(107 days)
No
The description focuses on mechanical functions (defoaming, filtering, storing blood) and performance studies compare it to similar non-AI/ML devices. There is no mention of AI, ML, or related concepts.
No
The description states the device receives, defoams, filters, and stores blood before returning it to an extracorporeal circuit. This is a support function within a medical procedure, not a direct treatment or therapy itself.
No
Explanation: The device is described as functioning in an extracorporeal circuit to defoam, filter, and store blood before returning it to the circuit. This is a therapeutic function, not a diagnostic one.
No
The device description clearly indicates a physical device (cardiotomy/reservoir) that receives, defoams, filters, and stores blood, which are hardware functions. The performance studies also focus on physical characteristics like cell damage, defoaming ability, and filtration efficiency.
Based on the provided information, the Bard® Quantum™ CVR is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as functioning in an extracorporeal circuit to receive, defoam, filter, and store blood before returning it to the circuit. This is a mechanical process involving blood handling outside the body, not a diagnostic test performed on a sample of blood or other bodily fluid to provide information about a patient's health status.
- Device Description: The description reiterates the mechanical function of the device in the extracorporeal circuit.
- Lack of Diagnostic Elements: There is no mention of analyzing blood components, detecting biomarkers, or providing any diagnostic information based on the blood processed by the device.
- Performance Studies: The performance studies focus on the device's ability to handle blood (cell damage, defoaming, filtration) and its biocompatibility, which are relevant to its function in an extracorporeal circuit, not its diagnostic capabilities.
IVD devices are typically used to test samples (like blood, urine, tissue) to diagnose diseases, monitor health conditions, or screen for specific substances. The Bard® Quantum™ CVR's function is purely related to managing blood flow and quality within a surgical or medical procedure.
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:
- (1) venous return
- intracardiac suction (2)
- (3) ventricular vent devices
- arterial-venous shunts (4)
It defoams, filters and stores this blood before returning it to the circuit.
Product codes
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Device Description
The Bard® Quantum™ CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from:
- (1) venous return
- intracardiac suction (2)
- (3) ventricular vent devices
- arterial-venous shunts (4)
It defoams, filters and stores this blood before returning it to the circuit.
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
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Summary of Performance Studies
The Bard H6770VR, the Cobe HVRF, and the Bard H-3700 were compared for performance and integrity characteristics. In addition, the Bard H6770VR was subjected to biocompatibility testing. The proposed device was found to be equivalent to or better than the predicated devices or differences were clinically insignificant in terms of cell damage, defoaming ability, and filtration efficiency. The Bard H6770VR passed all tests of biocompatibility required by the International Standard ISO 10993.
Key Metrics
Not Found
Predicate Device(s)
Bard® William Harvey® Cardiotomy Reservoir with MICRO Filter (H-3700) (510(k) #K902856), Cobe HVRF®-3700 Open Venous Reservoir with Integral Cardiotomy Filter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
CT 30 1996
Bard Vascular Systems Division C.R. Bard, Inc. 25 Computer Drive Haverhill, MA 01832 508-373-1000
(
BARD
510(k) SUMMARY FOR THE BARD® QUANTUM™ CVR
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
- Submitter's Information A.
| Name: | C.R. Bard, Inc., Bard Vascular Systems Division | |
|---|---|---|
| Address: | 25 Computer Drive, Haverhill, MA 01832 | |
| Phone: | (508) 373-1000 extension 3371 | |
| Fax: | (508) 374-6200 | |
| Contact Person: | Douglas E. Ferguson, Regulatory Affairs Specialist | |
| Date of Preparation:July 12, 1996 |
B. Device Name:
| Trade Name: | Bard® Quantum™ CVR |
|---|---|
| Common/Usual Name: | Cardiotomy and Venous Reservoir with |
| Defoamer | |
| Classification Name: | Cardiopulmonary Bypass Blood Reservoir |
| with Cardiopulmonary Bypass Defoamer |
C. Predicate Device Name(s):
-
- Bard® William Harvey® Cardiotomy Reservoir with MICRO Filter (H-3700) (510(k) #K902856)
-
- Cobe HVRF®-3700 Open Venous Reservoir with Integral Cardiotomy Filter
D. Device Description/Indications for Use:
The Bard® Quantum™ CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from:
- (1) venous return
- intracardiac suction (2)
- (3) ventricular vent devices
- arterial-venous shunts (4)
It defoams, filters and stores this blood before returning it to the circuit.
1
- Technological Characteristics Summary E.
The "510(k) Substantial Equivalence Decision-Making Process (Detailed)" decision tree (FDA 92-415, Premarket Notification 510(k): Regulatory Requirements for Medical Devices. Page 51) was utilized to make a determination of substantial equivalence as follows:
Does New Device Have Same Indication Statements? 1.
The Bard® Quantum™ CVR (Bard H6770VR) has the same Yes. indications as the Cobe HVRF although the Bard H6770VR includes additional detail. The Bard H-3700 and the Bard H6770VR have the same indications for use intraoperatively; however the Bard H6770VR will not be indicated for post-operative use as the Bard H-3700 is. Although the wording in the Indications for Use for all of these devices is not identical, all of these devices are indicated for use in extracorporeal systems during cardiopulmonary bypass.
2. Does New Device Have Same Technological Characteristics, e.g., Design, Materials, etc.?
Yes. The Bard H6770VR has the same technological characteristics and the same materials as at least one of the predicate devices or the difference is insignificant.
3. Are the Descriptive Characteristics Precise Enough to Ensure Equivalence?
No. Although the materials and technological characteristics are the same. bench testing is necessary to ensure equivalence because of (1) differences between vendors and manufacturing techniques and (2) the fact that neither of the predicate devices individually include all the same materials and technological characteristics as those of the proposed device.
4. Are Performance Data Available to Assess Equivalence?
Yes. The Bard H6770VR, the Cobe HVRF, and the Bard H-3700 were compared for performance and integrity characteristics. In addition, the Bard H6770VR was subjected to biocompatibility testing.
2
Performance Data Demonstrate Equivalence? 5.
Yes. The proposed device was found to be equivalent to or better than the predicated devices or differences were clinically insignificant in terms of cell damage, defoaming ability, and filtration efficiency.
The Bard H6770VR passed all tests of biocompatibility required by the International Standard ISO 10993.
SUBSTANTIALLY EQUIVALENT DETERMINATION:
The Bard H6770VR is substantially equivalent to the predicate devices, the Cobe HVRF and the Bard H-3700.