(255 days)
Not Found
No
The document describes a physical blood collection reservoir with a filter and defoamer, and the performance studies focus on physical and functional characteristics like vacuum integrity and hemolysis. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
No.
Explanation: The device is a "blood collection reservoir" used in CPB circuits and postoperative blood salvage, which are supportive functions during medical procedures, not therapeutic interventions.
No
The device description and intended use indicate that the Dideco Venomidicard and Midicard are blood collection reservoirs used in CPB circuits and for blood salvage procedures. They do not perform any diagnostic function.
No
The device description explicitly states it is a "hardshell blood collection reservoir" and describes physical components like a "polyurethane defoamer sponge and outer gross filter screen," indicating it is a hardware 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 "blood collection reservoirs intended for use in CPB circuits and postoperative blood salvage procedures." This describes a device used during a medical procedure to handle blood, not a device used to perform tests on blood or other biological samples to diagnose a condition.
- Device Description: The description focuses on the physical components for collecting and filtering blood (hardshell reservoirs, filter, defoamer sponge). This aligns with a medical device used in a procedure, not an IVD which would typically involve reagents, assays, or analytical components.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The device's function is purely mechanical (collection and filtration).
Therefore, the Dideco Venomidicard and Midicard are medical devices used in surgical procedures, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Venomidicard and Midicard reservoirs are intended to allow for the collection and autotransfusion of shed mediastinal blood following cardiopulmonary bypass procedures.
The Dideco Venomidicard and Midicard are hardshell blood collection reservoirs intended for use in CPB circuits and postoperative blood salvage procedures.
Product codes (comma separated list FDA assigned to the subject device)
74 DTN
Device Description
The Venomidicard and Midicard are sterile, nonpyrogenic, disposable, hardshell reservoirs that contain an integral cardiotomy filter. Each device 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
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Anatomical Site
mediastinal
Indicated Patient Age Range
Pediatric
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
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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 Venomidicard and Midicard and the Sorin Hardshell Venous Reservoir with respect to the expanded use of chest drainage autotransfusion.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
K-6-1-1-1
510(k) Notification
Sorin Biomedical Inc. Venomidicard / Midicard
510(k) SUMMARY
Aug. 21, 1997
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
Date Summary was Prepared D.
1
AUG 21 nat
510(k) SUMMARY (cont.)
Device Name E.
Trade or Proprietary Name:
| Venomidicard | Pediatric Venous Reservoir with Integral Cardiotomy Filter |
|---|---|
| Midicard | Pediatric Cardiotomy Reservoir |
Common Name:
Cardiotomy Reservoir, Venous Reservoir with Integral Cardiotomy Filter
Classification Name:
Cardiopulmonary Bypass Blood Reservoir Cardiopulmonary Bypass Cardiotomy Suction Line Blood Filter
Summary of Substantial Equivalence F.
The Venomidicard and Midicard reservoirs are 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). These device were designed for use in chest drainage and are marketed by DIDECO for that intended use outside the United States.
G. Device Description
The Venomidicard and Midicard are sterile, nonpyrogenic, disposable, hardshell reservoirs that contain an integral cardiotomy filter. Each device contains a polyurethane defoamer sponge and outer gross filter screen.
H. Intended Use
The Venomidicard and Midicard reservoirs are intended to allow for the collection and autotransfusion of shed mediastinal blood following cardiopulmonary bypass procedures.
I. Summary of Comparison of Technological Characteristics
The technological characteristics of the Venomidicard and Midicard are 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.
2
510(k) SUMMARY (cont.)
J. Summary of Nonclinical Tests
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 Venomidicard and Midicard 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 these devices are considered acceptable for their intended use.
K. Conclusions
Based upon the above information, Sorin Biomedical Inc. concludes that the Venomidicard Pediatric Venous Reservoir with Integral Cardiotomy Filter and the Midicard Pediatric Cardiotomy Reservoir are substantially equivalent to the Sorin Hardshell Venous Reservoir for use in chest drainage autotransfusion.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is written in a sans-serif font. The logo is black and white.
Food and Drug Administration 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
AUG 2 1 1997
K964907 Re: Venomidicard Pediatric Venous Reservoir with Integral Cardiotomy Filter Requlatory 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: (General requlation (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 - 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 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" (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. Callahion
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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Image /page/5/Picture/0 description: The image contains handwritten text. The text includes the number 870.4400, followed by "- DTN II - Cartictomy". The word "Reservoir" is also present in the image. The text appears to be part of a document or label.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K984907
Device Name: CARDIOTOMY FILTER
Indications for Use:
The Dideco Venomidicard and Midicard are hardshell blood collection reservoirs intended for use in CPB circuits and postoperative blood salvage procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bette R. Lumperle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_
Image /page/5/Picture/10 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CFR 801.109)" in a smaller font size. The text is left-aligned and appears to be part of a document or label. There is also a symbol to the right of the text.
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)