(16 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of tubing and connectors, with no mention of AI or ML.
No.
The device is tubing and connectors used during cardiopulmonary bypass surgery, which are accessories to a therapeutic procedure rather than a therapeutic device itself.
No
The device is described as tubing and connectors used in an extracorporeal circuit during cardiopulmonary bypass surgery, designed to interconnect other equipment. Its purpose is to facilitate blood flow and oxygenation, not to diagnose a condition or disease.
No
The device description explicitly states it is composed of physical components (tubing and connectors) made of polyvinyl chloride, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the extracorporeal circuit during cardiopulmonary bypass surgery." This describes a device used on a patient during a surgical procedure, not a device used to test samples from a patient in a laboratory setting.
- Device Description: The description details tubing and connectors used to connect various components in the extracorporeal circuit. This is a physical component of a medical procedure, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical and biocompatible characteristics of the tubing and connectors (coating leaching, spallation, pressure integrity, etc.), which are relevant to its function in the extracorporeal circuit, not its diagnostic capabilities.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The tubing consists of biocompatible polyvinyl chloride tubing in various lengths (see Appendix I). This tubing will be used in the extracorporeal circuit during I cardiopulmonary bypass to interconnect the catheters and cannula with an oxygenator and other accessory bypass equipment.
The connectors consist of molded fittings for use in interconnecting tubing, cannula and/or other extracorporeal devices (see Appendix I).
Tubing and connectors are coated with Trillium™ Biopassive Surface (a polyment containing non-leaching heparin).
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)
The biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the tubing and connectors with Trillium™ Biopassive Surface does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed cardioplegia delivery system. The in vitro bench testing included analysis of:
Coating Characteristics:
Coating Leaching
Physical/Performance Characteristics:
Spallation Pressure Decay/Pressure Integrity Kink Resistance Blood Trauma Pull Strength
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.
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
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
0
AUG 2 3 2001
Summary of Safety and Effectiveness
Company and Contact Person
Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Tel: 763-391-9183 Fax: 763-391-9603
Marie Holm, Associate Product Regulations Manager, Regulatory Affairs
Device Name
Tubing and Connectors with Trillium™ Biopassive Surface
Name of Predicated or Legally Marketed Device
Intersept Blood Tubing Packs (K800178) mensept Drood Tubing Packs (115001773)
Affinity Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)
Description of Device
The tubing consists of biocompatible polyvinyl chloride tubing in various lengths (see Appendix I). This tubing will be used in the extracorporeal circuit during I cardiopulmonary bypass to interconnect the catheters and cannula with an oxygenator and other accessory bypass equipment.
The connectors consist of molded fittings for use in interconnecting tubing, cannula and/or other extracorporeal devices (see Appendix I).
Tubing and connectors are coated with Trillium™ Biopassive Surface (a polyment containing non-leaching heparin).
Statement of Intended Use
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.
Statement of Intended Use of Predicate Device
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures.
| Special 510(k) Notification
Medtronic, Inc. | Tubing and Connectors with Trillium™
Biopassive Surface | Confidential |
|------------------------------------------------|------------------------------------------------------------|--------------|
| Medtronic Perfusion Systems | Appendix III | 17 |
1
Statement of Technological Characteristics and Comparison
Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".
Determination of Substantial Equivalence
This "SPECIAL 510(k)" is being submitted for a modification to various Medtronic tubing and connectors. The modification to the current tubing and connectors is to coat the blood contact surfaces with Trillium™
The Medtronic Tubing and Connectors with Trillium™ Biopassive Surface are being compared to the following marketed devices:
Tubing and connectors described in (K800178) Affinity Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)
The tubing and connectors with Trillium™ Biopassive Surface have the same indications statement and intended uses as the:
Tubing and connectors described in (K800178)
The tubing and connectors with Trillium™ Biopassive Surface have no "new technological characteristics (e.g., materials and manufacturing processes)" from the currently marketed tubing and connectors.
The technological characteristic of the Trillium™ Biopassive Surface is used in other cardiopulmonary devices currently in commercial distribution as follows:
Affinity Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)
This technological characteristic "could affect the safety and effectiveness of the device". However, these "new technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are acceptable scientific methods which exist for assessing effects of these new technological characteristics".
"Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the tubing and connectors with Trillium™ Biopassive Surface are substantially equivalent to other marketed tubing and connectors.
The biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the tubing and connectors with Trillium™ Biopassive Surface does not significantly affect safety and effectiveness and are substantially equivalent to other
| Special 510(k) Notification | Tubing and Connectors with Trillium™ | Confidential |
|---|---|---|
| Medtronic, Inc. | Biopassive Surface | |
| Medtronic Perfusion Systems | Appendix III | 18 |
2
commercially distributed cardioplegia delivery system. The in vitro bench testing included analysis of:
Coating Characteristics:
Coating Leaching
Physical/Performance Characteristics:
Spallation Pressure Decay/Pressure Integrity Kink Resistance Blood Trauma Pull Strength
| Special 510(k) Notification | Tubing and Connectors with Trillium™ | Confidential |
|---|---|---|
| Medtronic, Inc. | Biopassive Surface | |
| Medtronic Perfusion Systems | Appendix III | 19 |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
AUG 2 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marie Holm Associate Product Regulations Manager Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428
K012538 Re:
Tubing and Connectors with Trillium™ Biopassive Surface Regulation Number: 870.4210 Regulatory Class: II (two) Product Code: DWF Dated: August 6, 2001 Received: August 7, 2001
Dear Ms. Holm:
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 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.
4
Page 2 - Ms. Marie Holm
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) 594-4586. 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 International and Consumer 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,
lR
James E. Dillard III Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number if known: KO12538___________________________________________________________________________________________________________________________________________
Device Name: Medtronic Tubing and Connectors with Trillium™ Biopassive Surface
Indications for Use:
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012338
Prescription Use _
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Per 21 CFR 801.109