(76 days)
COBE® Sentry® 43 Micron Arterial Filter with PrimeGard®
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No
The description focuses on the mechanical and material properties of a blood filter and does not mention any computational or data-driven functionalities.
No.
The device is a component of an extracorporeal circuit (filters out micro-particles) used during cardiopulmonary bypass procedures, not a direct therapeutic device.
No
Explanation: The device is an arterial filter designed to remove micro-particles from blood during cardiopulmonary bypass procedures. It performs a filtering function, not a diagnostic one.
No
The device description clearly details physical components like a transparent cap, casing, barbed ports, filter cartridge, and support netting, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter blood in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures. This is a direct interaction with the patient's blood outside the body, but it's a therapeutic/supportive function, not a diagnostic one.
- Device Description: The description details a physical filter designed to remove particles and air from blood. It doesn't mention any components or processes related to analyzing or testing biological samples to provide diagnostic information.
- Performance Studies: The performance studies focus on the device's mechanical integrity, filtration efficiency, blood compatibility, and ease of use in the context of filtering blood during bypass. They do not involve evaluating the device's ability to diagnose a condition or provide information about a patient's health status.
IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to physically filter blood during a medical procedure, which falls under the category of a medical device used for treatment/support, not diagnosis.
N/A
Intended Use / Indications for Use
The COBE® Sentry® SMART™ 43 Micron Arterial Filter with PrimeGard® is indicated for use in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures, for periods of up to six hours.
Product codes
DTM
Device Description
The COBE® Sentry® SMART™ 43 Micron Arterial Filter with PrimeGard® is a sterile device with a nonpvrogenic fluid pathway. It is for single use only and is not to be resterlized by the user. The device is indicated for use in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures, for periods of up to six hours. It is designed to filter out micro-particles intrough the arterial line of a cardiopulmonary bypass circuit.
The Sentry® SMART™ Arterial Filter consists of a transparent cap and casing with 3/8" barbed inlet and outlet ports. The cap has an integral luer lock vent/purge port. The filter cartridge consists of a 43 micron screen filter media, fan-folded with support netting. The filter cartridge is attached to an internal support which minimizes the blood volume within the device and directs blood flow. Blood coming into the device contacts the flow director plate of the support, which slows the blood flow to facilitate removal of air. The PrimeGard® heparin coating enhances air removal during priming. The Sentry® SMART™ Arterial Filter contains surface-modifying additives that improve the blood compatibility of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arterial line of an extracorporeal circuit
Indicated Patient Age Range
Not Found
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
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Summary of Performance Studies
Biocompatibility and performance tests were performed to demonstrate that the COBE® Sentry® SMART™ 43 Micron Arterial Filter with PrimeGard® is substantially equivalent to the currently marketed COBE® Sentry® SMART™ 43 Micron Arterial Filter with PrimeGard®.
Performance testing consisted of:
- Mechanical Integrity
- Air Challenge
- Pressure Drop
- Blood Trauma (including platelet reduction, white blood cell reduction, and plasma free hemoglobin generation)
- Filtration Efficiency
- Ease of Prime
- Priming Volume
In-vitro testing was also performed to demonstrate improved blood compatibility of the materials containing the surface modifying additives.
These data support that the COBE® Sentry® SMART™ 43 Micron Arterial Filter with PrimeGard® is substantially equivalent to the currently marketed COBE® Sentry® 43 Micron Arterial Filter with PrimeGard®, and that the addition of the surface-modifying materials does not affect safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
COBE® Sentry® 43 Micron Arterial Filter with PrimeGard®
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”
0
SEP 1 0 1998
510(k) Pre-Market Notification: COBE®Sentry® SMART™ 43 Micron Arterial Filter with PrimeGard® 18
510(k) Summary
| 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: | June 25, 1998 |
| DEVICE TRADE NAME: | COBE® Sentry® SMART TM 43 Micron Arterial Filter with PrimeGard® |
| COMMON/USUAL NAME: | Arterial Filter |
| CLASSIFICATION NAMES: | Cardiopulmonary Bypass Arterial Line Blood Filter |
| PREDICATE DEVICE: | COBE® Sentry® 43 Micron Arterial Filter with PrimeGard® |
DEVICE DESCRIPTION:
The COBE® Sentry® SMAR T™ 43 Micron Arterial Filter with PrimeGard® is a sterile device with a nonpvrogenic fluid pathway. It is for single use only and is not to be resterlized by the user. The device is indicated for use in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures, for periods of up to six hours. It is designed to filter out micro-particles intrough the arterial line of a cardiopulmonary bypass circuit.
The Sentry® SMAR,T™ Arterial Filter consists of a transparent cap and casing with 3/8" barbed inlet and outlet ports. The cap has an integral luer lock vent/purge port. The filter cartridge consists of a 43 micron screen filter media, fan-folded with support netting. The filter cartridge is attached to an internal support which minimizes the blood volume within the device and directs blood flow. Blood coming into the device contacts the flow director plate of the support, which slows the blood flow to facilitate removal of air. The PrimeGard® heparin coating enhances air removal during priming. The Sentry® SMAR,T™ Arterial Filter contains surface-modifying additives that improve the blood compatibility of the device.
INDICATIONS FOR USE
The COBE® Sentry® SMAR,T™ 43 Micron Arterial Filter with PrimeGard® is indicated for use in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures, for periods of up to six hours.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The COBE® Sentry® SMAR, TM 43 Micron Arterial Filter with PrimeGard® has the same intended use as currently marketed COBE® Sentry® 43 Micron Arterial Filter with PrimeGard®. The primary difference is that the COBE® Sentry® SMAR, T™ 43 Micron Arterial Filter with PrimeGard® contains non-leaching, surface modifying additives that are added to the device to improve blood compatibility.
1
Biocompatibility and performance tests were performed to demonstrate that the COBE® Sentry® SMAR TT™ 43 Micron Arterial Filter with PrimeGard® is substantially equivalent to the currently marketed COBE® Sentry® SMAR T™ 43 Micron Arterial Filter with PrimeGard®
Performance testing consisted of:
-
- Mechanical Integrity
-
- Air Challenge
- Pressure Drop 3.
- Blood Trauma (including platelet reduction, white blood cell reduction, and plasma free ধ: hemoglobin generation)
-
- Filtration Efficiency
-
- Ease of Prime
-
- Priming Volume
In-vitro testing was also performed to demonstrate improved blood compatibility of the materials containing the surface modifying additives.
These data support that the COBE® Sentry® SMAR JT™ 43 Micron Arterial Filter with PrimeGard® is substantially equivalent to the currently marketed COBE® Sentry® 43 Micron Arterial Filter with PrimeGard®, and that the addition of the surface-modifying materials does not affect safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1998
Ms. Lynne Leonard Manager, Requlatory Submissions COBE Cardiovascular, Inc. 14401 West 65th Way Arvada, CO 80004-3599
Re : K982254 COBE® Sentry® SMAR,T™ 43 Micron Arterial Filter with PrimeGuard® Requlatory Class: III (three) Product Code: DTM Dated: June 25, 1998 Received: June 26, 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 further announcements concerning your device in the Federal Register. Please note: this
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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 requlations.
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, 2Misbranding 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. Callahon
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
K 98 225 510(k) Number (If known): __
COBE® Sentry® SMAR TTM 43 Micron Arterial Filter with PrimeGard® Device Name:
Indications For Use:
The COBE® Sentry® SMAR T™ 43 Micron Arterial Filter with PrimeGard® is indicated for use in the arterial line of an extracorporeal circuit during cardiopulmonary bypass procedures 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)
Berta O. Lemperle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices ್ರಿ ಇತ್ತಿ ಮ 510(k) Number _
Prescription Use
(Per 21 CFR 801.109) ✗
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________