(355 days)
COBE® Optima™ Hollow Fiber Membrane Oxygenator, COBE® CML Duo™ Flat Sheet Membrane Oxygenator
Not Found
No
The summary describes a membrane oxygenator and heat exchanger, which are mechanical devices for extracorporeal support. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is described as being used in "adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control," directly implying its role in treating or managing a medical condition.
No
The devices described (COBE Optima™ and CML Duo™) are oxygenators with integral heat exchangers used in extracorporeal gas exchange and temperature control during surgery. Their function is to support physiological processes, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a hollow fiber membrane oxygenator with integral heat exchanger and a flat sheet membrane oxygenator with integral heat exchanger, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control." This describes a device used on the patient's blood outside the body during surgery to perform physiological functions (gas exchange and temperature regulation).
- Device Description: The description details a "hollow fiber membrane oxygenator with integral heat exchanger" and a "flat sheet membrane oxygenator with integral heat exchanger." These are devices designed to interact directly with blood flow to modify its composition (oxygenation) and temperature.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze blood or other biological samples to diagnose a condition, monitor a disease, or determine a treatment. IVDs are specifically designed for in vitro (in glass/outside the body) examination of specimens from the human body.
This device falls under the category of extracorporeal circulation devices, which are used to support physiological functions during medical procedures, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The COBE Optima™ and CML Duo™ are intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.
Product codes (comma separated list FDA assigned to the subject device)
74 DTZ
Device Description
The COBE Optima™ is a hollow fiber membrane oxygenator with integral heat exchanger. Used in conjunction with other ancillary equipment and disposable products, this device will satisfy the patient's gas exchange and body temperature regulation requirements.
The CML Duo™ is a flat sheet membrane oxygenator with integral heat exchanger. Used in conjunction with other ancillary equipment and disposable products, this device will satisfy the patient's gas exchange and body temperature regulation requirements.
The products are sterilized by ethylene oxide gas and have nonpyrogenic fluid pathways.
This 510(k) covers a modification to the COBE Optima™ end cap to core joint and a modification to the COBE Optima and CML Duo heat exchanger seals. These modifications will not result in any labeling changes for the devices and are not intended to change the specifications or performance of these devices. There are no significant changes being made to the processes used to manufacture or sterilize the devices. The modifications to the COBE Optima and CML Duo seals are being made to improve the manufacturability of these devices.
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
adult
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:
Blood pathway pressure drop and blood pathway integrity for the COBE Optima oxygenator with modified seals were tested and did not significantly change from the predicate device. Blood pathway pressure drop and blood pathway integrity for the CML Duo oxygenator with modified seals were tested and did not significantly change from the predicate device.
Biocompatibility tests of the raw materials used for these modifications indicate that they are safe for use in the COBE Optima and the COBE CML Duo.
CLINICAL TEST RESULTS:
No clinical testing was performed. Safety and efficacy can be determined by in vitro testing.
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.
COBE® Optima™ Hollow Fiber Membrane Oxygenator, COBE® CML Duo™ Flat Sheet Membrane Oxygenator
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
§ 870.4350 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.”
0
K964043
Sept. 29, 1997
- 510(k) Summary
SUBMITTER:
COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004
-
Mary L. Armstrong CONTACT PERSON: Phone: (303) 467-6521 Fax: (303) 467-6525
October 7, 1996 DATE PREPARED: -
COBE® Optima™ Hollow Fiber Membrane Oxygenator DEVICE TRADE NAMES: COBE® CML Duo™ Flat Sheet Membrane Oxygenator
-
Hollow Fiber Membrane Oxygenator with Heat Exchanger COMMON NAMES: Flat Sheet Membrane Oxygenator with Heat Exchanger
-
Cardiopulmonary Bypass Oxygenator and Cardiopulmonary Bypass CLASSIFICATION NAME: Heat Exchanger
-
COBE® Optima™ Hollow Fiber Membrane Oxygenator PREDICATE DEVICES: COBE® CML Duo™ Flat Sheet Membrane Oxygenator
DEVICE DESCRIPTION:
The COBE Optima™ is a hollow fiber membrane oxygenator with integral heat exchanger. Used in conjunction with other ancillary equipment and disposable products, this device will satisfy the patient's gas exchange and body temperature regulation requirements.
The CML Duo™ is a flat sheet membrane oxygenator with integral heat exchanger. Used in conjunction with other ancillary equipment and disposable products, this device will satisfy the patient's gas exchange and body temperature regulation requirements.
The products are sterilized by ethylene oxide gas and have nonpyrogenic fluid pathways.
INDICATIONS FOR USE:
The COBE Optima™ and CML Duo™ are intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.
TECHNOLOGICAL CHARACTERISTICS:
This 510(k) covers a modification to the COBE Optima™ end cap to core joint and a modification to the COBE Optima and CML Duo heat exchanger seals. These modifications will not result in any labeling changes for the devices and are not intended to change the specifications or performance of these
()ntima™ and (ML Duo™ are trademarks of COBE Laboratories, Inc.
COBE® and COBE Cardiovascular® are registered trademarks of COBE Laboratories, Inc.
1
devices. There are no significant changes being made to the processes used to manufacture or sterilize the devices. The modifications to the COBE Optima and CML Duo seals are being made to improve the manufacturability of these devices.
NONCLINICAL TEST RESULTS:
Blood pathway pressure drop and blood pathway integrity for the COBE Optima oxygenator with modified seals were tested and did not significantly change from the predicate device. Blood pathway pressure drop and blood pathway integrity for the CML Duo oxygenator with modified seals were tested and did not significantly change from the predicate device.
Biocompatibility tests of the raw materials used for these modifications indicate that they are safe for use in the COBE Optima and the COBE CML Duo.
CLINICAL TEST RESULTS:
No clinical testing was performed. Safety and efficacy can be determined by in vitro testing.
CONCLUSION:
In vitro testing and biocompatibility testing show that the modified devices are safe and not significantly different from the predicate devices.
Optima™ and CML Duo™ are trademarks of COBE Laboratories, Inc.
COBE® and COBE Cardiovascular® are registered trademarks of COBE Laboratories, Inc.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Lynne Leonard Manager, Regulatory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, Colorado 80004-3599
SEP 2 9 1997
K964043 Re : COBE® Optima™ and COBE® CML Duo™ Membrane Oxygenators with Seal Modifications Regulatory Class: III (Three) Product Code: 74 DTZ Dated: September 15, 1997 Received: September 16, 1997
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 requlations 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 requlatory 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.
3
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) 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. Callahon
Thomas J. Čallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
510(k) Pre-Market Notification: COBE Optima and CML Duo Seal Modifications DTZ III - 870.4350 - CPB Oxygenator
- Indications For Use
510(k) Number (if known): X 9624045'
Device Names: COBE Optima™ Hollow Fiber Membrane Oxygenator COBE® CML Duo™ Flat Sheet Membrane Oxygenator
Indications For Use:
The Optima™ and CML Duo™ are intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Berr B. Bumper Co.
Division of Cardiovascular. Respiratory, and Neurological Devices
×964043 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
11
3