(258 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a cannula for delivering cardioplegia solution, with no mention of AI/ML capabilities or data processing.
Yes
The device is used to administer a cardioplegia solution, which causes asystole (stoppage of the heart), enabling surgical procedures. This action directly treats or modifies a physiological function.
No
The device is an infusion cannula used to deliver cardioplegic solutions during cardiac surgery to stop the heart and for left ventricular relaxation and aortic arch de-airing. It does not gather information for diagnosis.
No
The device description clearly describes a physical cannula used to administer a solution, and the performance studies focus on physical properties and biocompatibility, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Antegrade Cardioplegia Cannula is a surgical instrument used directly within the body during a surgical procedure. It is used to deliver a solution to the heart, not to analyze a sample taken from the body.
The description clearly states its use in "operative procedures where cardiopulmonary bypass is utilized" and its function in "administer[ing] cardioplegia solution into the heart." This is an in-vivo (within the body) application, not an in-vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Antegrade Cardioplegia Cannula acts as an infusion cannula for cardioplegic solutions. The cardioplegic solution is perfused via the aortic root into the coronaries. Furthermore, the Antegrade Cardioplegia Cannula can be used for left ventricular relaxation and aortic arch de-airing during cardiopulmonary bypass. The maximum duration of use is 6 hours.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The Antegrade Cardioplegia Cannula (N-Type) by MAQUET is used to administer cardioplegia solution into the heart in operative procedures where cardiopulmonary bypass is utilized. The cardioplegia solution causes asystole so that the operative procedure can be performed on a still heart.
The Antegrade Cardioplegia Cannula (N-Type) is inserted into the aortic root through a purse-string suture towards the aortic cross clamp. This method allows the cardioplegia solution to flow into the coronary arteries, which is known as antegrade delivery.
The Antegrade Cardioplegia Cannula (N-Type) is a redesign of the currently marketed Antegrade Cardioplegia Cannula, cleared under K020515. The main reason for designing the new cannula is to replace the plasticizer DEHP in blood contacting components containing PVC as the raw material. In addition, two new configurations of the Antegrade Cardioplegia Cannula (N-Type) are being added, the Cannula with Trocar and Pressure Monitoring System and the Cannula without a Trocar. Special configurations are being added, such as an additional clamp on the infusion line and different length of infusion line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, aortic root, coronaries
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 Antegrade Cardioplegia Cannula (N-Type) has been evaluated through non-clinical performance testing for flow rate, pressure resistance, leak testing, bond joint tensile strength, kink resistance, stress cracking of the handle, functional testing of the air plug and vent plug as well as the clamp and corrosion of the trocar. The Antegrade Cardioplegia Cannula (N-Type) met all of the acceptance criteria.
Biocompatibility testing was also performed and included Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Hemocompatibility and Genotoxicity. The Antegrade Cardioplegia Cannula (N-Type) passed all biocompatibility testing.
The Antegrade Cardioplegia Cannula (N-Type) was found to be substantially equivalent to the predicate device based on non-clinical testing.
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).
0
Public Health Service
Image /page/0/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping profiles facing to the right, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2014
MAQUET Cardiopulmonary AG Sarah Betz Manager Regulatory Affairs Kehler Strasse 31 76437 Rastatt, Germany
Re: K140569
Trade/Device Name: Antegrade cardioplegia cannula (n-type) Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula Or Tubing Regulatory Class: Class II Product Code: DWF Dated: October 17, 2014 Received: October 22, 2014
Dear Sarah Betz,
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.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 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: | To be assigned K140569 |
|---|---|
| Device Name: | Antegrade Cardioplegia Cannula (N-Type) |
Intended Use:
The Antegrade Cardioplegia Cannula acts as an infusion cannula for cardioplegic solutions. The cardioplegic solution is perfused via the aortic root into the coronaries. Furthermore, the Antegrade Cardioplegia Cannula can be used for left ventricular relaxation and aortic arch de-airing during cardiopulmonary bypass. The maximum duration of use is 6 hours.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary
| Device Proprietary Name: | Antegrade Cardioplegia Cannula (N-Type) |
|---|---|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula on |
| tubing | |
| Classification Regulation: | 870.4210 |
| Device Class: | II |
| Submitter's Name: | MAQUET Cardiopulmonary AG |
| Address: | Kehler Straße 31 |
| 76437 Rastatt, Germany | |
| Contact Person: | Sarah Betz |
| Telephone Number: | +49 7471 9973 440 |
| Fax Number: | +49 7471 9973 8667 |
Date Summary Prepared: February 22, 2014
Device Description
The Antegrade Cardioplegia Cannula (N-Type) by MAQUET is used to administer cardioplegia solution into the heart in operative procedures where cardiopulmonary bypass is utilized. The cardioplegia solution causes asystole so that the operative procedure can be performed on a still heart.
The Antegrade Cardioplegia Cannula (N-Type) is inserted into the aortic root through a purse-string suture towards the aortic cross clamp. This method allows the cardioplegia solution to flow into the coronary arteries, which is known as antegrade delivery.
Purpose of Submission
The Antegrade Cardioplegia Cannula (N-Type) is a redesign of the currently marketed Antegrade Cardioplegia Cannula, cleared under K020515. The main reason for designing the new cannula is to replace the plasticizer DEHP in blood contacting components containing PVC as the raw material. In addition, two new configurations of
4
the Antegrade Cardioplegia Cannula (N-Type) are being added, the Cannula with Trocar and Pressure Monitoring System and the Cannula without a Trocar. Special configurations are being added, such as an additional clamp on the infusion line and different length of infusion line.
Intended Use:
The Antegrade Cardioplegia Cannula acts as an infusion cannula for cardioplegic solutions. The cardioplegic solution is perfused via the aortic root into the coronaries. Furthermore, the Antegrade Cardioplegia Cannula can be used for left ventricular relaxation and aortic arch de-airing during cardiopulmonary bypass. The maximum duration of use is 6 hours.
Predicate Device:
The predicate device is the Jostra Antegrade Cardioplegia Cannula, manufactured by MAQUET Cardiopulmonary AG, which was cleared on April 24, 2002 under K020515.
Technological Characteristics/Substantial Equivalence:
The Antegrade Cardioplegia Cannula (N-Type) has the same intended use, is manufactured from the same or similar materials and incorporates the same technological characteristics as the predicate device.
The Antegrade Cardioplegia Cannula (N-Type) is provided sterile by ethylene oxide and is for single use only.
Performance Data:
The Antegrade Cardioplegia Cannula (N-Type) has been evaluated through non-clinical performance testing for flow rate, pressure resistance, leak testing, bond joint tensile strength, kink resistance, stress cracking of the handle, functional testing of the air plug and vent plug as well as the clamp and corrosion of the trocar. The Antegrade Cardioplegia Cannula (N-Type) met all of the acceptance criteria.
Biocompatibility testing was also performed and included Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Hemocompatibility and Genotoxicity. The Antegrade Cardioplegia Cannula (N-Type) passed all biocompatibility testing.
The Antegrade Cardioplegia Cannula (N-Type) was found to be substantially equivalent to the predicate device based on non-clinical testing.