(27 days)
No
The document describes a mechanical blood reservoir and filter used in cardiopulmonary bypass, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device is a component used during cardiac surgery, specifically for cardiopulmonary bypass, and does not directly provide therapeutic treatment.
No
The device is described as an open venous blood reservoir with an integral cardiotomy filter for use in cardiac surgical procedures, not for diagnostic purposes.
No
The device description explicitly states it is a "sterile device with non-pyrogenic fluid pathways" and a "hardshell venous reservoir," indicating it is a physical hardware device used in cardiopulmonary bypass procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "adult cardiac surgical procedures requiring cardiopulmonary bypass." This describes a procedure performed directly on a patient's body, not a test performed on a sample of bodily fluid or tissue outside the body.
- Device Description: The description details a "venous blood reservoir with integral cardiotomy filter." This is a component used in a surgical procedure to manage blood flow, not a device designed to analyze a sample for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any features or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to manage blood during surgery, which is a therapeutic and procedural function, not a diagnostic one.
N/A
Intended Use / 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.
Product codes
DTN, DTP
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.
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
adult
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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 Way
Arvada, CO 80004 |
|----------------------|--------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Lynne Leonard
Phone: (303) 467-6586
Fax:
(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 Defoamer
and 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.
1
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.
2
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
3
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