(114 days)
No
The device description focuses on the physical characteristics and materials of the cannula, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is used for collecting venous blood during cardiopulmonary bypass, which is a supportive function during surgery, not a therapeutic intervention to treat a disease or condition.
No
This device is used for collecting venous blood during cardiopulmonary bypass surgery, which is a therapeutic procedure rather than a diagnostic one. It functions to direct blood into a bypass circuit, not to analyze or diagnose a condition.
No
The device description clearly states it is comprised of physical components (PVC plastisol bodies, wirewound) and is a sterile, disposable, single-use device, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Function: The description clearly states that this device is a cannula used for the collection of venous blood from the right side of the heart and directing it into a bypass circuit during cardiopulmonary bypass surgery. It is a surgical tool used in vivo (within the body) to facilitate a medical procedure.
- Lack of Specimen Examination: The device itself does not perform any examination or analysis of the collected blood specimen. It is solely for the collection and transport of the blood.
Therefore, based on the provided information, this device is a surgical instrument used for blood collection during a medical procedure, not an IVD.
N/A
Intended Use / Indications for Use
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours of less.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
DLP® Single Stage Venous Cannulae devices are used during cardiopulmonary bypass surgical procedures for collecting and directing blood from the right side of the heart via the superior and inferior vena cava into the bypass circuit. These cannulae are comprised of wirewound, kink-resistant Polyvinyl Chloride (PVC) plastisol bodies with a nominal outer diameter of 12Fr to 40Fr (in 2Fr increments) and overall lengths from 12 inches to 15 inches. These cannulae are available in Carmeda® Bioactive Surface coated and uncoated versions. All DLP® Single Stage Venous Cannulae are provided as sterile, nonpyrogenic, disposable, single use devices.
Carmeda® BioActive Surface is a durable, non-leaching end point attached heparin Biosurface that mimics the heparin sulfate naturally found on the vascular endothelium lining the circulatory system. Carmeda® provides thromboresistance, enhanced biocompatibility, and enhanced blood compatibility while reducing platelet activation and adhesion formation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right side of the heart via the superior and inferior vena cava
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)
Not Found
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.
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
K120988 JUL 25 2012
2 5 2012
510(k) Summary
Date Prepared:
March 30, 2012
Submitter:
Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establishment Registration Number: 2184009
Contact Person:
:
Jacqueline A Hauge Regulatory Affairs Specialist Medtronic Perfusion Systems Phone: 763.514.9967 763.367.8360 Fax: 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: | DLP® Single Stage Venous Cannula
DLP® Right Angle Single Stage Venous Cannula
DLP® Single Stage Venous Cannula with Right Angle Metal Tip
DLP® Malleable Single Stage Venous Cannula |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
| Regulation Number: | 21 CFR 870.4210 |
| Product Code: | DWF |
| Product Classification: | Class II |
Venous Cannula with Bent, Tip Wire Malleable Single Stage Venous Cannula Malleable Single Stage Venous Cannula with Carmeda T BioActive Surface
1
Device Description
DLP® Single Stage Venous Cannulae devices are used during cardiopulmonary bypass surgical procedures for collecting and directing blood from the right side of the heart via the superior and inferior vena cava into the bypass circuit. These cannulae are comprised of wirewound, kink-resistant Polyvinyl Chloride (PVC) plastisol bodies with a nominal outer diameter of 12Fr to 40Fr (in 2Fr increments) and overall lengths from 12 inches to 15 inches. These cannulae are available in Carmeda® Bioactive Surface coated and uncoated versions. All DLP® Single Stage Venous Cannulae are provided as sterile, nonpyrogenic, disposable, single use devices.
Carmeda® BioActive Surface is a durable, non-leaching end point attached heparin Biosurface that mimics the heparin sulfate naturally found on the vascular endothelium lining the circulatory system. Carmeda® provides thromboresistance, enhanced biocompatibility, and enhanced blood compatibility while reducing platelet activation and adhesion formation.
Indications for_Use
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
Contraindications
These cannulae are contraindicated for long-term use. Do not use for extended terms such as Ventricular Assist procedures.
Comparison to Predicate Devices
A comparison of the modified product to the currently marketed product (K845045 and K022272) indicate the following similarities:
- I Same intended use
- 파 Same technological characteristics
- l Same operating principle
- 트 Same design features
- 트 Same base materials prior to coating
- Same shelf life
A comparison of the modified product and the currently marketed DLP® Single Stage Venous Cannula with Carmeda® BioActive Surface (K111972) indicated the following similarities:
- I Same Carmeda® BioActive Surface coating
2
Conclusion
Medtronic has demonstrated that the modifications made to the DLP® Single Stage Venous Cannula product family described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is depicted in a simple, black and white design, and the text is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 5 2012
Medtronic, Inc. c/o Ms. Jacqueline A. Hauge Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112
Re: K120988
DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right Angle Metal Tip and DLP Malleable Single Stage Venous Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: June 28, 2012 Received: June 29, 2012
Dear Ms. 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.
4
Page 2 - Ms. Jacqueline A. Hauge
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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
signature
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K120988
Device Name: DLP® Single Stage Venous Cannula
DLP® Right Angle Single Stage Venous Cannula
DLP® Single Stage Venous Cannula with Right Angle Metal Tip DLP®:Malleable Single Stage Venous Cannula
Indications For Use:
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours of less.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Divis of Sign-Off) f of Cardiovascular Devices Number
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