(101 days)
Not Found
No
The document describes a physical medical device (cannula) and its intended use and performance characteristics. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
It is an accessory used to deliver cardioplegia during cardiopulmonary bypass surgery.
No
The device delivers cardioplegia and aspirates air during cardiopulmonary bypass; it does not diagnose medical conditions.
No
The device description clearly indicates it is a physical cannula, a single-use, sterile, nonpyrogenic device designed to deliver cardioplegia. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for delivering cardioplegia and aspirating air during cardiopulmonary bypass surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a cannula designed for direct insertion into the aorta.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on bodily specimens.
The device is a surgical instrument used in vivo (within the body) during a medical procedure.
N/A
Intended Use / Indications for Use
The MiAR™ cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia up to 6 hours. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques.
Product codes
DWF
Device Description
MiARTM Cannulae are single-use, sterile, nonpyrogenic devices designed to deliver cardioplegia through the aorta in an antegrade manner, for periods up to six hours during cardiopulmonary bypass surgery. These devices are available in models that feature two tip sizes and the Flow-Guard™ feature to maintain hemostasis during removal of the introducer needle from the cannula. The increased overall length of these cannulae relative to standard models, make them easier to use when minimally invasive surgical approaches are utilized (i.e., mini-sternotomy and right thoracotomy).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aorta
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
Bench testing was used to establish the performance characteristics of the modifications of this device from previously marketed Medtronic cannula devices. Clinical testing was not required to establish substantial equivalence. The following performance tests were conducted:
- Flow Rate Versus Pressure Drop
- Distal tip visibility Under Fluoroscopic Visualization
- Structural Integrity (bonded joints)
Key Metrics
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).
0
Image /page/0/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" in bold, black letters on the right. The graphic appears to depict a stylized representation of the human body.
510(k) Summary
MiAR™ Aortic Root Cannula with Flow-Guard™ Traditional 510/k
| Date Prepared: | January 28, 2010 | MAY 10 2010 |
|---|---|---|
| Submitter: | Medtronic 7611 Northland Drive Minneapolis, MN 55428 Establish Registration Number: 2184009 | |
| Contact Person: | Caralee Walton Senior Regulatory Affairs Specialist Phone: (763) 514-9851 Fax: (763) 367-8360 Email: caralee.a.walton@medtronic.com |
Device Name and Classification
| Trade Name: | MiART™ (Minimally Invasive) Aortic Root Cannula with Flow-
Guard™ |
|--------------------|----------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
| Regulation Number: | 21 CFR 870.4210 |
| Product Code: | DWF |
| Classification: | Class II |
Predicate Devices
Medtronic DLP Aortic Root Cannula (K790565) Medtronic Pediatric Aortic Root Cannula (K040173)
Device Description
MiARTM Cannulae are single-use, sterile, nonpyrogenic devices designed to deliver cardioplegia through the aorta in an antegrade manner, for periods up to six hours during cardiopulmonary bypass surgery. These devices are available in models that feature two tip sizes and the Flow-Guard™ feature to maintain hemostasis during removal of the introducer needle from the cannula. The increased overall length of these cannulae relative to standard models, make them easier to use when minimally invasive surgical approaches are utilized (i.e., mini-sternotomy and right thoracotomy).
Indications for Use
The MiAR™ cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia for up to 6 hours. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques.
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Comparison to Predicate Devices
A comparison of the modified product and the currently marketed Aortic Root Cannula indicates the following similarities to the device which received 510(k) clearance:
- . Same technological characteristics
- Same operating principle .
- Same design features, only longer length .
- . Same Flow-Guard™ introducer
- Same connectors .
- Same materials ●
.
- Same shelf life .
Summary of Performance Data
Bench testing was used to establish the performance characteristics of the modifications of this device from previously marketed Medtronic cannula devices. Clinical testing was not required to establish substantial equivalence. The following performance tests were conducted:
- . Flow Rate Versus Pressure Drop
- . Distal tip visibility Under Fluoroscopic Visualization
- Structural Integrity (bonded joints) .
Conclusion
Medtronic has demonstrated that the MiAR™ Cannulae are substantially equivalent to the predicate device based upon design and test results. Any noted differences do not raise new issues of safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAY 1 0 2010
Medtronic, Inc. c/o Ms. Caralee A. Walton Senior Regulatory Affairs Specialist 710 Medtronic Parkway NE Minneapolis, MN 55432
Re: K100274
MiAR™ (Minimally Invasive) Aortic Root Cannula with Flow-Guard™ Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: II Product Code: DWF Dated: May 3, 2010 Received: May 4, 2010
Dear Ms. Walton:
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.
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
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Page 2 - Ms. Caralee A. Walton
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 (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.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" (21 CFR 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.him 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
R. Richmen
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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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MiAR™ Aortic Root Cannula with Flow-Guard™ Traditional 510(k)
Indications for Use
510(k) Number (if known): _ K100274
Device Name: MiAR™ Aortic Root Cannula with Flow-Guard™
Indications for Use:
The MiAR™ cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia up to 6 hours. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dina R. Viinik
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K\00274