(21 days)
Not Found
Not Found
No
The summary describes a catheter for aortic perfusion and does not mention any AI or ML capabilities.
Yes
The device is described as a catheter intended to perfuse an anatomical site (aorta) during a medical procedure, which indicates a therapeutic purpose.
No
Explanation: The device, the Cardeon® Aegis™ Catheter, is described as intended to "perfuse the aorta," which is a therapeutic function (delivering fluid), not a diagnostic one (identifying a condition or disease).
No
The device is described as a "Catheter," which is a physical medical device, not software. The summary focuses on the performance of this physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass". This describes a device used in vivo (within the living body) during a surgical procedure.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. The Cardeon® Aegis™ Catheter does not fit this description.
The device is a surgical catheter used directly on the patient's aorta during a procedure, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Cardeon® Aegis™ Catheter is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours.
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
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
Product Testing: The determination of substantial equivalence was also based on tests of biocompatibility, in vitro and/or in vivo performance conducted for the original and modified Aegis devices. Results of product testing demonstrated that the modified Aegis Catheter functions as safely and effectively as previously approved devices.
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
KC24058
DEC 3 0 2002
510(k) SUMMARY
510(k) number:
This summary of information is being provided for the modified Aegis Catheter 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: | 6 December 2002 |
| Device Trade Name: | Cardeon® Aegis™ Catheter |
| Device Common Name | Catheter, cannula and tubing, vascular, cardiopulmonary |
| Regulation No.: | bypass 870.4210 |
| Classification / Code: | Class II / DWF |
Indications for Use: The Cardeon® Aegis™ Catheter is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours.
The modified Aegis Catheter is substantially Summary of Substantial Equivalence: equivalent to the original Aegis Catheter and currently marketed devices with regard to intended use/indications, device performance and technological characteristics. These devices are used to directly cannulate the aorta and return perfusion to patients undergoing general cardiac surgery through standard connections to the extracorporeal circuit. Substantial equivalence is supported through comparison with several marketed devices with the same indications for use, including arterial return cannulae with directed flow (specified flow pattern). Differences between the Aegis Catheter and other devices do not alter or diminish the rate of arterial return required during cardiopulmonary bypass. Based on comparisons to premarket devices, the modified Aegis Catheter is substantially equivalent to the original Aegis Catheter and currently marketed devices.
Product Testing: The determination of substantial equivalence was also based on tests of biocompatibility, in vitro and/or in vivo performance conducted for the original and modified Aegis devices. Results of product testing demonstrated that the modified Aegis Catheter functions as safely and effectively as previously approved devices.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a bird or a stylized human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2002
Cardeon Corporation c/o Ms. Jane Beggs Vice President, Regulatory Affairs 10161 Budd Road Cupertino, CA 95014
Re: K024058
Trade Name: Cardeon® Aegis™ Catheter Regulation Number: 21 CFR 870.4210 Regulation Name: Vascular Catheter, Cannula, Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: December 6, 2002 Received: December 9, 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.
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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 (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. 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), 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 vours.
W. Dalton
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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
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Page 1 of 1
Device Name: Cardeon® Aegis™ Catheter
Indications for Use:
:
The Cardeon Aegis™ Catheter is intended to perfuse the aorta during open chest procedures on cardiopulmonary bypass up to 6 hours.
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 | K024058 |
|---|---|
| --------------- | --------- |