(173 days)
COBE® Tubing and Connectors
Not Found
No
The device description and performance studies focus on the physical properties and performance of tubing and connectors for extracorporeal support, with no mention of AI or ML.
No
The device is described as "Tubing and Connectors" used to create circuits for extracorporeal support, such as cardiopulmonary bypass. While crucial for surgical procedures, these components themselves do not directly provide therapy; rather, they facilitate the function of other therapeutic devices (e.g., oxygenators, pumps).
No
The device description indicates that the tubing and connectors are used to create circuits for extracorporeal support during surgical procedures, connecting components like oxygenators and reservoirs. It does not mention any diagnostic function such as detecting, identifying, or monitoring medical conditions.
No
The device description clearly states that the device is sterile tubing and connectors made of polyvinyl chloride (PVC), which are physical hardware components. There is no mention of software in the description or intended use.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "surgical procedures requiring extracorporeal support." This describes a procedure performed on a patient's body, not a test performed on a sample taken from a patient.
- Device Description: The device is described as tubing and connectors used to connect components in a cardiopulmonary bypass circuit. This is a system that supports the patient's circulation and oxygenation during surgery, directly interacting with the patient's blood within the body's circulatory system (albeit outside the heart and lungs temporarily).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to facilitate the flow of blood and other fluids during a surgical procedure.
IVDs are typically used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The COBE® SMAR,T™ Tubing and Connectors are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.
Product codes
DWE
Device Description
The COBE® SMAR, T™ Tubing and Connectors are sterile devices with non-pyrogenic fluid pathways, for single use only, and are not to be resterilized by the user. The devices are used in connecting oxygenators, reservoirs, filters, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support. The tubing may also be used in roller-type cardiopulmonary bypass blood pumps. In particular, tubing sizes with a 3/32 inch wall thickness are used in the pump head of a roller-type cardiopulmonary bypass blood pump, where the tubing is cyclically compressed by the pump to cause blood to flow through the cardiopulmonary bypass circuit.
COBE® SMAR.T™ Tubing is polyvinyl chloride (PVC) tubing ranging in size from 0.075" ID x 0.020" wall to 5/8" ID x 1/8" wall. COBE® SMAR, T™ Connectors are of the following generic types: straight with or without luer port, reducer with or without luer port, Y with or without luer port, male or female luer locks, and saturation/hematocrit monitor connectors.
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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing consisted of:
- Bond Strength Static Leak Test Rated Pressure Kink Resistance Tubing Pump Life Tubing Spallation Saturation/Hematocrit Connector Testing
In-vitro testing was performed to demonstrate improved blood compatibility of the materials containing the surface modifying additive.
These data support that the COBE® SMAR, T™ Tubing and Connectors are substantially equivalent to the currently marketed COBE® Tubing and Connectors, and that the addition of the surface-modifying material does not affect safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
COBE® Tubing and Connectors
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4390 Cardiopulmonary bypass pump tubing.
(a)
Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).
0
OCT 26 1998
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: | August 6, 1998 |
| DEVICE TRADE NAME: | COBE® SMARxT™ Tubing and Connectors |
| COMMON/USUAL NAME: | Cardiopulmonary Bypass Tubing and Connectors |
| CLASSIFICATION NAMES: | Cardiopulmonary Bypass Pump Tubing
Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing
Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting |
| PREDICATE DEVICE: | COBE® Tubing and Connectors |
DEVICE DESCRIPTION:
The COBE® SMAR, T™ Tubing and Connectors are sterile devices with non-pyrogenic fluid pathways, for single use only, and are not to be resterilized by the user. The devices are used in connecting oxygenators, reservoirs, filters, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support. The tubing may also be used in roller-type cardiopulmonary bypass blood pumps. In particular, tubing sizes with a 3/32 inch wall thickness are used in the pump head of a roller-type cardiopulmonary bypass blood pump, where the tubing is cyclically compressed by the pump to cause blood to flow through the cardiopulmonary bypass circuit.
COBE® SMAR.T™ Tubing is polyvinyl chloride (PVC) tubing ranging in size from 0.075" ID x 0.020" wall to 5/8" ID x 1/8" wall. COBE® SMAR, T™ Connectors are of the following generic types: straight with or without luer port, reducer with or without luer port, Y with or without luer port, male or female luer locks, and saturation/hematocrit monitor connectors.
INDICATIONS FOR USE
The COBE® SMAR,T™ Tubing and Connectors are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The COBE® SMAR, T™ Tubing and Connectors have the same intended use as currently marketed COBE® Tubing and Connectors. The primary difference is that the COBE® SMAR, T™ Tubing and Connectors contain a non-leaching, surface modifying additive that is added to the formulation prior to fabrication to improve blood compatibility.
1
Biocompatibility and performance tests were performed to demonstrate that the COBE® SMAR,T™ Tubing and Connectors are substantially equivalent to the currently marketed COBE® Tubing and Connectors.
Performance testing consisted of:
- Bond Strength Static Leak Test Rated Pressure Kink Resistance Tubing Pump Life Tubing Spallation Saturation/Hematocrit Connector Testing
In-vitro testing was performed to demonstrate improved blood compatibility of the materials containing the surface modifying additive.
These data support that the COBE® SMAR, T™ Tubing and Connectors are substantially equivalent to the currently marketed COBE® Tubing and Connectors, and that the addition of the surface-modifying material does not affect safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 1998
Ms. Lynne Leonard Manager, Regualtory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004
K981613 Re : COBE® SMARXT™ Tubing and Connectors Regulatory Class: II (Two) Product Code: DWE Dated: Auqust 7, 1998 Received: August 11, 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 atvice 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 provisions 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 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 Reqister. 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 Inis fecter will arow you one on the motification. The FDA finding described in Your 518(A) promise of your device to a legally marketed of substantial equivalence or flassification for your device and predicate actiour device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific advanced additionally 809.10 for in vitro regulacion (er ces), please contact the Office of Compliance at (1agnoscic devices), promally, for questions on the promotion and (Jor) Joing of your device, please contact the Office of advertising on (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your (aronsibilities under the Act may be obtained from the Division responsibilities 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
Enclosure
4
Indications For Use
Ic 98 510(k) Number (If known): ____________________________________________________________________________________________________________________________________________________
Device Names: COBE® SMAR TTM Tubing and Connectors
Indications For Use:
COBE® SMAR T™ Tubing and Connectors are intended to be used in surgical procedures requiring extracorporeal support 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)
Litte R. Loemperse
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K981613
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use __