(90 days)
No
The device description focuses on the physical components and function of a blood reservoir, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a hardshell venous reservoir used to collect, store, and filter blood during cardiopulmonary bypass; it is not directly involved in treating a disease or condition.
No
The device is a hardshell venous reservoir used in cardiopulmonary bypass surgery to receive, store, and filter blood; it is not described as providing diagnostic information.
No
The device description clearly outlines physical components such as a bucket, porting, defoamer, and cardiotomy filter, indicating it is a hardware device used in surgical 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 "surgical procedures requiring cardiopulmonary bypass." This describes a procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a device used to manage blood flow and volume during surgery. It receives, stores, and filters blood within the extracorporeal circuit. This is a therapeutic and supportive function, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood or other biological samples to provide information about a patient's health status, disease, or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide diagnostic information. This device operates in vivo (within the extracorporeal circuit connected to the body) and serves a supportive role during surgery.
N/A
Intended Use / Indications for Use
The COBE® HVR® 2200 Hardshell Venous Reservoir is intended to be used in surgical procedures requiring cardiopulmonary bypass for periods of up to six hours.
Product codes
DTN, DTP
Device Description
The COBE® HVR® 2200 Hardshell Venous Reservoir is a sterile device with non-pyrogenic fluid pathways. It is designed for single use only, and is not to be restenlized by the user. The device is an open, hardshell venous blood reservoir intended to be used during cardical procedures requiring extracorporeal support for periods of up to six hours. The COBE HVR 2200 is a smaller version of the COBE® HVR® 4000 Hardshell Venous Reservoir (K971669, K984456). The COBE® HVR® 4000 Hardshell Venous Reservoir has a maximum volume of 4000 ml, while the COBE® HVR® 2200 Hardshell Venous Reservoir has a maximum volume of 2200 ml. The smaller volume of the reservoir makes the COBE HVR 2200 more suited for smaller adult and pediatric patients, while the COBE HVR 4000 is for adult patients.
The COBE HVR 2200 is used during cardiopulmonary bypass surgery to receive and store the patient's venous blood and to act as blood volume buffer, as well as to receive raw cardiotomy suction blood and filter it prior to returning it to the circulating blood volume. Entrained air is removed from both the venous blood and cardiotomy suction blood by the defoamer. The major components of the device are the bucket, the porting, the defoamer, and the cardiotomy filter. The bucket serves both as a primary structural component of the device and as a transparent vessel to contain excess blood volume and to allow for the monitoring of changes in blood volume. The porting provides blood tubing connections between the reservoir and the patient, the defoamer serves to remove gross air from incoming venous and cardiotomy suction blood, and the filter removes particles from the cardiotomy suction return blood.
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
The smaller volume of the reservoir makes the COBE HVR 2200 more suited for smaller adult and pediatric patients, while the COBE HVR 4000 is for adult patients.
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)
Performance testing consisted of:
-
- Defoaming Capability
-
- Minimum Operating Volume
- Maximum Operating Volume 3.
-
- Filtration Efficiency
-
- Blood Pathway Integrity
- Port Integrity 6.
-
- Blood trauma
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic Minimax Filtered Hardshell Venous Reservoir
Reference Device(s)
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
510(k) Summary
| SUBMITTER: | |
|---|---|
| ------------ | -- |
COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004
CONTACT PERSON: Lynne Leonard Phone: (303) 467-6586 (303) 467-6429 Fax:
December 27, 1999 DATE PREPARED:
COBE® HVR® 2200 Hardshell Venous Reservoir, Filtered DEVICE TRADE NAME:
Hardshell Venous Reservoir with Integral Cardiotomy Filter COMMON/USUAL NAME:
Cardiopulmonary Bypass Blood Reservoir CLASSIFICATION NAMES: Cardiopulmonary Bypass Defoamer Cardiopulmonary Bypass Cardiotomy Suction Line Blood Filter
Medtronic Minimax Filtered Hardshell Venous Reservoir PREDICATE DEVICE:
DEVICE DESCRIPTION:
The COBE® HVR® 2200 Hardshell Venous Reservoir is a sterile device with non-pyrogenic fluid pathways. It is designed for single use only, and is not to be restenlized by the user. The device is an open, hardshell venous blood reservoir intended to be used during cardical procedures requiring extracorporeal support for periods of up to six hours. The COBE HVR 2200 is a smaller version of the COBE® HVR® 4000 Hardshell Venous Reservoir (K971669, K984456). The COBE® HVR® 4000 Hardshell Venous Reservoir has a maximum volume of 4000 ml, while the COBE® HVR® 2200 Hardshell Venous Reservoir has a maximum volume of 2200 ml. The smaller volume of the reservoir makes the COBE HVR 2200 more suited for smaller adult and pediatric patients, while the COBE HVR 4000 is for adult patients.
The COBE HVR 2200 is used during cardiopulmonary bypass surgery to receive and store the patient's venous blood and to act as blood volume buffer, as well as to receive raw cardiotomy suction blood and filter it prior to returning it to the circulating blood volume. Entrained air is removed from both the venous blood and cardiotomy suction blood by the defoamer. The major components of the device are the bucket, the porting, the defoamer, and the cardiotomy filter. The bucket serves both as a primary structural component of the device and as a transparent vessel to contain excess blood volume and to allow for the monitoring of changes in blood volume. The porting provides blood tubing connections between the reservoir and the patient, the defoamer serves to remove gross air from incoming venous and cardiotomy suction blood, and the filter removes particles from the cardiotomy suction return blood.
INDICATIONS FOR USE
The COBE® HVR® 2200 Hardshell Venous Reservoir is intended to be used in surgical procedures requiring cardiopulmonary bypass for periods of up to six hours.
1
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The COBE® HVR® 2200 Filtered Hardshell Venous Reservoir is substantially equivalent to the predicate device, the Medtronic Minimax Filtered Hardshell Venous Reservoir in intended use, operating principle and overall design and features. The devices have minor differences in performance specifications such as blood and cardiotomy flow rates, minimum operating volume, and maximum volume capacity.
Biocompatibility and performance tests demonstrate substantial equivalence of the two devices. Performance testing consisted of:
-
- Defoaming Capability
-
- Minimum Operating Volume
- Maximum Operating Volume 3.
-
- Filtration Efficiency
-
- Blood Pathway Integrity
- Port Integrity 6.
-
- Blood trauma
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
MAR 2 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lynne Leonard Manager, Regulatory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004-3599
Re : K994389 COBE® HVR® 2200 Filtered Hardshell Venous Reservoir Regulatory Class: II (two) and III (Three) Product Code: DTN and DTP Dated: December 27, 1999 Received: December 28, 1999
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 against 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 regulatory action. In addition, FDA may publish further 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.
3
Page 2 - Ms. Lynn 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 (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,
Keene R. Simpson Co.
James F. Dillard III
James E. Dillard III Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known): K994389
Device Name:
COBE® HVR® 2200 Filtered Hardshell Venous Reservoir
Indication For Use:
The COBE® HVR® 2200 Hardshell Venous Reservoir is intended to be used in 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)
Ortiz G. Romero Jr.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________