COBE VACUUM RELIEF CHECK VALVE

K982406 · Cobe Cardiovascular, Inc. · MJJ · Oct 7, 1998 · Cardiovascular

Device Facts

• Record ID: K982406
• Device Name: COBE VACUUM RELIEF CHECK VALVE
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: MJJ · Cardiovascular
• Decision Date: Oct 7, 1998
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.4400
• Device Class: Class 2

Intended 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.

Device Story

Sterile, single-use cardiopulmonary bypass accessory; prevents excessive vacuum and retrograde air flow during suctioning. Device features housing with 1/4" inlet and combination 1/4"/3/8" outlet; contains integrated unidirectional duckbill valve and vacuum-relief umbrella valve; includes over-pressure relief band for positive pressure management. Used in surgical settings by clinicians; provides mechanical safety regulation of suction lines; protects heart from vacuum-induced damage and air embolism.

Clinical Evidence

Bench testing only. Testing included vacuum pressure relief, positive pressure relief, retrograde flow prevention, hemolysis, leak testing, and connection bond strength.

Technological Characteristics

Sterile, non-pyrogenic fluid pathway; single-use. Housing with 1/4" inlet and 1/4"/3/8" outlet. Mechanical operation via unidirectional duckbill valve, vacuum-relief umbrella valve, and over-pressure relief band. No software or electronics.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring suctioning of the heart or surgical field; prevents excessive vacuum pressure and retrograde air flow.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• C.R. Bard, Inc. William Harvey® #H-130 Overpressure Safety Valve (K820297)
• American Omni Medical, Inc. #RLV-2100 Non-adjustable Suction Control Valve (K861428)

Submission Summary (Full Text)

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

K782406

21

### 7 1998 OCT 510(k) Summary

SUBMITTER:

COBE Cardiovascular, Inc. 14401 W. 65th Wav Arvada, CO 80004 CONTACT PERSON: Lynne Leonard Phone: [phone] [phone] 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

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.

# 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.
- 2. 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
- 2. Positive Pressure Relief
- 3. Retrograde Flow Prevention
- 4. Hemolvsis
- 5. 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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