(160 days)
Not Found
Not Found
No
The summary describes a physical medical device (membrane oxygenator) with a surface modification. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on the physical and biological properties of the device.
Yes
The device is used in adult surgical procedures to support extracorporeal gas exchange and blood temperature control, which are therapeutic interventions.
No
Explanation: The device is an oxygenator used for extracorporeal gas exchange and blood temperature control during surgery. Its function is therapeutic, supporting physiological processes rather than diagnosing conditions or identifying diseases.
No
The device description clearly indicates it is a physical medical device (membrane blood oxygenator with integral heat exchanger) and the performance studies focus on physical and biological characteristics, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "extracorporeal gas exchange support and blood temperature control" during surgical procedures. This describes a device that interacts directly with the patient's blood outside the body for therapeutic purposes (oxygenation and temperature regulation).
- Device Description: The description details a "flat sheet membrane blood oxygenator with integral heat exchanger." This further confirms its function as an external device for processing blood.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis. It modifies the blood itself.
Therefore, the COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is a therapeutic medical device used in extracorporeal circulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to six hours.
Product codes (comma separated list FDA assigned to the subject device)
DTZ
Device Description
The COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is a flat sheet membrane blood oxygenator with integral heat exchanger. A surface-modifying material is added to the primary blood contact surfaces of the oxygenator and integral heat exchanger to improve the blood competibility of the device. The product is sterlized by ethylene oxide, is for single use only, and has a nonpyrogenic fluid pathway.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
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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)
Biocompatibility testing, in-vitro testing, and ex-vivo testing were performed to demonstrate that the COBE® CML Duo® With SMAR TT* Surface Modified Membrane Oxygenator is substantially equivalent to the currently marketed COBE® CML Duo® Membrane Oxygenator.
In-vitro testing consisted of:
Stability testing, surface-modifying material SEM Analysis Blood pathway operating volume Pressure drop Gas pathway pressure drop Gas transfer Gas transfer duration Blood pathway integrity Unrecoverable blood volume Blood cell damage Heat exchanger performance Surface-modifying material leaching Surface-modifying material blood compatibility
Ex-vivo testing consisted of:
Perfusion and animal survivor experiments Surface-modifying material blood compatibility
These data support that the COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is substantially equivalent to the currently marketed COBE® CML Duo® Membrane Oxygenator, and that the addition of the surface-modifying material does not significantly affect safety and effectiveness.
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.
Not Found
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
510(k) Pre-Market Notification: COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator
29
. IUN 1 1098
510(k) Summary
SUBMITTER:
COBE Cardiovascular, Inc. ® 14401 W. 65th Way Arvada, CO 80004
Lynne Leonard CONTACT PERSON: Phone: (303) 467-6586 (303) 467-6429 Fax:
December 17, 1997 DATE PREPARED:
COBE® CML Duo® With SMAR.T™ DEVICE TRADE NAME: Surface Modified Membrane Oxygenator
Flat Sheet Membrane Oxygenator with Integral Heat Exchanger COMMON/USUAL NAME:
Cardiopulmonary Bypass Oxygenator with Heat Exchanger CLASSIFICATION NAME:
COBE® CML Duo® Membrane Oxygenator PREDICATE DEVICE:
DEVICE DESCRIPTION:
The COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is a flat sheet membrane blood oxygenator with integral heat exchanger. A surface-modifying material is added to the primary blood contact surfaces of the oxygenator and integral heat exchanger to improve the blood competibility of the device. The product is sterlized by ethylene oxide, is for single use only, and has a nonpyrogenic fluid pathway.
INDICATIONS FOR USE
The COBE® CML Duce With SMAR,T™ Surface Modified Membrane Oxygenator is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to six hours.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The COBE® CML Duo® With SMAR.T™ Surface Modified Membrane Oxygenator has the same intended use as the COBE® CML Duo® Membrane Oxygenator. The only differences between the Duo with SMAR.T Oxygenator and the currently marketed Duo Oxygenator are 1) the Duo with SMAR, T Oxygenator contains the surface-modifying material and the Duo Oxygenator does not; 2) a surfactant is used in the heat exchanger of the Duo Oxygenator but not in the heat exchanger of the Duo with SMAR, T Oxygenator. Otherwise, all materials, components, and sterilization and manufacturing processes for the two devices are the same.
Biocompatibility testing, in-vitro testing, and ex-vivo testing were performed to demonstrate that the COBE® CML Duo® With SMAR TT* Surface Modified Membrane Oxygenator is substantially equivalent to the currently marketed COBE® CML Duo® Membrane Oxygenator.
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1
510(k) Pre-Market Notification: COBE® CML Duo® With SMAR,T™ Surface Modified Membrane Oxygenator
In-vitro testing consisted of:
Stability testing, surface-modifying material SEM Analysis Blood pathway operating volume Pressure drop Gas pathway pressure drop Gas transfer Gas transfer duration Blood pathway integrity Unrecoverable blood volume Blood cell damage Heat exchanger performance Surface-modifying material leaching Surface-modifying material blood compatibility
Ex-vivo testing consisted of:
Perfusion and animal survivor experiments Surface-modifying material blood compatibility
These data support that the COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is substantially equivalent to the currently marketed COBE® CML Duo® Membrane Oxygenator, and that the addition of the surface-modifying material does not significantly affect safety and effectiveness.
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Public Health Service
JUN 1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lynne Leonard Manager, Requlatory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, Colorado 80004-3599
Re : K974812 COBE® CML® Duo With SMAR,T™ Requlatory Class: III (Three) Product Code: DTZ Dated: March 24, 1998 : Received: March 25, 1998
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 legally marketed predicate 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 A substantially equivalent determination assumes compliance with 895. 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 Please note: this response to your premarket Federal Register. 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 beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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.gov/cdrh/dsma/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 ------Radioloqical Health
4
510(k) Pre-Market Notification: COBE® CML Duo® With SMAR,T™ Surface Modified Membrane Oxygenator
Indications For Use
510(k) Number (if known): K974812
Device Name: COBE® CML Duo® With SMAR_T™ Surface Modified Membrane Oxygenator
Indications For Use:
The COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support 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)
Lou Campbell
(Division-Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K974812
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________