(27 days)
The COBE® HVR® 4000 Filtered Hardshell Venous Reservoir is intended to be used in adult cardiac surgical procedures requiring cardiopulmonary bypass for periods up to six hours.
The COBE® HVR" 4000 Fittered Hardshell Venous Reservoir is a sterile device with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. The device is an open venous blood reservoir with integral cardiotomy filter.
Here's an analysis of the provided text regarding the COBE® HVR® 4000 Filtered Hardshell Venous Reservoir, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K971669) rather than establishing novel safety and effectiveness acceptance criteria. Therefore, the "acceptance criteria" are implied to be that the modified device performs similarly or equivalently to the predicate device across various in-vitro tests. The "reported device performance" refers to the results of these comparative tests.
| Acceptance Criteria (Implied: Equivalent to Predicate Device K971669) | Reported Device Performance (Implied: Achieved Equivalence) |
|---|---|
| Venous Blood Flow Performance | Demonstrated equivalence to predicate device |
| Defoaming Capacity | Demonstrated equivalence to predicate device |
| Filtration Efficiency | Demonstrated equivalence to predicate device |
| Operating Volume (Range: Minimum & Maximum) | Demonstrated equivalence to predicate device |
| Breakthrough Volume | Demonstrated equivalence to predicate device |
| Unrecoverable Volume | Demonstrated equivalence to predicate device |
| Filter Loading Capacity | Demonstrated equivalence to predicate device |
| Blood Trauma Effects | Demonstrated equivalence to predicate device |
Note: The document explicitly states, "In-vitro tests were performed to demonstrate that the modified COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir described in this submission is substantially equivalent to the original, unmodified COBE® HVR® 4000 Filtered Hardshell Venous Reservoir (K971669)." This indicates that the goal of the study was to show similar performance, rather than meet specific numerical thresholds that aren't provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for the in-vitro tests. It only lists the types of tests performed.
- Data Provenance: The data is described as "In-vitro tests." This indicates the data was generated in a laboratory setting, likely in the US (where COBE Cardiovascular, Inc. is located). The data is prospective in the sense that it was generated specifically for this submission to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this submission. The "ground truth" for this type of device modification (material change in a component) is established through technical performance testing against a known predicate device, not through expert consensus or interpretation of medical images/outcomes.
4. Adjudication Method for the Test Set
This section is not applicable. Since the testing involved in-vitro performance measurements, there's no need for an adjudication method as would be used in studies involving human interpretation or clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. This submission is for a medical device (a venous reservoir used in cardiopulmonary bypass), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and concepts of human reader improvement with AI are irrelevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. Again, this involves a medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this study is the established performance characteristics of the predicate device (COBE® HVR® 4000 Filtered Hardshell Venous Reservoir, K971669). The in-vitro tests aimed to demonstrate that the modified device's performance aligns with, or is equivalent to, these known characteristics.
8. The Sample Size for the Training Set
This section is not applicable. This is a device modification submission, not a machine learning model development. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
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Special 510(k)-Device Modification: COBE® HVR® 4000 Filtered Hardshell Venous Reservoir
JAN 1 1 1999
510(k) Summary
| SUBMITTER: | COBE Cardiovascular, Inc.14401 W. 65th WayArvada, CO 80004 |
|---|---|
| CONTACT PERSON: | Lynne LeonardPhone: (303) 467-6586Fax:(303) 467-6429 |
| DATE PREPARED: | December 14, 1998 |
| DEVICE TRADE NAME: | COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir |
| COMMON/USUAL NAME: | Hardshell Venous Reservoir with Integral Cardiotomy Filter |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Blood Reservoir with Defoamerand Cardiotomy Suction Line Blood Filter |
| PREDICATE DEVICE: | COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir (K971669) |
DEVICE DESCRIPTION:
The COBE® HVR" 4000 Fittered Hardshell Venous Reservoir is a sterile device with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. The device is an open venous blood reservoir with integral cardiotomy filter.
INDICATIONS FOR USE
The COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir is intended to be used in adult cardiac surgical procedures requiring cardiopulmonary bypass for periods up to six hours.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The modified COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir described in this submission is substantially equivalent to the original, unmodified COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir (K971669). The modified COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir is identical to the original, unmodified COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir (K971669) in intended use, specifications, features, method of operation, and fundamental scientific technology. The two devices differ in the materials used in the defoamer and cardiotomy filter.
TESTING TO DETERMINE SUBSTANTIAL EQUIVALENCE
In-vitro tests were performed to demonstrate that the modified COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir described in this submission is substantially equivalent to the original, unmodified COBE® HVR® 4000 Filtered Hardshell Venous Reservoir (K971669). In-vitro testing consisted of venous blood flow, defoaming capacity, filtration efficiency, operating volume, breakthrough volume, unrecoverable volume, filter loading, blood trauma, and minimum/maximum operating volumes.
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Image /page/1/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird with three wavy lines extending from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 1999
Ms. Lynne Leonard Manager, Regulatory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004-3599
Re : K984456 COBE® HVR® 4000 Filtered Hardshell Venous Reservoir Requlatory Class: II (Two) and III (Three) Product Code: DTN/DTP Dated: December 14, 1998 December 15, 1998 Received:
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 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 Regulation (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 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 obliqation you miqht 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 - 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 Additionally, for questions on the promotion and (301) 594-4648. 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 Other general information on your responsibilities CFR 807.97) . 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. 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
510(k) Number (If known):
COBE® HVR® 4000 Filtered Hardshell Venous Reservoir Device Names:
Indications For Use:
The COBE® HVR® 4000 Filtered Hardshell Venous Reservoir is intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods of up to six hours.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bas la Campuele
(Division Sign-Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Numbe
Over-The-Counter Use
,
Prescription Use (Per 21 CFR 801.109) OR
§ 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.