(26 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 is a 510(k) summary for the Cardeon Aegis Catheter. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, not on presenting detailed acceptance criteria and a human-readability study as would be typical for AI/ML device evaluations.
Therefore, most of the requested information regarding acceptance criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available or applicable in this document. This document describes a traditional medical device (a catheter), not a software or AI/ML device, so the requested format does not align with the information provided.
However, I can extract the following based on the available text:
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A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the format of a table with specific performance metrics and acceptance criteria. The submission states that "Results of product testing demonstrated that the Aegis Catheter functions as safely and effectively as predicate devices." This is a general statement of performance rather than specific, quantifiable acceptance criteria.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable/not provided. The submission refers to "product testing," which included "biocompatibility, in vitro and/or in vivo performance." However, specific sample sizes, study methodologies (retrospective/prospective), or data provenance are not detailed as they would be for an AI/ML device's test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable/not provided. 'Ground truth' in the context of an AI/ML device typically refers to expert-labeled data. For a physical device like a catheter, performance is assessed through engineering tests and potentially animal or human clinical trials, where 'ground truth' doesn't fit the same paradigm.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided. This refers to consensus-building among experts for labeling data, which is not relevant for this type of device submission.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable/not provided. MRMC studies are specific to AI-assisted diagnostic or interpretive devices, which this catheter is not.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This refers to AI algorithm performance without human intervention, which is irrelevant for a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. As mentioned, the concept of 'ground truth' in this context doesn't align with AI/ML device evaluation. The assessment of this catheter's safety and effectiveness would rely on engineering specifications, biocompatibility testing results, and comparison to predicate devices' established safety and performance profiles.
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The sample size for the training set: Not applicable/not provided. This device is not an AI/ML model, so there is no "training set."
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How the ground truth for the training set was established: Not applicable/not provided.
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510(k) SUMMARY
510(k) number: K022174
This summary of information is being provided for the modified Aegis Catheter in accordance with 21 CFR 807.92(a).
| Applicant Information: | Cardeon Corporation10161 Bubb RoadCupertino, CA 95014 |
|---|---|
| Contact Person: | Jane BeggsRegulatory AffairsCardeon Corporation |
| Date: | 15 July 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.
Summary of Substantial Equivalence: The modified Aegis Catheter is substantially 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 an assessment of original and modified Aegis devices. Tests for biocompatibility, in vitro and/or in vivo performance were conducted. Results of product testing demonstrated that the Aegis Catheter functions as safely and effectively as predicate devices.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2002
Cardeon Corporation c/o Ms. Jane Beggs Vice President, Regulatory Affairs 10161 Bubb Road Cupertino, CA 95014
Re: K022174 Trade Name: Cardeon® Aegis™ Catheter Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular Catheter, Cannula, or Tubing. Regulatory Class: Class II (two) Product Code: DWF Dated: July 2, 2002 Received: July 3, 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, listing 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 (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 vours.
Aepant Mayn
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1022174 510(k) Number (if known): _ K422474
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
OR
Over-the Counter Use _________
M.G. Van Meter for D.B. Tillman
Richard L. Moore
ion Sibn-Off Division of Cardiovascular and Respiratory Devices
510(k) Number K022174
§ 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).