(89 days)
Not Found
No
The device description and performance studies focus on mechanical functions (valves, pressure relief) and do not mention any computational or learning-based components.
No
The device primarily manages vacuum pressure and prevents air flow, acting as a safety mechanism during surgery rather than directly treating a medical condition or restoring a bodily function.
No
The device description clearly states its function: "to help prevent the buildup of excessive vacuum pressure ... and to help prevent inadvertent flow of air into the heart." It is a mechanical safety valve, not a device used to obtain information about a medical condition.
No
The device description clearly outlines a physical, sterile, single-use device with specific ports, valves, and a housing, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage vacuum and pressure during cardiopulmonary bypass surgery, specifically to prevent excessive vacuum and inadvertent air flow into the heart. This is a direct intervention on the patient's circulatory system during a surgical procedure.
- Device Description: The device is a mechanical valve designed to regulate fluid and air flow within a surgical circuit. It does not involve the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The device's function is purely mechanical and related to the surgical process itself.
IVD devices are used to perform tests on samples (like blood, urine, tissue) to gain information about a person's health. This device operates within the surgical circuit and directly interacts with the patient's blood and the surgical field during a procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MJJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart or the surgical field (during cardiopulmonary bypass surgery)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Cardiopulmonary bypass surgery (Professionals in a clinical setting)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to demonstrate substantial equivalence of the COBE® Vacuum Relief Check Valve to the predicate devices. Performance testing consisted of:
-
- Vacuum Pressure Relief
-
- Positive Pressure Relief
-
- Retrograde Flow Prevention
-
- Hemolvsis
-
- 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
C.R. Bard, Inc. William Harvey® #H-130 Overpressure Safety Valve (K820297), American Omni Medical, Inc. #RLV-2100 Non-adiustable Suction Control Valve (K861428)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Pre-Market Notification: COBE® Vacuum Relief Check Valve
21
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
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).
1
The primary differences in the three devices are:
-
- 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.
-
- 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:
-
- Vacuum Pressure Relief
-
- Positive Pressure Relief
-
- Retrograde Flow Prevention
-
- Hemolvsis
-
- 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).
2
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.
3
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
4
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