(149 days)
No
The summary describes a mechanical device for delivering cardioplegia and mentions visualization techniques, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device delivers cardioplegia which temporarily stops the heart for surgical procedures, but it does not treat a disease or condition itself.
No
The device is intended for delivering cardioplegia, which is a therapeutic intervention, not for diagnosing a condition. It aids in verification of placement but its primary function is therapeutic.
No
The device description clearly describes a physical, single-use, sterile cannula with features like a malleable stylet and inflating cuffs, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The MiRCSP cannula is a surgical tool used during a medical procedure (cardiopulmonary bypass) to deliver a substance (cardioplegia) directly into a blood vessel (coronary sinus) within the body. It is not used to test samples taken from the body.
- Intended Use: The intended use clearly states it's for "delivery of cardioplegia retrograde through the coronary sinus" during surgery. This is a therapeutic/procedural use, not a diagnostic one.
- Device Description: The description focuses on its physical characteristics and function as a delivery device during surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on testing bodily fluids or tissues.
Therefore, based on the provided information, the MiRCSP cannula is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MiRCSP cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia retrograde through the coronary sinus for up to six hours. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct, echocardiographic or fluoroscopic visualization techniques.
Product codes
DWF
Device Description
MiRCSP Cannulae are single-use, sterile, nonpyrogenic devices designed to deliver cardioplegia through the coronary sinus in a retrograde manner, for periods up to six hours during cardiopulmonary bypass surgery. These devices are available in models that feature manual and auto inflating cuffs, and contain an aid in verification of cannula placement. The removable malleable stylet is used to provide stiffness and shape to the cannula body during insertion and features additional deflectability and rotation at the distal cannula tip to aid in placement into the coronary sinus. These cannulae have features that make them easier to use when minimally invasive surgical approaches are utilized (i.e., mini-sternotomy and right thorocotomy).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
echocardiographic or fluoroscopic visualization techniques
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)
Bench and animal testing were used to establish the performance characteristics of the modifications of this device from previously marketed MDT cannula devices. Clinical testing was not required to establish substantial equivalence. The following performance tests were conducted:
- Flow Rate Versus Pressure Drop
- Visibility Under Ultrasound and Fluoroscopic Visualization Techniques
- Structural Integrity (bonded joints and introducer)
- Biocompatibility Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K860149, K901074, K001565, K994243, K964248, K070311
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/1 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" on the right. The graphic appears to be a stylized representation of a human figure within a circle. The word "Medtronic" is written in a bold, sans-serif font.
AUG 2-7 2009
510(k) Summary
Date Prepared:
Submitter:
August 11, 2009
Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establish Registration Number: 2184009
Contact Person:
Jessica Sixberry Senior Regulatory Affairs Specialist Phone: (763) 514-9849 (651) 367-1893 Fax: Email: jessica.m.sixberry@medtronic.com
Device Name and Classification:
Trade Name:
Product Code:
Classification:
MiRCSP (Minimally Invasive Retrograde Coronary Sinus Perfusion) Auto and Manual Inflate Cannula Common Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulation Number: 21 CFR 870.4210 DWF Class II
Predicate Devices
- Medtronic DLP Venous Perfusion Cannula with Cuff (K860149) .
- Medtronic DLP Silicone RCSP Cannula with Auto-Inflate Cuff (K901074) .
- RMI (Edwards Lifesciences) Steerable Retrograde Cardioplegia Cannula (K001565) .
- Heartport (Edwards Lifesciences) Direct Arterial Cannula (previously known as StraightShot) . (K994243)
- Heartport (Edwards Lifesciences) Endocoronary Sinus Catheter (K964248) .
- Medtronic Cardioblate Gemini Device (K070311)
Device Description
MiRCSP Cannulae are single-use, sterile, nonpyrogenic devices designed to deliver cardioplegia through the coronary sinus in a retrograde manner, for periods up to six hours during cardiopulmonary bypass surgery. These devices are available in models that feature manual and auto inflating cuffs, and contain an aid in verification of cannula placement. The removable malleable stylet is used to provide stiffness and shape to the cannula body during insertion and features additional deflectability and rotation at the distal cannula tip to aid in placement into the coronary sinus. These cannulae have features that make them easier to use when minimally invasive surgical approaches are utilized (i.e., mini-sternotomy and right thorocotomy).
Alleviating Pain · Restoring Health · Extending Life
1
| Model | Cannula Body Type | Introducer Type |
|---|---|---|
| 94113TD | Manual-Inflate | Tip deflects away from slider |
| 94113TDT | Manual-Inflate | Tip deflects toward slider |
| 94533TD | Auto-Inflate | Tip deflects away from slider |
| 94533TDT | Auto-Inflate | Tip deflects toward slider |
Indications for Use
The MiRCSP cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia retrograde through the coronary sinus for up to six hours. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct, echocardiographic or fluoroscopic visualization techniques.
Comparison to Predicate Devices
MiRCSP Cannulae contain the same technological characteristics when compared to the existing Medtronic (MDT) retrograde cardioplegia delivery cannulae utilize the design features and materials of the Medtronic RCSP Models 94113 and 94533, including a removable stylet introducer with a malleable shaft to provide cannula shape and stiffness. The MiRCSP introducer features additional distal tip deflectability and rotation to further aid in cannula placement when used in conjunction with small incision surgical approaches (i.e. thoracotomies or mini-sternotomies). The cannulae bodies include enhanced visibility in-vivo.
- Intended Use: The MiRCSP Cannula has the same intended use as the Medtronic DLP . Retrograde Coronary Sinus Perfusion Cannula with Manual-Inflating Cuff and Silicone Body, and DLP PVC Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff; with the addition of information regarding visibility and surgical procedure access.
- Principles of Operation and Technology: .
- MiRCSP Cannulae use the same technologies in operation as currently marketed o manual and auto-inflating retrograde coronary sinus perfusion cannulae.
- Temporary coronary sinus occlusion for delivery of retrograde cardioplegia and o measurement of coronary sinus pressure are accomplished in the same manner.
- MiRCSP Cannulae are also made from the same base materials as their MDT o predicates.
- Cannula introduction is accomplished in the same manner using a removeable, o malleable stylet, fully contained within the cannula body,
- The MiRCSP Cannula introducer also features the additional ability to deflect and o rotate the distal portion of the cannula, in-vivo, to further aid in placement of the cannula into the coronary sinus. This uses similar technology as the RMI Steerable Retrograde Cannula.
2
- MiRCSP Cannulae are visible under ultrasound (TEE) and feature enhanced o visibility under fluoroscopy in the distal tip area, to aid in placement verification, These features are also available with the Heartport Endocoronary Sinus Catheters.
- Performance: The MiRCSP Cannulae Models 94113TD, 94113TDT, 94533TD and ● 94533TDT were compared to previously cleared Medtronic RCSP Model 94113 and 94533, respectively, as predicates for performance characteristics. The comparisons demonstrated that these cannulae were substantially equivalent in performance.
Summary of Performance Data
Bench and animal testing were used to establish the performance characteristics of the modifications of this device from previously marketed MDT cannula devices. Clinical testing was not required to establish substantial equivalence. The following performance tests were conducted:
- Flow Rate Versus Pressure Drop �
- . Visibility Under Ultrasound and Fluoroscopic Visualization Techniques
- Structural Integrity (bonded joints and introducer) t
- Biocompatibility Testing .
Conclusion
Medtronic has demonstrated that the MiRCSP Cannula is substantially equivalent to the predicate devices based upon design, test results, and indications for use. Any noted differences do not raise new issues of safety and effectiveness.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
IAUG 2 7 2009
Medtronic Perfusion Systems c/o Ms. Jessica Sixberry 7611 Northland Drive Minneapolis, MN 55432
Re: K090869
MiRCSP Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DWF Dated: August 11, 2009 Received: August 14, 2009
Dear Ms. Sixberry:
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 to legally marketed releated devices marketed in interstate commerce prior to May 28, 1976, the enactment date of produced as nevice 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. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the of alle all, be regionents. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
4
Page 2 - Ms. Jessica Sixberry
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 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/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Dura D. Varner
Image /page/4/Picture/7 description: The image shows a signature in black ink on a white background. The signature appears to be stylized, with curved lines and loops forming what might be letters or initials. The lines are bold and distinct, suggesting a deliberate and confident hand. The overall impression is that of a quick, yet legible, personal mark.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: MiRCSPTM (Minimally Invasive Retrograde Coronary Sinus Perfusion) Auto and Manual Inflate Cannula
Indications for Use: The MiRCSP cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia retrograde through the coronary sinus for up to six hours. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct, echocardiographic or fluoroscopic visualization techniques.
Prescription Use OR X Per 21 CFR 801.109
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dmer R. Vachner
(Divisi-Off)
Division of Cardiovascular Devices
510(k) K₀C