(41 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of tubing and connector components, with no mention of AI or ML.
No.
The device is described as components (tubing and connectors) used to interconnect primary devices in an extracorporeal circuit during cardiopulmonary bypass surgery, rather than directly treating a disease or condition itself.
No
The device description indicates that the product, "uncoated Tubing and Connector Components," is used to "interconnect the primary devices of the bypass circuit" and provide a "continuous pathway for the flow of blood and/or other fluids during cardiopulmonary bypass surgical procedures." This describes a functional component of a surgical system for fluid transport, not a device used to provide information about the diagnosis, treatment, or prevention of a disease.
No
The device description explicitly states the components are comprised of physical materials (polyvinyl chloride, polycarbonate, and Plastisol) and are intended for use in a physical extracorporeal circuit. The performance studies also focus on physical properties and biological interactions, not software functionality.
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 surgical procedures." This describes a device used during a surgical procedure to manage blood flow, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details tubing and connectors used to "interconnect the primary devices of the bypass circuit" and provide a "continuous pathway for the flow of blood and/or other fluids." This aligns with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information. The device's function is purely mechanical – facilitating the flow of fluids during surgery.
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 surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
DWF, DTL
Device Description
Medtronic uncoated Tubing and Connector Components are intended for use in the extracorporeal circuit during cardiopulmonary bypass surgery. These components are primarily used to interconnect the primary devices of the bypass circuit. The lumen of the uncoated Tubing and Connector Components consist of smooth blood-contacting surfaces which provide a continuous pathway for the flow of blood and/or other fluids during cardiopulmonary bypass surgical procedures. The uncoated Tubing Components are comprised of polyvinyl chloride (PVC) and the uncoated Connector Components are comprised of polycarbonate and Plastisol. The uncoated Connectors are provided in Y-type, straight, and reducer configurations with ½ inch to ½ inch connection sites.
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)
Medtronic conducted the following performance testing for the uncoated Tubing and Connector Components: Shelf life, Pressure Integrity, Kink Resistance, Pressure Decay, Spallation, Pull Force, Method of sterilization and sterility assurance level, Blood Trauma. Additionally, biocompatibility testing was performed in accordance with EN ISO 10993-1:2009 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process. Performance and biological tests confirm that the uncoated Tubing and Connector Components met pre-determined acceptance criteria and are substantially equivalent to the predicate device.
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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines extending from the bottom of the profiles. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2015
Medtronic, Inc. Jacqueline A. Hauge Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112
Re: K151523
Trade/Device Name: Uncoated Tubing and Connector Components Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF, DTL Dated: June 18, 2015 Received: June 22, 2015
Dear Jacqueline Hauge:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
M.A. Hillebrand
for Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151523
Device Name
Uncoated Tubing and Connector Components
Indications for Use (Describe)
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Image /page/3/Picture/7 description: The image contains the Medtronic logo. The logo consists of a stylized human figure on the left and the word "Medtronic" in blue on the right. The human figure is composed of multiple overlapping outlines, suggesting movement or transformation.
| Date Prepared: | June 4, 2015 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration Number: 2184009 | |
| Contact Person: | Jacqueline A. Hauge |
| Senior Regulatory Affairs Specialist | |
| Medtronic Perfusion Systems | |
| Phone: 763.514.9967 | |
| Fax: 763.367.8360 | |
| Email: jacqueline.a.hauge@medtronic.com | |
| Alternate Contact: | Susan Fidler |
| Senior Regulatory Affairs Manager | |
| Medtronic Perfusion Systems | |
| Phone: 763.514.9839 | |
| Fax: 763.367.8360 | |
| Email: susan.c.fidler@medtronic.com |
Device Name and Classification
| Trade Name : | Uncoated Tubing and Connector Components |
|---|---|
| Regulation Name : | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
| Regulation Number: | 21 CFR 870.4210 |
| Product Code: | DWF, DTL |
| Regulatory Class : | Class II |
| 510(k) Review Panel: | Cardiovascular |
Predicate Devices
| K113845 | Tubing, Connectors and Accessories with Balance Biosurface |
|---|---|
| K122811 | Connector Components with Balance Biosurface |
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De vice Description
Medtronic uncoated Tubing and Connector Components are intended for use in the extracorporeal circuit during cardiopulmonary bypass surgery. These components are primarily used to interconnect the primary devices of the bypass circuit. The lumen of the uncoated Tubing and Connector Components consist of smooth blood-contacting surfaces which provide a continuous pathway for the flow of blood and/or other fluids during cardiopulmonary bypass surgical procedures. The uncoated Tubing Components are comprised of polyvinyl chloride (PVC) and the uncoated Connector Components are comprised of polycarbonate and Plastisol. The uncoated Connectors are provided in Y-type, straight, and reducer configurations with ½ inch to ½ inch connection sites.
Indications for Use
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.
Comparison to Predicate
When compared to the predicate devices, the uncoated Tubing and Connector Components have the same:
Base materials
Packaging materials and configurations
- Intended Use
- Technological characteristics ●
- Operating principle - - -●
- Design features ●
- Performance ●
Summary of Performance and Biological Testing
Medtronic conducted the following performance testing for the uncoated Tubing and Connector Components:
Shelf life
- . Pressure Integrity Kink Resistance
- Pressure Decay ●
Spallation
.
●
.
.
●
-
Pull Force
Method of sterilization and sterility assurance level -
Blood Trauma ●
Additionally, biocompatibility testing was performed in accordance with EN ISO 10993-1:2009 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process.
Performance and biological tests confirm that the uncoated Tubing and Connector Components met pre-determined acceptance criteria and are substantially equivalent to the predicate device.
Conclusion
●
Medtronic has demonstrated that uncoated Tubing and Connector Components for use in extracorporeal cardiopulmonary bypass perfusion systems (tubing sets/packs) are substantially equivalent to the predicate devices based upon design, test results, and indications for use. The fundamental scientific principle, labeling and intended use are unchanged from the predicate devices.