(71 days)
Not Found
Not Found
No
The description focuses on the mechanical function of a balloon cannula and does not mention any AI/ML components or capabilities.
No.
The device perfuses the aorta, isolates the heart, allows delivery of cardioplegia, and vents the aortic root during surgery, but it does not directly treat a disease or condition.
No
The device is described as an "Ascending Balloon Cannula" intended to perfuse the aorta and isolate the heart during surgical procedures, deliver cardioplegia, and vent the aortic root. These functions are therapeutic and interventional, not diagnostic.
No
The device description clearly describes a physical medical device (cannula with an inflatable balloon) used in surgical procedures, not a software-only application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a surgical procedure (open chest sternotomy on cardiopulmonary bypass) to perfuse the aorta, isolate the heart, deliver cardioplegia, and vent the aortic root. These are all actions performed directly on the patient's body during surgery.
- Device Description: The description reinforces its use in a surgical setting, connecting to a cardiopulmonary bypass circuit and performing physical functions within the patient's circulatory system.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor a disease, or screen for health status.
IVD devices are typically used to analyze samples to provide information about a patient's health status, not to perform therapeutic or procedural actions directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The Cardeon® Ascending Balloon Cannula is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours. The occlusion balloon isolates the heart from the ascending aorta when inflated. The ABC also allows delivery of antegrade cardioplegia and venting of the aortic root.
Product codes
DWF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aorta, heart, aortic root
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
The determination of substantial equivalence was also based on an assessment of device biocompatibility, in vitro and in vivo performance. Results of product testing demonstrated that the Ascending Balloon Cannula functions as safely and effectively as predicate arterial return cannulae and aortic occlusive balloons.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
510(k) SUMMARY
K022042 510(k) number:
This summary of information is being provided in accordance with 21 CFR 807.92(a).
| Applicant Information: | Cardeon Corporation
10161 Bubb Road
Cupertino, CA 95014 |
|---------------------------------------|----------------------------------------------------------------------------|
| Contact Person: | Jane Beggs
Regulatory Affairs
Cardeon Corporation |
| Date Summary Prepared: | 23 August 2002 |
| Device Trade Name: | Cardeon® Ascending Balloon Cannula (ABCTM) |
| Device Common Name
Regulation No.: | Catheter, cannula and tubing, vascular, cardiopulmonary
bypass 870.4210 |
| Classification / Code: | Class II / DWF |
Indications for Use: The Cardeon® Ascending Balloon Cannula is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours. The occlusion balloon isolates the heart from the ascending aorta when inflated. The ABC also allows delivery of antegrade cardioplegia and venting of the aortic root.
Summary of Substantial Equivalence: The Ascending Balloon Cannula is substantially equivalent to currently marketed devices used to directly cannulate and perfuse from a general cardiac surgery patients undergoing coronary artery bypass grafting or valve replacement and/or repairs on CPB via sternotomy. Aortic occlusion is achieved by the fluid inflation of an integrated balloon thereby preventing the backflow of blood into the surgical field. Additional lumens allow delivery of antegrade cardioplegia or venting of the aortic root. The subject and predicate devices use standard attachments for connection(s) to cardiopulmonary bypass circuit. Substantial equivalence is supported through comparison with several marketed devices with the same indications for use, including arterial cannulae integral occlusive balloon and external cross clamps. Differences between the Ascending Balloon Cannula and other devices do not raise any new issues of safety and effectiveness.
Based on comparisons to currently marketed devices and performance testing of the subject device. the Cardeon Ascending Balloon Cannula is substantially equivalent to predicate devices with regard to intended use, indications for use, device performance and technological characteristics,
Product Testing: The determination of substantial equivalence was also based on an assessment of device biocompatibility, in vitro and in vivo performance. Results of product testing demonstrated that the Ascending Balloon Cannula functions as safely and effectively as predicate arterial return cannulae and aortic occlusive balloons.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized eagle or bird symbol, depicted with flowing lines to represent its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2002 SEP
Cardeon Corporation c/o Ms. Jane Beggs VP. Regulatory Affairs 10161 Bubb Road Cupertino, CA 95014
Re: K022042
Trade Name: Cardeon® Ascending Balloon Cannula (ABCTM) Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Catheter, Cannula, Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: June 13, 2002 Received: June 14, 2002
Dear Ms. Beggs:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 - Ms. Jane Beggs
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Noa Bram D. Zuckerman, M.D.
ABram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ΚύλλΟΥ Σ
Page 1 of 1
Device Name: Cardeon Ascending Balloon Cannula (ABC™)
Indications for Use:
The Cardeon Ascending Balloon Cannula is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours. The occlusion balloon isolates the heart from the ascending aorta when inflated. The ABC also allows delivery of antegrade cardioplegia and venting of the aortic root.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-the Counter Use _
(Division Sign-Off)
Division of Cardiovascular and Respiratory Devices
510(k) Number K022042