(164 days)
No
The description focuses on the physical components and function of a hollow fiber membrane oxygenator and heat exchanger, with no mention of AI or ML.
Yes
The device is described as an oxygenator intended for extracorporeal gas exchange support and blood temperature control during surgical procedures, which directly addresses a physiological dysfunction (respiratory failure) and supports the body's vital functions.
No
Explanation: The device is an oxygenator used for extracorporeal gas exchange and blood temperature control during surgery. It performs a therapeutic function by physically altering the blood and does not analyze or interpret physiological data to make a diagnosis.
No
The device description clearly details a physical medical device (oxygenator with integral heat exchanger) made of materials like polypropylene and stainless steel, with physical ports and pathways for blood and gas. There is no mention of software as the primary or sole component.
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 directly interacts with the patient's blood outside the body for therapeutic purposes (oxygenation and temperature regulation).
- Device Description: The description details a mechanical device with blood and gas pathways, a heat exchanger, and hollow fibers for gas exchange. This aligns with the function of an artificial lung and heat exchanger used during surgery.
- Lack of Diagnostic Function: 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 patient's health status. The performance studies focus on the device's ability to perform gas exchange and temperature control, not on its ability to provide diagnostic information.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device operates ex vivo (outside the body but connected to the patient) for therapeutic support.
N/A
Intended Use / Indications for Use
The COBE® Optimin™ Hollow Fiber Membrane Oxygenator is intended to be used in surgical procedures requiring extracorporeal gas exchange support and blood temperature control. It is intended to be used in procedures requiring a maximum blood flow rate of 5 liters/min and lasting up to six hours.
Product codes
74 DTZ
Device Description
The COBE® Optimin™ Hollow Fiber Membrane Oxygenator 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. Microporous polypropylene, hollow fiber membrane material separates the blood and gas pathways inside the oxygenator, with the blood pathway outside and the gas pathway inside the hollow fiber membrane. Blood is pumped into the blood inlet port. The blood inlet and blood outlet ports are 3/8" and include a locking mechanism which accepts a 1/4" reducing connector if the user desires to utilize 1/4" ID rather than 3/8″ ID circuit tubing. The blood is channeled into the blood pathway of the heat exchanger, where the blood temperature is varied by controlling the water temperature in the water pathway of the heat exchanger. As the blood exits the heat exchanger it passes around a stainless steel temperature probe well, where the temperature of the blood may be monitored as it enters the oxygenator. Blood from the heat exchanger enters the oxygenator through the inlet manifold, and then flows around the outside of the fibers are oriented horizontally in the oxygenator case, with flow entering the top of the fiber bundle and exiting the bottom to facilitate priming and debubbling. Gas exchange takes place as the blood makes its way into the bottom outlet manifold where it is directed out of the oxygenator through the blood outlet port and back to the patient. Sweep gas is introduced into the fibers through the gas inlet cap. The gas flows through the lumen of the hollow fibers. Gas exchange between the blood and gas pathways takes place through the micropores in the hollow fiber wall. Sweep gas flowing through the fibers collects in the outlet cap, where it may be scavenged.
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
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
Substantial equivalence was based on in-vitro testing of the COBE® Optimin™ Hollow Fiber Membrane Oxygenator. In-vitro testing consisted of:
-
- Blood pathway operating volume
-
- Blood pathway pressure drop
-
- Gas pathway pressure drop
- Oxygen transfer rate 4.
-
- Carbon dioxide transfer rate
- Oxygen transfer duration, minimum/maximum flow rates 6.
-
- Carbon dioxide transfer duration, minimum/maximum flow rates
-
- Blood pathway integrity
- Water pathway integrity 9.
-
- Unrecoverable blood volume
-
- Blood trauma (platelet reduction, white blood cell reduction, and plasma free hemoglobin generation)
-
- Heat exchanger efficiency
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was based on in-vitro testing of the COBE® Optimin™ Hollow Fiber Membrane Oxygenator. These data support substantial equivalence of the COBE® Optimin™ Hollow Fiber Membrane Oxygenator to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
COBE® Optima XP™ Hollow Fiber Membrane Oxygenator, K963518, TERUMO® Capiox® SX 10 Hollow Fiber Membrane Oxygenator, K960074
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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® Optimin™ Hollow Fiber Membrane Oxygenator
Image /page/0/Picture/1 description: The image shows a handwritten string of characters and numbers. The string starts with the letter 'K', followed by the numbers '99145'. The number '5' has a subscript of '15', and the string ends with the number '2'.
OCT 7 1999
510(k) Summarv
| SUBMITTER: | COBE Cardiovascular®, Inc.
14401 W. 65th Way
Arvada, CO 80004 |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Lynne Leonard
Phone: (303) 467-6586
Fax: (303) 467-6429 |
| DATE PREPARED: | April 20, 1999 |
| DEVICE TRADE NAME: | COBE® Optimin™ Hollow Fiber Membrane Oxygenator |
| COMMON/USUAL NAME: | Hollow Fiber Membrane Blood Oxygenator with Integral Heat Exchanger |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator with Heat Exchanger |
| PREDICATE DEVICES: | COBE® Optima XP™ Hollow Fiber Membrane Oxygenator
TERUMO® Capiox® SX 10 Hollow Fiber Membrane Oxygenator. |
DEVICE DESCRIPTION:
The COBE® Optimin™ Hollow Fiber Membrane Oxygenator 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. Microporous polypropylene, hollow fiber membrane material separates the blood and gas pathways inside the oxygenator, with the blood pathway outside and the gas pathway inside the hollow fiber membrane. Blood is pumped into the blood inlet port. The blood inlet and blood outlet ports are 3/8" and include a locking mechanism which accepts a 1/4" reducing connector if the user desires to utilize 1/4" ID rather than 3/8″ ID circuit tubing. The blood is channeled into the blood pathway of the heat exchanger, where the blood temperature is varied by controlling the water temperature in the water pathway of the heat exchanger. As the blood exits the heat exchanger it passes around a stainless steel temperature probe well, where the temperature of the blood may be monitored as it enters the oxygenator. Blood from the heat exchanger enters the oxygenator through the inlet manifold, and then flows around the outside of the fibers are oriented horizontally in the oxygenator case, with flow entering the top of the fiber bundle and exiting the bottom to facilitate priming and debubbling. Gas exchange takes place as the blood makes its way into the bottom outlet manifold where it is directed out of the oxygenator through the blood outlet port and back to the patient. Sweep gas is introduced into the fibers through the gas inlet cap. The gas flows through the lumen of the hollow fibers. Gas exchange between the blood and gas pathways takes place through the micropores in the hollow fiber wall. Sweep gas flowing through the fibers collects in the outlet cap, where it may be scavenged.
INDICATIONS FOR USE
The COBE® Optimin™ Hollow Fiber Membrane Oxygenator is intended to be used in surgical procedures requiring extracorporeal gas exchange support and blood temperature control. It is intended to be used in procedures requiring a maximum blood flow rate of 5 liters/min and lasting up to six hours.
1
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The COBE® Optimin™ Hollow Fiber Membrane Oxygenator is substantially equivalent to the currently marketed COBE® Optima XP™ Hollow Fiber Membrane Oxygenator (K963518). The COBE® Optimin™ Oxygenator has a lower priming volume and is rated for lower blood and gas flow rates than the COBE® Optima XP™ Oxygenator, thus the COBE® Optimin™ Oxygenator is for smaller adult and pediatric patients, whereas the COBE® Optima XP™ Oxygenator is for adult patients.
The COBE® Optimin™ Oxygenator is substantially equivalent to the currently marketed Terumo® Capiox® SX 10 Hollow Fiber Oxygenator (K960074). Specifications for the two devices are comparable and they are substantially equivalent in features and intended use.
Substantial equivalence was based on in-vitro testing of the COBE® Optimin™ Hollow Fiber Membrane Oxygenator. In-vitro testing consisted of:
-
- Blood pathway operating volume
-
- Blood pathway pressure drop
-
- Gas pathway pressure drop
- Oxygen transfer rate 4.
-
- Carbon dioxide transfer rate
- Oxygen transfer duration, minimum/maximum flow rates 6.
-
- Carbon dioxide transfer duration, minimum/maximum flow rates
-
- Blood pathway integrity
- Water pathway integrity 9.
-
- Unrecoverable blood volume
-
- Blood trauma (platelet reduction, white blood cell reduction, and plasma free hemoglobin generation)
-
- Heat exchanger efficiency
These data support substantial equivalence of the COBE® Optimin™ Hollow Fiber Membrane Oxygenator to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol in the center, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
7 1999 OCT -
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
K991452 Re : COBE® Optimin™ Hollow Fiber Membrane Oxygenator Regulatory Class: III (Three) Product Code: 74 DTZ Auqust 9, 1999 Dated: Received: August 10, 1999
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 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 .
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 findinq 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (If known): k99452/s'
Device Name: COBE® Optimin™ Hollow Fiber Membrane Oxygenator
Indications For Use:
The COBE® Optimin™ Hollow Fiber Membrane Oxygenator is intended to be used in surgical procedures requiring extracorporeal gas exchange support and blood temperature control. It is intended to be used in procedures requiring a maximum blood flow rate of 5 liters/min and lasting 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)
Bea B. Lemperle
(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular, Respira
Division of Cardiovascular, Devices Division of Caralogical Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use