(19 days)
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No
The provided 510(k) summary describes a blood reservoir and filter for extracorporeal circuits, focusing on mechanical functions like defoaming, filtering, and storing blood. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
Yes
The device is part of an extracorporeal circuit that processes and returns blood to the patient, which directly contributes to a medical procedure (cardiac surgery typically) to maintain physiological function.
No
The description indicates the device processes blood and returns it to a circuit, focusing on filtration and storage, not on providing information for diagnosis.
No
The device description clearly states it functions in an extracorporeal circuit and receives, defoams, filters, and stores blood, indicating it is a hardware device with physical components.
Based on the provided information, the Bard Quantum CVR is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as functioning in an extracorporeal circuit to receive, defoam, filter, and store blood prior to returning it to the circuit. This is a process that happens outside the body, but it's focused on processing the blood for reintroduction, not for diagnostic testing of the blood itself.
- Lack of Diagnostic Purpose: The description does not mention any analysis of the blood for diagnostic purposes (e.g., measuring analytes, identifying pathogens, etc.). Its function is purely mechanical/physical processing of the blood.
- Typical IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Bard Quantum CVR's function doesn't align with this.
Therefore, the Bard Quantum CVR is a medical device used in an extracorporeal circuit, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bard Quantum CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from:
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- Venous return;
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- Intracardiac suction;
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- Ventricular vent devices;
-
- Arterial-venous shunts.
It defoams, filters and stores this blood prior to returning it to the circuit.
- Arterial-venous shunts.
Product codes
74 DTN, 74 DTP
Device Description
The Bard Quantum CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from venous return, intracardiac suction, ventricular vent devices, and arterial-venous shunts. It defoams, filters and stores this blood prior to returning it to the circuit.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.4230 Cardiopulmonary bypass defoamer.
(a)
Identification. A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.”
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 1999
Ms. Sandra Perreand Regulatory Affairs Manager Bard Vascular Systems Division C.R. Bard, Inc. 25 Computer Drive 01832 Haverhill, MA
Re : K990514 Bard® Quantum™ CVR Requlatory Class: III (Three) Product Code: 74 DTN and 74 DTP February 17, 1999 Dated: February 18, 1999 Received:
Dear Ms. Perreand:
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 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 requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.
1
Page 2 - Ms. Sandra Perreand
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 oredicate 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
2
Bard® Quantum™ CVR "Special 510(k)" Premarket Notification
ారా
Indications for Use Statement Attachment 2
Device Name:
Bard H-6770VR Quantum CVR
Indications for Use:
The Bard Quantum CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from:
-
- Venous return;
-
- Intracardiac suction;
-
- Ventricular vent devices;
-
- Arterial-venous shunts.
It defoams, filters and stores this blood prior to returning it to the circuit.
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, | |
| Neurological Devices | |
| (k) Number | K990514 |
| Prescription Use | ✓ |
|---|---|
| ------------------ | -------------------------------------------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
Bard® Quantum CVR "Special 510(k)" Submission