(237 days)
The Cardeon® Aegis™ Catheter is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours.
Catheter, cannula and tubing, vascular, cardiopulmonary bypass
The provided text does not contain detailed information about specific acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment for the Cardeon Aegis™ Catheter in the way requested in the prompt. The document is a 510(k) summary and an FDA clearance letter, which typically focus on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report with the requested metrics.
The document states:
- Substantial Equivalence: "The determination of substantial equivalence was also based on an Product Testing: assessment of device biocompatibility, in vitro and in vivo performance. Results of product testing demonstrated that the Aegis Catheter functions as safely and effectively as a predicate devices."
- Performance Claim: "Differences between the Aegis Catheter and other devices do not alter or diminish the rate of arterial return required during cardiopulmonary bypass."
However, it does not provide the granular details requested in the prompt about specific acceptance criteria or the study that proved the device met them. It generally states that testing demonstrated safety and effectiveness compared to predicate devices.
Therefore, I cannot fully populate the requested table and answer all the questions based on the provided text.
Based on the provided text, here is what can be extracted and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Not Explicitly Stated, Inferred from "Substantial Equivalence") | Reported Device Performance |
|---|---|
| Biocompatibility: Device is biocompatible. | Demonstrated biocompatibility. |
| In vitro performance: Device functions effectively in vitro. | Demonstrated effective in vitro performance. |
| In vivo performance: Device functions effectively in vivo. | Demonstrated effective in vivo performance. |
| Rate of arterial return: Does not alter or diminish the rate of arterial return required during cardiopulmonary bypass. | Does not alter or diminish the rate of arterial return. |
| Safety and Effectiveness: Functions as safely and effectively as predicate devices. | Functions as safely and effectively as predicate devices. |
Note: The document emphasizes substantial equivalence to predicate devices and general statements about biocompatibility and performance rather than specific, quantitative acceptance criteria that would typically be found in a detailed study report.
Study Details
- Sample sizes used for the test set and the data provenance: Not specified in the provided text. The document mentions "in vitro and in vivo performance" testing but does not provide details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified in the provided text. This type of information is typically related to diagnostic devices or image analysis, not physical medical devices like catheters, where "ground truth" might be established through direct measurement or observation during testing.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not specified. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, not for performance testing of a physical medical device like this catheter.
- 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. This study type is for AI/diagnostic devices and involves human readers assessing cases. The Cardeon Aegis™ Catheter is a physical device for perfusion.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This study type is for AI/diagnostic devices. The Cardeon Aegis™ Catheter is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated in the context of "ground truth" as typically defined for AI/diagnostic devices. For this type of device, "ground truth" would likely refer to objective measurements of flow rates, pressure, material integrity, and biocompatibility observed during in vitro and in vivo testing, often compared against established medical standards or predicate device performance.
- The sample size for the training set: Not applicable. Training sets are for machine learning algorithms. The Cardeon Aegis™ Catheter is a physical medical device.
- How the ground truth for the training set was established: Not applicable.
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510(k) - Cardeon Aegis™ Catheter
APPENDIX G
JUN 2 4 2002
510(k) SUMMARY
510(k) number:
This summary of information is being provided in accordance with 21 CFR 807.92(a).
| Applicant Information: | Cardeon Corporation10161 Bubb RoadCupertino, CA 95014 |
|---|---|
| Contact Person: | Jane BeggsRegulatory AffairsCardeon Corporation |
| Date: | 29 October 2001 |
| Device Trade Name: | Cardeon® Aegis™ Catheter |
| Device Common Name | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| Regulation No.: | 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 Aegis Catheter is substantially equivalent to currently marketed devices used to directly cannulate the aorta and return perfusion to patients undergoing general cardiac surgery. Perfusion is achieved 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 currently marketed devices and device performance testing. the Cardeon Aegis Catheter is substantially equivalent to predicate devices with regard to intended use/indications, device performance and technological characteristics.
The determination of substantial equivalence was also based on an Product Testing: assessment of device biocompatibility, in vitro and in vivo performance. Results of product testing demonstrated that the Aegis Catheter functions as safely and effectively as a predicate devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2002
Cardeon Corp. c/o Ms. Jane Beggs 10161 Bubb Road Cupertino, CA 95014
Re: K013593
Cardeon® Aegis™ Catheter Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: 74 DWF Dated: May 3, 2002 Received: May 6, 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dr. Tiller, Ph.D.
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kols593
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
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 | ||
|---|---|---|---|---|
| ------------------ | -- | ---- | ---------------------- | -- |
(Division Sign-Off)
Division of Cardiovascular and Respiratory Devices
| 510(k) Number | K013593 |
|---|---|
| --------------- | --------- |
§ 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).