(461 days)
COBE® Optima TM Hollow Fiber Membrane Oxygenator
Not Found
No
The summary describes a physical medical device (oxygenator with heat exchanger) and its performance characteristics. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes.
The device provides extracorporeal gas exchange support and blood temperature control during surgical procedures, which are therapeutic interventions.
No
Explanation: A diagnostic device identifies a disease or condition. The Optima XP™ is an oxygenator and heat exchanger used for extracorporeal gas exchange and temperature control during surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "hollow fiber membrane oxygenator with integral heat exchanger," which are physical hardware components. The performance studies also focus on physical characteristics like oxygen transfer rate and pressure drop.
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 to perform a physiological function (gas exchange and temperature regulation).
- Device Description: The description confirms it's a "hollow fiber membrane oxygenator with integral heat exchanger." This is a device used in cardiopulmonary bypass or similar procedures, not for analyzing samples in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information. The performance metrics listed (oxygen transfer rate, pressure drop, etc.) relate to the device's function in processing blood, not to the accuracy of a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is therapeutic and supportive, not diagnostic.
N/A
Intended Use / Indications for Use
The Optima XP™ is 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)
DTŽ
Device Description
The Optima XP™ is a hollow fiber membrane oxygenator with integral heat exchanger. Used in coniunction with other ancillary equipment and disposable products, this device will satisfy an adult patient's gas exchange and body temperature regulation requirements during surgical procedures,
The product is sterilized by ethylene oxide gas and has nonpyrogenic fluid pathways.
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:
The oxygen transfer rate of the Optima XP is increased compared to the Optima. The new device also has a higher operating volume and gas side pressure drop. Carbon dioxide transfer rate, blood pathway pressure drop, unrecoverable volume, and blood trauma characteristics are not significantly different compared to the Optima.
The heat exchanger in both devices is identical in design, manufacture and installation, and therefore has not been evaluated for this 510(k).
CLINICAL TEST RESULTS:
No clinical testing was performed. Safety and efficacy were determined by in vitro testing.
CONCLUSIONS:
-
- The increased membrane surface area of the Optima XP increases the oxygen transfer when compared to the Optima as intended.
-
- Corresponding increases in priming volume and gas side pressure drop are acceptable.
-
- No statistically significant differences were detected in other performance aspects of the Optima XP when compared to the Optima.
-
- In vitro testing demonstrates the Optima XP is as safe and effective and performs as well as or better than the Optima.
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 TM Hollow Fiber 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
K.963518
510(k) Pre-Market Notification: Optima XP
,
ﺮ ﺍﻟﻤﺮﺍﺟﻊ
page 8
1997
9. 510(k) Summary
| SUBMITTER: | COBE Cardiovascular, Inc.®
14401 W. 65th Way
Arvada, CO 80004 | DEC - |
|----------------------|--------------------------------------------------------------------------------|-------|
| CONTACT PERSON: | Mary L. Armstrong
Phone: (303) 467-6521
Fax: (303) 467-6525 | |
| DATE PREPARED: | August 27, 1996 | |
| DEVICE TRADE NAME: | COBE® Optima XPTM Hollow Fiber Membrane Oxygenator | |
| COMMON NAME: | Hollow Fiber Membrane Oxygenator with Heat Exchanger | |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Oxygenator and Cardiopulmonary Bypass
Heat Exchanger | |
| PREDICATE DEVICE: | COBE® Optima TM Hollow Fiber Membrane Oxygenator | |
| DEVICE DESCRIPTION: | | |
The Optima XP™ is a hollow fiber membrane oxygenator with integral heat exchanger. Used in coniunction with other ancillary equipment and disposable products, this device will satisfy an adult patient's gas exchange and body temperature regulation requirements during surgical procedures,
The product is sterilized by ethylene oxide gas and has nonpyrogenic fluid pathways.
INDICATIONS FOR USE:
The Optima XP™ is 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:
The Optima XP™ is a new device created by modifying the existing Optima oxygenator by decreasing the fiber diameter and increasing the number of fibers. The result is an increase in membrane surface area in the Optima XP compared to the Optima.
The is no change in the intended use of the device.
There is no change to the heat exchanger. There are no significant changes to the processes or materials used to manufacture or sterilize the device.
Optima XPTM and OptimaTM are trademarks of COBE Laboratories, Inc.
COBE® and COBE Cardiovascular® are registered trademarks of COBE Laboratories, Inc.
1
NONCLINICAL TEST RESULTS:
The oxygen transfer rate of the Optima XP is increased compared to the Optima. The new device also has a higher operating volume and gas side pressure drop. Carbon dioxide transfer rate, blood pathway pressure drop, unrecoverable volume, and blood trauma characteristics are not significantly different compared to the Optima.
The heat exchanger in both devices is identical in design, manufacture and installation, and therefore has not been evaluated for this 510(k).
CLINICAL TEST RESULTS:
No clinical testing was performed. Safety and efficacy were determined by in vitro testing.
CONCLUSIONS:
-
- The increased membrane surface area of the Optima XP increases the oxygen transfer when compared to the Optima as intended.
-
- Corresponding increases in priming volume and gas side pressure drop are acceptable.
-
- No statistically significant differences were detected in other performance aspects of the Optima XP when compared to the Optima.
-
- In vitro testing demonstrates the Optima XP is as safe and effective and performs as well as or better than the Optima.
Optima XP™ and Optima™ are trademarks of COBE Laboratories, Inc.
COBE® and COBE Cardiovascular® are registered trademarks of COBE Laboratories, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.
Rockville MD 20857
DEC - 8 1997
J. Dennis Bruner, Ph.D. Director of Quality COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, Colorado 80004
Re : K963518 COBE® Optima XP™ Hollow Fiber Membrane Oxygenator Regulatory Class: III (Three) Product Code: DTŽ Dated: November 21, 1997 Nobember 25, 1997 Received:
Dear Dr. Bruner:
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 Regulations, 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 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 - J. Dennis Bruner, Ph.D.
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.gov/cdrh/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
510(k) Pre-Market Notification: Optima XP
- Indications For Use
510(k) Number (If known): _ 9 / 35 / 8 / 35 / 8 / 55 / 8
Device Name: COBE® Optima XP TM Hollow Fiber Membrane Oxygenator
Indications For Use:
The Optima XP™ is 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)
Lita K. Remacle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
K 96 3518 510(k) Number
Prescription Use_V (Per 21 CFR 801.109)
OR
Over-The-Counter Use_