of flow through the device.

AI/ML Overview

The COBE® Vacuum Relief Check Valve is intended for use during cardiopulmonary bypass surgery to prevent excessive vacuum pressure during suctioning from the heart or surgical field and to prevent accidental air flow into the heart.

Here's an analysis of the provided information regarding the acceptance criteria and study for the COBE® Vacuum Relief Check Valve:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a general statement that "Performance testing was conducted to demonstrate substantial equivalence of the COBE® Vacuum Relief Check Valve to the predicate devices." It then lists the types of performance testing, but does not explicitly state specific numerical acceptance criteria (e.g., "vacuum pressure relief must occur within X mmHg") nor the precise quantitative results ("device relieved vacuum at Y mmHg") for the COBE device or the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Vacuum Pressure Relief	Substantially equivalent to predicates
Positive Pressure Relief	Substantially equivalent to predicates
Retrograde Flow Prevention	Substantially equivalent to predicates
Hemolysis (minimal/comparable)	Substantially equivalent to predicates
Leak Testing	Substantially equivalent to predicates
Connection Bond Strength (adequate)	Substantially equivalent to predicates

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

The document states that "Performance testing was conducted," but does not specify the sample size used for the test set for any of the listed tests. Furthermore, there is no information provided about the data provenance (e.g., country of origin, retrospective or prospective nature). Given the nature of a 510(k) submission for a device, it's highly probable these were prospective laboratory tests.

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

This information is not applicable to this type of device and study. The testing described involves objective physical and mechanical measurements (e.g., pressure, flow, leaks, material integrity), not subjective interpretation requiring expert consensus on a "ground truth" like in imaging studies.

4. Adjudication Method for the Test Set

This is not applicable as the tests are objective physical measurements and not subject to expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and an AI's impact on their performance is being evaluated. The COBE® Vacuum Relief Check Valve is a mechanical device, and its performance is evaluated through engineering and biological testing, not human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a mechanical component and does not involve an algorithm or AI. The performance discussed is inherent to the device's physical function.

7. The Type of Ground Truth Used

For the performance tests conducted, the "ground truth" would be established by objective physical measurements and engineering standards. For example:

Vacuum Pressure Relief: Measured pressure at which the valve opens.
Positive Pressure Relief: Measured pressure at which the relief band opens.
Retrograde Flow Prevention: Observation and measurement of any backward flow.
Hemolysis: Laboratory analysis of blood samples for signs of red blood cell damage.
Leak Testing: Observation or measurement of any fluid leakage.
Connection Bond Strength: Measurement of the force required to dislodge connections.

This is a form of objective measurement against defined physical parameters or established ASTM/ISO standards often used in medical device testing.

8. The Sample Size for the Training Set

This is not applicable. As a mechanical device, there is no "training set" in the context of machine learning or AI development. The device's design is based on engineering principles and prototypes are tested.

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

This is not applicable. Since there is no training set, there is no ground truth establishment process for it.

Summary

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510(k) Pre-Market Notification: COBE® Vacuum Relief Check Valve

K782406

7 1998 OCT 510(k) Summary

SUBMITTER:

COBE Cardiovascular, Inc. 14401 W. 65th Wav Arvada, CO 80004 CONTACT PERSON: Lynne Leonard Phone: (303) 467-6586 (303) 467-6429 Fax: DATE PREPARED: July 9, 1998 COBE® Vacuum Relief Check Valve DEVICE TRADE NAME: Vacuum/Pressure Safety Valve COMMON/USUAL NAME: Cardiopulmonary Bypass Adaptor. Stopcock, Manifold, or Fitting CLASSIFICATION NAME: (21 CFR 870.4290) PREDICATE DEVICES: C.R. Bard, Inc. William Harvey® #H-130 Overpressure Safety Valve (K820297)

American Omni Medical, Inc. #RLV-2100 Non-adiustable Suction Control Valve (K861428)

INDICATIONS FOR USE

DEVICE DESCRIPTION

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The COBE® Vacuum Relief Check Valve is substantially equivalent in intended use, performance, method of operation, and design features to the C.R. Bard, Inc. William Harvey® #H-130 Overpressure Safety Valve (K820297), and the American Omni Medical, Inc. #RLV-2100 Non-adjustable Suction Control Valve (K861428).

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The primary differences in the three devices are:

1. The unidirectional duckbill valve and the vacuum umbrella valve in the COBE® Vacuum Relief Check Valve are of a one piece design. Both the C.R. Bard, Inc. William Harvey® #H-130 and the American Omni Medical, Inc. #RLV-2100 have a separate unidirectional duckbill valve and vacuum umbrella valve.
1. The COBE® Vacuum Relief Check Valve and the American Omni Medical, Inc. #RLV-2100 contain an over-pressure relief band. The C.R. Bard, Inc. William Harvev® #H-130 uses a second umbrella valve to relieve excessive positive pressure.
The American Omni Medical. Inc. #RLV-2100 and the C.R. Bard. Inc. William Harvey® #H-130 3. have 1/4" inlet and outlet ports. The COBE® Vacuum Relief Check Valve has a 1/4" inlet port and a combination 1/4" and 3/8" outlet port to accept either tubing size on the outlet side.

Performance testing was conducted to demonstrate substantial equivalence of the COBE® Vacuum Relief Check Valve to the predicate devices. Performance testing consisted of:

1. Vacuum Pressure Relief
1. Positive Pressure Relief
1. Retrograde Flow Prevention
1. Hemolvsis
1. Leak Testing
Connection Bond Strength 6.

Data from these tests support that the COBE® Vacuum Relief Check Valve is substantially equivalent to the C.R. Bard, Inc. William Harvey® #H-130 Overpressure Safety Valve (K820297), and the American Omni Medical, Inc. #RLV-2100 Non-adjustable Suction Control Valve (K861428).

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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 depiction of an eagle with three human profiles incorporated into its body. The eagle is facing left, and the profiles are stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 1998

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

Re : K982406 COBE™ Vacuum Relief Check Valve Requlatory Class: II (Two) Product Code: MJJ Dated: July 9, 1998 " Received: July 10, 1998

Dear Ms. Leonard:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of The general controls provisions of the Act include the Act. requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against 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 In addition, FDA may publish further announcements action. 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" (21 CFR 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. Callanan

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

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Indications For Use

4992406 510(k) Number (If known):

COBE® Vacuum Relief Check Valve Device Name:

Indications For Use:

The COBE® Vacuum Relief Check Valve is intended to be used during cardiopulmonary bypass surgery to help prevent the buildup of excessive vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent flow of air into the heart.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bete L. Rempelee
(Division Sign-Off)

)ivision of Cardiovascular, Respiratory, and Neurological Device

510(k) Number: K982406

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.