(78 days)
Maxima Hardshell Venous Reservoir - Top Entry, Model MHR-T
Not Found
No
The device description and performance studies focus on the physical characteristics and blood handling capabilities of a venous reservoir, with no mention of AI or ML.
No.
This device is for the storage and filtration of blood during surgical procedures. It is not designed to directly treat a disease or adverse condition.
No
This device is intended for storage and filtration of blood during surgical procedures. It does not perform any diagnostic function.
No
The device description clearly describes a physical, hardware-based blood reservoir used in surgical procedures, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the storage and filtration of blood during surgical procedures requiring extracorporeal circulation. This is a direct interaction with the patient's blood outside the body for a therapeutic or supportive purpose during surgery.
- Device Description: The device is described as a blood reservoir with defoamer and filter, used in conjunction with other equipment for cardiopulmonary bypass. This is a component of a system used to manage blood flow and properties during surgery.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze blood, detect substances, or provide information for diagnosis, monitoring, or screening. Its function is purely for the physical handling and processing of blood during a surgical procedure.
IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or screening purposes. This device's function is entirely focused on supporting a surgical procedure by managing the patient's blood extracorporeally.
N/A
Intended Use / Indications for Use
The HVR 4000 Filtered is intended for storage and filtration of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.
The HVR 4000 Nonfiltered is intended for storage of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.
Product codes
74 DTN
Device Description
The HVR™ 4000 Filtered Hardshell Venous Reservoir is an open cardiopulmonary bypass blood reservoir with defoamer and cardiotomy suction filter. Used in coniunction with other ancillary equipment and disposable products, this device will satisfy an adult patient's blood storage and cardiotomy filtration requirements during surgical procedures.
The HVR™ 4000 Nonfiltered Hardshell Venous Reservoir is an open cardiopulmonary bypass blood reservoir with defoamer. Used in conjunction with other ancillary equipment and disposable products, this device will satisfy an adult patient's blood storage requirements during surgical procedures
The product is sterilized by ethylene oxide gas and has nonpyrogenic fluid pathways.
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
adults
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)
NONCLINICAL TEST RESULTS: The blood trauma characteristics of the HVR 4000 Filtered and the HVR 4000 Nonfiltered are not significantly different compared to the Maxima Hardshell Venous Reservoir. Filtration efficiency of the HVR 4000 Filtered meets specification. Volume capacity of both COBE devices meet specification. Material biocompatibility, sterilization and packaging of both COBE devices meet requirements. All labeling claims have been substantiated. The COBE HVR 4000 Hardshell Venous Reservoirs will be labeled with a one year expiration period.
CLINICAL TEST RESULTS: No clinical testing was performed. Safety and efficacy were determined by in vitro testing.
CONCLUSIONS:
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- The COBE devices' blood trauma characteristics are comparable to those of the predicate device.
-
- The COBE devices' maximum operating volumes meet claims
-
- The COBE devices' minimum operating volumes meet claims
- The COBE devices' filtration efficiency meets claims 4.
-
- Material biocompatibility, sterilization and packaging for the COBE devices meet requirements
-
- All labeling claims for the COBE devices have been substantiated
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Maxima Hardshell Venous Reservoir - Top Entry, Model MHR-T
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.
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510(k) Premarket Notification
510(k) Summary
- Jul 2 3 1997
- COBE Cardiovascular, Inc. ® SUBMITTER: 14401 W. 65th Way Arvada, CO 80004
- CONTACT PERSON: Mary L. Armstrong Phone:(303) 467-6521 Fax:
5/5/97 DATE PREPARED:
COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir DEVICE TRADE NAME: COBE® HVR™ 4000 Nonfiltered Hardshell Venous Reservoir
- Hardshell venous reservoir with integral cardiotomy filter COMMON NAME: Hardshell venous reservoir
- CLASSIFICATION NAME: Cardiopulmonary bypass blood reservoir with defoamer and cardiotomy suction filter
Cardiopulmonary bypass blood reservoir with defoamer
PREDICATE DEVICE: Maxima Hardshell Venous Reservoir - Top Entry, Model MHR-T
DEVICE DESCRIPTION: The HVR™ 4000 Filtered Hardshell Venous Reservoir is an open cardiopulmonary bypass blood reservoir with defoamer and cardiotomy suction filter. Used in coniunction with other ancillary equipment and disposable products, this device will satisfy an adult patient's blood storage and cardiotomy filtration requirements during surgical procedures.
The HVR™ 4000 Nonfiltered Hardshell Venous Reservoir is an open cardiopulmonary bypass blood reservoir with defoamer. Used in conjunction with other ancillary equipment and disposable products, this device will satisfy an adult patient's blood storage requirements during surgical procedures
The product is sterilized by ethylene oxide gas and has nonpyrogenic fluid pathways.
INDICATIONS FOR USE: The HVR 4000 Filtered is intended for storage and filtration of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.
The HVR 4000 Nonfiltered is intended for storage of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.
TECHNOLOGICAL CHARACTERISTICS: Comparing the HVR™ 4000 Filtered Hardshell Venous Reservoir and the HVR™ 4000 Nonfiltered Hardshell Venous Reservoir with the Maxima Hardshell Venous Reservoir, some similarities and differences are noted in the design and technology employed to accomplish their intended uses.
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510(k) Premarket Notification
All three devices use a knitted polyester fabric as the outer defoamer covering. In the filtered devices (i.e., the HVR 4000 Filtered and the Maxima Hardshell Venous Reservoir), filtration is accomplished through use of polyurethane foam for gross filtration and polyester depth media for fine filtration.
All three devices include the same functional types of porting in essentially the same numbers and sizes. For venting, the Maxima Hardshell Venous Reservoir uses a port on its cover where the COBE HVR 4000 Hardshell Venous Reservoirs use an open cover design. Both COBE devices use a one-piece, molded venous inlet port, whereas the Maxima device uses a two-piece inlet comprised of a rigid, injection molded port joined to a flexible, polyvinylchloride tube.
NONCLINICAL TEST RESULTS: The blood trauma characteristics of the HVR 4000 Filtered and the HVR 4000 Nonfiltered are not significantly different compared to the Maxima Hardshell Venous Reservoir. Filtration efficiency of the HVR 4000 Filtered meets specification. Volume capacity of both COBE devices meet specification. Material biocompatibility, sterilization and packaging of both COBE devices meet requirements. All labeling claims have been substantiated. The COBE HVR 4000 Hardshell Venous Reservoirs will be labeled with a one year expiration period.
CLINICAL TEST RESULTS: No clinical testing was performed. Safety and efficacy were determined by in vitro testing.
CONCLUSIONS:
-
- The COBE devices' blood trauma characteristics are comparable to those of the predicate device.
-
- The COBE devices' maximum operating volumes meet claims
-
- The COBE devices' minimum operating volumes meet claims
- The COBE devices' filtration efficiency meets claims 4.
-
- Material biocompatibility, sterilization and packaging for the COBE devices meet requirements
-
- All labeling claims for the COBE devices have been substantiated
COBE® and COBE Cardiovascular® are registered trademarks of COBE Laboratories, Inc. HVR™ is a trademark of COBE Laboratories, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
JUL 2 3 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Public Health Service
Ms. Mary L. Armstrong Regulatory Affairs Manager COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, Colorado 80004-3599
Re : K971669 COBE® HVR™ 4000 Reservoirs Requlatory Class: II (Two) Product Code: 74 DTN Dated: May 5, 1997 Received: May 6, 1997
Dear Ms. Armstrong:
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 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 requirement, 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 regulations.
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Page 2 - Ms. Mary L. Armstrong
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) Additionally, for questions on the promotion and 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 CFR 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/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- 440 -
Reservoir
510(k) Premarket Notification
Indications For Use
510(k) Number (If known): ____________________________________________________________________________________________________________________________________________________
Device Name: COBE® HVR™ 4000 Filtered Hardshell Venous Reservoir COBE® HVR™ 4000 Nofiltered Hardshell-Venous Reservoir · ----------------------------------------------------------------------------------------------------------------------
Indications For Use:
The HVR 4000 Filtered is intended for storage and filtration of blood during surgical procedures on adults requiring extracorporeal circulation for periods of up to six hours.
The HVR 4000 Nonfiltered is intended for storage of blood during surgical procedures on adults requiring extracorporeal circulation 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)
Zote L. Lamperle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 971669
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Prescription Use x (Per 21 CFR 801.109) OR
510(k) Number
Over-The -Counter Use
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