(21 days)
The Cardeon® Aegis™ Catheter is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours.
Not Found
The provided text describes a 510(k) summary for the Cardeon® Aegis™ Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study report with performance metrics.
Here's an analysis of the information available, structured according to your request, with a necessary acknowledgement of missing data:
1. Table of Acceptance Criteria and Reported Device Performance
The submission for the Cardeon® Aegis™ Catheter does not explicitly state specific numerical acceptance criteria for performance. Instead, it relies on demonstrating "substantial equivalence" to predicate devices. The performance is assessed through "product testing" to show that the modified device "functions as safely and effectively as previously approved devices."
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated (implied: substantial equivalence to predicate devices in terms of safety and effectiveness) | "Results of product testing demonstrated that the modified Aegis Catheter functions as safely and effectively as previously approved devices." |
| Biological compatibility | Tested (mentioned in "Product Testing") |
| In vitro performance | Tested (mentioned in "Product Testing") |
| In vivo performance | Tested (mentioned in "Product Testing") |
| Device performance characteristics (e.g., flow pattern, rate of arterial return) | Differences between the Aegis Catheter and other devices "do not alter or diminish the rate of arterial return required during cardiopulmonary bypass." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "product testing" without these specifics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The submission does not mention the use of experts to establish ground truth for a test set in the context of this 510(k) summary. The evaluation appears to be based on engineering and biological testing, comparing the device against established performance characteristics of predicate devices, rather than an expert-driven assessment of diagnostic accuracy.
4. Adjudication Method for the Test Set
As no expert-based ground truth establishment is described, there is no mention of an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned. This type of study is more common for diagnostic devices where human reader performance is a key metric. The Aegis Catheter is a surgical device, and its evaluation focuses on its physical and biological performance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The concept of a "standalone" algorithm performance is not applicable here as the Aegis Catheter is a physical medical device, not an algorithm. The "Product Testing" mentioned would be considered the standalone performance evaluation of the device itself.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance relies on engineering specifications, direct measurements of physical properties (e.g., flow rate), and biological compatibility testing to ensure it meets the requirements for its intended use and is comparable to predicate devices. It is not an "expert consensus," "pathology," or "outcomes data" in the typical sense for a diagnostic device. The ground truth essentially is that the device performs its intended mechanical and biological functions safely and effectively as demonstrated through testing.
8. The Sample Size for the Training Set
As this is a physical medical device and not an AI/ML algorithm that requires training data, there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
Summary of Device and Study Focus:
The K024058 submission for the Cardeon® Aegis™ Catheter is a 510(k) premarket notification. The primary goal of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
The "study" described is a series of "product testing" efforts, including biocompatibility, in vitro, and in vivo performance tests. These tests were conducted for both the original and modified Aegis devices to confirm that the modified device's performance aligns with the original and other marketed devices. The level of detail on specific test parameters, sample sizes, and quantitative results is typical for a 510(k) summary (i.e., often not fully elaborated in the public summary document). The FDA's decision to grant substantial equivalence indicates that the information provided (which would have been more detailed in the full submission, not just the summary) was sufficient to meet their requirements.
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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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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 |
|---|---|
| --------------- | --------- |
§ 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).