(28 days)
Not Found
No
The document describes a blood oxygenator with an integral heat exchanger and does not mention any AI or ML capabilities.
Yes
The device is a blood oxygenator with an integral heat exchanger used in surgical procedures requiring extracorporeal gas exchange and blood temperature control, which directly treats a physiological condition.
No
Explanation: The device is described as a blood oxygenator with an integral heat exchanger used in surgical procedures for extracorporeal gas exchange and blood temperature control, not for diagnosis.
No
The device description explicitly states it is a "sterile device with non-pyrogenic fluid pathways" and a "blood oxygenator with integral heat exchanger," indicating it is a physical 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 "surgical procedures requiring extracorporeal gas exchange support and blood procedure control." This describes a device used during a medical procedure to support physiological functions, not a device used to test samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description clearly states it is a "blood oxygenator with integral heat exchanger." This is a device that interacts directly with the patient's blood during surgery, facilitating gas exchange and temperature control. This is not the function of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, the COBE® SMARxT® Optimin™ is a medical device used in surgical procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The COBE® SMARxT® Optimin™ is indicated for use in surgical procedures requiring extracorporeal gas exchange support and blood procedure control. It is intended to be used in procedures requiring a tomporature comrow rate of 5 liters/min and lasting up to six hours.
Product codes (comma separated list FDA assigned to the subject device)
DTZ, DTR
Device Description
The COBE SMARxT Optimin is a sterile device with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. The device is a blood oxygenator with integral heat exchanger, intended to be used in surgical procedures requiring extracorporeal gas exchange support and blood temperature control, requiring a maximum blood flow rate of 5 liters/minute and lasting up to six hours. The size and specifications of the device make it particularly suited for smaller adult and pediatric patients.
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
The size and specifications of the device make it particularly suited for smaller adult and pediatric patients.
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)
In-vitro tests were performed to demonstrate that the COBE SMARXT Optimin Hollow Fiber Oxygenator described in this submission is substantially equivalent to the COBE Optimin Hollow Fiber Oxygenator (K991452).
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.
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.”
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Special 510(k)-Device Modification: COBE SMARxT Optimin
19
510(k) Summary
COBE Cardiovascular, Inc. SUBMITTER: 14401 W. 65th Way Arvada, CO 80004
NOV 1 6 2001
KD13480
Shawn Riedel CONTACT PERSON: Phone: (303) 467-6521 Fax: (303) 467-6429
October 18, 2001 DATE PREPARED:
COBE SMARxT Optimin Surface Modified Hollow Fiber DEVICE TRADE NAME: Membrane Oxygenator
Hollow Fiber Membrane Blood Oxygenator with Integral COMMON/USUAL NAME: Heat Exchanger
Cardiopulmonary Bypass Oxygenator CLASSIFICATION NAME: Cardiopulmonary Bypass Heat Exchanger
COBE Optimin Hollow Fiber Membrane Oxygenator, #K991452 PREDICATE DEVICE:
DEVICE DESCRIPTION/INDICATIONS FOR USE
The COBE SMARxT Optimin is a sterile device with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. The device is a blood oxygenator with integral heat exchanger, intended to be used in surgical procedures requiring extracorporeal gas exchange support and blood temperature control, requiring a maximum blood flow rate of 5 liters/minute and lasting up to six hours. The size and specifications of the device make it particularly suited for smaller adult and pediatric patients.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The COBE SMARxT Optimin Hollow Fiber Oxygenator is identical to the COBE Optimin Hollow Fiber Oxygenator in design, intended use, method of operation, components, packaging, and fundamental scientific technology. The primary difference between the two devices is that the COBE SMARxT Optimin Hollow Fiber Oxygenator contains a surface-modifying additive that improves the blood compatibility of the device.
TESTING TO DETERMINE SUBSTANTIAL EQUIVALENCE
In-vitro tests were performed to demonstrate that the COBE SMARXT Optimin Hollow Fiber Oxygenator described in this submission is substantially equivalent to the COBE Optimin Hollow Fiber Oxygenator (K991452).
Image /page/0/Picture/17 description: The image shows the word "CONFIDENTIAL" in large, bold, black letters. The word is slightly tilted upwards from left to right. The font appears to be a sans-serif typeface, and the letters are closely spaced together.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2001
Mr. Shawn Riedel COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004
Re: K013480
COBE SMARxT Optimin Surface Modified Holow Fiber Membrane Oxygenator Regulation Number: 804.4350, 870.4240 Regulation Name: Cardiopulmonary Bypass Oxygenator Cardiopulmonary Bypass Heat Exchanger Regulatory Class: II (Two) Product Code: DTZ, DTR Dated: October 18, 2001 Received: October 19, 2001
Dear Mr. Riedel:
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 Regulations, 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
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Page 2 - Mr. Shawn Riedel
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.
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" (21CFR 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,
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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NOV 1 6 2001
Indications For Use
510(k) Number (If known):
KD13480
Device Name: COBE® SMARxT® Optimin™ Hollow Fiber Membrane Oxygenator
Indications For Use:
The COBE® SMARxT® Optimin™ is indicated for use in surgical procedures requiring extracorporeal gas exchange support and blood procedure control. It is intended to be used in procedures requiring a tomporature comrow rate of 5 liters/min and lasting up to six hours.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) a---------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K063480
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
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