(78 days)
American Omni Vent Valve
Not Found
No
The device description focuses on a mechanical valve and its functional equivalence to a predicate device, with no mention of AI or ML.
No.
The device is a vacuum relief valve used in cardiotomy reservoirs to maintain a low level of vacuum; it does not directly treat a disease or condition.
No
Explanation: The device is described as a vacuum relief valve used in cardiotomy reservoirs to maintain a low level of vacuum. Its function is to regulate pressure, not to identify, monitor, or determine the presence or absence of a disease or condition.
No
The device is described as a physical, single-use, disposable valve made of materials, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "maintain a low level of vacuum in cardiotomy reservoirs." This is a mechanical function related to a medical device (cardiotomy reservoir) used during a medical procedure (likely cardiac surgery).
- Device Description: The description focuses on the physical characteristics, operation, manufacturing, and materials of a vacuum relief valve. It describes a component used within a larger medical system.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide diagnostic information. This device's function is purely mechanical and related to maintaining a specific condition within a medical system.
N/A
Intended Use / Indications for Use
The IBC Vent Valve is a single use, disposable, vacuum relief valve that is intended for use to maintain a low level of vacuum in reservoirs. The Cardiotomy Vent Valve is indicated for use to maintain a low level of vacuum in cardiotomy reservoirs.
Product codes
MNJ
Device Description
The IBC Vent Valve is a single use, disposable, vacuum relief valve that is intended for use to maintain a low level of vacuum in reservoirs. The valve is closed until the vacuum reaches a pre-determined value in the reservoir and operates best when the pump runs at a very slow rate. The fully assembled IBC Vent Valve is basically identical to the American Omni Vent Valve, which is the predicate device for purposes of this 510(k) submission. The operating principles, performance and indications for use of the two devices are the same.
The IBC Vent Valve is manufactured in a Class 100,000 clean room. The device will be packaged and sterilized for single use. Additionally, the IBC Vent Valve will be packaged in bulk form and non-sterile for the Custom Perfusion Pack market. The materials used to manufacture the IBC Vent Valve are non-toxic and meet current ISO biocompatible tripartite standards using the FDA matrix.
A perfusionist substituting an IBC Vent Valve for an American Omni Vent Valve with his or her cardiotomy reservoir will be unable to distinguish between the two valves functionally.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
American Omni Vent Valve
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV 1 9 1999
510(k) SUMMARY
The IBC Vent Valve is a single use, disposable, vacuum relief valve that is intended for use to maintain a low level of vacuum in reservoirs. The valve is closed until the vacuum reaches a pre-determined value in the reservoir and operates best when the pump runs at a very slow rate. The fully assembled IBC Vent Valve is basically identical to the American Omni Vent Valve, which is the predicate device for purposes of this 510(k) submission. The operating principles, performance and indications for use of the two devices are the same.
The IBC Vent Valve is manufactured in a Class 100,000 clean room. The device will be packaged and sterilized for single use. Additionally, the IBC Vent Valve will be packaged in bulk form and non-sterile for the Custom Perfusion Pack market. The materials used to manufacture the IBC Vent Valve are non-toxic and meet current ISO biocompatible tripartite standards using the FDA matrix.
A perfusionist substituting an IBC Vent Valve for an American Omni Vent Valve with his or her cardiotomy reservoir will be unable to distinguish between the two valves functionally.
1
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov 1 9 1999
Mr. H. David Shockley, Jr. President International Biophysics Corporation 4020 South Industrial Drive Suite 160 Austin, TX 78744
K992964 Re : IBC Cardiotomy Vent Valve Requlatory Class: II (two) Product Code: MNJ August 31, 1999 Dated: Received: September 2, 1999
Dear Mr. Shockley:
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 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further regulatory action. 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 - Mr. David Shockley, Jr.
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 diaqnostic 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,
S. Maria Maddalena
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: IBC Cardiotomy Vent Valve
Indications for use:
The Cardiotomy Vent Valve is indicated for use to maintain a low level of vacuum in cardiotomy reservoirs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Bette L. Temperell |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| (Division Sign-Off) | |
| 510(k) Number | K992964 |
| Prescription Use (Per 21 CFR 801.109) | X | or Over-The-Counter-Use | |
|---|---|---|---|
| --------------------------------------- | --- | ------------------------- | -- |