(110 days)
Not Found
No
The description focuses on the physical components and intended use of a cannula, with no mention of AI or ML capabilities.
Yes
The device is used to deliver cardioplegia solution, which is a therapeutic intervention, during surgery.
No
The device is described as a cannula intended for delivering cardioplegia solution during cardiopulmonary bypass surgery. Its function is to perfuse the coronary sinus with a solution, which is a therapeutic intervention, not a diagnostic one. It does not mention collecting or analyzing data to determine a medical condition or characteristic.
No
The device description explicitly details physical components (PVC or silicone body, auto-inflate cuff, luer connector, guidewire/stylet) and mentions performance testing on these physical components (retention force testing). This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states the device is a cannula used for the delivery of cardioplegia solution directly into the coronary sinus during surgery. It is an invasive surgical tool used in vivo (within the living body).
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its purpose is to deliver a substance, not to perform diagnostic tests on samples.
Therefore, based on the intended use and device description, this is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is intended for use during cardiopulmonary bypass surgery up to six hours or less, for the delivery of cardioplegia retrogradely through the coronary sinus.
Product codes
DWF
Device Description
The cannulae consist of either a Polyvinyl Chloride (PVC) body or a silicone wire-wound kink-resistant body with auto-inflate cuff. The cannula is used for direct cannulation within the coronary sinus to deliver cardioplegia solution during cardiopulmonary bypass surgery. The back of the cannula body terminates in a locking female luer. These cannulae utilize a guidewire or solid stylet to facilitate trans-atrial introduction. The cannulae are nonpyrogenic. single use, and sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus
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 DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family added an additional French size option, which was tested through the design verification process. The samples were subjected to a kink test, a simulated use test, functional tests of the cannula (bond joint tensile test and leak testing of all bonded connections), and functional tests of the introducer (twist test and tensile test). All samples passed the verification testing.
The DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family added an additional cuff style, which was performance tested. The samples were subjected to retention force testing to ensure acceptable retention within the coronary sinus. All samples passed the verification testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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510(k) Summary
December 6, 2012 Date Prepared: Submitter:
Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establishment Registration Number: 2184009
Contact Person:
Chelsea L. Pioske Associate Regulatory Affairs Specialist Medtronic Perfusion Systems Phone: 763.514.9838 Fax: 763.367.8360 Email: chelsea.pioske@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
DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Trade Name: Cuff Common Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing 21 CFR 870.4210 Regulation Number: Product Code: DWF Product Class II Classification:
Predicate Devices
Retrograde Coronary Sinus Perfusion Cannula K901074 K030696 Retrograde Coronary Sinus Perfusion Cannula without Pressure Monitoring Lumen
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Device Description
The cannulae consist of either a Polyvinyl Chloride (PVC) body or a silicone wirewound kink-resistant body with auto-inflate cuff. The cannula is used for direct cannulation within the coronary sinus to deliver cardioplegia solution during cardiopulmonary bypass surgery. The back of the cannula body terminates in a locking female luer. These cannulae utilize a guidewire or solid stylet to facilitate trans-atrial introduction. The cannulae are nonpyrogenic. single use, and sterile.
Indications for Use
This device is intended for use during cardiopulmonary bypass surgery up to six hours or less, for the delivery of cardioplegia retrogradely through the coronary sinus.
Comparison to Predicate Devices
A comparison of the modified product to the currently marketed products (K901074 and K030696) indicates the following similarities:
- Same intended use
- 트 Same technological characteristics
- Same operating principle
- Same design features
- Same base materials
- Same shelf life ■
Summary of Design Verification Testing
The DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family added an additional French size option, which was tested through the design verification process. The samples were subjected to a kink test, a simulated use test, functional tests of the cannula (bond joint tensile test and leak testing of all bonded connections), and functional tests of the introducer (twist test and tensile test). All samples passed the verification testing.
Summary of Performance Testing
The DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family added an additional cuff style, which was performance tested. The samples were subjected to retention force testing to ensure acceptable retention within the coronary sinus. All samples passed the verification testing.
Conclusion
Medtronic has demonstrated that the modifications made to the DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family described in this submission result in a substantially equivalent device the fundamental scientific principle, operating principle, design features and intended from the predicate devices.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of a human figure with three arms or lines extending from the body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 27, 2013
Medtronic, Inc. C/O Chelsea Pioske 8200 Coral Sea Street NE Mounds View, MN 55433
Re: K123762 Trade/Device Name: DLP Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula or tubing Regulatory Class: Class II Product Code: DWF Dated: March 7, 2013 Received: March 8, 2013
Dear Ms. Pioske:
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. Iisting 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
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html 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.htmfor 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,
Matthew G. Hillebrenner
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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Statement of Indications for Use
510(k) Number (if known): K123762
Device Name: DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff
Indications for Use:
This device is intended for use during cardiopulmonary bypass surgery up to six hours or less, for the delivery of cardioplegia retrogradely through the coronary sinus.
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)
Matthew G. Hillebrenner
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