(268 days)
Not Found
No
The device description and performance studies focus on physical and functional characteristics of a blood reservoir and filter, with no mention of AI or ML.
No
The device is described as a "Venous Reservoir with Integral Cardiotomy Filter" used for collecting and autotransfusing shed blood, and its function is to salvage blood, not to directly treat a disease or condition.
No
The device is a venous reservoir with an integral cardiotomy filter, intended for the collection and autotransfusion of shed blood during or after cardiopulmonary bypass procedures. Its purpose is to salvage blood, not to diagnose a medical condition.
No
The device description clearly states it is a "hardshell venous reservoir with an integral cardiotomy filter" and mentions physical components like a "polyurethane defoamer sponge and outer gross filter screen," indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the collection and autotransfusion of shed blood during and after surgical procedures (cardiopulmonary bypass). This is a therapeutic and blood management function, not a diagnostic one.
- Device Description: The description details a physical device for blood handling and filtration, not for analyzing biological samples to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to test, analyze, or provide information about a patient's health status or condition based on in vitro examination of samples.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on managing blood within the context of a surgical procedure.
N/A
Intended Use / Indications for Use
The VRF40 is intended to allow for the collection and autotransfusion of shed mediastinal blood following cardiopulmonary bypass procedures or other procedures where shed blood is expected.
The VRF40 Venous Reservoir with Integral Cardiotomy Filter is intended for use in CPB circuits and postoperative blood salvage procedure
Product codes (comma separated list FDA assigned to the subject device)
74 DTN
Device Description
The VRF40 is a sterile, nonpyrogenic, disposable, hardshell venous reservoir with an integral cardiotomy filter. It contains a polyurethane defoamer sponge and outer gross filter screen,
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was based on a comparison of test results from the following in vitro physical and functional tests:
Physical Tests Vacuum Integrity
Functional Tests Hemolysis Residual Volume Filter Pressurization
All testing was conducted on nonaged, sterile devices. Test results show similar performance characteristics between the VRF40 and the Sorin Hardshell Venous Reservoir with respect to the expanded use of chest drainage autotransfusion.
Biocompatibility testing was previously performed on a finished, sterilized device in accordance with the Tripartite Guidelines for Biocompatibility testing for short term blood contacting materials. All test results were comparable to the negative control groups. Therefore, the materials used in the VRF40 are considered acceptable for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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) Notification
Sorin Biomedical Inc. VRF40 Venous Reservoir with Integral Cardiotomy Filter
K964908
Sept. 3, 1997
510(k) SUMMARY
Name and Address of Submitter A.
Sorin Biomedical Inc. 17600 Gillette Avenue Irvine, California 92614-5751
Telephone and Fax Numbers of Submitter B.
| Telephone: | (714) 250-8320 |
|---|---|
| Fax: | (714) 250-1524 |
Name of Contact Person C.
Richard J. DeRisio Vice President Quality & Regulatory Affairs
D. Date Summary was Prepared
1
510(k) SUMMARY (cont.)
II. Device Name
Trade or Proprietary Name:
VRF 40 Venous Reservoir with Integral Cardiiotomy Filter
Common Name:
Cardiotomy Reservoir, Venous Reservoir with Integral Cardiotomy Filter
Classification Name:
Cardiopulmonary Bypass Blood Reservoir Cardiopulmonary Bypass Cardiotomy Suction Line Blood Filter
F. Summary of Substantial Equivalence
The VRF40 Venous Reservoir with Integral Cardiotomy Filter is judged to be substantially equivalent in intended use, materials, design, and performance characteristics to the Sorin Hardshell Venous Reservoir (HSVRF). The HSVRF was cleared for chest drainage on September 30, 1987 (K872719). The VRF40 was designed for use in chest drainage and is marketed by DIDECO for that intended use outside the United States.
G. Device Description
The VRF40 is a sterile, nonpyrogenic, disposable, hardshell venous reservoir with an integral cardiotomy filter. It contains a polyurethane defoamer sponge and outer gross filter screen,
H. Intended Use
The VRF40 is intended to allow for the collection and autotransfusion of shed mediastinal blood following cardiopulmonary bypass procedures or other procedures where shed blood is expected.
I. Summary of Comparison of Technological Characteristics
The technological characteristics of the VRF40 is similar to the Sorin Hardshell Venous Reservoir with respect to chest drainage autotransfusion. These devices have a similar number of cardiotomy inlet ports, have similar filter elements, and are similar in setup and use for chest drainage.
108
2
510(k) SUMMARY (cont.)
Summary of Nonclinical Tests J.
Substantial equivalence was based on a comparison of test results from the following in vitro physical and functional tests:
Physical Tests Vacuum Integrity
Functional Tests Hemolysis Residual Volume Filter Pressurization
All testing was conducted on nonaged, sterile devices. Test results show similar performance characteristics between the VRF40 and the Sorin Hardshell Venous Reservoir with respect to the expanded use of chest drainage autotransfusion.
Biocompatibility
Biocompatibility testing was previously performed on a finished, sterilized device in accordance with the Tripartite Guidelines for Biocompatibility testing for short term blood contacting materials. All test results were comparable to the negative control groups. Therefore, the materials used in the VRF40 are considered acceptable for their intended use.
K. Conclusions
Based upon the above information, Sorin Biomedical Inc. concludes that the VRF40 Venous Reservoir with Integral Cardiotomy Filter is substantially equivalent to the Sorin Hardshell Venous Reservoir for use in chest drainage autotransfusion or any procedure where shed blood is expected.
104
SORIN BIOMEDICAL INC. CONFIDENTIAL
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administra lon 9200 Corporate Boulevard Rockville MD 20856
Mr. Paul Butorac Manager, Quality Engineering Department Sorin Biomedical, Inc. 17600 Gillette Avenue P.O. Box 19503 Irvine, California 92713-9503 ················································································································································
SEP - 3 1997
Re: K964908 VRF40 Venous Reservoir with Integral Cardiotomy Filter Regulatory Class: II (Two) Product Code: 74 DTN Dated: June 10, 1997 Received: June 12, 1997
Dear Mr. Butorac:
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 Requlations, 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 regulations.
4
Page 2 - Mr. Paul Butorac
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 requlation (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" (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.qov/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
5
510(k) Number (if known):_K964908
270 4400
ר.
Device Name: VRF40 Venous Reservoir with Integral Cardiotomy Filter
Indications for Use: The VRF40 Venous Reservoir with Integral Cardiotomy Filter is intended for use in CPB circuits and postoperative blood salvage procedure
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bera L. Remoule
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)