(90 days)
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No
The summary describes physical medical devices (blood reservoirs and oxygenators) used in extracorporeal circulation and makes no mention of software, algorithms, or AI/ML technologies.
Yes
The devices, particularly the oxygenators, are explicitly described as providing "extracorporeal gas exchange support and blood temperature control," which are direct physiological interventions aimed at sustaining or improving bodily function during surgical procedures.
No
Explanation: The devices described are for storage, filtration, and gas exchange of blood during surgical procedures. Their intended use is to support bodily functions during extracorporeal circulation, not to diagnose medical conditions.
No
The device descriptions clearly indicate physical medical devices (venous reservoirs, oxygenators) used in surgical procedures requiring extracorporeal circulation. There is no mention of software as the primary or sole component.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly describes these devices as being used during surgical procedures on patients requiring extracorporeal circulation. They are for handling and processing blood outside the body as part of a medical procedure, not for analyzing blood or other biological samples to diagnose a condition.
- Nature of the Devices: The descriptions (reservoirs, oxygenators) indicate devices that are part of an extracorporeal circuit to support physiological functions (blood storage, gas exchange, temperature control) during surgery. This is distinct from devices used to perform tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, these devices fall under the category of medical devices used in surgical procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
COBE® HARD SHELL VENOUS RESERVOIRS. UNFILTERED AND FILTERED are intended for storage (and filtration, if filtered) of blood during surgical procedures on adults requiring extracorporeal circulation for periods up to six hours.
COBE® VENOUS RESERVOIR BAGS are intended for use as a blood reservoir during extracorporeal blood circulation.
COBE® FLAT SHEET MEMBRANE OXYGENATORS are intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to six hours (one model is a variable prime oxygenator intended to be used during cardiac surgical procedures on neonates, infants, pediatrics, and small adults requiring cardiopulmonary bypass).
COBE® HOLLOW FIBER MEMBRANE OXYGENATORS are intended to be used in adult surgical procedures requiring extracorporeal gas exchange suppport and blood temperature control for periods of up to six hours.
Product codes
74 DTZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adults, neonates, infants, pediatrics, small adults
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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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.
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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).
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§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
JAN 27 1998
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: K974085 COBE® Oxygenator Products Regulatory Class: III (Three) Product Code: 74 DTZ October 24, 1997 Dated: October 29, 1997 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 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.
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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 (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. Callahon
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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Indications For Use
510(k) Number (If known):
Device Names: Cobe® Hard Shell Venous Reservoirs, Unfiltered and Filtered Cobe® Venous Reservoir Bags Cobe® Flat Sheet Membrane Oxygenators Cobe® Hollow Fiber Membrane Oxygenators
Indications For Use:
COBE® HARD SHELL VENOUS RESERVOIRS. UNFILTERED AND FILTERED are intended for storage (and filtration, if filtered) of blood during surgical procedures on adults requiring extracorporeal circulation for periods up to six hours.
COBE® VENOUS RESERVOIR BAGS are intended for use as a blood reservoir during extracorporeal blood circulation.
COBE® FLAT SHEET MEMBRANE OXYGENATORS are intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to six hours (one model is a variable prime oxygenator intended to be used during cardiac surgical procedures on neonates, infants, pediatrics, and small adults requiring cardiopulmonary bypass).
COBE® HOLLOW FIBER MEMBRANE OXYGENATORS are intended to be used in adult surgical procedures requiring extracorporeal gas exchange suppport and blood temperature control 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)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use